Process based Audit Approach vs. Clause based Audit Approach

U

uzaimi - 2008

#1
:confused:Our parent company, a Germany based plan an internal audit every month (KPI 1 audit/month), and we have to follow them.
The audit is one ISO clause or element (described by the company as process) each at every month for the period of 2 years.

It is really bothering me since It is difficult fo me to audit as process approach because I have to audit as per element.This style of an audit is accepted by Germany CB.

I think I'll have a tough time with local auditor. Last certification audit he has raised the question of KPI for every process, since our company described each element as our process.

What you think ? Any idea
 
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harry

Super Moderator
#2
Re: Process Audit Approach vs. Clause Audit Approach

I think I'll have a tough time with local auditor. Last certification audit he has raised the question of KPI for every process, since our company described each element as our process.
Is the audit for your TS 16949 or ISO 9001 certification?
 
#3
Re: Process Audit Approach vs. Clause Audit Approach

:confused:Our parent company, a Germany based plan an internal audit every month (KPI 1 audit/month), and we have to follow them.
The audit is one ISO clause or element (described by the company as process) each at every month for the period of 2 years.

It is really bothering me since It is difficult fo me to audit as process approach because I have to audit as per element.This style of an audit is accepted by Germany CB.

I think I'll have a tough time with local auditor. Last certification audit he has raised the question of KPI for every process, since our company described each element as our process.

What you think ? Any idea
You will indeed have a tough time with any auditor who knows their stuff. It sounds to me as if you have more that that on your plate, but to address the principle issue, you should do a process based audit, no more no less. Doesn't matter if you are ISO or ISO/TS registered. You are required to do process approach audits, not element. I have seen a number of CB auditors accept an element audit even in recent years! It's a shame!

Can you write a local work instruction to the corporate audit document to allow you to plan your own audits? Or a deviation notice?

You could just escalate it by allowing a nc against the procedure/plan for it not requiring a process audit. If you actually do the audits by process, the nc could simply be that the procedure/plan doesn't describe a process methodology - that's better IMHO.

Is the CB in Germany the same as your local CB? If so, you could point out that you're doing the right thing and have them send a message back to their office in Germany that the audit plan needs updating at 'corporate'.

Good luck!
 

Stijloor

Staff member
Super Moderator
#4
Re: Process Audit Approach vs. Clause Audit Approach

Doesn't matter if you are ISO or ISO/TS registered. You are required to do process approach audits, not element. I have seen a number of CB auditors accept an element audit even in recent years! It's a shame!
I am a big proponent and teacher of process-based auditing. However, there is no "shall" in ISO 9001:2000 requiring to perform process-based audits.
 
Last edited:

RoxaneB

Super Moderator
Super Moderator
#5
Re: Process Audit Approach vs. Clause Audit Approach

Maybe I'm taking a very simplistic approach here, but why can't a clause-based audit also be a process-based one? Document control is a process...so apply the audit throughout the site ensuring that everyone is following the appropriate protocols. Internal audits are a process. Heck, Management Review is a process.

This is why I developed a matrix for my site that showed the clauses along one axis and the processes/departments along the other. By then indicating the relationship between the clause and process, I was able to ensure the audit really focused on what applied to a process.

Unfortunately, I really dislike KPIs such as 1 audit/month. That promotes quantity over quality and it becomes very difficult to have an audit which adds value to the organization.
 
#6
Re: Process Audit Approach vs. Clause Audit Approach

I am a big proponent and teacher of process-based auditing. However, there is no "shall" in ISO 9001:2000 requiring to perform process-based audits.
A requirement doesn't have to come from a standard specifically saying 'shall'. Firstly, the CB's often add requirements - in this case many have enforced a process approach - and common sense (maybe not so common) says if you structure your qms on processes, then to ensure they meet requirements and are effect, an audit of that process is a natural thing to do.
 

