capa problem solving tool

Staying on the Journey to Success: How CAPA Can Sustain Your Organization

By Andy Marker | January 30, 2018 (updated July 21, 2021)

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Experience, training, and sound procedures in your facility may mean that problems rarely arise. But, what about when they do? CAPA , or corrective action and preventive action , can provide a structure for finding the root cause of problems, solving those problems, documenting the conditions and solutions for the future, and looking for potential problems and their solutions. Corrective actions are often used in HR and other manufacturing contexts, but other industries may also be required by the Food and Drug Administration (FDA) to document CAPA processes and then follow the processes if a problem occurs — especially food processing or pharmaceutical and medical device manufacturing.

This article covers the important differences between corrective action and preventive action. It discusses CAPA within ISO 9001 and within the regulation FDA 21 CFR 820 and outlines how and what data sources serve users well in preventive action analysis. In addition, a CAPA consultant discusses how the essential tool, CAPA, can provide lasting support to your company.

What Is Corrective and Preventive Action?

Corrective and preventive actions are processes for identifying, documenting, and addressing defects, deficiencies, and nonconformities.

“CAPA is the immune system of your organization,” explains Nathan Conover, President of the consulting and training firm Pathwise . “It’s a system by which you can identify deviations or quality events, investigate them, and implement corrective and/or preventive actions to improve your organization,” he adds.

What Is CAPA?

CAPA is the abbreviation for corrective action and preventive action. These two aspects of CAPA have traditionally been connected, but are ideally are only distantly related. Here is the main difference between the two:

• Corrective Action: Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to prevent recurrence.
• Preventive Action: Identification and elimination of the cause(s) of potential nonconformities in order to prevent occurrence.

In standards such as ISO 9000 and FDA 21 CFR 820, the description of preventive action follows directly after the description of corrective action, which has led to the misconception that the two processes must work together in series. In fact, they are separate, and preventive action ideally precedes corrective action to prevent or avoid the need for corrective action.

CAPA processes are used particularly in food processing, medical device development and manufacturing, and pharmaceuticals. FDA 21 CFR 820 is the quality system regulation that requires corrective and preventive procedures to be documented in medical device manufacturing facilities.

Corrective and preventive actions also have a place in the quality management process as defined in the Project Management Book of Knowledge (PMBOK). Corrective and preventive action is also considered a tool within Six Sigma for understanding regular business operations. CAPA has strong parallels with Design for Six Sigma (DFSS) , used to design new products or redesign existing products. The analytical aspects of both corrective and preventive actions also harken back to PDCA . The component of preventive action that encourages documentation and company education on innovations and lessons learned is similar to Yokaten in lean manufacturing.

What Is the Difference between Corrective Action and Preventive Action?

Corrective is reactive. Preventive is proactive. Although these two actions use similar processes and some of the same analytical tools, they are not necessarily used together.

What Is the Meaning of Corrective Action?

Corrective action involves the identification, documentation, and elimination of the root cause of a nonconformity or problem to prevent the problem from recurring. Corrective actions are taken under more intense consideration than corrections (which address immediate issues), and you typically enact corrective actions over a slightly longer time period to prevent recurrence. For example, if you put a bucket under a leaking garburator, that’s a correction. If you inspect the entire sink and drain, learn that the unit repeatedly leaks and blocks because of a damaged seal and joint, and then remove and replace the garburator with an effective garburator that will not leak or clog, that’s a corrective action.

Most corrective action procedures use a variation of 8D problem solving. The following are some of the types of steps in a corrective or problem solving process:

• Promptly identify and document the problem. Use 5 Why questioning to acquire details and determine if this is an isolated event or if it is significant and has the potential to recur. Reporters may indicate that the problem is pervasive, but it may be limited. When documented, quality events should be reported to management. The 5 Why template below will help you identify the root cause of a problem.

Download 5 Whys Template

Excel  |  Word  | Smartsheet

• Implement a correction or containment or temporary repair. This may include removing a defective item from production.
• Find the cause of the issue. Use 5 Whys to help pinpoint a problem statement. Use an Affinity or Ishikawa (fishbone) diagram to help determine the root cause. You can use the free Ishikawa diagram template below to get started.

‌ Download Fishbone Diagram Template - Excel

• Determine the solution that will prevent a recurrence. Solutions can include new parts, process changes, and even system changes.
• Implement the corrective action and ensure that everything is documented.
• Verify that the action continues to be effective and that the problem does not recur. Document the evidence of continued success.

Risk-Based Prioritization

Along with the defined corrective action procedures, a predefined risk-based prioritization eliminates small nonconformities that teams can solve when they discover problems without initiating corrective procedures. Weight matrices help with these questions  — the criteria often include frequency (frequently, occasionally, or rarely) and impact (negligible, critical, or even resulted in injury or death). Safety usually trumps frequency in action response.

What Is Preventive Action in ISO?

Until the release of ISO 9000:2015, preventive action was one of the few mandatory procedures required by ISO 9001. Companies were also required to keep records on nonconformities and preventive actions taken. However, some practitioners considered the standard to be unclear regarding where to look for potential problems. Pundits explained that preventive actions concerned risk and directed practitioners to ISO 9004, “managing for the sustained success of an organization — a quality management approach,” which was considered a pointer to what preventive actions should address.

ISO 9000:2015 eliminates the requirement for predefined procedures for both corrective action and preventive action. In fact, preventive action is now considered a part of good planning and risk management. It fully incorporates the notion that prevention comes first and eliminates problems and, thereby, the need for corrective action. As of 9001:2015, you simply document what happened and how you fixed it. Following are the essential CAPA-related definitions:

• Correction or Immediate Action: This eliminates the immediate problem. It doesn’t eliminate the issue permanently, but it allows a process or work to continue. In PMBOK, correction is also known as defect repair . An example of this process is mopping up water and adding a bucket under the leak.
• Corrective Action: This eliminates the cause of the nonconformity and prevents repetition. Corrective actions move products, procedures, processes, and projects back to baselines. On a large scale, corrective action is necessary if a project moves away from the project management golden triangle of budget, schedule, and quality. An example of corrective action would be investigating the sink, drain, and supply system, learning that the garburator backed up twice before, replacing the garburator, and confirming that nothing leaks.
• Preventive Action: This prevents potential occurrences. Preventive action determines what in a project might veer away from the project management golden triangle of budget, schedule, or quality. An example of this process would be checking the other garburator in another sink as well as U traps in two other sinks for existing problems and asking if any parts should be replaced now before they fail.

The following are tools that you can use to analyze risk or potential problems:

• Hazard and Operability Study (HAZOP): A HAZOP is a sequenced and methodical study of a process that is in development or in operation. The HAZOP seeks to identify problems that may represent risks to personnel or equipment.
• Failure Modes and Effects Analysis (FMEA): FMEA is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. Failure modes means the ways (or modes) in which something might fail.
• Fault Tree Analysis (FTA): FTA is commonly used in safety and reliability engineering to break a system into subsystems to understand where problems may occur. FTA is often used in pharmaceutical development and manufacturing.

What Is a Preventive Action Process?

A preventive action process , in addition to including a specific preventive action plan to mitigate potential problems, also comprises the implementation of controls to ensure that any preventive measures continue to work. Preventive action means identifying not only potential problems, but also opportunities for improvement. With changes that are enacted through a preventive action process, controls should be included to prevent and check for possible nonconformities.

What Is an Example of Preventive Control?

A preventive control , also known as an internal control , serves to reduce the chances of problems and nonconformities that occur. Although many fields employ them, preventive controls form a particularly important part of food preparation quality control. Under the FDA’s Food Safety Modernization Act (FSMA), for example, certain food preparation facilities must write a food safety plan, which begins with a hazard analysis and addresses specific types of controls. For instance, among other preventive controls, food preparation must include allergen tracking, and packaging must be labelled appropriately. However, preventive controls can be as simple as employees washing their hands and segregating utensils used for raw foods. The FSMA lists corrections and corrective actions as a management aspect of preventive controls to be implemented in quality events, such as when a deviation from a preventive control occurs. The practice of preventive controls for food safety even has its own professional support group, the Food Safety Preventive Controls Alliance ( FSPCA ).

Approaches to Preventive Analysis and Actions

One complaint with regard to CAPA in ISO 9000 was that it was vague about how possible problems might be found. So, where do you look for for possible problems? Think about what could go wrong.

According to Conover, “It’s when you’re in production. That’s when all the unanticipated risks typically occur. It’s where you think, ‘Oh my gosh, we didn’t anticipate that this would happen.’” He says that’s why the analogy to a human immune system is strong: “Your immune system reacts to antigens that are unknown or toxic to the body. Once the antigens are discovered, [your immune system] applies antibodies. In the future, in some cases, T-cells will selectively recognize previously known antigens and minimize any effect. Just like with CAPA, those things that happen in pre-production, production, or post-production should have corrective and/or preventive actions that ensure that they do not occur or recur,” he emphasizes.

Teams may find potential problems in internal or external data sources. Internal data sources may include process control data, trend analysis, the results of proficiency testing, or internal audits. External data includes customer complaints, service reports, and even data for similar products produced by other companies.

Risk analysis should be done when you adopt new tools or software. Preventive actions may also be sparked through the results of regularly assessing employees and then deciding if more or revised training is required. Risk analysis can help target costs, so the exercise doesn’t appear to be a waste of money when problems don’t occur. FMEA is one tool to view potential problems.

Here are some examples of preventive actions:

• Creating disaster recovery plans for hazards and unexpected situations throughout your facility
• Implementing or updating safety and security policies
• Creating checklists
• Implementing lean practices to reduce waste that can contribute to problems and nonconformities
• Implementing and following preventive maintenance plans to ensure that equipment performs efficiently, effectively, and safely

Some experts still think that preventive actions follow the experience of corrective actions. This sensible approach focuses on capturing the experience for the future, including tagging keywords from the action report in databases and updating documents, such as FMEA, requirements documents, and procedures.

What Is 21 CFR 820?

21 CFR 820 stands for Title 21 Code of Federal Regulations 820. Title 21 governs food and drugs for the FDA. CFR 820 is the quality system regulation that applies to manufacturers of medical devices. 21 CFR 820 borrows heavily from ISO 9000: It requires facilities to create and maintain procedures for implementing corrective and preventive actions so that employees can address problems with devices currently or imminently on the market.

A well-defined CAPA process, or subprocess , as the FDA calls it, provides structure for accomplishing three things:

• Gathering and analyzing information to find existing and potential problems and nonconformities
• Observing quality issues and applying effective corrective or preventive actions as needed
• Ensuring that corrective and preventive actions have been effective

In the FDA’s view, a CAPA process also provides a structure for communicating CAPA activities to employees, reporting to management, and documenting activities for review and future improvement purposes.

The CAPA concept is also integral to the Current Good Manufacturing Process (cGMP), an approach advocated by the FDA. CAPA may be applied to a variety of aspects of product development, such as design, production, product testing, and post-market use. CAPA may also be applied in product packaging, distribution, and shipping.

Questions in a CAPA Inspection

When the FDA inspects your facility, it may seek to ensure that you have documented CAPA procedures and make sure that they contain certain elements. For example, your records should show that you could find the root cause of problems and that you are tracking trends to ensure you avoid future problems or recurrences of problems. Investigators also look for evidence that you tested CAPA actions to ensure effectiveness before you implemented them. Moreover, the FDA wants to verify that the data source and statistical process methods you employed were sufficient for the task.

What Is a CAPA Report?

A CAPA report provides a consistent vehicle for recording defects and issues as well as the method of their correction. Usual details include where the problem occurred, the customer’s name and address, the details of the problem, whether there was a product breakdown, whether there was an injury, and so on. The report also states what immediate action or correction was taken. The report may walk you through the process, suggest tools for the root cause analysis (such as 5 Whys and cause and effect analysis), and provide room to record analysis results. It may also provide guidance on how to route the report depending on the outcome of the analysis.

You can use the free template below to create a CAPA report.

Download CAPA Report Template

Misconceptions About CAPA

Although regulations may require organizations to document CAPA processes and follow them during quality events, and tons of web content exists concerning how to implement CAPA, employees and managers often harbor the following doubts and misconceptions about CAPA:

• It’s a Punishment because Something Has Gone Wrong: For the health of a company, someone has to implement the CAPA process. Training a dedicated CAPA team can help to depersonalize CAPA assignments.
• It’s Extra Work: “When everybody has a part-time job of being an investigator, typically nothing changes,” says Conover. He gives the example, “‘You’re a QE and, by the way, in your spare time, which you don’t have, you’re an investigator.’” In that scenario, he says, the extra work remains undone. The solution is to establish a review board with people trained in appropriate roles so that CAPA becomes a regular responsibility.
• Training Is Too Expensive: Management often complains that neither budgets nor schedules offer resources for training employees in the efficient execution of CAPA. You can save money by having the process in place. You should also ask yourself how much it costs to have a product recalled. “Here are our biggest comments: We don’t have time to train. We don’t have the money to train. There's no budget. I can’t pull people off the floor for a day and a half,” says Conover. The bottom line? “Organizations that train are the ones that sustain, and those that don’t won’t survive beyond five, 10, or 15 years,” he concludes.

Software Solutions for CAPA

The many details and documents necessary for a good quality management system are represented in CAPA. Although software can’t make up for a poor CAPA procedure or lack of follow through, a strong platform can help track the many updates that should be added to assorted documents. Software can also support documentation and audit trail requirements for the FDA’s GMP, GLP (good laboratory practice), and GCP (good clinical practice). With a web-based system, authorized users can access a central repository to get all the documents and information they require. Online templates and automated workflows provide routing, notification, and electronic approval. Finally, software can help with analytics and reporting.

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Virtual Leaders Academy

CAPA Tools in Problem Solving: Mastering Continuous Improvement

Corrective and Preventive Actions (CAPA) tools serve as invaluable instruments, allowing organizations to identify, analyze, and eliminate the root causes of problems. This comprehensive exploration delves into the world of CAPA tools, understanding their significance, exploring various types, and elucidating their role in fostering a culture of continuous improvement.

Understanding CAPA Tools

What is CAPA?

Corrective and Preventive Actions, commonly abbreviated as CAPA, is a systematic approach to solving problems, identifying the root causes of issues, and implementing measures to prevent their recurrence. It’s a vital component of quality management systems, ensuring that organizations not only address existing problems but also proactively work to prevent similar problems in the future.

The Significance of CAPA Tools

CAPA tools are designed to provide a structured framework for problem-solving. They enable organizations to:

• Identify Problems : CAPA tools facilitate the identification of problems or discrepancies in processes, products, or services.
• Investigate Root Causes : These tools help in conducting in-depth investigations to identify the underlying causes of the problems.
• Implement Corrective Actions : CAPA tools guide the implementation of immediate corrective actions to address the existing issues promptly.
• Develop Preventive Actions : By understanding the root causes, organizations can develop preventive actions to stop similar issues from occurring in the future.
• Monitor and Review : CAPA tools assist in monitoring the effectiveness of the implemented actions and reviewing their impact on the overall process or system.

Types of CAPA Tools

• Fishbone Diagram (Ishikawa Diagram) : This graphical tool is instrumental in identifying and categorizing potential causes of a problem. It helps in visualizing the various factors contributing to an issue, making it easier to identify root causes.
• 5 Whys Technique : Rooted in simplicity, the 5 Whys technique involves asking “why” repeatedly until the root cause of a problem is identified. It’s a powerful tool to uncover deeper issues beyond surface-level symptoms.
• Failure Mode and Effects Analysis (FMEA) : FMEA is a systematic method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures. It prioritizes failure modes and guides corrective and preventive actions.
• Pareto Analysis : As previously discussed, Pareto Analysis helps in identifying the vital few causes that contribute the most to a problem. It assists in prioritizing efforts and resources to address the most significant issues.
• Control Charts : Control charts are graphical representations of processes over time. They help in identifying patterns, trends, and abnormalities in processes, enabling organizations to take corrective actions when necessary.

Implementing CAPA Tools Effectively

• Clear Documentation : Proper documentation of the problem, investigation process, identified root causes, and implemented actions is crucial. Clear documentation ensures that everyone involved understands the issue and the steps taken to address it.
• Cross-Functional Teams : In complex issues, involving cross-functional teams with diverse expertise can provide a well-rounded perspective. Different viewpoints can aid in comprehensive problem analysis.
• Data-Driven Decisions : CAPA tools rely heavily on data. Ensuring that the data collected is accurate, relevant, and comprehensive is vital for making informed decisions and implementing effective solutions.
• Continuous Monitoring : Implementing CAPA is not a one-time task. Continuous monitoring and regular reviews are essential to ensure that the implemented actions are effective and that new issues are promptly addressed.
• Employee Training and Engagement : Training employees in the proper use of CAPA tools and fostering a culture of engagement where employees feel comfortable reporting issues is essential. Employees are often the first to notice problems and can provide valuable input during the CAPA process.

Real-World Applications of CAPA Tools

• Healthcare Industry : In healthcare, CAPA tools are utilized to address patient safety incidents, medical errors, and regulatory compliance issues. They help healthcare providers in identifying the causes of adverse events and implementing measures to prevent their recurrence.
• Manufacturing and Quality Control : Manufacturing industries employ CAPA tools to identify defects in products and processes. By addressing these defects, manufacturers enhance product quality and reduce waste, ultimately saving costs.
• Information Technology : IT companies use CAPA tools to investigate software bugs, system failures, and security breaches. Rapid identification and resolution of these issues are critical in maintaining the reliability and security of IT systems.
• Pharmaceutical Sector : Pharmaceutical companies rely on CAPA tools to ensure product quality, compliance with regulations, and patient safety. CAPA processes are essential in addressing deviations in manufacturing processes and preventing the distribution of faulty products.
• Food and Beverage Industry : Ensuring food safety is paramount in this industry. CAPA tools help in identifying and rectifying issues related to food contamination, processing errors, and quality control, safeguarding consumers’ health.

Challenges and Considerations in Implementing CAPA Tools

• Resistance to Change : Implementing CAPA tools often requires a cultural shift within an organization. Resistance to change can hinder the adoption and effectiveness of these tools.
• Resource Allocation : CAPA processes can be resource-intensive, requiring time, expertise, and technology. Allocating sufficient resources while balancing other organizational needs is a challenge.
• Compliance and Regulations : Industries such as healthcare and pharmaceuticals need to adhere to stringent regulations. Ensuring that CAPA processes comply with these regulations adds complexity to the implementation.
• Complex Systems : In intricate systems, identifying the root cause of a problem can be challenging due to numerous interconnected components and variables. Simplifying the problem without oversimplifying it is a delicate balance.
• Data Integrity : Ensuring the integrity and accuracy of the data used in CAPA processes is crucial. Inaccurate data can lead to misguided analyses and ineffective solutions.

