Poll: Should auditors promote the process approach?

[DrM2u]

No, I would never try to bend 4.1a to suit the process approach because there's more to the process approach than determining what needs to be controlled in the QMS. An approach is a method of application, while a process is more like a thing.

Jennifer, I have to disagree with you on this one. For a starter, a process is not more like a 'thing', it is a systematic series or actions directed to some end (see the definition you have posted).

The key word in QMS is 'System' (the S in QMS). Therefore a QMS is a management (or quality management if you wish) system implemented by an organization. I am sure that Dictionary.com has a definition for 'system' also but here's my take on its meaning: a system is a set of interrelated systematic processes that systemically operate together in an environment to transform an input into an output.

It is my deduction that, in order to evaluate the effectiveness of the system one needs to evaluate the systemic effectiveness of the processes within the system (the ability of said processes to achive the system's goal/objective together). This implication stretches from the share holders to the top management to the internal auditors to the external auditors. As I mentioned in my previous post, my personal experience is that majority of the executives, management and internal auditors do not understand the concepts of system and process, therefore they cannot usually evaluate the effectiveness of the system. Therefore, as a third party auditor, one should strongly urge/suggest/promote/advertise/(whatever other choice word) that the organization educates itself and takes a systemic and process approach to business.

This is my HO and I stand by it until someone can persuade me otherwise.

 

[Richard Pike]

Therefore, as a third party auditor, one should strongly urge/suggest/promote/advertise/(whatever other choice word) that the organization educates itself and takes a systemic and process approach to business.

This is my HO and I stand by it until someone can persuade me otherwise.

The people to persuade you will be the client.

If established with existing Certification - how dare you - second guess the Auditors who have been before you. They thought the QMS was - effectively compliant - and now you will disagree under the guise of "adding value". or "continuous improvement".

I am curious ! - genuinely - Will you accept full responsibility, accountability and liability if your Client accepts your "advice" and for whatever reason - your "advice" does not have the effect that you assumed it would have?

If its a non-conformance, then have the moral fortitude to explain to your Client why! thereby providing them with the opportunity to officially dispute your finding.

If its a recommendation - explain to your client -in cold hard facts - precisely how their organizational is going to benefit from your recommendation - AND what will be the real consequences if they don't follow it!

If you are going to imply that if they don't follow your "advice" then they may pay the price at a subsequent Audit - then shame on you!!! your CB would be politely informed that if they want to keep the Business - they must provide another Auditor!

 

[ISO 9001 Guy]

Jennifer, I have to disagree with you on this one. For a starter, a process is not more like a 'thing', it is a systematic series or actions directed to some end (see the definition you have posted).

The key word in QMS is 'System' (the S in QMS). Therefore a QMS is a management (or quality management if you wish) system implemented by an organization. I am sure that Dictionary.com has a definition for 'system' also but here's my take on its meaning: a system is a set of interrelated systematic processes that systemically operate together in an environment to transform an input into an output.

It is my deduction that, in order to evaluate the effectiveness of the system one needs to evaluate the systemic effectiveness of the processes within the system (the ability of said processes to achive the system's goal/objective together). This implication stretches from the share holders to the top management to the internal auditors to the external auditors. As I mentioned in my previous post, my personal experience is that majority of the executives, management and internal auditors do not understand the concepts of system and process, therefore they cannot usually evaluate the effectiveness of the system. Therefore, as a third party auditor, one should strongly urge/suggest/promote/advertise/(whatever other choice word) that the organization educates itself and takes a systemic and process approach to business.

This is my HO and I stand by it until someone can persuade me otherwise.

Well stated, Dr. M. A question requiring an honest answer is, "Does management see value in ISO 9001 audits?" Really? Or is the value in retaining a certificate? (A similar question: does management really see value in a standard-based QMS beyond the certificate?)
Yet an auditor will find conformity however an organization chooses to demonstrate it. (Not that this is wrong, but ISO/IAF APG appears now to be saying it must be within reason--a QMS must meet the basic intent of being based upon processes.) If an organization chooses to define its QMS using the element-by-element approach, the resulting system is one of standard-based documents that do not reflect a system of processes. A QMS IS a system of documents if management has defined it as such. An auditor verifying conformity to a system of documents will never have much of a chance at adding value to a process, or a system of processes. Until a QMS is viewed as a system of processes, rather than a system of documents, the value of ISO 9001 will continue to escape organizations hoping ISO 9001 would be useful. With its guidance, ISO/IAF APG apparently wants end customers--organizations--to benefit from ISO 9001.

