What is External Documentation? Equipment Operation Manuals and Handbooks

[Ruthie J]

ok...so External Documentation would obviously cover things such as Standards and Specifications. But how far would this go.....would this include operational manuals for example?
The reason I am asking this is because I have come into a company with a massive listing of all equipment operation manuals and handbooks. I'm not convinced this is necessary.
I want to remove all of this. I have a surveillance audit coming up and am hesitant to suddenly drop all of this, in case it leads to some kind of non-conformance.


What is your experience???? Do operational manuals need to be controlled? We have hundreds of them!

 

[RoxaneB]

Our logic for not including the books on machinery was that it was not directly related to the product. We controlled our external documents such as our copies of ASTM specs, but the books on the production line were not controlled.

 

[Marc]

My experience has been that departments control documents applicable to their area. For example, a laboratory (let's say the laboratory manager) would have a listing (at the very least) of the equipment manuals they had. I've seen the equipment manual and its location put into comments of calibration software which is a means of control.

Same with production. For example, let's say you have a turnkey design and build a line. You do runoffs at their facility and then again at install. The turnkey gets manuals for things they buy for the line. Those manuals should be included in the turnkey's master manual. The master manuals from the turnkey give source and part numbers for motors, servos, transmitters or whatever, including those from suppliers. Those manuals are critical to maintenance, thus they should be closely controlled, even revision wise. I was in one company which had a machine that had a simple timer motor. The original motor failed rather regularly, as in once or twice a year. Maintenance found a motor guaranteed for 10 years. They updated the line manual to reflect this.

But - Even at home I'm a document nut. I have a couple of file drawers that have manuals, warranty certs, sales receipts, and all that stuff for everything I buy from my chipper to my dish washer. I use plastic 'folders' with the ties a lot. I admit I don't keep a listing such as a spreadsheet, but I can go through my files and find every manual for everything. I do use folder indexing such as 'bathroom' or 'roof' or 'kitchen' or 'yard', etc.

Last year I paid US$5 for shipping for a Price Pfister 'lifetime guaranteed' kitchen sink faucet replacement that was 12 years old. I had my receipt, the guarantee and all that.

In any company, if departments are not controlling essential equipment manuals, it becomes a cost/waste issue. I have seen quite a few discussion threads here where the person was looking for a manual for some type of equipment they had.

There are a number of 'manual' web sites out there that charge for equipment manuals which you can no longer get from the manufacturer. This also accentuates that not keeping and controlling equipment manuals is a cost issue.

 

[Sidney Vianna]

What is your experience???? Do operational manuals need to be controlled? We have hundreds of them!

Be aware that we've had this discussion here a couple dozen times. If you do a search, you will find several threads around this topic. One example: Documents of external origin not identified? ISO9001 Clause ISO 9001:2000 5.4.1

 

[JaneB]

ok...so External Documentation would obviously cover things such as Standards and Specifications. But how far would this go.....would this include operational manuals for example?
The reason I am asking this is because I have come into a company with a massive listing of all equipment operation manuals and handbooks. I'm not convinced this is necessary.
I want to remove all of this. I have a surveillance audit coming up and am hesitant to suddenly drop all of this, in case it leads to some kind of non-conformance.

What is your experience???? Do operational manuals need to be controlled? We have hundreds of them!

You could be right that there are too many listed. Or then again, maybe not. You need to know who uses them, when, how & why.

Focus on what it says in the Standard (2008 - italics added): you have to define the controls needed (ie, that your org determines are necessary) in order to:

ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled

So for each doc, ask yourself: is it necessary? What happens if we don't identify this one? What's the risk of using the wrong version? The impact?

If it turns out that it's possibly just 'nice to have, might read it sometime', don't. But if it's 'tells us how this piece of equipment operates & how to set it up etc' - do. Your incoming auditor will expect that you have answers to the same questions.

 

[afterburner27]

can't find any doc of numerex mod 2828-24mnl.
wonder is somebody has the same equipment.