What to Cite for Failure to Follow Defined Procedures

[Gary L. Phillips - 2007]

Puzzled

I'm wondering where to look for the correct portion of the 9K:2K or T/S 16949 in which there is a failure to follow defined procedures or instructions? In the 9001:1994 edition there was a subset of Process Control (I think it is 4.9 f) which addressed this issue. In the 9K:2K system I can not find such an animal. So where would be the appropriate requirement be listed in which to reference if this is discovered during an audit???

 

[Cari Spears]

I'm wondering where to look for the correct portion of the 9K:2K or T/S 16949 in which there is a failure to follow defined procedures or instructions? In the 9001:1994 edition there was a subset of Process Control (I think it is 4.9 f) which addressed this issue. In the 9K:2K system I can not find such an animal. So where would be the appropriate requirement be listed in which to reference if this is discovered during an audit???

I'm looking in ISO9002:1994 at 4.9.1c "compliance with reference standards/codes, quality plans and/or documented procedure;"

In ISO9001:2000 - 7.5.1b calls out "the availability of work instructions, as necessary" as a controlled condition.

However - if there is a failure to follow defined procedures or instructions, I'd write it up against (or reference) that procedure/instruction - not the standard.
I don't see anything in either standard that says anything about "failure to follow defined procedures". There is the "where the absence of such procedures could adversely affect quality" - but that addresses the absence of an instruction, not that it wasn't being followed.

 

[howste]

I've heard this discussion many times in audits. The best answer I've been able to find is 7.5.1 which requires the organization to "plan and carry out production and service provision under controlled conditions" which includes the 7.5.1b work instructions. The instructions are the plan, following them is carrying them out.

If it's an issue with following a control plan, you can go to 8.2.3.1 that requires the organization to "ensure that the control plan and process flow diagram are implemented, including adherence to..."

Of course, like Cari said above, you can always reference their own documented requirement.

 

[RoxaneB]

I was trained to cite the clause applicable to the area being audited.

They have documentation so 4.2 may be covered.

Let's the document not being followed was in the Purchasing area. Then, depending on the scope of the procedure, I'd cite something from 7.4 with a phrase to the effect of "Documented process does not reflect followed process" or "Practice does not follow documented process"...you get the idea.

 

[Jimmy Olson]

I've heard this discussion many times in audits. The best answer I've been able to find is 7.5.1 which requires the organization to "plan and carry out production and service provision under controlled conditions" which includes the 7.5.1b work instructions. The instructions are the plan, following them is carrying them out.

I would agree that 7.5.1 would probably be the best choice if you want to cite the standard. If the person is not following the procedure then it is not a controlled condition.

If it's an issue with following a control plan, you can go to 8.2.3.1 that requires the organization to "ensure that the control plan and process flow diagram are implemented, including adherence to..."

Is this in 16949 or do you have a different version of 9001 than me?

 

[howste]

LOL, it's in 16949.

 

[Gary L. Phillips - 2007]

Auditing against the '94 edition, I would address a finding's description against the requirements of the organization (QP's, WI's, etc) and the ISO Element along with /4.9 c) citing failure to follow "reference standards/codes, quality plans and/or documented procedures." Writing up a finding against a clause or sub-clause was always thought more meaningful citing the 4.9 c) area. An organization has implemented , for instance, a well defined system; however, due to whatever reason, someone dropped the ball. It was a lot more easier to cite the 4.9 c) area especially when this happens on numerous occasions which might be able to provide evidence of a systemic problem within an organization.

The standard has a number of locations which specifies types of procedures, the availability of documents, and so on, just as did the '94 edition, nothing new here in that regard.

The closest point I can find to addressing this issue especially if it if either problematic or systemic would be under

4.1 c) "determine the criteria and methods needed to ensure that both the operation and control of these processes are effective".

6.2.2 d) "ensure that personnel are aware of the revelance and importance of their activities and how they contribute to the achievement of the quality objectives".

and possibly management committment if a serious condition exists attributable to a failure connected to either: 5.1.a); 5.3; 5.4.1.

Ijust would be a lot easier if requirements from circa '94 4.9.c) were still on the books. One thing for sure, the standard as it now exist requires a lot of thought on the part of auditors to ensure that there is enough information provided in the audit report, especially the final summary for the auditee to be able to have a complete understanding of theresults of the audit and the effectiveness of it's QMS.

Thanks all, I just was looking for the best approach to use.

 

[Gary L. Phillips - 2007]

I actually referenced ISO 9001:2000 for this question. The T/S 8.2.3.1 is specific to process measurement and the "...including adherence to the specified" section concerns measurement techniques, sampling plans, acceptance criteria..." (all basically inspection) and "reaction plans when acceptance criteria are not met" which is a corrective action.

There could exist a failure to follow procedures anywhere in an orgaization: Sales, Engineering, Production, Quality, Purchasing, or even inside the Management Review clause where a company defines a number of issues as input into the review process that goes well beyond the requirements of the standard, yet many are never reviewed, or acted upon.

In the 'old days' ( 1994 ), especially if there were a number of these types of issues, there was a place to commonily write findings; now there isn't.

 

[Cari Spears]

...the document not being followed was in the Purchasing area...
..."Practice does not follow documented process"...

LOL - do you know my auditor? That is exactly the one minor n/c that we rec'd during our 9k2k registration audit. I'm currently rewriting my procedure for supplier control.

What I was doing was compliant, what my procedure said was compliant, but they weren't the same. There was no reference to the standard for this particular write up. Also - since our internal auditors audit using our internal documents - they do not reference the standard either. I review procedures and practices for compliance to the standard at creation/implementation and when revised.

 

[Randy Stewart]

I agree with writting the NC to the process/procedure and not the standard. If the area was still in compliance with the standard but not following the procedure how can you validate an NC to the standard? This is especially important during an internal review. If written correctly it will forewarn of Document Control issues as well as process issues. Many times processes will be improved without the flow, map, wi, or procedure being updated.
Instead of being an addition to the CI initiative if ends up being a minor NC.