If we do not have Preventive Action, is it an ISO 9001 Nonconformance?

[Big Jim]

Re: If we do not have Preventive Action, is it a nonconformance?

Nope. The purpose of PA is the prevention of nonconformities.
If you have an occurrence of a nonconformity, your PA process has failed.

Stijloor.

That's a bit harsh but I think you are on the right track.

 

[howste]

Re: If we do not have Preventive Action, is it a nonconformance?

Further, the standard requires that "the organization shall determine" (but not necessarily 'TAKE') "action to eliminate the causes of potential nonconformities";

Why would you determine action to take, but not take the action? Let's see how that logic would work with another important clause of the standard:

The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective...

By the logic above, we would determine the processes of the system, but not actually implement them. We would determine interactions of the processes, but not actually have interactions. We would also determine criteria and methods to ensure that the processes were effective, but choose instead to have ineffective processes. Oh wait -- the processes coudn't be effective anyway because we didn't implement them to begin with...

Essentially that logic rips the guts out of the whole QMS. No thanks. I choose to believe that if the standard requires us to determine something, it also requires us to implement it.

 

[Stijloor]

Re: If we do not have Preventive Action, is it a nonconformance?

That's a bit harsh but I think you are on the right track.

Thank you Jim.

I always look at this from a Customer's point of view. We must protect the Customer from receiving sh*tty product. See, this customer could be you or me.

Stijloor.

 

[Sorin]

Re: If we do not have Preventive Action, is it a nonconformance?

Why would you determine action to take, but not take the action? Let's see how that logic would work with another important clause of the standard:

By the logic above, we would determine the processes of the system, but not actually implement them. We would determine interactions of the processes, but not actually have interactions. We would also determine criteria and methods to ensure that the processes were effective, but choose instead to have ineffective processes. Oh wait -- the processes coudn't be effective anyway because we didn't implement them to begin with...

Essentially that logic rips the guts out of the whole QMS. No thanks. I choose to believe that if the standard requires us to determine something, it also requires us to implement it.

Well...sigh...you took the quote of 4.1 out of context. The whole clause reads:

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization.....

 

[Richard Pike]

Re: If we do not have Preventive Action, is it a nonconformance?

Why would you determine action to take, but not take the action?

Because that is exactly how Business is conducted!

Risk acceptance is based on, amongst other things, Cost Benefit Analysis. During FMEA for example, a number of recomend actions are often put forward, however not all are implemented.

Theoretically if enough resources are thrown at a process, most things can be prevented!

Poka Yoke is another example, yes most things can be fool proofed, but the available resources coupled with Cost Benefit will determine "what" is fool proofed.

Again I maintain that it is not the Auditors business to interfere with the specifics of what should be prevented and what should not.

 

[Stijloor]

Re: If we do not have Preventive Action, is it a nonconformance?

<snip> Again I maintain that it is not the Auditors business to interfere with the specifics of what should be prevented and what should not.

Reporting a sloppy Preventive Action process IS the auditor's business.

Stijloor.

 

[Sorin]

Re: If we do not have Preventive Action, is it a nonconformance?

Nope. The purpose of PA is the prevention of nonconformities.
If you have an occurrence of a nonconformity, your PA process has failed.

Stijloor.

Not really....an occurrence of the same kind of NC could mean that the real root cause was not yet found. And the PA process could be really working.

It's all nice and dandy in organizations that have the time and manpower to go through in-depth, to the bone, root cause analysis, but in real life , small to medium size companies, most of the time, the trial and error is still the most, single used approach (I am not advocating, just stating what I saw).

And the reason behind that is that those companies can move really fast in terms of trials, where in big organizations, it could be a real headache.

It's just a different approach. But I would not raise a NC for occurence of the same NC IF it's part of trial and error approach.

 

[Richard Pike]

Re: If we do not have Preventive Action, is it a nonconformance?

Well...sigh...you took the quote of 4.1 out of context. The whole clause reads:

Thanks for that!

Far too many Auditors want to inflict their morals and ambitions onto an Organization, instead of doing what they get paid for - Audit.

A year ago there was evidence that an effective Preventive Action Process was in place.

What did that "approved" procedure require in respect to the raising of preventive actions. If those procedures do not adequately cover the continued formulation of Preventive Actions - then the NC is Procedures don't adequately cover the requirements !!! and state exactly what is missing.

I reiterate, if no new processes or products are introduced during the subsequent year, then what preventive action is being looked for?

If new processes / products were introduced, then did the organization follow their own procedures? If they did, then what is the problem, if they didn't (follow their own procedures) then there would surely be no argument on the non-conformance?

 

[Richard Pike]

Re: If we do not have Preventive Action, is it a nonconformance?

Reporting a sloppy Preventive Action process IS the auditor's business.

Stijloor.

Who says its sloppy? That is an assumption based on some very limited information provided by the originator.

Because the Organization chooses NOT to implement certain preventive actions does not imply it is sloppy.

What is sloppy, is a half constructed NC without any supporting evidence coupled with poor auditing technique which jumps to the conclusion that because the auditor is not presented with "a preventive action" (whatever their interpretation of that is) then the Preventive Action Process is non compliant.

Many other examples of what constitutes preventive action (aside from a "preventive action") have been quoted in this thread.

From what I am understanding there are a couple of auditors here that would have been happy had the Organization simply documented a couple of Preventive Actions; and that in my opinion is what would indeed have been "sloppy" !

 

[Big Jim]

Re: If we do not have Preventive Action, is it a nonconformance?

Not really....an occurrence of the same kind of NC could mean that the real root cause was not yet found. And the PA process could be really working.

It's all nice and dandy in organizations that have the time and manpower to go through in-depth, to the bone, root cause analysis, but in real life , small to medium size companies, most of the time, the trial and error is still the most, single used approach (I am not advocating, just stating what I saw).

And the reason behind that is that those companies can move really fast in terms of trials, where in big organizations, it could be a real headache.

It's just a different approach. But I would not raise a NC for occurence of the same NC IF it's part of trial and error approach.

I'm having trouble following your line of thought. I'm wondering if you have a basic misunderstanding of the difference between corrective action and preventive action. A repeating nonconformance would be a corrective action issue. What you do to prevent a recurrance is still corrective action not preventive action.