QUICKSAND OF QUALITY PROCEDURES
jajit...@gmail.com
By J. Ajith Kumar
Mosquitoes breed in stagnant water and bed bugs multiply in unclean bed
spreads. Similar is the case with Quality Assurance Managers (QAMs) in
the services sector who survives on Quality Procedures and Internal
Audits. One of the first things they do whenever new QAMs take over in
a company is to encourage and coerce their colleagues to go in for
newer or additional procedures under the guise of covering as many
Business Processes involved in the business as possible. The name of
ISO (and even WTO) will be brought in at all times to substantiate
their suggestion and impress the colleagues about the absolute
necessity of having procedures for anything and everything. But little
do the executives realise at that stage that the 'clever climber'
is preparing noose for hanging them at a not-so-distant future.
In a Quality environment, those who do the real work are the owners of
any procedure they make for themselves. And any procedure we make for
ourselves is very much dependent upon the various external factors
prevalent at that particular point of time. This dependency is much
more acute in the case of services than in manufacturing sector. While
in a manufacturing environment one deals with machines, in the services
sector we are dealing with human beings of various characteristics,
capabilities and moods. It is very easy to draw up procedures for dead
machines than live humans. The impossible task of standardising human
beings and their activities is what is being attempted by way of ISO
certification in the services sector. The harm that it brings is much
larger than the pleasure one gets by way of watching a team of
innovative humans being forced to perform as robots in a uniform manner
but in an inefficient way.
Procedural Traps
Any procedure will bring in rigidity and inflexibility. The true
meaning of services, be it engineering, education, management or
administration, is to provide the right solution to a particular
customer in an efficient way as needed. There is absolutely no use in
giving services as per a pre-determined procedure but not in tune with
the requirements of the customer. The delivery vehicle must be flexible
enough to accommodate the changing requirements of the customer and
make profit for those who are providing the services. In the modern
world when time is money, the single factor that can determine the fate
of any services company is its flexibility. Quality certification,
procedures and plan are all secondary or tertiary when it comes to
clinching a deal and making profit for survival.
Most quality procedures are traps that the so-called owners make for
themselves. To make any procedure for any business process, there are
assumptions to be made. And it is these very assumptions that turn out
to be the stumbling blocks in implementation. No one is against having
a pre-determined policy on doing things and giving a prior idea to
customer about how the services he require will be provided. And we
always used to have them in olden days in the form of method statements
or execution plans. But the era of procedures ushered in by the QAMs
has changed all that. What we have now in all erstwhile efficient
companies are only procedures and policies but no services. Every
employee in such companies is handicapped by a set of procedures he or
she was coerced to make for his or her work. Fulfilling the
requirements of the procedure and not the customer's requirements has
become more important. The net result is loss for the organisation and
dissatisfied customers.
ISO Misuse
Misuse of ISO name is becoming rampant in the services sector now. For
anything and everything, the QAMs are calling for procedures in the
name of ISO requirements. Their only aim is to prolong their existence
by periodic internal audits based on these procedures. But does the
core policy of ISO insist on such procedures? My own firm opinion is
negative in this regard. ISO does not call for detailed written
procedures for each and every one of those processes involved in any
business. Those who have formulated the basic requirements for ISO
certification are not foolish enough to insist on rigid procedures for
inherently flexible activities like business development and invoicing.
Any business runs on certain unique skills of a single or set of
individuals. And none of the activities or processes that depend on
those special skills will be amenable to written down procedures
applicable at all times. It would be foolish to tie down human
creativity to ISO procedures.
Engineering industry is the most hit by the QAMs' misinterpretation
of ISO policies. In many companies we can find procedures for even
frivolous activities. The dirty work of an incompetent survivor in the
form of QAM in the company will be very much evident in such cases.
Under the guise of an ISO requirement, the cheeky QAM will force the
vulnerable CEO to go in for procedures in all areas of operation. It is
now common knowledge that almost all aspects of Design and Engineering
are standardised by the work of several professional bodies and
associations. The need for additional ISO procedures to cover these
activities is either unwanted or counter productive. Yet many such
organisations fall into the trap set by the Quality Assurance brigade
and become white elephants in no time.
