Quality Manual 2

[Nashanas]

Hello everyone,

I am revising the quality manual of my company. The older quality manual has the boxes on front page to select:
. Controlled copy
. Uncontrolled copy

If controlled copy is sent to a client, then it has to be kept in records, and in case of update of Quality Manual, that client has to be sent the latest one. If the uncontrolled copy is sent to a client, then there is no need to track it and send updated version in future.

I want to remove this rule, to reduce the document tracking etc. It seems un-necessary to me. But I want to know if this procedure is required by any standard? I dont find this requirement in ISO 9001.

 

[3DDave]

You want all copies to be uncontrolled? Doesn't matter who needs updates? Then don't send controlled copies to anyone.

My company QA did that - they got rid of all printed material and just put it on the company website. Of course they didn't really use any tracking feature so if you looked at it one day, they could replace whatever it was with something entirely different the next and you'd be out of compliance the next day.

The only good news was they were not only terribly lazy (so the guy in charge of it could cut out early on Friday to play golf with the VP of Engineering, but count it as work development) and they were eliminating most every thing in it "to allow maximum flexibility." That is, free-for-all.

 

[Nashanas]

Well actually, the quality policy and quality manual are rearely updated or changed. The quality modules might get revised more frequently, and should be controlled. So probably your comapny SQE should be sending updated modules to suppliers and the QC must be using updated modules for internal control. Reducing un-necessary paper work in not always laziness.

 

[3DDave]

As to your problem - why do you have a problem when all you need to do is not mark the printouts "controlled"? I missed your reasoning on that.

Since YOU NEVER MET MY QA guy, you have no idea how lazy that jerk was.

 

[Nashanas]

The point is that if this is a requirement of ISO 9001 or any other QMS standard? Or its just a company policy?

 

[MintJulep]

ISO 9001 and most other quality standards recommend that you have documented document control policies and procedures.

What you put in your procedures is up to you.

If you don't want to send controlled copies to clients, then write into your policy "Clients are allowed uncontrolled copies of documents only."

If your concern is only about the specific "Quality Manual" document, then write into your policy "Only uncontrolled copies of the 'Quality Manual' can be provided to clients".

Then you have clear policy that can be audited for compliance.

If you simply delete the choices you create ambiguity.

 

[3DDave]

ISO 9001 usually says: Pick a policy and stick with it. That reminds me - that's one of the reasons given for trashing the company processes. If we don't have them, we can't be accused of not following them. They usually left for the golf course around 1 pm for their off-site executive meetings.

https://the9000store.com/articles/iso-9000-tips-document-control-requirements/

 

[david339933]

It's your manual...do what you wish. Sending controlled docs to clients seems silly...but more worrisome is

Well actually, the quality policy and quality manual are rearely updated or changed.

 

[MintJulep]

.but more worrisome is

Well actually, the quality policy and quality manual are rearely updated or changed.

This really depends on the architecture of the quality system.

It is possible - in my view preferable - to have the Quality Manual very high-level. Then it can be a very stable document, and should rarely need to be changed. It should still be reviewed and reaffirmed every occasionally, but it really shouldn't require changes if scoped and written correctly.

Then write more, smaller procedure documents to actually handle the work. These then have the flexibility to be scoped to specific tasks, and even specific projects if needed by client requirements.

Of course the cost of this approach is a greater number of documents to manage.

The other extreme is to try and write a single, giant, all-encompassing Quality Manual.

This can be viable for a small company, but at some point the document will be constantly under revision in response to every internal, customer or certification audit, every new project, every new task, etc.

 

MintJulep,

I totally concur. The QAM should be as slim as possible, but have beneath it a thorough structure of subsidiary procedures. Those are the documents that should be revised as necessary, hopefully not impacting the QAM.

"Everyone is entitled to their own opinions, but they are not entitled to their own facts."

 

[david339933]

NB/ASME are pretty particular in the QA Manual....to the point of putting out a NB-57 guide.
Subsidiary procedures should be listed in the QA manual, and if revised, the manual needs revision, as the manual should list procedure editions/revisions.
If you change what you do, you need to change the manual to reflect it. I see a QA manual as an evolving document....not one to create and forget.
How do you know if a procedure is changed/revised? Normally you would look in the manual to see the current revision in use.

 

[MintJulep]

@david339933
You are referring to this document, yes?

https://www.nationalboard.org/SiteDocuments/NB-57.pdf

I don't see that it requires a list of subsidiary procedures. Would you cite the section please.

 

[weldstan]

Our Company always sent uncontrolled copies to Customers. Controlled copies were seent to our project QC Managers and specified in house personnel.