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

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• 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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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.

Guide: Corrective and Preventive Actions (CAPA)

Author: Daniel Croft

Daniel Croft is an experienced continuous improvement manager with a Lean Six Sigma Black Belt and a Bachelor's degree in Business Management. With more than ten years of experience applying his skills across various industries, Daniel specializes in optimizing processes and improving efficiency. His approach combines practical experience with a deep understanding of business fundamentals to drive meaningful change.

The importance of a systematic approach to addressing discrepancies cannot be overstated in an era where quality assurance is paramount. The Corrective and Preventive Actions (CAPA) methodology is a beacon in this realm, providing a structured path to not only identifying and resolving nonconformities, but also preventing their recurrence. CAPA, which is widely recognized in a variety of industries ranging from healthcare to manufacturing, not only improves the quality and dependability of products and services but also fosters a culture of continuous improvement. This guide walks businesses through the CAPA process step by step, ensuring they are prepared to face challenges and raise their standards.

What is CAPA?

Corrective and Preventive Actions (CAPA) form a key approach in quality management systems. They provide a structured approach to managing and resolving issues as they arise. Both corrective and preventive actions are often used within other methodologies, such as 8D.

CAPA is divided into two focuses:

• Correct Actions: Corrective actions focus on identifying and resolving existing issues, which are often triggered by customer complaints, the results of internal or external audits, and process monitoring.
• Preventive Actions:  Preventive actions are a proactive approach to identifying potential failures before they result in actually being an issue and allowing businesses to take action to prevent them. 

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Corrective Actions

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

Step 1: Identification

The first step of taking corrective action is to identify existing issues or non-conformity. These can come in various forms such as customer feedback or complaints, internal audits, external audits from customers who review your processes, government regulator audits, or internal performance metrics. 

Most medium to large businesses will have various forms of audits such as finance, health and safety or environmental, the audits review processes and usually result in corrective actions needing to be taken.

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.

Root cause analysis tools such as Fishbone Analysis or 5 Whys are usually used. These tools are used as they provide a clear demonstration of root cause analysis of the issue which can be demonstrated to the stakeholder who raised the issue, such as the auditor or customer.

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

Preventive actions are proactive measures that aim to reduce the likelihood of problems occurring in the first place. Where Corrective Actions deal with existing issues, Preventive Actions seek to avoid potential future issues.

Here’s a breakdown of the steps involved:

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

Once the potential risks of failure are identified, the next step is to assess the risk. A risk assessment looks into what the impact, detectability and likelihood of the risk occuring and can be scored a risk priority number (RPN) which is calculated when using an FMEA analysis

Example of FMEA:

Based on the risk assessment, a preventive action plan should then be developed. This could involve process changes, employee training, or resource allocation. 

Preventive actions are not a set-it-and-forget-it process; they are a continuous process of reviewing and improving. Businesses need to continuously monitor processes and feedback, adjust, and improve as necessary.

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.

• Motschman, T.L. and Moore, S.B., 1999. Corrective and preventive action .  Transfusion science ,  21 (2), pp.163-178.
• Raj, A., 2016. A review on corrective action and preventive action (CAPA).   African Journal of Pharmacy and Pharmacology ,  10 (1), pp.1-6.
• Westcott, R., 2005. Corrective vs. preventive action.   Quality Progress ,  38 (3), p.104.

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

A: The CAPA process aims to identify, address, and prevent nonconformities or issues within processes, products, or services, ensuring continuous improvement and adherence to quality standards.

Q: How is a Corrective Action different from a Preventive Action?

A: Corrective Actions address existing nonconformities or issues, ensuring they do not recur. In contrast, Preventive Actions focus on identifying potential issues or risks and implementing measures to prevent them from occurring in the first place.

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?

A: Absolutely! Documenting each step of the CAPA process ensures traceability, facilitates reviews, provides evidence for regulatory compliance, and offers a reference for future problem-solving activities.

Q: What tools can be used for Root Cause Analysis?

A: Several tools aid RCA, including the “5 Whys” technique, Fishbone Diagram (Ishikawa), and Fault Tree Analysis. The choice of tool depends on the nature of the problem and the preference of the investigating team.

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?

