Tried a search but came up empty. One of my auditors audited ISO 9001:2000 clause 7.1 - this clause only. The auditor collected data that does not quite correlate with what should have been collected. Regardless of the clause or standard, the data collected does not support the clause that was audited. What would a Cover do? CAR or No CAR? :confused:

I have to go back and reassign the 7.1 audit for the June audit anyway. But should I not bother writing a CAR and handle discreetly...or just the opposite?

Tried a search but came up empty. One of my auditors audited ISO 9001:2000 clause 7.1 - this clause only. The auditor collected data that does not quite correlate with what should have been collected. Regardless of the clause or standard, the data collected does not support the clause that was audited. What would a Cover do? CAR or No CAR? :confused:

I have to go back and reassign the 7.1 audit for the June audit anyway. But should I not bother writing a CAR and handle discreetly...or just the opposite?

Aside from the fact that your Internal Auditor went outside the "scope" of 7.1, did the audit evidence demonstrate a nonconformity? Against what requirement? If so, I would still issue a CAR.

By the way, are you auditing "clauses" or processes? If you audit processes (the preferred approach), several clauses may apply to the process that's being audited.

Hope this helps.

Basically the wrong data was collected. A process approach is used but I have to (forced is a better way to describe it) split up the audit team - hence this one auditor had this portion (7.1) of the audit.

Basically the wrong data was collected. A process approach is used but I have to (forced is a better way to describe it) split up the audit team - hence this one auditor had this portion (7.1) of the audit.

I see. This could be an opportunity for learning for the Auditor.
I would give both the auditor (and the auditee) the benefit of the doubt. After all, I learned during the various Lead Assessor courses to be "flexible."

Yeah, I was leaning that way. I've never experienced this type of situation before. Thanks for your opinion. :bigwave:

7.1? You audit the Product Realization clauses to show conformance to 7.1 you don't audit it specifically.

The only way to verify conformance to 7.1 would be to audit everything between 7.2 and 7.6. Clause 7.1 is a general clause that is broken down into greater and more specific detail in the clauses that follow it.

7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes)
and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

Crusader!

To avoid the 'next time', because it could happen to another auditor, may I suggest that you sit down with each auditor before the audit, and review with them what they will take as 'samples' of 'evidence' during the audit??

When coaching internal auditors, I'm careful to ensure that each one gets a chance to 'tell their story' about how they are going to approach the audit. I got this technique from being a supervisor for a registrar, with a lot of newbie candidates to 'sign off'. It is potentially very serious to have an auditor 'go off' on you/the team, and I believe that it has benefits internally too.

I'm sure you'll deal with the current situation appropriately, but please try the above and let me know what happened..........

http://elsmar.com/Forums/showpost.php?p=164786&postcount=11

The attachment in this post is the audit preparation worksheet we use. The auditors identify inputs, outputs, controls, checkpoints, acceptance criteria, performance indicators, etc. during review of the process prior to the audit thus identifying what evidence to gather.

More to your original question, I would not issue CARs. I'd reaudit the process and then re-evaluate the way auditor competence is determined. Maybe that one auditor needs a little more training or time with experienced auditors - maybe the process of determining auditor competency needs to be revised - maybe better auditing tools are necessary...

http://elsmar.com/Forums/showpost.php?p=164786&postcount=11

The attachment in this post is the audit preparation worksheet we use. The auditors identify inputs, outputs, controls, checkpoints, acceptance criteria, performance indicators, etc. during review of the process prior to the audit thus identifying what evidence to gather.

More to your original question, I would not issue CARs. I'd reaudit the process and then re-evaluate the way auditor competence is determined. Maybe that one auditor needs a little more training or time with experienced auditors - maybe the process of determining auditor competency needs to be revised - maybe better auditing tools are necessary...

I think this is good advice. If you send your kid to the store to get a gallon of milk and a dozen eggs and he comes home with a loaf of bread and some Twinkies, something's not right. It could be that the kid doesn't know the difference, which isn't likely, or that that the kid just needs a list (or a good whuppin'). :D In any case, a CAR probably isn't the right weapon vehicle unless you think that a record of what took place might be helpful in the future.

Tried a search but came up empty. One of my auditors audited ISO 9001:2000 clause 7.1 - this clause only. The auditor collected data that does not quite correlate with what should have been collected. Regardless of the clause or standard, the data collected does not support the clause that was audited. What would a Cover do? CAR or No CAR? :confused:

I have to go back and reassign the 7.1 audit for the June audit anyway. But should I not bother writing a CAR and handle discreetly...or just the opposite?

Fellow Covers,

Crusader asked a very good question, something of concern.
I believe that the question has been appropriately answered.

Based on (some of) the later responses, it appears that a major (audit) violation has been committed. Is it necessary, or even helpful to make a mountain out of a mole hill?

Finally:

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Finally:

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

I guess that is where I was concerned. Still, just a bit more instructional training and preparation for audits will prevent this from happening again. Randy put it out there pretty well - I was looking at the whole realization audit and trying to make too much out of it. Sometimes those "general" clauses get me caught up and confused as to what the darn stanadrd is asking for. The auditor actually did capture the remainder of the audit from 7.2 to 7.6 perfectly. So I will learn from my own mistakes here.

Also, It's not so easy to train when I'm 100 miles away. I'll manage.
Thanks everyone for your input - woke me up. :bigwave: