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When Do I See a CAPA Specialist?

dion119x138Denise Dion, Vice President
of Regulatory and Quality Services for EduQuest

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, offers design insight.

Question: My company struggles with deciding when to elevate a complaint to the level of a CAPA. At times we disagree about how to differentiate complaints, non-conformances and CAPAs. Can you help?

I see this problem at a lot of companies. You’re far from alone. First of all, a complaint is a record of a reported non-conformance or what a customer believes is a non-conformance with your product. After you receive a complaint, you should undertake an initial complaint investigation, gathering data and asking yourself questions such as:

  • What is the extent of the problem, and what is its impact to patients, users or bystanders?
  • Has this complaint been previously investigated, or is it the subject of an ongoing investigation?
  • Has this problem been anticipated previously? For example, is it occurring at an expected frequency and/or with an expected severity?
  • Do you need to understand the true root cause of the complaint? 

If your answers to these questions—coupled with the data you collect—indicate a need to further investigate, then you should open a CAPA. Your CAPA investigation should be designed to provide you with sufficient data to make corrections or field actions (such as a recall) if needed.


Chicago | June 13-15

Verification vs. Validation is one of the most misunderstood aspects of Design Controls. Ms. Dion will clear up misconceptions and provide applicable, actionable examples during her two-hour review of the topic at
OMTEC 2017. 


A CAPA also can be initiated directly from a non-conformance report. You may be thinking of the CAPA as a non-conformance report itself, but that’s not the case. Think of the CAPA as a referral to a specialist. Here’s an analogy:

If you visit an emergency room, the doctor treats you based on the subjective data you provide and the objective data she collects. The ER doctor performs an assessment to determine what actions must occur next. If the doctor cannot rule out a heart attack or appendicitis or some other condition that requires immediate further investigation and corrective action, she sends you immediately to a specialist who can sort things out.

So the ER doctor handles the initial complaint investigation. If you are cut, have a broken bone or have an obvious infection, the ER doctor treats your symptoms (prescribes medication, sews you up, puts a cast on you, etc.). In other words, the ER doctor administers the correction.

If the doctor doesn’t think you need anything more at the moment, he prescribes something to treat your symptoms (correction and containment) and tells you to come back if anything changes or worsens (track and trend).

In contrast, the specialist uses all the information gathered by the ER doctor and, if needed, does additional tests to determine your problem (the root cause determination) and takes the appropriate measures to cure you (corrective or preventive actions).

Not everyone who goes to the ER ends up seeing a specialist. Sometimes, the initial investigation is sufficient to fix the problem.

Now back to our world of non-conformances: if you find a product or process that is not conforming, do an initial investigation the same as you would for a complaint.

If there is a need for further investigation, you open a CAPA. If you have internal audit findings that indicate—say, a non-conforming quality management system, you open non-conformance or potential non-conformance investigations for each finding and determine from those investigations what, if any, CAPAs are needed.

You should maintain complaints and CAPAs in separate but linked systems. You also should maintain non-conformances that are not complaints in a separate system linked to your CAPA system. When you open a CAPA, it should be linked to a unique non-conformance or to a complaint (or a list of complaints).

Assign identification numbers to each non-conformance and complaint and include them in the CAPA record. Conversely, a non-conformance or complaint closed to a CAPA should include a CAPA identification number in the record of the non-conformance or complaint.

You may also like these CAPA resources:

Why Won't May CAPA Process Work?

How to Avoid Risky CAPA Decisions


Ms. Dion has been with EduQuest since 2002, following 18 years with FDA. Her final eight years with FDA were served at headquarters as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health, as well as between ORA headquarters and field staff. EduQuest can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..