Do you use paper or web-based templates for CAPA processes?

[Bill M.]

I am involved in implementing an ISO 13485 for a certain startup. Since some of them got used to working with paper-based QMS, they want to keep paper-based templates for CAPA processes, even they are planning to try eQMS. But I truly believe that is going to be easier for them in case they try to transfer to an electronic version.

Please help me convince them.

 

[Tidge]

I recommend that you present the company with CAPA processes enforced by off-the-shelf digital solutions. There will be tangential concerns (electronic records & signatures) but it is less likely that the startup will customize their process in such a manner that leads to non-compliance. An off-the-shelf solution for medical device manufacturers is less likely to have skipped process steps and ought to reinforce a standard CAPA process. CAPA is one of the key areas reviewed using the FDA QSIT approach; you don't really want to risk handling one CAPA differently than another.

Tangentially: I have heard rumblings that certain auditors (e.g. for MDSAP) have expressed expectations such that there is little practical difference between CA and PA; specifically that there is an expectation of evaluation of effectiveness for PA. Can anyone speak to this?

 

[yodon]

Tangentially: I have heard rumblings that certain auditors (e.g. for MDSAP) have expressed expectations such that there is little practical difference between CA and PA; specifically that there is an expectation of evaluation of effectiveness for PA. Can anyone speak to this?

The standard is pretty clear:

8.5.3 e) reviewing the effectiveness of the preventive action taken, as appropriate.

To me, it's a bit silly since, with a PA, no NCs have occurred so you're assessing the effectiveness of a process that has never been technically broken. But, yes, the question is asked and there should be a response. Like with CAs, I always have an effectiveness evaluation plan as part of the CAPA.

 

[Tidge]

To me, it's a bit silly since, with a PA, no NCs have occurred so you're assessing the effectiveness of a process that has never been technically broken. But, yes, the question is asked and there should be a response. Like with CAs, I always have an effectiveness evaluation plan as part of the CAPA.

This is pretty much the circle everyone is landing in. I agree that it is silly (that once an action is determined to be PA, it defaults to being appropriate to have an effectiveness check).