System for Controlling Documents of External Origin

[b.u..]

All internal and external documents of all departments are listed in the same documentation plan for ease. Is it a problem? All documents from other sources (such as catalogs, weekly construction magazines, etc.) are counted as external documents in the system documentation which is unnecessary actually. Can the scope of external documents be limited? As a minimum, which type of external documents are obligutary to be defined as external documents where it would not result in non- conformity?

 

[Jim Wynne]

All internal and external documents of all departments are listed in the same documentation plan for ease. Is it a problem? All documents from other sources (such as catalogs, weekly construction magazines, etc.) are counted as external documents in the system documentation which is unnecessary actually. Can the scope of external documents be limited? As a minimum, which type of external documents are obligutary to be defined as external documents where it would not result in non- conformity?

"External documents" are specifications, standards, and other sources of customer requirements.

 

[vanputten]

Can or should "external documents" also include documents with requirements which the organization imposes on themselves? Our external doc process includes any external document which includes requirements that we have imposed on ourselves. These are documents that include requirements which are not imposed on us by our customers.

Our process also includes external documents that we want to reference but are not necessarily requirement documents. For example, we have included ISO 9004:2000 in our external doc process. We designed our external doc process to include any document we recieved which we want to know we have. Customer drawings, industry standards, reference documents, non-normative standards like ISO 10001, ISO 10003, ISO 10014, ISO 9004, JEDEC, EIA, ANSI, ASTM, Military, etc. (I am listing these by memory from home so I may be off on some of these.)

Regards, Dirk

 

[Jim Wynne]

Can or should "external documents" also include documents with requirements which the organization imposes on themselves? Our external doc process includes any external document which includes requirements that we have imposed on ourselves. These are documents that include requirements which are not imposed on us by our customers.

Our process also includes external documents that we want to reference but are not necessarily requirement documents. For example, we have included ISO 9004:2000 in our external doc process. We designed our external doc process to include any document we recieved which we want to know we have. Customer drawings, industry standards, reference documents, non-normative standards like ISO 10001, ISO 10003, ISO 10014, ISO 9004, JEDEC, EIA, ANSI, ASTM, Military, etc. (I am listing these by memory from home so I may be off on some of these.)

Regards, Dirk

You're correct--all external documents required for the functioning of the quality system should be included, not just those that support explicit customer requirements. Thanks for the clarification.

 

[Maja34 - 2007]

Which external doc. should be controlled?

As a minimum, which type of external documents are obligutary to be defined as external documents where it would not result in non- conformity?

I am asking myself this exact question so I resurrected this thread.

After going through many threads regarding this problem I got that basicly there are two kinds of external documents that require control:
1. Standards, regulations and manuals followed by company
2. Documents that specify customer requirements
(please correct if I am wrong)

My puzzle regards the second kind. Our company do not receive any specs or blueprints to follow. Customers indicate their requirements during sales process in a phone conversation and e-mail. Most of the requirements are voiced over the phone and maybe some issues are agreed via e-mail. Our reference for fulfilling customer requirements is an order (where seller collects all the info) that is confirmed by customer.

Should I explicitly mention this fact in our doc control procedure? So that it is justified and will not create NC?

Here is how the procedure looks at the moment
"XYZ recognises external documents that are relevant for the control procedure as those that are affecting the final product delivered to XYZ customers but are not originating in XYZ. Specifically those documents are:
Governmental regulations pertaining to XYZ
Standards and operating manuals followed by XYZ
External documents are controlled by Master list maintained by MR"

Is such delimitation correct? I want to avoid unnecessary work when the system is running and include things like eg. business correspondance we receive.

I read the 9001 norm, use my common sense and I really do not see any other external documents that we must have a control of.

Please help and thank you so much for all advice.

--
Maja

 

[ScottK]

I am asking myself this exact question so I resurrected this thread.

After going through many threads regarding this problem I got that basicly there are two kinds of external documents that require control:
1. Standards, regulations and manuals followed by company
2. Documents that specify customer requirements
(please correct if I am wrong)

My puzzle regards the second kind. Our company do not receive any specs or blueprints to follow. Customers indicate their requirements during sales process in a phone conversation and e-mail. Most of the requirements are voiced over the phone and maybe some issues are agreed via e-mail. Our reference for fulfilling customer requirements is an order (where seller collects all the info) that is confirmed by customer.

Should I explicitly mention this fact in our doc control procedure? So that it is justified and will not create NC?

Here is how the procedure looks at the moment
"XYZ recognises external documents that are relevant for the control procedure as those that are affecting the final product delivered to XYZ customers but are not originating in XYZ. Specifically those documents are:
Governmental regulations pertaining to XYZ
Standards and operating manuals followed by XYZ
External documents are controlled by Master list maintained by MR"

Is such delimitation correct? I want to avoid unnecessary work when the system is running and include things like eg. business correspondance we receive.

I read the 9001 norm, use my common sense and I really do not see any other external documents that we must have a control of.

Please help and thank you so much for all advice.

--
Maja

Maja - it sounds to me that you don't really receive customer specs, per se, but are receiving customer requirements as part of the sales order process(section 7.2 of ISO9000:2000) which used to be called "Contract Review".

In the system I am building right now, a customer specification is a standard format (whether drawing or document or both) that has a revision history and is a controlled document byt the customer that the customer references when making a purchase.
Anything else goes into the sales order documentation (which are quality records, of course).

 

[antoine.dias]

External documents

In our system the following are controlled external documents:

- Quality related external documents. ( mostly system requirements )
- External documents related to safety & health.
- Customer related testinstructions / standards and reference manuals.
- Customer product specifications (drawings, specs, masters, visual samples,etc).
- Customer specific requirements.
- National or international test standards / specifications.
- Regulatory and statutory external documents.

The different process owners have the responsibility to search - on a regular basis - for the newest information. This is done via internet and / or the customers.

Best regards,

Antoine