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

[CliffK]

In Reply to Parent Post by rcap1

Well said,

Just for those who still may be confused, I would like to give you my version.

Production line 1 - Produces reject parts. You implement a fix....This is Corrective Action

I guess it goes without saying that "fix" includes removing the cause.

Right?

[20110108 Request]

Without getting the details for the foregoing discussion, I can add this: The revision of ISO 9001 with a target of 2015 has started. As the Design Specification is developed, user imput will be sought. I would highly recomend that you provide your points of view to the US TAG. Better yet, join the TAG. Industry representatives are needed.

[Sidney Vianna]

In Reply to Parent Post by Bear41

Without getting the details for the foregoing discussion, I can add this: The revision of ISO 9001 with a target of 2015 has started. As the Design Specification is developed, user input will be sought. I would highly recommend that you provide your points of view to the US TAG. Better yet, join the TAG. Industry representatives are needed.

Yes, joining the US TAG could be a start, even though some people, including myself feel the process is too "political". See the General Info on ISO 9000 and Technical Committee 176 - Getting Involved where Marc was even considering sponsoring someone's participation there.
But I stand by my previous post where I expressed my concern that, since 1994 when ISO 9001 highly emphasized preventive action and explicitly separated the requirement from corrective action, quality system professionals endure countless, protracted, frustrating discussions on the APPLICATION of preventive action. Here at the Cove, we have some of the longest threads dealing with preventive action deployment. Based on that body of evidence, I can attest that the PRATICAL IMPLEMENTATION of preventive action is weak, around the World.

It miffs me to realize that the forthcoming revision of ISO 9001, designed and intended to CLARIFY the requirements of the standard, proposes NOT a SINGLE clarification other than

e) reviewing the effectiveness of the preventive action taken.

Why in the World the TC 176 fails to realize that preventive action needs clarification leads me to believe that, as I said before, they are out of touch with "ordinary people and systems" or realized they are powerless to come up with a better text.

[Jim Wynne]

In Reply to Parent Post by Sidney Vianna

Yes, joining the US TAG could be a start, even though some people, including myself feel the process is too "political". See the General Info on ISO 9000 and Technical Committee 176 - Getting Involved where Marc was even considering sponsoring someone's participation there.
But I stand by my previous post where I expressed my concern that, since 1994 when ISO 9001 highly emphasized preventive action and explicitly separated the requirement from corrective action, quality system professionals endure countless, protracted, frustrating discussions on the APPLICATION of preventive action. Here at the Cove, we have some of the longest threads dealing with preventive action deployment. Based on that body of evidence, I can attest that the PRATICAL IMPLEMENTATION of preventive action is weak, around the World.

It miffs me to realize that the forthcoming revision of ISO 9001, designed and intended to CLARIFY the requirements of the standard, proposes NOT a SINGLE clarification other than Why in the World the TC 176 fails to realize that preventive action needs clarification leads me to believe that, as I said before, they are out of touch with "ordinary people and systems" or realized they are powerless to come up with a better text.

As most here know, there is much about the ISO view of corrective and preventive action that doesn't make much sense to me. I won't rehash my misgivings again in this thread, but it seems to me that when there's such a perception of widespread misunderstanding, something's wrong with the standard, and not the implementation of it.

In this post you can see evidence of the unnecessary complications suppliers are faced with when it comes to CA reporting. Cover World Quality, who has been very generous in posting attachments here, recommends the latest thing: a five page CA reporting form that requires the ridiculous "5 whys," a fishbone diagram, and other time-wasting form-filling activities that are not likely to be helpful or make anything better. The fact that customers often ask for all of this busy-work when the defect in question is an obvious outlier, or doesn't disturb the supplier's mandated PPM levels, is further evidence that no one understands what they're doing.

Then there's this recent thread wherein the OP isn't sure about how to measure CAPA effectiveness. As I've often said, if you don't know what to measure, you haven't even defined the process, or even know why there's a process to begin with.

Even the idea of "continuous improvement" makes no sense on close examination. Surely some sort of a state of equilibrium will be reached sooner or later if a company practices process control efficaciously, a state where the economics of the situation moves "the organization" into a maintenance mode and additional significant improvement is no longer a reasonable goal.

We need to concentrate on process control:

• Do the best you can to understand variation and reduce it as much as possible, and then monitor.
• Make sure that everyone understands the requirements and is expected to meet them consistently.
• Know the difference between a bad process and a bad operator, and take decisive action on one of them.
• When something goes wrong, find out why, and fix it so that the chance of recurrence is acceptably small.
• Don't make promises to customers that you know you can't keep, and then blame the workforce when the chickens come home to roost.
• Never guess when the requirements are ambiguous, and make an honest effort to remove ambiguity before something bad happens.

Achieving acceptable quality levels is a function of leadership and determination and force of will, and can't be encapsulated in a clause of the standard. Filling out a five-page form never helped anyone to understand anything worth knowing, and haggling over the difference between CA and PA is equivalent to arguing about whether a carnivorous reptile is an alligator or a crocodile while it's eating you.

[howste]

In Reply to Parent Post by Jim Wynne

...haggling over the difference between CA and PA is equivalent to arguing about whether a carnivorous reptile is an alligator or a crocodile while it's eating you.

...or it potentially might eat you.