Establishing and Maintaining a CAPA System


Q: We have a Corrective Action and Preventative Action (CAPA) system, and we find that CAPAs are almost always completed late — even though we do have an extension request form for CAPAs, and the system sends automated reminders to  employees in advance.

What can we do to resolve this issue and avoid late CAPAs?

A: I will answer this question based on the information provided.

1. Does the CAPA system rank the CAPA based on risk? If not, each CAPA should be ranked either high, medium, or low.

High risks generally mean that the problem behind the CAPA could have a negative affect on the business and put it at risk. For example, in the medical device industry, a high risk CAPA could include a regulation violation, something that can harm a device user or patient, or issues that could result in legal action against the company.

2. Does the CAPA system have a way to involve top management? If not, it should — especially if timely corrective action is not being taken in instances of high risk CAPAs.

3. Does the management review process include a statistical analysis of the time it takes to complete CAPAs?

Often, reports to management include the number of CAPAs greater than 90-days old and greater than 180-days old. In addition to reporting on the number of open CAPAs, also report on the number of CAPAs completed by the due date and the number of CAPAs that are overdue (past the original, assigned completion date).

It is a good idea to also convert these numbers into percentages to make data digestible and to allow for comparison making.

4. Next, discuss with management (if possible) to consider consequences for employees if company problems that result in a CAPAs are not addressed in a timely manner.

With this approach, proceed with caution. You must make certain that the CAPA system is robust. Not every little problem is a CAPA. A good way to weed out the CAPAs from the non-CAPAs is to ask: is this an issue that requires an investigation into the root cause? And, does this problem require corrective action to fix it? If the answers are yes, then it is probably a CAPA.

5. You may want to consider benchmarking how other organizations structure their CAPA system and look to guidance documents for help. The Global Harmonization Task Force published a guidance document help establish CAPA systems. It is for the medical device industry, but it can be applied elsewhere.

Jim Werner
Voting member to the U.S. TAG to ISO TC 176
Medical Device Quality Compliance (MDQC), LLC.
ASQ Senior Member
ASQ CQE, CQA, RABQSA Lead QMS Assessor

Related Content:

Preview a sample chapter from the ASQ Quality Press book CAPA for the FDA-Regulated Industry, along with the full table of contents by clicking here.  Find more information about this book by visiting its ASQ Quality Press webpage.

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One Response to Establishing and Maintaining a CAPA System

  1. Néstor Oscar Aversa says:

    Dear Sirs, one of the factors that could affect adversely to close a CAPA is the level of the burocracy of the form. You can ask if all signatures are mandatory, if CAPA form could be part of an intranet as to notify quickly to other stakeholders. I agree with the previous comment to clasify according to the risk involved but even within the same ranking you must fix a date to search for the root cause. To find the root causes is not the same to close the CAPA. You can need much more time if for example to make the corrections it is needed a strong investment in facilities.
    Néstor Aversa
    Biochemist, CQE

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