Confusion on declared (part of the quality manual) and non-declared documents

[Polly Pure Bread]

I’d greatly appreciate if anyone can enlighten me on my confusion on declared and non-declared documents.

Let me define first what I mean by declared and non-declared document:

Declared document – part of the quality manual
Non-declared document – procedure, instruction, forms or guidelines that is internal to the department or section, however, not included in the quality manual.

Auditee’s scapegoat is that the raised issue is not declared in the documented QMS, therefore, auditor cannot tag it as NC. I believe that even undeclared document but are critical to the operation or has significant impact in the delivery of service can be tagged as an NC. Thank you for your views.

 

[Jim Wynne]

Re: confusion on declared and non-declared documents

I’d greatly appreciate if anyone can enlighten me on my confusion on declared and non-declared documents.

Let me define first what I mean by declared and non-declared document:

Declared document – part of the quality manual
Non-declared document – procedure, instruction, forms or guidelines that is internal to the department or section, however, not included in the quality manual.

Auditee’s scapegoat is that the raised issue is not declared in the documented QMS, therefore, auditor cannot tag it as NC. I believe that even undeclared document but are critical to the operation or has significant impact in the delivery of service can be tagged as an NC. Thank you for your views.

Welcome to the Cove.

I'm assuming that you're referring to ISO 9001. The requirement is for "documented procedures" to be part of the quality manual, or referenced in the quality manual. If you have an important document that doesn't fit either description, you've discovered a problem different from the one you're asking about.

I also don't know if you're referring to an internal or external (CB) auditor. If it's the former, she should have noticed what I pointed out above. If it was an internal auditor, he was correct to point out that process requirements weren't being followed, regardless of whether they're "declared" or not.

I think you need to update your QM with the proper documents and/or references, and make sure that processes are operated according to requirements.

 

[Polly Pure Bread]

Re: confusion on declared and non-declared documents

Welcome to the Cove.

I'm assuming that you're referring to ISO 9001. The requirement is for "documented procedures" to be part of the quality manual, or referenced in the quality manual. If you have an important document that doesn't fit either description, you've discovered a problem different from the one you're asking about.

I also don't know if you're referring to an internal or external (CB) auditor. If it's the former, she should have noticed what I pointed out above. If it was an internal auditor, he was correct to point out that process requirements weren't being followed, regardless of whether they're "declared" or not.

I think you need to update your QM with the proper documents and/or references, and make sure that processes are operated according to requirements.

Thank you for your reply. Yes Jim, I am referring to ISO 9001:2008 and internal auditor. It’s hard to say that the process requirement weren’t being followed since the specific procedure is internal to them. Auditor, despite the fact that internal, may or is not aware of the said procedure since he/she comes from other department. He/she simply felt that there was something wrong with the actual practice if the ISO standard is concerned.

Is it really a requirement that all documented procedures to be part of the quality manual or referenced in the quality manual? Or the six mandatory procedures plus documents needed by the organization to ensure the effective planning, operation and control of its processes will do?

Again, thank you for the reply and for tweaking the description title. By the way, did I post in the wrong forum? Sorry.

 

[AndyN]

Re: confusion on declared and non-declared documents

Is it really a requirement that all documented procedures to be part of the quality manual or referenced in the quality manual? Or the six mandatory procedures plus documents needed by the organization to ensure the effective planning, operation and control of its processes will do?

In principle, the answer is 'yes' to your first question. But we have to know a bit more about the document you are referring to. What is its purpose? Who uses it? What does it contain? If it is part of defining some aspect of 'effective planning, operation etc.' then it surely should be part of the doucment control system and part of the quality management system.

 

[Polly Pure Bread]

Re: confusion on declared and non-declared documents

In principle, the answer is 'yes' to your first question. But we have to know a bit more about the document you are referring to. What is its purpose? Who uses it? What does it contain? If it is part of defining some aspect of 'effective planning, operation etc.' then it surely should be part of the doucment control system and part of the quality management system.

Thank you for your reply AndyN. I think we addressed already each clause of ISO standards as an initial point for our QM. We referenced the procedures and a process map describes the sequence and interaction of our core process. However, there are still undeclared (not in the QM) documented procedures internal to the department. I managed to make an impression that if undeclared document is allowed, auditees can make 2 opposite procedures or perhaps as many as they can. During audit, of course, I will suspect that auditee will show the one that is conforming to actual practice if other undeclared procedures are not.

 

[AndyN]

Re: confusion on declared and non-declared documents

However, there are still undeclared (not in the QM) documented procedures internal to the department. I managed to make an impression that if undeclared document is allowed, auditees can make 2 opposite procedures or perhaps as many as they can. During audit, of course, I will suspect that auditee will show the one that is conforming to actual practice if other undeclared procedures are not.

If this is so, you have a problem! You appear to have both controlled (why not call them that, instead of declared etc?) and uncontrolled documents. So, you have something fundamentally wrong happening here. You run some risks of allowing these uncontrolled documents to exist, both from an operational sense and if you wish to achieve and maintain an external Certification.

Do your management understand that these uncontrolled documents may put you at risk of making a mistake that could affect customers etc?

 

[SteelMaiden]

Your company has tried to do what many before have tried. "This only affects my dept., so we will take care of it, there is no reason to put it in the QMS"

First. The quality manual does not have to have the procedures included as a part of it. They can be referenced.

Second. You need to control work instructons (or whatever you choose to call them (undeclared documents?)) If it affects the quality management system, the product and its ability to meet specified requirements, and/or customer (internal, external, direct, indirect, stakeholders, stockholder, whatever you want to call all these people) then it must be controlled. You can control them within the departments, but they must be controlled, and you must define that within a procedure that is part of the quality manual, or referred to within the quality manual.

Third, if someone is found working off of a document that you cannot show some sort of trail back to your documented Quality Management System (of which you quality manual is a part of, not the sum of) then you are in nonconformance, because you have an uncontrolled document.

 

[bobdoering]

Your company has tried to do what many before have tried. "This only affects my dept., so we will take care of it, there is no reason to put it in the QMS"

...if someone is found working off of a document that you cannot show some sort of trail back to your documented Quality Management System (of which you quality manual is a part of, not the sum of) then you are in nonconformance, because you have an uncontrolled document.

This becomes almost amusing over time. People will spend more effort shortcutting the system than just using it, with more problems in the end. They just do not get the point of controlling documents.

Part of the problem may be they use difficult 'systems', maybe too many signoffs, etc. - and the fear of all of that overhead blurs the vision of the control.

 

[Sidney Vianna]

I believe that even undeclared document but are critical to the operation or has significant impact in the delivery of service can be tagged as an NC.

Let me join the stampede. ISO 9001 is about control of processes that are part of your QMS. ISO 9001 states that, IN ADDITION to the minimum 6 processes that need to be documented, the organization must develop documents determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. (ISO 9001 4.2.1d). Then in 4.2.3, ISO 9001 states: Documents required by the quality management system shall be controlled.

The basic conclusion is: if a department believes they need a document to establish control over a process that is part of the QMS, then, the document must be controlled, like many others have already explained. It is totally acceptable to have a different document control process for the different types of documents. In other words, the way of controlling that departmental instruction does not need to be the same way you control the quality manual, but some of form of control is mandatory.

 

[Sirlard]

This has all the ear marks of the proverbial dual accounting books! The documents you show and the ones you hide.