A: A blame-free environment promotes openness and transparency. When team members feel safe reporting issues without fear of reprisal, it leads to quicker identification and resolution of problems and encourages a culture of continuous improvement.

Daniel Croft

Hi im Daniel continuous improvement manager with a Black Belt in Lean Six Sigma and over 10 years of real-world experience across a range sectors, I have a passion for optimizing processes and creating a culture of efficiency. I wanted to create Learn Lean Siigma to be a platform dedicated to Lean Six Sigma and process improvement insights and provide all the guides, tools, techniques and templates I looked for in one place as someone new to the world of Lean Six Sigma and Continuous improvement.

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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.

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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.

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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.

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A3 Thinking: A Structured Approach to Problem Solving

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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.

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What is Corrective Action Preventive Action (CAPA)?

What is CAPA? The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects and non-conformities.

Effective CAPAs are the backbone of your quality management system , acting as the mechanism for fixing problems and optimizing your processes.

Let's dive in and take a look at everything you need to know about the CAPA process.

CAPA meaning

The CAPA acronym isn't unusual: the world of quality management is full of acronyms.

SOPs. NCRs. GxP. And CAPAs.

So what does 'CAPA' mean?

What does CAPA stand for?

CAPA stands for 'corrective and preventive action'.

As the name suggests, CAPAs are about problem-solving. And it's a two-step process: when something goes wrong, a CAPA is executed to ' correct ' the immediate issue, then to ' prevent ' it reoccurring with a tweak or improvement that addresses the cause.

What is the definition of CAPA?

CAPA is defined as a systematic approach used in various regulated industries, including manufacturing, healthcare, and quality management, to identify, investigate, and address problems or non-conformities in products, processes and systems.

The purpose of CAPA is to rectify existing issues and prevent their recurrence in the future.

A CAPA system is therefore a crucial part of the modern quality management system, since quality in general is all about ensuring the integrity and quality of the products and services your company provides.

Learn how to establish a CAPA management system

We can see how important this is when we consider that over half of the causes of a business failure can be attributed to internally generated problems that weren't properly addressed.

The Shewhart Cycle, more commonly known as Plan Do Check Act, is a classic quality management approach that enshrines CAPA procedures.

In this case, the 'check' and 'act' portions of the cycle are synonymous with CAPAs: systems and processes are checked , problems are found, then those problems are fixed with corrective and preventive actions .

What is CAPA in practice?

What does a CAPA system look like in real life, then?

Remember, establishing CAPAs requires a commitment to quality and continuous improvement. It's an ongoing process that helps you identify and resolve issues proactively, ensuring that your business operates efficiently and delivers high-quality products or services.

And it's not always something businesses get right.

CAPA requirements for medical devices marketed in the United States are laid out in FDA 21 CFR 820.100(a) - and failure to instil proper CAPAs is a consistent leading cause for FDA audit failure and the sending of Form 483s as a slap on the wrist.

FURTHER READING: 5 major CAPA medical device requirements

Analysis of FDA warning letter citations sent to drug companies between 2015 and 2023 reveals a similar pattern.

'Quality unit and investigations', 'complaints handling', 'process validation', and even 'cleaning validation & techniques', are all major recurring warning letter triggers which could have been avoided with robust CAPAs in place.

CAPA meaning in quality

CAPAs and quality really go hand-in-hand. CAPA corrective actions and preventive actions, after all, are how your organization can eliminate quality weaknesses and ensure your products and services are optimized.

CAPAs are essential for maintaining high standards and ensuring continuous improvement, so you'll find them in any mature and effective quality management system.

The CAPA process typically involves several steps:

• Identification : Recognizing a problem or potential issue.
• Evaluation : Assessing the significance and impact of the problem.
• Investigation : Determining the root cause of the issue.
• Action Plan : Developing corrective and preventive actions to address the root cause.
• Implementation : Executing the action plan.
• Follow-Up : Monitoring the effectiveness of the actions taken.

Your quality system should contain CAPA procedure documents to record how your organization intends to detect and react to defects and nonconformances. They should also lay out how each step will be executed and closed out to ensure CAPA success.

And because CAPAs are so critical for modern regulated businesses, it's important that you choose the right tools and systems to manage them efficiently.

