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Tom Pleasant
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   Posted 14/06/2007 16:46 (GMT +1)    Quote This PostAlert An Admin About This Post.
In June’s QW, Paul Simpson calls third party assessment ‘an industry of attack and defence’ (click here). What do you think? Post your views on this forum and make yourself heard.

Post Edited By Moderator (Steve Coles) : 6/14/2007 5:48:04 PM GMT

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Paul Simpson
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   Posted 19/06/2007 18:55 (GMT +1)    Quote This PostAlert An Admin About This Post.
Well I had thought this article might have ruffled a few feathers and raised a response but it appears:
  • all the CBs are happy with an implied criticism of their employees (and by implication their management)
  • all consultants and systems implementers are happy with a perceived slight on their profession that they have no original thought
  • the status quo is too ingrained to be challenged


Now there are good auditors out there and some good systems - they weren't featured in the article (it is a soapbox, after all! ;-) ).

There is another possible couple of reasons the soapbox has been ignored:
  • Apathy - not a great beacon of hope for our profession.
  • Everyone hopes I'll just go away - can't promise anything! lol


Regards, Paul Simpson
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Steve Coles
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   Posted 20/06/2007 12:32 (GMT +1)    Quote This PostAlert An Admin About This Post.
Paul, I'd really like to take issue with your article and defend the certification industry - but I agree with what you've said. My current contract has moved me away from auditing but, until last September, most of my work since the mid-90's was focused on auditing. Not for 9001 certification, mind you - audits with a focus on client (customer) requirements; these were either laid down by the customer or drawn up by me in consultation with them.

Most companies I audited were 9001 certified but there have been few, when looking at how their management system delivers products or services to their clients, who I would say met the full gamut of 9001 requirements. Most of the companies I visited were well established in their market and respected - whist not meeting 9001, their systems were capable of delivering quality. To me, this illustrates the point that 9001 is not the only way to succeed - it is, after all, a compromise standard. My beef is that, irrespective of how good the system is, it should only be certified to 9001 if it fully meets it. There have been other companies whose systems were not delivering quality yet were certified, too.

When BS5750 was first published it included a statement to the effect that it was a standard for customers to audit their suppliers - the benefit of adoption was going to be the elimination of individual and often conflicting client system standards. Only later was it hijacked by the embryonic certification industry bandwagon. I've long wished that access to 9001 was restricted to certified auditors and system developers/managers were forced to use 9004 - entirely impossible to achieve, but I can still wish it!

Yes, Paul, I've seen companies who have two "quality manuals" - one that tells staff how to manage their work and another rolled out just for auditors; I recall one company where the latter was kept in a locked cupboard to make sure it was never used by mistake. I've seen little change with the switch to 9001:2000 - I've seen manuals which have retained the original 20 sections (aligned with the previous 20 clauses) and have had a few extra sections added to cover additional requirements (customer satisfaction, etc). This isn't a surprise as one only has to look at ISO29001, the specific version for suppliers to the worldwide oil and gas industry, and see that it's added the old clauses back in!

In most cases I've seen, certification is market driven - it's needed to get onto the starting line - companies then succeed in spite of it rather than because of it.


Steve
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Paul Simpson
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   Posted 21/06/2007 17:43 (GMT +1)    Quote This PostAlert An Admin About This Post.
Thanks for your reply, Steve. I’m not sure if your post really addresses the points in the original article where I challenge the attitude (on both sides) to assessment but believe your contribution adds to the thread:
Steve Coles said...
Paul, I'd really like to take issue with your article and defend the certification industry - but I agree with what you've said.
Although the article issues a challenge to the certification industry it does not say anything about the idea of certification – just that there are pockets of poor practice and, in general the process needs to be looked at again.

As an individual (consultant / auditor / certification manager) I and others I know are trying to do the right thing within the system, not trying to break the system down.

As I’m sure many CQI members are

Steve Coles said...
Most companies I audited were 9001 certified but there have been few, when looking at how their management system delivers products or services to their clients, who I would say met the full gamut of 9001 requirements.
This is an interesting point. If the company is ISO certified and they are delivering quality product I cannot think of a substantial part of ISO 9001 they could not be meeting – perhaps you can give us a (confidential) example.

