Corrective and Preventive Actions aligned to design related defects.

#1
In 21 CFR 820.100 in the code of regulations, it has a checklist in the back of the book as auditing questions for the various processes. A few of the questions are "Is there a documented and properly implemented procedure for the collection and processing of design-related defects? Does the procedure explain the decision process to pursue the investigation and corrective action of the root cause? Also, " Are appropriate statistical techniques applied to analyze design-related defect data to identify opportunities for corrective or preventative action and to detect recurring problems? 21 CFR 820. 100 (a). With all of this being said, does an organization have to include design defects in their CAPA system or can it be completed through change control? Also, does the CAPA system have to align with the design control process according to the 21 CFR 820.100 clause?
 
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chris1price

Trusted Information Resource
#2
My understanding of these statements is that when evaluating defects, you should consider design related issues and use appropriate statistical trending, and not just consider manufacturing non-conformance or other post-design issues. So this is using CAPA to feedback into design; and not trying to embed CAPA into the design process.

Out of interest, which book are you referring to?
 

Tagin

Trusted Information Resource
#3
With all of this being said, does an organization have to include design defects in their CAPA system or can it be completed through change control?
820.100 is rather short, and does not refer explicitly to Design. Instead, as chris1price notes, when analysis of "processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data" leads to "identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems", and those actions happen to be design-related, then a CAPA raised and design actions taken. Depending on your QMS, I would think that the CAPA feeds into your change control system. That is, the CAPA 'actions to be taken' acts as an input to change control, not supplanting the change control system. Just my view.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
FDA expects failures in devices through the lifecycle of the product. Can you capture those failures? How?

FDA is using Remote Regulatory Assesments for low risk devices. CAPA and another subsytems are ALWAYS chosen bare minumum. You need solid processes and CAPA system to show them.
 

yodon

Staff member
Super Moderator
#5
In 21 CFR 820.100 in the code of regulations, it has a checklist in the back of the book as auditing questions for the various processes.
There's no "checklist" in the regulation. Are you maybe talking about the QSIT Guide?

does an organization have to include design defects in their CAPA system or can it be completed through change control?
As several said, the CAPA process can certainly feed the change process but ALSO, the defect analysis should feed the CAPA system. Not every defect should be thrown into the CAPA pool - that's only going to bog the system down. Instead, look for trends that may indicate a process issue. That's the real intent for the CAPA system. 1 bug: fix the problem; a trend: fix the process (as well as the problems).
 
#6
My understanding of these statements is that when evaluating defects, you should consider design related issues and use appropriate statistical trending, and not just consider manufacturing non-conformance or other post-design issues. So this is using CAPA to feedback into design; and not trying to embed CAPA into the design process.

Out of interest, which book are you referring to?
Chris, the book I am referring to is the code of Federal Regulations GMP Auditor's Basic Handbook for part 21 CFR 820 in the QSR audit checklist section in the back of the book. I think we are both thinking the same way. not actually embedding CAPA into the design process but just as feedback into the design so when changes are made in the design process it can be captured with a cause and a justification for the change which would feed into the corrective action. Thanks for your input.
 
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