Dedicated CAPA software can accelerate and automate your CAPA processes, providing bespoke workflows and analytical reports to help you keep up with your CAPA demands at scale.

FURTHER READING: Learn how to write a CAPA report

When is a CAPA required?

A CAPA is required whenever a non-conformity or potential issue is identified that could impact your product quality, safety, or compliance.

CAPA 'triggers' can occur from routine inspections, audits, customer complaints, or internal reviews.

It's important that your business gets these observation mechanisms in place so defects and nonconformances don't go unnoticed and unaddressed.

CAPA in manufacturing: an example

To illustrate in more detail when a CAPA would be needed, let's consider a CAPA example in a drug manufacturing setting.

CAPA example kick-off : A batch of pharmaceutical product fails quality inspection due to a defect in its critical quality attributes (CQAs).

Corrective Action :

• Identification : The defect is identified during quality control.
• Evaluation : The extent of the defect is assessed, and it's determined that the issue affects the entire batch rather than just a single tablet. Past batch records are analyzed for the root cause and potential recurring issues.
• Investigation : The root cause is traced back to an error in the operation of piece of equipment: the reactor temperature has been set too low, causing residual starting material which has affected drug purity
• Action Plan : The reactor is properly set and the affected batch is discarded and reworked.
• Implementation : The reactor updates are made, and batch production resumes 
• Follow-Up : Additional inspections are conducted to ensure the batch defect does not recur.

Preventive Action :

• Identification : Potential equipment operation error is identified as a risk.
• Evaluation : The risk is assessed, and it's determined that an SOP and staff training could prevent future issues.
• Action Plan : Operating staff are trained on the importance of reactor temperature control, and a new SOP is rolled out to cover this activity
• Implementation : Training and new documentation are rolled out to educate staff on the importance of good equipment operation
• Follow-Up : The effectiveness of the training and the integrity of the manufacturing process is monitored regularly.

Why is CAPA important?

CAPAs are crucial for several reasons:

• Quality Assurance : They help maintain high product quality and compliance with your industry standards
• Customer Satisfaction : By addressing and preventing issues, CAPAs ensure that customers receive reliable, high-quality products, reducing complaints and churn
• Regulatory Compliance : Many regulated businesses are required to have CAPA processes in place to comply with regulatory standards. CAPA in pharma companies, for instance, is a routine activity for ensuring drug efficacy and safety.
• Continuous Improvement : CAPAs promote a culture of continuous improvement, helping your business to constantly enhance your processes and products.

Getting your CAPAs in place

Understanding what CAPA is and its importance in quality management is essential for any organization committed to excellence.

By implementing effective CAPA processes, and even adopting CAPA and nonconformance management software , your organization can address existing issues, prevent future problems, and continuously improve your operational strength and maturity.

Whether in manufacturing, pharmaceuticals, or any other industry, CAPAs play a vital role in ensuring quality, compliance and customer satisfaction.

Lola is an ASQ Certified Medical Device Auditor with extensive experience working for large multinational corporations and start-ups across Europe and North America. She works closely with Qualio customers to implement and maintain their eQMS, helping them to achieve their quality goals and bring their product to market efficiently.

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Understanding Corrective and Preventive Action: A Systematic Approach to Problem-Solving

Updated: June 16, 2024 by Ken Feldman

Often organizations do a root cause analysis after a problem has occurred. Is there something you can do as a preventive action prior to something happening. Let’s learn more about CAPA.

Corrective and Preventive Action (CAPA) is a systematic approach used in various industries, including manufacturing, healthcare, and quality managemen t, to identify and address the root causes of problems and prevent their recurrence. CAPA is an essential component of quality management systems and is often required for compliance with regulatory standards, such as ISO 9000.

Overview: What is CAPA? 

