Management Team "Actions" vs. CAPA (Corrective Actions)

[mdbincincy]

At various levels of our organization, management team tracks action items from various meetings. Typically these are staff meetings or project meetings.

Recently, an ISO 9001 based nonconformity was raised that these action items are not classified and documented as corrective actions or preventive actions.

I'm really struggling with this finding. We have a formal CAPA system related to audit findings, customer complaints, and process improvement inputs, but I cannot fathom subjecting every action - mostly tasks, really - to the CAPA system. Similarly, I cannot see having every manager in the organization - frontline to senior management - classifying each and every item they not as a follow up during the course of conducting all staff and project meetings. It feels like "ISO for the sake of ISO" or even worse...

Any thoughts on how to approach this in a value adding manner?

Thanks!

 

[RoxaneB]

At various levels of our organization, management team tracks action items from various meetings. Typically these are staff meetings or project meetings.

Recently, an ISO 9001 based nonconformity was raised that these action items are not classified and documented as corrective actions or preventive actions.

I'm really struggling with this finding. We have a formal CAPA system related to audit findings, customer complaints, and process improvement inputs, but I cannot fathom subjecting every action - mostly tasks, really - to the CAPA system. Similarly, I cannot see having every manager in the organization - frontline to senior management - classifying each and every item they not as a follow up during the course of conducting all staff and project meetings. It feels like "ISO for the sake of ISO" or even worse...

Any thoughts on how to approach this in a value adding manner?

Thanks!

If the actions/tasks are being implemented to support existing items in the CAPA system, I'd suggest ensuring the meeting minutes show the link. Example - "Develop training manual for activity XXX (refer to CAPA# 123 for additional information)". And CAPA# 123 can be updated by referencing the meeting that was held as a means to demonstrate forward movement.

If, however, the action/task is a stand-alone activity that may impact the QMS, then entering it into the CAPA is a nice idea. In a previous life, our teams would do this and the meeting minutes would capture "CAPA#456 initiated" as a way to address an identified concern.

 

[somashekar]

Recently, an ISO 9001 based nonconformity was raised ~~~~

What is this ... ?
ISO9001 based nonconformity
Please do not look from the ISO9001 viewing glasses.
A nonconformity is a nonconformity, and if you have a management team tracking down such areas for action, be happy that a methodology is in place for CAPA identification.
Simply map this into your CAPA process and facilitate how such management tracking can be established as a meaningful CAPA that is effective to your organization and then how they can be recorded.
Look at and into your organization working. Map such good processes to the requirements of the ISO9001 standard.

~~ Good Luck ~~

 

[Jim Wynne]

At various levels of our organization, management team tracks action items from various meetings. Typically these are staff meetings or project meetings.

Recently, an ISO 9001 based nonconformity was raised that these action items are not classified and documented as corrective actions or preventive actions.

I'm really struggling with this finding. We have a formal CAPA system related to audit findings, customer complaints, and process improvement inputs, but I cannot fathom subjecting every action - mostly tasks, really - to the CAPA system. Similarly, I cannot see having every manager in the organization - frontline to senior management - classifying each and every item they not as a follow up during the course of conducting all staff and project meetings. It feels like "ISO for the sake of ISO" or even worse...

Any thoughts on how to approach this in a value adding manner?

Thanks!

What was the source of the finding? If "action items" are just stuff people need to do as a result of the meeting discussion, there shouldn't be any need to classify them as corrective or preventive actions. There might be a preventive action nugget here or there that's worth recording, but in general plain ol' meeting minutes should necessarily trigger CA or PA.

 

[Kales Veggie]

At various levels of our organization, management team tracks action items from various meetings. Typically these are staff meetings or project meetings.

Recently, an ISO 9001 based nonconformity was raised that these action items are not classified and documented as corrective actions or preventive actions.

I'm really struggling with this finding. We have a formal CAPA system related to audit findings, customer complaints, and process improvement inputs, but I cannot fathom subjecting every action - mostly tasks, really - to the CAPA system. Similarly, I cannot see having every manager in the organization - frontline to senior management - classifying each and every item they not as a follow up during the course of conducting all staff and project meetings. It feels like "ISO for the sake of ISO" or even worse...

Any thoughts on how to approach this in a value adding manner?

Thanks!

I am curious to see the actual write up and what clause. Was it written against the standard or your internal procedure? If the latter, you should consider rewriting / clarifying the internal procedure.

ISO 9001 says this:

"Corrective actions shall be appropriate to the effects of the nonconformities encountered"

It does not say any where in the standard that you must document C/A in a CAPA system. Your procedure may say this.

 

[Motorhead]

I am also interested to see the basis for the alleged nonconformance. Every action your company takes does not necessarily qualify as a CAR or PAR. It's up to you to decide which do. Who decided this was an "ISO9001 based nonconformity", and why?

 

[mdbincincy]

The basis for the nonconformities cites has been clauses 8.5.2 and 8.5.3. Our internal process classifies that risk and impact determination drives the tracking as formal CAPA.

The evidence along with the requirements cited is:
Corrective and preventive actions are recorded in an action table at the end of weekly meeting minutes; however root cause has not been recorded and the items have not been differentiated and recorded as corrective or preventive.


What has been observed and referenced as evidence is the staff meetings of several teams across the organization. The actions vary greatly in significance - from the day-to-day to long-term cross-team items. Many actions are simply work tracking items. The team status varies significantly across the sample with some consisting of mid-management and other on the front-lines.

 

[Ninja]

Hi mdbinincy,

you are making us guess. What are the "actions" ?

Are they "Determine root cause for late shipment to automotive supplier resulting in line shutdown" or are they "Determine the number of tables to rent for the company picnic" ?

You'll see a quite different reaction here depending on which "actions" you are talking about. They are both actions items that can result from management meetings...one belongs in your CAPA system, the other one doesn't.

 

[Motorhead]

I also suspect there's more to the story we don't yet know. Are all of your CAR/PAR's recorded only as action items in your meeting minutes? Or are CAR/PAR's recorded somewhere else? If only in meeting minutes, how do you distinguish CARs from PARs from normal everyday tasks?

 

[mdbincincy]

Thanks for the reply!

Anything that is related to a line shutdown would drive CAPA which would require RCA. Risk / impact assessment drives inclusion in the CAPA system. Highest risk classification requires 8D.

Most of the items are a little more serious than tables for the company picnic, but they quite often look like "Sam talk to Ted to assure planning for changeover", "Bill to report on project status in two weeks" or "Assure everyone has completed health and safety training". I'm struggling with adding any extra overhead to these sorts of things. I really like the fact they are tracked in the action list and that seems more than sufficient.