Steve Coles said...
Most of the companies I visited were well established in their market and respected - whist not meeting 9001, their systems were capable of delivering quality.
The reverse of the above. My attitude would be that these well run companies are meeting ISO 9001 – even if they are not certified to it.

Steve Coles said...
To me, this illustrates the point that 9001 is not the only way to succeed - it is, after all, a compromise standard.
Not sure where “compromised” is from? Any “standard” has to be a compromise between what is possible and what is realistic. ISO 9001 is, however, a model that can be stretched to fit the size and technology of the organization.

Steve Coles said...
My beef is that, irrespective of how good the system is, it should only be certified to 9001 if it fully meets it. There have been other companies whose systems were not delivering quality yet were certified, too.
Again, difficult to discuss without examples. “Fully meeting” ISO 9001 is difficult to quantify as every interaction within the organization and with its working environment changes the picture.

It is true that organizations that continually fail to meet customer requirements should not be certified.

Steve Coles said...
When BS5750 was first published it included a statement to the effect that it was a standard for customers to audit their suppliers - the benefit of adoption was going to be the elimination of individual and often conflicting client system standards.
I’ll have to check my 1979 copy. I always remember it as 3 uses. 1 – as a model for your quality system, 2 – for supplier audits and 3 – for certification.

Steve Coles said...
Only later was it hijacked by the embryonic certification industry bandwagon.
Hmmm, I take it you’re not in favour of third party certification, Steve. Not sure what gave me that idea.. lol

My memory was that private industry asked for a means of demonstrating quality conformance in the same way that MOD assessments to AQAP worked for military suppliers.

Steve Coles said...
I've long wished that access to 9001 was restricted to certified auditors and system developers/managers were forced to use 9004 - entirely impossible to achieve, but I can still wish it!
Personally …. Going back to the article I wish auditors had a better knowledge of 9004 and quality principles. Then we wouldn’t get nit picking audit non-conformances which leads to organizations producing tick box systems to avoid the picking of nits.

Steve Coles said...
Yes, Paul, I've seen companies who have two "quality manuals" - one that tells staff how to manage their work and another rolled out just for auditors; I recall one company where the latter was kept in a locked cupboard to make sure it was never used by mistake.
I have heard of multiple manuals but only in addressing two customers (or their SQA engineers) with conflicting requirements

Steve Coles said...
I've seen little change with the switch to 9001:2000 - I've seen manuals which have retained the original 20 sections (aligned with the previous 20 clauses) and have had a few extra sections added to cover additional requirements (customer satisfaction, etc). This isn't a surprise as one only has to look at ISO29001, the specific version for suppliers to the worldwide oil and gas industry, and see that it's added the old clauses back in!
ISO29001 is out of my sphere of expertise, I’m afraid. The layout of the manual, however is totally up to the client.

Aping the clause structure of any standard in “your” system always raises concerns with me, though. It implies to me a lack of thought as to how you want your system to meet your needs. Nobody thinks in ISO clauses (except us saddos ;-) )

Steve Coles said...
In most cases I've seen, certification is market driven - it's needed to get onto the starting line - companies then succeed in spite of it rather than because of it.
Again, not sure of the connect between certification beiong market driven and the success of its users. I believe an effective implementation of good practice will work for anyone – whether it is called ISO 9001, EFQM or any other model.


Regards, Paul Simpson
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Steve Coles
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   Posted 21/06/2007 19:59 (GMT +1)    Quote This PostAlert An Admin About This Post.
To give others a chance of joining in, I'll just respond to one question - an example of a system (ie one that delivers good quality) but doesn't meet ISO9001: one where they don't have a documented or fully implemented audit programme per 8.2.2, or nonconformance records per 8.3 - places where the standard is quite specific. One quite specific case in the early days of transition to 9001:2000 was a company that was awarded its new certificate (by one of the major bodies) with a note that they should work out and document some management objectives before the next routine visit.

I'm quite happy that companies can perform well without full compliance with the standard - it's the fact that a third party declares that they do comply.

Companies should establish systems that deliver what they (and their customers) need - then get it certified; far to many set out with the standard and develop their formal system to meet that.


