Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product.
Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a former FDA investigator, what specific kind of quality system maintenance activities does FDA expect to see?
A: Fortunately, the regulation provides a pretty good outline of how to maintain your quality system.
First of all, the regulation tells you that you’re going to do quality audits. You’re going to document the results of those audits, and you’re going to make sure management is aware of the audit results by conducting management reviews.
Then you’re going to use those audit findings, as well as all your other quality data, to help you continuously improve your products, processes, and quality system.
That’s where your CAPA system — the feedback loop – comes in and serves a key role in maintaining your overall quality system.
In addition, you’re going to maintain good control over changes to your product’s design, suppliers, manufacturing systems, and servicing procedures. You’re going to audit your suppliers. You’re going to control nonconforming product.
Last but not least, you’re going to review complaints to better understand how your product is performing and being used in the marketplace.
“Use that field data to help you continuously improve your product and processes.”
And, again, you’re going to use that field data — adding it into your feedback loop — to help you continuously improve your product and processes.
These are all considered fairly standard activities under an effective quality system. Do them and document them, and you’ll go a long way in meeting FDA’s expectations for quality system maintenance.
Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and who was co-editor of FDA’s Investigations Operations Manual, which is updated annually as a resource for FDA’s own investigators. Denise is the lead instructor for EduQuest’s training class on QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality System Regulation. The class can be delivered on-site at the time and place of your choosing, and is also offered publicly twice each year.