The whole services sector is flooded with QAMs at present. And many of
them are outdated professionals past their expiry date. One quick
survey of the average age and health of QAMs in the services sector
companies in one metropolis is enough to prove this point. The only way
for these hangers-on to survive in the industry is to make procedural
cocoons and trap those who are doing the real work. Regular internal
audits and making 'arrangements' for external auditors are some of
the most 'sophisticated' exercises they can survive on. The immense
damage they are doing to the name of ISO in the industry is something
that shouldn't miss the attention of the ISO office bearers. The
sooner ISO come crystal clear about their minimum requirements in the
service industry the better for the prestigious organisation.
Otherwise, ISO's would become an unwanted certification very soon,
buried deep in the quicksand of unwanted procedures.
NewMan
to justify their existence and has no idea what they are doing.
I am the QAM in a SMALl company, and I don't have time for that kind
of crap!
We need Quality and Regulatory compliance on a BUDGET! We have
precisely the number of policies and procedures that are required -
and not one single one more! "Total Quality Management" involving "all
business processes" does NOT exist for us! We can't aford it! Our
Accounting department is ONE PERSON! And the "GAP" defines the
requirements for her! Why the h-e-double-hokey-sticks would we want to
try and re-invent THAT wheel???
Our SOPs are FLEXIBLE - allowing Engineering to do their job and
achieve compliance with a MINIMUM of restrictions! Our Manufacturing
Procedures are highly detailed to keep training to a minimum and to
clarify requirements!
Sorry to hear that your experience with ISO Quality Systems has been
so bad. But I am here to tell you it does NOT have to be that way!
more below...
This is absolutely FALSE. The Professional Associations that represent
Engineers (and other technical professionals) set standards for
membership in the Professional Association! If you are lucky, then
they are also involved with the evaluation and accrediation of
educational institutions which educate Engineers. And graduates who
matriculate form accredited programs will be elligible ot register as
"Professional Engineers"
This has NOTHING to do with satisfying a regulatory requirement! ISO
is part of our regulatory requirement. And our ISO system details what
Design Output Documents SHALL be in place to objectively verify that
our company is in FULL regulatory compliance. Our ISO system DOES NOT
tell Engineers how to do their jobs - rather we define the required
Design Outputs that are MANDATORY for completion of a design project.
As long as the required documents are present in the Design History
File, then we can demonstrate regulatory compliance. Plain and Simple.
But let me tell you! I have worked with LOTS of Engineers! And many of
them most assuredly would NOT provide the documents unless there is a
written compnay policy that tells them in NO UNCERTAIN TERMS that
producing ALL the paperwork IS THEIR JOB.
Not all Engineers are "good", just like not all Engineers are
"experienced". By formaizing Design Requirements, you nip problems in
the bud! From formalized procedures you can summarize a Project
Check-list. It is AMAZING how fast an unco-operative Engineer can be
motivated when - as the QAM - you put your foot down and say that the
product DOES NOT SHIP because the product has not been released - due
to a deficiency in the Engineering Dept! Especially one that the QAM
has been bringing to the attention of the Engineering Project Leader
for weeks, and possibly MONTHS!
:)
Money talks. It takes money to pay the high priced salary of those
Engineers! And when Engineering is suddenly seen as the major
road-block to a revenue stream.... Well, lets just say things tend to
get resolved VERY quickly!
> The need for additional ISO procedures to cover these
>activities is either unwanted or counter productive.
Unless there is a mandatory regulatory or legal requirement, SOPs that
are properly written should not be counter-productive. Time is money!
Ideally, you want the Engineers off a project as quickly as possible
so they can be using their tallents on the NEXT project and keeping
you ahead of the competition!
> Yet many such
>organisations fall into the trap set by the Quality Assurance brigade
>and become white elephants in no time.
