Quality System Records: What Evidence Do FDA Inspectors Expect to See in Them?

Q: Within our company and others, there are varied interpretations of FDA’s expectations of 21 CFR 820.186 — Quality System Records. Can you provide me with guidance on what’s expected to meet this requirement? 
 
Also, during an FDA inspection, what are some questions the investigator might ask specifically about Quality System Records? What evidence do inspectors expect to see?

A: Under FDA’s Quality System Regulation (QSR), Quality System Records are all those records — not including device-specific records — you must have to demonstrate your compliance with the overall QSR requirements. 
 
Rather than repeating for each QSR requirement, “maintain records for…”, 21 CFR 821.186 is more of an umbrella statement saying that all records not explicitly discussed before in the regulations still must be maintained. 
 
Quality System Records include those for training, management review, CAPA, non-conformances (other than device-specific ones), electrostatic discharge (ESD), calibration, equipment maintenance, and building environmental records (if applicable), to name just a few of the most common ones.

FDA will not specifically ask for your “quality records” but will look at your policies, SOPs, work instructions, and quality manual.

So FDA will not specifically ask for your “quality system records” — but it will look at your policies, SOPs, work instructions, and quality manual. It will see if you have defined all the records the Agency considers necessary and if you can demonstrate you have your quality system records properly identified and maintained.
 
Regarding questions an FDA inspector will ask, there are so many possible ones. I recommend you have someone do a mock FDA inspection to prepare you and your staff fully (EduQuest provides this service for many of our clients). 
 
But here are a few likely questions to expect from an FDA inspector:

  • Do you have a quality manual?
  • Do you have an SOP on training? Let me see the training records, CVs and job descriptions for the following people…
  • Do you have a CAPA SOP? Let me see a list of CAPA records for the past “X” amount of time. Let me see the following CAPAs…
  • Do you have a Management Review procedure? Let me see the agenda and list of attendees from your last management review meeting…
  • Do you have a Change Control process and procedure? Let me see the following records…
  • Do you have a non-conformance process? Let me see a list of non-conformances for the past “X” amount of time. Let me see the following non-conformances….

After these kinds of initial questions, the inspector’s questions will build on each other and go into more depth — and possibly go in different directions, depending on your answers.

Answered by Janis Olson, Vice President of Regulatory & Quality Services at EduQuest (22 years as an expert FDA investigator and as the FDA regional director of information management resources). Jan also is the co-instructor and developer of EduQuest’s 1.5-day Managing & Auditing Supplier Quality training class.

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