Corrective and Preventive Actions and Management Reviews

[qcqueen94]

Hi everyone - My company's management review is done once per month with our Executive Team. For the summary of the meeting notes, I post the most significant corrective and preventive actions taken and then refer to our corrective and preventive action logs on our Intranet computer system for all the rest. I try to do this so I don't bog down our review on very small issues and focus instead on the bigger ones (i.e. high-dollar returns, preventive actions impacting many or all products, etc.). Much of the management team present is already aware of pretty much all the bigger issues and many of the smaller ones through e-mail discussions, other meetings, etc. I thought this was sufficient for our review, but we were recently audited and told that there was an opportunity for improvement (not a nonconformance) because in the auditor's eyes we did not sufficiently review them. Any thoughts on whether what I described above is sufficient for ISO 9001 purposes in your eyes? Thanks for your help.

 

[Mikishots]

Hi everyone - My company's management review is done once per month with our Executive Team. For the summary of the meeting notes, I post the most significant corrective and preventive actions taken and then refer to our corrective and preventive action logs on our Intranet computer system for all the rest. I try to do this so I don't bog down our review on very small issues and focus instead on the bigger ones (i.e. high-dollar returns, preventive actions impacting many or all products, etc.). Much of the management team present is already aware of pretty much all the bigger issues and many of the smaller ones through e-mail discussions, other meetings, etc. I thought this was sufficient for our review, but we were recently audited and told that there was an opportunity for improvement (not a nonconformance) because in the auditor's eyes we did not sufficiently review them. Any thoughts on whether what I described above is sufficient for ISO 9001 purposes in your eyes? Thanks for your help.

I'd be curious as to the wording of the OFI. Management review requires an assessment of the effectiveness of the processes in the QMS; perhaps your review didn't include results of actions taken or the the effectiveness of the actions taken?

Many companies fall into the trap of simply presenting the findings at the review meeting without presenting any actions or effectiveness results.

 

[Coury Ferguson]

Hi everyone - My company's management review is done once per month with our Executive Team. For the summary of the meeting notes, I post the most significant corrective and preventive actions taken and then refer to our corrective and preventive action logs on our Intranet computer system for all the rest. I try to do this so I don't bog down our review on very small issues and focus instead on the bigger ones (i.e. high-dollar returns, preventive actions impacting many or all products, etc.). Much of the management team present is already aware of pretty much all the bigger issues and many of the smaller ones through e-mail discussions, other meetings, etc. I thought this was sufficient for our review, but we were recently audited and told that there was an opportunity for improvement (not a nonconformance) because in the auditor's eyes we did not sufficiently review them. Any thoughts on whether what I described above is sufficient for ISO 9001 purposes in your eyes? Thanks for your help.

I am also interested in the exact wording of the OFI. Could you please provide that? It will help us better understand what the Auditor is seeing.

 

[milind dhakad]

OFI means

Opportunity for improvement​

 

[milind dhakad]

Sorroy imcomplete answer. Mangement review doesnot means only for the CA & PA on issue . It should consider other points also like review for resource requirement,adequacy for QP and QB for organization, the target for Qo and their trends, NCR in audit and all these points are clearly defined in the standard also . So only data for CA & PA can not be MRM

Thanks
Milind

 

[Jen Kirley]

I would also like to see the exact wording of the OFI.

Even so, there is a risk involved with being selective when presenting the audit results, and corrective actions as input for Management review. If you don't want to bog them down, is it because there are many nonconformances? If you were to summarize the many small issues, might you provide some kind of insight to management such as "five audits found nonconformances with document control - superceded documents found at workstations. This indicates an opportunity to improve this part of our system" or some such.

I have been known to take three or four seemingly unrelated nonconformances and point out they all appeared to lead back to inadequate resourcing. This prompted the GM to ask for details, which I was prepared to provide and explain how 6.1 of the standard involves resources of many kinds: the right people for the job, the right tools for the job, the right environment/facilities to do the job. In this way the audit input turned out to provide information, not just data.

 

[somashekar]

Hi everyone - My company's management review is done once per month with our Executive Team. For the summary of the meeting notes, I post the most significant corrective and preventive actions taken and then refer to our corrective and preventive action logs on our Intranet computer system for all the rest. I try to do this so I don't bog down our review on very small issues and focus instead on the bigger ones (i.e. high-dollar returns, preventive actions impacting many or all products, etc.). Much of the management team present is already aware of pretty much all the bigger issues and many of the smaller ones through e-mail discussions, other meetings, etc. I thought this was sufficient for our review, but we were recently audited and told that there was an opportunity for improvement (not a nonconformance) because in the auditor's eyes we did not sufficiently review them. Any thoughts on whether what I described above is sufficient for ISO 9001 purposes in your eyes? Thanks for your help.

If the inputs to management review about CAPA mentions:
1. Effectiveness of actions taken.
2. Ongoing status of actions being taken
3. Recommendation of certain resources for action implementation
AND
the outputs of management review mentions:
1. Agreement or further actions on effectiveness monitoring
2. Agreement or further new inputs for actions being taken
3. Sanction of resource or need for more information to make sanction
you have covered.
Do you have these ?
Very small issues perhaps can be closed with a correction and not blown up to a CAPA.