Procedure is not Implemented - Audit Finding - ISO 9001 Clause 7.5.1?

[Camit0212]

Hi,

If a procedure or activity in a procedure is not implemented, in what clause in ISO 9001 should it be called?

This has been a debate among our auditors on what specific clause in ISO 9001 this finding should called.

Our senior auditors and even one of the trainings we attended said it should be called againts clause 7.5.1 Control of Production and Service Provision.

However, other auditors said it is more appropriate to call it agains 4.1 (f) implement actions necessary to achieve planned results and continual improvement of these processes.


I just would like to know the practice of other auditors...

Please help... Your explanation on this matter would be appreciated...

Thanks!

[howste]

Write it against the requirement in the procedure! You don't have to write every nonconformity against ISO 9001.

If you still want to do it though, 7.5.1 would work for production operations, along with the requirement from your internal procedure. If it's an inspection operation, 8.2.4 would be more appropriate, along with the requirement from your internal procedure. For design use 7.3.1, along with the requirement from your internal procedure. Etc...

[brahmaiah - 2010]

In Reply to Parent Post by Camit0212

Hi,

If a procedure or activity in a procedure is not implemented, in what clause in ISO 9001 should it be called?

This has been a debate among our auditors on what specific clause in ISO 9001 this finding should called.

Our senior auditors and even one of the trainings we attended said it should be called againts clause 7.5.1 Control of Production and Service Provision.

However, other auditors said it is more appropriate to call it agains 4.1 (f) implement actions necessary to achieve planned results and continual improvement of these processes.


I just would like to know the practice of other auditors...

Please help... Your explanation on this matter would be appreciated...

Thanks!

If a procedure or activity of a procedure is not implemented the non-conformity is against the clause which was not implemented.You cannot generalise any one or two clauses.
V.J.Brahmaiah

[Allan66]

In Reply to Parent Post by howste

Write it against the requirement in the procedure! You don't have to write every nonconformity against ISO 9001.

If you still want to do it though, 7.5.1 would work for production operations, along with the requirement from your internal procedure. If it's an inspection operation, 8.2.4 would be more appropriate, along with the requirement from your internal procedure. For design use 7.3.1, along with the requirement from your internal procedure. Etc...

I would agree with this. If an internal audit, then I would not get hung up on the ISO9001 clause. If it is policy to write up against ISO9001, then it does not have to be a 1:1 relationship. Depending on the purpose of the procedure, you may have an NC against 7.5.1 and another appropriate clause.

[seank]

I think you need to give consideration to the activity or procedure that is missing;

Is it a required procedure in ISO9001? I.E. "A documented procedure shall be established to define requirements for......"

Yes (and its missing) = Non-Conformity against the relevant clause.

No....

Does the procedure or activity impact on quality or regulatory compliance?

Yes - Then some control is required, such as described in 7.5.1, ask to see evidence of this control. If the organisation can suitably demonstrate and provide evidence of the control, you have no non-conformity. If they say, "Dave know's what he's doing, it's all in his head........." I would raise a non-conformity against 7.5.1 to in that no evidence could be shown that processes are being conducted under controlled conditions...

If the missing procedure or activity does not impact on quality or regulatory compliance, and is not explicited stated as required by the organisation, I would be inclined to say its an observation or recommendation for improvement at best.....

[Colin]

I agree with Allan66 - if it is an internal audit raise it against the procedure, it will probably make more sense to internal people. If it is an external audit I would always raise against the standard.

I also agree with howste's comments and I would add that whilst quoting the standard and the procedure at the same time is fine, I think that only 1 clause of the standard should be quoted for any one situation. i.e. don't quote multiple clauses of the standard for the same N/C, it often causes confusion.

[Jim Wynne]

In Reply to Parent Post by howste

Write it against the requirement in the procedure! You don't have to write every nonconformity against ISO 9001.

While I heartily agree in principle, I don't think it's a good idea to cite requirements that don't exist (which is what I take "not implemented" to mean).

What we need is for the OP to tell us what it means, why the procedure should have been implemented but wasn't, and what the requirements are for such things in his company. At what point must a procedure be implemented? Upon approval? Tuesday of next week? I think the problem might lie in the idea that such structure doesn't exist, and someone (perhaps justifiably) believes that he can satisfy an approval process and then implement the procedure when he gets around to it.

[Doug Tropf]

In Reply to Parent Post by Jim Wynne

While I heartily agree in principle, I don't think it's a good idea to cite requirements that don't exist (which is what I take "not implemented" to mean).

It seems to me that if the requirement has been called out in a written procedure then it exists, regardless of its merits or lack there of.