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

phxsun2001

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#1
4.2.3.f states,"Has a documented procedure been established to define the control need to ensure that documents of external origin and their distribution controlled". I could not find anywhere in any documents that list the specific documents of External Original (EO).

In the scope of the Document and data Control Operating Procedure, it says " This procedure covers all controlled documents or technical specs that originated from a customer, vendor or any regulatory agency". It does not mention what documents of EO are. The company says that they meet the ISO requirement. I believe there is a N/C because :

1) Documents of EO is not list anywhere in the QMS documents.
2) The company claims that most/all document of external origin have been listed. These are examples of documents of EO are not listed that should be controlled by a department:
Example 1- Machine shop machine owners manual and Preventive maintenance manual
Example 2- Equipment (Compressor) owners and preventive maintenance manuals and others.

What do you think?
 
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Sidney Vianna

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#2
2) The company claims that most/all document of external origin have been listed. These are examples of documents of EO are not listed that should be controlled by a department:
Example 1- Machine shop machine owners manual and Preventive maintenance manual
Example 2- Equipment (Compressor) owners and preventive maintenance manuals and others.

What do you think?
If you go this path, you will expect the company to control the yellow pages, suppliers catalogs, etc... In my view point this is a non-value added NC. How will "controlling" Equipment (Compressor) owners and preventive maintenance manuals improve this organization performance? There are many types of documents of external origin that can have a significant impact in an organization's quality management. The examples you listed don't fall in that category, IMO.
 

phxsun2001

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#3
is an important Document of External Origin because it is related to production. Companies use it to set up PM to prolong the life of equipment and reduce down time for improved productivity. I am a consultant for a company setting up their QMS. I have to review their Equipment Preventive Maintenance (PM) manual to set up their PM schedule on some machines.
There are very specific timetable to clean pre-filters every week and replace them every six month. The compressor oil has to be the correct type and you have to bleed the line and the list goes on. The PM manuals were lost on some French made machines and they have no way to replace them because they are not new.
You can't compare it to a phone book ,which it is not product or production related.

The standard 4.2.3.f is very specific- Has a document procedure been established to ensure that documents of external orginal are identified ...... show me that you comply to this requirement.
 

Sidney Vianna

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#4
The standard 4.2.3.f is very specific- Has a document procedure been established to ensure that documents of external orginal are identified ...... show me that you comply to this requirement.
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.
 
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BradM

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#5
Good question, but to me it evolves around impact. Have they identified and controlled documentation that will have impact? Drawings, specifications, change control documents, etc.

A line needs to be made, IMO, on this. The control is necessary when not controlling the external document could have adverse impact.

Have you identified documents that could impact their quality that are not controlled?
 

phxsun2001

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#6
Good question, but to me it evolves around impact. Have they identified and controlled documentation that will have impact? Drawings, specifications, change control documents, etc.

A line needs to be made, IMO, on this. The control is necessary when not controlling the external document could have adverse impact.

Have you identified documents that could impact their quality that are not controlled?
This is a FAA repair station. I know for a fact that Preventive Maintenance and machine manuals have not been identified as doc of EO. They are also 14000 certified, so there may be a whole bunch of other documents of EO. The company is starting to design and build expensive FAA test stations too. They are purchasing new equipments and the manuals needs to be controlled......There may be other doc that I am not aware of that may have an impact.
 

Randy

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#7
Sidney has pretty much said it as has Brad. It pretty much boils down to those doc's related to product realization, infastructure and your ability to achieve customer satisfaction.
 

phxsun2001

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#8
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 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.
 
T

Ted Schmitt

#9
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 think what everyone is trying to say is that you can give an NC for the situation you described, it´s YOUR management system.... heck, you can give yourself an NC for the tone of the wall color interfering with the production... what everyone is trying to say is that is isn´t necessary to go that deep.... you may be creating difficulties for yourself...extra work that just may not be worthwhile....

How mature is your QMS? I´m sure your company would gain much more ($$) if you concentrated efforts on your KPI and their results.... that´s where the Big Boss is going to look and see the yield and then maybe say "Hey, this ISO thing really does pay off ! "
 

Sidney Vianna

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#10
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.
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.
 
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