How do you structure your QA (QMS) Manual? A Historical Discussion

AL-
No need to worry about that. Now that I have it roughed in I am going back over it and making sure we are doing just that. The Gap Analysis helps here, and fits right in with the matrix to the procedures. I guess now the biggest job I have is extracting the few procedures that have been included in the QM that didn't need to be there. I need them, but in the procedure section not in the QM.

Russ...starting to see the light!

Could you come back to me on this one, as it all seems to good to be true. Just to check my understanding, how would you rewrite for example section 7.5.2 Identification and Traceability.

The organization shall identify, where appropiate, the product by suitable means throughout production and service operations.

The organisation shall identify the status of the product with respect to measurement and monitoring requirements.

The organization shall control and record the unique identification of the prodctt where traceability is a requirement.


Just interested to see a real life example. Could you add an example of a reference to a process.

Regards


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Andy B

This is from an audit a month ago. This does not relieve you from having to be ready to explain everything.... In this case they probably should have referenced their design process map in 7.5.2. Oops!

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7.5 Production and service provision

7.5.1 Control of production and service provision
As applicable, the organization plans and carries out production and service provisions under controlled conditions. Controlled conditions include:

a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement activities, and
f) the implementation of product release, delivery and post-delivery activities.

Supporting Documentation:
Production Control Map
Process Control Map
Delivery Map
Equipment Maintenance Map
Nonconformance Control Map
Quality Control Map
Product Identification Map
Product Handling and Storage Map
Technical Service Map

7.5.2 Validation of processes for production and service provision
The organization validates any processes for production and service provisions where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. As applicable, the organization establishes arrangements for these processes including:

a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

7.5.3 Identification and traceability
Where appropriate, the organization identifies the product by suitable means throughout product realization. The organization identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization controls and records the unique identification of the product (4.2.4).

Supporting Documentation:
Quality Control Map
Delivery Map

[This message has been edited by Marc Smith (edited 01 August 2001).]

Do you really need Supporting Documentation: after each section when you point to a procedure matrix that connects everything? Where should I reference this matrix? I have it referenced in 4.2.2 now, should I reference it in all sections?

Russ

Well, ISO 9001:2000 states:

4.2.2 Quality Manual
Also see: 4.2.1b

The company shall establish and maintain a quality manual that includes

a) The scope of the quality management system, including details of and justification for any exclusions (see 1.2),

The scope is very important. This scope defined here will be matched against the scope of your registration. Do note that should you plan an exclusion from section 7 you will have to give a documented explanation (reason) rather than a verbal explanation.

b) The documented procedures established for the quality management system, or reference to them, and

Technically by saying "…or reference to them…" this almost allows you to have an index of your procedures with a scope statement. In the strictest sense of the words here - you explicitly have to have reference to your procedures. To comply you simply make a matrix, if you have one, part of the quality manual.

c) A description of the interaction between the processes of the quality management system.

Line item ‘c’ can best be illustrated through Flow Charts. This is discussed in more detail in 4.1 herein. Key word: Interaction. The above is just how one client did it. They also had a matrix, but the linkage was desired within the manual. Technically yes - the above is redundant since they also had a matrix. If there was no matrix I'd be worrying.

[This message has been edited by Marc Smith (edited 01 August 2001).]

I am still hesitating a little before taking this route. A verbatim copy of the ISO 9000 standard does not tell an auditor how the company is complying with the standard. My guess is that this will have to be added in some way, in which case you end up writing a complete Quality Manual, and inevitably doubling up on the content that exists in the Processes and Work Instructions.

I also note various comments strongly promoting that all staff are well trained on the contents of the Manual. As i see a Quality Manual as not providing ANY value add (I am not talking about the Processes etc that CAN add value to a companies operation) i was desperately trying to avoid this potentially demotivating training erxercise.

I have always followed the concept that company employees should know very well their own processes, but do not need to be overburdened with ISO 9000 details, it should be enough if just one person in the company is translating the needs of ISO 9000 into the company processes.

Thanks for input so far



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Andy B

-> I am still hesitating a little before taking this route.
-> A verbatim copy of the ISO 9000 standard does not tell an
-> auditor how the company is complying with the standard.

Nope - it's not. Your procedures do that.

-> My guess is that this will have to be added in some way,

Nope - not really, see the following...

-> it should be enough if just one person in the company is
-> translating the needs of ISO 9000 into the company
-> processes.

That's the idea. That person explains to the auditor how everything fits together. If you want to fluff up a quality manual and sink days or weeks working on it or something - be my guest. I'm just pointing out the baseline.

-> My guess is that this will have to be added in some way,
-> in which case you end up writing a complete Quality
-> Manual, and inevitably doubling up on the content that
-> exists in the Processes and Work Instructions.

As I said, your procedures provide the detail (to me when I say procedure I 'mean' flow chart(s), of course!) You're over complicating this. Now you're bringing in work instructions!

-> I also note various comments strongly promoting that all
-> staff are well trained on the contents of the Manual.

Only parts that apply to them. But what does apply to them they must know - including understanding what the words mean. Just as they have to know and understand local (departmental) procedures which affect them. The same as the fact that they have to know and understand the corporate REDACTED harassment policy.

As far as ISO 'training' for everyone, I do beileve an ISO awareness training 'presentation' is a good idea early in implementation. Just the basics. After that, new hires should get the awareness presentation during orientation. 15 to 30 minutes of the basics.

Andy, it sounds to me like you're seriously over-complicating things.

-> As i see a Quality Manual as not providing ANY value

Which is precisely why you want to keep the 'quality' manual simple. It's just a skeleton to hang things on.

-> I have always followed the concept that company employees
-> should know very well their own processes, but do not
-> need to be overburdened with ISO 9000 details

Exactly right. If it doesn't affect them, it's none of their business.

OK Marc, point taken.

Just as a matter of interest, do you ever get involved yourself in writing the Quality manuals? Do you strictly avoid this, or does it depend on the capability of the company?

Regards

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Andy B

[This message has been edited by Andy Bassett (edited 03 August 2001).]

I try to pressure the company to do it. They almost always do. It's really pretty simple. One key is to not try to write your quality manual and then write procedures to fit it. Start with a matrix and document mapping with consideration to your gap analysis results. Have the main body of the manual (the ISO text) set up and ready. As your matrix fills out, you go to the appropriate section of your manual and insert the appropriate reference. Again, I admit this is redundant because technically you have the matrix.

<FONT COLOR="#FF0000">A word of serious caution here</FONT>

Many companies do insert some additional details in their quality manuals. In fact, some companies have all the relevant level 2 'procedures' in their quality manual. The folks I worked with last winter did exactly this. They inserted flow charts in the MS Word document which was their 'systems manual' (as opposed to calling it a 'quality' manual) in the 'appropriate' sections of their manual. It was still relatively short - maybe 50 pages - and just about everything was there. Departments controlled their own work instructions and such, but for all intents and purposes the main systems are defined entirely within their systems manual.

When I work with a client I often do, in fact, suggest clarification statements here and there throughout the manual.

Look at how your system is structured (including corporate, if you're in a big company - they have many documents which apply to your location {and other locations}, I would bet). Ask yourself what you need in your manual. But - don't go overboard. Don't complicate issues and <FONT COLOR="#FF0000">Don't be redundant!</FONT>

I attended a meeting yesterday of regional quality professionals and one of the ISO Registrars said the following question was raised at a session he attended in Cleveland, OH recently.

"Are we ready to accept (1) page Quality Manuals?"

Any comments???