Steve
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Paul Simpson
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   Posted 21/06/2007 21:54 (GMT +1)    Quote This PostAlert An Admin About This Post.
Thanks, Steve. Fascinating example - was the last visit shortly before the end of the transition period by any chance? I know a lot of the CBs worked up to the deadline (and beyond) to get existing clients through. For what its worth I would hope that examples like these were raised to UKAS for investigation to start to get some rigour into the process.

Anyone fancy a "Name and shame" thread on the forum? ;-)


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Steve Coles
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   Posted 22/06/2007 7:54 (GMT +1)    Quote This PostAlert An Admin About This Post.
Yes, Paul, within the third year, I seem to recall. It wasn't the only case of "liberal thinking" I found - but then, few certification bodies want to lose clients. I was looking into these companies' systems from a privileged position (i.e. having the backing of major customers) and it would not have been ethical to make formal representations to UKAS as that would have adversely affected the companies - even if they should not have been certified to 9001 in my view, it was not for me to influence individual cases. Needless to say, any shortcomings that may have impacted a company's ability to deliver the required products or services were subject to specific comment and recommendations in my reports to my clients (their customers) - and the one in question was left in no doubt that they needed to get some management objectives in place tout suite!

As far as naming and shaming, I suspect that would be a step too far for the CQI lawyers!!!!


Steve
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Tom Pleasant
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   Posted 22/06/2007 12:04 (GMT +1)    Quote This PostAlert An Admin About This Post.
Oh, I don't know...
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Paul Simpson
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   Posted 23/06/2007 0:15 (GMT +1)    Quote This PostAlert An Admin About This Post.
Tom Pleasant said...
Oh, I don't know...


Tom, I realize this may have been said with tongue in cheek. But I do believe that honest reporting is within CQI's remit and would not expose us to criticism / legal action. If CQI really wants to carve out a niche as an independent arbiter on matters of certification then this could be a really useful service.

I have suggested this before to CQI - but us adopting the role of honest broker for our members who have real beefs with assessment / certification / accreditation could add a whole lot of value to members while adding interest / learning to those not directly involved. From my personal opinion, although I fight against it, the process is littered with examples of "smoke and mirrors" auditing and judgement that would benefit from "outing" - short term pain for long term gain!

If CQI is serious I will be happy to help broker something with individual CBs. the ABCB, UKAS to create a forum for open discussion of issues to do with assessment / certification / accreditation. It is a bit of a Pandora's box but - after the pain of a name and shame - the industry will be better for it.

What do members think?

Give Tom some ammunition to go back to the powers that be to bring us a voice.


Regards, Paul Simpson
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Tom Pleasant
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   Posted 25/06/2007 12:38 (GMT +1)    Quote This PostAlert An Admin About This Post.
It was certainly meant partly tongue in cheek but your sentiment is correct: members must have a way to be able to tell exactly what they have experienced so that others can learn from it. Maybe it would even lead to large-scale changes in laws/standards/best practice. etc.

However, finding a way to do this without suffering the risk of libel is problematic. Suggestions are most welcome

Tom
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Paul Simpson
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   Posted 25/06/2007 15:44 (GMT +1)    Quote This PostAlert An Admin About This Post.
Here's how I think it could work ... the CQI invites its registered members to "post" original excerpts (scanned, electronic, pdf) from audit reports with "their" interpretation of the clause of ISO 9001 or the relevant standard(s) the assessor used. Forum members can then comment on how they perceive the nonconformity and what they think.

Many employees of CBs and ABs are also members of CQI - so they (and we) have a direct route in to the directing minds. The originator of the nonconformity or their employer can then comment on why it is a nonconformity (or withdraw it) within the realms of confidentiality (bearing in mind the original text is now in the public domain).

If we are dealing with actual facts then the risk of CQI perpetuating a libel would be minimal. By opening it only to registered members we have a comeback in the event the assessment body queries CQI's "judgement" and effective moderation will quickly spot a contentious issue.

I would welcome the immediacy of this form of feedback about audits (and auditors) I have responsibility for. It is easy to get too far away from what is happening, thinking everything is going well. Only to reel back in horror at the standard of your own organisation's nonconformity and audit reporting when a customer reaches the end of their tether and complains.