 

[Paul Simpson]

"Quality professionals" is such a broad term. It encompasses concerns that are not management system related like ISO 9001 is, such as six sigma (which does not focus on management systems) or metrology (which does not focus on management systems).

I agree that quality professionals don't always control the organisation's quality management systems but would guess that in a vast majority of cases they do. There are quality professionals doing things other than management systems (like metrology) but even so I think they should still be promoting a process approach. So in summary quality is bigger than ISO 9001 but all quality professionals should promote the process approach - not just quality auditors. The original thread is in the ISO 9001 section and ISO 9001 is about management systems for quality after all.

BTW you mentioned 6 sigma. IMHO six sigma is a management systems approach - merely pulling together a range of quality tools in a systematic approach.

Since the ISO guidance is directed at auditors, the question is also limited to auditors, so as not to exceed the scope of the guidance in question, which provides basis for the question.

ISO 9001 places requirements - it does not offer guidance and it is not aimed at auditors but at quality professionals )) implementing systems. I don't object to asking this question about auditors but think that the first poll should be aimed at those designing and implementing quality management systems.

I agree that all quality professionals concerned with management systems should promote the process approach. If the guidance stated that quality professionals should promote the process approach, so would have the question. ISO/IAF can't hope to control all quality professionals, but it seems reasonable and appropriate that the IAF should have a say in how ISO 9001 auditors behave, doesn't it?
BTW, I agree that the idea of the process approach IS to start with the processes first, and not the requirements of the standard.

The ISO committee developing ISO 9001 is made up of quality profesionals understanding quality requirements. IAF on the other hand is made up of people with expertise in accreditation and conformity assessment. They may or may not have quality backgrounds.

 

[Jen Kirley]

Jennifer, I have to disagree with you on this one. For a starter, a process is not more like a 'thing', it is a systematic series or actions directed to some end (see the definition you have posted).

The key word in QMS is 'System' (the S in QMS). Therefore a QMS is a management (or quality management if you wish) system implemented by an organization. I am sure that Dictionary.com has a definition for 'system' also but here's my take on its meaning: a system is a set of interrelated systematic processes that systemically operate together in an environment to transform an input into an output.

It is my deduction that, in order to evaluate the effectiveness of the system one needs to evaluate the systemic effectiveness of the processes within the system (the ability of said processes to achive the system's goal/objective together). This implication stretches from the share holders to the top management to the internal auditors to the external auditors. As I mentioned in my previous post, my personal experience is that majority of the executives, management and internal auditors do not understand the concepts of system and process, therefore they cannot usually evaluate the effectiveness of the system. Therefore, as a third party auditor, one should strongly urge/suggest/promote/advertise/(whatever other choice word) that the organization educates itself and takes a systemic and process approach to business.

This is my HO and I stand by it until someone can persuade me otherwise.

All that is fine, but it's not being asked for in 4.1a; IMO that clause is simple, direct and limited in scope.

 

[ISO 9001 Guy]

I agree that quality professionals don't always control the organisation's quality management systems but would guess that in a vast majority of cases they do. There are quality professionals doing things other than management systems (like metrology) but even so I think they should still be promoting a process approach. So in summary quality is bigger than ISO 9001 but all quality professionals should promote the process approach - not just quality auditors. The original thread is in the ISO 9001 section and ISO 9001 is about management systems for quality after all.

BTW you mentioned 6 sigma. IMHO six sigma is a management systems approach - merely pulling together a range of quality tools in a systematic approach.
ISO 9001 places requirements - it does not offer guidance and it is not aimed at auditors but at quality professionals )) implementing systems. I don't object to asking this question about auditors but think that the first poll should be aimed at those designing and implementing quality management systems.
The ISO committee developing ISO 9001 is made up of quality profesionals understanding quality requirements. IAF on the other hand is made up of people with expertise in accreditation and conformity assessment. They may or may not have quality backgrounds.

To be clear, ISO TC 176 clearly promotes the process approach, right?

