Guidelines for Making Quality System Changes

Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality system changes.

I’ve been told by some that verification of quality system changes is simply confirming they actually got changed and went live. This, to me, sounds surprisingly weak.

So with a CAPA change to a quality system procedure, what activities typically are required to verify those changes prior to their implementation? Also, what documentation is needed on these activities?

A: You’re right — there’s more to it than just confirming the implementation of quality system changes.

Often when we make a change to a quality system procedure, we forget all the links it may have with other procedures.

When making a change to your quality system, you need to make sure:

  1. You haven’t broken any links to other systems. Often when we make a change to a quality system procedure, we forget all the links it may have with other procedures. I’ve seen broken links more often than not, and those broken links have resulted in FDA 483 observations.
  2. You have updated all SOPs that reference the procedure that’s been changed.
  3. Everyone that should be trained on the procedure has been trained and/or is aware of the change, according to company policies.
  4. The change is applicable to the root cause of the issue identified by your CAPA investigation.
  5. The change is compliant with all applicable regulations and standards.

Regarding documentation: in your change order, document all associated documents that have been updated. Also, document that you’ve looked for links to other systems and ensured they have not been impacted by the change.

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 contributed to the development of FDA’s Quality System Inspection Technique (QSIT). Denise is the lead instructor for EduQuest’s two-day training class, The CAPA Compliance Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.


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