ISO 14001 Document and Data Control Corrective Action Request

[Marc]

Originally posted by Randy
Whoever unregistered is he's right on there too. A list of the required elements with the corresponding documentation meets what you need at a minimum. IMO

I agree.

> The one for D&D addressed "Linkage of procedures/work
> instructions. The auditor wanted to see back and forth
> linkage between the manual, procedures, work instructions
> and forms.

I don't have a problem with a flow down, but a 'flow up' where a lower level document calls out a higher level document is a danger sign to me. The reason is it can put a company in the position where every time a low level document changes it could trigger a change in the upper level document. Keep it simple - flow down, not up. Flow ups generally cause problems which is why I have clients go through a document mapping process to ensure all the linkages are correct.

I guess if an auditor challanged me on not having 'flow ups' where a lower level document calls out a higher level document, or where they point to each other I'd switch to the old stand-by: "Show me where it says I have to do it this way...."

 

[JodiB]

Flip-flop?

Marc,

Do you mean the other way around.....You don't want to reference lower-level documents in the upper-level ones because the lower-level ones change much more frequently and you don't want to have to change the upper ones each time also.

I thought that was how it went anyway...

 

[Marc]

Flow Downs (citing lower level documents within a higher level document) is typical - which I thought was what I was saying. But - for example - citing a page or section in your quality manual within you calibration procedure (flowing up) is tempting fate. If the quality manual is changed, what triggers a review of lower level documents which have references that flow up. This is less of an issue in smaller companies (or should be) than in larger companies.

What happens is someone revises one without revising the other. This is what I commonly see - one document references another and over time one or the other is changed and there is nothing to trigger review of the 'other' document.

Document linkages can be critical factors and they're easy to screw up over a couple of years.

 

[Bruce Wade]

The Level I and Level II documents in our system point to each other. Level I clauses "flow down" to refer to the Level II documents and Level II documents "flow up" to reference Level I clauses.

However, in neither case are revision levels or issue dates referenced. For example: the Management System Manual refers to MSP21: Internal audit (not MSP21: Internal audit Rev.2, February 4th, 2002). And MSP21: Internal audit Rev.2, February 4th, 2002 references Management System Manual (not Management System Manual Rev.4, February 4th, 2002).

This way, when one document changes it does not trigger the "domino effect" requiring changes to all other documents in the system.

Eventually, we intend to link the Level III documents to the Level II in similar fashion.

And, the Level III work instructions refer to forms in the same way (i.e. FM106: Nonconformance report - not FM106: Nonconformance report Rev.2, 12/11/01).

Altough I do not see how this system would conflict with the ISO 9001:2001 and ISO 14001:1996 standards, I am relatively new to my function as QMS/EMS Manager/Management Representative. I defer to the wisdom of 16949.com participants. Is such a system within the "spirit" of the standards?

BTW: in a previous life, as a line manager in another company, we addressed this issue by refering to documents and forms as "current version" instead of revision level and issue date...

 

[Marc]

> Altough I do not see how this system would conflict with
> the ISO 9001:2001 and ISO 14001:1996 standards, I am
> relatively new to my function as QMS/EMS
> Manager/Management Representative. I defer to the wisdom
> of <16949.com> participants. Is such a system within the
> "spirit" of the standards?

I'm not sure what the 'spirit' of the standard is, but it sounds fine to me. If it was me I wouldn't go so far as to reference higher level documents within my lower level documents unless there is some type of review trigger. If you are in a company in one location this is less of an issue. It becomes more of an issue when you have several locations and things begin to get 'sticky'. It gets stickier when you are part of a division or such under a corporate umbrella where your have many 'brother and sister' divisions.

Personally I think many companies far over do - make overly complex - their document control systems not to mention the content of their documents. Tgheir document control systems are not scalable. Many have too many documents to begin with.

I guess my problem with this thread is where the thread originator seemed to have gotten a registrar RCA for not having two way links. I don't know where an auditor can go to show me where two way (back and forth) links are required. I think they're reading something in that isn't there.

> Our auditor is looking to be able to pick up our Level I's
> and be able to walk through our process unassisted, just
> by following the links clear through to the final step
> being record retention. In a nutshell every SJP must be
> linked specifically to the Level I, or be directed or
> linked to another SJP. No SJP can exist in my manual
> without a linkage.

The highlighted phrase above is silly. Many companies have lower level procedures which aren't referenced in higher level procedures.

Sam wrote:

> And yes the same criteria applies to ISO/QS, but is not as
> rigidly enforced.

I don't agree with this - the inference is that ISO/QS require 'back and forth' links which they don't and I don't believe its because the requirement is not "...strictly enforced...".

> The auditor wanted to see back and forth linkage between
> the manual, procedures, work instructions and forms.

I just can't see anywhere this is called out. Again, I think the auditor is reading things into the requirement that aren't there. Cheryl put them side by side:

Q.S. 4.2.1 The quality manual shall include or make reference to the quality system procedures....
EMS 4.4.4 b) Provide direction to related documentation.

I don't see where 'back and forth' linkages are called for within these words (the requirements verbatum).

No one has yet convinced me that an auditor has a basis for a writeup because there are not 'back and forth' linkages. "...Provide direction to related documentation..." does not say anything about how you link your documents other than that you do it.

 

[Randy]

A review of ISO 14004:1996, 4.3.3.2

Documents can be in any medium and should be easily understood.......

- documents can be identified with appropriate organization, division, function, activity, and/or contact person;


The catch word is "CAN", not MUST or SHALL.

 

[Bruce Wade]

Randy,

ISO 14004:1996 is a guideline document, not the specification of the standard.

From ISO 14001:1996:

4.4.4 Environmental management system documentation
The organization shall establish and maintain information, in paper or electronic form, to
a) describe the core elements of the management system and their interaction;
b) provide direction to related documentation.

I believe 4.4.4b is where registrars and other auditors get "hung up". Given they have limited time and exposure to the documented system, references to other documents in "flow up" or "flow down" fashion can make it easier to identify the important "interactions" between "related documentation".

I agree the standard does not "require" this information. However, given the dynamics inherent in the registration/auditing process, I have found it easier to provide the linkages in the documentation, instead of having to "leaf" back-and-forth through the documentation while the registrar/auditor looks over my shoulder...

 

[Marc]

I agree it's easier, Bruce. I always have clients do a matrix to link things together. And I have no problem with a one way (down) reference to link them. The 'back and forth' still is not something I can swallow. I've done a lot of QS and ISO 9K registrations in the last 10 years and never had an auditor call out for lack of a 'back and forth' reference system. However, I do strive to ensure it's easy for an auditor to see the linkages through a matrix and through reference(s) within documents. My motto has been "Keep the auditor as happy and don't confuse them". I tell clients that auditors are not stupid but that one should prepare for a stupid one or one that's just an outright :ca:. You do this, in part, by ensuring it is easy to see (and follow) the relationships and links in documents including how they relate to the standard. I ALWAYS do a relationship matrix - Standard Requires vs. company document which addresses that element, paragraph, line item, etc.

 

[Bruce Wade]

Marc,

I fully agree with your position. I too want to: "Keep the auditor happy and (not) confuse them". And I agree the standards do not require a "back and forth" reference direction.

Although I also have never had an auditor ask for the "back and forth", they never have had to ask as they were present in the system documents. Perhaps I should re-think inclusion of these references.

I also have included a "requirements" matrix in our system... Hmmm, this too I have done with "back and forth"! Seems I have "Requirements to documents" and "Level II documents to requirements" matrices. Could be a little overkill!

 

[Marc]

I will admit to 'over documenting' my clients from that perspective, as well.