Stijloor

Staff member
Super Moderator
#7
Re: Process Audit Approach vs. Clause Audit Approach

A requirement doesn't have to come from a standard specifically saying 'shall'. Firstly, the CB's often add requirements - in this case many have enforced a process approach - and common sense (maybe not so common) says if you structure your qms on processes, then to ensure they meet requirements and are effect, an audit of that process is a natural thing to do.
I do not disagree with the process approach. I just made a note saying that ISO 9001:2000 does not include a shall for process audits. We must be very cautious mentioning requirements that do not exist or are misinterpretations from registrars and auditors. If CB's add requirements that are not in the Standard (even with the right intent), is that not defeating the purpose of having a Standard in the first place? Re: Many previous discussions abouts audits (internal/external) here at The Cove.
 
Q

qualityboi

#8
Re: Process Audit Approach vs. Clause Audit Approach

Maybe I'm taking a very simplistic approach here, but why can't a clause-based audit also be a process-based one? Document control is a process...so apply the audit throughout the site ensuring that everyone is following the appropriate protocols. Internal audits are a process. Heck, Management Review is a process.

This is why I developed a matrix for my site that showed the clauses along one axis and the processes/departments along the other. By then indicating the relationship between the clause and process, I was able to ensure the audit really focused on what applied to a process.

Unfortunately, I really dislike KPIs such as 1 audit/month. That promotes quantity over quality and it becomes very difficult to have an audit which adds value to the organization.
Although addressed before, I agree with Rox, the clauses can be processes, i.e., Management Review process, Training process, Product Realization process etc. Some processes that address the ISO clauses in our organization are shared and owned by multiple functional areas. An example is the CAPA process, wow, how many functional process within your company have a stake in the corrective action process at system level? We have a mixture of both ISO and functional area processes in which we roll into high level metrics. It is not nececessary to have a KPI for every process, just the ones you deem critical to customer satisfaction or the quality system.

ISO has not required management to be horizontally organized, until it does people will always have a tough time applying horizontal process principles to vertically managed organizations.
 

michellemmm

Quest For Quality
#9
Re: Process Audit Approach vs. Clause Audit Approach

I do not disagree with the process approach. I just made a note saying that ISO 9001:2000 does not include a shall for process audits. We must be very cautious mentioning requirements that do not exist or are misinterpretations from registrars and auditors. If CB's add requirements that are not in the Standard (even with the right intent), is that not defeating the purpose of having a Standard in the first place? Re: Many previous discussions abouts audits (internal/external) here at The Cove.
Stijloor,

Doesn't requirements of 4.1 apply to IA? As far as I am concerned, IA is a process...The "shalls" may not be expressed, by IMHO implied....

My BSI auditor called my system "Unique" and linked appropriately to continual improvement....

I personally have a problem with elemental approach. The results are digital and I can only perform check-sum with the results....With process approach, I challenge the effectivess of each process and related processes and when I see a deficiency, I examine the effectiveness of PDCA application and then look for elemental deficiency....
 
D

David DeLong

#10
Re: Process Audit Approach vs. Clause Audit Approach

Process Auditing vs. Clause Auditing

In the old QS 9000 or ISO, we did clause or element auditing and it was performed once a year (or every 6 months) just before the 3rd party Auditor came in. That was it.

Once I understood process auditing (AIAG training was not the best on this subject), it became clearer that process auditing could be quite useful.

Let's say that we have a complaint of some sort. Should we not review all the processes involved to confirm that they have been performed correctly? Should we not review the Operators reports on the date isolating the particular product? Should we confirm that the respective gauges used have been calibrated? Were work instructions at the job site? Were inspection instructions at the job site? Were they clear? Was the reported deficiency actually checked or not?

I think you get my point. I have just covered. In-process, Gage Control, Work Instructions, Control Plans, etc all relating to the problem.

Is this useful? I think it is and I would never suggest going back to perform an element approach unless a company is developing their systems for TS or ISO compliance. Use it there but on the shop floor, the process audit reins supreme.
 
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