Here’s a breakdown of the key elements of CAPA:

• Problem Identification – CAPA begins with the identification and documentation of a problem or nonconformance. This can be done through various means, such as customer complaints, internal audits, quality control checks, or other forms of monitoring.
• Root Cause Analysis (RCA) – Once a problem is identified, a thorough investigation is conducted to determine its root cause(s). RCA techniques like the 5 Whys , fishbone diagrams , or fault tree analysis may be employed to delve deeper into the underlying factors contributing to the issue.
• Corrective Action – Corrective actions involve implementing measures to address the root cause of the problem. These actions aim to eliminate or mitigate the identified issue. Corrective actions can include process changes, equipment repairs, retraining employees, or revising procedures.
• Preventive Action – In addition to addressing the immediate problem, CAPA also focuses on preventing similar issues from occurring in the future. Preventive actions involve implementing proactive measures to identify and eliminate potential causes of problems before they happen. This can include process improvements, employee training, enhanced quality controls, or changes in design or materials.
• Documentation and Verification – Throughout the CAPA process, it is crucial to document all steps taken, including the problem description, root cause analysis, corrective actions, and preventive actions. This documentation serves as evidence of compliance and provides a reference for future evaluations. Furthermore, the effectiveness of the implemented actions should be monitored and verified to ensure that they have effectively resolved the problem and prevented its recurrence.
• Continuous Improvement – CAPA is closely tied to the concept of continuous improvement. By addressing problems and preventing their recurrence, organizations can enhance their overall quality and efficiency. Lessons learned from the CAPA process can be used to improve processes, systems, and procedures across the organization.

An industry example of CAPA

Problem: The company has been receiving customer complaints about a specific product’s packaging being damaged during transit, leading to product loss and customer dissatisfaction.

• Problem Identification – The company’s quality control team receives multiple customer complaints regarding damaged packaging.
• Root Cause Analysis (RCA) – The team conducts a root cause analysis and identifies that the packaging material used is not strong enough to withstand the transportation process, resulting in damage.
• Corrective Action – The company decided to address the immediate problem by changing the packaging material to a stronger and more durable alternative. They communicate this change to the packaging supplier and implement the new packaging material in the production process.
• Preventive Action – To prevent similar packaging issues in the future, the company decides to conduct a thorough review of its packaging specifications and requirements. They collaborate with the packaging supplier to assess the suitability of different materials, conduct packaging tests, and establish updated packaging standards that ensure product protection during transit.
• Documentation and Verification – The company documents the customer complaints, the RCA findings, and the implemented corrective and preventive actions. They also established a monitoring system to track future customer complaints related to packaging damage. Regular audits and inspections are conducted to verify the effectiveness of the new packaging material and adherence to updated packaging standards.
• Continuous Improvement – The company uses the lessons learned from this CAPA process to continuously improve its overall packaging process. They proactively review other products’ packaging, assess potential risks, and implement preventive actions, such as enhanced packaging design, additional protective measures, or improved packaging handling procedures.

Frequently Asked Questions (FAQ) about CAPA

Here are some frequently asked questions about Corrective and Preventive Action (CAPA):

What is the difference between corrective action and preventive action? 

Corrective action is taken to address an existing problem or nonconformance, focusing on resolving the root cause and preventing its recurrence. Preventive action, on the other hand, aims to identify and eliminate potential causes of problems before they occur, thus preventing future issues.

Why is CAPA important? 

CAPA is important because it helps organizations improve their quality management systems, enhance customer satisfaction, and ensure compliance with regulatory standards. It provides a systematic approach to problem-solving, root cause analysis, and prevention of recurring issues.

How can the effectiveness of CAPA be measured? 

The effectiveness of CAPA can be measured by monitoring key performance indicators (KPIs) related to the identified problem. This can include tracking the recurrence of similar issues, monitoring customer feedback and complaints, assessing process or product quality metrics, and conducting internal audits or inspections.

Can CAPA be applied in non-manufacturing industries? 

Yes, CAPA principles can be applied in various industries beyond manufacturing. It is widely used in healthcare, pharmaceuticals, information technology, aerospace, automotive, and other sectors where quality management is important. The specific implementation may vary based on industry-specific requirements and regulations.

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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
• Walkthrough of how you can apply the 8D approach
• Useful tips and practical examples

The 5 most common risk assessment tools explained - plus handy infographics!

• Fishbone diagram
• 5 Whys analysis
• Fault Tree Analysis (FTA)
• Failure Mode and Effects Analysis (FMEA)
• Risk Ranking

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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