Flexing Your CAPA Muscle

Making Your CAPA System a Strength of Your Quality Management System



Is your corrective and preventive action (CAPA) system a strength or weakness of your Quality System? Have you been frustrated by tying up valuable company resources, mired in too many CAPAs, and getting ineffective results? 

Well, maybe you have a CAPA knowledge problem, or your procedures are not well defined, or you just don’t have the resources to support CAPA improvement activities. There is ample industry guidance on how to develop a robust CAPA system, including regulations and standards that provide requirements for developing a CAPA process.

You’ve probably heard of the term “death by CAPA.” Not every issue needs to be escalated to a CAPA. Knowing when to initiate a CAPA will help avoid this common pitfall. This article will address key elements to developing a robust CAPA process by following a systematic approach. The question isn’t whether you need to implement CAPA. The question is how much benefit do you want to achieve from your CAPA system?

According to the Food and Drug Administration (FDA), the following is a trend of inspectional observations for medical device manufacturers. As you can see, CAPA is at the top of the list for citations issued by the FDA.

Op 4-Year (2016-2020) Cumulative Trending CGMP FDA Inspectional Observations — Drug And Devices


21 CFR 820.100(a) - 1,348 citations - CAPA (establishing and maintaining procedures)

21 CFR 820.198(a) - 1,162 citations - Complaint files (procedures for receiving, reviewing, and evaluating complaints by a designated unit)

21 CFR 820.90(a) - 577 citations - Control of nonconforming product

21 CFR 820.75(a) - 551 citations - Process validation

Paying Attention To Your CAPA System Matters

Understanding CAPA requirements and documenting them in a procedure is the foundation to having an effective CAPA system. Training employees to understand the principles of CAPA and to develop competency is vital to achieving positive results. Everyone that touches or is involved in execution of the CAPA system needs to be trained to the appropriate level of use. 

Too many times, I have audited companies that can’t provide sufficient evidence of training. It is fundamental that employees responsible for conducting investigations have the appropriate documented competency to perform adequate investigations, determine correct root cause(s), and formulate proper resolution plans. Companies benefit from providing external CAPA training for employees.

A robust CAPA system will leverage the appropriate resources and incorporate the following elements for a systemic approach:

  1. Bring the right people to the table and set up a strong cross-functional team for your CAPA. Do not underestimate the importance of reaching out early to the subject matter experts (SMEs) associated with the issue. Include research and development, engineering, and regulatory as needed, which ensures that the issue is appropriately identified and investigated from the beginning.
  2. Clearly identify the issue to be addressed. This includes ensuring the issue is vetted by a governing board and having factual supporting evidence. A well identified problem will ensure a thorough and accurate investigation leading to correct root cause identification. 
  3. It is good practice to identify the regulation, standard, and/or internal procedure which is not being met. Avoid the common mistake of including potential root causes in your problem statement.
  4. Provide background for reader understanding. This includes an overview of how the process is supposed to flow when working correctly, where the nonconformity took place in the process, and when and how the nonconformity was identified or discovered.
  5. Quarantine and bracketing. This includes segregating product determined to be nonconforming or suspected of potentially being nonconforming. You need to document, with proper rationale, what you determined to be impacted and how you arrived at that conclusion. The scope of the issue should also be established by identifying which production or quality system processes to include in the CAPA.
  6. Risk and impact determinations. This includes reviewing risk documents, as appropriate, to understand the failure mode and associated potential risk. The level of risk impact determines whether a CAPA should be raised depending on whether the issue is minor, moderate, or major/critical.
  7. Investigation process. This includes selecting the appropriate tool to investigate the issue. For example, you would use a fishbone diagram for a complex problem and a 5-WHY exercise for a more straightforward issue. Consider utilizing two root cause analysis tools for a more robust investigation. The investigation should include rationale for either retaining or eliminating potential failures. All remaining failures are considered root causes or likely causes and need to be appropriately addressed through a resolution plan.
  8. Resolution plans. These plans should be systematic and a template may be used to address each specific element of the plan such as what will be done to correct the problem/address the root cause(s), how the action prevents recurrence of the issue, and what verification will be performed to ensure actions can be suitably implemented and do not raise any adverse issues.
  9. Effectiveness monitoring. This includes establishing criteria to measure the effectiveness of the implemented actions. This also includes activities such as determining how measurement will be performed, which method will be used for evaluation, what rationale will be used for duration and/or sample size, and how to ensure no adverse consequences are raised.
  10. Trending data. This includes having a set of metrics to measure the performance of your CAPA system, whether CAPAs are being closed in a timely manner, and so forth.

“If It Isn’t Documented Then It Didn’t Happen"

You’ve likely heard this proverbial statement mentioned before, either from an auditor or from a previous manager. Documentation is a critical part of having an effective CAPA system. 

In the long run, it provides traceability of the issue, what was done to investigate it and resolve it, and the necessary rationale for decisions made as a result of data analysis. A well-documented CAPA can stand up under the scrutiny of any auditor or FDA inspector.

The best way to determine the effectiveness of your CAPA system is to perform a gap assessment. The assessment should, first of all, determine your level of compliance with the ISO standards or health authority regulation requirements. 

Secondly, the gap assessment should include the review of recently completed CAPA records to determine adequacy of documentation. The third step is to take initiative and update your procedures. It may be wise to hire a consulting company with extensive industry experience to review your CAPA system and make recommendations to assist in developing a robust and effective CAPA system.

Benefits of a Well-Established CAPA System

  • Following a well-documented systematic process will yield more consistent improvements and results.
  • Prevent potential failures by implementing preventive action when adverse trends are observed.
  • Reduce costs of poor quality by addressing major or systemic problems in design, manufacturing, and other areas of the QMS.
  • Avoid regulatory compliance audit findings related to inadequate development and implementation of a CAPA system.

Related content

  • Save the Date for Your Label!

  • Mergers and Acquisitions: Labeling Part 1 of 2

  • Good Documentation Practices: A Quick Guide To Tips, Tricks, and Common Pitfalls