Corrective and Preventive Actions (CAPA) tools represent a cornerstone in the realm of quality management and continuous improvement. In a world where problems are inevitable, the ability to identify their root causes and implement effective solutions is a hallmark of successful organizations. By employing diverse CAPA tools, understanding their nuances, and fostering a culture of problem-solving, industries can not only address existing issues but also proactively prevent future challenges. In essence, the effective implementation of CAPA tools transforms problems from obstacles into opportunities, propelling organizations toward excellence and sustained growth.

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7 Powerful Problem-Solving Root Cause Analysis Tools

The first step to solving a problem is to define the problem precisely. It is the heart of problem-solving.

Root cause analysis is the second important element of problem-solving in quality management. The reason is if you don't know what the problem is, you can never solve the exact problem that is hurting the quality.

Manufacturers have a variety of problem-solving tools at hand. However, they need to know when to use which tool in a manner that is appropriate for the situation. In this article, we discuss 7 tools including:

• The Ishikawa Fishbone Diagram (IFD)
• Pareto Chart
• Failure Mode and Effects Analysis (FMEA)
• Scatter Diagram
• Affinity Diagram
• Fault Tree Analysis (FTA)

1. The Ishikawa Fishbone Diagram IFD

The model introduced by Ishikawa (also known as the fishbone diagram) is considered one of the most robust methods for conducting root cause analysis. This model uses the assessment of the 6Ms as a methodology for identifying the true or most probable root cause to determine corrective and preventive actions. The 6Ms include:

• Measurement,
• Mother Nature- i.e., Environment

Related Training: Fishbone Diagramming

2. Pareto Chart

The Pareto Chart is a series of bars whose heights reflect the frequency or impact of problems. On the Chart, bars are arranged in descending order of height from left to right, which means the categories represented by the tall bars on the left are relatively more frequent than those on the right.

Related Training: EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS (CAPA) Establishing and resolving the root causes of deviations, problems and failures

This model uses the 5 Why by asking why 5 times to find the root cause of the problem. It generally takes five iterations of the questioning process to arrive at the root cause of the problem and that's why this model got its name as 5 Whys. But it is perfectly fine for a facilitator to ask less or more questions depending on the needs.

Related training: Accident/Incident Investigation and Root Cause Analysis

4. Failure Mode and Effects Analysis (FMEA)

FMEA is a technique used to identify process and product problems before they occur. It focuses on how and when a system will fail, not if it will fail. In this model, each failure mode is assessed for:

• Severity (S)
• Occurrence (O)
• Detection (D)

A combination of the three scores produces a risk priority number (RPN). The RPN is then provided a ranking system to prioritize which problem must gain more attention first.

Related Training: Failure Mode Effects Analysis

5. Scatter Diagram

A scatter diagram also known as a scatter plot is a graph in which the values of two variables are plotted along two axes, the pattern of the resulting points revealing any correlation present.

To use scatter plots in root cause analysis, an independent variable or suspected cause is plotted on the x-axis and the dependent variable (the effect) is plotted on the y-axis. If the pattern reflects a clear curve or line, it means they are correlated. If required, more sophisticated correlation analyses can be continued.

Related Training: Excel Charting Basics - Produce Professional-Looking Excel Charts

6. Affinity Diagram

Also known as KJ Diagram, this model is used to represent the structure of big and complex factors that impact a problem or a situation. It divides these factors into small classifications according to their similarity to assist in identifying the major causes of the problem.

7. Fault Tree Analysis (FTA)

The Fault Tree Analysis uses Boolean logic to arrive at the cause of a problem. It begins with a defined problem and works backward to identify what factors contributed to the problem using a graphical representation called the Fault Tree. It takes a top-down approach starting with the problem and evaluating the factors that caused the problem.

Finding the root cause isn't an easy because there is not always one root cause. You may have to repeat your experiment several times to arrive at it to eliminate the encountered problem. Using a scientific approach to solving problem works. So, its important to learn the several problem-solving tools and techniques at your fingertips so you can use the ones appropriate for different situations.

ComplianceOnline Trainings on Root Cause Analysis

P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3 This webinar will define what are the US FDA's expectation for Production and Process Control / Product Realization, the use of statistical tehniques, 6 sigma, SPC, for establishing, controlling , and verifying the acceptability of process capability and product characteristics, product acceptance or validation and other studies. Non-conformance, OOS, deviations Failure Investigations, and Root Cause Analysis, PDCA, DMAIC, and similar project drivers to improvement, A# and similar dash boards.

Accident/Incident Investigation and Root Cause Analysis If a major workplace injury or illness occurred, what would you do? How would you properly investigate it? What could be done to prevent it from happening again? A properly executed accident/incident investigation drives to the root causes of the workplace accident to prevent a repeat occurrence. A good accident/incident investigation process includes identifying the investigation team, establishing/reviewing written procedures, identifying root causes and tracking of all safety hazards found to completion.

Root Cause Analysis - The Heart of Corrective Action This presentation will explain the importance of root cause analysis and how it fits into an effective corrective and preventive action system. It will cover where else in your quality management system root cause analysis can be used and will give examples of some of the techniques for doing an effective root cause analysis. Attendees will learn how root cause analysis can be used in process control.

Addressing Non-Conformances using Root Cause Analysis (RCA) RCA assumes that systems and events are interrelated. An action in one area triggers an action in another, and another, and so on. By tracing back these actions, you can discover where the issue started and how it grew into the problem you're now facing.

Risk Management Under ISO 14971 ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.

Introduction to Root Cause Investigation for CAPA If you have reoccurring problems showing up in your quality systems, your CAPA system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your CAPA system will not be successful.

Root Cause Analysis and CAPA Controls for a Compliant Quality System In this CAPA webinar, learn various regulations governing Corrective and Preventive Actions (CAPA) and how organization should collect information, analyze information, identify, investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

How to Design and Implement a Dynamic Control Plan This webinar training will discuss how to design a dynamic control plan that combines FMEA and the control plan by extending the FMEA to encompass the elements of the control plan and create a living document that helps to drive continual improvement.

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.

The Use and Mis-use of FMEA in Medical Device Risk Management The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process. Most medical device manufacturers use FMEA as a part of their risk management system. Most medical device manufacturers use FMEA as a part of their risk management system.

Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm) Emphasis will be placed on realizing system interactions and cultural environment that often lies at the root of the problem and prevents true root cause analysis. This webinar will benefit any organization that wants to improve the effectiveness of their CAPA and failure investigation processes.

Root Cause Analysis for Corrective and Preventive Action (CAPA) The Quality Systems Regulation (21 CFR 820) and the Quality Management Standard for Medical Devices (ISO 13485:2003), require medical device companies to establish and maintain procedures for implementing corrective and preventive action (CAPA) as an integral part of the quality system.

Strategies for an Effective Root Cause Analysis and CAPA Program This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and describing the uses of CAPA data.

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Guide: Corrective and Preventive Actions (CAPA)

Author: Daniel Croft

What is CAPA?

CAPA is divided into two focuses:

Corrective Actions

Corrective actions target existing problems and  usually follow the following steps:

Step 1: Identification

Step 2: investigation.

Once an issue has been identified the next step is to understand the cause of the issue. Structured methods are usually used to understand the root cause of the issue that occurred in the first place.

Step 3: Action Plan

Step 4: review.

Finally, after the actions are implemented, there should be a review of the effectiveness of the actions. To understand if the actions sufficiently resolved the problem, if they did not the cycle should be repeated again until the issue is fully resolved.

Preventive Actions

Step 1: forecasting.

The first step in taking preventive action is to foresee ways in which potential issues might occur. This can involve looking at KPIs for trends, control charts behaviour, FMEA , SWOT analysis , customer feedback, and market trends.

Step 2: Risk Assessment

Through its systematic approach, CAPA is two-fold: It addresses current non-conformities via Corrective Actions and aims to reduce future risks through Preventive Actions. This guide provided you a structured walk-through of each stage in the CAPA process, ensuring your business is fully equipped to both tackle challenges and elevate its standards. So, it’s not just about compliance or ticking boxes; it’s about ingraining a culture of continuous improvement.

Q: What is the primary purpose of the CAPA process?

Q: how is a corrective action different from a preventive action, q: why is root cause analysis important in the capa process.

A: Root Cause Analysis (RCA) identifies the underlying reasons for an issue, rather than just addressing its symptoms. By understanding and addressing the root cause, organizations can implement more effective and long-lasting solutions.

Q: Is documentation crucial in CAPA? Why?

Q: what tools can be used for root cause analysis, q: how often should the effectiveness review be conducted.

A: The frequency of the Effectiveness Review can vary based on the severity of the initial issue and the industry’s regulatory standards. However, it’s generally advised to set regular intervals (e.g., monthly, quarterly) to ensure continued effectiveness of implemented actions.

Q: Why is it important to foster a blame-free environment in CAPA?

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Corrective and Preventive Action (CAPA): The Definitive Guide [2024]

“Insufficient corrective and preventive action procedures”   has consistently topped the list of most common FDA inspectional observations within the medical device industry since the fiscal year 2010.

Its prevalence as the top problem year after year makes it clear that many device companies have issues, both known and unknown, within their CAPA programs.

While the immediate compliance threats are obvious, less so are those that leave companies vulnerable to serious quality system issues that can grow and metastasize under the radar of their quality management system, putting both patients and their businesses at risk.

This guide tackles CAPA from a slightly different perspective than most are used to seeing in industry publications and seminars.

We’ve gathered insights from the quality and compliance experts who have seen it all and fixed it all firsthand. In addition to exploring the solutions that have proven to be effective in the field, we’ll also examine one, if not the , most pivotal component of CAPA: root cause analysis .

Table of Contents

Use the links below to jump around this guide.

CAPA 101: The Basics

What the fda expects from your capa process, root cause analysis: a practical perspective, an informed approach to addressing and preventing "human error", determining when capa is appropriate, how capa interfaces with your quality management system, the anatomy of an effective and compliant capa form, an adaptable capa model you can use, common capa problems to avoid, the value an expert third-party consultant can bring to your capa program.

• Get Expert Assistance

Since this guide is comprehensive, we suggest downloading our PDF version, which you can access, save, and use below.

The Guide to CAPA & Root Cause Analysis in FDA-Regulated Industries

Download the full white paper version of this guide below. It offers everything we cover here and more in a handy PDF you can use to assess and enhance your CAPA program.

Meet the Contributors

Watch our free CAPA webinar

What is CAPA?

According to the U.S. Food and Drug Administration (FDA) , corrective and preventive action aims to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent recurrence.

Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. 

Corrective and Preventive Action (CAPA) was first formally introduced by the U.S. Food and Drug Administration (FDA) in 2006 as a component of the Quality Systems Guidance. This guidance would go on to form the basis of the ICH Guideline Q10. Since then, it’s found its way into the EU GMP Guide, laying out the CAPA process within the pharmaceutical space.

For medical device companies, CAPA is addressed in ISO 13485, which, unlike Q10, divides the concept into its two concepts: “Corrective measures” (addressed in Chapter 8.5.2) and “Preventive measures” (addressed in Chapter 8.5.3). Despite separating  these processes, both must be documented and evaluated to demonstrate improvement and preventive action, making CAPA the practical process by which both are united. With this in mind, we’ll treat it as one concept here.

What is CAPA used for?

A CAPA procedure addresses deviations or problems that have already occurred and puts measures in place to avoid future deviations or problems. This entire process of analyzing errors, deviations, and their effects can— and should —be carried out as a component of broader risk assessment rooted in a well-defined and documented risk management program.

CAPA-triggering deviations can originate from a variety of sources within a quality management system, such as internal audits, customer feedback, or in the most serious cases, safety or security-related incidents that result in faulty products due to inadequate controls.

No matter why or where CAPA is initiated, it should always begin by identifying and taking immediate actions to stabilize the situation and limit its further effects. This is where an honest and accurate assessment of its severity is absolutely crucial. In the worst-case scenarios, this could mean an immediate halt to the production and distribution of all impacted products.

What does a typical CAPA process look like?

In most cases, a CAPA is executed much like a typical PDCA (Plan-Do-Check-Act) cycle:

• Begin with a detailed problem description by accurately evaluating and documenting it. Similar to the planning stage of the PDCA cycle, all CAPAs should start by describing the problem in detail, ensuring everything is documented accurately.
• Perform a root cause analysis. Once the problem is clearly defined, determine its root cause by performing a thorough root cause analysis.
• Implement, verify, validate, and document necessary corrective and preventive measures . This change should seek to remedy the root cause of the problem and ensure no further problems will occur. This could be a change in the production process, a training improvement, or another transformative measure.
• Check for effectiveness and evaluate success. Finally, the effectiveness and success of the measures implemented is checked and evaluated accordingly. Like with the “Act” phase of PDCA, this justifies whether and why the CAPA process was successful. If the CAPA process was not or only partially successful, another CAPA process must be initiated. A successful CAPA process may result in a re-evaluation or addition to the risk analysis.

The diagram below offers a simplified look at the general steps of CAPA. An adaptable model for CAPA is offered later in the paper.

Given the numerous inspectional observations citing insufficient established CAPA procedures, it’s worth revisiting what regulators expect to see from your process.

In a 2014 presentation , FDA’s Joseph Tartal described the basics of effective corrective and preventive action—a resource every company should use to evaluate against their own processes. Among many important points, one stands out as particularly useful when ensuring your procedure meets regulators’ expectations:

“Manufacturers should consider that their corrective action and preventive action documentation can demonstrate to FDA that the manufacturer’s quality system is effective and enables the manufacturer to identify problems quickly and implement effective corrective and preventive actions (or not).” — Brian Dense

In addition to helping manufacturers meet the broad expectations for effective CAPA, FDA also makes public its own inspectional guide , which lays out the specific objectives for investigators when evaluating a device company’s CAPA system and related documentation.

We’ve summarized its main points below.

This should serve as your ultimate preparedness checklist when evaluating your CAPA processes for compliance with FDA regulations.

Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.

Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.

Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.

Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate, and timely.

Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if the results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.

Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine the root cause (where possible). Verify that there is control for preventing the distribution of nonconforming product.

Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.

Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.

Verify that corrective and preventive actions for product and quality problems were implemented and documented.

Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.  

⚠️  A few action items to consider:

• Evaluate your current CAPA process on the criteria listed above.
• Highlight and remediate any gaps that exist between regulatory expectations and current processes.
• Follow up on all changes with the necessary documentation, training, or other actions needed to implement, support, and maintain those improvements.
• Note any gaps or improvements that require third-party assistance from a qualified CAPA professional and contact a firm to pair you with the appropriate resource.  

Need expert assistance with any of these considerations? Get in touch with us to discuss the best way to close gaps, ensure compliance, and enhance your CAPA program.

While much attention is given to the tools, techniques, and methodologies for “extinguishing the problem at the source,” much less attention is given to the fact that none of them will be effective if they aren’t implemented properly.

The factors for proper use boil down to two fundamentals every organization should immediately evaluate against and enhance if room for improvement exists:

Having the right team(s) in place to collect data and conduct the investigation in order to determine what factors should and shouldn’t be included in the analysis

Crystal clear communication with the proper measures in place to minimize bias and the role of inter-organizational politics in obstructing the free and open exchange of facts and ideas

Without these two fundamentals, even the best root cause analysis process will likely fail to properly identify and address the true root causes of the problems affecting your products and quality system.

Once a foundation is established on these two important pillars, turn your attention to the major challenges companies face in conducting root cause effectively.

• Challenge #1: Devoting too little time to investigating and determining the root cause of an issue
• Challenge #2: Simply restating the problem statement as the root cause of the problem
• Challenge #3: Not having a reliable set of tools and methods for carrying out an effective investigation
• Challenge #4: Failing to reference the tools you do use in your CAPA procedure, thereby opening the door to regulatory scrutiny

Since each company faces its own set of challenges, prescribing a universal set of solutions is impossible. A solution for one organization can end up introducing more problems when applied the same way in another.

It’s important to reiterate that this guide is intended to reveal the realm of possible solutions and improvements available to you—not compel you to use one or another. Given this frame, let’s explore a topic that’s familiar to many, but provides the critical foundation from which action is taken: root cause analysis .

“In many organization, politics are allowed to influence the CAPAs simply because there are too many people involved in the approval process—approval to actually open a CAPA, or approval to finish one. Very often there are too many people, or the wrong people, in the approval process. I’ve seen real problems get swept under the rug because somebody won’t approve the effort to go forward with it. I’ve also seen good solutions get shot down on real problems, because somebody didn’t want to spend the money or the time. I would be cautious about adding too many levels and too many people to the process.” — Brian Dense

A Brief Overview of Root Cause Analysis Methodologies

There are a number of reliable methodologies for analyzing root cause, however, not all are equally effective in every scenario. Applying the same methodology to every investigation can fail to go far or wide enough into the problem, undermining the entire effort.

While each methodology deserves to be thoroughly understood by those putting them to use, we’ve summarized the key takeaways for three of the most common models to help you choose the right one for a given scenario.

Fault Tree Analysis (FTA)

This deductive procedure is used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred to as top events) at the system level.

The generic example below was developed for sixsigmastudyguide.com's FTA explainer:

• Advantages: FTA values the judgment of experts from many disciplines and provides a common perspective on a given problem.
• Disadvantages: FTA relies on multiple expert opinions and judgments at various stages, making it prone to inaccuracy and bias. For larger systems, the quantitative analysis might be so complex, it requires computer algorithms to accomplish.
• Understanding the logic leading to a “top event” or undesired state
• Demonstrating compliance with system safety and reliability requirements
• Prioritizing multiple contributors which led to a top event or undesired state Recommended Applications
• Analyzing and forecasting system reliability, maintainability, and safety

Fishbone Diagram

Also called a “cause and effect” or “Ishikawa” diagram (among others), a fishbone diagram is a visual tool for looking at cause and effect. A problem or effect is displayed at the “head” or “mouth” of the fish, and possible contributing factors are listed on the “bones” under various cause categories. These models work best when the “head” of the fish contains a very detailed problem statement. This helps eliminate the scope creep of the team’s discussions. What happened? When? Where? These can help narrow the focus to solve the problem.

Here's an example pulled from tulip.co's explainer guide on the concept:

• Advantages: Fishbone diagrams are particularly useful for organizing potential causes, helping teams think through causes they might otherwise miss, and providing a living document that shows the status of all potential causes and whether they have been proved, disproved, or acted upon.
• Disadvantages: Fishbone diagrams are by nature a divergent approach to problem-solving, so they make it possible for teams to expend a lot of energy speculating about a potential cause that may have no effect on the problem.
• Directing a team to focus on identifying all possible categories and consider alternative causes
• Refocusing a team on the causes of a problem rather than the symptoms
• Improving product design
• Preventing quality defects
• Identifying potential factors causing an overall effect  

The 5 Whys is arguably the simplest technique for root cause analysis. It can be very effective when answers come from people with hands-on experience in examining the process. It is remarkably simple: when a problem occurs, you drill down to its root cause by asking “why?” five (or more) times. Then, when a countermeasure becomes apparent, you follow it through to prevent the issue from recurring.

