View Full Version : TS 16949 Clause 4.2.1 - Required Documents
Howard Atkins 26th October 2003, 10:21 AM As far as I understand the requirements of TS for documentation are 7 procedures, QM and Quality Policy
I have received a demand from a CB that I refer to every question in the IATF Checklist with the reference to procedure, QM or any other controlled document.
This appears to me to be completely out of line with the requirement of the Standard :
4.2.1
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,
Have any of our registered companies had such a demand.
Has anyone any comments on what appears to be a requirement founded in QS9000 but removed in TS.
bpritts 26th October 2003, 09:57 PM Howard,
Our client experience (only 2 TS audits, but many I9k2k) is consistent with your expectation. The intent of the developers of the standard was to reduce documentation requirements.
That said, the requirement (4.1) to ... identify the processes... determine sequence and interaction... determine criteria and methods to ensure operation is effective... begs for some form of written documentation.
Our experience, though, is that auditors are willing to settle for a much lower standard of documented procedure. (relative to QS-9000 practice).
Regards,
Brad
p_tww 27th October 2003, 06:46 AM As far as I understand the requirements of TS for documentation are 7 procedures, QM and Quality Policy
I have received a demand from a CB that I refer to every question in the IATF Checklist with the reference to procedure, QM or any other controlled document.
This appears to me to be completely out of line with the requirement of the Standard :
Have any of our registered companies had such a demand.
Has anyone any comments on what appears to be a requirement founded in QS9000 but removed in TS.
Hi, Howard,
I belive you understood that it is not sufficient for a system implementation/maintenance if you only have documented 7 procedures, quality manual and quality policy. As you know, method on process control should be identified during process model analysis.
I agreed with you it would be picky for CB when they ask you refer every question in checklist with the reference to any documentation.
DavidO 27th October 2003, 08:17 AM As far as I understand the requirements of TS for documentation are 7 procedures, QM and Quality Policy
I have received a demand from a CB that I refer to every question in the IATF Checklist with the reference to procedure, QM or any other controlled document.
This appears to me to be completely out of line with the requirement of the Standard :
Have any of our registered companies had such a demand.
Has anyone any comments on what appears to be a requirement founded in QS9000 but removed in TS.
My understanding is that there are 7 procedures, Quality Policy, Quality Manual, plus any documentation (process definitions or flows) used to define or control your key processes to the extent required by your organisation - an organisation cannot exist on only the 7 required procedures without defining its key processes.
Rob Nix 27th October 2003, 09:36 AM Not meaning to put too fine a point on this, but there is a requirement for procedures for 7 topics, not necessarily 7 procedures. Another thread shows two topics, preventive action and corrective action, combined into ONE PROCEDURE. The same might be said for "document" and "records" control.
To prevent the tail from wagging the dog, develop your documented system based on the needs of your organization (whether little or much), THEN see how it fits the ISO standard.
Tom W 27th October 2003, 10:22 AM Have any of our registered companies had such a demand.
Has anyone any comments on what appears to be a requirement founded in QS9000 but removed in TS.
We recently went through our registration audit, successfully I might add, (as I pat myself on the back looking stupid doing it). We had no such request. We had two auditors, one used the QSA and one did not. They were completing seperate audits on our different facilities, thus the different approach. We did devise a tool that we call a "Shalls Matrix" that we use for reference. It lists out all of the shalls and then were you can find them addressed in our quality manual. We converted from QS and we kept the same element based procedures that we had for QS, just tweeked them where we needed. We found that the element based procedures that we had developed actually laid out many of our processes, so we kept that approach for now. We didn't want to re-create the wheel so to say.
It sounds like someone is trying to get you to do work that they should be doing???
Sam 27th October 2003, 10:25 AM As far as I understand the requirements of TS for documentation are 7 procedures, QM and Quality Policy
I have received a demand from a CB that I refer to every question in the IATF Checklist with the reference to procedure, QM or any other controlled document.
This appears to me to be completely out of line with the requirement of the Standard :
Have any of our registered companies had such a demand.
Has anyone any comments on what appears to be a requirement founded in QS9000 but removed in TS.
