Process Approach: Types & number of processes required?

[MVladimir]

Dear John, Sidney and colleagues, thanks a lot for well-advised replies!
I completely agree that lack of clear guidance from ISO TC 176 on process approach eventually resulted in the failure of understanding what a QMS should be!!
There are very good comments from Sidney regarding minimalistic approach in AS9100C process identification, because CB auditors are required to perform PEAR forms. I share this concern as aerospace auditor.
And good advice to "forget" the term QMS processes for a while and keep in mind the organization's BUSINESS PROCESSES.

Vladimir

 

[John Broomfield]

Dear John, Sidney and colleagues, thanks a lot for well-advised replies!
I completely agree that lack of clear guidance from ISO TC 176 on process approach eventually resulted in the failure of understanding what a QMS should be!!
There are very good comments from Sidney regarding minimalistic approach in AS9100C process identification, because CB auditors are required to perform PEAR forms. I share this concern as aerospace auditor.
And good advice to "forget" the term QMS processes for a while and keep in mind the organization's BUSINESS PROCESSES.

Vladimir

Vladimir,

As I see it standards do not lead, they follow.

I'm not sure why standards-makers owe us a duty to explain process management. All they did in the year 2000 is fully recognize the importance of the process-based management systems already widely accepted as good practice since the early 1980's (if not before).

As a management profession, we should have been up to date enough to understand the process approach.

Indeed, the first edition of ISO 9001 (clause 4.2.3) had already specified the importance of processes to quality planning in 1987 when industry was still heavily siloed behind the walls of isolated departments.

ISO 9001 followed the adopters of teachers like Deming, Porter, Champy and Hammer.

Instead of relying on TC176 guidance (and the books of the standards-makers explaining their standards) we have to educate ourselves on what they are copying from others. I do not think it is reasonable to blame TC176 for the failure of the quality profession, system auditors and the developers of management systems to study BPM.

John

 

[MVladimir]

John, I understand.
My opinion related this topic is the following:

1. In accordance with EU standardization system principles Standard generally is voluntary document. But if the Organization decide to use (implement) any standard in BMS (QMS), standard becomes MANDATORY document for organization. Hope the US approach is the same.

2. Relating the product, the main goal of standardization is to ensure the similar characteristics of product, manufactured by different organizations. If I buy one and the same product in different countries, manufactured by different companies in accordance with the identical standard, I hope to find the identical product performances (characteristics). Otherwise - no sense in standardization activities.

3. The standardization of Management Systems (QMS, EMS, OHSAS etc.) is more complex in comparison with product standardization. It may be no accident that a lot of clarification Guides (QMS auditing topics) have been issued during last years by ISO 9001 Auditing Practices Group (more than 20) regarding the various ISO 9001 requirements. One of them is “Understanding the process approach” - very short and not clear. Obviously, it is impossible to ensure the total unification of implementation of each ISO 9001 requirement for different organization. In terms of ISO – it is up to organization… But it is possibly (and from my point of view - absolutely necessary) to provide the identical understanding regarding the approach for implementation of various requirements. Otherwise a lot of discussion (in some instances - conflicts) will happen between auditors and auditee, organization staff and consultants and so on by reason of misunderstanding and misinterpreting of requirement. As the result – no add value for organization and a lot of problems with certification. It happen every day. Everybody involved in QMS activity have to have identical understanding of principal approaches. It is the direct responsibility of ISO TC 176 and IAF.

Vladimir

 

[John Broomfield]

John, I understand.
My opinion related this topic is:
1. In accordance with EU standardization system principle Standard generally is voluntary document. But if the Organization decide to use (implement) any standard in BMS (QMS), standard becomes MANDATORY document for organization. Hope the US approach is the same.
2. Relating the product, the main goal of standardization is to ensure the similar characteristics of product, manufactured by different organizations. If I buy one and the same product in different countries, manufactured by different companies in accordance with the identical standard, I hope to find the identical product performances (characteristics). Otherwise - no sense in standardization activities.
3. The standardization of Management Systems (QMS, EMS, OHSAS etc.) is more complex in comparison with product standardization. It may be no accident that a lot of clarification Guides (QMS auditing topics) have been issued by APG (more than 20) regarding the various ISO 9001 requirements. One of them is “Understanding the process approach”. Obviously, it is impossible to ensure the total unification of implementation of each ISO 9001 requirement for different organization. In terms of ISO – it is up to organization… But it is possibly and from my point of view - absolutely necessary to provide the identical understanding regarding the approach for implementation of various requirements. Otherwise a lot of discussion will happen between auditors and auditee, organization staff and consultants and so on by reason of misunderstanding and misinterpreting of requirement. As the result – no add value for organization and a lot of problems with certification. Recently it happen every day. Everybody involved in QMS activity have to have identical understanding of principal approaches. It is the direct responsibility of ISO TC 176 and IAF.

Vladimir

Vladimir,

Standard products do not need standard realization processes; even less standard management systems.

