Poll: Should auditors promote the process approach?

[Big Jim]

Re: What criterial do you use to identify a company using the "process approach"?

Sorry, I was paraphrasing the standard, but I do not feel I was adding additional requirements.

I was emphasizing the criteria for effectiveness in cl 4.1.c is a vital link that many companies overlook. It is the shadow to the process approach, just like the misunderstandings about Preventive Actions.

I do not believe in overdocumenting a QMS or over defining the processes in a company.

A company with 250 defined processes is an example of what I have been saying. The clearly did not understand the intent of the process approach, and I am sorry they went to that mauch effort. Just about any system with more than a couple dozen processes has probably elevated a lot of subprocesses to the level of a full process, and that rarely adds clarity. It usually bogs things down.

As to your specific example of resources, obviously "resources must be determined," before the company can make available the "resources and information necessary to support the operation of these processes." I was really not adding requirements to the standard. I don't do that.

It appears that you and I agree much more than we disagree.

 

[Wayne G.]

Re: Should auditors promote the process approach?

I have been auditing TS16949 for many years using the process approach and have just began a new position with a company registered to AS9100. What shocked me is that the company is auditing using the element method. What's worse, the checklist used is merely a copy of all the "shalls" in the standard. I don't think there is any value to this and it amounts to a remedial desk audit.

Question:

1. Is the process approach not used in the aerospace industry?

2. Is it required to cover the "shalls" at least once within a registration cycle?

Thanks

 

[Big Jim]

Re: Should auditors promote the process approach?

I have been auditing TS16949 for many years using the process approach and have just began a new position with a company registered to AS9100. What shocked me is that the company is auditing using the element method. What's worse, the checklist used is merely a copy of all the "shalls" in the standard. I don't think there is any value to this and it amounts to a remedial desk audit.

Question:

1. Is the process approach not used in the aerospace industry?

2. Is it required to cover the "shalls" at least once within a registration cycle?

Thanks

Thankfully, the checklist will not be part of the CB audit program for AS9100C. Even thought CB auditors still use the checklist for AS9100B, they are required to use the process approach. Sometimes there isn't much evidence of that approach other than a process based audit plan.

Until a company transitions to AS9100C the checklist (which is part of a standard dedicated to performing aerospace CB audits) is still required. Companies will not be able to register to AS9100C for a few more months (the actual timeframe is still unclear).

AS9100B also requires internal audits to use detailed tools and techniques, such as checksheets and charts. As a result, many companies use the same checklist for internal audits. This requirement goes away with AS9100C.

 

[Wayne G.]

Thank you.

Where could I find the requirement to use the process approach? If I want to sell this to management, I'll need evidence of a requirement or prefered method. There is more value in using the process approach, as I want processes measured against specific targets.

Thanks again.

 

[Helmut Jilling]

Thank you.

Where could I find the requirement to use the process approach? If I want to sell this to management, I'll need evidence of a requirement or prefered method. There is more value in using the process approach, as I want processes measured against specific targets.

Thanks again.

The best evidence is in ISO 9004, and advanced version of the ISO 9001 standard. It is a very good book to show management. Many of my ISO clients use it instead of ISO 9001.

In the 2005 version, check clauses 4.1, and 7.0-7.1.3.3. An excellent case made for the process approach.

In ISO 9001, you have the intro sections, and cl 4.1, and 8.2.3.

Also, ANAB and APG have written some supportive documents for the process approach. ANAB supposedly requires their CB's to do it. IATF/IAOB for TS have actually written a section into the TS Rules.

Wish they just wrote it as a shall in the standard. Don't know why they don't.

 

[Sidney Vianna]

Re: Should auditors promote the process approach?

Thankfully, the checklist will not be part of the CB audit program for AS9100C.

Just to clarify. As part of the conformity assessment protocol for AS9100C, the AS9101D document will mandate the completion of several forms, one of them being the Objective Evidence Record (OER). This OER table will be used so the auditors provide a record of the objective evidence assessed, during the audits. As this matrix contains (if I am not mistaken) 463 rows of evidence to filled, one can see that it will be a time consuming exercise.
The inclusion of the OER in 9101D was a contentious issue, but, as it was felt that the audit reports must provide evidence of what has been assessed during the course of the audit, the OER was kept as part of the mandatory forms.

 

[Jim Wynne]

<snip>
Wish they just wrote it as a shall in the standard. Don't know why they don't.

Read through this thread and you'll see why a "shall" would be a terrible idea in the absence of a much more rigorous definition than what ISO currently offers. No one knows exactly what "process approach" means, and unless a bullet-proof auditable definition is forthcoming, there won't be a "shall."

 

[dknox4]

Thank you.

Where could I find the requirement to use the process approach? If I want to sell this to management, I'll need evidence of a requirement or prefered method. There is more value in using the process approach, as I want processes measured against specific targets.

Thanks again.

Related to TS, some customer specific requirements require auditor training to include the "process approach".

IMHO there should not be an issue with how you audit to the standard. You should be able to audit using the process approach against the standard without getting buy-in or agreement from anyone.

 

[Wayne G.]

Thank you, everyone.

 

[snappy]

Re: Should auditors promote the process approach?

While the "Process Approach" makes a lot of sense, it is a recommendation and not a requirement. If an organization decides to audit based on the clause-by-clause approach, that is their choice. If the process approach is not well understood or not well implemented, it may be a better choice for such an organization.

Stijloor.

IMHO,the requirement to use the process approach resides in 4.1.