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Tom Pleasant
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   Posted 25/06/2007 15:57 (GMT +1)    Quote This PostAlert An Admin About This Post.
It certainly a good idea however any reproduction of audit reports will definitely run the risk of infringing intellectual property rights or, considering the subject matter, rile up the organisations concerned (I'm aware that there would be no mention of the org's name but it's amazing how these things slip out or an org decides it's them being discussed when it isn't).

I'll be forwarding these thoughts onto those with more legal knowledge but further discussion and suggestions are still welcome.
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Paul Simpson
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   Posted 25/06/2007 16:14 (GMT +1)    Quote This PostAlert An Admin About This Post.
Hi, Tom. Trust me there is nothing "intellectual", let alone IP about some of the duff nonconformity reporting I am talking about. I am presuming CQI members will only be reporting with an "Agony Uncle" type question about audits of their own organisation. This could be established in the rules.

When I do audits part of the standard patter at opening and closing meetings is for the auditor to say something about the confidentiality of the audit process with a proviso that the accreditation body may have an oversight of the reports. I look forward to the day when the auditee responds with: "But bear in mind we reserve the right to publish your findings on the CQI forum." lol


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Steve Coles
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   Posted 25/06/2007 20:04 (GMT +1)    Quote This PostAlert An Admin About This Post.
If answers are rewritten by the poster and no names are mentioned, this might be feasible, but your initial inclusion of "scanned, electronic, pdf" could easily lead to copyright issues; remember, under strict copyright law, you couldn't include the audit report form (especially if it included their logo) - text only, retypred by the posting member would be safest.

However, for the majority of submissions, I suspect the cases will be on "unjust nonconformances" and we'll likely have only one side of the case (the auditee's) - we won't know what was actually presented during the audit. I can't believe that many people will write in to say they should not have been awarded their certificate. Allowing comments on suppliers will be very difficult to cover as the necessary evidence is unlikely to be available. We will probably end up with open ended discussions. Have a look at the IRCA forum as they look for these sort of discussions.

On the basis of the above, there's nothing to stop anyone starting threads on the General forum here. (As far as member-only access is concerned, that will need to wait until we have a system that allows such restriction - we could set something up on this forum but the administrative burden of managing access to the numbers of members to make it worthwhile is probably beyond current resources.)

It's a good idea but one that will need a lot of consideration if we want to do something that has impact. Tom has said he'll pass this back for full consideration - any decision will probably end up with the PPB (either the full board or its editorial committee), so I'll probably see it on its travels...


Steve
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David Hoyle
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   Posted 02/07/2007 12:09 (GMT +1)    Quote This PostAlert An Admin About This Post.
Interesting thread. It reminds me of the BNFL scandal over the falsification of Quality Control records. If I remember correctly, the third party auditors at the time were LRQA and they wrote in Quality World something to the effect that checking for fraudulent QC Records was outside the scope of certification. This shows how misguided the certification industry is but they got away with it. To my knowledge they were not challenged by UKAS probably because there is no requirement in ISO 9001 addressing culture directly. However, an effective auditor would use the requirement for managing the work environment to test for evidence of a culture that supported or was in conflict with the implementation of the stated quality policy.
The BNFL case was widely resported in the press and it is not beyond our capability to highlight these sort of cases and link them with failures of the management system and certification. I admit we would not be dealing with the cases that don't reach the media but those that do are fair game. Trading Standards web site have lots of cases which with a bit of research could reveal that many of these are ISO 9000 registered companies.
I think we would be breaching confidentiality to make public that which is a private matter between the company and the CB unless it got into the media through wistleblowers anonymous.
Regarding your article in QW Paul, I would agree wholehartedly with your observations. The whole industry has lost its way. If you go back and look at ISO 9000:1987 you will find that the series was billed as embodying a rationalization of the many and various national approaches to achieving and sustaining good economic performance through continual improvement in the customer specification and the organizational system to design and produce the product or service to satisfy the user’s needs or requirements”.
A requirement to demonstrate a connection between the management system and business results was omitted from ISO 9001 thus making it easy for firms to get the badge.
Steve is right too about ISO 9004. Again in ISO 9000:1987 it clearly advocated that after considering the concepts in ISO 9000, ISO 9004 be used to develop and implement a quality system and should certification be required only then to select the appropriate “quality assurance” standard. But of course very few people read ISO 9000 or ISO 9004. They only read what they were examined on - ISO 9001. So the certification industry and the consuiltants and trainers are the culprits not the standard.
But does any CEO really care? ISO 9000 is synonymous with certification and this ihas become a joke and nothing to do with business and economic performance. It is all about vested interests and regretably once a firm has the badge, it may find it difficult to withdraw without sending the wrong signals to its customers - so they maintain the charade.
I put the root cause with TC 176. They could have forseen the impact and if they had adopted the tried and tested practice from the military thay would have put the system design requirements together with the system verification requirements in one specification and prevented the auditors deviating from the true intent of the standard.
If you have read the proposed 2008 revision to ISO 9001 you will see that  TC 176 is in complete denial about culture as they plan to exclude psycological factors from the Work Environment  thus refusing to accept that the achievement of product quality depends upon culture. They even ignore the definition of Work Environment in ISO 9000:2000 (If anyone has the 2005 version can you please check if this has changed?) Here is what it says
Note: The term work environment relates to conditions necessary to achieve conformity to product requirements such as clean rooms, anti-static precautions and hygiene controls
Incidentally, ISO have been ask me to write an article in their Magazine on the impact of ISO 9000 as it's the 20th anniversary. Suffice it to say that unlike the CBs and Standard Bodies  I don't have any vested interest to mainitain.


