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

[Richard Pike]

Re: if we do not have preventive action,we have nonconformance?

I wrote a nonconformance for exactly that last week. The company had been registered for a year, and not one preventive action had been written. It is not optional.

I assume you were unable to find evidence of preventive action and not necessarily a written record of any specific preventive action? (depending of course on what their own procedures required)

Would I be correct that in order to gain registration (a year ago) there must have been procedures in place as well as some evidence demonstrating that those procedures were effective?

If so, my argument to the Auditor would be ..

If a year has passed and no new products/processes have been introduced, then any further "preventive" action on existing products/processes would indicate that the initial "preventive" action/s were ineffective.

In this scenario further preventive actions would result in a non-conformance for ineffective procedures; unless of course the auditor would like to move from preventive action to constant improvement.

Of course using this theory, any corrective action taken is a result of ineffective preventive action and therefore also may result in a non-conformance for ineffective procedures.

I think this is perhaps another example of not knowing the full facts surrounding the Non Conformance. i.e how deep did the auditor look for Prevention activities?

 

[Big Jim]

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

I think that we are dealing with a wrong interpretation of the standard.
The way I see it, I (as an audited company) may be written up IF I have no tools in place to foresee potential NCs (analyzing trends, etc.)

However, IF the tools are in place, IF the trends are being discussed and IF there is evidence that the company DETERMINED there is no need for a CA, I would really like to be written up for not having PAs.

So….the PAs ARE optional. What is important is:

1.Tools in place to foresee potential NCs.

2. Analyzing the trends as revealed at no 1.

3. Take action aka PA (IF determined as necessary by the COMPANY).

In my opinion, you are living in a dream world if you believe that there are no opportunities for improvement which is the only way there could be no preventive actions.

Murphy is alive and well in every company i have visited, providing ample opportunity for both corrective actions and preventive actions.

It just isn't that hard to find examples with the auditee, and once he realizes it there is no resistance to the write-up.

 

[Sorin]

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

In my opinion, you are living in a dream world if you believe that there are no opportunities for improvement which is the only way there could be no preventive actions.

Murphy is alive and well in every company i have visited, providing ample opportunity for both corrective actions and preventive actions.

It just isn't that hard to find examples with the auditee, and once he realizes it there is no resistance to the write-up.

It's not about what I believe....what am I talking about is the interpretation of clause 8.5.3.

BTW, improvement can exist without PAs. But that is another debate I suppose.

 

[Richard Pike]

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

Murphy is alive and well in every company i have visited, providing ample opportunity for both corrective actions and preventive actions.

It just isn't that hard to find examples with the auditee, and once he realizes it there is no resistance to the write-up.

I don't think anybody is arguing about absence of corrective actions; its preventive actions that the originator highlighted.

If those opportunities are there to that extent and there is no evidence that they are being addressed; then i would suggest that the organization has bigger problems than "no prevention actions written". If that was the only way the auditor was able to express the obvious underlying problems then (without any other information to go on) I would suggest the auditor would be out of line.

 

[samsung]

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

This interpretation is specific to 8.5.3a, not to the whole preventive action clause. If you read it in isolation, it sounds like preventive actions are optional. They're not.

Yes, it's specific to 8.5.3 a) and does satisfy OP's query in every respect, i.e.; whether records of actions taken are required to prove that a PA was taken?

in our last audit,IMQ auditor issues a NCR coz our organization do not have any preventive actions.is it correct? i said to him it is not correct but i can not prove it.

Further, the standard requires that "the organization shall determine" (but not necessarily 'TAKE') "action to eliminate the causes of potential nonconformities";only IF the potential nonconformities exist, otherwise no. It's like taking (corrective) actions, only if real NCs are identified, else no need to take any CA.

 

[vanputten]

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

If an organization has a Preventive Action procedure in place, opportunities for PA have been analyzed, and they did all of the things required in 8.5.3 but identified no PA opportunities, this is a non-conformance?

If an organization puts a PA process in place and evaluates the need for PA but finds no need, this is a non-conformance?

Where does the standard say this? I think it is up to auditor to find a PA opportunity that was not determined, evaluated, and acted upon.

An organization must determine, evaluate and act upon at least one PA at all times? There must always be an identified and implemented PA at any given time?

Sorin: Great posts.

 

[samsung]

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

If an organization has a Preventive Action procedure in place, opportunities for PA have been analyzed, and they did all of the things required in 8.5.3 but identified no PA opportunities, this is a non-conformance?

If an organization puts a PA process in place and evaluates the need for PA but finds no need, this is a non-conformance?

Where does the standard say this? I think it is up to auditor to find a PA opportunity that was not determined, evaluated, and acted upon.

An organization must determine, evaluate and act upon at least one PA at all times? There must always be an identified and implemented PA at any given time?

Sorin: Great posts.

1. If the organization analysed the opportunities but it could find no opportunity for a PA or a PA worth execution, it shouldn't be an NC.

2. If an opportunity is traced and analysis indicates that it's not worth execution, the organization can desist from taking an action. Again no NC.

3. The standard doesn't say so yet it implies from the description of the clause. However, an auditor can determine if the organization, having evaluated a detected nonconformance, failed to implement an action horizontally across the other sections (with similar problems). Or if there are evidences (e.g. a trend analysis) that something can go wrong, if timely actions are not taken, an auditor can raise an issue.

4. In my opinion, it's not a requirement for an organization to have atleast one PA being acted upon at all times.

Thanks.

 

[Richard Pike]

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

However, an auditor can determine if the organization, having evaluated a detected nonconformance, failed to implement an action horizontally across the other sections (with similar problems). Or if there are evidences (e.g. a trend analysis) that something can go wrong, if timely actions are not taken, an auditor can raise an issue.

Thanks.

A corrective action in one area may identify potential Preventive Actions in other areas, quite correct. (Discipline 7 of a typical 8D style Corrective Action). In the Originators organization I am assuming the Auditor checked this and found no evidence of Preventive Action (for other areas) being identified. (of course we don't know this and hence are making, possibly incorrect assumptions)

Whether or not that Preventive Action (or any other identified Preventive Action) is implemented is most certainly (sorry! -in my opinion!) no business of the Auditor. The decision to evaluate and accept Risk, (of not implementing preventive action) for whatever reason, remains not only the prerogative of the Organization but also the specific legal responsibility of that organizations Directors.

Of course if there are no requirements to record (prove) Preventive Action identification and assessment, then the Auditor has to employ a little bit more of that skill they get paid for in order to state a non-conformance.

Certainly just stating its a non-conformance because they cant find evidence to the contrary demonstrates poor auditing skill.
PS: do you think it might be a good idea to Ban all partial incomplete references to 3rd Party Audit Findings, unless they are quoted in their entirety?

 

[Golfman25]

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

So basically what I am hearing is that you should go ahead and "do" a PA so you have "something" to show the auditor regardless of how substanative the PA was.

 

[Stijloor]

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

So basically what I am hearing is that you should go ahead and "do" a PA so you have "something" to show the auditor regardless of how substanative the PA was.

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

Stijloor.