CAPA for missed Sales KPI?

[KarenA01]

We had an internal audit today by an external consultant or 9001 (we are also 13485)

We go over our high level KPI's at management review and we lack about missed targets and what we would so about them and that winds up in the minutes... and if there is anything different that needs to be done about to then what we are doing it would wind up as an action item.

This auditor today said we need to open a CAPA when we miss a KPI for things likes a sales target. He said it's a non conformance that we did not meet the target so a CAPA needs to be opened.

That is his interpretation of the standard...
Is that a common interpretation of the standard?

I did not think of a target as a specification , so while management does need to deal with things like that. missing it would not a non-conformance per say.

-Karen

 

[geoffairey]

I don’t agree with the auditor at all. that would mean that you’d have to open a CAPA if you failed to achieve an agreed objective. What rubbish.

Unless, you’re failing to comply with one of your own policies or procedures.

It sounds like you already have a “lessons learned” discussion and if you can see an improvement you raise an action to implement change. I’d push back on this.

 

[Bev D]

The auditor is an idiot. They are wrong. Full stop.
And there is no such thing as a “CAPA”.

 

[KarenA01]

The auditor is an idiot. They are wrong. Full stop.
And there is no such thing as a “CAPA”.

Ok so think CA... instead of CAPA

We have a blended 9001 and 13485 quality system so we do have a CAPA SOP and form as 13485 is based on 9001:2008 and not a separate CA SOP/Form.

So would be we need to issue a formal corrective action for missing something like a sales KPI?

-Karen

 

[Sidney Vianna]

Your subcontracted internal auditor is “less than brilliant”. You might start a corrective action request against your hiring practices of approving questionably qualified consultants to perform an internal audit. It is amazing how many people having no business acumen end up in the “ISOsphere”.

 

[KarenA01]

I don’t agree with the auditor at all. that would mean that you’d have to open a CAPA if you failed to achieve an agreed objective. What rubbish.

That was what I thought.

-Karen

 

[Bev D]

So would be we need to issue a formal corrective action for missing something like a sales KPI?

-Karen

No your auditor is wrong. There is no requirement to issue a corrective action for missing a KPI goal.

 

[Randy]

Missing a KPI like that is no big deal, crap maybe it was just too lofty, so missing it and not doing any anything to correct or possibly review and revise is where the problem is. It's your KPI (objective) so you can say "hey, not this year" and flush the thing into the septic tank.

 

[KarenA01]

Thanks All.

I though he was wrong about that... thanks for confirming it.

I don't think he will write it as a non-conformance , but he might write it up as an OFI or an observation. I'll see when we get the audit report.

-Karen

 

[qualitymanagerTT]

We had an internal audit today by an external consultant or 9001 (we are also 13485)

...

This auditor today said we need to open a CAPA when we miss a KPI for things likes a sales target. He said it's a non conformance that we did not meet the target so a CAPA needs to be opened.

Which ISO 9001 clause did he / she cite as not being fulfilled?

Or is it a requirement of your organization?