Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015

[Mike S.]

Do you have proof the document was reviewed and when?

Why? Review is only required when creating or updating the document. Neither applies to this case.

 

[brandieb1230]

That's the kind of bureaucracy expectation that adds no value and just creates animosity towards "quality professionals". If there is any question if the document reflects the current process, just go and check for yourself.

Creating a "record" that document has been reviewed and deemed current is just MUDA.

While I agree with you, I was always under the impression that if there isn't evidence of something than it didn't happen. Other than a walk of the document to prove it is still accurate every time it is in question- how would a company quickly be able to say- "Yes, this document is 7 years old- but it is accurate".

I see 7.5.2 - c- discusses review and approval for suitability and adequacy while creating and updating a document. That doesn't have any mention of a document that doesn't need changed.

The company I work for requires annual document reviews in our document control software as a means to have the "proof" that the document was reviewed- this is all at the direction of our corporate quality office. They believe it falls under 7.5.3.2 (A)- Use of the document. Was the document actually reviewed? probably not- people just go in and click - document ok and move onto their next task of the day..

 

[Sidney Vianna]

I was always under the impression that if there isn't evidence of something than it didn't happen.

That one and it's counterpart say-what-you-do-do-what-you-say are just two examples of archaic mental paradigms that are useless in terms of modern quality management.

Other than a walk of the document to prove it is still accurate every time it is in question- how would a company quickly be able to say- "Yes, this document is 7 years old- but it is accurate".

There is a fundamental misunderstanding here. Documentation is NOT an end in itself. Documentation is ONE of many components that define and facilitate process control. The PROCESS OWNERS should be the ones with responsibility to ensure adequacy and currentness of any supporting piece of command media that enables true process control. If a risk-based thinking approach determines that we should have an annual mandatory review of every piece of command media in the system, then do it. But to establish that mandatory periodic review as the baseline, even when we don't have palpable risks of working with outdated documents, is senseless.

 

[Johnnymo62]

Just have a line on the Internal Audit form/report where the Process Owner can sign that the current revision of documents is adequate.

Annual or whenever your Internal Audit is performed, is sufficient for the POs to vouch for their documents.

 

[normzone]

Currently wading through a sea of documentation, some of it not touched for twenty years.

Sorting it into piles:

Forget these, we don't do that any more
Of value to historians re products still in the field, but not requiring update
Requiring update for real
Fine as is