• Advantages: This is essentially a simpler form of a fault tree analysis, making it a straightforward process when investigating specific accidents instead of chronic problems.
• Disadvantages: Results can be non-reproducible and inconsistent. For instance, two teams analyzing the same issue may reach a different solution. It also leaves the door open to stopping short of reaching the true root cause.
• Resolving simple or moderately difficult problems
• Resolving issues involving human factors
• Resolving issues where statistical analysis is not needed or possible  

The Importance of Cross-Functionality When Conducting Root Cause Analysis

Today, it’s common for organizations to place a high value on taking personal responsibility for quick problem resolution. While this value is rooted in good intention, placing the focus at least in part on speed must be done with extreme caution to ensure root causes are fully identified and resolved.

Speed, in this case, is a risky substitute for thoroughness. When this risk is ignored, the incentive to kick the can down the road to get it cleared and closed as fast as possible begins obstructing your ability to conduct a thorough investigation and analysis. Rather than resolving problems, they’re simply moved from one function to another in a dangerous game of hot potato.

Processes that give rise to problems are rarely localized to a single department or function. In many cases, the more complex a process is, the more functions it crosses. To truly resolve problems at their root—quickly and completely—a cross-functional group consisting of stakeholders from all inputs, work tasks, and outputs involved must be established to solve the problem from every angle.

To be reliably successful, root cause investigation and analysis must start by defining the process in which an issue (or issues) have arisen from one end to the other—evaluating all inputs, work done, and outputs being handed off to the next process. To do this effectively, knowledgeable representatives and owners from all functional areas must work together, including engineering, sales, quality, regulatory, etc. .

Cross-functionality is especially important given that the point at which a problem is detected is rarely where the root cause truly lies. The further upstream you need to travel to find it, the more you can expect to rely on the knowledge of other functions you’re led to when tracing the principal cause. This is where communication and cooperation between functions become critical. Without a cross-functional approach, assumptions made by one function conveniently replace the informed knowledge of another—leading to dangerous gaps in understanding how other steps in the process are impacted.

Creating a cross-functional team may slow down the process and ask more of those involved, but this added investment is often returned in the quality of the results it achieves.

• Evaluate the current methodologies and tools utilized when investigating the root cause.
• Determine whether current processes suffer from the challenges described and consider ways to overcome them.
• Determine how well current processes ensure the best methodologies and tools are selected from diverse options based on applicability to specific goals.
• Adjust processes as necessary to include currently unused methodologies and tools given staff are fully trained and confident in using them.
• Consider how prior problems could have been solved better if addressed with another methodology or tool and prepare to employ them if similar issues arise in the future.
• Evaluate your current root cause analysis process on its degree of cross-functionality.
• If needed, revise this process to incorporate more stakeholders from other functions.
• To accelerate problem resolution, establish the team’s assignment and timeline up-front.

Genuine human errors do happen, but they’re cited far more frequently than they should be. In truth, most problems that appear to be caused by human error— especially those that occur multiple times—are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them.

When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being investigated thoroughly enough, thereby shifting them into problem-hunting mode and opening your quality management system up to even greater scrutiny.

But what about the rare instances where one-time errors are made by otherwise well-trained personnel following well-defined processes? A moment of inattention due to a passing distraction can lead to serious problems. In these cases, the human error classification may be justified after a thorough investigation reveals nothing in every possible place there is to look. Again, this conclusion should never be jumped to as a convenient way to avoid the important work of problem-solving (as it often is). It should only be considered as a viable justification when every other possible cause has been exhaustively explored and eliminated.

Given this caveat, it’s helpful to arm yourself with a model for analyzing what might appear to be human errors in order to determine whether actions (or inactions) were deliberate or inadvertent. The outcome can help you determine whether or not human behavior really is to blame as well as where you might expect to find a problem elsewhere (such as inadequate training, poor SOPs, etc.) if the root cause appears to be less human than you initially thought upon further analysis.

Enter the Skills, Rules Knowledge/Generic Error Modeling System illustrated below. It’s relatively simple but offers a reliable way to tease out genuine human errors from other problems while pulling real human errors apart even further to reveal their motivating factors.

Following this model, errors that are shown to be “inadvertent” can be considered genuinely “human”, which then fall into one of three categories: skill-based, rule- based, or knowledge-based mistakes.

Those that are skill-based can be broken down one more time, into either a slip or a lapse. Both of these point to the same root cause: a lack of attention, which manifests itself in two different ways: momentary memory loss or a routine action that wasn’t performed.

Once more, it’s important to note that these types of errors should not be happening frequently. The vast majority of problems that appear to be a human error at first should lead you elsewhere upon further analysis.

Errors shown to fall into one of the two other categories should be viewed through a different lens. In these situations, processes—particularly related to training and oversight should be scrutinized as contributors as explained in the breakdown below.

Knowledge-based Errors

• Were they tasked with doing too many things at once?
• Is that department under-resourced?
• Was this individual’s supervisor aware that the person is multitasking beyond their limit?

Rule-based Errors

• Did they receive insufficient practice in training?
• Did practice actually reflect the operations they were performing on the floor?
• Does the procedure specify the details to the degree they need to be explained in order to be performed correctly?
• Conduct an objective assessment of your internal problem-solving processes (ideally with the help of an experienced third party) and remediate accordingly.
• Replace metrics that establish problematic incentives with goals focused on long-term trending.
• Explore ways to improve problem-solving within your QMS to reduce backlogs while thoroughly investigating issues.

Many companies suffer from either overusing or underusing their CAPA program— each presenting its own set of risks. Overusing CAPA typically results in a never-ending backlog of open projects, which prevents issues from being resolved in a timely manner, thereby allowing them to worsen while in queue. Underusing CAPA risks letting issues fly under the radar, which again enables them to grow and become harder and more expensive to fix when they’re finally detected. It would be reckless to prescribe hard-and-fast rules for when or when not to open a CAPA, but for those struggling with over or under-use, some general advice may be useful for taking immediate initial steps to correct yourself and set the stage for gradual improvement.

• Ramp up or scale back your CAPA program to deal with systemic or potentially systemic issues first. While not every problem deserving of a CAPA should be “systemic” in nature, these types of problems are typically a great fit when addressed with CAPA.
• Did the incident or event result in injury? If so, CAPA should obviously be mandatory.
• Has the issue, incident, or event occurred multiple times? If so, you likely have a system problem on your hands, which should definitely be handled through CAPA.
• Can the issue be managed effectively another way? “Effectively” is the keyword here. This question shouldn’t be used as an excuse to not open a CAPA if it’s necessary, but if other methods are worth considering, they should be explored.
• Does the issue appear to be critical following a risk assessment? High-risk issues like those deemed to be “critical” should be addressed through a formal CAPA.

Use creative trending techniques. Despite no hard-and-fast criteria for CAPA, quality system expert Brian Dense explains that trending data can be used to make informed decisions about the types of problems CAPA should be considered for while also reducing the amount of work involved.

“If companies did appropriate trending, they could actually combine and condense a lot of the work they’re doing in their CAPA program. You may have five different corrective action efforts going on at once, but you might have five problems that are each only slightly different. After investigating, you might discover they all have the same root cause. At that point, you should consider moving all of these CAPAs into one. Close the others, so that you’re not spending all this time worrying about a record. Have good procedures, with clear rationale. Give a good, solid justification for why you’re doing what you’re doing. Close the record, and put your focus on the best one to implement the corrective action. Trending helps companies reduce the amount of work they actually have to do within their CAPA programs.” — Brian Dense

• Consider establishing a system for recording internal CAPA trends in order to better use your program to address appropriate issues.
• Consider using general questions to better screen issues resulting in a CAPA.

Corrective and preventive actions should always be utilized when necessary throughout any area of your organization. Given this very important point, it’s also helpful to know which systems typically give rise to the problems CAPA is used to solve (and prevent). While again, these are by no means the only areas to expect issues to occur, it can help you prioritize regular monitoring and realize the true scope of problems by identifying their early indicators.

• Nonconforming Product: While one-time nonconformance issues aren’t necessarily worthy of a CAPA, systemic issues almost always are. Confident decisions here rely on your process for analyzing nonconformance data. This is one area where effective analysis can help you be proactive rather than reactive to addressing situations.
• Complaint Handling: Complaint handling processes are critical from FDA’s perspective. Investigating complaints requires a thorough process very similar in concept to a CAPA process. It should define the issue, determine root cause, and establish a plan to address and correct the situation. When this process is effective, CAPA should mainly be reserved for systemic issues. Again, this requires monitoring and analyzing to know when in fact complaints are being caused by an underlying systemic issue.
• Production & Process Controls: In most cases, product issues identified during the production process should be captured as nonconformances—the initial way issues with out-of-spec products are addressed. If the nonconformance is systemic, CAPA will likely be necessary. In other cases, you may identify issues with production-related processes. These require smart corrective and preventive action. While many of these can be addressed via your change-management process, again, CAPA should be considered when issues are revealed to be systemic.
• Supplier Management: Supplier issues that are beyond the scope of a nonconformance—again, mainly those shown to be systemic, should be dealt with either via internal CAPA or a supplier corrective action request (SCAR). Issues elevated and floated back to the supplier should be closely tracked and documented.
• Audits: While audits are typically seen as straining and time-consuming, they can be great opportunities for making improvements and discovering potential issues before they become problems. Once again, any systemic issues revealed during an audit should be prime candidates for a CAPA investigation.

In addition to being fully compliant with ISO 13485:2016 and 21 CFR 820.100, your CAPA procedure must also be effective. This means it has to be clear and functional for its users, the majority of whom likely aren’t CAPA experts.

We've outlined the high-level components of a CAPA form below. Download our accompanying white paper for more detail into each.

• Date of initiation
• Cross-reference number
• CAPA source
• Description of CAPA issue
• Investigator assigned and target due date
• Investigation of Root Cause
• Containment of nonconforming product
• Correction(s)
• Corrective action plan/target deadline for implementation
• Preventive action plan/target deadline for implementation
• Corrective and preventive actions implemented
• Plan for Verification of Effectiveness
• Verification of Effectiveness
• Signature and Closure Date

While CAPA doesn’t lend itself to a universal model or set of procedural steps, the high-level steps presented below offer a dependable baseline from which to compare your current process, build the foundation of a new one, or adjust to improve its effectiveness in correcting and preventing problems.

1. Create and Submit a Request

Begin with a request outlining the possible causes and probable sources.

“Do you have a document that describes how to request a CAPA? You need to have a way for personnel to approach the quality group and provide the critical information needed to request this.” — Larry Stevens, RAC

2. Review the Request Appropriately

CAPA request review should be handled by a Quality Manager or Quality Review Board to determine if it’s warranted. Ideally, a QRB should meet regularly to review CAPA requests and other open quality matters. If rejected, the rationale must be documented in case the issue resurfaces. If initiated, it should be assigned a unique sequential ID number and moved forward.

“Requests need to be documented and reviewed within a certain timeframe. If it’s rejected, that rationale needs to be documents and placed where requests are filed. Make sure you can justify these decisions on a risk basis. If you do open a CAPA, it needs to be uniquely identified and given a CAPA owner—typically the person who requested it who takes responsibility for moving it forward.” — Larry Stevens, RAC

3. Finalize Sources and Build Your Team

Identify all personnel, processes, procedures, and functions that could be involved with the CAPA and document in full. Create a team responsible for conducting the investigation and creating the action plan. Ensure your team is cross-functional and inform them of their roles in the investigation.

“Create a cross-functional team that will meet on these matters. Any individual CAPA may have a team of anywhere from three to five (or more) people. The CAPA owner, then, will ensure the members of the team understand what they’re doing and hold them accountable to the action plan that was created, documenting the progress as it evolves.” — Larry Stevens, RAC

4. Identify Immediate Corrective (and Other) Actions

Detain nonconforming products or materials. Take any other immediate steps to correct glaring problems and document in full.

“CAPAs dealing with nonconforming products often require quarantining those products and getting them out as an immediate step. Other types of glaring problems might be an employee incorrectly assembling a piece of equipment. That needs to be fixed right away while analyzing the reasons why that problem happened.” — Larry Stevens, RAC

5. Investigate and Record Findings

The cross-functional team should conduct a thorough investigation. Very importantly, the degree of effort, resource investment, and documentation should correspond to the level of risk for the given problem.

“A good record of your investigation should be generated. And please tell your engineers, or whoever is writing this that they should not be writing it for other employees to read. It should be written for FDA or outside auditors to read. Put enough detail into it so it doesn’t raise more questions. A “lack of training” resulting in “additional training” only raises more questions. What additional training was done? Who did it? How was it documented? These reports should be very detailed and written so that someone reading it gets the full story. If you give that document to FDA and the details aren’t there, you just told them you didn’t do anything.” — Larry Stevens, RAC

6. Determine Root Cause

Select an appropriate analytical approach and use it to arrive at the root cause of the CAPA. Remember that effective action plans require accurate analysis, so this step is absolutely critical.

“As part of that analytical procedure, you need to identify the tools you’ll use for root cause determination and create a formal document that identifies the root cause. This is a critical step in defining your action plan.” — Larry Stevens, RAC

7. Develop, Execute, and Implement Your Action Plan

Define and document the required action steps for correcting the issue now and preventing it in the future. Once documented, assign roles and responsibilities to your team and conduct the action steps. Common actions include updating procedures, reworking a process, adding inspections, training, supplier changes, manufacturing or storage changes, policy changes, etc.

“All of these actions should be well-documented and managed by the CAPA owner.” — Larry Stevens, RAC

8. Review, Approve, and Verify Effectiveness

Once finished, the Quality Manager, or ideally, the QRB conducts a review to ensure the process was completed exactly as described. Once reviewed, the Quality Manager or QRB certifies the CAPA was carried out correctly. Then, a set of requirements must be established to prove that the CAPA plan was effective at correcting and preventing the problem. Lastly, verification requirements must be validated to ensure they were met and the issue was resolved.

“This is something FDA looks at in determining the efficiency and effectiveness of your CAPA program. Are CAPAs reviewed on a regular basis and are they closed in a reasonable amount of time? Now, occasionally, a CAPA may extend to weeks or months for the effectiveness check. So, maybe there’s a provisional closure pending the completion of that check—showing everything you needed to do is essentially done.” — Larry Stevens, RAC

• Importing the 8D problem-solving model:  You’ll notice that the process laid out above positions verification after implementing corrective and preventive actions. This is often found to be flipped in CAPA procedures, specifically when the process is derived from the Eight Disciplines (8D) methodology. While this system is commonly used among quality engineers in the automotive industry, its import into the device world puts it at odds with regulatory demands both under FDA and ISO regulations. In short, verification of effectiveness must be conducted after those actions are implemented.
• Unreasonable timeframes and deadlines: Another common problem is a tendency to use short, arbitrary timeframes for completing activities in an effort to convey a sense of tight control. While the logic here is simple—tight control looks compliant—timeframes set in a vacuum are a recipe for disaster when they can’t be met. In this case, a procedure that can’t be carried out as written can be even worse than not having a procedure in the first place. By design, it’s set up to fail.
• Feedback loops: Sources of information are incredibly important in just about any procedure. Misaligned inputs mean missing information. To ensure your inputs are aligned, identify the various processes that have worked for revealing root causes in the past. Discuss these matters with each of the stakeholders and write out a process in flow chart form. With this in hand, a procedure can be written or updated with verbiage, steps, and sections for responsibilities, purpose, scope, etc.
• Political influence: Problems caused by political dynamics can be particularly insidious and difficult to address within an organization. While endless white papers could be written on the effects of ego, power, and personalities, detecting their influence on your CAPA program is often relatively simple: Are too many people touching it? Overcommitting staff in the approval process, in particular, can be a clear signal that problems may be getting swept under the rug—or conversely—the program is being overused. Politics are also usually at play when viable solutions get turned down for a myriad of reasons. In general, the remedy is having the right people—and the right number of people—at each level. If one step feels bloated, it typically is.

We’d like to leave you with a well-stated perspective on the value of partnering with quality systems experts when establishing or improving processes, procedures, and more.

“I’ve spent thirty years working in the industry and there’s nothing in medical device manufacturing quality systems I haven’t touched one way or another—most of it many times over. When it comes to the value of an effective, knowledgeable consultant, there’s real fresh perspective, untainted by the, ‘we don’t do it that way here.’ Consultants come in from the outside and they’ve seen a million ways to do it. They’re adaptable to help you develop a process that best fits that organization, rather than just something that’s been 'bandaid-ed' over the years and never really was made efficient. I’m overusing the word politics, but and they come in with no politics. The consultant has no ax to grind with any department. You don’t have any fighting between, or power struggles, between functions because the consultants coming in, and he just wants to give them the best answer.” — Brian Dense

4 Ways Regulatory Compliance & Quality Assurance Consultants/Contractors Offer Unique Value and Cost Effectiveness

While some circumstances clearly underscore the need for outside expertise, the value of engaging a consultant, both financially and operationally, may not always be apparent. To avoid wasted time and budget—and potentially serious quality and compliance problems that could otherwise be avoided with the help of an experienced consultant, we’ve summarized a few of the major ways companies realize the benefits of bringing in an expert.

1. Answering complex regulatory questions and navigating new regulatory territory

While new regulatory challenges impact both drug and device companies, the device industry, in particular, is contending with sweeping new requirements on top of an increasing number of combination products that present complex regulatory issues of their own (regulatory authority jurisdictions, pre-market submission types, clinical trial design, multi-center review, etc.).

Third-party experts who specialize in specific domains are very often relied upon to step in and help internal teams navigate these complex areas.

The benefit, in this case, isn’t lost when the consultants leave. In addition to leading audits and conducting remediation and revision projects to bring a company into compliance with new requirements, these individuals offer unique and often indispensable training resources that give internal teams the insight needed to implement and maintain new processes, procedures, and systems well after the consultant’s work is done.

2. Preventing the costs of enforcement and its expensive aftermath

Increased regulatory compliance enforcement over the past few years has led to an explosion of new codes while underscoring the importance of putting effective compliance safeguards in place. The costs of these preventive measures are almost always far less than the expensive consequences of enforcement action.

In addition to the disruption and costs of an investigation itself, resulting settlements, subsequent multi-year reviews, effectiveness audits, and related litigation from shareholders and plaintiffs can all lead to massive combined expenses that pale in comparison to effective prevention measures.

Third-party consultants can provide objective assessments through robust quality system auditing to evaluate the key areas that come under regulatory scrutiny in areas such as GMP, GCP, GLP, Vendor/Supplier Management, Pharmacovigilance, and Data Integrity. These measures, when conducted routinely by unbiased outside experts, can be invaluable in preventing quality system issues from developing into system-wide problems that can have enormous implications, both financially and otherwise.