Our voluntary adoption of management system standards encourages innovation and creativity in making bespoke and standard products from capable processes supported by a wide variety of organizations.

We learn from each other instead of blindly complying with a centralized control or methodology.

In my opinion, these are some of the reasons why people demand non-prescriptive system standards and non-prescriptive guidance (if there can be prescriptive guidance).

John

 

[MVladimir]

John,
Innovations are always ahead of standardization. For developed countries ISO9001 is already "obsolete" as against developing countries. You are correct - related the innovations people demand non-prescriptive system standards and non-prescriptive guidance.

Vladimir

 

[Sidney Vianna]

As I see it standards do not lead, they follow.

I'm not sure why standards-makers owe us a duty to explain process management.

John, ISO 9001, ISO's best selling standard of all times, is, for many organizations around the world, their first model towards a (somewhat) formalized management system.

So, while ISO 9001 is a BASIC set of requirements, with non-sophisticated concepts and requirements, for practical purposes, it is an advanced document for organizations that are in the very early steps of their quality journey.

Further, according to ISO TC176 SC 2, their own mission statement includes the need to provide guidance and support, when needed, to ensure continued credibility of their products (ISO 9001 and 9004).

As you know, they do provide guidance via a number of documents, available via the ISO website.

Support for implementing ISO 9001:2008

ISO 9001:2008 is published by ISO technical committee (TC) ISO/TC 176, sub-committee 2. When the standard was revised and updated in 2008 the TC prepared some guidance documents to help organizations and companies implement the revised version of the standard.

Guidance on some of the frequently used words found in the ISO 9000 family of standards - Download pdf
Guidance on the concept and use of the process approach for management systems - Download pdf
Implementation guidance for ISO 9001:2008 - Download pdf
Guidance on ISO 9001:2008 - Sub-clause 1.2 Application' - Download pdf
Guidance on the documentation requirements of ISO 9001:2008 - Download pdf
Guidance on 'Outsourced processes' - Download pdf

So, they DO ATTEMPT to educate the masses on the concepts around quality management and/or ISO 9001. The problem is: the quality of the guidance documents is poor, in my opinion. They are so concerned to make authoritative statements that they always end up with a document that, while, technically correct, it is of very little practical application.

If you look at the Guidance on Process Approach, they never attempt to explain it via business processes, siloing even more the QMS. To me, that is the BIGGEST failure of the TC 176 (not only SC2): failure to explain the context of a QMS within the business world. Unfortunately, they are apparently incapable of framing the QMS and how it is supposed to fit within the business and the business processes.

 

[John Broomfield]

Sidney,

Their failure to guide according to commonly agreed principles may come from the fact that quality management is polarised into at least two camps (and several in between):

1. Little-q where quality is about product quality only, and
2. Big-Q where quality is everything the organization does.

The little-q thinkers may have won because Big-Q thinkers would eventually have ISO 9001 address by-products instead of ISO 14001 and the quality of health and safety instead of 18001, etc...

Consequently, quality is marginalized as a sideshow (along with the other subsystem standards) instead being mainstream or the only stream.

Big-Q thinkers had to settle for ISO Guide 83 which eventually may end up with the much needed guidance on the commonly agreed principles of business process management to deliver quality, safety, security and sustainability.

But some/many organizations may still fail to understand and realize the power of process management as their leaders remain incapable or unwilling to allocate resources to processes instead of departments.

John

 

[Sidney Vianna]

I still think that if you are going through the trouble of issuing guidance documents, make it worthwhile and CONCLUSIVE.

If the TC 176 is dominated by small q thinkers, then, they don't deserve to be where they are. On the other hand, if BIG Q supporters comprise the majority of the committee, they are not doing a good job of delivering on their mission statement.

As for Guide 83, it has been obsoleted and replaced by the HLS in the ISO Directive 1, which has been recently revised, by the way.

Or do you mean ISO Guide 82, instead?

 

[John Broomfield]

Sidney,

Yes, I was referring to ISO Guide 83. That was its designation when I reviewed it before it morphed to became the HLS.

I'm not sure if those responsible for maintaining and supporting the HLS are now planning to publish guidance on the commonly agreed principles of business process management to deliver quality, safety, security and sustainability.

John

 

[MVladimir]

The problem is: the quality of the guidance documents is poor, in my opinion. They are so concerned to make authoritative statements that they always end up with a document that, while, technically correct, it is of very little practical application.

If you look at the Guidance on Process Approach, they never attempt to explain it via business processes, siloing even more the QMS. To me, that is the BIGGEST failure of the TC 176 (not only SC2): failure to explain the context of a QMS within the business world. Unfortunately, they are apparently incapable of framing the QMS and how it is supposed to fit within the business and the business processes.

Sidney,
I completely agree with you.

Excellent conception of ISO9001 is not supported by the comprehensive quality guidances, issued by ISO TC 176 and IAF (APG). It's a big problem so far in particular for organization implemented QMS in conformance with ISO9001 for the first time!

Vladimir