Fulfilling ISO 9001 Document Review Requirements

harry

Super Moderator
#11
Re: Fulfilling ISO 9001 Document Reviewing Requirements

............I was think more in terms of reviewing the procedures rather than all documents. I agree that the internal audits will only take a sample of documents but I suspect that most procedures will be reviewed as part of the internal audit programme ......................
I think internal audit results when tabled for management review often act as a trigger for document review (especially in situations where an increase in NC's or trend were noted) when questions such as 'relevance' were asked against any background changes that management are more aware than any others.
 
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A

amanbhai

#12
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Thanks Pancho for sharing the valueable information with us.
 
P

pldey42

#13
Re: Fulfilling ISO 9001 Document Reviewing Requirements

I think it's important to do things, not simply for the sake of conformance and satisfying auditors, but to do something useful. There's a risk that a rigid two year cycle makes work for someone that's not really useful. And if it's boring or not perceived as useful work they're likely either to make mistakes or make unnecessary work, e.g. picking on insignificant details that really don't matter in the broad scheme of things.

If it were me I'd make the change management system slick and easy for anyone to invoke. Useful documents inevitably change because someone spots a better way, something changes in customer requirements, quality objectives ratchet up and so forth. So anyone using a document is automatically reviewing it for adequacy and raising a change request if, while when originally reviewed it was adequate, now it's not.

Then, any periodic review would identify documents that have not changed and review them, and only them, for continued adequacy. The record of the review could perhaps be a fresh, dated approval signature.

I'd probably do the review whenever major regulations or laws or customer requirements or quality objectives change, or whenever it seems "a good idea" (e.g. we notice several documents being changed because they're inadequate and we thought they were ok), with every two years as a safety backstop.

An aside: I saw one quality manager once, faced with a large pile of largely useless quality documentation, conduct the review by removing anything remotely questionable from the QMS documentation saying, "If it's adequate, someone will complain to me and we'll review and approve it." Brutal but quick.

Hope this helps,
Pat
 
B

Bonhomme

#14
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Useful documents inevitably change because someone spots a better way, something changes in customer requirements, quality objectives ratchet up and so forth. So anyone using a document is automatically reviewing it for adequacy and raising a change request if, while when originally reviewed it was adequate, now it's not.
<grasshopper searching for enlightment>
That would be the ideal way of dealing with document review, I think. Anyone reading actually reviews and is actor in the perpetual improvement of the QMS

But what about people who "know" what they're doing and don't read the docs anymore ?
What about newcomers that are taught verbally what to do instead of giving them a commented read of their work instruction/whatever ?
Don't the docs slowly fall into unemployment ?

Not a personal question, or not even a question at all ...

Today I'm faced with a documentation system which, as I see it, would need gas, a match (and their electronic counterparts), and a complete rewriting.
Procedures link to records that aren't used anymore ... when they actually exist and haven't been destroyed since years ago, either because the info to be tracked is now in the ERP, or somebody made an excel spreadsheet, or ...
Infos are recorded on "fantom" documents which existence the QMS isn't aware of ...

At the end of the day (most of) the things are done right, and the datas needed are kept.
But it's totally out of control. It all depends on people's professionnalism/goodwill. And that seems very questionable to me.

So, maybe, when you don't have the ideal case described, a "hard set" 2 years review period, although a huge pain, is better than nothing to ensure your documentation system somehow stays close to the reality :/

</grasshopper searching for enlightment>
 
P

pldey42

#15
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Well, if everything is done right, and the records required both to aid problem diagnosis and to maintain regulatory compliance are properly maintained, then the system is in control - but through leadership, skill, professionalism and peer pressure instead of formal documentation - and that's arguably more powerful. Done right, it's also conformant with ISO 9001 which, contrary to popular misconception, requires neither redundant documentation nor records.

So if people really do know what they're doing, and if it can be communicated to them verbally, or through mentoring, why not scrap the now-redundant documents? Or save everyone a bit of time by transforming them into on-line training presentations for new hire induction? Or capture the essential reference materials people do actually need and put those alone into fresh documents that are a valuable day-to-day reference.

If information that was once on paper is now in ERP, then again, the paper's useless, so scrap it. If it's in spreadsheets, fine - but make sure they're properly controlled in terms of versioning and backups. (When they're on one person's laptop and it gets lost ...)

Another way of cleaning up such a system might be the old "management by walking around" thing. Instead of doing it with formal reviews and audits, perhaps walk around the workplace and informally engage everyone in a discussion about what's useful in terms of documentation and records, such that they can help you build a system that's useful to everyday work and which they become engaged in keeping up to date.

Just a thought,
Pat
 
#16
Re: Fulfilling ISO 9001 Document Reviewing Requirements

I have walked into a situation where the internal auditing is subcontracted out and the S/C firmly believes that no document review is necessary in an ISO system. I have had non-conformances issued for not having adequate records of document review and when I read the standard i think its pretty clear (and good practice) that documents must be reviewed. I am incorrect in this interpretation?
 

qusys

Trusted Information Resource
#17
Re: Fulfilling ISO 9001 Document Reviewing Requirements

I have walked into a situation where the internal auditing is subcontracted out and the S/C firmly believes that no document review is necessary in an ISO system. I have had non-conformances issued for not having adequate records of document review and when I read the standard i think its pretty clear (and good practice) that documents must be reviewed. I am incorrect in this interpretation?
The fact that you have outsourced this activity does not free you from controlling it. Audit results are one of the input of mgmt review, also including 2nd and 3rd parties audit. Management representative should be aware of this.
Please give us more details if I was not clear.

PS: What do you intend with S/C??? :bigwave:
 
#18
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Sorry, S/C is sub-contractor.
The management rep agrees with the subcontractor that there is not a need to review documents. I will eventually assume more control over the quality system I am sure but at this point it is the management rep who is being led by the internal auditor...
 

qusys

Trusted Information Resource
#19
Re: Fulfilling ISO 9001 Document Reviewing Requirements

Sorry, S/C is sub-contractor.
The management rep agrees with the subcontractor that there is not a need to review documents. I will eventually assume more control over the quality system I am sure but at this point it is the management rep who is being led by the internal auditor...
Could you please share the statement of the non conformity, the violeted clause of the standard and the evidence to support it?
Was this non conformity raised up by an external auditor?
What do you mean for "review documents"? I think you have a documented procedure for internal audit and the internal audit reports have a distribution list to be issue . The mgmt representative should be reference for this because he/she should report the result of the audit to the mgmt review. Maybe I am missing something , but my feeling from what you said is that the activities could be jeopardize if it is not controlled. How do you manage non conformity?
:bigwave:
 
K

kgott

#20
Re: Fulfilling ISO 9001 Document Reviewing Requirements

We currently have our review scheduled for every 2 years, however, this requirement is not currently being managed. It is hard to provide evidence that the procedure had or had not been reviewed. Do you have any examples of a system that worked well to provide this objective evidence and helped to maintain compliance to the requirement?

Tarrah
Good Morning Tarrah; Perhaps another way to go you might like to consider is to review documents whenever:
  • a member of staff identifes a possible deficiency, or improvement, in the document.
  • whenever a customer requests a change in the document
  • whenever an investigation into a NC indicates that the document may, at least in part, lie in the content of the document.
  • whenever there is a change in the process the document relates to
  • whenever an audit identifes a potential improvement to the document
I believe the team or the process owner are the persons who should review and decide on a change, or no change, to a document not the Q person.

What would most Q people know about wether a finance, a OH&S document or a project/product delivery document, is adequate or not?
 
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