3. Avoiding the practical challenges of hiring from a small talent pool

For most small or medium-sized companies, hiring high-salary internal regulatory compliance staff is simply unfeasible from a business perspective. Even for large firms, finding the top talent to fill these positions can be incredibly challenging. The relatively small pool of QA/RA talent creates intense competition for skilled personnel.

With the regulatory environment becoming increasingly globalized, it can be difficult for in-house regulatory departments to keep up with various regulatory requirements and changes. Third-party experts can achieve harmony between disparate sets of requirements by conducting integrated regulatory assessments against national requirements from multiple jurisdictions.

4. Bringing industry best practices and standards to your processes, procedures, and systems

Third-party consultants encounter a variety of challenges working in the field, and thus, develop a variety of solutions to address them. This gives them a very unique perspective into what works best when addressing a certain problem or preparing for new development.

In general, most companies like to know what other companies are doing to handle similar issues. While consultants are obviously bound by contract not to reveal specifics, they’re expected to use their experience when developing best practices and standards to bring to each organization they work while also adding the scale and bandwidth needed to augment internal teams.

Consider the Costs

For many companies, seeking outside help from third-party experts can provide overall greater value compared to doing all regulatory work internally. While per- hour billing rates may initially appear high, the total financial picture can be one of cost savings when consultants are able to provide an ROI on overall efficiency versus the alternative.

• Effective consultants are valued for their ability to complete work quickly and without rework. This factor on its own is often enough to realize cost savings. Consultants who have conducted the same work many times and aren’t affected by the distractions of daily tasks that internal personnel are can often perform tasks far faster. Of course, consultants can only perform fast, effective work when the goals of the project are well-defined and organized ahead of time. This, in addition to ensuring a consultant is hired for their expertise rather than their billing rate are the two major factors that maximize efficiency while getting achieving the goals of a project.
• Companies can lower overall costs by carefully choosing the types of projects and processes that they outsource. While just about any situation can warrant the added assistance of a consultant, consider those that require a high degree of specialization and/or those that are conducted on a periodic or project-based frequency. As FDA-regulated manufacturers continue to compete for top talent in a globalized market while navigating a more complex regulatory environment, regulatory compliance and quality assurance consultants will continue to offer valuable pathways for planning and completing projects quickly, reliably, and cost-effectively.

Join the thousands of companies executing their projects with The FDA Group.

The FDA Groups  helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in  Quality Assurance ,  Regulatory Affairs , and  Clinical Operations .

Our auditors can perform a detailed assessment of your existing quality systems and processes to highlight problem areas, and recommend and optionally implement improvements to build quality systems that are appropriate for your company’s stage of development. We can assist you with all aspects of compliance as they impact your product, including GLP, GMP, QSR, and GCP.

The FDA Group also specializes in planning and conducting comprehensive remediation projects, Our team of former FDA and industry professionals works hand-in-hand with regulated manufacturers to uncover the root cause of compliance issues, remediate them, and implement the necessary measures to safeguard your reputation for quality both now and in the future.

With over 2,500 resources worldwide,  over 225  of whom are former FDA , we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Get direct access to the specialized life science talent you need to bring products to market and keep them there. Whether you’re looking for consulting or project support, full-time contract, contract-to-hire, or direct-hire talent, we rapidly identify the right resource the first time.

Learn more about our services by functional area:

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Get in touch with us to learn more and get the support you need—when and where you need it.

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What is a CAPA? Understanding corrective and preventive actions

July 28, 2023

TABLE OF CONTENTS

It’s important that organizations maintain exceptional product quality, minimize risks, and meet regulatory requirements. Corrective and preventive actions, or “CAPAs,” are a powerful way to identify, investigate, and address deviations, nonconformances, and potential issues within processes, products, and services.

Below, we’ll define a CAPA and explain how it can be implemented into your day-to-day operations.  We’ll share how CAPAs can improve your hardware products, benefit your teams, and address issues with newfound confidence.

What is corrective and preventive action (CAPA)?

A CAPA is a systematic process to identify, investigate, and resolve issues that arise during  product development , manufacturing, or service delivery: Take  corrective  actions to address existing problems and implement  preventive  measures to avoid future occurrences. The primary goal of a CAPA is to improve processes, maintain product quality, and minimize defects.

Corrective action vs. preventive action

There are distinct differences between corrective and preventive actions.

Corrective action is more of a reactive approach. It aims to address existing problems by eliminating root causes or putting out fires that are currently affecting your organization. 

As you may have guessed, preventive action is a proactive and anticipatory protocol. It helps you anticipate potential issues  before  they arise or become more severe. An internal audit, for example, can be used as a preventative tool during a management review to mitigate or eliminate developing topics.

Why is it important to have a CAPA process?

Defining the issue is half the battle. You also need to collaborate with your team to determine a solution and move forward. Here’s why a defined CAPA process is a crucial business strategy:

Provides a uniform method for problem-solving

Consistency and efficiency across your organization is the most prominent advantage of the CAPA system. Without a defined, standardized procedure, your team may be unable to effectively identify, analyze, and resolve existing and potential issues.

Ensures compliance

Some industries have extremely stringent regulations that can limit your options when dealing with an issue. Securing compliance with all relevant regulatory bodies helps you avoid costly penalties.

For example, regulatory bodies such as the Food and Drug Administration (FDA) require you to have a robust CAPA process in place for things such as  medical devices, biological products, and pharmaceuticals . A description of what the FDA requires is described below.These 

Maintains product quality and minimizes defects

Organizations can address current issues, eliminate root causes, and prevent future problems. By systematically managing product-related issues, CAPAs enhances product quality, reduces defects, improves customer satisfaction, and ensures adherence to regulatory standards.

Increases customer satisfaction

An effective CAPA process will ensure the timely resolution of customer complaints and give your organization a mechanism for gathering and acting on customer feedback. You can then use this feedback to improve future iterations of your product. 

When customers see their feedback is valued, it builds trust and brand loyalty. As a result of this customer-first approach, your brand perception will improve, and you’ll be better positioned to cultivate long-term customer relationships.

Who should set up a CAPA process?

Organizations.

Various types of companies and industries would benefit from a CAPA system. However, there are a number of complex product-oriented industries where an effective process is required. Here are some industries where CAPAs are essential:

• Medical device :  Medical devices have many restrictions. CAPA helps ensure that any issues or nonconformities in medical device design, manufacturing, or distribution are promptly addressed.
• Pharmaceutical:  A CAPA process is required to address quality deviations, adverse events, product recalls, and other issues which improve both the safety and impact of your pharmaceuticals.
• Aerospace:  A CAPA process enables you to identify, plan, and resolve any issues that may compromise airworthiness and quality.
• Automotive:  Automotive companies use CAPA to address defects, quality issues, recalls, and noncompliance with regulatory standards.
• Electronics:  The electronics industry, encompassing manufacturers of electronic components, devices, and equipment, relies on CAPA for quality, reliability, and compliance with regulations.
• Food and beverage:  The food and beverage industry requires a robust CAPA process to address food safety hazards, product contamination, quality deviations, and regulatory noncompliance.
• Biotechnology:  Biotechnology companies involved in developing biological products, diagnostics, and therapeutics, need a CAPA process to ensure the quality, safety, and efficacy of their products.
• Quality managers:  Quality managers oversee the implementation and maintenance of the CAPA process within an organization. They’ll ensure compliance with quality standards, lead investigations, and monitor the effectiveness of corrective and preventive actions.
• Design engineers:  Design engineers collaborate with their teams and play a crucial role in the CAPA process. They’re particularly valuable in addressing design-related issues that may impact product quality or performance with cross-functional teams to implement corrective actions and  design changes .
• Regulatory affairs professionals:  Regulatory affairs professionals monitor regulatory changes, provide guidance on compliance, and ensure that CAPA activities address any regulatory noncompliance effectively.
• Production managers:  As a production manager, you will work closely with quality teams to identify process-related issues and implement improvements to enhance product quality and consistency.

Understanding CAPA in the context of ISO 13485 and 21 CFR 820

Two primary  quality management  standards require a corrective and preventive action plan: 21 CFR 820 and ISO 13485.

Understanding the CAPA processes and quality processes outlined in both standards is essential for organizations seeking to meet regulatory requirements and maintain high-quality standards.

21 CFR 820, also known as the Quality System Regulation (QSR) for medical devices, sets forth the requirements for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices intended for commercial distribution in the United States.

Under 21 CFR 820, the CAPA process requires medical device manufacturers to establish procedures for investigating and addressing nonconformities and implementing corrective and preventive actions.

It includes steps such as identifying and documenting nonconformities, determining root causes, implementing corrective actions, verifying their effectiveness, and maintaining records of CAPA activities.

ISO 13485 is an international standard for quality management systems in the medical device industry. This standard is essential for companies looking to deliver products globally and remain compliant.

This provides a framework for organizations to establish and maintain a comprehensive quality management system that meets regulatory requirements and ensures the safety and effectiveness of medical devices.

The CAPA process in ISO 13485 requires organizations to have procedures for identifying, investigating, and correcting nonconformities and causes of nonconformities.

The ISO 13485 CAPA process involves problem identification, investigation, determining root causes, implementing corrective and preventive actions, and verifying their effectiveness.

The CAPA process

Now that we have explored the importance and significance of the CAPA process, let’s look at the process itself.

1. Problem identification

Problem identification is the recognition and documentation of quality issues, nonconformities, or deviations from established standards or requirements. It serves as the foundation for the subsequent steps of the CAPA process, as it sets the stage for investigation and resolution.

You can initiate this step through various means, such as customer complaints, internal audits, quality control checks, or regulatory inspections.

2. Investigation and root cause analysis

Root cause analysis  helps identify the immediate causes of a problem and the underlying systemic or process-related issues. This step involves gathering relevant data, examining processes, procedures, and systems, conducting analyses, and identifying the primary factors contributing to the problem.

3. Corrective action implementation

Corrective actions should be carefully planned, documented, and executed to ensure their effectiveness and alignment with regulatory requirements and quality objectives.

Take decisive steps during this stage. Include process adjustments, system modifications, employee training, rework or repairs, or other necessary actions to resolve the matter and mitigate its impact.

4. Documentation and verification

Validation activities, such as testing and analysis, are part of this crucial step. Documentation and verification play a vital role in ensuring the effectiveness and traceability of the CAPA process.

Documentation records the entire process, demonstrating compliance with regulatory requirements and serving as a reference for future audits or inspections. Verification involves evaluating the results of corrective actions. Then, confirming their effectiveness in resolving the problem and preventing it from happening again.

5. Review and follow-up

The review and follow-up step involves assessing the overall effectiveness of the CAPA process and monitoring the implemented corrective actions over time.

Follow-up activities may involve occasional audits, performance monitoring, and ongoing surveillance to confirm sustained compliance and continuous improvement.

What the FDA looks for in your CAPA process

The  FDA  is one of the strictest regulating bodies in the United States. They’ll review your CAPA process to ensure it includes root cause analysis, verification and validation, in addition to the following:

Procedures and documentation

Your company must establish and maintain documented procedures for various quality processes, including CAPA management. These procedures outline the step-by-step approach for identifying, investigating, and resolving quality problems.

You are also required to define the roles and responsibilities of stakeholders involved in the CAPA process.

Documentation includes CAPA forms, templates, reports, and other relevant documents that capture the details of the quality issue, investigation findings, root cause analysis, and corrective/preventive actions implemented.

Risk-based approach

Companies are required to perform a risk analysis, which typically includes methods such as failure mode and effects analysis (FMEA) or fishbone diagrams. This analysis helps identify the root cause of the problem by examining potential failure modes and their potential impacts.

Implementing a risk-based approach lets you focus on critical issues impacting patient safety, product quality, and regulatory compliance. 

Timeliness and efficiency

It’s crucial to promptly identify and address quality problems to mitigate their impact on patient safety and product quality; timely CAPA actions help prevent potential harm and minimize the scope of issues.

It would be best to establish appropriate timeframes and escalation procedures to confirm that CAPA activities are conducted promptly. Timeliness and efficiency in CAPA execution demonstrate a commitment to effective quality management and regulatory compliance.

Training and competency

Personnel involved in the CAPA process should receive appropriate training to understand their roles and responsibilities and the procedures and requirements associated with CAPA management.

Training programs should cover problem identification, investigation techniques, root cause analysis methods, corrective action planning, and documentation requirements.

You can conduct competency assessments to evaluate the proficiency of personnel involved in CAPA activities. That way, you’ll identify any training needs or opportunities for improvement.

Continuous improvement

Emphasizing the ongoing enhancement of processes, products, and systems increases efficiency, effectiveness, and customer satisfaction.

Within the CAPA process, continuous improvement involves evaluating the effectiveness of implemented actions, monitoring outcomes, and seeking opportunities for further enhancements.

This may include analyzing data and trends, conducting periodic reviews and audits, and implementing additional preventive measures or process controls.

Optimize your CAPA process with Duro

A well-implemented CAPA process is critical for organizations operating in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive, electronics, and food and beverage.

This process involves critical steps such as problem identification, investigation and root cause analysis, corrective action implementation, documentation and verification, and review and follow-up.

When it comes to establishing sound CAPA processes, your organization needs to lean on the right tools to maintain compliance. Duro’s PLM and  integrated tech stack  provides businesses a centralized way for teams to collaborate and share information. Tie CAPA information back to your original designs with Duro. That way, you’ll ensure that everyone is on the same page and can easily manage revisions. 

See how  Carecubes leverages Duro  for compliance, collaboration, and  quality control. 

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Corrective Action and Preventive Action (CAPA). The Only Guide You Need

July 12th, 2024

Quality, compliance, and continuous improvement are key for consistent growth and survivability for organizations irrespective of industry. The corrective and preventive action (CAPA) is a structured approach that enables organizations to identify, analyze, and address nonconformities, deviations, and potential risks.

A critical aspect of achieving these goals is implementing an action plan that powers operational efficiency and maximizes output.

Corrective and preventive action plan (CAPA) is a problem-solving methodology that involves root cause analysis , corrective actions to address identified issues, and preventive actions to mitigate potential risks.

It is a comprehensive process that powers organizations to resolve existing problems and also prevent them from recurring. Overall, it sets the mindset and culture of quality and continuous improvement in an organization.

Implementing an effective CAPA system is crucial for organizations operating in regulated industries, such as pharmaceuticals, medical devices, aerospace, and food and beverage, where compliance with regulatory requirements and industry standards is essential.

Regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO), have established guidelines and standards that emphasize the importance of Corrective and Preventive Action (CAPA) in quality management systems.

Key Highlights

• Fixing problems and stopping them from happening again is important for quality. This is what corrective and preventive action (CAPA) is about.
• CAPA follows a process. It helps companies find the root cause of issues , fix the problems, and take steps to prevent them in the future.
• Having a good Corrective and Preventive Action (CAPA) plan set up right helps improve quality over time. It keeps companies meeting rules and standards.
• Doing CAPA right needs clear directions, writing stuff down, training, and checks. Tools and tech can help too.
• It’s smart for companies to check on their Corrective and Preventive Action (CAPA) regularly. That way they can see how well it’s working and ways they could make it better in the long run.

What is Corrective and Preventive Actions (CAPA)?

Mistakes happen, whether it’s a faulty product, off workflow, audit finding, or unhappy customer, companies need a process for figuring out what’s wrong and preventing it from happening again. That’s where corrective and preventive action (CAPA) steps in.

CAPA plays an important role in quality control . It lays out steps to pinpoint the root causes behind issues, fix current problems, and keep future ones from appearing too.

The Corrective and Preventive Action (CAPA) method involves:

• Documenting the quality issue
• Finding out what’s causing it
• Fixing the immediate trouble
• Taking steps to stop it from recurring
• Checking the fixes worked
• Updating procedures if needed

Used correctly, CAPA moves firms beyond just containing glitches toward permanently fixing real issues at their source. It drives businesses toward higher-quality cultures that always refine and improve.

Following CAPA ensures safer, more reliable work through relentless learning from errors spotted. It keeps any operation thriving no matter what changes come next.

Learn how CAPA fits into a broader quality improvement framework. Lean Six Sigma Overview short course introduces you to a comprehensive toolkit for driving quality and efficiency.

Root Cause Analysis

One of the critical first steps in the corrective and preventive action (CAPA) process is to perform a thorough root cause analysis .

Root cause analysis aims to identify the underlying sources or reasons for a non-conformance, deviation , or undesired event occurring.

Without pinpointing the true root causes, any corrective or preventive actions taken may only address surface-level symptoms rather than resolve the core issues.

There are various root cause analysis techniques and methodologies that can be employed, such as:

• 5 Whys – Repeatedly asking “why” to peel back layers of symptoms to uncover root causes
• Fishbone (Ishikawa) Diagram – Visually mapping out potential causes across categories like people, methods, materials, etc.  
• Fault Tree Analysis – Deductive failure analysis working backward from the undesired event
• Change Analysis – Investigating changes or differences preceding the problem

The root cause analysis process typically involves gathering data from multiple sources, such as process records, personnel interviews, and quality records.

A cross-functional team with diverse expertise is often leveraged to bring different perspectives. Root cause investigators must remain objective and avoid making assumptions.

It’s important to recognize that there can be multiple root causes contributing to a single issue. The root cause analysis should identify all significant factors to develop comprehensive corrective and preventive action(s).

Common root causes include training deficiencies, process inadequacies, material variability, and environmental impacts.

Investing sufficient time and resources into rigorous root cause investigation is crucial. Skipping this step and jumping straight to corrective actions raises the risk of Band-Aid fixes that fail to prevent future recurrences.

Difference between Corrective Action and Preventive Action

Corrective actions.

Corrective actions are an essential part of the Corrective and Preventive Action (CAPA) process. They are steps taken to eliminate the root causes of existing nonconformities, defects, or other undesirable situations.

The goal of corrective actions is to prevent the recurrence of the problem and restore conformity to requirements.

Corrective actions typically involve:

• Identifying and reviewing the nonconformity or problem
• Investigating and determining the root cause(s)
• Developing a corrective action plan to address the root cause(s)   
• Implementing the corrective action plan
• Verifying the effectiveness of the corrective actions
• Updating relevant procedures, documentation, training, etc.
• Closing out the corrective action once verified as effective

Corrective actions must be appropriate to the effects of the nonconformities encountered. For example, reworking or re-inspecting defective products may be part of the short-term containment actions, but the root cause(s) must still be investigated and addressed through systemic corrective actions.

It’s important that corrective actions are risk-based, and well-documented, and their effectiveness is verified through objective evidence. The CAPA process should drive continuous improvement by ensuring corrective actions are comprehensive and prevent recurrence over the long term.

