Integrating CAPA and Change Control processes

[ir_ahm]

We are a small medical device manufacturer that has EN ISO 13485:2016 implemented and certified. We are having a bit of trouble understanding how to comply both with CAPA and Change Control process requirements of the standard.

Our usual flow is that we open a Nonconformity and after analysis of the problem, we decide the actions (e.g. notifying the problem, doing a design change, etc.). For example, we open a Nonconformity because a part has broken and then we re-design this part. We will open a "Change record" to follow up on the design change (ISO 13485, Clause 7.3.9). If the change is also acting as a Corrective Action (ISO 13485, Clause 8.5.2), we open a "CAPA record" instead of a Change record.

In our CAPA record, we have a specific "Analysis/Evaluation" section where we verify that the corrective action "does not adversely affect the ability to meet applicable regulatory requirements or the safety or performance of the medical device" (ISO 13485, Clause 8.5.2 e)). Is this enough to comply with the review requirements for design changes defined in Clause 7.3.9?

It has always confused me that almost all CAPAs involve some type of change (either QMS or product changes), so it does not fit well with having "a CAPA record" and "a Change Control record". Do you have any advice on simple implementations of these two processes? Are we understanding the whole thing wrong?

Thank you very much!

 

[Billy Milly]

Evaluaton of "absence of adverse effect" does not cover all aspects of a design change. When doing a design change, you still have to assure all of the (original) design inputs are met - a "CAPA change" could adversely effect your inputs, which stretch beyond regulatory requirements.
I do not see much sense in combining CAPAs and design change in one process, but tying them together makes sense (design change is the action plan of the CAPA, once you finish the design change you feed this back to CAPA for effectiveness evaluation).

 

[Golfman25]

I would flow chart it with the change control a ”detour” to you change control process. In other words after you do root cause as part of your Capa and determine a change is necessary go into your change process to do the change and then come back to Capa for effectiveness, etc. There might be some duplication but you can just refer to each process in your documentation.

 

[Tidge]

IMO: CA/PA and Change Control should be separate processes, and should have distinct records. If you are a small company, it may be the same people participating in each process, but that doesn't mean the processes are the same.

CA/PA can result in specific Action Items which warrant using the Change Control process. Some CA/PA Action Items won't require invoking the change control process.

Changes can be motivated for (m)any reasons, not just because of NCRs or Corrective Actions.