>
>The whole services sector is flooded with QAMs at present. And many of
>them are outdated professionals past their expiry date. One quick
>survey of the average age and health of QAMs in the services sector
>companies in one metropolis is enough to prove this point. The only way
>for these hangers-on to survive in the industry is to make procedural
>cocoons and trap those who are doing the real work. Regular internal
>audits and making 'arrangements' for external auditors are some of
>the most 'sophisticated' exercises they can survive on. The immense
>damage they are doing to the name of ISO in the industry is something
>that shouldn't miss the attention of the ISO office bearers. The
>sooner ISO come crystal clear about their minimum requirements in the
>service industry the better for the prestigious organisation.
>Otherwise, ISO's would become an unwanted certification very soon,
>buried deep in the quicksand of unwanted procedures.
But ISO's requirements ARE clear! It is just the interpretation and
application can be vastly different!
You have to know your own business. ISO wont guarantee good quality! A
company I worked or years ago used to have a particular raw circuit
board manufacturer as a supplier. I watched them like a hawk! They
were ISO9002 certified - and I must confess they WERE consistent! Too
bad they produced consisten GARBAGE!
Repeated reporting of nonconformance and corrective action showed that
they had on clue how to determine the root cause of their problems.
They took a bad system, and got it certified! Unfortunately, the
system as deployed was ineffectual in that the higher level QAM
functions of Management Review, CAPA, and Internal Audit were
improperly deployed. We disqualified them.
ISO ususally gives you all the rope you need to hang yourself. When I
look at suppliers now, if they are certified, I look at HOW LONG they
have been ceritifed! Anyone who has had ISO longer than 10 years
should be OK to look at. There is little chance that a company
producing crap consistently could do so profitably for 10 years
(unless, of course, they have a captive market).
But all this often comes down to something that even the QAM has no
control over - Management Commitment. If "top management" are
unwilling to have the guts not only to be realistic, but to truly
commit the required resources, then the quality system is doomed.
How many places have I worked where "quality" was deemed a "neccesary
evil". How sad.
Quality can help demostrate a company has excercised "due dilligence"!
It can make things more efficent! Increas productivity and
profitability! Demonstrate regulatory compliance! Protect the company
from ltitgation.......
SOOOOO many positives!
And yet still the attitude. Everyone wants Quality. Just no one
willing to pay what it is really worth.
Andrew Morgan
George B.
you would likely be trapped by procedures you write. The documented
procedures specifically required by ISO 9001 are the same for all
industries. There are six. In addition the organization must prepare
additional procedures as requred for successful implementation of the
Quality Management System. This varies with the needs of your business.
ISO 14001 which is the model for Environmental Management Systems has no
requirements for procedures other than those required for successful
implementation of the Environmental Management System. I should add that
the customers often have expectations that must be considered.
<jajit...@gmail.com> wrote in message
news:1164712324.5...@h54g2000cwb.googlegroups.com...
Andrew Morgan
> We need Quality and Regulatory compliance on a BUDGET!
Whikle I probably could understand what youre trying to say, a
"real"[tm] QAM would say that Quality provides its own budget. Quality
is always cheap and a QMD does nothing but document how cheap youre
going to be getting when you do everything right ;-).
> We have
> precisely the number of policies and procedures that are required -
> and not one single one more!
And thats how its supposed to be.
> "Total Quality Management" involving "all
> business processes" does NOT exist for us!
Yes it does, you just said it yourself: "We have precisely the number
of policies and procedures that are required"
Thats TQM involving all business processes. If you dont need it, you
dont need it.
> We can't aford it!
Yes you can. Quality is cheap. Quality systems that are not backed up
with quality awareness are expensive, but if youve got one of those
qoure not doing your job as QAM properly.
> Our SOPs are FLEXIBLE - allowing Engineering to do their job and
> achieve compliance with a MINIMUM of restrictions! Our Manufacturing
> Procedures are highly detailed to keep training to a minimum and to
> clarify requirements!
"Keep training to a minimum?" Why is that positive? How do the
operators become aware of the contents of the procedures?
> Sorry to hear that your experience with ISO Quality Systems has been
> so bad. But I am here to tell you it does NOT have to be that way!
I think that guy is just one of these strange Inter- and usenet
denizens that lock onto a Jihad and focus on it until it becomes life
filling. Sad.
> This has NOTHING to do with satisfying a regulatory requirement!