Some examples of common corrective actions include:

• Revising procedures or work instructions 
• Implementing new controls or inspections
• Upgrading equipment or facilities
• Enhancing training programs
• Improving verification activities

By taking robust corrective actions based on thorough root cause analysis , organizations can systematically eliminate nonconformities, enhance product/service quality, and strengthen their overall quality management system.

Preventive Actions

While corrective actions are reactive measures taken to address existing nonconformities or quality issues, preventive actions are proactive steps implemented to eliminate the causes of potential nonconformities or problems before they occur.

Preventive actions are a crucial aspect of a robust quality management system and play a pivotal role in continuous improvement efforts.

The primary objectives of preventive actions are to:

• Identify and address potential sources of nonconformities or quality issues before they manifest.
• Prevent the recurrence of similar problems in the future.
• Enhance process efficiency , effectiveness, and overall performance.
• Reduce costs associated with nonconformities, such as rework, scrap, and customer dissatisfaction.

Preventive actions can be initiated based on various sources of information, including:

• Risk assessments : Conduct risk analyses to identify potential failure modes, effects, and criticalities, and implement preventive measures accordingly.
• Data analysis : Analyzing process data, quality records, customer feedback, and other relevant information to identify potential areas for improvement .
• Lessons learned : Leveraging knowledge gained from past experiences, both internal and external, to prevent similar issues from occurring.
• Audits and inspections : Findings from internal and external audits, as well as process inspections, can highlight areas for preventive action.
• Employee suggestions : Encouraging employee participation and leveraging their insights and observations for preventive action opportunities.

Effective preventive actions typically involve a systematic approach, such as:

• Identifying potential nonconformities or quality issues through risk assessments , data analysis, or other means.
• Investigating and determining the root causes of potential problems.
• Developing and implementing preventive action plans to address the identified root causes .
• Monitoring and reviewing the effectiveness of the preventive actions taken.
• Continuously improving the preventive action process based on lessons learned.

By proactively addressing potential issues through preventive actions, organizations can enhance product and service quality, improve operational efficiency, reduce costs, and foster a culture of continuous improvement within their quality management system.

Corrective Action and Preventive Action (CAPA) Plan and Implementation

Once the root causes of a nonconformance or deviation have been identified through thorough investigation, the next critical step is developing and implementing an effective CAPA plan.

A robust Corrective and Preventive Action (CAPA) plan outlines the specific corrective and preventive action(s) that will be taken to address the root causes and prevent recurrence.

Corrective actions are steps taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. These actions are focused on containment, correction, and remediation of the specific issue that has occurred. Common corrective actions may include:

• Reworking or reprocessing defective products/materials
• Increased monitoring and inspection
• Process adjustments or modifications  
• Retraining personnel
• Revising procedures, work instructions, or specifications
• Repairing or replacing defective equipment/instruments

While corrective actions address the immediate issue, preventive actions are proactive processes or solutions implemented to prevent potential nonconformities from occurring. Effective preventive actions help eliminate root causes and systemic issues to avoid recurrence over the long term. Examples of preventive actions are:

• Enhancing procedures or quality systems 
• Providing more robust training programs
• Upgrading or implementing new technologies/automation
• Improving environmental conditions
• Increasing process validation activities  
• Enhancing risk management programs

When determining CAPA actions, they must be directly linked to the verified root causes. A cross-functional team should develop the plan, ensuring actions are specific, achievable, measurable , and have an owner responsible for implementation.

Corrective Action and Preventive Action (CAPA) Implementation

With a formal, approved Corrective and Preventive Action (CAPA) plan in place, implementation of the defined actions should follow a systemic approach with clear timelines, resources, and oversight. Key steps include:

• Detailed planning of each action item
• Securing necessary resources (personnel, budget, equipment, etc.)
• Executing corrective and preventive actions per the plan
• Documenting all completed actions
• Verifying the effectiveness of actions taken
• Revising the plan as needed based on the results

Communication and training are vital during CAPA implementation, ensuring all affected personnel understand their roles and responsibilities.

Dive deeper into root cause analysis techniques crucial for effective CAPA. Root Cause Analysis course offers practical training in these essential skills.

Effective implementation paves the way for long-term monitoring of the CAPA’s effectiveness.

Corrective Action and Preventive Action (CAPA) Monitoring, Review, and Continuous Improvement

Implementing a Corrective and Preventive Action (CAPA) system is not a one-time event, but rather an ongoing process that requires continuous monitoring, review, and improvement. This helps ensure the effectiveness of corrective and preventive action(s) over time and drives sustainable quality improvements .

Corrective Action and Preventive Action (CAPA) Monitoring

Regular monitoring of Corrective and Preventive Action (CAPA) activities is crucial to verify that actions are being properly executed and achieving the desired results. This involves tracking key metrics such as:

• Number of open/closed CAPA events
• Cycle times for Corrective and Preventive Action (CAPA) completion 
• Effectiveness checks on implemented actions
• Recurrence of similar non-conformances

CAPA monitoring helps identify potential issues or bottlenecks early so adjustments can be made. It also provides visibility into the overall health of the CAPA program.

CAPA Review

In addition to ongoing monitoring, periodic reviews of the entire Corrective and Preventive Action (CAPA) process should be conducted. This allows for a higher-level assessment of the process’s effectiveness and opportunities for improvement . Areas to review include:

• Metrics and trends related to Corrective and Preventive Action (CAPA) events
• Feedback from process owners on CAPA activities
• Outcomes and learnings from closed CAPA events
• Alignment with current regulations and industry best practices

CAPA reviews often involve cross-functional teams and quality management . Outputs may include Corrective and Preventive Action (CAPA) process updates, enhanced training, or system improvements.

Continuous Improvement

The data gathered from Corrective and Preventive Action (CAPA) monitoring and review activities should drive continuous improvement of the CAPA process itself. This closes the loop by:

• Implementing corrective actions to address CAPA process weaknesses
• Preventive actions to proactively enhance Corrective and Preventive Action (CAPA) capabilities
• Adopting new tools, technologies, or CAPA best practices
• Refining CAPA procedures and documentation

By fostering a mindset of continuous Corrective and Preventive Action (CAPA) improvement, organizations can ensure their programs remain effective and support sustained compliance and quality performance.

This cycle of monitoring, reviewing, and improving the Corrective and Preventive Action (CAPA) process is critical for maintaining a robust and value-adding approach to corrective and preventive actions long-term.

Want to lead quality improvement initiatives using CAPA and other advanced techniques? Lean Six Sigma Green Belt course prepares you to implement and manage complex improvement projects.

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Create an effective capa form, learn to use the 8d approach to plan and build a compliant and efficient corrective and preventative actions (capas) report.

What's inside?

• Introduction to the 8D approach
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The 5 most common risk assessment tools explained - plus handy infographics!

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Everything you need to build an effective CAPA form

In order to manage Corrective and Preventative Actions (CAPAs) properly, A comprehensive CAPA report is a must. This downloadable will walk you through the problem-solving process known as the Eight Disciplines model a.k.a the 8D approach . This methodology, when followed in the way we describe it, is a great way to create your own effective and fully compliant CAPA form .

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CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process

An effective CAPA process is one of the most important parts of your quality management system (QMS). It’s your tool for addressing systemic or highly critical issues in your manufacturing or quality processes.

And yet, according to our 2022 Industry Benchmark Report , only 17% of the medical device companies surveyed said they had achieved “excellence” with their CAPA process. Roughly half said their CAPA process was average or below average.

If you aren’t part of that 17%, then check out these CAPA best practices that will help take your CAPA system from average to excellent.

BONUS RESOURCE: Click here to download a free CAPA Report Template to help guide you as you’re creating your CAPA system.

1. Establish and follow your CAPA procedures

This first piece of advice may seem like a no-brainer, but missing or inadequate CAPA procedures has been the top cause of 483s and warning letters from FDA for over a decade. You need to take the time to create a compliant CAPA procedures document that details the guidelines for your organization’s approach to corrective and preventive actions. 

Your CAPA procedures should define the objectives, criteria, steps and responsibilities of your CAPA system , and it should contain the following:

An overview of the CAPA procedures, including the scope, purpose, involved personnel, and list of external resources referenced in the document. 

Definitions of terms like “corrective action,” “incident,” or “nonconforming product.”

CAPA Process Flow, which lays out steps to the CAPA process and how it advances through each phase. 

CAPA forms to be filled out when events occur, and as the investigation proceeds.  This is your documentation and should be centralized. 

Additional information explaining the role of management in the review process. 

Be sure to get input from every department and all your subject matter experts on your CAPA procedures document, as well as your SOPs and work instructions. Getting cross-functional input is the best way to ensure that people will actually follow the SOPs you’ve created. 

2. Use a proactive CAPA methodology

When it comes to CAPA management , corrective action is usually the star of the show. It’s human nature to react to problems rather than seek out potential issues and prevent them from occurring.

On top of that, everyone knows preventive action is a part of CAPA, but they’re often not really sure what it means to take preventive action. The difference between the two comes down to a single word.

Corrective action is taken to prevent the recurrence of an issue.

Preventive action is taken to prevent the occurrence of an issue. 

This IMDRF guidance document defines preventive action as “action to eliminate the cause of a potential nonconformity or other undesirable situation.”

So, by definition, preventive action is proactive. The same guidance document offers this example of what proactive action might look like:

For example, production or acceptance testing trend data indicates that control limits are being approached and revision of product or production (process, equipment or facilities) requirements may be necessary. These revisions could constitute a preventive action.

Notice that control limits are being approached. Nothing has technically gone wrong, but why wait until it does? Other actions that may fall under the preventive umbrella include:

Redesigning a process

Implementing training for staff

Instituting quarterly reviews with staff

Creating a new supplier agreement 

Making improvements to a manufacturing environment

Remember, it feels good to put out fires, but it’s more efficient to stop them from occurring in the first place. 

3. Perform root cause analysis (RCA) with a cross-functional team

Your root cause analysis is arguably the most important part of the CAPA quality process. If you can’t figure out what’s causing the issue—and I mean what’s really causing the issue—then you’ll likely be dealing with it again soon. 

There are a number of different ways to perform RCA , and I can’t tell you which will be the most effective for you. But I can say you should involve a cross-functional team in the root cause analysis, whichever method you choose. 

The reason you need a cross-functional team is that CAPAs, by their very nature, are rarely limited to one department or job function. The types of systemic issues that trigger CAPAs tend to involve multiple different areas within a business. And the point at which the problem is detected is often much farther downstream from the root cause. 

If you leave root cause analysis to one or two individuals in the same department, it may be difficult to follow the thread of the problem all the way back to its true cause. When you build a cross-functional group, the team has access to every functional area, which increases cooperation and makes it easier to trace the problem to its source—wherever that may be.

4. Think carefully about initiating CAPAs

There are two traps that companies fall into with their CAPA methodology: underuse and overuse.

Underusing CAPAs is a serious issue because it means that quality events which should result in a CAPA—meaning a thorough investigation, root cause determination, and corrective or preventive action—are flying under the radar. That’s dangerous, not only for your business, but for the patients and end users your product is intended for.

Overusing CAPAs may not be as dangerous, but it’s still detrimental to your business. When companies get “CAPA happy,” they start opening a CAPA for every nonconformance or complaint they receive. And while a nonconformance or complaint may warrant a CAPA, it’s highly unlikely that they all will. CAPA happy companies tie up enormous resources in trying to close the large number of lingering CAPAs they keep open at all times.

If you’re unsure about whether you should open a CAPA , try asking these questions:

Did this event result in an injury? If the answer is yes, you should open a CAPA.

Is this a recurring issue? If the answer is yes, there’s a good chance the problem is systemic and you should open a CAPA. 

Does a risk assessment show this to be a critical issue? Critical issues, even if they are not recurring, should trigger your CAPA process.

Can this issue be effectively managed another way, like through your nonconformance process, complaint handling, or change management? If you tend to suffer from overuse of CAPAs, this is a good question to begin asking before opening a new one. 

Remember, CAPAs are for systemic or highly critical problems. Don’t be afraid to open a CAPA when it’s necessary, but don’t use the process as a catch-all for every quality issue you encounter. 

Greenlight Guru builds CAPA best practices into your QMS from day one

CAPAs often take a back seat to other projects and initiatives that seem more important. But CAPA is more than just one more set of procedures in your QMS. The way you handle CAPAs is a primary indicator of the health of your company’s quality management system.

That’s why at Greenlight Guru, we built our eQMS with a dedicated CAPA Management Software workflow that makes it easy to effectively manage CAPAs from the moment a problem occurs to the moment you close the CAPA. 

By managing all data and CAPA processes in a single system, you’ll understand how they relate to all other parts of your QMS and get visibility into how your customer complaints, audits, nonconformances, and other quality subsystems impact your CAPA system.

If you’re ready for cross-functional visibility into your CAPA process, then get your free demo of Greenlight Guru today →

Etienne Nichols

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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What are CAPAs (corrective and preventive action)? 

Are you curious about what CAPAs stand for and their significance across different sectors? If you’re involved in business management, quality control, or just interested in process enhancement, grasping the concept of Corrective and Preventive Actions (CAPAs) is essential. This article aims to explore the intricacies of CAPA, including its definition, situations necessitating its application, the methodologies employed, key instruments for successful implementation, and practical illustrations of both corrective and preventive measures.  

What is CAPA?  

CAPA, which stands for Corrective and Preventive Action, is a systematic approach to identifying and resolving issues within an organization’s processes. It is an essential part of quality management systems across various industries.  

 Understanding the depth of CAPA meaning and its application is critical for businesses striving for excellence and sustainability. In quality management, CAPA is a testament to an organization’s commitment to continuous improvement. The CAPA process, a cornerstone of robust quality systems, is multifaceted, involving intricate steps that go beyond mere problem-solving. It includes a comprehensive approach towards addressing current issues and preempting potential future challenges.  

When we explore what is CAPA, we find that it is divided into two primary components: corrective actions and preventive actions. Corrective actions are reactive measures, a response to existing problems or detected non-conformities. They are aimed at identifying and rectifying the root cause of a specific issue, ensuring that it does not recur. Preventive actions, on the other hand, are proactive. They focus on predicting and mitigating potential risks before they materialize, thereby averting future non-conformities. The CAPA procedure is rigorous and systematic. It commences with an accurate identification and thorough documentation of the issue, often revealed through advanced audit CAPA methods, meticulous customer feedback analysis, or internal performance assessments. This is succeeded by a detailed CAPA analysis, a critical phase where the issue is dissected to discern its fundamental causes.  

Developing a CAPA plan involves formulating a strategy that is precise, measurable, attainable, relevant, and time-sensitive (SMART). This phase of the CAPA methodology underscores the necessity of actionable and pragmatic resolutions, tailored to address and prevent specific issues effectively.  

Execution of the CAPA plan marks the beginning of a continuous improvement cycle. This phase is not the conclusion but a segment of an iterative process that includes rigorous monitoring and verification. These steps are pivotal in assessing the effectiveness of the implemented CAPA, involving CAPA testing and possibly the deployment of sophisticated corrective and preventive action software for tracking and evaluation. The choice and application of CAPA tools and procedures are critical to the process’s success. These tools provide the structural framework and resources essential for the effective execution of CAPAs, ranging from simple diagnostic tools to complex software systems designed for comprehensive tracking and analysis.  

For instance, an example of corrective action and preventive action in a pharmaceutical environment might involve addressing a contamination issue in the production line (corrective action) and subsequently revising the quality control protocols to enhance monitoring and prevent future occurrences (preventive action). In essence, CAPA is not merely a compliance obligation but a strategic approach for sustained organizational growth.  

When is a CAPA required?  

Understanding when to implement a Corrective and Preventive Action (CAPA) is a key aspect of effective quality management. CAPA, an essential component in numerous industries, is required whenever there are deviations or potential risks that could adversely affect product quality, safety, or regulatory compliance. The initiation of a CAPA is often necessitated by various situations, some of which are highlighted below:  

Manufacturing Non-Conformities: During the manufacturing process, any deviation from standard operating procedures, equipment malfunctions, or human errors that lead to non-conformities are clear indicators for the need for a CAPA. The CAPA process in such cases focuses on identifying the root causes of these issues and implementing corrective actions to rectify them and prevent their recurrence.  

Preventive Measures: CAPA is not only reactive but also proactive. Preventive actions are crucial when there is an identified risk of potential issues. This proactive approach, an integral part of the CAPA methodology, helps in anticipating and preventing problems, ensuring a consistent focus on improvement and excellence within the organization.  

Regulatory Compliance: In certain sectors, such as pharmaceuticals and medical devices, regulatory compliance is a major driver for CAPAs. The CAPA abbreviation often comes into play when there is a need to align with industry regulations and standards. Regulatory bodies may require CAPAs as part of their compliance audits (audit CAPA), and failing to adequately address these requirements can lead to significant consequences.  

Customer Feedback: Customer complaints and feedback are critical triggers for CAPAs. They provide valuable insights into potential issues with products or services. By analyzing customer feedback and implementing CAPAs, organizations can address underlying problems and enhance customer satisfaction.  

Internal Audits: Regular internal audits are a vital tool in the CAPA toolkit. They help in identifying systemic issues or recurring problems within organizational processes or systems. Audit findings often necessitate corrective and preventive actions to ensure that the identified issues are addressed and do not reoccur.  

Continuous Improvement: CAPA is also essential in the pursuit of continuous improvement. By regularly reviewing processes, systems, and outcomes, organizations can identify areas for improvement and implement CAPAs to enhance overall performance and quality.  

CAPA Tools and Software: The use of specialized CAPA tools and corrective and preventive action software facilitates the effective management and tracking of CAPA processes. These tools aid in documenting, analyzing, and monitoring CAPAs from initiation through to resolution.  

In conclusion, CAPAs are triggered by a range of factors from production non-conformities, regulatory requirements, customer feedback, to findings from internal audits. The implementation of a well-structured CAPA plan, guided by thorough CAPA analysis and supported by appropriate CAPA procedures and tools, is instrumental in ensuring that organizations not only address current issues but are also well-equipped to prevent potential future problems. This holistic approach underscores the critical role of CAPA in maintaining high standards of quality and compliance across various industries. 

CAPA process  

The CAPA (Corrective and Preventive Action) process is a crucial component of any quality management system. It involves identifying, investigating, and addressing issues or nonconformities to prevent their recurrence in the future.    The first step in the CAPA process is to identify the problem or issue that needs to be addressed. This can be done through various means such as customer complaints, internal audits, or even observations made by employees.    Once the problem has been identified, it’s important to thoroughly investigate its root cause. This may involve gathering data, conducting interviews with relevant stakeholders, and analyzing processes or systems that may have contributed to the issue.    Based on this investigation, corrective actions are then developed and implemented. These actions are intended to address the immediate problem and prevent its recurrence. They may include changes to procedures, training programs for employees, or modifications to equipment or software.    In addition to corrective actions, preventive actions are also taken as part of the CAPA process. These actions aim at identifying potential issues before they occur and implementing measures to mitigate them proactively.    Throughout the CAPA process, it’s essential to track progress and measure effectiveness. This can be done using various tools such as performance indicators or statistical analysis techniques.    By following a robust CAPA process, organizations can continuously improve their products and services while ensuring compliance with regulatory requirements. It helps maintain customer satisfaction while minimizing risks associated with quality defects or noncompliance incidents. 

