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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
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.
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The
Rise and Fall of ISO 9001?