Process based Audit Approach vs. Clause based Audit Approach

Helmut Jilling

Auditor / Consultant
#11
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.

This is one of my major frustrations in the ISO based standards. When they came out, there was much talk about "Process Approach" as if ISO invented it. At first it was not very clear, and the documents did not mandate it, it only inferred. However, it is evolving each year toward more clarity that a process approach is expected.

TS made it very clear (finally) in the Rules, 2nd ed. ISO has been a little slower, but both the ANAB in the US and the TGA in Germany are pressing more and more to expecting a process approach, not an element approach. Thus the CB's and auditors are pressing that as well.
 
Elsmar Forum Sponsor
#12
Re: Process Audit Approach vs. Clause Audit Approach

I have a mental block over how and why elements would be audited. I'm fortunate that my instructor taught me process auditing and the materials I've taught for the past 15 years are process based.

In addition, I can't conceive why (apart from getting ready for registration) anyone would audit an element. Why would you audit doc. control, or any one part of the standard? In my world, it's the interfaces between the processes where the problems lie, not in the pocess. So looking at the outputs/inputs etc is vital.
 

Stijloor

Staff member
Super Moderator
#13
Re: Process Audit Approach vs. Clause Audit Approach

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....
Hi Michelle,

You are correct! There are many references to "processes" in ISO 9001:2000. The emphasis on the process approach is very clear. As indicated in a previous post, I am not against the process approach at all. My issue was about a comment that was made in a post stating that: "You are required to do process approach audits, not element." Hence my comment: There is no shall in ISO 9001:2000 requiring process audits.

I hope this clarifies....:)

Stijloor.
 
Last edited:

Colin

Quite Involved in Discussions
#14
Re: Process Audit Approach vs. Clause Audit Approach

I love this discussion regarding the preferred methods of conducting audits - processes, clauses, procedures, departments, etc. From the evidence of 3rd party audits that I conduct, I would just be happy to see audits of a decent standard to start with :(

I must be honest and say that well structured, conducted and reported audits are a rarity when I visit companies. I agree, process audits are the way to go but for now - just good audits of any type would be a bonus. :rolleyes:
 
P

pinpin - 2009

#15
Re: Process Audit Approach vs. Clause Audit Approach

:thanks:Some processes may be just within a Department, whereas some other processess may be cross-departments. As such the auditor may have to travel from one department to the others to complete his audit of particular process.... Can the auditor not doing so himself but to rely on his members (other auditor in the team) that perform audits at other departments to colloborate info or evidence require for that process?

In performing audit, we are to determine whether the process or the area we audited is ok or not. As such, we need to look at the elements that contribute to the effectiveness of the process or area, i.e. Man, Machine, Method, Material, Environment used in that process or area. All these elements should be ok so that the process is under control, i.e. it can produce output that meet customer requirements. This is also similar to the requirements of 7.5.1. But, must the auditee set objectives or kpi for ALL THE PROCESSESS because without that auditor cannot determine the process audited is effective or not? Where in TS Std say so?

Must we use TURTLE DIAGRAM to do internal audit otherwise it will be an NC? Say so in TS Std?

I saw Turtle Diagram which is a one page form with few boxes for things such as Measurement, Input, Output, Man, Machine, etc. But not having sufficient space to record evidence of audit throughout the audit. Is it acceptable to use element-based audit checklist to record evidence besides using this Turtle Diagram?

Can someone help to attach a sample to clear my doubts? :thanx:
 
#16
Re: Process Audit Approach vs. Clause Audit Approach

Hi Michelle,

My issue was about a comment that was made in a post stating that: "You are required to do process approach audits, not element." Hence my comment: There is no shall in ISO 9001:2000 requiring process audits.

I hope this clarifies....:)

Stijloor.
The statement was mis-interpreted - It didn't say 'ISO SAYS SO'!

The point is that since a QMS is constructed from processes, not elements, requires you to audit processes, since that will tell you if they are effective. Doing any other audit won't reveal much in the way of interest to management. Auditing a procedure, element, department, area, or similar won't tell you much about the process, what it delivers, if it meets management's needs etc.

There are simply too many people who rely on ISO to tell them you 'shall' do something. And as a result they miss opportunities - to do the right thing!
 

RoxaneB

Super Moderator
Super Moderator
#17
Re: Process Audit Approach vs. Clause Audit Approach

The problem appears to be in defining what level or kind of process is in the scope of a process audit. For the most part I would hope that most of us would summarize a process as "input(s) to value-added transpformation to output(s)".

Some people here are defining a process as a department. Some are defining it as an clause. I apologize if it sounds like I'm sitting on the fence, but is it not possible that both parties are correct?