Importance of Auditing in the CAPA Process   

Auditing plays a crucial role in the Corrective and Preventive Action (CAPA) process.  

Regular audits are essential for several reasons:  

Identification of CAPA Needs: Audits help in identifying discrepancies and non-conformances within processes and systems. These findings are often the starting points for initiating CAPAs. By uncovering areas that require improvement, audits ensure that corrective and preventive measures are taken promptly.  

Ensuring Compliance: Audits are critical for ensuring that organizations comply with industry standards, legal regulations, and internal policies. They help in identifying areas where the organization may be at risk of non-compliance, thereby triggering CAPAs to rectify these issues.  

Preventing Security Incidents and Data Leaks: Regular audits can identify vulnerabilities in information security systems. The process of reporting security incidents as part of preventive actions is crucial. Audits can help in establishing a protocol for quickly and efficiently reporting and addressing security breaches, thereby minimizing their impact.  

Internal Audits : These are invaluable in the CAPA process as they provide an in-depth look at internal processes and operations. Internal audits can uncover systemic issues and operational risks, providing an opportunity to address these problems before they escalate. This proactive approach is fundamental in the CAPA methodology.  

Internal Control : Effective internal controls are key to the successful implementation of CAPAs. They ensure that the actions taken are appropriate, executed correctly, and are effective in addressing the identified issues. Internal controls also ensure that the organization’s resources are used efficiently and that risks are managed effectively.  

Strategies to Avoid Data Leaks: In the digital age, protecting sensitive data is paramount. CAPA can be instrumental in formulating strategies to prevent data leaks. This includes regularly auditing data protection measures, identifying potential vulnerabilities, and implementing actions to strengthen data security.  

Compliance and Regular Audits: Compliance with regulatory standards and internal policies is non-negotiable for most organizations. Regular audits help maintain this compliance by continuously monitoring and evaluating the effectiveness of current practices and introducing CAPAs where necessary.  

Risk Management : CAPA is an integral part of risk management strategies. It allows organizations to systematically identify, assess, and mitigate risks. Audits provide the necessary data and insights to inform risk management decisions, ensuring that preventive actions are effective and aligned with the organization’s risk profile.  

In summary, the importance of auditing in the CAPA process cannot be overstated. Regular audits not only aid in identifying areas for improvement but also play a critical role in ensuring compliance, preventing security incidents and data leaks, and effectively managing risks. They are foundational to a proactive, responsive, and responsible approach to quality management and organizational integrity. 

CAPA tools  

When it comes to implementing a successful CAPA (Corrective and Preventive Action) process, having the right tools in place is crucial. These tools not only streamline the entire process but also ensure efficient tracking and monitoring of corrective and preventive actions.    One important tool for managing CAPAs is a robust software solution specifically designed for this purpose. With such software, organizations can easily document, track, and manage all aspects of their CAPA activities. From identifying the root cause of an issue to assigning responsibilities for corrective actions and monitoring their progress, these tools provide a centralized platform for seamless collaboration among team members.    In addition to software solutions, other essential tools include investigation templates that guide users through thorough root cause analysis, action plan templates that help structure corrective and preventive actions effectively, as well as documentation templates that standardize reporting processes.    Furthermore, data analysis tools play a significant role in evaluating the effectiveness of implemented CAPAs. By analyzing trends and patterns from collected data points over time, organizations can identify recurring issues or systemic problems that require further corrective measures.    To maximize the benefits of using various CAPA tools, it’s essential to invest in user training programs tailored to each tool’s functionality. This ensures that employees understand how to utilize them efficiently while adhering to established procedures.    By leveraging these CAPA tools effectively within your organization’s overall quality management system (QMS), you can drive continuous improvement initiatives while ensuring compliance with regulatory requirements – ultimately leading to enhanced product quality and customer satisfaction. 

Example of corrective action and preventive action  

In this article, we have explored the concept of Corrective and Preventive Actions (CAPAs) and their importance in various industries. We started by understanding what CAPA is and when it is required. We then delved into the CAPA process, highlighting its steps and key considerations.    To effectively implement CAPA, organizations can leverage a range of tools available in the market. These tools facilitate efficient data collection, analysis, documentation, and tracking of corrective actions taken to address issues or prevent them from recurring.    Now let’s take a closer look at an example that illustrates both corrective action and preventive action:    Imagine a manufacturing company that has been experiencing quality issues with one of its products. Customer complaints regarding product defects have increased significantly. To address this issue:    Corrective Action:  1. The company initiates an investigation to determine the root cause of the defects.  2. They identify that a specific component used in production is faulty.  3. The company replaces all defective components with high-quality ones.  4. A thorough inspection process is implemented to ensure consistent product quality.    Preventive Action:  1. The company reviews its supplier selection criteria for components.  2. They update their quality control protocols to include more rigorous testing measures during production.  3. Regular training sessions are conducted for employees involved in production processes to enhance their skills and awareness of quality standards.    By implementing these corrective actions, they resolve existing issues with defective products promptly while preventing similar problems from occurring again in the future.    The significance of Corrective and Preventive Actions cannot be underestimated as they help organizations improve their operations continuously and maintain high levels of customer satisfaction.    In conclusion,  Corrective actions focus on rectifying existing problems or non-conformances identified within a system or process, while preventive actions aim to anticipate potential issues before they happen through proactive measures such as system enhancements or employee training programs.

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Problem Solving & Decision Making for CAPA (Corrective And Preventive Actions)

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Problem Solving & Decision Making for Corrective and Preventive Actions (CAPAs) is an FDA-recognized, step-by-step approach to close out deviations with complete, well-documented investigations. Through this workshop, you’ll learn how to respond to deviations with a process that is focused, rapid, and fully documented. Ideal for pharmaceutical and medical device companies, Problem Solving & Decision Making for CAPAs provides the essential framework for satisfying agency investigation requirements and eliminating future deviations.

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Anyone who has to investigate, find root cause, manage investigations or CAPAs. This includes operators who support investigations through to managers who approve investigations.

• Learn root cause analysis to cut through the complexity of pharmaceutical and bio-pharmaceutical manufacturing, confidently respond to warning letters, satisfy auditors, and avoid future issues
• Establish a systematic approach to classify and prioritize investigations, find cause, choose the most effective and efficient corrective and preventive actions to maintain compliance and improve throughput
• Reduce cycle time for investigation approval and the number of open investigations
• Incorporate risk analysis into decision making to avoid future problems and leverage opportunities for improvement

Skills Developed

• Take corrective and preventive actions by using a structured troubleshooting approach
• Use logic and data to systematically find and confirm true and root causes
• Reduce the cost of investigations by increasing the efficacy and speed of CAPAs
• Use incisive, easy-to-learn and apply questioning techniques
• Focus on accurate results even when tensions are high and costs are rising
• Improve transparency with structured thinking and clear communications

Return on Investment

• Reduce outstanding investigations
• Increase accuracy of investigations
• Avoid FDA 483s Warning Letters
• Improved ratings on internal audits
• Speed reviews/approvals. Reduce time to find root cause
• Reduce recurring problems. Decrease average time to closure

“Reinforcing the communication and follow-up on who-does-what has led to better communication and less falling through the cracks. In our matrix organization, this is rather critical.” — Group Project Manager, Life Sciences   “KT PSDM CAPA provides a common approach and logical process to develop corrective action and preventive action.” – Assisant QC Manager

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Drive continuous improvement (CI) of operations with a comprehensive yet easy-to-use system designed to effectively manage your corrective and preventive action (CAPA) processes. Our solution supports various methodologies like 8D, 5W-2H, and world class manufacturing (WCM) with smart recommendations at every step to guide your team to CAPA closure.

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Regulatory compliance is stringent. With an electronic approach to document management across the enterprise, you’ll have a central repository to create, modify, review, approve, store, organize, access and share documents globally in a controlled manner. Track each document from origin to obsolescence with analytics, graphical dashboards, integrated collaboration and workflow tools.

With CQ CAPA Management Software

With CQ CAPA Management Solution, you can identify and initiate a corrective and/or preventive action process, then conduct an investigation and/or link it to existing investigations or root causes for a complete record. CQ’s AI capabilities also allow you to detect trends early on and define the appropriate action plan. CQ’s advanced RCA tools help you ensure success along with effectiveness checks, structured verification and closure.

For any enterprise, a robust CAPA process is crucial to address systemic issues and drive continuous improvement of your business processes. CQ CAPA Management Solution uses predictive analytics and intelligence to identify the right issues to solve. Our key focus is on helping you implement effective preventive action plans to mitigate risks. Our solution supports various methodologies like 8D, 5W-2H, and world class manufacturing (WCM) with smart recommendations at every step to guide your team to CAPA closure.

There are eight key processes in a robust quality management system. These include NonConformance, Customer Complaints, CAPA , Equipment , Product and Process Inspections , Workforce Digitization, Audit/Risk and Compliance , and Supplier Management. The key to addressing any quality issue at a system level is to have a unified QMS that is connected end-to-end. CQ CAPA Management Solution integrates with the rest of the quality processes making it easier for the quality leaders to collaboratively implement action plans and verify the effectiveness of a CAPA. There are eight key processes in a robust quality management system. These include Nonconformance, Customer Complaints, CAPA , Equipment , Product and Process Inspections, Workforce Digitization , Audit/Risk and Compliance, and Supplier Management. The key to addressing any quality issue at a system level is to have a unified QMS that is connected end-to-end. CQ CAPA Management Solution integrates with the rest of the quality processes making it easier for the quality leaders to collaboratively implement action plans and verify the effectiveness of a CAPA.

The eight disciplines (8D) model of problem-solving is extremely popular among quality professionals in the automotive, manufacturing, and healthcare sectors. If you are a fan or if your organization relies on the methodology to identify, correct, and eliminate recurring problems, ComplianceQuest has a built-in 8D CAPA workflow. Other models like world class manufacturing (WCM) and 5W-2H are also offered. The CQ CAPA solution is made up of foundation blocks along with a built-in workflow indicator operating system that companies can use as is or configure to suit their needs.

The CQ CAPA Management Solution is designed to offer integrated risk management , along with the CAPA process. This offers quality leaders far more insight into risk detection and corresponding prioritization, allowing them to design appropriate action plans and close CAPAs in sync with the stated risk management goals.

In today’s rapidly changing world, you need to take advantage of the latest Artificial Intelligence ( AI ) and data technology to make life easier for your team. With CQ, your teams can leverage analytics, pattern recognitions, trends, and data visualization to spot key issues that need immediate corrective action in a fraction of time. CQ’s platform automatically serves recurrent nonconformances and similar CAPA records to help you identify trends before they become major quality events. Also, during investigations and RCA, it helps to derive insights from quality analytics to drive a more efficient investigation, and ultimately a better CAPA workflow.

Collaboration and teamwork are at the core of a CAPA process. For example, while using the 8D methodology, the first step is to select a team with both product and process knowledge. CQ CAPA Management Solution is designed for ease of collaboration. It also integrates with ERP and CRM systems to include customer, business and supplier data to drive decision making that is inclusive of the various stakeholders.

Cost of poor quality (COPQ) includes all costs associated with poor quality products or services. Broadly, this is put into three buckets – appraisal costs or the costs of evaluating if a product meets quality standards; internal failure costs or quality-related costs incurred before the product reaches customers; and external failure costs, or quality-related costs incurred after the product reaches customers. Implementing CQ CAPA Management Solution will certainly help reduce the Cost of Quality (CoQ) within your organization by helping you implement a continuously improving quality management system.

Support Your Entire Organization

Get visibility across issues in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences.

Improve process control to reduce quality gaps and lead time, increase production yield and the associated customer satisfaction, and prevent nonconforming products from reaching the marketplace.

Manufacturing

Enable teams to quickly capture, triage, find the root cause, and take any remedial steps to effectively prevent waste, rework, and delays.

Engineering

Quickly access necessary nonconformance data to perform investigation and risk assessment to eliminate the root cause(s).

Easy retrieval of information to reduce review cycle time and for data-driven decisions to authorize disposition of nonconforming material.

Gain visibility, improve collaboration and minimize lag times for supplier corrective actions .

What They Say About Us

ComplianceQuest is amazingly robust and easy to use. We first started using CQ for Document Control but today we use it for Training, CAPA, Complaints, Change Control, Supplier Management, and Audit Management. Our experience has been very positive throughout selection to implementation. The CQ solution is extremely powerful and has a variety of applications and modules. Configurable reporting and dashboarding features allow for ease of communication and transparency of data within the company. All processes are electronically linked, adding both ease and traceability to interrelated processes (I can launch a CAPA from my Complaint form!) (I can launch an Engineering Change Order from my CAPA form!). Configuration can be as simple or as complex as you make it.

Manager, Quality Assurance

Global Life Sciences Company

We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.

Helen Cary, Document Control Specialist

Lin Engineering

Key Features of CQ CAPA Management Solution

Centralized Database

Central repository for storing and organizing all types of documents based on various templates and classification criteria. Eliminate the risk from outdated, manual paper documentation.

Effectiveness Verification & Closure

Track the effectiveness of CAPA actions with as many verification plans and effectiveness reviews as needed.

Link to other EQMS Processes

Ease of integration with Audit Management , Change , Complaints , Nonconformance , and other key EQMS Processes.

Communication/Collaboration

Collaborate with team members, suppliers , and other stakeholders to ensure the CAPA steps have been implemented as needed.

ERP/CRM Integration

CQ EQMS integrates with ERP and CRM, to ensure quality data is tracked across the product lifecycle, end-to-end.

Mobile Access

Access your EQMS solution on the go — anywhere, anytime, and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts, etc.

Reporting and Analytics

Utilize pre-developed best practices-based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.

Social Like and Follow

Like and follow relevant records in the system. Choose to be notified via email, dashboard , and/or mobile to stay abreast of developments.

Identify and Initiate

Analyze all possible issues that need a CAPA, irrespective of whether the source of the issue is a product, process, or even a continuous improvement (CI) initiative. Document different types of CAPA events using user-friendly web forms.

Assess Risk

Each documented event may be systematically evaluated for risk to determine the type and priority of CAPA. Risk assessment can be performed using established risk standards and can be followed both locally and globally.

Investigation & 5 WHY Root Cause Analysis

Enables collaboration and teamwork for investigation and RCA. Depending on the nature of the issue, the CQ solution enables ease of collaboration with suppliers and external subject matter experts. 5 WHY Root Cause Analysis provides functionality to document numerous root causes, attach evidence and capture decisions as needed for the investigation.

Define Action Plans

Capture clearly defined action plans along with due dates, for various CAPAs and link them to related root causes.

Reviews & Approvals

Route the CAPA record for reviews to relevant people and solicit feedback and necessary approvals. Approvers can either be predefined based on the type of CAPA or can be defined dynamically.

Implementation

Enables plan assignees to implement the approved corrective and preventive action plans. Additional plans can be recorded as deemed necessary to effectively address the root cause

Request a Personalized Demo

CAPA Management Solution Datasheet

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Why take the guided tour of CQ Document Management

What you can expect.

• The Document Master List for those who manage documents
• How to manage documents
• Using Document Templates to drive the workflow
• Options for approving documents
• How training is automatically assigned upon document approval
• Collaborating and Reviewing documents
• The CQ Home Page to access tasks and documents and enter records
• Dashboards and Reports for tracking, trending and KPIs

Why take the guided tour of CQ Change Management

• Working with Change Requests and Change Orders
• Assessing the impact of the proposed change
• Planning and implementing changes
• Modifying Change Orders
• The CQ Home Page to access training tasks and documents and enter records

Why take the guided tour of CQ Training Management

• An overview of Document Management and how it relates to Training Management using Job Functions
• Understanding employee Personnel records and assigning them to their related Job Functions
• Training AssessmentsTracking In-Person training
• Reporting on Training activities including Dashboards, trending and KPIs

Why take the guided tour of CQ CAPA Management

In this guided product walk-through tour, we will show you:

• CAPA Workflow process
• Managing Containments
• Performing Investigations
• Managing Corrective and Preventive Actions
• CQ Home Page to access tasks
• CAPA Reporting including Dashboards, trending and KPIs

Why take the guided tour of CQ Nonconformance Management

• Nonconformance Workflow process
• Dispositioning Nonconforming Materials
• Escalating an NC to CAPA
• NC Reporting including Dashboards, trending and KPIs

Why take the guided tour of CQ CAPA 8D

• CAPA 8D Workflow process
• CAPA Reporting including Dashboards, trends and KPIs

Why take the guided tour of CQ Supplier Management

• Supplier 360 (Profile)
• Supplier Qualification and Onboarding
• Supplier Quality Management
• Supplier Portal - Secure Collaboration & Communication
• Supplier Performance - Reports, Dashboards, Scorecards, Trends, and KPIs

Why take the guided tour of CQ Safety Incidents

• CQ Home Page to report a Safety Incident
• Working the Incident through to completion
• Regulatory Reporting
• Reporting including Dashboards, Trending, Analytics and KPIs

Why take the guided tour of CQ Audit Management

• Scheduling Audits
• Preparing to Perform an Audit
• Performing Audits
• Communicating with Auditees (and others)
• Responding to Findings
• Reporting including Dashboards, Trends and KPIs

Why take the guided tour of CQ Complaints Product Tour

• Complaint Intake
• Complaint Investigations
• Reporting including Dashboards, Trending and KPIs

Why take the guided tour of Complaints Medical Device

• Regulatory Reporting (Medwatch 3500A)

Why take the guided tour of Operational Risk Management Software

• A Risk Register
• Managing Risks using a Quantitative workflow model
• Managing Risks using a Qualitative workflow model
• Reporting including Dashboards and KPIs

Why take the guided tour of Equipment Management

In this guided product tour, we will show you:

• Adding and managing equipment
• Scheduling and performing calibration
• Performing maintenance (Scheduled or ad-hoc)
• Reporting including dashboards and KPIs

Why take the guided tour of Product Inspection

• Managing Product Inspections
• Managing Inspection Criteria
• Handling Inspection Failures
• Sampling Plans and skip lots

Why take the guided tour of CQ Lab Issues

• Managing Laboratory Errors
• Managing Suspect Results (OOT and OOS)
• Assigning Action tasks
• Managing Escalations on all Lab Issues
• Viewing escalated Nonconformances
• The CQ Home Page
• Dashboards and Reporting

Why take the guided tour of CQ Management Review

• Scheduling Meetings
• Initiating and Conducting Meetings
• Managing required Actions
• Viewing related data used in decision-making
• Lessons Learned

Why take the guided tour of Product Design Control

In this guided product walkthrough tour, we will show you:

• Working with Projects
• Managing Design Files
• Managing Requirements
• Managing Risk
• Creating and accessing your DMR and DHF
• The CQ Home page

Why take the guided tour of Digital SOP

• Show you how to access your Digital SOPs
• Walk through using a Digital SOP
• See how to access related documentation
• Watch an embedded video
• Complete a related form as part of the workflow
• Understand how to build Digital SOPs

Why take the guided tour of Product Lifecycle Management

• Managing Parts (products and raw materials)
• Part Revisions
• Bills of Material
• Revision and BOM Comparisons
• Standard vs. Concept Parts
• Supplier Qualification
• Where parts are used
• Connection to Design Control
• Part Quality Issues
• Part Change Orders

Continuous Improvement Toolkit

Effective Tools for Business and Life!