Im not sure thats quite true. professional bodies exist in part to
provide bottom line standards as a response to increased regulatory
pressure, but membership in them is usually voluntary.
> ISO is part of our regulatory requirement.
It might be part of your company objectives, but its not a rquirement
in any industry, AFAIK (a defacto requirement perhaps, but not
regualtory)
> And our ISO system details what
> Design Output Documents SHALL be in place to objectively verify that
> our company is in FULL regulatory compliance.
Yupp.
> Our ISO system DOES NOT
> tell Engineers how to do their jobs - rather we define the required
> Design Outputs that are MANDATORY for completion of a design project.
> As long as the required documents are present in the Design History
> File, then we can demonstrate regulatory compliance. Plain and Simple.
And, as many have mentione, just having an ISO system in place and
fulfilling the formal requirements on procedures does not necessarily
mean you make a better product. most of the world now understands this.
> But let me tell you! I have worked with LOTS of Engineers! And many of
> them most assuredly would NOT provide the documents unless there is a
> written compnay policy that tells them in NO UNCERTAIN TERMS that
> producing ALL the paperwork IS THEIR JOB.
We engineers are lazy buggers by nature ;-)
> Not all Engineers are "good", just like not all Engineers are
> "experienced". By formaizing Design Requirements, you nip problems in
> the bud!
Can you say FMEA?
> Money talks. It takes money to pay the high priced salary of those
> Engineers! And when Engineering is suddenly seen as the major
> road-block to a revenue stream.... Well, lets just say things tend to
> get resolved VERY quickly!
But unfortunately, not always correctly.
> I must confess they WERE consistent! Too
> bad they produced consisten GARBAGE!
:-)))
> Repeated reporting of nonconformance and corrective action showed that
> they had on clue how to determine the root cause of their problems.
You should have showed them then
> We disqualified them.
It might have been worth doing some supplier development with them, ut
i assume you had an alternative lined up.
> But all this often comes down to something that even the QAM has no
> control over - Management Commitment.
Bingo with bells on.
> If "top management" are
> unwilling to have the guts not only to be realistic, but to truly
> commit the required resources, then the quality system is doomed.
Well, the qualty system can live quite a long time, but the company
might not.
> And yet still the attitude. Everyone wants Quality. Just no one
> willing to pay what it is really worth.
Naah. Too many people still banging on about how quality costs money
because they havent understood that quality is cheap. Real quality pays
for the quality system many times over.
andy M
NewMan
<andrew...@nurfuerspam.de> wrote:
>NewMan schrieb:
>
>> We need Quality and Regulatory compliance on a BUDGET!
>
>Whikle I probably could understand what youre trying to say, a
>"real"[tm] QAM would say that Quality provides its own budget. Quality
>is always cheap and a QMD does nothing but document how cheap youre
>going to be getting when you do everything right ;-).
>
>> We have
>> precisely the number of policies and procedures that are required -
>> and not one single one more!
>
>And thats how its supposed to be.
>
>> "Total Quality Management" involving "all
>> business processes" does NOT exist for us!
>
>Yes it does, you just said it yourself: "We have precisely the number
>of policies and procedures that are required"
>
>Thats TQM involving all business processes. If you dont need it, you
>dont need it.
>
>> We can't aford it!
>
>Yes you can. Quality is cheap. Quality systems that are not backed up
>with quality awareness are expensive, but if youve got one of those
>qoure not doing your job as QAM properly.
>
What I meant is that some people think you have to have ALL
administrative and account procedures included within the scope fo the
quality system. They copnfuse Total Quality Management with Total
Proceddure Management! ;)
If it affects quality - it is "IN". If it does not affect Quality - it
is "OUT". The minute a procedure is "in" the system, it is auditable,
and a potential source of non-conformance.
>> Our SOPs are FLEXIBLE - allowing Engineering to do their job and
>> achieve compliance with a MINIMUM of restrictions! Our Manufacturing
>> Procedures are highly detailed to keep training to a minimum and to
>> clarify requirements!
>
>"Keep training to a minimum?" Why is that positive? How do the
>operators become aware of the contents of the procedures?