Best Regards
David Hoyle Hon.FCQI

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Paul Simpson
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   Posted 04/07/2007 10:36 (GMT +1)    Quote This PostAlert An Admin About This Post.
David Hoyle said...
It reminds me of the BNFL scandal over the falsification of Quality Control records.
For those viewers (readers?) of the forum who are not familiar with the example there are a couple of web links here and here.
David Hoyle said...
If I remember correctly, the third party auditors at the time were LRQA and they wrote in Quality World something to the effect that checking for fraudulent QC Records was outside the scope of certification. This shows how misguided the certification industry is but they got away with it. To my knowledge they were not challenged by UKAS probably because there is no requirement in ISO 9001 addressing culture directly. However, an effective auditor would use the requirement for managing the work environment to test for evidence of a culture that supported or was in conflict with the implementation of the stated quality policy.
I don’t remember the LRQA response being quite like that, David. From memory they make a (valid) point that 3rd party assessment and certification cannot guarantee to uncover fraud when it is as isolated as the HSE report (2nd link above) identified.

David Hoyle said...
The BNFL case was widely resported in the press and it is not beyond our capability to highlight these sort of cases and link them with failures of the management system and certification. I admit we would not be dealing with the cases that don't reach the media but those that do are fair game. Trading Standards web site have lots of cases which with a bit of research could reveal that many of these are ISO 9000 registered companies.
Agreed. Examples in the public domain should be debated.

The CQI should have an opinion.

My vision is that Trading Standards / news media should be coming to us for our opinion.

Perhaps this forum is the vehicle – albeit the lack of a uniform view (that we see evidence of in these threads) is a serious concern.

David Hoyle said...
I think we would be breaching confidentiality to make public that which is a private matter between the company and the CB unless it got into the media through wistleblowers anonymous.
Agreed. So we only publish information in the public domain. Put there by a customer of the CB / AB.

David Hoyle said...
Regarding your article in QW Paul, I would agree wholehartedly with your observations. The whole industry has lost its way.
Not quite what I said. I am in the industry you believe I am attacking across the piece, hardly sensible on my part if it were true, but the article is a direct challenge to others involved to try to move things forward.

There are pockets of consistency and even excellence in our industry but, from my experience, mediocrity and even downright silliness is starting to get the upper hand.

If CQI stands for anything then it should be seen to be challenging this. Not just by giving a platform to the “anti ISO” brigade but by providing a balanced view and attacking inadequacy, wherever it comes from.

