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The Rise and Fall of ISO 9001?

I just finished reading the article by Ashok Thakkar in September’s issue and wanted to say, “Bravo!”

I was pleasantly amazed at the directness, bluntness and accuracy of Thakkar’s article. Being in the medical manufacturing field--also regulated by the Food and Drug Administration--90 percent of the article applies to the FDA’s QSR/cGMP regulations. I salute Thakkar for returning his card to the RAB (and Quality Digest for printing this article).

An important point was made in Thakkar’s statement that, “A marginal system produces marginal results and loses credibility in the eyes of executives, whose commitment, involvement and provision of resources ultimately support a successful QMS.” However, it’s even more important to look at this from the perspective of employees who are delegated to implement the QMS. Marginal results lose credibility with the employees who provide the daily actions required to produce and maintain quality. If the employees don’t respect the QMS, they won’t feel it’s important to executive management and “The Company,” and therefore will not totally adhere to it.

After working with two small and medium-sized companies involved in quality control for medical device manufacturing, both stated that the quality management systems were “good” for the company but handled and set up like the “necessary evils” they were perceived as. Both established the quality systems to accommodate minimal bother by executive management and to minimally meet the requirements--quite the demotivator for myself and others who would like to do
it right.

--Name and company withheld

Ashok M. Thakkar is quite justified in calling on the American Society for Quality and ANSI-RAB to take action to preserve the integrity of ISO 9000 registration. Too many audits of ISO 9000-registered suppliers have left us with the impression that they got their certificate by sending in the requisite number of cereal box tops. When you build a shell of a system that you dust off and shine up once a year to go through the motions of a surveillance audit, you do a great disservice to your customers as well as your own business.

--Charles Pille

Thanks for telling it like it is. From the different point of view of an auditor, I’ve found that some registrars will only hire auditors who audit to their requirements and not necessarily to the requirements of the standard. In the four years I’ve retained IRCA certification, I’ve worked for one registrar. I was told I was too stringent. I questioned the certification when the internal audits consisted of “Did they have a procedure?” and “Was the procedure signed by the correct person?” I received an e-mail from the registrar that stated the consultant did not want me as the auditor. It was a wake-up call for me.

I realized I had to change my work ethics or look elsewhere for a job.

One thing Thakkar didn’t mention was that some registrars have a consultant in each area that provides them with clients, and it’s almost a guarantee to the company that with that registrar and that consultant you’ll receive your certification. Is this what we call a win-win situation?

--Alice Jacobi

This article by Ashok M. Thakkar hit the nail on the head. In 1999, I worked for a large automotive supplier and was the quality system administrator responsible for QS-9000 implementation and adherence along with various other related hats we all wear these days. We had an auditor representing our registrar who made a finding that I challenged all the way to the RAB. The RAB first sided with me and then did an about-face and sided with the registrar. In the meantime, the registrar’s president bent my ear and complained about how far behind the RAB was in re-certifying its auditors, and they had auditors in the field who had not been re-certified by the RAB. I left the automotive business and went into the wood industry. I was hired as the new corporate quality manager in late 1999 and was asked by my new company about whether I would recommend getting registered to ISO 9000 and I said, “No!”

If the leaders of the organization support a QMS structured around the framework of both ISO 9000 and QS-9000 and it’s tied into their key performance measurables to include cost of quality, employee evaluation and strategic planning, then there is very little to be gained from getting registered. It’s amazing how sensitive this issue is today in the quality profession and the economic power base that fights to keep things as a status quo.

--Peter Muller
Conestoga Wood Specialties

The article written by Mr. Thakkar was a refreshingly honest assessment of the current state of ISO 9001. I have seen recent statistics that tout the glowingly positive response about the value of ISO 9001. The problem about the statistics is that only 5 percent of the companies queried responded. I may be a cynic, but I believe that those who responded are the few companies that feel there’s a positive result from registration. Companies that don’t feel there’s any return on investment probably couldn’t be bothered to respond.

One must ask why is this so. My belief is that ISO 9001 is well-intended, but you cannot legislate upper management’s buy-in to a quality system. I believe that this is what the current version of ISO 9001 is trying to do. Many executives feel the peer pressure to have ISO registration but don’t want to be bothered with the day-to-day responsibility of its proper functioning.

For any QMS to provide a full ROI and the full benefit of a QMS, upper management must see both the marketing side of ISO’s benefit as well as the process improvement side of the benefit. Upper management must assume its proper role of being the company’s cheerleader for improved quality. The quality manager doesn’t have the total authority to get everyone behind a QMS. Only upper management can provide the drive needed to get everyone on board.

--Larry Winroth

Tribal Knowledge

In Scott Paton’s October 2003 editorial, he describes “tribal knowledge” as “organizational wisdom that isn’t documented.” I think that is a problem with many quality systems implemented in manufacturing. Look at the first rule of the three-step ISO process (at least in my mind): Write down what you do. Don’t write down what you would like to do. Write it down the way it is done now. It may not look pretty or nice, but it needs to be documented that way. Bottom line, if it’s needed or looked up once, put it in the official specifications or you will end up with a tribal system in order to get product out the door.

--Dennis Smouse

Your real business management system comprises the sum total of your team’s tribal knowledge, including the balance of how much the team values tasks and relationships.

Your tribe’s values (organizational beliefs) probably vary according to Quality Digest’s monthly publishing cycle. At critical times, certain tasks have to be done a certain way, and they are. At other times, the tribe’s leader and members can enjoy each other’s company and bond more by showing complete disregard for those beastly procedures.

It sounds to me that your documented procedures don’t reflect the real Quality Digest quality management system.

Two actions to consider:

1. Thoughtfully, elegantly and ergonomically document/automate the real system. Engage the team in this thinking so the real system is seen, understood, used and continually improved by the team.

2. By using and improving their real system, your team can evolve its tribal knowledge to become even better at growing customer loyalty. When the tribe genuinely agrees on its objectives, it can also improve its system to meet its agreed goals beyond customer loyalty.

Last, forget about trying to change your talent for leadership. Your tribe and the system have already adapted to your leadership style. There is no substitute for understanding your real system, including the way you actually lead your tribe.

--John R. Broomfield
Quality Management International Inc.