Approving documents prior to issue - What guarantees their adequacy?

[the son of quality]

Hi all,
What is the best way of approving documents prior to issue? does signature of responsible persons guarantee the adequecy of them ?

 

[Greg B]

Hi all,
What is the best way of approving documents prior to issue? does signature of responsible persons guarantee the adequecy of them ?

Hi Son,

We do not sign any issued documents except our Specification sheets. All of our document approvals are done by a 'Continuous Suggestion Form' (CIS). These forms are used to make suggestions or changes to ANY part of our systems (QA, ENV, OH&S, Plant, Process etc). In the case of our document system, people suggest changes via the CIS and it goes thru a series of approvals (Supervisor and Manager). These approvals are then the authority for the change to be incorporated in the document and issued. The CISs are kept on file. In this way we do not have to change documents if titles or responibilities change.

 

[SteelMaiden]

How you approve documents will depend on your system. If you use paper, or partial hardcopy, signatures are a good way to show someone said OK. We use an electronic approval. What ever you use is fine as long as it matches your policies/procedures.

No, a signature does not necessarily guarantee anything...it all depends on your company culture. Some companies you can stake your life on that signed document being up to date and accurate. Some just sign on the line cuz it's easier to sign than to read and update. Which is your company? The name of the game should be responsibility and accountability. It's your job to train and reinforce the culture (along with management, of course.)

 

[the son of quality]

Of course the culture of that company depends on this process , but i am looking for a strong and reliable process that ensures the system that those documents are adequate .

 

[Greg B]

Of course the culture of that company depends on this process , but i am looking for a strong and reliable process that ensures the system that those documents are adequate .

Son,
Here is my procedure for our Continuous Improvement Suggestion System. It allows the responible department and manager to change and apporve their documents (along with any other facte of the company.
https://elsmar.com/elsmarqualityforum/attachment.php?attachmentid=1843

And here is the form that goes with it (it is very simple to use)
https://elsmar.com/elsmarqualityforum/attachment.php?attachmentid=1729

 

[Claes Gefvenberg]

Hello SoQ, and welcome to the Cove.

i am looking for a strong and reliable process that ensures the system that those documents are adequate .

That would involve getting the most suitable people (people with good knowledge about the processes concerned) to write them, as well as people with the proper authoroty (enough clout to make it happen) to approve them. SteelMaiden is right, of course, and Greg's attachments could come in handy.

/Claes

 

[km214]

Approval of Documents for an ISO 9001;2000 Registered Manufacturer

Hello forum,
I am looking to obtain your thoughts on acceptable Document approval methods. I am with a manufacturing company now and hopefully for a long time to come. We do not need to be ISO certified but it helps as we are expanding our business into non-retail markets. I am looking over the last TUV ISO audit and revising many of our documents including the QM. We had a system in place where some (not all) of our OP's (operating procedures) and WI's (work instructions) were signed as approved but not really controlled. Coming from a med device/Pharma background in Quality, I want to get this QMS under stricter control. Of course I cannot be as anal as I had been due to the nature of the business, but I feel consistancy is the key in any document system. We do have "document control forms where there is a history of approvals and would like to use these as the means of approval solely. No more signatures on OP's or WI's. Do you think this would be acceptable to ISO?
Thank You all
km214

 

[km214]

Update on my Profile

Hello all, I updated my profile after I saw the "invalid e-mail" on my last post.
Thank You
km214

 

[Al Rosen]

Hello forum,
I am looking to obtain your thoughts on acceptable Document approval methods. I am with a manufacturing company now and hopefully for a long time to come. We do not need to be ISO certified but it helps as we are expanding our business into non-retail markets. I am looking over the last TUV ISO audit and revising many of our documents including the QM. We had a system in place where some (not all) of our OP's (operating procedures) and WI's (work instructions) were signed as approved but not really controlled. Coming from a med device/Pharma background in Quality, I want to get this QMS under stricter control. Of course I cannot be as anal as I had been due to the nature of the business, but I feel consistancy is the key in any document system. We do have "document control forms where there is a history of approvals and would like to use these as the means of approval solely. No more signatures on OP's or WI's. Do you think this would be acceptable to ISO?
Thank You all
km214

I think that's acceptable.

 

[RoxaneB]

Hello forum,
I am looking to obtain your thoughts on acceptable Document approval methods. I am with a manufacturing company now and hopefully for a long time to come. We do not need to be ISO certified but it helps as we are expanding our business into non-retail markets. I am looking over the last TUV ISO audit and revising many of our documents including the QM. We had a system in place where some (not all) of our OP's (operating procedures) and WI's (work instructions) were signed as approved but not really controlled. Coming from a med device/Pharma background in Quality, I want to get this QMS under stricter control. Of course I cannot be as anal as I had been due to the nature of the business, but I feel consistancy is the key in any document system. We do have "document control forms where there is a history of approvals and would like to use these as the means of approval solely. No more signatures on OP's or WI's. Do you think this would be acceptable to ISO?
Thank You all
km214

Would it be correct of me to assume that there are revision numbers and/or dates of revision on the documents themselves so that people know that they are working with the latest and greatest?

Signatures are not required. Some companies use them as a means to show that they have been reviewed for adequacy. My company has a electronic signature approval process - which can only be done upon the approver entering in his/her password.

Develop a system that works for you and the users of the system.