Process vs Elements/Checklist - Is the old method of auditing the clauses still legal

[Helmut Jilling]

I've searched your site and perhaps you are aware of where I might find this info or have some type of template that I can use as a starting point - although each company and process is different - I am trying to implement process auditing structure versus "standards" auditing to my internal audit procedure - is there something which would list for example "purchasing" and then if this process is audited what "standards" it will "hit" during theprocess ... I can do it manually but if I had something basic I can expand on it would save me time. Thanks,

I can offer you these tools. Not sure of they are what you are looking for.

 

[chaosweary]

Not by process or clause

First and foremost we implemented the 16949 standard to be able to sell to the automotive industry. Improving processes is a great thing. Making money is why businesses exist. For the most part we met ISO 9001 requirements even without being certified as a matter of good business practice.
As far as the process approach we make our audit schedule by department, not by process or clause! Depending on the needs of the organization (not the customer) we will audit a process, otherwise we do our "regular" audits by departments we list in our quality manual because our company is very siloed. Now you can say all you want about siloed organizations but the reason they are siloed is to prevent diseconomy of scale (see HP). I see nothing wrong with the process approach but it doesn't really work well in siloed organisations such as ours where there are very few processes that transcend the entire global organisation. But I personally use a processes approach when auditing a department...(how is that for confusing?)

 

[Helmut Jilling]

First and foremost we implemented the 16949 standard to be able to sell to the automotive industry. Improving processes is a great thing. Making money is why businesses exist. For the most part we met ISO 9001 requirements even without being certified as a matter of good business practice.
As far as the process approach we make our audit schedule by department, not by process or clause! Depending on the needs of the organization (not the customer) we will audit a process, otherwise we do our "regular" audits by departments we list in our quality manual because our company is very siloed. Now you can say all you want about siloed organizations but the reason they are siloed is to prevent diseconomy of scale (see HP). I see nothing wrong with the process approach but it doesn't really work well in siloed organisations such as ours where there are very few processes that transcend the entire global organisation. But I personally use a processes approach when auditing a department...(how is that for confusing?)

With all due respect, it does not matter what you or I "think" we should do. The requirement and expectation of the TS auto industry is that we stop running our businesses as "silos" and operate in a "process approach." We are suppose to define our systems by the processes in our company. We are to audit by these processes. We are to do management review by these processes. If it doesn't fit your company structure, then they want you to adjust your structure to fit a process approach.

Read the TS Rules. It is mentioned in a number of places. It is further reinforced by interpretive documents by the ANAB and IAOB.

Folks, let's stop this incessant discussion of what WE want. The OE customers have stated they want TS and ISO to be operated and audited to a process approach. The ISO AB's have stated it too.

You don't have to do it this way. But, if you want to work in automotive, or under ISO rules, then you have to do it this way. This is the entry requirement.

Your CB is under orders and mandates to audit you to a process approach and NOT certify you if you don't do it. If they certify you without a process approach it is a major nonconformance against them if the witness auditors discover it.

It is what it is. They make the rules, and we have to follow them...

Now, having said all that, if you really understand this "process approach," you wouldn't want to do it any other way. It is truly excellent. But, as the posts on the Cove demonstrate, many, many companies do not understand it, so they don't get the benefit.

It really is that good, when you truly understand and implement it.

 

[Caster]

Who wants to be a Millionaire?

First and foremost we implemented the 16949 standard to be able to sell to the automotive industry. Improving processes is a great thing. Making money is why businesses exist. For the most part we met ISO 9001 requirements even without being certified as a matter of good business practice.

As far as the process approach we make our audit schedule by department, not by process or clause! Depending on the needs of the organization (not the customer) we will audit a process, otherwise we do our "regular" audits by departments we list in our quality manual because our company is very siloed. Now you can say all you want about siloed organizations but the reason they are siloed is to prevent diseconomy of scale (see HP). I see nothing wrong with the process approach but it doesn't really work well in siloed organisations such as ours where there are very few processes that transcend the entire global organisation. But I personally use a processes approach when auditing a department...(how is that for confusing?)