David Hoyle said...
A requirement to demonstrate a connection between the management system and business results was omitted from ISO 9001 thus making it easy for firms to get the badge.
Now my article was suggesting that because ISO 9001 is now more focussed on business objectives and measures that it could even have been “rebadged.” This doesn’t match with your comments at all.

However,I believe the audit process is still too compliance focussed and perhaps some auditors are unable to deal with standing in the spotlight areas of “the business,” preferring the dark corners of document control and calibration.

David Hoyle said...
But of course very few people read ISO 9000 or ISO 9004. They only read what they were examined on - ISO 9001. So the certification industry and the consuiltants and trainers are the culprits not the standard.
Not blowing my trumpet (or even yours, David). CQI members like us are working in certification bodies, acting as consultants and providing training (sometimes all three ;-) ). So are we all culprits?

CQI is trying with the Body of Quality Knowledge to ensure that members at least have access to the founding principles of quality and how it fits into business and strategy.

All we now have to define is competence criteria that exclude those that do not understand while ensuring that those members that do buy in to the quality “thing” can become (for example) Chartered Quality Professionals. Maybe that is the route to getting some consistency?

I do agree with you that the standard is not the problem. There are, however, some CQI members who disagree even with this and their argument is given credence whenever stories go around of poor systems, duff non-conformities and dodgy auditing.

This is manna from heaven if you are selling another message.

David Hoyle said...
But does any CEO really care? ISO 9000 is synonymous with certification and this ihas become a joke and nothing to do with business and economic performance. It is all about vested interests and regretably once a firm has the badge, it may find it difficult to withdraw without sending the wrong signals to its customers - so they maintain the charade.
Again I can’t agree with this generalization. The implication that all ISO 9001 certified companies are sad fools is unhelpful. It is true it takes a brave CEO to stand up and say “We don’t deserve our certificate because our systems are poor” – perhaps they should.

CBs like mine are all clamouring for the discerning customer. The organization that understands the value of assessment as well as certification.

David Hoyle said...
I put the root cause with TC 176. They could have forseen the impact and if they had adopted the tried and tested practice from the military thay would have put the system design requirements together with the system verification requirements in one specification and prevented the auditors deviating from the true intent of the standard.
Too much to place on the shoulders of a small group.
  • CBs have a responsibility for services they offer.
  • Accreditation bodies for maintaining a level playing field and ensuring standards are maintained.
  • Certified organizations for ensuring they understand the eight principles and developing systems that suit their needs and (secondary) meet standard requirements.

I have left consultants and trainers off the list because they will be driven by the market. If, as has been implied, customers and CBs only want certificates then that is what support organisations will provide. If, in the brave new world, customers want "real" systems and CBs are only prepared to certify same then consultants and trainers will adapt or leave.

David Hoyle said...
If you have read the proposed 2008 revision to ISO 9001 you will see that TC 176 is in complete denial about culture as they plan to exclude psycological factors from the Work Environment thus refusing to accept that the achievement of product quality depends upon culture.
I haven’t heard this rumour – is there a source we can check?
David Hoyle said...
They even ignore the definition of Work Environment in ISO 9000:2000 (If anyone has the 2005 version can you please check if this has changed?) Here is what it says
Note: The term work environment relates to conditions necessary to achieve conformity to product requirements such as clean rooms, anti-static precautions and hygiene controls
Changed to: work environment – set of conditions under which work is performed

Note: Conditions include physical, social, psychological, and environmental factors (such as temperature,recognition schemes, ergonomics and atmospheric composition)

The big caveat in terms of saying this gives free rein to auditors to cover “culture” is that 9001 says:
“The organization shall determine and manage the work environment needed to achieve conformity to product requirements.”

So if products are OK then work environment is, de facto, OK.

David Hoyle said...
Incidentally, ISO have been ask me to write an article in their Magazine on the impact of ISO 9000 as it's the 20th anniversary. Suffice it to say that unlike the CBs and Standard Bodies I don't have any vested interest to mainitain.
While I agree you don’t belong to the groups mentioned, that doesn’t mean you don’t have any vested interests, we all have our opinions and messages we are trying to convey, "vested interests" in my book.

I look forward to reading the article – perhaps you can post it here?

