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

[SteelMaiden]

I'll go with the majority. If you want to write it up, do it, but it probably won't add much value. You control documents to keep people from (accidently, or on purpose) making changes that will affect the process. It is pretty hard to make a change to an owner's manual without being able to spot it, after all, isn't it obvious if you cross something out and write over it? If it is something you can pull off a website any ol' time, it is not controlled at the source, so why would you control it? (i.e. the specs you were talking about...just say we go to the web and look it up.)

The fact that you worked in a company of 5,000 means absolutely nothing. Control is control, 1, 5, 10 or 10,000. The fact that the company chose to do what it did does not mean that it is the only way things can be done. Quality systems have evolved since the first ISO systems were put into place.

Insanity is not doing the same things over and over, it is doing the same things over and over again and expecting a different result (improvement within the system).

 

[harry]

TY, In my early days of auditing, me too, had the approach of: if it is a requirement, you better comply. As I matured and seasoned as an auditor, my take on things changed. Compliance with requirements is very important, but adding value is much more important. As Brad says, you have to draw lines when you audit. In this specific issue, PM is very important. Having a "controlled list" of maintenance manuals is useless, IMO. Are you going to expect them to have a list of customer POs as EO documents? POs are documents coming from the customers that are revised from time to time. So, they fit your definition of EO documents that must be controlled. Still, I don't know of a single organization that controls customer POs as part of 4.2.3.

Good luck in your audits.

Well put! That segregates the 'boys' from the 'man'. Who wants to be audited by 'boys'??

 

[al40]

This type of dogmatic approach to implementation and auditing leads no non value added "solutions", in my experience.
Imagine for a second that the company has created a list with these operators, owners and maintenance manuals. How has this list improved the organization?

You asked for ideas and I shared mine with you. If you are only asking for concurrence with your ideas, then your post was not clear.

I agree, We focus on controling documents that are critical to our organization and adds value e.g. External customer drawings, specifications, Mil-Specs, etc.

I would not pursue this N/C because it doesn't add value to the audit or the organization.

Best Regards,

al40

 

[Helmut Jilling]

I worked for a company with 5,000 employees. Our D/C Operating Procedure lists almost every doc of External origin and where they are kept. EG- the Machine manuals are kept in the company library and copies are scanned and stored in the company network system folder XXXX\XXX\XXX. Mil specs can be downloaded from a website and the web address and access information is available in the OP. It is very helpful and definitely value added.

If you don't agree with this N/C, tell me why and just don't say that it is a non value added "solutions". Since it is an ISO requirement, it may mean something.

I'm inclined to agree with Sidney. As we gain experience in auditing, it tends to focus the efforts toward the more important things. Even the standards committees are going in this direction.

Many newer auditors tend to really focus on doc control. It is important, and I certainly make sure my clients control their docs appropriately. However, we are not the doc police, and doc control is only a means to an end.

To clarify, I describe doc control as a series of concentric circles - like a bull-eye target. The most important documents are closest to the middle and must be controlled pretty carefully. As documents decline in importance, or the risk of changing goes down, put them more in the outer rings. The further out the rings are, the less critical it is to control the documents formally. Some can be controlled with just date revisions, and maybe a signature.

Please remember why doc control is important in the first place.

 

[Steve Painter]

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.

 

[Sidney Vianna]

Here is the stance I intend to take with this NC:....I do not know how this will fly with the auditor, but it makes perfect sense to me.

You can use this as a test to see if your auditor understands the concept of added value.

You ask the auditor what is required to consider the PM manual "controlled". Chances are, the answer you are going to get is: It has to be listed in a list of documents of external origin. Then you ask. Assume I do that, how will that make my organization any better? And the fun begins...

 

[Stijloor]

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.

Hello Steve,

During my career, I have been involved with many document discussions such as the ones in this thread. Documents, document control, valid and invalid nonconformities, etc., Here is a simple question I always ask: "Is there value in maintaining this (hard-copy and/or electronic) document?" If yes, then I ask the following question: "Can you afford to lose this document?" If no, my response is: "Control it!"

It's that simple. Often, we get too wrapped up in (emotional) discussions without considering the purpose of documentation in the first place. We need to start looking at all this from a business perspective rather than beating ourselves up with standards and auditors.

Sorry, it's Friday, I know.....

Hope this helps a little.

Stijloor.

 

[Jim Wynne]

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.

Where was the manual found by the auditor? Is it true that the manual isn't used? If so, throw it out, and tell the auditor that it doesn't need to be controlled because it's gone. While Sidney makes a good point, if the manual is used, even occasionally, it probably should be referenced in your documentation. Keep in mind that warranties will probably be voided if you don't follow the manufacturer's maintenance requirements, and have records as evidence of maintenance.

 

[Jim Wynne]

Hello Steve,

During my career, I have been involved with many document discussions such as the ones in this thread. Documents, document control, valid and invalid nonconformities, etc., Here is a simple question I always ask: "Is there value in maintaining this (hard-copy and/or electronic) document?" If yes, then I ask the following question: "Can you afford to lose this document?" If no, my response is: "Control it!"

It's that simple. Often, we get too wrapped up in (emotional) discussions without considering the purpose of documentation in the first place. We need to start looking at all this from a business perspective rather than beating ourselves up with standards and auditors.

Sorry, it's Friday, I know.....

Hope this helps a little.

Stijloor.

There's another consideration when we talk about control of documents, and that's control of processes. If there is a requirement to maintain a machine in accordance with the manufacturer's guidelines (or requirements for keeping a warranty in force), then the documents needed to carry out those requirements should probably be controlled, regardless of origin.

 

[Gary E MacLean]

WOW, I must say I am a little bit surprised. Hands down you have a legitimate and a value adding nonconformance. I don't see any room at all for wavering even.

As we mature as auditors rather than become more accepting to breaches of the standard we should get even less accepting. I wanteed to quote at least one thing from almost every post but I figured that wouold just take too long (not value added).

In trying to make an approach brief let's start with maintenance schedules.
Q: How often do you conduct maintenance on this piece of key equipment?
A: Once every three months
Q: Have you ever had anything wrong during scheduled maintenace?
A: Oh yeah, we've had to change certain things and so on.
Q: Where did you come up with your every three month schedule?
A: Its recommended through the owners manual
Q: May I see the owner's manual?
A1: Well we don't have it any more
A2: I don't know where it is right now
A3: I loaned it out to a company that has the same machine
A4: Sure, here it is
Q: The manual is dated 1963
A: That's when we bought the equipment
Q: Have there been any changes to the equipment?
A: Oh sure, we rebuilt the gearbox, we added the frim fram and removed the flammer. The cfompany had a required re-call on the safety mechanism, and on and on.
Q: Do you have a new owners manual for the changes?
A: No.
Nonconformance

This is a made up scenario bu based entirely on fact. It isn't even outrageous - it is very common.

Document control touches so many areas of our documents. One of the key areas is "...to ensure that relevant versions of applicable documents..."

So many maintenance plans, schedules, directions, instructions, methods and so on come from owners manuals. Would you settle for the 1993 issue of the Chilton or Haynes repair manual for a 1984 Mustang if you owned a 1985 Corvette?

Find 'em, list 'em and control 'em. Write the NC and hold them to it. Of course there is value added. They may end up with a legitimate collection of maintenance information.