Establishing and Maintaining a CAPA System

CAPA process, CAPA requestsQ: 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.

Root Cause Analysis Samples

Q: I am looking for samples of a RCA.  I will be doing training on that topic and I would like to have some samples to use with the participants.

A: Thank you for contacting ASQ and the Quality Information Center.  I received your request for samples of root cause analysis.  Root cause analysis is defined as a “quality tool used to distinguish the source of defects or problems.  It is a structured approach that focuses on the decisive or original cause of a problem or condition” (from The Quality Improvement Glossary by Donald L. Siebels).

Root cause analysis figure

The image (right) is take from Root Cause Analysis: Simplified Tools and Techniques.

I found over 100 resources on RCA in the ASQ Knowledge Center (if you would like to browse through them all, here is the link to my original search results).  I thought you might be most interested in case studies which provide examples of how root cause analysis has been used.  I found almost 40 case studies which focus on root cause analyais and I’ve listed some case studies below which I thought would be helpful:

Abstract: Customer Complain investigations weren’t getting to root causes.  Logic trees proved more effective than fault trees in determining what actually went wrong.  After root cause analysis, complaint numbers dropped by half.  That and indirect benefits led to bottom-line results.

Abstract: The authors used Six Sigma to improve the process of manufacturing gear boxes for mechanical power transmission at a foundry in India. The goal was to improve product performance by reducing variation in the casting of components, thereby reducing defects. The analyze phase used root cause analysis and failure mode and effect analysis to identify several process variables, including pattern design and maintenance, worker training, and the proportions of scrap and coal inputted into the molds, that were increasing the frequency of the major defects.

Abstract: A root cause analysis project saved Clipper Windpower $1 million in lost revenue. By identifying the root causes of turbine failure during inclement weather, Clipper increased customer satisfaction through improved turbine availability. This project also supported a key supplier’s quality process, as Clipper’s team helped redesign and test an improved anemometer. Team members mastered quality tools and strategies, preparing them for future improvement projects.

Abstract: Cross-functional teams identified root causes of injuries and reduced accidents by 48 percent in one year while saving an estimated $714,000 in cost avoidance over a 24-month period. To compile data and identify root causes, team members used trend graphs, Pareto diagrams, bar charts, and fishbone diagrams. A key tool used in developing an action plan was the solution selection matrix, a systematic approach that allows for the best possible solutions to surface.

The following webcasts may also be helpful for those who are new to root cause analysis:

Root Cause Analysis for Beginners, Part 1” & “Root Cause Analysis for Beginners, Part 2

I hope that this information is helpful.  Please feel free to contact me with any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI

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