Documents for Manufacturing Environment

[Al Rosen]

7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this International
Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

 

[AndyN]

Part of this endless debate about what needs to be controlled is the understanding of what "control" actually means. Far too many organizations go overboard on "control" and do things which are actually a) not a control and b) are ineffective as a control.

If you have useful cards which the people like to use as a means to control process/product, what is it about a control that would prevent the cards from being "controlled"... (Ask your "ISO trainer" if they know the answer!)

 

[John Broomfield]

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?

ISO_Man,

Are your machine operators competent to operate their machines? If they are why do they need an instruction card on each machine?

Perhaps they are seeking to become competent, in which case they should be closely supervised if only for their safety.

Or they may just be trying to keep a traditional “ISO person” happy.

Please let us know.

Thanks.

John

 

[RoxaneB]

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.

Having worked in those areas is great. Always a plus to have a solid foundation in the business beyond just quality. But are there current process owners? If so, I'll be honest, I'd rather see their approval than the QM's.

 

[Mike S.]

Andy,

An ISO guidance doc defines control as such: Control - verb - direct, restrain or regulate
noun - power to direct, restrain or regulate; means of restraining or regulating

So what's the answer to your riddle, and how does it help the OP?

 

[AndyN]

So what's the answer to your riddle, and how does it help the OP?

Many organizations have taken "control" to mean some bizarre things, done in the name of "ISO", including giving documents a 14 digit numbering scheme. It's not a riddle, it's a perfectly legitimate question! What is understood - in their organization - by "control"?

An ISO guidance doc defines control

Which one? If it's NOT the ISO 9000 normative reference, then the definition doesn't count...

 

[Mike S.]

ISO/TC176/SC1 N 400

ISO/TC176/SC1/WG1 N 318
ISO 9000 Introduction and support package:
Guidance on some of the frequently used words found in the ISO 9000 family of standards

2012 version

 

[AndyN]

ISO/TC176/SC1 N 400

ISO/TC176/SC1/WG1 N 318
ISO 9000 Introduction and support package:
Guidance on some of the frequently used words found in the ISO 9000 family of standards

2012 version

Yup, not normative references...

 

[Mike S.]

Yup, not normative references...

So show us a more acceptable definition that, in your view, "counts" and explain to us how it adds light to this conversation.

 

[Jen Kirley]

The term procedure was changed to documented information in order to clarify that we can also have our instructions on flip charts, cards, videos, posters, signs, TV monitors etc. The point, as always, is that the information's user has ready access to clear, current, approved instructions. Control requirements in 7.5 apply, but not every document needs the same number or organizational-level approvals and obsolescence controls will also vary based on the media. I imagine these cards would function on the level of work instructions, which are also to be controlled but don't necessarily require the same methods as higher-level procedures. The organization decides the control methods.

An organization is also empowered to identify those with authority to approve the various kinds of documents. A past employer used a matrix approach for listing such approvers.