I will however not view it as being the work of a totally impartial observer – I have read your posts on this forum, after all! lol


Regards, Paul Simpson
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   Posted 04/07/2007 18:53 (GMT +1)    Quote This PostAlert An Admin About This Post.
Glad to see a positive comment on 3rd party certification in the letters page of Quality World. Perhaps we can see how it works for this organization?


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David Hoyle
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   Posted 06/07/2007 19:44 (GMT +1)    Quote This PostAlert An Admin About This Post.
Paul
Many thanks for your comments. I followed the links you provided and found this:
Without effective awareness training or briefing to the process workers carrying out these fuel pellet diameter measurement tasks, such individuals are unlikely to appreciate the importance of the task or take ownership of it. This was another example of management failure within MDF
ISO 9001:1994 applied at the time not the 2000 version as I had implied but even so clause 4.18 required "Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required" Clearly the staff were not educated sufficiently to know that what they were supposed to do was important. I accept the 3rd party auditor cannot be expected to find every fault but if he had only asked one question it should have been. When was the last occasion you reviewed the inspection methods and what changes were made as a result?
For LRQA to say that at 'there was no evidence of a failure of the 'Quality Management System' begs the question "What does LRQA think a QMS is supposed to do? According ISO 9001:1994 it is supposed to ensure that product meets specified requirements and it didn't as data for 31 lots were falsified and the customer was dissatisfied.
Anyway its history now but if audits don't detect such deficiencies we have to ask if they are of any value . The financial sector has gone through a major change because financial audit results could not be trusted (e.g. Sarbanes Oxley ) There is a movement on the horizon that might see quality system audits subsumed into Business Performanec Audits with the 3rd Party QMS Audits becoming defucnt,
On the question of your Soapbox Article, I concluded from it and my own observations that the industry has lost its way. I didn't intent to imply you said that but a little self criticism is good for the soul! 
Regarding my comment addressing the omission of a requirement for demonstrating connectivity between business results and the QMS, I was attempting to draw your attention to the oringinal intent of the standards of defining an approach for achieving and sustaining economic performance. If the approach adopted is working, there will be a link between the QMS, the business results and customer satisfaction. Therefore a requirement to demonstrate this would be a wake up call for both managers and auditors.
I do agree with Paul that auditors are often too compliance focused but compliance audits do not have to be performed against ISO 9001 clause by clause. Auditors can
  1. Ask to look at business objectives, then
  2. Ask to look at business results, then
  3. Ask for a description of the processes that achieved these results, then
  4. Look for evidence that these processes are being managed effectively, then if not already detected,
  5. Ask for evidence that action has been taken where results are not as planned, then and only then
  6. Verify from the evidence gathered that the requirements of ISO 9001 have been met.
This is a process approach to auditing for compliance - would this work do you think?
Regarding ISO CD 9001:2008 I saw it through the SDG but you should be able to get hold of copies from BSI.
It is interesting that the defintion of Work Environment has not changed and still includs the pyscological factors. Therefore TC 176 are saying the these are not assessed elements of a QMS which I find rather odd.
The logic of, if product quality is ok the work environment is ok is flawed in the same that we haven't got any customer complaints therefore the customer must be satisfied was flawed. 
 


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David Hoyle Hon.FCQI

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   Posted 10/07/2007 16:36 (GMT +1)    Quote This PostAlert An Admin About This Post.
David Hoyle said...
There is a movement on the horizon that might see quality system audits subsumed into Business Performanec Audits with the 3rd Party QMS Audits becoming defucnt,
Interesting idea. Just who would do these audits? As has been mentioned in other places, as well as on this forum, 3rd party certification is now a large industry (if still immature). I can’t see any other industries apart from maybe the financial auditors having the infrastructure to take on the number of existing certificates worldwide.

Anyone fancy your financial auditors being responsible for your certification?

David Hoyle said...

On the question of your Soapbox Article, I concluded from it and my own observations that the industry has lost its way. I didn't intent to imply you said that but a little self criticism is good for the soul!
Thanks for that, I am happy to take on board any critical comments in the spirit they are intended and, David, you have always been fair.

My purpose in having a soapbox "rant" was to try to help the industry to find its way a little better.

To moderate and misquote LB Johnson - I still want to be inside the tent peeing out rather than outside peeing in!

