Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Jim Wynne said:

For instance, the actions taken to prevent nonconforming conditions from occurring aren't preventive action if they happen as a result of a nonconforming condition. It's preventive, but no, it's not preventive. The language is being tortured and not only does no one seem to care, a lot of people seem to delight in tightening the screws.

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I agree. That is why I would like to see ISO 9001:2008 changing the way they address the requirements for preventive actions. I know it is not going to happen, but one can hope. Maybe in 2013...
The ISO APG paper states:

2.3) There is often significant “philosophical” discussion between the auditor and the organization about where corrective action ends, and where preventive action begins. For example, if a nonconformity is detected in process “A”, are actions taken to avoid future nonconformities in processes “B”, “C” and “D” preventive actions, or simply within the scope of the corrective actions taken for process ”A”? The auditor should avoid being “side-tracked” by these discussions, and concentrate on whether or not the actions were effective. The “labeling” of the actions taken is of secondary importance!

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Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Sidney Vianna said:

I agree. That is why I would like to see ISO 9001:2008 changing the way they address the requirements for preventive actions. I know it is not going to happen, but one can hope. Maybe in 2013...
The ISO APG paper states:

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The passage you quote is the equivalent of ISO saying, "I'm going to set your pants on fire, while you're wearing them, but don't be distracted by the smoke, flames and pain."

The CAPA (Corrective and Preventive / Predictive Action) circle

I want to follow up on "definitive discussion"...If you can visualize the CAPA circle:

1. How can we predict detection of problems that allow information flow to go to Upper Management.
2. Management than help with resource allocation (priorities, structure) that drive better CAPA results.
3. Which improve flow of information and predictability...

Is this a global view of CAPA or something else?

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Jim Wynne said:

The passage you quote is the equivalent of ISO saying, "I'm going to set your pants on fire, while you're wearing them, but don't be distracted by the smoke, flames and pain."

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Jim, I always value your feedback. Could you please review this official ISO interpretation on 8.5.3 and offer your assessment? If it was not clear before, this interpretation should put an end to this discussion . Once and for all.

Re: The CAPA (Corrective and Preventive Action) circle

Michael Malis said:

I want to follow up on "definitive discussion"...If you can visualize the CAPA circle:

1. How can we predict detection of problems that allow information flow to go to Upper Management.
2. Management than help with resource allocation (priorities, structure) that drive better CAPA results.
3. Which improve flow of information and predictability...

Is this a global view of CAPA or something else?

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Any thoughts on a CAPA circle?

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Sidney Vianna said:

Jim, I always value your feedback. Could you please review this official ISO interpretation on 8.5.3 and offer your assessment? If it was not clear before, this interpretation should put an end to this discussion . Once and for all.

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Interpretation Request:​

​

Clause 8.5.3 a)
Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of “potential nonconformities and their causes”?​

Interpretation: No​

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If the answer is "No!" then why on earth does the clause even exist? For twenty years, we have been told to eschew anecdotal evidence in favor of documented evidence. Yet this interpretation literally says, "Forget documenting anything. Just tell the auditor you do it and he can't ask for any non-anecdotal evidence."

Sidney Vianna said:

But Jim, why do you think the definitions are stupid? Actually, imo, the definitions are straightforward. The application of preventive action is the problem, from my view point.

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The interpretation cries out for the word "stupid" in keeping the clause in the Standard.

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

It is mind boggling. ISO 9001:2000 8.5.3.d) requires records only for the results of preventive actions taken, but no records required to determine if preventive actions were warranted.

This element of the standard - PREVENTIVE ACTION - begs for clarification. Or like Wes suggests, be obliterated. A requirement that adds so much confusion to the users of the Standard and assessors verifying conformance to it, should either be thoroughly revised or eliminated from the document.

There may be a easier solution.....

How many contributors to this thread have PA (Preventive Action) procedures that list other clauses of the applicable standard (ISO 9001, ANS/ISO/IEC 17025, TS 16949, ISO/IEC 17020, etc.) and identify the activities under those clauses as preventive action?

After all, you will have records for most of those.....

Hershal

Hershal said:

There may be a easier solution.....

How many contributors to this thread have PA procedures that list other clauses of the applicable standard (ISO 9001, ANS/ISO/IEC 17025, TS 16949, ISO/IEC 17020, etc.) and identify the activities under those clauses as preventive action?

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Are we going round in circles? Hershal, are you suggesting that the solution for this problem is for the PA procedure to identify clauses of the standard such as, for example, 7.3 - Design and Development, as preventive actions?

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Sidney Vianna said:

It is mind boggling. ISO 9001:2000 8.5.3.d) requires records only for the results of preventive actions taken, but no records required to determine if preventive actions were warranted.

This element of the standard - PREVENTIVE ACTION - begs for clarification. Or like Wes suggests, be obliterated. A requirement that adds so much confusion to the users of the Standard and assessors verifying conformance to it, should either be thoroughly revised or eliminated from the document.

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I certainly agree with you and Wes. Threre's another thread going on right now about what should be changed in the '08 go-round, and if they don't clean up this part of it... :truce: