Why do so many ISO 9001 Implementation Programs Fail?

[Stijloor]

Re: Why do many ISO 9001 implementation programs fail?

The question really is 'Why do many <insert name of quality initiative here> implementation programs fail?'

In truth, you can add in SPC, Quality Circles, Lean, Six Sigma, et al...

ISO 9001 has an additional component of a CB verifying implementation, but in all honesty the reasons are just as applicable to any significant undertaking such as these...

Bottom line: Programs and tools do not fail; users do.

Stijloor.

 

[John Broomfield]

Re: Why do many ISO 9001 implementation programs fail?

Big Q thinking tells me that everything the organization does should be for quality. Organizations thinking this way leads to highly successful holistic system development projects. Some organizations, though, are stuck in little-q thinking, perhaps kept in that state of mind by their dying QA department.

Since 1986 here are four reasons I have seen for organizations failing to obtain the full benefits of ISO 9001:

• The leaders are not willing volunteers in developing their system.
• The leaders ignore the system that actually is their organization.
• The leaders delegate implemention of procedures written around ISO 9001 instead.
• The quality professionals do not include the financial processes in the management system.

The key to developing a process-based management system is to go with the grain. It is more a voyage of discovery than implementing a standard:

1. Discover what the organization already does to determine customer requirements (and get paid for meeting them).
2. Discover what the organization already does to fulfill these and other requirements.
3. Discover the processes in the management system (and determine any new ones needed by the management system).
4. Discover what is done in each process to prevent nonconformity instead how nonconformity is detected.

Telling someone who is about to retire or any individual to implement ISO 9001 is not a good idea. The system development project needs a cross-functional team that is able to analyze its system, determine its key processes and analyze those key processes.

Just a few of the management system's processes need to be newly designed complete with training of the process team.

Respect the system that is the organization otherwise the program will fail. One way to do this is to use the "as-is rule". Document the process lightly as it is not as you would like it to be. Then, by using and improving the management system it will cause any needed improvements and grow the detail where needed.

What if the process is so bad it does no conform to the standard? Well then, use the two-week rule: "you have a fortnight to correct the process then we will document it".

In summary:

• Leaders not showing their commitment to requirements is a mistake.
• Putting the documented procedure ahead of the process is a mistake.
• Ignoring the system that is the organization is a mistake.
• Making people slaves to the system is a mistake.

The system should help people to determine and meet requirements including the requirement for continual improvment. The procedures should be owned by the people not the "we know best department". That way QA is delivered as a result of everyone using their management system to fulfill requirements.

John

 

[Pancho]

Re: Why do many ISO 9001 implementation programs fail?

...:

• The leaders are not willing volunteers in developing their system.
• The leaders ignore the system that actually is their organization.
• The leaders delegate implemention of procedures written around ISO 9001 instead.
• The quality professionals do not include the financial processes in the management system.

The key to developing a process-based management system is to go with the grain. ...

Respect the system that is the organization otherwise the program will fail. One way to do this is to use the "as-is rule". Document the process lightly as it is not as you would like it to be. Then, by using and improving the management system it will cause any needed improvements and grow the detail where needed.

...
The system should help people to determine and meet requirements including the requirement for continual improvment. The procedures should be owned by the people not the "we know best department". That way QA is delivered as a result of everyone using their management system to fulfill requirements.

Great post, John. Couldn't agree more.

Now, pursuing the next "why"...

Why are leaders failing to participate in the development of the system? Lets remember that "human error" is not usually an acceptable root cause. Particularly for something as prevalent as this failure.

Could it be that ISO 9001 lacks guidance in one of the most basic requirements of a functioning system? I suspect so... in particular for document control. Setting up basic document control is one of the first tasks to do in a ISO 9001 implementation project. But a paper based system is terribly cumbersome to maintain as soon as the number of documents gets beyond a dozen. Even a computer system based on office software and a hierarchical folder structure is a nightmare after a few dozen documents.

Maybe here is where ISO 9001 loses many leaders' interest. If the CEO perceives that his time investment in participating (producing, approving, controlling or making documents available) is not as valuable as the time dedicated to his other tasks, then he will "delegate" (abdicate) the whole implementation. The tradeoff is a no-brainer with an ineffective documentation system. And ISO 9001 has lost a leader.

Most of the questions I see here at the Cove about document control are precisely about ineffective office-based systems, but these questions are seldom posed by leaders of companies. By the time these questions come up, the platform has been decided, and the leader has delegated the whole ISO 9001 implementation.

There are, of course, many alternatives that are miles ahead of paper or office systems, such as custom software or wikis. I think that a consultant that does not strongly point out these alternatives at the outset is doing a disservice to his clients and is risking another zombie-registration.

Pancho

 

[AndyN]

Re: Why do many ISO 9001 implementation programs fail?

Pancho - part of the (complex) problem with ISO is that it has the word Quality on the cover...and how many executives actually can differentiate between the quality function 'who take care of such things' and quality as it applies to running the business. As a topic, quality isn't in most MBAs etc. So how does anyone bridge that gulf in understanding...

 

[John Broomfield]

Re: Why do many ISO 9001 implementation programs fail?

