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Documents of external origin not identified? ISO9001 Clause ISO 9001:2000 5.4.1

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Helmut Jilling

Auditor / Consultant
#22
I'm a little late to this thread, but I just had an auditor write up a non-conformance for an injection machine maintenance manual that was not controlled. Here is the stance I intend to take with this NC:

Nowhere in my Quality Manual or procedures do I say that maintenance activities; preventive, predictive, reactive, or otherwise are carried out in accordance with the manufacturer's manual. Therefore these documents are used "For Reference Only," and are not subject to our procedure for control of external documents.

As soon as you make a statement like the one described above, not only for maintenance, the referenced manual(s) become a part of the quality system and must be controlled to ensure you have the latest and greatest. If the manufacturer's recommendations are taken from a manual and put into say, a preventive maintenance schedule, then the schedule is then what needs to be controlled and not the manual.

I do not know how this will fly with the auditor, but it makes perfect sense to me.
I think you are correct.

It is common for less experienced auditors to make an issue of this. But, we tend to either outgrow it, or a more seasoned auditor shows the error of our thinking. (One more reason why auditors should get a little more experience before being designated as Lead Auditor).

However, here is a better ISO argument:

The manuals are somewhat important, so it could appear logical to control them. However, as you said, you use the manual for reference and build the important information into your work instructions. The only benefit to controlling them is to ensure that future revisions are propoerly reviewed and distributed. However, equipment manuals generally do NOT get revised, so you would never have to recall and replace the manual copies.

Thus, as Sidney asked, what difference would it make?
 

Helmut Jilling

Auditor / Consultant
#23
WOW, I must say I am a little bit surprised. .... It isn't even outrageous - it is very common.

Wow, Gary... To be this passionate on such a tiny issue, I am indeed surprised.

I have performed a little over a 1000 3rd party audits. Somewhere back in the first 50 or so, I might have agreed, but, I moved on very early.

You have to be kidding. The OP even stated he does not follow the maintenance in the manual. He used it as a starting point.

You may review my other comment in this thread, to see my reasoning...
 
S

somerqc

#24
I am late joining this one as well. However, I was written up on this by a very seasoned auditor during an audit.

Why? Because the manual outlines exactly how to replace blades, tools, etc. It also outlines what type/make of cutting tools the machine will accept.

Are the proper tools for the machine critical in ensuring product conformity? You bet!

Does following the proper procedure for replacing worn tools/blades ensure safe operation and product conformity? You bet! (btw, we are also starting the consolidation of 9001 and 18001).

I didn't argue with him on this one. If he just wanted me to list them and this type of information wasn't in the manual...I would have thrown him in the nearest snowbank! (our audit was during the one of the biggest snowstorms of the winter!). He was trying to help us ensure our system was robust enough to ensure that all operators followed the same protocol; thereby, ensuring a safe environment and product that conforms to requirements (and of course, happy customers).

John
 

Jim Wynne

Staff member
Admin
#25
The manuals are somewhat important, so it could appear logical to control them. However, as you said, you use the manual for reference and build the important information into your work instructions.
What does "used for reference" mean? Does it mean that the manual is referred to when doing maintenance?

The only benefit to controlling them is to ensure that future revisions are propoerly reviewed and distributed.
Not true, at least not always. There's always a lot of talk around here about documents being "useful," meaning documents being regularly used in the operation of processes. This overlooks another important function of QMS documents, namely process design and control. When we design processes, one of the goals should be to establish a proven method for obtaining the desired results. In many, possibly most, cases, the process must be operated as designed in order for the outcome to be predictable. In such cases, QMS documentation serves as a primary source for process operation. It may be that operators can be trained in accordance with the proven method, and never have to look at a work instruction. On the other hand, if someone comes along and says, I think we should do x instead of what we have been doing, the document provides a point of reference for the established requirements, and should serve to notify everyone that they should do x at their own peril.

A document doesn't have to be constantly read in order to be useful.

However, equipment manuals generally do NOT get revised, so you would never have to recall and replace the manual copies.
It's not uncommon at all for errata sheets to be published, and for previously undocumented safety issues to be addressed by equipment manufacturers. In point of fact, maintenance and operation documents do get updated.
 

Helmut Jilling

Auditor / Consultant
#27
I am late joining this one as well. However, I was written up on this by a very seasoned auditor during an audit.

Why? Because the manual outlines exactly how to replace blades, tools, etc. It also outlines what type/make of cutting tools the machine will accept.

Are the proper tools for the machine critical in ensuring product conformity? You bet!

Does following the proper procedure for replacing worn tools/blades ensure safe operation and product conformity? You bet! (btw, we are also starting the consolidation of 9001 and 18001).

I didn't argue with him on this one. If he just wanted me to list them and this type of information wasn't in the manual...I would have thrown him in the nearest snowbank! (our audit was during the one of the biggest snowstorms of the winter!). He was trying to help us ensure our system was robust enough to ensure that all operators followed the same protocol; thereby, ensuring a safe environment and product that conforms to requirements (and of course, happy customers).

John

1. If your operators refer to the manual as a work instruction to tell them what tools to use, it needs to be controlled.

2. If you choose to put it in the doc control system, then it needs to be controlled.

I am a fan of doc control, but if neither of these rules apply, then it does not have to be controlled.

Remember, ISO allows you to decide what documents are needed to ensure control over your processes (cl 4.2.1.d). Most companies I know, decide these manuals do not need to be "controlled" because they do not change. But, if you want to control them, that is fine.
 

Jim Wynne

Staff member
Admin
#28
Can someone enlighten me and explain what would be required to consider an external maintenance manual "controlled"?
Although I don't agree with Gary's premise, control is an issue when a document--regardless of origin--is to be used as a standard. It probably doesn't apply to the case at hand, but if a maintenance or operation manual is considered a "bible," then it should be referred to as such in the process documentation, which is a form of control. As I pointed out in another response in this thread, it's not unusual at all for such manuals to be updated, especially when new safety issues are discovered.
 
G

Gary E MacLean

#30
1. Most companies I know, decide these manuals do not need to be "controlled" because they do not change.
The fact that a document's contents can change shouldn't be the only deciding factor for control. There is also the concern about where is it? Who has copies? Is it still legible and in readable condition? Can it be easily accessed? These are all a part of document control.
 
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