Quality Document Definition

[TacitBlue]

How can I define and classify a "quality document" in relation to non-quality documents like finance, HR, or Security for example?

In other words, what types of documents would be defined as a "quality document"? for example, are engineering, manufacturing operations, document control documents classified as "quality documents"?

Thanks,

 

[TheSouthernDandy]

Greetings TacitBlue, can you be more specific on the context?

 

[TacitBlue]

Greetings TacitBlue, can you be more specific on the context?

Sure thing, no problem. We refer to documents that directly affect the QMS or products as "quality documents" or "QMS" documents. But this is misleading because technically all documents relate to the organization's quality. However, does your company or anyone else's differentiate between quality-related and non-quality-related documents?

 

[Mike S.]

AS9100 doesn't define a "quality document" but does reference "documented information" as in documents that are used in support of meeting the requirements of the AS9100 QMS.

We have "HR documents" and "HR Procedures" that are also documented information that is used in support of meeting the requirements of the QMS.

 

[Mike S.]

But this is misleading because technically all documents relate to the organization's quality.

Not really. My company generates many documents that have no association with our QMS. I'll bet yours does as well.

 

[TacitBlue]

AS9100 doesn't define a "quality document" but does reference "documented information" as in documents that are used in support of meeting the requirements of the AS9100 QMS.

We have "HR documents" and "HR Procedures" that are also documented information that is used in support of meeting the requirements of the QMS.

Hi Mike,

Do you have a specific standardized set or combination of approvers for each category of documents, such as HR, Engineering, and Design? Do you, for example, have a process owner, a process owner manager, and a QMR approve each document in your doc control process?

 

[Mike S.]

Any QMS procedure or work instruction is approved by the Quality Manager and the Manager/Leader of the Dept that owns the associated process.

 

[Enternationalist]

I am assuming you want a definition here for some practical reason - for example, perhaps you want to loosen controls or approvals for some documentation that isn't "important".

Realistically, you need to read the standards you are applying and just ensure you meet the requirements within. Trying to generate a non-standard definition is probably counterproductive.

If you really want to be able to reason about it, it's better to think about quality-related activities. What are things that you do to ensure your product is good/safe/effective? This will include any processes mandated by your regulations and standards, any activities you need to do to implement those processes (e.g., testing quality systems software).

For each of those activities, you want to be able to prove you did them. Therefore, you will need documents and records - and those are the important ones to keep a hold of.

That's basically what you ask yourself - "Is this information needed to show that we are doing things properly, or needed to be available so that people know how to do things properly?". If the answer is yes, treat it like it's "quality". Trying to group "types" of documents is sidestepping the real crux. What is the document for? If you can answer that question, it should be obvious how you need to treat it.