Documents for Manufacturing Environment

[ISO_Man]

I have teams in a manufacturing environment who want to create instruction cards to hang on the machines; do those cards have to be controlled documents?

 

[CCaantley]

I was told by our ISO trainer that anything that provides instructions needs to be controlled.

 

[ISO_Man]

I was told by our ISO trainer that anything that provides instructions needs to be controlled.

How about approvals?

 

[CCaantley]

For our shop, as Quality Manager, all document approval goes through me. Not knowing the size of your workplace, I don't know if approval can be a one person job or require a team effort. Like a lot of things, I expect the less people involved the more likely the process remains sound.

 

[RoxaneB]

I have teams in a manufacturing environment who want to create instruction cars to hang on the machines; do those cards have to be controlled documents?

What is the purpose behind these cards?

I was told by our ISO trainer that anything that provides instructions needs to be controlled.

Anything? That seems rather extreme.

 

[RoxaneB]

For our shop, as Quality Manager, all document approval goes through me. Not knowing the size of your workplace, I don't know if approval can be a one person job or require a team effort. Like a lot of things, I expect the less people involved the more likely the process remains sound.

Why does each document go to you for approval? Are you the process owner and/or expert on procurement or manufacturing/production or shipping/logistics? Ideally, the process owners are the ones approving a document. The QM "approval" is, in my experience, more conformity check - Were all the appropriate sections completed properly? Is the formatting correct? Is the revision table up to date? And so on.

 

[JoshuaFroud]

I have teams in a manufacturing environment who want to create instruction cards to hang on the machines; do those cards have to be controlled documents?

As some of the others have said, this really depends on what the cards are for and what information they contain. If they have the potential to impact product quality then I would suggest they are controlled, if noting else to ensure oversight and make sure any of the instructions captured do not contradict any other procedures or practices in place.

 

[CCaantley]

What is the purpose behind these cards?



Anything? That seems rather extreme.

I felt the same way when he told us that, but my boss has taken it as gospel.

 

[CCaantley]

Why does each document go to you for approval? Are you the process owner and/or expert on procurement or manufacturing/production or shipping/logistics? Ideally, the process owners are the ones approving a document. The QM "approval" is, in my experience, more conformity check - Were all the appropriate sections completed properly? Is the formatting correct? Is the revision table up to date? And so on.

It is more or less as you describe, but having worked in all the major areas where the documents are applied, I do have the knowledge to judge that a document is needed and/or correct.

 

[ISO_Man]

I checked in with the most experienced ISO person I know in manufacturing and she said that anything that's part of the process needs to be a controlled document.