Quality Assurance Exclusions- Writing my department's Quality Manual

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Rich 1123

I'm in the process of writing my department's Quality Manual. We are an internal auditing department (QA). I understand being able to take Design and Development as an exclusion and Control of Measuring and Monitoring devices. But what is the guidelines on 7.4 Purchasing and 7.4.2 Supplier Control Process? It looks to me like most of the Product Realization clause (7.0) could be excluded. Within reason! What have others done in this regard?
 

Wes Bucey

Prophet of Profit
In my experience, it is unusual for a department to have its own Quality Manual, usually the organization has an overall Quality Manual and individual departments have Procedures. The concept is one of tiers or levels of documents (and responsibility and authority.)
  • First tier - Quality Policy (entire organization)
  • Second tier - Quality Manual (entire organization - may include Standard requirements)
  • Third tier - Procedures (applicable departments)
  • Fourth tier - Work Instructions (individual processes)
  • Fifth tier - Records (that plans covered in above four tiers were carried out)
It just may be a confusion over terminology or nomenclature, but I assure you, individual departments rarely are responsible for ALL the factors and facets of an International Standard.
 

Sidney Vianna

Post Responsibly
Leader
Admin
I have seen, over the years, many large organizations developing department level quality manuals. In my experience, for the most part it is a wasted effort. I don't believe that a department should have a quality manual. An organization should. Creating departmetal level quality manual leads invariably to conflicts with other departments similar documents. A department does not exist alone.

I strongly suggest to you that, instead of creating a manual, develop adequate documentation describing how your processes are supposed to work. Keep in mind the process approach and define inputs, resources, activities and outputs, including records. If the other departments do the same, you end up with your organization's quality manual. A collective effort.

Just a suggestion.
 

Al Rosen

Leader
Super Moderator
Rich 1123 said:
I'm in the process of writing my department's Quality Manual. We are an internal auditing department (QA). I understand being able to take Design and Development as an exclusion and Control of Measuring and Monitoring devices. But what is the guidelines on 7.4 Purchasing and 7.4.2 Supplier Control Process? It looks to me like most of the Product Realization clause (7.0) could be excluded. Within reason! What have others done in this regard?
Hi Rich, welcome to the cove. It appears you were able to follow my instructions.

If I understand correctly, you are writing a document for your department. There would not be a need for an exclusion since this is the level 2 document or Standard Operating Procedure (SOP). The level 1 document, one level higher, called the Quality System Manual (QSM) or Quality Manual would be written to address the whole organization and that is where an exclusion is stated.

Usually the levels are

  1. QSM says what your organization does
  2. SOPs describe how things are done
  3. Work Instructions (WI) describe how in more detail
  4. Forms
I'm sure you can find more information in the Documentation Systems, Forms and Templates forum or if you use the search function towards the top of the page.
 
R

Rich 1123

Al Rosen said:
Hi Rich, welcome to the cove. It appears you were able to follow my instructions.

If I understand correctly, you are writing a document for your department. There would not be a need for an exclusion since this is the level 2 document or Standard Operating Procedure (SOP). The level 1 document, one level higher, called the Quality System Manual (QSM) or Quality Manual would be written to address the whole organization and that is where an exclusion is stated.

Usually the levels are

  1. QSM says what your organization does
  2. SOPs describe how things are done
  3. Work Instructions (WI) describe how in more detail
  4. Forms
I'm sure you can find more information in the Documentation Systems, Forms and Templates forum or if you use the search function towards the top of the page.
Thank you all.
I used the wrong term in "deparment". I am writing a QA organization Quality Manual. We have all the tiers of documentation you described. I'm sorry I didn't make my question clear. As you said, Wes "just a confusion over terminology".
So I still have to write this manual. And I'm stuck at the what exclusions to take.
 

Al Rosen

Leader
Super Moderator
Rich 1123 said:
Thank you all.
I used the wrong term in "deparment". I am writing a QA organization Quality Manual. We have all the tiers of documentation you described. I'm sorry I didn't make my question clear. As you said, Wes "just a confusion over terminology".
So I still have to write this manual. And I'm stuck at the what exclusions to take.
You can only take an exclusion if it doesn't apply to your organization. If you don't design a product, you can exclude 7.3, Design and development or if you do not use customer supplied material in your product you can exclude 7.5.4, Customer property.
 
D

D.Scott

Al, are you sure about the 7.5.4 exclusion? I was under the impression that the only exclusions allowable were in 7.3 and then only when the company is not responsible for product design and development. See: 1.2 Application.

Dave
 
K

Kevin H

Dave, my initial take was to agree with you, but as we're ISO/TS registered and my approach is colored by that I double checked the ISO 9001 standard. For ISO 9001:2000, the requirement is 1.2: "Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

So yes, 7.5.4 can be excluded. In general, though your registrar and auditor will want to see some justification as to why you are excluding that part of the standard.

Rich - maybe a little more about your business - for me, it's a stretch to drop out purchasing as it sounds like you want to in your first post. Don't forget product is not just a physical entity, it can be a service.
 
R

Rich 1123

Hey D. Scott

It is my understanding and after looking at 1.2 Application, that exclusions are limited to requirements within clause 7 (the whole clause). The meaning of my first question is in regards to the fact that we are a QA Org. What other clause 7 exclusion have other QA Org taken? Like 7.5.4 and others, like 7.4.3 or purchasing 7.4.1. I don't what to be held to these if I can avoid them.
 

Al Rosen

Leader
Super Moderator
Rich 1123 said:
Hey D. Scott

It is my understanding and after looking at 1.2 Application, that exclusions are limited to requirements within clause 7 (the whole clause). The meaning of my first question is in regards to the fact that we are a QA Org. What other clause 7 exclusion have other QA Org taken? Like 7.5.4 and others, like 7.4.3 or purchasing 7.4.1. I don't what to be held to these if I can avoid them.
Can you elaborate on what you mean by "QA Org and "We are an internal auditing department (QA)". Does your organization perform audits? If so, are they financial audits? We can answer your questions better if we have more of a handle on what you do.
 
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