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LAKE FOREST ISO
9002 AUDIT SUCCESSFULLY COMPLETED
!!!
August 20, 2002
Congratulations
to all!
NO
Action Requests
NO Observations!
ISO AUDIT vs. IRS AUDIT
ow would you feel if you got selected for an IRS audit?
A little dread because of all the work it takes to get your receipts and records
in order?
A little anxiety about the gray areas subject to interpretation?
ortunately, I have no personal experience with an IRS audit.
But, the chore of keeping records straight for an IRS audit seems it
would be mighty similar to what it takes for an ISO audit.
We believe we’re sticking to the intent of the law (standard). We work hard to follow our own planned guidelines to build in
quality. But making sure all our
records show it, and that we can find the records…this is another discipline
on top of it all.
Are procedures being followed?
Are the M.O.s are signed off correctly to prove it?
Are employees trained? Do
the training records show it?
That defective material we found – is it labeled properly? Is it segregated from good stuff?
Is the humidity in spec in prepreg storage?
Is the chart recorder calibrated so we know it is right?
Do we have the calibration cert? Do
we have the charts to show history of storage?
Is this material where the computer says it is?
Does the computer show where this material is?
Has material expired? Does
the label show expiration date? Does
the computer show when it expires? Does
it match? What stops expired
material from shipping?
Oh shoot, it’s just another audit.
LAKE FOREST AUDIT SUMMARY
- The framework:
a
day with the auditor
The audit starts with introductions and the UL
ISO auditor, Carlton Patterson told us the items to be covered throughout the
day. At Lunch we discussed
changes with the new ISO 9000 2000 standard.
Insulectro needs to be in compliance next year!
Main changes are more top management involvement; focus on Customer
satisfaction and continuous improvement.
The closing meeting we reviewed the good the bad and the ugly from the
day’s audits. Some items were
discussed as opportunities for improvement, but no formal action requests or
observations. Thank you Linda
Brigham for managing the morning comfort food to set the right tone!
Linda Brigham, Donna Davis, Dan Diesel, Shari Frank, David Klebba,
Dan Morales, Bert Paulite, Ann Williams attended some of all of the
meetings. Thank you Laurel
Schaus for managing the mid-day replenishments so we could make it thru
the day.
- “Thou shalt not mix the good with the bad”.
Review of the open nonconformance (action request) from the May 2002 Lake
Forest audit….
If you walk
into the prepreg storage room, you should be able to tell – what is good, what
is bad. There should be no chance
of accidentally shipping bad stuff. But
this is not what the auditor found in May.
In one pile, there were rejected bags of material inter-mixed with bags
of good prepreg. Even though the
defective material was marked defective in the computer, it was not segregated.
Now it is!
David Klebba has had Arturo Pineda, Bert Paulite and
the warehouse gang go through and move all the rejected prepreg into separate
locations. All the reject material
locations now start with RJ. The
same segregation is important for other materials, so there are now RJ locations
for rejected chemistry in a designated area, and for laminate, et.al.
Now, someone would really have to work hard to accidentally pick bad
material when they are looking for good material to ship.
The correction was accepted and the action request closed.
The internal corrective action is still open, though, until all the
material is also labeled as rejected. When
the warehouse personnel have been trained to make sure the material stays
segregated going forward, and when the material is re-labeled, the internal CAR
can be closed. Target completion: 8/27/02.
- How does Fab know what they are supposed to do?
How do we know who did what? - Quality Planning
If you look at some Manufacturing Orders, you can tell the Quality
requirements and who did what - who pulled material, who checked size and
tooling, any special requirements, and when it was done. So, we looked
at a bunch of M.O.s for Prepreg, Copper and Laminate. We only found one
where operator failed to put the date for closure. Thank you to Hector
Hernandez, for doing and stamping QC on the M.O.s, to all of FAB for signing
M.O.s.
4. What happens when it goes wrong? - Corrective Actions.
Warped material, wrong grain direction, packaging doesn’t meet customer
specs, tooling error, surface scratches from Fab process, surface scratches from
Supplier – how do we get to root cause, implement correction, and put
prevention in place so it doesn’t happen again? Going through over 10
examples of Internal errors and Supplier defects, issued by Customers, issued by
Insulectro, we looked at how each issue was addressed. If we said we
changed a procedure, we had to show that. If we said we re-trained, we
better have the training record. Every corrective action has to have some
objective evidence to show implementation was verified. Thanks to Jeff
Murray for the completed training record for a NH change to support the
procedure change to make sure we meet IBM packaging requirements.
5. Are we following procedures?? - Internal Audits.
We
need to be our own best detective, to walk around and make sure we’re doing
what we say we should. Jeff
Murray and Alex Monteforte
have started doing audits. To keep
it objective, the Fab Manager has to audit Warehouse, not their own area and
vice versa. The Insulectro goal is to have more “cross-audits” to
increase the frequency of auditing different areas.
Every item found out of compliance has to be fixed and re-audited.
We are in the process of fixing areas recently audited in Lake Forest and
in New Hampshire. The auditor could see we are using the audits to drive
improvement.
6.
How do we make sure we know Customer requirements:
Sales has to define the Contract and make sure we have the ability to
meet the Customer specs.
Donna Davis
was on the spot to show where Sales inputs special Customer requirements in the
Customer Profile with support from Linda
Brigham. Donna
whizzed thru the
screens showing how to set up a new Customer, how pricing exceptions are
approved & recorded, how an order can be changed and the system notes who
and when, the one making the change writes what was changed for
the record.
7.
Just how do you know the chart recorder humidity is right-on?
How can you tell the caliper is accurate?
- Calibration
The
auditor looked in the RCC refrigerator to make sure the chart recorder was
identified with a calibration sticker, that it was current, and it matched the
Master list. Same for the calipers
we use to check tooling. We also
looked at the pin gages that we started checking internally to reduce
calibration cost. Of course we have
to use calibrated calipers so there is traceability to a NIST standard, keep a
log of measurements and make sure everything is current. No problems found.
*************************************************************************************
COMING
SOON……………….
LONDONDERRY is scheduled for an audit the week of October 21st.
Mountain View will be Feb/March 2003,
along with Lake Forest.
If you would like any further info, please feel free to
call.
Shari Frank
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