 

[ISO 9001 Guy]

No, I would never try to bend 4.1a to suit the process approach because there's more to the process approach than determining what needs to be controlled in the QMS. An approach is a method of application, while a process is more like a thing. See how Dictionary.com describe the terms:

ap⋅proach

–verb (used with object)
1. to come near or nearer to: The cars slowed down as they approached the intersection.
2. to come near to in quality, character, time, or condition; to come within range for comparison: As a poet he hardly approaches Keats.
3. to present, offer, or make a proposal or request to: to approach the president with a suggestion.
4. to begin work on; set about: to approach a problem.
5. to make advances to; address.
6. to bring near to something.

proc⋅ess

–noun
1. a systematic series of actions directed to some end: to devise a process for homogenizing milk.
2. a continuous action, operation, or series of changes taking place in a definite manner: the process of decay.

I agree that "process" is a noun. (Of course, it can also be a verb.) Like "football game" (another noun), it's something that happens. It has a beginning and an ending. Objectives are clearly involved, as is performance measurement. So, a "process" is like a "football game." Go Vikings.

 

[DrM2u]

If established with existing Certification - how dare you - second guess the Auditors who have been before you. They thought the QMS was - effectively compliant - and now you will disagree under the guise of "adding value". or "continuous improvement".

First, one can atempt to explain how the standard has evolved over time and how its scope and intent have changed over time. This can be supported by the organization attending formal courses or presentations on the topic. Second, whenever I came across an out-of-the-box approach to the QMS I tried to make the client aware that another auditor might not understand their system and challenge them on the compliance.

I am curious ! - genuinely - Will you accept full responsibility, accountability and liability if your Client accepts your "advice" and for whatever reason - your "advice" does not have the effect that you assumed it would have?

There is not much to take responsibility for. As an auditor one cannot demand or request that the client applies and follows a process approach (that's a consultant's job). An auditor should only suggest that the organization educates itself about the concepts of system and process. The suggestion can be made based on the effectiveness of the systems, internal audits or simply to better relate the requirements of the standard to the business when the business and the QMS seem to be two separate entities. The only risk is that the organization will spend the money for training and get nothing out of it while following your suggestion. Either way, any contract auditor or consultant should carry professional insurance, just in case.

If its a non-conformance, then have the moral fortitude to explain to your Client why! thereby providing them with the opportunity to officially dispute your finding.

If its a recommendation - explain to your client -in cold hard facts - precisely how their organizational is going to benefit from your recommendation - AND what will be the real consequences if they don't follow it!

An auditor should not write a nonconformance that is not backed by a requirement from the applicable standard or from client's QMS. I wrote findings against ineffective internal audit systems when there were a large number of findings and opportunities in the surveillance audit and none or few (1/2 or less than external audit) in the internal audit. I also wrote findings for internal audits failing to evaluate the effectiveness of processes if the process metrics showed poor results and that was not identified in the internal audits. I didn't and couldn't write findings directly for nto following a process approach to audits because there was no such requirement (unless specified in the procedure).

If you are going to imply that if they don't follow your "advice" then they may pay the price at a subsequent Audit - then shame on you!!! your CB would be politely informed that if they want to keep the Business - they must provide another Auditor!

Indeed, shame on those auditors who threaten their clients, regardless if they are internal, second or third party!!!

 

[DrM2u]

All that is fine, but it's not being asked for in 4.1a; IMO that clause is simple, direct and limited in scope.

Agreed regarding clause 4.1.a; it is simple, direct and limited in scope. On the other hand, how is going clause by clause different that the time-proven ineffective 'element' approach promoted and used pre-ISO 9001:2000?!? Unfortunately life is complicated by things not being black and white (or whatever color combination you prefer). There is a lot of a grey area otehrwise we would not be having these debates. Perfect example: take the Bible. There is only one book called The Bible yet there are many religions that interpret it in their own way. Which is right and which is wrong? The one you subscribe to is right, the others are wrong until convinced otherwise. Why else would I have people knocking at my door trying to convince me that their version is the one to folow?!?

 

[DrM2u]

I agree that "process" is a noun. (Of course, it can also be a verb.) Like "football game" (another noun), it's something that happens. It has a beginning and an ending. Objectives are clearly involved, as is performance measurement. So, a "process" is like a "football game." Go Vikings.

A team is a system. Each game evaluates the system's ability to meet its goals and objectives. The most effective and efficient system will win the Super Bowl. Go Vikings (no other reason but they are from the same division as the pathetic Lions that I hope one day will grow up)!