David Hoyle said...

Regarding my comment addressing the omission of a requirement for demonstrating connectivity between business results and the QMS, I was attempting to draw your attention to the oringinal intent of the standards of defining an approach for achieving and sustaining economic performance. If the approach adopted is working, there will be a link between the QMS, the business results and customer satisfaction. Therefore a requirement to demonstrate this would be a wake up call for both managers and auditors.

Below is a quote sent through from BSI in response to a request for the origins of BS 5750.
BSI said...


The reason given for the conversion of BS 5179 into the BS 5750 series is "the growing demand for the application of quality assurance principles to contracts and for the assessment of suppliers' quality management systems, has led to the publication of a number of quality assurance standards by various purchasing and third party organizations.
This proliferation has highlighted the need for a British Standard that will encourage the rationalization envisaged in Sir Frederick Warner's report on 'Standards and specifications in the engineering industries', published by the National Economic Office (NEDO), February 1977.

So my reading is that the national standard was developed to reduce proliferation of industry standards for quality systems and for this to be included in contracts. So more of a compliance focus from a customer point of view.

Yes, the end result should still have been for improved quality and hence reduced costs / improved profits.

There is a need for a wake up call – as I mentioned identikit systems do nobody any favours and a “tick box” mentality to quality is no quality at all.

David Hoyle said...

I do agree with Paul that auditors are often too compliance focused but compliance audits do not have to be performed against ISO 9001 clause by clause. Auditors can

1. Ask to look at business objectives, then
2. Ask to look at business results, then
3. Ask for a description of the processes that achieved these results, then
4. Look for evidence that these processes are being managed effectively, then if not already detected,
5. Ask for evidence that action has been taken where results are not as planned, then and only then
6. Verify from the evidence gathered that the requirements of ISO 9001 have been met.

This is a process approach to auditing for compliance - would this work do you think?
With the proviso that “quality” should be in the assessment mix (not solely business objectives / measures) then this type of approach should (and does) work – all we need now is more of it. lol


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   Posted 10/07/2007 18:21 (GMT +1)    Quote This PostAlert An Admin About This Post.
Paul,

Glad you got that quote from BSI as it confirms my own recollection of the situation - I moved from a technical/engineering job in aerospace to quality engineering/management in the oil and gas industry in 1979 was trying to get myself up to speed with what was happening. I well recall the problems suppliers had when each customer audited against different (and, sometimes, contradicting) in-house standards; BS5750 was to be a common standard for all to adopt. And I think, based as it was on the well used DEF-STAN-05 series, it did a good job; the problems started (in my view) when it was used by third parties with no involvement with the customers - it then changed from an assessment standard looking at product or service delivery to one looking at the management systems.


Steve
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   Posted 10/07/2007 19:52 (GMT +1)    Quote This PostAlert An Admin About This Post.
Yes indeed BS 5750 did come from BS 5179 which came from BS 4891 which came from AQAP 1 and 2. If we go back to AQAP 1 we find this:
"It is essential that products and services be designed, manufactured and provided so as to conform to the purchasers requirements and this be effected as economically as practicable. The quality of products and services depends upon the contractor’s control of design, manufacture and other operations that affect quality"
 
The concept of economy was conveyed through these British Sstandards to ISO 9001:1987 but was not made an assessed element of a quality system. The notion that there were operations that affect quality other than design andufacture was crutial and indicative that perhaps the creation of a quality culture might be one of them. However, again this was not an assessed element in ISo 9001.
 
Yes BS 5750:1979 did arise out of Sir Fred Warner's report (it says so in the Introduction of the copy I have) but the quote I gave was from ISO 9001:1987 thus indicating that there was an economic motive but I would like to think it was more than reducing proliferation of standards - you could well be right though. We shall see because I made this the thrustof my article to ISO. However, I don't think anyone is going to claim that ISO 9000 was only ever intended to reduce the proliferation of standards and not really improve economic performance - will they?
 
Steve -there would have been no problem if the third party auditors had perceived the product or service as an output from the management system but they seemed (and continue to this day ) to see it as a set of documents.
 


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David Hoyle Hon.FCQI

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