QSP 4.2.3 Control of Documents Procedure - Content and Requirements

T

tnott

Hello I have a question regarding the control of documents procedure. It is my understanding that the company must have a documented procedure for the control of documents 4.2.3.

My question is... Am I able to create a high level QSP 4.2.3 that states the responsibilities for the control of documents and then state that for requirements for the identification, approval, and etc.. please see the Control of Quality Documents work instruction (#) and the Control of Engineering Documents (3)? Or do I have to keep it as one document and as a Quality System procedure instead of two work instructions?

Your help would be appreciated.

Tanya
 

Pancho

wikineer
Super Moderator
Re: QSP 4.2.3 Control of Documents Procedure

Hi Tanya,

It is your system, and you can slice it any way that works for you.

We started with a single procedure for document control. As our system matured we split the original into a few more procedures and work instructions. Now we have the following documents,

  • SP: Control of Documents
  • SP: Control of External Documents
  • SP: Control of Records
  • WI: Monitoring Document Changes
  • WI: Creating New QMS Documents
This works for us right now, but it is likely to change as the system continues to improve.

Good luck!
Pancho
 
T

tnott

Re: QSP 4.2.3 Control of Documents Procedure

I appreciate your response.... I have another question :)

I notice we have external documents that are used by our engineering department, production and by QA.

I have created a form entitled "Master List of External Documents". Is it normal practice for QA to control only one log that contains all of the external documents or am I able to give a copy of form to each of the departments and have them be responsible for maintaining external documents that are applicable to their department?

I appreciate your help!
 

Pancho

wikineer
Super Moderator
Again, whatever works for your company is the right way to do it. Variables to consider are the quantity of documents, how often they change, how involved are the process owners or department heads, etc.

We organize most of our controlled external documents by project. Each project has its own list compiled from contract references or defaults. The list is under the control of the project manager. A few external documents are controlled by functional managers. For example, our safety manager is charged with reviewing and updating links to applicable OHS legislation periodically.

Hope this helps!
Pancho
 

Ettore

Quite Involved in Discussions
If you have external documents that are used by your engineering department or production are you sure that they should be controlled by a quality system procedure?
Don't spend time to do something that is not useful or required by the norms!!!
 

Ettore

Quite Involved in Discussions
Re: QSP 4.2.3 Control of Documents Procedure

This works for us right now,
Pancho
Everywere In the cove I have seen this exclamation, we are sure of that, or we could do better than what works for us?
 
T

tnott

That is where I am getting confused. My understanding is that all external documents that affect the overall product quality should be controlled.

The production floor uses guides such as "Standard Steel Bolt Torque Specifications" and guides on how to cut hydraulic hoses.

Engineering may have general guides or specifications or books regarding valve sizes. Like which ones to use and so forth. I am just not sure where I should stop when it comes to controlling external documents.

Tanya
 

Pancho

wikineer
Super Moderator
That is where I am getting confused. My understanding is that all external documents that affect the overall product quality should be controlled.

The production floor uses guides such as "Standard Steel Bolt Torque Specifications" and guides on how to cut hydraulic hoses.

Engineering may have general guides or specifications or books regarding valve sizes. Like which ones to use and so forth. I am just not sure where I should stop when it comes to controlling external documents.

Tanya

Actually, the external documents that you control are those determined by your organization to be "necessary for the planning and operation" of the QMS, not those that affect overall product quality.

The first set of documents is much smaller than the second.

In your engineering library you may have hundreds of references, any of which may inspire your engineers to come up with a better solution to your client's problem and thereby affect overall product quality. But most likely you are not promising contractually such inspiration. It is not necessary to control every external doc in your company's library.

What you are promising to your clients is that your product will meet certain specifications. These specs refer to external documents (standards, codes, regulations, etc.). You must make sure that you use those docs, in their required version, in designing and delivering your product.

We make custom structures. Each client's contract goes into great detail on what specs we must meet, and the external docs referred to by those specs vary. Thus, it makes sense for us to control docs by contract (project), and that is why we prepare a external doc list for each individual project. Conversely, in a company that makes standard products, you should look at your standard product specs and contract forms to determine external docs that need be controlled.

For example, if your product or contract spec calls (directly or indirectly) for all bolts to be torqued in accordance with the "Standard Steel Bolt Torque Specification, 2007 edition", then you'd better control that document. If it says "latest edition", then you'd better be continually monitoring for new issues of that doc. Conversely, if bolts in your product do not regularly need torque per your spec, but that doc sits in you ref library, it does not need control.
 
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Pancho

wikineer
Super Moderator
Re: QSP 4.2.3 Control of Documents Procedure

Everywere In the cove I have seen this exclamation ("this works for us right now..."), we are sure of that, or we could do better than what works for us?

Yes and yes. Yes, we are sure of that, and yes, we could do better.

That's the essence of continuous improvement. :D
 
T

tnott

Ahh I see what you are saying.. You have helped me a lot. I think I will be off to a great start now.

In my previous company I was the Quality Administrator. I was responsible for auditing and maintaining all of the QMS documents. Now in my current company I am the only Quality person and have to implement ISO. So pretty much all of my guidance and help is coming from the internet and blogs. Therefore, I sincerely appreciate your help!
 
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