A3 Thinking: A Structured Approach to Problem Solving

• 5 MINUTES READ

Also known as A3 Problem Solving.

Variants include 8D and CAPA.

A significant part of a leader’s role involves addressing problems as they arise. Various approaches and tools are available to facilitate problem-solving which is the driving force behind continuous improvement. These methods range from the advanced and more complex methodologies like Six Sigma to the simpler and more straightforward A3 thinking approach.

The power of the A3 approach lies in its systematic and structured approach to problem-solving. Although it appears to be a step-by-step process, A3 is built around the PDCA philosophy. It relies on the principle that it is much better to address the real root-cause rather than trying to find a solution. Hence, it’s important not to jump to the solution when solving a problem as it is likely to be less effective.

A3 thinking provides an effective way to bring together many of the problem-solving tools into one place. For example, techniques such as the 5 Whys and fishbone analysis can be used during the ‘Analysis’ stage to help identifying the root causes. Additionally, visual aids and graphs are highly recommended in the A3 report, as they are more effective than text in communicating ideas and providing concise project updates.

A3 thinking involves the practice of consolidating the problem, analysis, countermeasures, and action plan onto a single sheet of paper, commonly an A3-sized sheet. This brief document serves as a summary of the project at hand and is regarded as a valuable storytelling tool for project communication. Utilizing the A3 approach doesn’t require any specialized software or advanced computer skills. You may however use readily available A3 templates , or rely on basic tools such as paper, pencil and an eraser as you will need to erase and rewrite several times.

One of the characteristics of the A3 approach is that it does not get into specific details. Detailed documents are usually attached to the A3 report to prevent overwhelming the reader with an excess of information.

The A3 process is typically structured in multiple stages based on the PDCA model. The primary focus is on developing understanding of the current situation and defining the desired outcome before thinking about the solution. While the exact number of stages may vary depending on the preference of the company, what truly matters is adhering to a structured approach to problem-solving.

A3 Seven Stages Model

An A3 process is often managed by an individual who should own and maintain the A3 report. This individual takes the lead in steering the process, facilitating team involvement, and preparing the A3 report with team input. One of the most common models for A3 thinking is the seven stages model which is described in the following.

1. Background – The first step is to identify the business reason for choosing this problem or opportunity. In this stage, you need to identify the gap in performance and the extent of the problem.

2. Current situation – The purpose of this stage is to document the current state of the problem. You may need to refer to the process map or go to the Gemba to truly understand the current situation.

3. Target – The purpose of this stage is to define the desired future state. Clearly identify the expected benefits from solving the problem, the scope, and the key metrics that will help measure the success of the project.

4. Analysis – The objective of this stage is to conduct an in-depth analysis of the problem and understand why it’s happening. It might involve tools like the 5 Whys and cause-and-effect analysis, as well as advanced statistical methods.

5. Countermeasures – Countermeasures are the actions to be taken to eliminate root causes or reduce their effects. The team should brainstorm and evaluate possible countermeasures based on the analysis conducted earlier.

6. Implementation Plan – To achieve the target, develop a workable plan to implement the countermeasures. Gantt charts are great ways to manage implementation plans very simply and easily. Once the action plan is finalized, the team should begin working on the activities needed to implement the countermeasures.

7. Follow-up – The final stage involves evaluating the implementation of the plan and the results achieved. Follow-up actions are important to ensure the benefits extend beyond the project’s completion.

A3 thinking is considered to be the practical form of the PDCA model.

There are many online templates that can be used to manage your problem-solving efforts. One of the simplest and most straightforward ways is to use this A3 problem solving template .

Wrapping Up

A3 thinking represents a logical and structured approach for problem solving and continuous improvement. This approach can be used for most kinds of problems and in any part of the business. Originating from the Toyota Production System (TPS), it has been adopted by many Lean organizations around the world.

A3 thinking not only provides a systematic approach for problem-solving. The development of a continuous improvement culture is at the core of A3 thinking. It has become one of the most popular Lean tools today where people and teams work together to solve problems, share results and learn from each other.

Other Formats

Do you want to use the slides in your training courses?

A3 Thinking Training Material – $18.85

Related Articles

Project Charter

Gantt Chart

Related Templates

A3 Problem Solving

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Corrective and Preventive Actions (CAPA)

Inspectional Objectives

• Decision Flow Chart
• Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
• Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
• Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
• Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
• Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.
• Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.
• Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.
• Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.
• Verify that corrective and preventive actions for product and quality problems were implemented and documented.
• Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.

Review the firm's corrective and preventive action procedure. If necessary, have management provide definitions and interpretation of words or terms such as "nonconforming product", "quality audit", "correction", "prevention", "timely", and others. It is important to gain a working knowledge of the firm's corrective and preventive action procedure before beginning the evaluation of this subsystem.

The CAPA procedure should include procedures for how the firm will meet the requirements for all elements of the CAPA subsystem. All procedures should have been implemented.

Once you have gained a knowledge of the firm's corrective and preventive action procedure, begin with determining if the firm has a system for the identification and input of quality data into the CAPA subsystem. Such data includes information regarding product and quality problems (and potential problems) that may require corrective and/or preventive action.

The firm should have methods and procedures to input product or quality problems into the CAPA subsystem. Product and quality problems should be analyzed to identify product and quality problems that may require corrective action.

The firm should routinely analyze quality data regarding product and quality problems. This analysis should include data and information from all acceptance activities, complaints, service, and returned product records. Determine if the firm is capturing and analyzing data from acceptance activities relating to component, in-process and finished device testing. Information obtained subsequent to distribution, which includes complaints, service activities and returned products, as well as information relating to concessions (quality and nonconforming products), quality records, and other sources of quality data should also be captured and analyzed. Examples of other sources of quality data include quality audits, installation reports, lawsuits, etc.

Determine if the firm is identifying product and quality problems that may require a preventive action. This can be accomplished by reviewing historical records such as trending data, corrective actions, acceptance activities (component history records, process control records, finished device testing, etc.) and other quality system records for unfavorable trends. Review if preventive actions have been taken regarding unfavorable trends recognized from the analysis of product and quality information. Product and quality improvements and use of appropriate statistical process control techniques are evidence of compliance with the preventive action requirement.

Determine if the firm is capturing and analyzing data regarding in-conformance product. Examples include capturing and analyzing component test results to detect shifts in test results that may indicate changes in vendor processes, component design or acceptance procedures. Identification of these indicators may necessitate a vendor investigation as a preventive action. Monitoring in-process and finished device test results may reveal additional indicators of potential quality problems. For devices where stability is an issue, test results of reserve samples are continually monitored. These monitoring activities may trigger process changes, additional training activities and other changes required to maintain the process within its tolerances and limits.

Determine if the firm is using statistical control techniques for process controls where statistical techniques are applicable. An example would be "Statistical Process Control" (SPC). SPC is utilized to monitor a process and initiate process correction when a process is drifting toward a specification limit. Typically, SPC activities are encountered with large volume production processes such as plastic molding and extrusion. Any continuing product improvements (in the absence of identified product problems such as non-conforming product) are also positive indicators of preventive actions.

Select one or two quality data sources. Using the sampling tables, review records from the chosen data sources to determine if the data were entered into the CAPA system. In addition, determine whether the data are complete, accurate and entered into the CAPA system in a timely manner.

The analysis of product and quality problems should include appropriate statistical and non-statistical techniques. Statistical techniques include Pareto analysis, spreadsheets, and pie charts. Non-statistical techniques include quality review boards, quality review committees and other methods.

The analysis of product and quality problems should also include the comparison of problems and trends across different data sources to establish a global, and not an isolated view, of a problem. For example, problems noted in service records should be compared with similar problem trends noted in complaints and acceptance activity information.

The full extent of a problem must be captured before the probability of occurrence, risk analysis and the proper course of corrective or preventive action can be determined.

Review the firm's CAPA procedures for conducting failure investigations. Determine if the procedures include provisions for identifying the failure modes, determining the significance of the failure modes (using tools such as risk analysis), the rationale for determining if a failure analysis should be conducted as part of the investigation, and the depth of the failure analysis.

Discuss with the firm their rationale for determining if a corrective or preventive action is necessary for an identified trend regarding product or quality problems. The decision process may be linked to the results of a risk analysis and essential device outputs.

Using the sampling tables, select failure investigation records regarding more than one failure mode (if possible) and determine if the firm is following their failure investigation procedures.

Confirm that all of the failure modes from your selected sample of failure investigations have been captured within data summaries such as reports, pie charts, spreadsheets, Pareto charts, etc.

Determine whether the depth of the investigation (where possible) is sufficient (root cause) to determine the corrective action necessary to correct the problem. Select one significant failure investigation that resulted in a corrective action and determine if the root cause had been identified so that verification or validation of the corrective action could be accomplished.

Using the sampling tables, review a number of incomplete failure investigations for potential unresolved product nonconformances and potential distribution of nonconforming product. Unresolved problems that could be of significant risk to the patient or user may require product recall if the problem cannot be resolved.

Using the sampling tables, review records regarding nonconforming product where the firm concluded corrective or preventive action was not necessary. As noted above, verify that the firm is not continuing to distribute nonconforming product. This may be an important deficiency based on the class of, and the risk associated with, the product.

Using the sampling tables, review nonconforming product and quality concessions. Review controls for preventing distribution of nonconforming products. Product and quality concessions should be reviewed to verify that the concessions have been made appropriate to product risk, within the requirements of the quality system and not solely to fulfill marketing needs.

Where appropriate, this may include recall actions, changes in acceptance activities for components, in-process and finished devices, etc.

Using the sampling tables, select and review significant corrective actions and determine if the change or changes could have extended beyond the action taken. A significant action would be a product or process change to correct a reliability problem or to bring the product into conformance with product specifications. Discuss with the firm their rationale for not extending the action to include additional actions such as changes in component supplier, training, changes to acceptance activities, field action or other applicable actions. Investigators should discuss and evaluate these issues but be careful not to say anything that could be construed as requesting a product recall.

Using the selected sample of significant corrective and preventive actions, determine the effectiveness of these corrective or preventive actions. This can be accomplished by reviewing product and quality problem trend results. Determine if there are any similar product or quality problems after the implementation of the corrective or preventive actions. Determine if the firm has verified or validated the corrective or preventive actions to ensure that such actions are effective and do not adversely affect the finished device.

Corrective actions must be verified and (if applicable) validated. Corrective actions must include the application of design controls if appropriate. Good engineering principles should include: establishing a verification or validation protocol; verification of product output against documented product requirements and specifications; ensuring test instruments are maintained and calibrated; and that test results are maintained, available and readable.

Using the sampling tables, select and review records of the most recent corrective or preventive actions (this sample may consist of or include records from the previously selected sample of significant corrective actions). To determine if corrective and preventive actions for product and quality problems and changes have been documented and implemented it may be necessary to view actual processes, equipment, facilities or documentation.

Determine that the relevant information regarding quality problems, as well as corrective and preventive actions, has been submitted for management review. This can be accomplished by determining which records in a recent CAPA event were submitted for management review. Review the raw data submitted for management review and not the actual results of a management review.

Review the CAPA (and other procedures if necessary) and confirm that there is a mechanism to disseminate relevant CAPA information to those individuals directly responsible for assuring product quality and the prevention of quality problems.

Review information related to product and quality problems that has been disseminated to those individuals directly responsible for assuring product quality and the prevention of quality problems. Using the sample of records from Objective 9 above, confirm that information related to product and quality problems is disseminated to individuals directly responsible for assuring product quality and the prevention of quality problems.

Basic Problem Solving

Course summary.

This course is designed for production employees, managers, and supervisors who will learn to describe the problem, formulate an accurate problem statement, apply root cause analysis tools, and implement potential solutions

Dave Margil

Event Details

Description, who should attend, learning objectives, course outline, prerequisites, instructors.

8 hours Combination lecture and classroom exercises Available virtually, at QSG’s training facilities or on-site at your organization

When failure occurs, we demand a rigorous process of investigation be initiated to identify why it occurred. Problem Solving is a process that investigates and solves problems, identifies causes, takes corrective action, and prevents recurrence of the root causes. The ultimate purpose of problem solving is to ensure the problem can never be experienced again. Problem solving can be applied in many disciplines, including:

• Manufacturing
• Product Design
• Testing Verification and Validation
• Distribution, Shipping, Transport and Packaging
• Use-Applications

As everyone probably knows, “perfect” is a rare state. Problems pop up from time to time and people need to solve them. As a result, it is important that people become effective problem solvers. Having a workforce with well-developed problem-solving skills is a significant competitive advantage for a company.

All people can benefit from strong problem-solving skills. However, those skills don’t come “built-in” to every person. And even those with a natural knack for it can always get better or learn to apply those skills more effectively in each work circumstance. As a result, it’s a good idea to provide resources to help people develop and use problem-solving skills at work.

Why “Problem Solving for Employees” Matters:

• Employees should recognize the importance of being good problem solvers.
• Understanding the positive impact of employee problem solving increases workplace productivity.
• Identifying the basic steps in the problem-solving process helps employees manage problems efficiently when they do arise.
• Using effective problem-solving techniques on the job keeps problems from reoccurring.

This course is designed for production employees, managers, and supervisors.

Through training, participants will learn to:

• Describe the problem
• Formulate an accurate problem statement
• Apply root cause analysis tools
• Implement potential solutions

Course Outline The problem-solving process has four major parts:

1. Grasp the Situation During the first part of the problem-solving process, Grasp the Situation, participants learn to:

• Identify the problem
• Clarify the problem
• Use the 5W2H tool

2. Cause Investigation During Cause Investigation, participants learn to use several Root Cause Analysis (RCA) tools, including:

• Conducting a “5-Why” investigation to identify the root cause
• Is/Is-Not Techniques
• Cause & Effect Diagrams

3. Problem Correction Problem Correction involves the use of specific actions to correct the problem. Participants learn to implement short-term temporary measures (required to protect their customers) and follow with longer-term corrective actions.

4. Prevention In the fourth and final part of the problem-solving process, participants learn to take specific actions to make sure a problem cannot recur, typically through error proofing and capturing the lessons learned.

Upcoming Events

Basic problem solving – virtual september 2024, failure mode and effects analysis (fmea) based on aiag-vda harmonized edition – virtual october 2024, corrective action/root cause analysis workshop – employing the 8d problem solving methodology – virtual september 2024, measurement system analysis (msa) for gauge r&r – virtual october 2024, design of experiments (doe) basic – on-site september 2024, design for manufacturing and assembly (dfm&a) – on-site october 2024, blueprint reading – on-site october 15-16, 2024, gd&t part 1 (basic) – on-site october 29-31, 2024, leadership effectiveness training (l.e.t.) for process improvement – on-site, september 16-17, 2024, customer reviews, john gaumond.

All the participants in your training were also very impressed with you and your training. They each mentioned to the management team how this was the best training they have received and how your energy and enthusiasm kept them excited and motivated. We really appreciate all you and the team have done for us. We will be in touch soon to review and discuss future trainings.

Paul was definitely very knowledgeable, shared much of his experiences and was very personable. He was able to take a topic that could be very dry and made it interesting. The overall thoughts were that both classes were valuable – especially to those with only several years in the industry.

Curtis Schmidt

Hi Barbara and Angelo,

Thank you for the Holiday cheers! We look forward to working with QSG in 2018. We’ve accomplished a lot together as partners and our Training Program has been a great success thanks to you and QSG. Autoliv’s employees are very grateful to QSG for the opportunities to learn new skills and Autoliv appreciates our employees using these new skills to continually improve our Organization.

The training workshops have been very well received and we are very happy with all that have been completed. The upcoming 5S training is full and we already have others interested so we will be looking to add a class. I am also pushing for additional training with all the training events in all areas of our business.

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What is 8D ? 8D CAPA Report | Eight Disciplines of “Problem Solving”

“ 8D ” Methodology basically uses eight disciplines or principles of “ Problem Solving “. This Problem Solving Technique is widely used by quality engineers and managers of automotive industries. 

This approach is also commonly used by other professionals working in Manufacturing, Government, Construction, Healthcare, IT/BPO, and other service sectors.

The objective/purpose of the 8D Methodology is to identify and define the problem statement effectively for necessary Corrective and Preventive actions – CAPA to stop/prevent the recurrence and occurrence of the problem.

The corrective actions are basically taken on the identified root cause to prevent the recurrence of the problem whereas preventive actions are taken in advance on potential causes of failure to prevent the occurrence of the problem.

The horizontal deployment of corrective action i.e. corrective actions implementations in other products, machines, or services sometimes referred to as preventive actions also.

The basic 7 QC Tools are commonly used in 8D Report generation and problem-solving methodology/approach/steps.

And apart from 8D , there are various Problem-Solving techniques or methodologies like PDCA Deming Cycle, Quality Circle , and Six Sigma – DMAIC , etc. that are commonly applied in a variety of organizations to identify and solve work-related quality problems.

8D CAPA Report is mainly demanded by all OEMs and IATF 16949 certified companies from their suppliers ( at least ISO 9001 certified) to solve customer complaints or quality-related issues.

Table of Contents

8D Approach | 8D Problem-Solving Steps

The eight disciplines for process improvement or problem-solving are as follows:

8D Step – D1: Establish the Team

• Identify team leader and team members.
• Establish a team of competent people with product/process knowledge.
• Cross-functional team-CFT members must be related to the concerned problem.
• Identify the team’s goals and objectives.

D2: Defining the problem

• Define the problem clearly using the 5W2H approach and Process flow diagram-PFD.
• Problem definition shall be based on facts, not opinions.

D3: Containment or Interim Actions

• Containment action is also known as Interim action or Short term action.
• Interim actions are immediate actions/first aid taken against the problem to stop defects/suspected material outflow at the customer end.
• Interim actions protect the customer’s production line from the arisen quality problem until we define the root cause and implement necessary countermeasures.
• Examples of containment actions are: Displaying of QAN-Quality Alert Note, customer complaint awareness training to all concerned, defective or suspected material/parts segregation at the WIP stage, store location, ready for the dispatch-RFD stage, supplier end, transit, and customer end.

