Franklin
If you go with Document 1, several auditable questions arise: how is the 45
degree angle measured and controlled, how is 32 in/lbs controlled, how is
pressure applied only to selected pins. These questions are typically not
audited during an ISO quality system audit, but they could be checked. If
you live in the world of TS 16949, a mandatory internal process audit or a
third party audit could raise the same questions.
If you go with Document 2 there are still restrictions placed on the
operation, and you are requiring the generation of much documentation. What
happens when the assembly up revs to Rev E? Does the operator require
retraining? The work instruction will definitely require a revision. What
happens if the yellow thing becomes a blue thing or an orange thing because
of availability or a supplier's whim?
Personally, I would not recommend either approach. There are many methods
that can be used to accomplish your goals. Under ISO 9001:1994 one could
simply have a training record stating that the operator was trained in hand
insertion. Other standards often require proof of competency or validation
of training in which case a documented proficiency test might be needed.
The proficiency test might consist of stuffing a sample board and receiving
a passing grade from a "qualified" evaluator. A qualified operator and a
print or other work instruction or one of those semi-automatic machines that
present one bin of parts and shine lights to identify the part location
could adequately address ISO requirements.
The point is that ISO has mandatory requirements which contain the word
"shall". The requirements generally do not tell you how to run your company
only what you have to address to have a quality system that conforms to the
standard. The challenge is to keep the restrictions to a minimum consistent
with doing a good job. Read the response from Mike Sewell, Steve's Quality
Manager, who documented a system that allows the engineers to do whatever is
necessary to get a prototype built in an ISO system.
Reviewing what I wrote, it looks like once again after I get on a roll, I
forget to stop. I trust this answered your question. If not ask for more
information and somebody will give it a go.
Regards,
Don Vischulis
-----Original Message-----
From: TechNet [mailto:[log in to unmask]]On Behalf Of Franklin D
Asbell
Sent: Wednesday, June 04, 2003 1:58 PM
To: [log in to unmask]
Subject: Re: [TN] ISO and prototypes....
Example
Document 1 - Procedure or Intruction
SOP or WI states....." Place component "B" into slot "A" at slight 45 degree
angle oriented to the thingy over in the corner there, by the other yellow
thing that's square shaped, ensure proper fit by applying 32 in/lbs pressure
on pins 3, 17, 21, and 22"
Submit for Inspection
Document 2 - Training need or requirement, evaluation of proficiency
Training Requirement...Requirement "Ability to insert components A, B, and
C, into board A10232 Rev D as required by Technical Document QQ (replace
technical document with customer requirement, etc, etc, etc) as proven by
meeting all inspeciton criteria and passing electrical testing.
Looking at the two documents above, an SOP or Work Instruction, and a
Personnel Training Record (required task explained plus proven efficiency}
which document is more auditor proof? more flexible?, beneficial to a
company? easier to maintain? relevant to quality?
Now of course, these all require a subjective answer but in my opinion,
mostly for smaller companies and especially for companies desiring a
decrease or minimization of redundant, audit fodder/paperwork...move more of
it to the training portion thus eliminating procedural
nonconformances...revisions...not to mention with personnel properly
trained...the information stays with the company...
Just one persons throught and opinion...
Franklin
---------------------------------------------------
Technet Mail List provided as a free service by IPC using LISTSERV 1.8e
To unsubscribe, send a message to [log in to unmask] with following text in
the BODY (NOT the subject field): SIGNOFF Technet
To temporarily halt or (re-start) delivery of Technet send e-mail to
[log in to unmask]: SET Technet NOMAIL or (MAIL)
To receive ONE mailing per day of all the posts: send e-mail to
[log in to unmask]: SET Technet Digest
Search the archives of previous posts at: http://listserv.ipc.org/archives
Please visit IPC web site http://www.ipc.org/html/forum.htm for additional
information, or contact Keach Sasamori at [log in to unmask] or 847-509-9700
ext.5315
-----------------------------------------------------
---------------------------------------------------
Technet Mail List provided as a free service by IPC using LISTSERV 1.8e
To unsubscribe, send a message to [log in to unmask] with following text in
the BODY (NOT the subject field): SIGNOFF Technet
To temporarily halt or (re-start) delivery of Technet send e-mail to [log in to unmask]: SET Technet NOMAIL or (MAIL)
To receive ONE mailing per day of all the posts: send e-mail to [log in to unmask]: SET Technet Digest
Search the archives of previous posts at: http://listserv.ipc.org/archives
Please visit IPC web site http://www.ipc.org/html/forum.htm for additional
information, or contact Keach Sasamori at [log in to unmask] or 847-509-9700 ext.5315
-----------------------------------------------------
|