Great post, John. Couldn't agree more.

Now, pursuing the next "why"...

Why are leaders failing to participate in the development of the system? Lets remember that "human error" is not usually an acceptable root cause. Particularly for something as prevalent as this failure.

Could it be that ISO 9001 lacks guidance in one of the most basic requirements of a functioning system? I suspect so... in particular for document control. Setting up basic document control is one of the first tasks to do in a ISO 9001 implementation project. But a paper based system is terribly cumbersome to maintain as soon as the number of documents gets beyond a dozen. Even a computer system based on office software and a hierarchical folder structure is a nightmare after a few dozen documents.

Maybe here is where ISO 9001 loses many leaders' interest. If the CEO perceives that his time investment in participating (producing, approving, controlling or making documents available) is not as valuable as the time dedicated to his other tasks, then he will "delegate" (abdicate) the whole implementation. The tradeoff is a no-brainer with an ineffective documentation system. And ISO 9001 has lost a leader.

Most of the questions I see here at the Cove about document control are precisely about ineffective office-based systems, but these questions are seldom posed by leaders of companies. By the time these questions come up, the platform has been decided, and the leader has delegated the whole ISO 9001 implementation.

There are, of course, many alternatives that are miles ahead of paper or office systems, such as custom software or wikis. I think that a consultant that does not strongly point out these alternatives at the outset is doing a disservice to his clients and is risking another zombie-registration.

Pancho

Pancho,

Many thanks.

Yes, the management system is becoming more and more part of the computer network or infrastucture.

ISO could lead the way with wiki-based management systems by enabling the global community of users of the ISO 9000 family to maintain their standards as a collective rather like Wikipedia.

But, we both realize that the management system is much more than its documents and we must continue to help people not to forget that.

The biggest reason for leaders not getting involved is that they often do not see a system development project with the charter for the resulting management system to "add value faster and prevent loss sooner while assuring quality". I must admit that I would rather get that message across before explaining the wonders of information management!

Best regards,

John

 

[Jim Wynne]

Re: Why do many ISO 9001 implementation programs fail?

Pancho - part of the (complex) problem with ISO is that it has the word Quality on the cover...and how many executives actually can differentiate between the quality function 'who take care of such things' and quality as it applies to running the business. As a topic, quality isn't in most MBAs etc. So how does anyone bridge that gulf in understanding...

I think a lot of the general failure of leadership in American business can be tied to the Dunning-Kruger effect a concept that says that (a) incompetent people are likely to have greater confidence in their own competence than people who are competent and (b) people who are competent tend to go in the opposite direction, doubting their own competence.

Combined with the Peter Principle (in a hierarchy people tend to rise to a level of incomptency) the Dunning-Kruger effect seems to have great explanatory power.

 

[Stijloor]

Re: Why do many ISO 9001 implementation programs fail?

Friends,

As long as MBA programs of study ignore the importance of quality (management systems), the new "Managers" will have no clue, and the chase for number$ will prevail..

Stijloor.

 

[Sidney Vianna]

Re: Why do many ISO 9001 implementation programs fail?

Now, pursuing the next "why"...

Contrary to what some other people want to believe, in my estimation, 99%+ of organizations going for ISO 9001 implementation do so because they were either mandated, coerced, strongly advised, etc... to seek certification. So, certification becomes the end goal. That is the biggest negative contributor to the problem. Certification, not performance, becomes the final target and "measure of success".

The consulting and conformity assessment practitioners have trivialized the product, so it could be marketed more promptly and to the masses. A significant percentage of such practitioners have no idea of what business processes are and what a system comprised of processes is. In this post, we have a very representative image:

We had even shared with him some process mapping...he was like a dog watching a ceiling fan...something was going around him but it was all over his head.

Back to my point, if certification is the end goal and, substandard systems are awarded and maintain certification undeserving, with no involvement from top management, with no corrections to dysfunctional business processes, with no change in negative corporate culture, why would we expect top management to be involved? And, worse, in those instances where a competent third-party auditor wants to keep the organization accountable to the INTENT of the standard, but the organization doesn't, it is so easy to find another CB and/or auditor that won't be "so demanding".

If we really want ISO 9001 (and it's inexorably connected certification piece) to be what is meant to be, many stakeholders would have to change their behaviors. Accountability would have to be exercised. And accountability is something that many people avoid, given a chance.

 

[AndyN]

Re: Why do many ISO 9001 implementation programs fail?

I wonder who it was who popularized the phrase 'Say what you do, do what you say"...

 

[AndyN]

Re: Why do many ISO 9001 implementation programs fail?

Friends,

As long as MBA programs of study ignore the importance of quality (management systems), the new "Managers" will have no clue, and the chase for number$ will prevail..

Stijloor.

And, sadly, Jan, it's also prevalent at even the local community college. One of my sons has been tasked with finding some education in basic quality methods etc - he works in an FAA regulated industry - and the local colleges have NOTHING to educate our new entry employees on what 'ISO' (nor any related topics) is - yet, here I am living in 'Automation Alley', at the very heart of ISO/TS 16949 world! Useless...