>
What I mean is that the clarity of the procudures is such that only
ONE training session is required, and some cursory observational
follow-up to verify efficacy of the training. To me, that is positive.
There is little value in having to spend weeks of training time fro
us. We are a small company - so small in fact that training can easily
negatively impact productivity. We WILL spend the time that is
necessary, but we are careful to balance things. Better to pay an
Engineer extra time on a project and make the process SIMPLE for the
shop floor - as opposed to a skimpy procedure that will tie up
production with excess training time, lots of questions, and poor
quality requiring rework / scrap.
>> Sorry to hear that your experience with ISO Quality Systems has been
>> so bad. But I am here to tell you it does NOT have to be that way!
>
>I think that guy is just one of these strange Inter- and usenet
>denizens that lock onto a Jihad and focus on it until it becomes life
>filling. Sad.
>
Truly, it is.
>
>> This has NOTHING to do with satisfying a regulatory requirement!
>
>Im not sure thats quite true. professional bodies exist in part to
>provide bottom line standards as a response to increased regulatory
>pressure, but membership in them is usually voluntary.
>
>> ISO is part of our regulatory requirement.
>
>
>It might be part of your company objectives, but its not a rquirement
>in any industry, AFAIK (a defacto requirement perhaps, but not
>regualtory)
>
ISO13485:2003 and CMDCAS (Canadian Medical Devices Conformity
Assessment Scheme) are regulatory requirements for marketing medical
devices in Canada.
http://www.bsi-global.com/MedicalDevices/CMDCAS/index.xalter
This is Health Canada's answer to the US FDA. The US FDA seems rather
bent on keeping their version of the wheel alive and well. Eventually,
they will realize that they are wasting time and precious resources.
ISO13485:2003 does everything the US FDA does, and there is NO value
added in having multiple methods like QSIT to muddy the waters. Time
the US Government re-wrote the CFR and recognized ISO13485.
>> And our ISO system details what
>> Design Output Documents SHALL be in place to objectively verify that
>> our company is in FULL regulatory compliance.
>
>Yupp.
>
>> Our ISO system DOES NOT
>> tell Engineers how to do their jobs - rather we define the required
>> Design Outputs that are MANDATORY for completion of a design project.
>> As long as the required documents are present in the Design History
>> File, then we can demonstrate regulatory compliance. Plain and Simple.
>
>And, as many have mentione, just having an ISO system in place and
>fulfilling the formal requirements on procedures does not necessarily
>mean you make a better product. most of the world now understands this.
>
Yup! Been there, done that.
>> But let me tell you! I have worked with LOTS of Engineers! And many of
>> them most assuredly would NOT provide the documents unless there is a
>> written compnay policy that tells them in NO UNCERTAIN TERMS that
>> producing ALL the paperwork IS THEIR JOB.
>
>We engineers are lazy buggers by nature ;-)
>
:)
>> Not all Engineers are "good", just like not all Engineers are
>> "experienced". By formaizing Design Requirements, you nip problems in
>> the bud!
>
>Can you say FMEA?
>
Yup! Part of the ISO149971 Risk Assesment! Fits nnicely into that
Design History File. :)
>> Money talks. It takes money to pay the high priced salary of those
>> Engineers! And when Engineering is suddenly seen as the major
>> road-block to a revenue stream.... Well, lets just say things tend to
>> get resolved VERY quickly!
>
>But unfortunately, not always correctly.
>
Oh how true! Seen that too.
>> I must confess they WERE consistent! Too
>> bad they produced consisten GARBAGE!
>
>:-)))
>
>
>> Repeated reporting of nonconformance and corrective action showed that
>> they had on clue how to determine the root cause of their problems.
>
>
>You should have showed them then
>
Believe me, I tried.
>> We disqualified them.
>
>It might have been worth doing some supplier development with them, ut
>i assume you had an alternative lined up.
>
Oh yes! We had about six PCB vendors, all rated for quality .vs.
complexity of PCB (space and trace, number of layers, etc...).