Chaosweary

Departments can be processes - it's up to you how you define your processes!

We are also very siloed.

Just for fun why not try "the spirit of process auditing"?

Look at the "process interface" (hand offs) between these 3 typical Silos

• Sales to Design
• Design to Manufacturing

If you are a reasonable size company, I bet you can easily find more than a million$ in costs.....

Its also called sub optimization, where each department tries to do its best but the overall effect is bad.

Look at Tom Peters for a contrarian view of economies of scale. Cellular manufacturing often features expensive equipment sitting idle. The Goal by Goldratt argues against economies of scale.

But heck, if you're making money..all the rest is theory!

I completely agree when you when you say "..met ISO 9001 requirements even without being certified as a matter of good business practice." An enlightened and rare comment!

 

[chaosweary]

Process Approach

I agree the process approach is the best way for an audit plan, however, when your in a company where those siloes are headed by people whose authority (and pay) far exceeds our own you find yourself writing up the entire organization. I have been there already and we have had to actually delete non-conformances out of our database because of such findings.
Well I am always coming up with strategies to approach this. I know we are suboptimizing greatly. I guess the way I look at it is we are still making a profit and those jobs that are sub optimized would be in jeopardy. I guess you can't be win win for all stakeholders. Right now the issue is between a rock and hard place.

 

[Neil V.]

Re: Process vs Elements/Checklist - Is the old method of auditing the clauses still l

Great Thread. Very informative. I've read that "you can't audit in conformance". Does it make sense then, when initially switching over from a clause based Quality Management System Internal Audit to a process based QMS Internal Audit (because, among other things, thats what ISO/TS asks for), to use a type of checksheet like the one HJilling provided as a gap analysis of sorts? An example would be that Sales is identified as one of our key processes but we have very little in terms of work instructions or process map, or flowchart, or turtle diagram. So I would then make a decision to remove Sales from our Key Process list or come up with W.I. or a process map for sales.....Does it matter what comes first, our current Quality Management System or our Quality Management System Internal Audit. Can the Internal Audit be the driving force to setting up a QMS?

((Additional info, I am about to begin our Quality Management System Internal Audit for all clauses. I am auditing to ISO/TS 16949:2002. Our quality manuel is pretty much in line with the ISO/TS manuel. We have used a checklist in the past and audited clause by clause and then re-written the info onto looseleaf paper because--naturally--you can't/shouldn't use a checklist approach to conduct the audit. I don't agree with this method and don't think it complies with the standards.))

Maybe i'm looking at the "audit in conformance" quote too literally.

Just when I think I have the Internal Audit requirements sorted out, doubt creeps in.....

 

[Helmut Jilling]

Re: Process vs Elements/Checklist - Is the old method of auditing the clauses still l

Great Thread. Very informative. I've read that "you can't audit in conformance". Does it make sense then, when initially switching over from a clause based Quality Management System Internal Audit to a process based QMS Internal Audit (because, among other things, thats what ISO/TS asks for), to use a type of checksheet like the one HJilling provided as a gap analysis of sorts? An example would be that Sales is identified as one of our key processes but we have very little in terms of work instructions or process map, or flowchart, or turtle diagram. So I would then make a decision to remove Sales from our Key Process list or come up with W.I. or a process map for sales.....Does it matter what comes first, our current Quality Management System or our Quality Management System Internal Audit. Can the Internal Audit be the driving force to setting up a QMS?

((Additional info, I am about to begin our Quality Management System Internal Audit for all clauses. I am auditing to ISO/TS 16949:2002. Our quality manuel is pretty much in line with the ISO/TS manuel. We have used a checklist in the past and audited clause by clause and then re-written the info onto looseleaf paper because--naturally--you can't/shouldn't use a checklist approach to conduct the audit. I don't agree with this method and don't think it complies with the standards.))

