CAPA for missed Sales KPI?

Golfman25

Trusted Information Resource
This thinking comes from 20+ years ago. I remember the discussions with the group I was using to work thru the old iso/qs standards. The result was to make your targets “achievable“ to avoid a NC. As most here said, complete rubbish.

The key is to review and react. If one is trending the wrong way, what do you do to explain or correct it.
 

qusys

Trusted Information Resource
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
The question is: did you put in place actions (PDCA approach) to have an improvement of that missed KPI) ? How long did the downtrend last? Did you recover? Was it a single event due to a temporary issue? Consider that this could be one of the item of the management review input: results of the monitoring and measurements. This is concerns with the paragraphs of performance evaluations (par.9.1) and improvement (par.10.1 and 10.2). of the standard ISO 9001. KPI downtrend alerts your organization that there is problem in the Sales process, that could impact its effectiveness.
 

Mike S.

Happy to be Alive
Trusted Information Resource
There are certainly auditors and consultants who issue BS non-conformances. I've seen my share. But sometimes I think things may be lost in interpretation between the actual NC and what is stated in a post.

The OP went from saying that the auditor "...said it's a non conformance..." to later say "I don't think he will write it as a non-conformance".

Thus it is always preferable to give us the exact wording used by the auditor. If he documents it, let's see exactly what he said.
 

KarenA01

Involved In Discussions
The OP went from saying that the auditor "...said it's a non conformance..." to later say "I don't think he will write it as a non-conformance".

He most definitely said it was a non-conformance because not meeting a KPI is not meeting a specification... and i tried arguing that with him that a KPI target was not a specification, but he was having none of it.

Why I said the latter, was at the end he said he would not write some things up (not specifically this) that he said were non-conformances, saying we could do what he says or not , but implying we would have nonconformaces with registrar audits if we don't.

So although he states things in no uncertain terms when discussing them, in the end somethings seem to be basically his recommendations for what we should do, acting as a consultant. I'm not 100% sure where this particular item falls.

-Karen
 

KarenA01

Involved In Discussions
The question is: did you put in place actions (PDCA approach) to have an improvement of that missed KPI) ?
It was mainly over the last year due to to fewer orders from our primary customer and that had nothing to do do with us. We expect their orders to increase by the end of the year, but we have been working to broaden out customer base... In fact that is why we got 13485 certified (which was at the end of last month - BTW We just got initially ISO9001 certified 1 year ago).

We have stared going to trade shows and doing other things ...We are new to the industry so working to to get better known an be more attractive to customers.

Consider that this could be one of the item of the management review input: results of the monitoring and measurements. This is concerns with the paragraphs of performance evaluations (par.9.1) and improvement (par.10.1 and 10.2). of the standard ISO 9001. KPI downtrend alerts your organization that there is problem in the Sales process, that could impact its effectiveness.

All the above was discussed, along with the other KPIs at management review.

-Karen
 

Tidge

Trusted Information Resource
I don't think this is an obvious non-conformance (I seriously question the application of "failure to meet a specification") , but it certainly is a legitimate red-faced question to ask... at least in my thinking about "management review" in the context of 13485. "Sales KPI" are not a required element of Management Review (per 5.6.2) but if they have been made part of Management Reviews then it is possible that Management should be addressing these missed goals in a manner consistent with missed goals in other areas required by 13485 compliance. Typically Management Reviews in 13485 have a 'track and trend' element... even if such a thing found its way into a CA / PA system, usually there is some sort of scaling mechanism to avoid non-value-added efforts.

It is not inconceivable (to me) that an organization could be monitoring sales to get an extra window onto other areas required by 13485 Management Reviews. Just off the top of my head: If sales were vanishing in a certain region because of new regulatory requirements that somehow the folks responsible for the regulatory component of Management Reviews (5.6.2 (l)) were ignorant of, this would be worth tracking by the same team.
 

qusys

Trusted Information Resource
It was mainly over the last year due to to fewer orders from our primary customer and that had nothing to do do with us. We expect their orders to increase by the end of the year, but we have been working to broaden out customer base... In fact that is why we got 13485 certified (which was at the end of last month - BTW We just got initially ISO9001 certified 1 year ago).

We have stared going to trade shows and doing other things ...We are new to the industry so working to to get better known an be more attractive to customers.



All the above was discussed, along with the other KPIs at management review.

-Karen
Understood Karen, so I think you have also documented the reasons why of theat KPI falling action in mgmt review. No ncn to me, let me suggest to review eventually your KPI if they fit no longer to your organization.
 

Sidney Vianna

Post Responsibly
Leader
Admin
If sales were vanishing in a certain region because of new regulatory requirements that somehow the folks responsible for the regulatory component of Management Reviews (5.6.2 (l)) were ignorant of, this would be worth tracking by the same team.
Any organization that “needs” an internal audit nonconformity to react to vanishing sales is more dysfunctional than anyone could save it from itself.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Management Review Summer 2022 we stated we wanted to have quarterly meetings with our NB to meet MDD expiration in 2023. We had a meeting in January then the MDR changes were approved by the EU allowing us EU market status until 2028..

The message is, the world isn't static. Things that appear to be critical to business can change drastically and take on a new level of risk.
 

Jim Wynne

Leader
Admin
People use abbreviations without regard for what they actually mean. In this case, the abbreviation is "KPI" and the salient letter is "P." Periodic sales numbers is not a process. You can have a goal or objective for annual sales, but that doesn't mean it's a process. The attachment of a KPI in this case is entirely inappropriate.

When a goal is established, another thing that people forget is that there must be a plan for achieving it. Unless there's a clear and objective path to the goal, and everything in the way of resources has been provided for achieving it, it's doomed to failure.

No goals/objectives should be established for anything that the company doesn't have complete control over.

Finally, you have an incompetent auditor.
 
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