ISO 14001 Document and Data Control Corrective Action Request

[Cheryl]

D & D Car

Hi Guys, just finished our pre-assessment audit on EMS hich resulted in a few minor CAR's, 1 of them being Document and Data Control and I could use a little guidance please.

We have incorporated our EMS system into our current QS system to eliminate much fo the duplication such as Doc & Data and Internal Audits. We have been QS registered since 1997 and have never recevied a CAR or CI Opportunity for Doc & Data.

As I understand our External Auditor it is a requriement to show/reference a direct linkage from our Level I's to the specific Standard Job Procedures. Under our current QS system our references are generalized under our Level I's to examples such as QS-9000 Element 4.5, Level II; or Quality Level III manual; but not specific procedures. 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.

This leads me to question the validitiy of our current QS system. Do I need to now spend the next few momonths and link together all of the QS SJP (in excess of 1,000) ? or Have we perhaps been extremely fortunate with our present QS auditor or perhaps, is our EMS auditor asking for more than is really required under the standard. I would really like to hear your "best practices" how is our organization providing linkage or are you?

 

[Randy]

I assume (that makes an A-- out of you and me) you are refering to 4.4.5 Document control. I can't find in the ISO 14001:1996 in my hot little hands the requirement you are speaking of. Check below and see if you can find it.

"4.4.5 Document Control

The organization shall establish and maintain procedures for controlling all documents required by this International Standard to ensure that

a) they can be located

b) they are periodically reviewed, revised as necessary and approved for adequacy by authorized personnel;

c) the current version of relevant documents are available at all locations where operations essential to the effective functioning of the environmental management system are performed;

d) obsolete documents are promptly removed from all points of issue and points of use, or otherwise assured against unintended use

e) any obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified.

Documentation shall be legible, dated (with dates of revision) and readily identifiable, maintained in an orderly manner and retained for a specified period. Procedures and responsibilities shall be established and maintained concerning the creation and modification of the various types of document."

 

[Unregistered]

Unless I "blew it" I don't see the requirement. 4.4.4 EMS Documentation (a) references "describe the core elements..... and to provide direction to related documentation".

We have been thru a document review and Step 1 of Two Step Registration process and lack of linkages has not been an issue.

 

[Al Dyer]

Cheryl,

QS-9000 4.2.1 addresses the need for the quality manual (policy) to include or make reference to quality system procedures.

I don't know your specific document control structure so I really don't want to go into further detail yet.

 

[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

 

[Al Dyer]

Here is a sample list in Excel that you can use to document the requirements and where they are found in the quality system.

 

[Cheryl]

Thanks for your input guys and the attachment Al. I guess it all comes down to "interpretation".

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

 

[Sam]

Cheryl,

Apparently this is one of those "special topics" used by the EMS auditors.
We just completed our stage 1 audit and received minors in two areas; Operational controls and D&D.

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.

And yes the same criteria applies to ISO/QS, but is not as rigidly enforced.
Personally I think it is a good idea. It helps to keep track of the who, what, where, when, why and how.

 

[Marc]

This is why I have for years used spreadsheets to provide a matrix to tie all the requirements - and where they're met - together. See the file QS-Req.pdf in the pdf_files directory as an example. Of course, the individual documents also define linkages and such within themselves.

If you look through the slides in http://Elsmar.com/Imp/ you will see where I talk about 'Document Mapping'. This is where you ensure all the linkages are correct

 

[Marc]

After re-reading this thread, I thought about what was going on. When I go through inplementations, I use the process in http://Elsmar.com/Imp/ Part of the process is what I call it Document Mapping. See http://Elsmar.com/Imp/sld191.htm and I describe 'linkages'.

Just some thoughts.