To set frequency to review documents in ISO 9001 7.5?

[qualprod]

Hello everybody.

Now in the standard in 7.5 Documented information.

I don´t see an exact clauseb to raise a NC, this is the case.

In my QMS there is a procedure to manage changes 6.3, into it there are mentioned
some positions which existed in the past, now they are different.
At auditing the QMS we found that this document is obsolete regarding the positions mentioned there.
This document was created in 2015 in the 2015 version.
Could this nc raised against 7.5.2 c) review and approval for suitability and adequacy.?
or how can this issue be managed?
Into the QMS, I think we have to establish at certain frequency to review all the documents
to ensure them for adequacy.
I remember in the 2008 version, existed in the users some ideas focusing to review all the documents.

Any idea?

Thanks

 

[Big Jim]

ISO 9001:2015 doesn't require a specified interval or even that the organization needs to have a specified interval. Anything in 9004 is guidance and are not requirements.

As for the obsolete documents the term obsolete as far as documented information is not mentioned in the 2015 version of ISO 9001:2015. A nonconfromance case could probably be easily made for 7.5.3.1a for "suitable for use".

 

[qualprod]

Marc is 9001 : 2015
Jim, but really do you think this case will deserve to raise the Nc?
The point is, because this document was not used for long time, it was "forgotten" and nobody
noticed the errors.
Other point, the "suitable for use" term, which means to have the documents reviewed, in your opinion, will be recommended to
have established somewhere into the QMS as a task to ensure all documents are reviewed?

Thanks

 

[Big Jim]

Suitable for use would seem to mean just that. Something obviously "forgotten" but found in use would certainly not suitable for use. It doesn't matter how or why or what the good intentions may be.

Without knowing more fully the circumstances I would not say that it is a slam dunk nonconformance, just that a case may be able to be made for it.

 

[John Broomfield]

A lot of folk don’t realize that by changing the organization they are also changing the system.

Most managers would also agree that “failure to keep the documented parts of the management system up to date with changes in the organization” is a nonconformity worthy of correction and corrective action.

Regular reviews of the continued accuracy of system documentation may limit the decay. Better still may be to connect the process for organizational changes to the upkeep of system documents.

Failure to plan upkeep of the system may be a better clause (10.1a for example) if this is a system wide (chronic) problem instead of an isolated document control issue.

 

[Tagin]

Using an interval essentially means you are scheduling to fix all the broken things on a periodic basis.

Make it part of the HR onboarding/offboarding/role-changes process to review relevant QMS docs for any needed updates, so they occur when the change happens, and not later.

 

[qualprod]

A lot of folk don’t realize that by changing the organization they are also changing the system.

Most managers would also agree that “failure to keep the documented parts of the management system up to date with changes in the organization” is a nonconformity worthy of correction and corrective action.

Regular reviews of the continued accuracy of system documentation may limit the decay. Better still may be to connect the process for organizational changes to the upkeep of system documents.

Failure to plan upkeep of the system may be a better clause (10.1a for example) if this is a system wide (chronic) problem instead of an isolated document control issue.

I have seen two practices somewhere in companies.

1- When auditing every process, the process owner is asked to show their documents, thus, adequacy is reviewed.
2- Monthly the QMS responsible, take documents of every process, print them, goes with every process owner and
ask he/she the review for adequacy. In case the need to update or cancel a document, this is the moment.

Regards

 

[John Broomfield]

qualprod,

1 uses the auditor to help control the process for the upkeep of the system documents. This limits the freedom of the auditor to verify the effectiveness of the process (and the manager's monitoring of this process) for keeping the system documents up to date.

2 On this I agree with Tagin.

 

[qualprod]

Using an interval essentially means you are scheduling to fix all the broken things on a periodic basis.

Make it part of the HR onboarding/offboarding/role-changes process to review relevant QMS docs for any needed updates, so they occur when the change happens, and not later.

Thanks Tagin
Could you explain how the HR onboarding/offboarding can be more effective than in other processes regarding
the adequacy of documents?

Thanks

 

[Tagin]

Thanks Tagin
Could you explain how the HR onboarding/offboarding can be more effective than in other processes regarding
the adequacy of documents?
Thanks

This suggestion was specifically referring to the OP's issue of personnel/role changes not being reflected in the QMS documentation. By making those personnel change processes incorporate a document review it would (hopefully) prevent personnel/role changes from causing QMS documentation issues. (I'd also add, as I think about it, personnel/role changes should probably also be reviewed for effects on organizational knowledge.)

A more general approach would be identify all such areas where change occurs that could affect QMS documentation and build similar reviews into those processes. (Essentially, there's a Check-Act piece missing from these kinds of changes.)

An even broader, more uniform approach would be to pipeline all changes (including personnel changes) through a company-wide change management system. That might be impractical, and perhaps cumbersome. An alternative might be some system to gather changes as they occur and forward them to Quality so they can review potentially affected documentation.

A scheduled interval review is a Check-Act. But it has two deficiencies that are apparent:
1) it presumes that incorrect documentation is acceptable for X period of time, and presents minimal risk,
2) detection of incorrect documentation is not now based on known actual changes in the processes; instead it relies on the detective skills of the reviewer and how obvious or not the mismatch is between the documentation and the actual current processes.

A scheduled interval review would however provide some potential protection against unintended changes; e.g., where processes 'drift' over time and soon the incorrect way becomes the 'the way we've been doing it'.