D4: Identifying & Verifying Root Cause

Root Cause Analysis-RCA is a systematic approach to determining and identifying the Root Cause of the problem. We can use 7 QC tools,5 Whys, 4M or 6M factors, and a Fishbone diagram for RCA.

Steps for Root Cause Identification:

• Use the Brainstorm technique and Fishbone diagram to identify all possible potential causes related to your problem. Consider all 4M or 6M factors in potential cause identification.
• Verify/Validate the identified potential causes.
• Now, Select the best potential cause that contributes to the problem/effect.
• Drill down the selected potential cause using the 5-Why approach to arrive at the root cause of the problem.
• Identify the root cause on both the Occurrence and Detection or Inspection side.
• Verify the root cause for necessary measures.

Note: Don’t end the root cause with the operator’s negligence, lack of training, etc. while identifying the root cause using the 5Why tool. The problem always occurred when there is a gap in the system/procedure/standards.

D5: Identify Permanent Corrective Actions-PCA

• Identify and Select the permanent corrective actions that address and correct the root cause. In other words, the selected PCA will resolve the problem of the customer.
• Solutions/PCA determined to be the best of all the alternatives.
• Document and verify the Permanent Corrective Action (PCA).

D6: Implementing the Permanent Corrective Action

• Implement the best permanent corrective actions (PCA) and ensure effective monitoring of implemented actions.
• Detect any undesirable side effects of implemented corrective actions.
• Return to root cause analysis, if necessary. In other words, if a still problem exists, you may need to fine-tune your actions or re-analyze the problem to identify a new root cause.

D7: Preventive Actions

• Ensure horizontal deployment of corrective actions, i.e. Ensure similar types of problems will not occur in other machines, products, and services.
• Update the Systems, Processes, Procedures, and Documents like PFC , control and FMEA to prevent a recurrence.
• Implement Poka-Yoke (mistake-proofing or error-proofing) to make the system or processes safer and more reliable.
• Ensure effectiveness/sustenance monitoring of permanent corrective actions.

8D Step – D8: Team Recognition

• Congratulations to your team.
• Celebrate the successful conclusion of the problem-solving effort.
• Organization to express thanks to the team.
• Document lesson learned card-LLC and display at all respective areas.

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Effective Root Cause Analysis for CAPA Management

The ability to conduct a comprehensive root cause analysis to identify the origin of concerns and formulate and execute remedial processes, such as corrective and preventive actions (CAPA), is essential for food companies. Following we look at how to effectively conduct a root cause analysis and the benefits digital tools can offer teams in both identifying and preventing deficiencies.

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Businesses often overlook the power of well-executed, competent complaint-handling systems in boosting business growth. Data from ABa Quality Monitoring Ltd revealed nearly 70% of customers are more likely to stick with a company if their complaints are resolved, and this figure jumps to an impressive 95% if complaints are addressed immediately.

Every company faces distinct operational challenges that can result in missed deadlines, product holds, supply chain disruptions and customer complaints. Each of which can impact the quality of the enterprise’s product or service.

This is why the ability to conduct a comprehensive root cause analysis (RCA) to identify the origin of concerns and formulate and execute remedial processes, such as corrective and preventive actions (CAPA), is essential for food companies. Root cause analyses reduce the risk of future nonconformances and complaints and help streamline business operations and protect your bottom line.

An Overview of CAPA and Root Cause Analysis

Corrective and Preventive Action, or CAPA, is a methodical system used across industries to identify, rectify and avert issues, errors or noncompliance in processes, products or systems. Corrective actions fix existing problems, while preventive actions stop their recurrence.

Root Cause Analysis (RCA) encompasses various problem-solving methodologies, permitting teams to identify the fundamental reasons behind issues. It goes beyond just detecting the main problem to determine contributing factors, implement corrective and preventive measures, and foster continuous improvement in business processes.

Conducting a Root Cause Analysis

A CAPA management system’s success hinges on the RCA strategy’s efficiency. Whether businesses are facing a manufacturing defect, a customer complaint, a safety incident or any other problem, conducting an RCA is instrumental in identifying the underlying reasons and implementing effective solutions. Rather than relying on a one-size-fits-all approach, RCA should comprise a highly adaptable toolkit of techniques, and methods. Here are the basic steps for performing a root cause analysis:

Step 1: Understand the Issue

Initiate the process by clearly defining the problem or incident that must be examined. Ensure that the problem statement is specific, measurable and well-documented, enabling a precise understanding of what needs investigation.

Step 2: Collect Information

Aggregate all available data related to the issue, which may include incident reports, witness statements, photographs, process documentation and any other pertinent information. The more data you collect, the better your grasp of the problem.

Step 3: Identify Root Causes

Recognize the immediate or proximate factors that directly contributed to the problem. These are the most visible elements that directly played a role in the incident. Beyond these immediate causes are the contributing factors, often systemic, which may have indirectly influenced the problem. Thoroughly investigate and unearth the foundational reasons behind the issue using appropriate RCA techniques or methods.

Step 4: Develop Corrective and Preventive Actions

Once the root causes are uncovered, brainstorm and assess suitable corrective and preventive actions. Prioritize these solutions based on their practicality, impact and cost-effectiveness, and put the chosen solutions into effect.

Step 5: Establish a Coordinated Plan

Be sure to establish a plan for carrying out the corrective and preventive actions. This plan should include details about the required resources, the assignment of responsible individuals for task execution and an evaluation of the potential risks associated with these corrective measures.

Step 6: Monitor and Verify

Continuously monitor the situation to ensure that the problem does not reoccur. This may involve ongoing training, regular audits or process improvements.

Methods for Root Cause Analysis

Each root cause analysis method offers a unique approach to uncovering the root cause of a problem, providing a systematized way to investigate and address issues. Following are root cause analysis techniques that are adaptable for standalone or combined use, determined by the issue’s intricacy and the particular objectives of the RCA.

• The 5 Whys: This technique involves asking “why” multiple times to dig deeper into a problem. Repeatedly questioning the cause behind a situation helps uncover the underlying issues. The goals is to identify the fundamental reason and avoid assumptions.
• Fishbone Diagram: This visual tool organizes potential causes of a problem into categories, such as people, processes, equipment, environment and materials. It’s great for exploring multiple factors contributing to an issue.

• FMEA (Failure Modes and Effects Analysis): This method evaluates potential failure modes and their impacts before they occur. It helps in identifying failure points and assessing the existing controls to address these issues.
• DMAIC (Define, Measure, Analyze, Improve, Control): A data-driven improvement cycle, dividing the problem-solving process into five steps: defining the problem, collecting data, analyzing root causes, putting solutions into action and establishing controls for sustained improvement.
• Pareto Analysis: Based on the Pareto Principle, it suggests that a significant portion of issues (80%) can be linked to fewer causes (20%). This tool helps prioritize efforts and resources for problem-solving by focusing on the vital few causes.
• FTA (Fault Tree Analysis): This deductive method works backward from an undesirable event, using graphical representations to analyze relationships between various events and their causes. It uses boolean logic to determine root causes.

Tech-Enabled Solutions to Optimize RCA Processes

In a world where time-consuming manual tasks can hinder productivity, embracing CAPA management and root cause analysis process technology can drive excellence across your enterprise. By digitalizing CAPA processes, organizations can seamlessly manage the entire lifecycle of complaints, holds and deviations.

Digital systems and software for RCA and CAPA management can enable food companies to centralize and automate the recording and tracking of customer complaints, product holds and deviations from established standards, which will evidently lead to faster response times, improved data analysis and better communication across departments. These digital tools aid in identifying recurring issues for swift remediation while preventing similar problems in the future by facilitating real-time monitoring and reporting.

An ideal CAPA management solution will possess the following digital functionalities to revolutionize the process:

Configurable Record Templates. Customized templates for recording complaints, deviations, holds and CAPA can be created or tailored flexibly, allowing users to accommodate differing data requirements to solve a problem. This helps standardize and streamline the documentation processes involved in RCA and CAPA procedures, as these templates help in the consistent recording of incident details, root causes, corrective actions and preventive measures, simplifying the generation of auditable records. Not to mention, they would play a significant role in reducing data entry errors and saving time, consequently supporting a proficient CAPA management system.

CAPA Workflow Automation. CAPA management tools are designed to facilitate the automation of various stages of CAPA, from incident reporting to the review and approval process. By automating tasks such as routing for reviews, approvals and monitoring deadlines for corrective actions, workflow automation significantly reduces the need for manual intervention, saving time and minimizing the potential for human error within the workflow. As a result, the entire CAPA process becomes less resource-intensive and more refined, ensuring a more seamless journey from identification to resolution.

Investigation & Root Cause Analysis. Digitalization ushers a thorough investigation process by collecting documentary evidence in an organized manner, enabling a quicker and more accurate determination of root causes and leading to more efficient corrective and preventive actions to prevent recurrence.

Integrated systematic RCA models into the digital system expedites the root cause analysis process while amplifying its efficacy. Through continuous data gathering from machinery and processes, advanced analytics platforms identify patterns and anomalies, aiding in pinpointing the root cause of failures or issues. Visualization tools provide clear insights into complex relationships among various factors, aiding in understanding causality and devising adequate solutions.

Collaboration is also substantially improved through digital platforms, allowing multidisciplinary teams to collaborate seamlessly regardless of their locations. These tools help structure the RCA process, ensuring tasks are assigned, progress is monitored, and deadlines are met, thus driving the investigation into a more optimal and exhaustive RCA analysis.

Non-Compliance Management. Well-defined planning and implementation of noncompliance action items become possible through digital tools by assigning corrective and preventive actions to respective stakeholders for prompt rectification, compliance maintenance and future risk mitigation. Furthermore, evaluating and validating the effectiveness of corrective and preventive actions is a critical step in RCA. Ensuring the successful closure of the CAPA process by reviewing and confirming the resolution of nonconformances becomes more efficient with digital solutions.

Notification & Alerts. CAPA management systems can be configured to send timely notifications and alerts to relevant stakeholders and responsible parties involved in the CAPA process. These notifications serve as unique reminders, ensuring that individuals are promptly informed about their tasks and impending deadlines. By doing so, the risk of missed actions or delays is considerably mitigated. This real-time communication not only keeps everyone on track but also supports a more responsive and accountable approach to handling corrective and preventive actions.

Reporting & Trend Analysis. Digital CAPA management tools also empower organizations to generate customized reports and analyze data trends. These serve as a window into the performance of the detection, rectification and thorough review of outliers within CAPA processes, providing invaluable insights for informed decision-making and continuous improvement initiatives.

In essence, the transformative power of digital tools is instigating a monumental shift in technology adoption, heralding a new era in establishing efficacious root cause analysis for successful CAPA management. By harnessing these tools, organizations can unlock avenues for enhanced efficiency, elevated quality standards and fortified regulatory compliance. This paradigm shift is paving a path toward sustained progress, where proactive problem-solving becomes the cornerstone of organizational growth and resilience.  

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Defcon AI closes $44M seed round to solve a problem of ‘maximum complexity’: Military logistics

The U.S. Department of Defense is a mammoth organization. It not only employs millions of service members and hundreds of thousands of civilian employees, but also has the world’s largest military budget that’s used to buy and maintain more equipment than can likely fit into a single paragraph. 

It’s a lot to coordinate. Operators within the various agencies of the DOD must make decisions about how to plan their operations, coordinate resources and stay within budget for events that are likely contested — whether that’s from a hurricane or an adversary.

Two years after it was incubated, Virginia-based startup Defcon AI has raised a $44 million seed round led by Bessemer Venture Partners, with participation from Fifth Growth Fund and Red Cell Partners, among others, to solve this seemingly intractable problem.

Consider the Air Mobility Command, a command of the U.S. Air Force. When operators plan airlifts, they have to consider a whole slew of variables: available aircraft, the number of crews required, places for crews to rest, where to refuel, relevant airfields, cargo handling locations. Defcon AI says it has developed a set of software that allows the operator on the front end set these parameters “and then turn the software loose,” Defcon’s co-founder, chief strategy officer and retired U.S. Air Force General Paul Selva told TechCrunch. The software essentially operates against those parameters or inputs to generate the best plan — including the cost tables, resource requirements and schedule. 

This type of planning is difficult enough in the best of circumstances, but during a crisis, defense operators don’t even have the luxury of a day to allocate their resources. That’s where Defcon AI comes in.

“I’ve had all the jobs that we’re actually impacting,” Selva said. During his long military career, Selva held many titles, including the commander of the Air Mobility Command, which oversees nearly all of the Air Force’s fleet of air lift aircraft. He later became the commander of the U.S. Transportation Command, which coordinates transportation missions around the world, including those delivered by ships, trucks, trains and other forms of transportation. Before he retired in 2019, he was nominated by President Barack Obama to be the vice chairman of the Joint Chiefs of Staff. 

He co-founded Defcon in 2022 with Yisroel Brumer and Grant Verstandig, both founding partners of Red Cell Partners (Verstandig is also CEO). Red Cell has an interesting model: The firm makes internal investments but it also incubates companies (including Defcon), often identifying promising entrepreneurs that could lead them. Sometimes, entrepreneurs approach Red Cell before they found a company, and the firm handles things like board building, legal, HR and finance while the company grows. 

In the case of Defcon, Selva says that the company got started “because Air Mobility Command articulated a mission need that wasn’t being filled by industry.” The trio “had a conversation about whether or not we thought this was a tractable problem, and … our intuition was it is a mathematically and software tractable problem, but we have to do it a different way.” 

Brumer and Verstandig have their own impressive pedigrees. Before joining Red Cell, Brumer worked at the Pentagon as acting director of OSD/CAPE (Office of the Secretary of Defense, Cost Assessment and Program Evaluation), an enormous role that essentially functions as the “chief analytics officer” for the DOD, he said, and the overseer for the budget submission process. Verstandig is an entrepreneur who has incubated or grown businesses including Rally Health and defense startup Epirus. 

Defcon AI is targeting a problem of “maximal complexity,” Brumer said. The startup’s system combines different algorithms, including machine learning and mathematical optimization algorithms, to simulate a given scenario and generate the best logistical outcome to meet it. In the initial stages of product development, Defcon used reinforcement learning algorithms that don’t require data, but the company says it is now ingesting more and more data provided by the DOD to power the software. Operators can also choose whether to have the system simulate how an adversary might disrupt the operations, and can tell it to optimize for different variables, like speed versus cost effectiveness.

The company has earned around $15 million in government contracts and delivered a production version that was deployed for a real-world operation with Air Mobility Command less than two years after founding. The company is in the process right now of certifying the software to handle classified, secret information, both to expand its uses in the DOD and to enable it to ingest even more data. It’s also expanding to include trucks, trains and ships to its planning and simulation software.

Defcon is not planning on slowing down. The company sees even more applications across the DOD where its software can make an operational difference, and Brumer said they’re seeing “a very strong demand signal” from the private sector for the product too. Overall, the company says working closely with the end users will result in a better product and a genuine competitive edge in adversarial situations.

“Operational planners are actually trying to assess risk for their commanders,” Selva said. “They’re probably the most skeptical audience for decision support tools, so the extent to which you can partner with them you achieve a better outcome.” 

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Intelligent Optimization Algorithms for Solving the Integrated Nesting and Tool Path Problem for CNC Sheet Cutting Machines

• Conference paper
• First Online: 30 August 2024
• Cite this conference paper

• A. F. Tavaeva   ORCID: orcid.org/0000-0001-9770-4298 15 , 16 &
• A. A. Petunin   ORCID: orcid.org/0000-0003-2540-1305 16 , 17  

Part of the book series: Lecture Notes in Networks and Systems ((LNNS,volume 1089))

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• International Conference on Intelligent and Fuzzy Systems

The paper considers the problem of developing intelligent algorithms for solving the integrated optimization problem of nesting and the tool routing for CNC sheet cutting machines, dubbed “The Integrated Nesting and Routing Problem (INRP)”. INRP combines two well-known optimization problems: the irregular strip packing problem (Nesting Problem), which belongs to the class of Cutting & Packing problem and the problem of optimal tool path routing for CNC sheet cutting machines (Tool Path Problem or Cutting Path Determination Problem). As an objective function, INRP uses an integrated additive cost criterion: the cost of the material used for nesting and the cutting process cost on CNC technological equipment. In this paper, INRP is considered in relation to the class of rectangular congruent parts, which are grouped with the possibility of using the common cut technique. In this case, the so-called multi-contour cutting technique is used. Two algorithms for the rectangular parts packing and tool routing are proposed, aimed at minimizing the cutting process cost and the total objective function. For the packing result with the minimum value of the integrated objective function, a control program for the CNC laser cutting machine is automatically generated. The results of computing experiments are presented. It is also shown that in order to generate a set of admissible nesting layouts at the first stage of solving the INRP problem, it is advisable to use neural networks.

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Acknowledgments

The research was supported by RSF (project No. № 23-21-00343).

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Urals Optical-Mechanical Plant, 33B Vostochnaya Str., Ekaterinburg, 620100, Russia

A. F. Tavaeva

Ural Federal University, 19 Mira Str., Ekaterinburg, 620002, Russia

A. F. Tavaeva & A. A. Petunin

IMM UB RAS, 16 S.Kovalevskaya Str., Ekaterinburg, 620108, Russia

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Department of Industrial Engineering, Istanbul Technical University, Istanbul, Türkiye

Cengiz Kahraman

Sezi Cevik Onar

Department of Industrial Engineering, Yildiz Technical University, Besiktas, Istanbul, Türkiye

Selcuk Cebi

Department of Industrial Engineering, Istanbul Technical University, Besiktas, Istanbul, Türkiye

Basar Oztaysi

Department of Industrial Engineering, Galatasaray University, Istanbul, Türkiye

A. Cagrı Tolga

Irem Ucal Sari

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Tavaeva, A.F., Petunin, A.A. (2024). Intelligent Optimization Algorithms for Solving the Integrated Nesting and Tool Path Problem for CNC Sheet Cutting Machines. In: Kahraman, C., Cevik Onar, S., Cebi, S., Oztaysi, B., Tolga, A.C., Ucal Sari, I. (eds) Intelligent and Fuzzy Systems. INFUS 2024. Lecture Notes in Networks and Systems, vol 1089. Springer, Cham. https://doi.org/10.1007/978-3-031-67195-1_53

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Title: desi data and refinement of standard recombination theory help solve the hubble tension problem.

Abstract: The values of the Hubble constant obtained from the data of the early and of the late Universe differ by 10%. Data obtained by DESI Collaboration can help solve this problem, establishing with high precision the value of the product of the Hubble constant h and comoving of sound horizon at the end of drag epoch to be equal to 101.8 Mpc. This value agrees very well with the earlier refinement of the standard recombination theory and the value of the Hubble constant H0=73.5 km/s/Mpc obtained from measurements in the late Universe.

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