Howard,
Your CB is within bounds with their request.
I had these same concerns,initially, with our CB. They sent me their own checklist,which was identical to the IATF, only in a different order for their auditing purposes with the same directions; provide objective evidence in the form of a procedure, reference to QM document or some other documentation.
You are correct there is a TS2 requirement for only 7 procedures, however, your system may need a few additional. You decide. Your CB asked for a procedure or any other controlled documentation.For those questions that you cannot answer with a procedure you can answer with a record and/or a process definition.
Howard Atkins 27th October 2003, 10:39 AM Thank you for your comments.
Obviously I do not expect a system to exist without Work Instructions etc as said by you all.
I was interested in the attitude of CB's
As Sam said
Howard,
Your CB is within bounds with their request.
I had these same concerns,initially, with our CB. They sent me their own checklist,which was identical to the IATF, only in a different order for their auditing purposes with the same directions; provide objective evidence in the form of a procedure, reference to QM document or some other documentation.
You are correct there is a TS2 requirement for only 7 procedures, however, your system may need a few additional. You decide. Your CB asked for a procedure or any other controlled documentation.For those questions that you cannot answer with a procedure you can answer with a record and/or a process definition.This is what I believed as in the checklist the column of "what to look for" refers to records in a large number of cases.
db 27th October 2003, 11:09 AM I have received a demand from a CB that I refer to every question in the IATF Checklist with the reference to procedure, QM or any other controlled document.
One of the things I tell my clients is to take the checklist, and annotate where and how the "shall" is addressed. This ensures that all of the requirements are met and helps you understand your own documentation. I do have a problem with the "controlled document" part. Not all requirements will be found in controlled documents.
ben sortin 27th October 2003, 11:35 AM Every "shall" needs a procedure. Every procedure needs a work instruction. Every work instruction needs a visual aid. Every visual aid needs a frequency for review. Every review needs a sign off. Every sign off needs a quality resource. Every quality resource needs a raise.
Rob Nix 27th October 2003, 12:17 PM Ben,
the only thing I agreed with was the "every quality resource needs a raise" part. I hope the rest was typed while your tongue was in your cheek! :eek:
db 27th October 2003, 12:18 PM Ben,
the only thing I agreed with was the "every quality resource needs a raise" part. I hope the rest was typed while your tongue was in your cheek! :eek:
I was too askaird to ask! :agree:
Tom W 27th October 2003, 01:30 PM Every "shall" needs a procedure. Every procedure needs a work instruction. Every work instruction needs a visual aid. Every visual aid needs a frequency for review. Every review needs a sign off. Every sign off needs a quality resource. Every quality resource needs a raise.
Please tell us you were kidding????? :rolleyes: :eek:
Manoj Mathur 28th October 2003, 06:22 AM Some how I am not convinced with more and thick documentation especially with large large good nos. of Work Instructions or SOPs (Standard Operating Procedures). I don't know what we are going to achieve by pasting beautiful neetly typed workinstructions near a machine. While a operator who is operating the machine since ten years and without any voilation of so called SOP. Infact he/she knows SOPs better than the the person who just typed the SOP or paste the SOPs. In my opinion, need of SOP is either by Training personnel or by ISO Auditors. Then why to paste at point of use?
Howard Atkins 28th October 2003, 08:40 AM Some how I am not convinced with more and thick documentation especially with large large good nos. of Work Instructions or SOPs (Standard Operating Procedures). I don't know what we are going to achieve by pasting beautiful neetly typed workinstructions near a machine. While a operator who is operating the machine since ten years and without any voilation of so called SOP. Infact he/she knows SOPs better than the the person who just typed the SOP or paste the SOPs. In my opinion, need of SOP is either by Training personnel or by ISO Auditors. Then why to paste at point of use?
I agree but how much documentation did you show to your auditor.
p_tww 28th October 2003, 12:10 PM I agree but how much documentation did you show to your auditor.
How much documentation is depended on capability of your staff and complexity of your operation. excepted thosed documentation required in the standard and process method for those element required a process, you maybe need not other documents if you can show auditor your staff have same understanding on those not defined.
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