Process-based auditing leaves it up to us to determine what level of process we wish to focus on...how detailed or how high up is up to us. We determine the level which will add the best value to our organization.

I'll grant you that there are probably some fields/industries where process-based auditing is meant to focus solely on the operational processes resulting in the finished product and/or service. But why stop there?

Let say we wish to audit a document "How to Calibrate the Spectrometer". That's a process...a very detailed process. But if auditing to that level adds value, go for it.

Then there's the process of the Warehouse or Logisitics. A slightly more complex process than our previous one. In fact, it makes the calibration exercise look more like a task, but from a higher altitude, everything looks tinier on the ground. This level of process auditing will include tasks like maintenance on the overhead cranes to understanding what to load onto the railcar. But it will also include clauses dealing with customer satisfaction, record control, operational control, etc. A process-based audit focusing on the departments allows for a multi-clause audit and indicates the state of application of the requirements.

Let's not forget auditing the process of customer satisfaction. This will entail everything from Sales/Marketing to Manufacturing to Shipping. Or operational control which my result in visits to manufacturing, maintenance and potentially quality (all depends on your organizational structure). A process-based audit focusing on the clauses will allow for more of a cross-functional audit and indicates the state of implementation of the shalls.

At the end of the day, developing an audit plan that addressess the last two methods of "process-based auditing" creates a 'basket weave' which will allow an organization to ascertain the state of the Management System from all angles. Auditing processes to the detailed stuff is a way of dotting our i's and crossing our t's.

Personally, I find we get so hung up on the word "process" that we forget why we do audits in the first place. It's all about ensuring there is value added to the organization. If we're doing this just because ISO or a CB or a Registrar or an Auditor says we must, then we've lost the whole meaning behind this process.
 
Q

qualityboi

#18
Re: Process Audit Approach vs. Clause Audit Approach

Your explaination above adds more to the argument that a KPI should never be number of audits performed as one process audit such as the calibration may only take a matter of days while others may take months. My real life example is an audit of the a fab diffusion process took one week from opening meeting to closing with only myself auditing. The process audit of our product lifecycle took 3 months from begining to end with 5 auditors. Both only counted as 1 process audit.
Very unfortunately my boss is using number of process audits for team member goals and that number of audits does not even closely align to the audit schedule :bonk:go figure, he has an MBA and I only have 2 yrs of college and you can guess what audits get cherry picked out of the schedule come the last two months before goals are reviewed! :notme:

The better KPI would be performance to plan, but hey I am the uneducated one!:sarcasm:
 

Jim Wynne

Staff member
Admin
#19
Re: Process Audit Approach vs. Clause Audit Approach

I have a mental block over how and why elements would be audited. I'm fortunate that my instructor taught me process auditing and the materials I've taught for the past 15 years are process based.

In addition, I can't conceive why (apart from getting ready for registration) anyone would audit an element. Why would you audit doc. control, or any one part of the standard? In my world, it's the interfaces between the processes where the problems lie, not in the pocess. So looking at the outputs/inputs etc is vital.
After reading through the comments thus far, I think this post comes the closest to identifying what the problem is. The expectation is not that audits should be performed according to the process approach; it's that the QMS, and the business itself, should be designed around it. Most companies today are still highly compartmentalized and don't recognize the interactions between processes because processes are "owned" according to departmental boundary lines. My own opinion is that registrars have dropped the ball by not issuing major findings when it's clear that the process approach exists only in the turtle diagrams. It's no wonder that people are confused about what to audit, and often default to just making sure that the "shall" clauses are satisfied. There is no process approach until companies actually adopt it.
 
D

David DeLong

#20
Re: Process Audit Approach vs. Clause Audit Approach

Must we use TURTLE DIAGRAM to do internal audit otherwise it will be an NC? Say so in TS Std?

I saw Turtle Diagram which is a one page form with few boxes for things such as Measurement, Input, Output, Man, Machine, etc. But not having sufficient space to record evidence of audit throughout the audit. Is it acceptable to use element-based audit checklist to record evidence besides using this Turtle Diagram?

Can someone help to attach a sample to clear my doubts? :thanx:
I would suggest using the turtle diagram to develop a process audit but that is about it. Of course I would keep the turtle diagram for "show and tell" when 3rd party auditors come it.

It does not state this in the TS standard and the rules seem to change all the time. TS auditing training with AIAG in Southfield, Michigan does go into some depth on the turtle diagram.

I used to think that the turtle diagrams were a bit of bunk but after a while I could really see the value when designing your process audit.
 
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