As soon as we started having problems, we started to bring a new
vendor on-board into the qualification process - JUST IN CASE! :)
My biggest problem was that this shop was in Toronto, and we were in
Vancouver. The big boss woul simply NOT approve a budget for use to go
visit the vendor. He felt it was cheaper and mor productive to qualify
a new supplier. He MAY have been right. We could have spent a lot of
money and time and disqualified them anyways. Hard to tell.
>> But all this often comes down to something that even the QAM has no
>> control over - Management Commitment.
>
>Bingo with bells on.
>
>> If "top management" are
>> unwilling to have the guts not only to be realistic, but to truly
>> commit the required resources, then the quality system is doomed.
>
>Well, the qualty system can live quite a long time, but the company
>might not.
>
Indeed.
>> And yet still the attitude. Everyone wants Quality. Just no one
>> willing to pay what it is really worth.
>
>Naah. Too many people still banging on about how quality costs money
>because they havent understood that quality is cheap. Real quality pays
>for the quality system many times over.
>
>andy M
<sigh> You are talking to the converted.
Andrew Morgan
> They copnfuse Total Quality Management with Total
> Proceddure Management! ;)
With you on that. Its most prevalent with companies and QAMs who had a
very overblown 9001:1994 system and havent learnt to spot the
differences in 9001:2000 yet.
> The minute a procedure is "in" the system, it is auditable,
> and a potential source of non-conformance.
But also a valuable source of information on how the process/system is
running.
> What I mean is that the clarity of the procudures is such that only
> ONE training session is required, and some cursory observational
> follow-up to verify efficacy of the training. To me, that is positive.
Ok.
> We WILL spend the time that is
> necessary, but we are careful to balance things.
With you on that As little as possible, as much as necessary.
> Better to pay an
> Engineer extra time on a project and make the process SIMPLE for the
> shop floor - as opposed to a skimpy procedure that will tie up
> production with excess training time, lots of questions, and poor
> quality requiring rework / scrap.
FACK.
> ISO13485:2003 and CMDCAS (Canadian Medical Devices Conformity
> Assessment Scheme) are regulatory requirements for marketing medical
> devices in Canada.
You learn something every day. Not my country (not even my continent!),
not my industry.
> As soon as we started having problems, we started to bring a new
> vendor on-board into the qualification process - JUST IN CASE! :)
If you have the chance then its agood idea.
> He felt it was cheaper and mor productive to qualify
> a new supplier. He MAY have been right. We could have spent a lot of
> money and time and disqualified them anyways. Hard to tell.
Its always tempting to jump suppliers because the new guy will always
promise you the earth. At some point you run out of new ones though.
And changing is expensive too.
andy M
Oxebridge
jajit...@gmail.com wrote:
> Similar is the case with Quality Assurance Managers (QAMs) in
> the services sector who survives on Quality Procedures and Internal
> Audits. One of the first things they do whenever new QAMs take over in
> a company is to encourage and coerce their colleagues to go in for
> newer or additional procedures under the guise of covering as many
> Business Processes involved in the business as possible.
>
> anything and everything, the QAMs are calling for procedures in the
> name of ISO requirements. Their only aim is to prolong their existence
> by periodic internal audits based on these procedures.
>
> of ISO policies. In many companies we can find procedures for even
> frivolous activities. The dirty work of an incompetent survivor in the
> form of QAM in the company will be very much evident in such cases.
> Under the guise of an ISO requirement, the cheeky QAM will force the
> vulnerable CEO to go in for procedures in all areas of operation.
>
> them are outdated professionals past their expiry date.
Another unnecessary, undocumented, and unsupported slam against Quality
Managers. The level of vitriol in this post against them reveals
something else at work here... a personal grudge, a bad history, a
serious ax to grind. But these comments against "QAM's" are simply not
supported by facts in any industry, engineering included.
I would say that such personal rants be left to one's own diary, but
since the so-called quality industry magazines -- I'm looking at you,
Quality Digest -- fill their pages with the same kind of grunts written
by their editors (who rail against Wal-Mart, airlines and fast food
joints -- their only personal interaction with "quality" these days),
then perhaps a very profitable career awaits the author in industry
journal editing.
In the mean time, I'll stick to analyzing the successes and failures of
ISO 9001 by looking at data and supported evidence.