Maybe i'm looking at the "audit in conformance" quote too literally.

Just when I think I have the Internal Audit requirements sorted out, doubt creeps in.....

You ask some very good questions. It might be a bit premature for you to teach a class on "internal auditing" until you are clear about what you should be teaching.

You may use a gap analysis checklist, as a gap analysis checklist to determine whether your system addresses all the requirements. You may do all kinds of things, and may find the add value and benefit. But, don't call them an "internal audit" because they want the internal audit to be performed to a process approach. The TS Rules specifically state that. The ISO supporting literature supports that intent. And, the ISO 19011 guidelines for auditing promotes it as well. I wish they made it more clear, but I think their intent can be determined.

If you don't have work instructions for Sales, you can still do a process approach. You certainly have to remove it from your core processes.

1. Do the "report card" stuff. Review the criteria and metrics for this process. Are they meeting their objectives. Review the inputs and outputs. These are all requirements of the statndard for each process.

2. Review the process. Ask the participants to walk you through the process step by step. Ask multiple people to particpate, and see if they agree with the description.

3. Review links to supporting processes. Are they working? Are the outputs going to the next process efficiently?

Draw conclusions related to compliance, and effectiveness. Does it meet requirements, and does it work well? Can you identify problem or improvement areas? Before you know it, you have done a process audit.

(PS: if you still wrestle with this, that's OK. Obviously, a lot of folks struggle with this. If you'd like, I do 3 day onsite training sessions to groups on this.)

 

[fireonce]

Re: Process vs Elements/Checklist - Is the old method of auditing the clauses still l

Thouth it was listed as an observation,you are supposed to upgrade the checklist according to the new standard iso9k2k.

Kane

 

[Helmut Jilling]

Re: Who wants to be a Millionaire?

If you are a reasonable size company, I bet you can easily find more than a million$ in costs.....

Its also called sub optimization, where each department tries to do its best but the overall effect is bad.

I agree with the potential savings.

...But heck, if you're making money..all the rest is theory!

The interesting thing is that eventually, this rationalization results in making less and less money...then, none at all. Then, they blame the Q Manager because obviously he wasn't doing his job!

 

[Neil V.]

Re: Process vs Elements/Checklist - Is the old method of auditing the clauses still l

You ask some very good questions. It might be a bit premature for you to teach a class on "internal auditing" until you are clear about what you should be teaching.

You may use a gap analysis checklist, as a gap analysis checklist to determine whether your system addresses all the requirements. You may do all kinds of things, and may find the add value and benefit. But, don't call them an "internal audit" because they want the internal audit to be performed to a process approach. The TS Rules specifically state that. The ISO supporting literature supports that intent. And, the ISO 19011 guidelines for auditing promotes it as well. I wish they made it more clear, but I think their intent can be determined.

If you don't have work instructions for Sales, you can still do a process approach. You certainly have to remove it from your core processes.

1. Do the "report card" stuff. Review the criteria and metrics for this process. Are they meeting their objectives. Review the inputs and outputs. These are all requirements of the statndard for each process.

2. Review the process. Ask the participants to walk you through the process step by step. Ask multiple people to particpate, and see if they agree with the description.

3. Review links to supporting processes. Are they working? Are the outputs going to the next process efficiently?

Draw conclusions related to compliance, and effectiveness. Does it meet requirements, and does it work well? Can you identify problem or improvement areas? Before you know it, you have done a process audit.

(PS: if you still wrestle with this, that's OK. Obviously, a lot of folks struggle with this. If you'd like, I do 3 day onsite training sessions to groups on this.)

I won't be doing any teaching anytime soon -- unless you've heard something I haven't! :mg: Thanks for the rundown. Really added clarity to the process for me. I plan to conduct the internal audit as you described. Where we are lacking I will make make note and write a non-conformance and/or correcetive action. It will be hardest the first time around doing the process audit I'm sure. Thanks for the training offer too. Timing is not good now though.