All Internally Generated Documents ? Required to be Controlled or Not All?

[makaurag]

All Internally Generated Documents – Required to be Controlled or Not All?

Hello everyone!

This is my first post. I’m new here. I registered because I found some posts very helpful and excellent. I feel that I am in the right place.

Please shed light on my first question. Is it a requirement that all internally generated documents must be controlled? I assume that people knew that I am referring to ISO 9001 since I am posting this in ISO 9001 – Quality Management Systems Standard discussion threads.

Thank you in advance.

Honestly, I’m not an expert but I will do my best to participate in the discussions, contribute and be able to help others.

 

[brahmaiah]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

Welcome to Elsmar.You donot have to be an expert to be here.But you are sure to become an expert if you stay here long enough.
Now coming to your query, all documents of QMS are required to be controlled irrespective of their level.I presume here that you have a clear idea about what is a document and what is not.
V.J.Brahmaiah

 

[makaurag]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

Thank you Barhmaiah for your quick response. Yes, I know what document is and the basics of ISO 9001 documentation. Since we are practicing ISO 9001, of course, we do have our quality policy and departmental quality objectives, policies and procedures, instructions, and other reference documents. These documents are part of our quality manual. However, there are other existing documents not part of our manual that can be found from different departments that are not controlled or if there are controls but not as sophisticated as documents that is part of our quality manual.

 

[makaurag]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

May I post additional questions related to my previous posts. How would I explain to the rest of the organization members the significant and critical processes that need to be documented? As for processes that are documented already, how would I explain to them that it should be controlled per 4.2.3?

It should be in lay mans term for them to understand. Otherwise, they will not subscribe to the idea and they might feel that this is additional work.

I hope you could help me on this.

 

[brahmaiah]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

Thank you Barhmaiah for your quick response. Yes, I know what document is and the basics of ISO 9001 documentation. Since we are practicing ISO 9001, of course, we do have our quality policy and departmental quality objectives, policies and procedures, instructions, and other reference documents. These documents are part of our quality manual. However, there are other existing documents not part of our manual that can be found from different departments that are not controlled or if there are controls but not as sophisticated as documents that is part of our quality manual.

Now you have come with a new information by saying that there are other documents in differant departments.If the 'other' documents you mention are related to product quality they should also be controlled.No document has a right to declare independence from control.
If a document is irrelevant to product quality or QMS it is not a QMS document.Can you give some examples of such documents existing in your departments?

 

[makaurag]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

Now you have come with a new information by saying that there are other documents in differant departments.If the 'other' documents you mention are related to product quality they should also be controlled.No document has a right to declare independence from control.
If a document is irrelevant to product quality or QMS it is not a QMS document.Can you give some examples of such documents existing in your departments?

I think even if I won’t mention the specific documents you will still understand the situation correctly. I can say that these documents are relevant to QMS. But what is the degree of relevance needed to say that it should be controlled the way it should be? I would say that some documents are very relevant, slightly relevant, and some are not so relevant. Are the slightly relevant documents required to be controlled per 4.2.3? If so, I hope that it doesn’t have to be part of the quality manual. It can be controlled within the department level or functions. We don’t want to be swamped with documentation.

 

[brahmaiah]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

I think even if I won’t mention the specific documents you will still understand the situation correctly. I can say that these documents are relevant to QMS. But what is the degree of relevance needed to say that it should be controlled the way it should be? I would say that some documents are very relevant, slightly relevant, and some are not so relevant. Are the slightly relevant documents required to be controlled per 4.2.3? If so, I hope that it doesn’t have to be part of the quality manual. It can be controlled within the department level or functions. We don’t want to be swamped with documentation.

A document is either controlled or not controlled, there are no 'less controlled' documents,'more controlled' documents or 'slightly controlled' documents.It is ok if they are departmentally controlled.But they shall be controlled.
We are discussing an immaginary problem because you have not given examples I had asked for. You must know we are spending our valuable time and resources.
V.J.Brahmaiah

 

[makaurag]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

A document is either controlled or not controlled, there are no 'less controlled' documents,'more controlled' documents or 'slightly controlled' documents.It is ok if they are departmentally controlled.But they shall be controlled.
We are discussing an immaginary problem because you have not given examples I had asked for. You must know we are spending our valuable time and resources.
V.J.Brahmaiah

As much as I wanted to provide you the specific documents, I cannot because I am not the owner of those documents, thus I am not familiar and cannot even name them. As far as our group’s documents (QA group) are concerned, I am confident to say that all documents are controlled. As for other departments, do they have to have a documented procedure on control of documents internal to them apart from the centralized documented procedure on control of documents owned by DC? If yes, we will end up with more than one procedure on control of documents to be managed.

With regard to which documents needs to be controlled and which don't need, I found practical suggestions from similar threads.

The Cove is full of informative and engaging read.

 

[makaurag]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

A document is either controlled or not controlled, there are no 'less controlled' documents,'more controlled' documents or 'slightly controlled' documents.
V.J.Brahmaiah

I appreciate your replies but please don't get me wrong if I disagree with you on this. I didn’t say ‘less controlled’ documents, ‘more controlled’ documents, and ‘slightly controlled’ documents. I said ‘very relevant’, ‘slightly relevant’, and ‘not so relevant’. I take a strongly stand that there is such things as that.

 

[SteelMaiden]

Re: All Internally Generated Documents – Required to be Controlled or Not All?

Welcome to the Cove. I see you have run into the biggest problem of document control where each department has its own procedure. First, if the documents are related (in any degree) to your QMS, product quality, etc., they need to be controlled. So, if you are saying another department has a bunch of instructions on how to do things, yes, they need controlling. Forms that record data pertinent to quality assessment and results need to be controlled. If memos are being used to tell people how to do their jobs, that information needs to be included as instructions and controlled. Does that help?

We don't need to know what these documents you are talking about say, but if you could give us some description of the nature of them, it would be helpful so we could give better answers.