Documents of External Origin - Identification, Control and Distribution - 4.2.3 f)

[florin pirvulescu]

4.2.3 f) ask to ensure that documents of external origin are identified and their distribution controled.
What kind of external documents is about?
Thanks

Florin

 

[Mike S.]

Florin,

Most often they are customer documents such as drawings, specifications, purchase orders, contracts, etc. Also included might be regulatory or ISO standards, etc.

 

[RoxaneB]

The way my organization has defined an External Document is any piece of documentation that has a direct impact on one's ability to perform one's job.

Yes, our ISO 9000 Compedenium Edition ??? is controlled and is maintained on our list of External Documents. The document on how to maintain/use the software that controls our documentation is not on this list as the exact same information is contained in the software's help files (and is thus controlled through the vendor). Our copies of the ASTM requirements are External Documents and are controlled. We even identify our Registration Certificate as a controlled External Document.

The ongoing battle is whether or not the equipment manuals need to be controlled. At my last place of employment, all manufacturer's manuals were controlled. At this place, they are not and so far, no external auditor has commented on them...not sure if it's because they have bigger fish to fry or if they don't consider it to be an issue or they just haven't gotten around to it yet.

 

[M Greenaway]

The concept of 'control' of documents is primarily to ensure that people have access to the latest version. A manufacturers manual is normally provided with a piece of equipment, and is never updated - hence 'control' in this instance to my mind is not required.

 

[RoxaneB]

Actually "M", you'd be surprised at how frequently our manufacturer's manuals are updated. It's not uncommon for us to receive updated inserts - sometimes due to the fact that we upgraded the equipment and sometimes due to the fact that a new "aspect" of the equipment has been discovered (e.g., machine can allows so many tonnes to pass through before fatigue become apparent, etc.).

 

[M Greenaway]

Then possibly you need to control.

like every question posted in this forum regarding what you should do for ISO9001, ask what you need to do for yourself.

 

[florin pirvulescu]

M Greenaway said:


like every question posted in this forum regarding what you should do for ISO9001, ask what you need to do for yourself.

Because it's a virtual scool and a mind challenging maybe this forum should be recomended to all the external auditors, and presented to all lead auditor courses.
Unfortunately for me it would be enough to ask myself what I need to do for my self. What about the auditor. The way I see a solution it's not allways the same with the auditor. Years in the position of auditor make some of them acting as inspector-professor. That's why they probably hardly accept other solution then their own.
Every strange question I have been asked pushed me in the internet looking for confirmation and support on my way of thinking.
I know you will advice me to change the registration body. But the top management knows that is cheaper to complete a couple of papers to give satisfaction to a person then to change the certification body. So the spirit of ISO is killed. Poor ISO!
Florin

 

[M Greenaway]

Florin - exactly right.

Maybe we need to go back to school and re-learn the principles of quality assurance, rather than what ISO9001 is supposedly telling us to do.

Risk analysis or FMEA would be a good place to start !

 

[florin pirvulescu]

M Greenaway said:


Risk analysis or FMEA would be a good place to start !

I'm amaised! Are you 24 h/d in the forum?
Did you wright few books on quality matters, or it's a confusion in my mind? Scuse me if so.
What is actualy FMEA?

 

[Claes Gefvenberg]

Failure Mode Effect Analysis

potential Failure Mode and Effect Analysis.

Basically, you list potential problems, the risk for occurence, severity if it occurs, and the chance of detection, rate the findings and start taking action. It's a great tool. Have a look at the FMEA forum.

/Claes