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

[Helmut Jilling]

Like Jim, I say, thanks for taking on the challenge and having the courage to post it.

When I dissect your examples, I see that scenario 1 and 4 have nothing to do with quality issues, thus beyond ISO 9001.

Thanks for your reply. Not sure why 2 and 3 would "have nothing to do with quality issues" as they deal with product quality. But, that's OK. This thread has run it's course. I think we can all lay it to rest.

Those who can get value from the white paper are welcome to use it. I will probably trun it into a PowerPoint at some point.

To be honest, I am just tired of this never ending discussion. ...If a specific paragraph creates so much discussion and dissent, it should be flagged for clarification. Why doesn’t the TC 176 see that? Beats me.

No argument there.

The book is supposed to provide advice on implementing ISO 9001. Do you consider this to be what 8.5.3 refers to? If it is crystal clear to you, excellent. Keep up the great work you do.

Not sure that I would be buying the book, but at least they tried.


OK, gang, let's be proactive, for that is what is important. What we call it is far less critical. And, maybe, someday they will word it better.

signing off on this one...folks...

 

[joshua_sx1]

"Lost in translation should be the culprit of confusion…"

…for me, the definition of corrective action (8.5.2) & preventive action (8.5.3) in ISO9001:2000 is clearly defined…

…I don’t know, but I guess most of those who are “lost in translation” confused not really on the definition itself but on the implementation aspect…

 

[Randy]

"Lost in translation should be the culprit of confusion…"

…for me, the definition of corrective action (8.5.2) & preventive action (8.5.3) in ISO9001:2000 is clearly defined…

Excellant, except now it's ISO 9000:2005

 

[amanbhai]

This post has re vitalized my interest in ISO 9001:2000 :truce:

 

[rcap1]

"Lost in translation should be the culprit of confusion…"

…for me, the definition of corrective action (8.5.2) & preventive action (8.5.3) in ISO9001:2000 is clearly defined…

…I don’t know, but I guess most of those who are “lost in translation” confused not really on the definition itself but on the implementation aspect…

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

Production Line 2 - Has the same parts and process with no reject, you implement the same fix as line 1. This is preventive action. You are preventing line 2 from producing the same rejects as line 1.

Continual Improvement, Review the entire process, implement additional improvements, this is also preventive action, the additional improvements is to eliminate any other potentially errors before they occur.

 

[Helmut Jilling]

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

Production Line 2 - Has the same parts and process with no reject, you implement the same fix as line 1. This is preventive action. You are preventing line 2 from producing the same rejects as line 1.

Continual Improvement, Review the entire process, implement additional improvements, this is also preventive action, the additional improvements is to eliminate any other potentially errors before they occur.

I agree with your general intent, but not your specific examples.

Unfortunately, if you follow the model you outlined, you will do 3 different pieces of paper, and 3 different projects, for the same set of actions. That is not very efficient.

What if we looked at it the way automotive would. (I think they get this right.)

Your example #1 is correct. That is corrective action. However, if you have 4 similar lines, and the corrective action made sense and was effective on line 1, then it must be applied to the others as well. TS-16949 calls that Corrective Action Impact and files it under 8.5.2.3. The premise is it does not make sense to apply the corrective action only to one machine, and wait for the failure to reoccur on the others.

A better example for a preventive action in example #2 would be, you are observing that line running, and see a potential for this failure to occur. You decide to take "proactive preventive action" to ensure it does not occur. You apply it to line 1, verify it was effective and worthwhile, and apply it to the others. That whole process was a preventive Action.

Continual Improvement projects should not "also be preventive actions." That just muddies the water again. If it is a preventive action, then call it a preventive action. In automotive, if it is already good, and you make it better, that would fit the Continual Improvement project paradigm.

All three make the company better, and they are similar, but the starting intent comes from 3 different angles. And that is why it was justified to identify them as 3 different tools. There are many similar tools in my toolbox at home, but each wrench and tool is similar but different, and has a different specific purpose.

 

[CliffK]

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]

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]

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.