B
Bill Putney
Guest
Dori A Schmetterling wrote:
> ...As you may know, when a business first starts writing SOPs (standard
> operating procedures) for getting the quality system registered under 9000,
> the SOPs should reflect actual practice, but I am sure a lot write what they
> think they should be. SOPs have to be updated regularly to take into
> account changes in practice.
> 2) It also has to be understood that if I as a client approve a sample
> product (at whatever level of quality), whether it is a tyre or a chemical
> or whatever, then I expect it to remain at that quality until there is an
> authorised change.
Also, even if the process per se does not change, at least in the
automotive industry, if location of a production line changes - whether
from one room in a building to another room in the same building OR from
a plant in the US to a plant in Mexico or vice-versa, the production
line has to be certified all over again (in the automotive industry,
that is called PPAP'ing - pronounced pee-pap - what in the "old days"
was called "first article approval").
> IIRC 9002 does not cover the development process whereas 9001 does. ISO
> 9001 itself has nothing to do with the design of a new product, just with
> the process of getting there.
Yes - and even that is a joke in the U.S. auto industry. The process
"requires" that a FMEA (Failure Modes and Effects Analysis - pronounced
feemah - just like the federal agency for disaster relief) be done both
for the assembly or component design *and* for the manufacturing process
for same. A FMEA on the simplest part can take a team of various
disciplines several man-weeks to complete - a very tedious process that
sometimes requires those involved to lock themselves in a room or rent a
hotel room for several days.
By its very definition, the paper work and numbers generated by the
design FMEA had to feed into the beginning of the process FMEA. If you
follow the book, it is, by definition, impossible to do the process FMEA
(P-FMEA) without the design FMEA (D-FMEA) already in hand.
When I was in automotive, our first tier customer (the ones that imposed
all this crap on us) were the designers. It was their responsibility to
feed us the completed D-FMEA before we started the P-FMEA. But the way
it really worked was that they would tell us that they did not have the
resources to do the D-FMEA, but they were still going to require a P-MEA
out of us - even though that was a philisophical, technical, and
practical impossibility. When we protested, we were told that that's
the way it had to be. It was clear that not to do it would mean we
could not do business with them. Inevitable results: We had to fake the
intitial input to start our P-FMEA (prime the pump so to speak), yet a
meaningful and useful P-FMEA relies on the starting point being good
information. Ever hear the expression "Garbage in, garbage out"? Well
that was it by definition.
So there you have it. The faking of the entire quality system started
with firm direction and winking from the customer themselves - the ones
who required us to use the system. Any wonder the suppliers end up
faking the rest of it when the faking was formally kicked off by the
customer themselves? Any wonder the Firestone/Ford tire debacle
happened, followed by the inevitable finger pointing?
Bill Putney
(To reply by e-mail, replace the last letter of the alphabet in my
address with the letter 'x')
> ...As you may know, when a business first starts writing SOPs (standard
> operating procedures) for getting the quality system registered under 9000,
> the SOPs should reflect actual practice, but I am sure a lot write what they
> think they should be. SOPs have to be updated regularly to take into
> account changes in practice.
> 2) It also has to be understood that if I as a client approve a sample
> product (at whatever level of quality), whether it is a tyre or a chemical
> or whatever, then I expect it to remain at that quality until there is an
> authorised change.
Also, even if the process per se does not change, at least in the
automotive industry, if location of a production line changes - whether
from one room in a building to another room in the same building OR from
a plant in the US to a plant in Mexico or vice-versa, the production
line has to be certified all over again (in the automotive industry,
that is called PPAP'ing - pronounced pee-pap - what in the "old days"
was called "first article approval").
> IIRC 9002 does not cover the development process whereas 9001 does. ISO
> 9001 itself has nothing to do with the design of a new product, just with
> the process of getting there.
Yes - and even that is a joke in the U.S. auto industry. The process
"requires" that a FMEA (Failure Modes and Effects Analysis - pronounced
feemah - just like the federal agency for disaster relief) be done both
for the assembly or component design *and* for the manufacturing process
for same. A FMEA on the simplest part can take a team of various
disciplines several man-weeks to complete - a very tedious process that
sometimes requires those involved to lock themselves in a room or rent a
hotel room for several days.
By its very definition, the paper work and numbers generated by the
design FMEA had to feed into the beginning of the process FMEA. If you
follow the book, it is, by definition, impossible to do the process FMEA
(P-FMEA) without the design FMEA (D-FMEA) already in hand.
When I was in automotive, our first tier customer (the ones that imposed
all this crap on us) were the designers. It was their responsibility to
feed us the completed D-FMEA before we started the P-FMEA. But the way
it really worked was that they would tell us that they did not have the
resources to do the D-FMEA, but they were still going to require a P-MEA
out of us - even though that was a philisophical, technical, and
practical impossibility. When we protested, we were told that that's
the way it had to be. It was clear that not to do it would mean we
could not do business with them. Inevitable results: We had to fake the
intitial input to start our P-FMEA (prime the pump so to speak), yet a
meaningful and useful P-FMEA relies on the starting point being good
information. Ever hear the expression "Garbage in, garbage out"? Well
that was it by definition.
So there you have it. The faking of the entire quality system started
with firm direction and winking from the customer themselves - the ones
who required us to use the system. Any wonder the suppliers end up
faking the rest of it when the faking was formally kicked off by the
customer themselves? Any wonder the Firestone/Ford tire debacle
happened, followed by the inevitable finger pointing?
Bill Putney
(To reply by e-mail, replace the last letter of the alphabet in my
address with the letter 'x')
