How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action)

[Jim Wynne]

In Reply to Parent Post by Wullie23

How do you prioritise Urgent?

You put it above semi-urgent.

[Ajit Basrur]

In Reply to Parent Post by Jim Wynne

You put it above semi-urgent.

Thats a good one

[kgott]

In Reply to Parent Post by somashekar

You seem to have just missed a point ... and here it is in ISO9001 8.5.2 c) and 8.5.3 b)
Evaluate the need for action to ensure that nonconformities do not recur.
Evaluate the need for action to prevent occurrence of nonconformities.

Somashekar; I agree with your point re 8.5.2 but could you, or anyone else, please comment on why, in the previous job, did a CB auditor and the quality manager both, separately, tell me that if we don't respond to and fix each and every NC the CB notes in their report then the certification is in jeopardy?

The only reason I can think of is that the NC procedure said that this is what was to be done.

thanks

[somashekar]

In Reply to Parent Post by kgott

Somashekar; I agree with your point re 8.5.2 but could you, or anyone else, please comment on why, in the previous job, did a CB auditor and the quality manager both, separately, tell me that if we don't respond to and fix each and every NC the CB notes in their report then the certification is in jeopardy?

The only reason I can think of is that the NC procedure said that this is what was to be done.

thanks

Every NC that the CB notes and reports to you is after the evaluation that it needs a corrective action. So it goes without saying that you need to respond to it (the CA), and fix the same if they are fixable. (the correction)
Ex. If the NC is about use of shelf life expired materials without any assessment, you need to first fix it (take off all the shelf life expired material from your use and storage and quarantine same so as to prevent its unintentional usage) ...
and then find out the CA which will track and prevent issue / use of such shelf life expired materials, without assessing its validity.

[kgott]

In Reply to Parent Post by somashekar

Every NC that the CB notes and reports to you is after the evaluation that it needs a corrective action. So it goes without saying that you need to respond to it (the CA), and fix the same if they are fixable. (the correction)
Ex. If the NC is about use of shelf life expired materials without any assessment, you need to first fix it (take off all the shelf life expired material from your use and storage and quarantine same so as to prevent its unintentional usage) ...
and then find out the CA which will track and prevent issue / use of such shelf life expired materials, without assessing its validity.

Thanks for that, if the NCs they were referring to were those which related to the management system itself, would that make any difference.??

thanks

[somashekar]

In Reply to Parent Post by kgott

Thanks for that, if the NCs they were referring to were those which related to the management system itself, would that make any difference.??

thanks

When the NC relates to the management system itself, it would make no difference for a CA requirement. Rather the NC is of a more serious nature.
Management system is something of a structural nature over which the various functions operate. This interacts with a whole lot of functions and could reflect upon the very strength and robustness of the quality management system. A CA on a management system NC would hence need that much more depth of root cause analysis and systematic CA's which could also trigger one or more CA's in other related systems.

[Aguas]

Many Corrective Actions is an evidence of poor management commitment, a tip to dealing with this scenario that worked for us is as follows, and this tip may sound simple but this will remove people from their comfort zone:
Do 5 why’s analysis splitting on 3 sections:
1) First Step of the 5 why Analysis (Why we produce non conformed part/service), this section should be responded by direct labor participants, Production, Product and Process responsible. Once they drill down to root cause, for the corrective action, than challenge the Corrective action, The action should be involve a physical change on the process, avoid responds such lack of training, human error etc. (Here we are looking for a physical change to correct the issue).
2) Second Step 5 Whys Analysis (Why the discrepant material/service was not caught internally), This section should be responded by QC personnel and all persons involved to define product criteria and specifications. Once they drill down to root cause, ask for the corrective action, this should include devices to catch the problem internally also re-evaluate control limits and implement warning limits that works for the production and avoid manufacturing product out of specification (Here we are looking for realistic tolerance and sampling plans that works for customer and manufacturing).
3) Third Step 5 whys Analysis (Why Management and Quality system allows producing non conforming product and let escape). This section should be responded by Management and Company Quality System responsible, but before completing these 5 whys path, they need to ask if they already allocated resources to implement the two above corrective actions, than they can start working on their 5 whys analysis. At this section looks for a strategy or plan to deploy the action obtained during this investigation and deploy to similar products or process as a Corrective Action.
Hope this help to you to be out of this scenario.

[kgott]

In Reply to Parent Post by Aguas

Many Corrective Actions is an evidence of poor management commitment, a tip to dealing with this scenario that worked for us is as follows, and this tip may sound simple but this will remove people from their comfort zone:
Do 5 why’s analysis splitting on 3 sections:
1) First Step of the 5 why Analysis (Why we produce non conformed part/service), this section should be responded by direct labor participants, Production, Product and Process responsible. Once they drill down to root cause, for the corrective action, than challenge the Corrective action, The action should be involve a physical change on the process, avoid responds such lack of training, human error etc. (Here we are looking for a physical change to correct the issue).
2) Second Step 5 Whys Analysis (Why the discrepant material/service was not caught internally), This section should be responded by QC personnel and all persons involved to define product criteria and specifications. Once they drill down to root cause, ask for the corrective action, this should include devices to catch the problem internally also re-evaluate control limits and implement warning limits that works for the production and avoid manufacturing product out of specification (Here we are looking for realistic tolerance and sampling plans that works for customer and manufacturing).
3) Third Step 5 whys Analysis (Why Management and Quality system allows producing non conforming product and let escape). This section should be responded by Management and Company Quality System responsible, but before completing these 5 whys path, they need to ask if they already allocated resources to implement the two above corrective actions, than they can start working on their 5 whys analysis. At this section looks for a strategy or plan to deploy the action obtained during this investigation and deploy to similar products or process as a Corrective Action.
Hope this help to you to be out of this scenario.

Your approach sounds good in but I for one dont know enough about the 5 why methodology to go beyond that so hopefully those more knowledeable about 5 why than I will come in here and elaborate a little more this good idea.

Thanks for raising it.