Should the TC 176 Re-word the Requirements for Preventive Action?

Sidney Vianna · Nov 4, 2007

I posted this on another thread, because I really believe the TC 176 missed the boat (again). Since the 1994 Edition of ISO 9001 when an emphasis was added to the preventive action aspect of ISO 9001, countless discussions have ensued on corrective vs. preventive actions. Here, at the Cove, we have had prolonged discussions on the subject.

I like to poll the Cove membership to see if you agree that a re-wording of clause 8.5.3 should have been part of the ISO 9001:2008 amendment, which was supposed to clarify the existing requirements of the 3rd Edition of 9001. It is too late now for the TC 176 to do anything about this aspect of the Standard for next year's release (unless we see a miracle). But is it just me or do you agree that 8.5.3, the way is presently written, is very confusing and ambiguous?

Cast your vote, please.

Jim Wynne · Nov 4, 2007

Sidney Vianna said:
I posted this on another thread, because I really believe the TC 176 missed the boat (again). Since the 1994 Edition of ISO 9001 when an emphasis was added to the preventive action aspect of ISO 9001, countless discussions have ensued on corrective vs. preventive actions. Here, at the Cove, we have had prolonged discussions on the subject.

I like to poll the Cove membership to see if you agree that a re-wording of clause 8.5.3 should have been part of the ISO 9001:2008 amendment, which was supposed to clarify the existing requirements of the 3rd Edition of 9001. It is too late now for the TC 176 to do anything about this aspect of the Standard for next year's release (unless we see a miracle). But is it just me or do you agree that 8.5.3, the way is presently written, is very confusing and ambiguous?

To me, the corrective/preventive dichotomy has always been the most glaring weakness of the standard. It causes much unnecessary confusion. Anything done to prevent problems from happening is preventive, regardless of the reason(s) for taking the action in the first place. When there's a mandate in place already for continualous improvement, there's no need to create a separate category for preventive action.

Stijloor · Nov 4, 2007

Sidney Vianna said:
I posted this on another thread, because I really believe the TC 176 missed the boat (again). Since the 1994 Edition of ISO 9001 when an emphasis was added to the preventive action aspect of ISO 9001, countless discussions have ensued on corrective vs. preventive actions. Here, at the Cove, we have had prolonged discussions on the subject.

I like to poll the Cove membership to see if you agree that a re-wording of clause 8.5.3 should have been part of the ISO 9001:2008 amendment, which was supposed to clarify the existing requirements of the 3rd Edition of 9001. It is too late now for the TC 176 to do anything about this aspect of the Standard for next year's release (unless we see a miracle). But is it just me or do you agree that 8.5.3, the way is presently written, is very confusing and ambiguous?

Cast your vote, please.

I don't think that changing the wording would help companies that don't give a hoot about correcting/preventing problems. Smart companies do this already; they verify that their CA/PA actions work and that they are effective. In addition, any process within a quality management system that fails to deliver the expected results is ineffective; thus a nonconformity against ISO 9001:2000.

Stijloor.

Helmut Jilling · Nov 4, 2007

I voted for the clarification. The paradox is this. To me, the wording is crystal clear. I read it to mean exactly what is says. However, because so many smart folks here on the Cove and elsewhere, interpret it differently, obviously it is not clear enough. If it is too late to get into the new standard, perhaps they could do an interpretation to help clarify their intent. The data (and arguments) speak for themselves.

Eric ng · Nov 5, 2007

I don't know what is exactly not clear about the Corrective Action & Prevention Action clauses in ISO 9001:2000. Anyone having doubts about the exact impretation of these clauses, should post his/her questions to ISO Technical Committee. They are in a better position to clarify any doubt you may have. As long as you are very clear on the definitions of Corrective and Preventive Action, and genuinely spend time to identified root causes and confirm them with facts, including actions for those potential causes which may happen already but may happen in future, and not simply fill up the CAPA form, I don't see you are going to face any problem with auditors.

I think the ISO TC did a good in coming out with guidlines to enhance the correct interpretations of various clauses when new ISO is launched.

Eric

Sidney Vianna · Nov 5, 2007

Eric ng said:
I don't know what is exactly not clear about the Corrective Action & Prevention Action clauses in ISO 9001:2000. Anyone having doubts about the exact impretation of these clauses, should post his/her questions to ISO Technical Committee.

We already established that the TC 176 makes mistakes. You are new to the Cove. You probably have not had the time to see 5% of the discussions concerning the subject. This one for example. If you are so sure of your position, do us a favor. Post 5 examples of clear preventive actions from your organization here, and let us dissect it. Just for the fun of it. :tg:

vanputten · Nov 8, 2007

Why do we only get those 2 choices in the vote? How about this choice, "No. Becaue no one really cares about preventive action" or something similar? Why is this an either/or proposition? This or that, A or B?

Are we saying that if 8.5.3 in ISO 9001 is re-worded, then users will acutally value preventive action?

ISO 9001 is all about certification. If I get the certification, what do I care what any section of ISO 9001 states?

Helmut Jilling · Nov 8, 2007

vanputten said:
Why do we only get those 2 choices in the vote? How about this choice, "No. Becaue no one really cares about preventive action" or something similar? Why is this an either/or proposition? This or that, A or B?

Are we saying that if 8.5.3 in ISO 9001 is re-worded, then users will acutally value preventive action?

ISO 9001 is all about certification. If I get the certification, what do I care what any section of ISO 9001 states?

Gee, Mr. van P, I hope you are only being facetious? ISO is all about certification? That is the last point of value. It is a program that can induce much improvement and benefit, when done right.

Helmut Jilling · Nov 8, 2007

vanputten said:
Why do we only get those 2 choices in the vote? How about this choice, "No. Becaue no one really cares about preventive action" or something similar? Why is this an either/or proposition? This or that, A or B?

Are we saying that if 8.5.3 in ISO 9001 is re-worded, then users will acutally value preventive action?

ISO 9001 is all about certification. If I get the certification, what do I care what any section of ISO 9001 states?

Gee, Mr. van P, I hope you are only being facetious? "ISO is all about certification?" That is the lowest point of value from ISO. The program can induce much improvement and benefit, when done right. Even ISO 14001 regularly saves my clients $30,000-50,000, based on their numbers.

CarlDaniel · Nov 9, 2007

Since the topic is about preventive actions...our ISO/TS16949 auditor was not satisfied with our FMEA process and were looking for other alternatives to implement preventive action processes. Does anyone have suggestions?

Should the TC 176 Re-word the Requirements for Preventive Action?

Should the TC 176 have re-worded 8.5.3 to clarify the requirements for prev. action?

Yes. Most definitely 8.5.3 needs clarification.

No. Preventive action requirements are very clear. No clarification is needed.

Sidney Vianna

Post Responsibly

Jim Wynne

Stijloor

Helmut Jilling

Auditor / Consultant

Eric ng

Involved In Discussions

Sidney Vianna

Post Responsibly

vanputten

Helmut Jilling

Auditor / Consultant

Helmut Jilling

Auditor / Consultant

CarlDaniel

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