Internal Audit - Is This A Nonconformance?

[Carla]

I am conducting internal audits and when performing the one for management responsibility, I questioned the auditee about responsibility and authority and benchmarking. This "manager" had written procedures (which I knew he had) but at the time of the audit did not remember he had written them. I pointed out that the procedures existed and he pretty much made a joke about it, stating that these were pretty good procedures he had written.

Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?

Thanks,
Carla

Personal opinion:

IF the procedure is being followed, and IF when asked how he operates, this "manager" describes the process that is defined in the procedure, then for me, this indicates that the quality policy and management system are indeed well understood and implemented within the organization.

Nowhere in ISO9001:2000 does it state that anyone needs to be able to cite chapter and verse of the procedures, rather that they exist, are respected, and are periodically reviewed for suitability, applicability and effectiveness.

However, if you wanted to make a point, I would report a "remark" (not an NC) against chapter 5.3 phrase d: "Top management shall ensure that the quality policy is communicated and understood within the organization".

Other opinions?

Bruce

[M Greenaway]

I agree with Bruce.

You could not say that the documented system was not being followed, and you could not say that the system was ineffective. These are the two crucial issues in an audit (effectiveness probably more so than compliance).

You might argue that the document was 'not available at the point of use' if you want to argue that the managers inability to locate the document means that it was un-available. But it is a pretty minor issue in itself.

You might use it as an audit trail to see if he can locate other applicable documents that he might use. If he is unable to locate any quality system documentation it might give more weight to an NC.

Just goes to show that no-one actually uses procedures !

[Randy Stewart]

I agree with the other comments also. The one issue I would look at is how can the procedure be reviewed for applicability if the approval authority doesn't know it exists? If you have evidence that the procedure is being followed I would hesitate in writing an NC. I would look at it more as the system is working but you need a little tune up to ensure the procedures maintain their applicability.

[Aaron Lupo]

Originally posted by Carla


Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?

Thanks,
Carla

No, if you have nothing that supports your n/c. You should have objective evidence that the procedure is not being followed then how can you write the n/c what would you to support it? It is very difficult to wite an n/c with no evidence. JMHO

[tomvehoski]

I believe you can write a nonconformance against this.

ISO 9001: 2000 4.1 General Requirements: "The organization shall establish, document, implement and maintain a quality managment system..."

In this case a procedure has been established and documented, but not implemented effectively. I would not have a problem if someone could not recite the procedure from memory, but not knowing of the existance of procedures that relate to one's job is an indication of lack of implementation and maintenance.

If this is someone responsible for management and involved in management review, there may also be a nonconformance against 5.6.1 "Top management shall review the organization's quality management system..." How can the system be reviewed if management does not know it exists?

It may not be a huge nonconformance, but it is something that should be documented and corrected.

[M Greenaway]

Tom

I would consider the procedure implemented effectively if the guy is doing what it says in the procedure. Just because he cannot put his hand on it does not mean it isnt effectively implemented.

Also with regard to management review you could know the system exists without knowing every single procedure in it.

Still dont think its an NC.

Originally posted by Carla

Can I write a non-conformance for him not knowing he has procedures he should be following? Note: I could not prove that the procedures were not being followed.
If I can write a non-conformance for this what section would it be under?
Thanks,
Carla

Here we go. I agree with M. Greenway on this one. Believe it?
Carla, You couldn't prove that the procedures were not being followed. Put your pen away, even though you are bent on writing an N/C. You're job isn't to issue N/C's. It's to ensure compliance to the standard/procedure. If you can't find something to write up, don't feel bad. You still did your job.