Hello Joe,
Seems lately the only thing I can contribute is
old war stories. Well, if you don't mind the
length, you've asked what could be a big ole
Can-O-Worms-U-Us ... < g > Forgive me cause
I'm assuming you're a blank slate with this.
I'm going to assume by your email signature having
Biosystems in it, that this might be medical? And
changes as such can be critical.
Okay, there's two process I've had to deal with
over the years. I've worked in design departments,
as well as been a quality manager setting up the
company for ISO registration in a small telco mfr
where this type of thing was critical.
And each has their own benefits, drawbacks, costs,
paperwork, heartache, expediency ... The whole
focus/intent/purpose/effort is to communicate
*valid* engineering changes as efficiently and
accurately and quickly as possible to the pertinent
people/positions/departments/companies/customers
in a step by step process where everyone is so
confident that prior steps once passed don't
require backtracking. That's the ideal world.
The two systems for doing this with which I'm
familiar are:
1. ECR driven companies where the process goes
Start
AR -> ECR -> ECO -> ECN -> PCN
Finish
2. ECO driven companies where the process goes
Start
ECO -> ECN -> PCN
Finish
AR: Action Request
ECR: Engineering Change Request
ECO: Engineering Change Order
ECN: Engineering Change Notice
PCN: Product Change Notice
#2 is a cutdown version of #1, so I'll try to
briefly explain #1.
Initial Step
------------
Step #1: AR - A change requested by anyone.
Sent to the department supervisor of the requester
who decides to pass it on to the supervisor of
the department that will handle the change.
It may not require going to the ECR stage
for some reason.
Step #2: ECR - Sometimes initiated by an AR, but
mostly not. A change is identified to be done
within a department (usually engineering but
certainly not limited to). It's identified to be
done by the need to change revision numbers.
That is very important to remember. Things can
get really screwed up if this simple little
concept isn't followed to the dirt.
The Manager or supervisor of that department identifies
someone as the initiator of the ECR. It is as if this
person is putting together a brief for presentation in
court with evidence. Schematics have red lined corrections.
BOMs have yellowed out items maybe, red additions.
Parts have been identified, internal part numbers
have been approved and added to where they are going
to go on schematics, BOMs, process sheets, work
sheets, effective dates, obsolete dates, purging
parts from stock, etc. ...
Review Step
-----------
The entire ECR package (which can get bulky) gets
presented at an ECR committee meeting. Members of
this committee represent at least one representative
from all major departments within your company, and
possibly from other companies. When all agree to the
request, they all sign and turn it over to doc control.
The ECR explains - "This is what we want to do .."
Implementation Step
-------------------
Doc control essentially changes the ECR package
into valid paperwork with new revisions numbers,
changes to drawings, effective dates, ... It submits
this as a package back to the ECR committee who
review it and all sign it off. The ECO explains -
"This is what we're going to do." After signoff,
copies go to the pertinent individuals.
Think of the ECR going up the chain and the ECO
coming down the chain.
The ECN
-------
It's just a periodic notice summarizing the ECOs done.
The PCN
-------
This goes out to marketing, sales people, beta sites,
and customers about changes done.
OEM Stuff
---------
This can get rather complicated. As such, you want
to be in on the sign offs with the other company
as stated in the contract. This may require
actually going to the other company a couple of
times before things smooth out. Everybody has
their own way of doing things. So it's best to
go and actually see how their system is done.
Besides, it may end up being a two way street
with suggestions and improvements.
As a compliance engineer, you should try to include
yourself not only as a signatory within the ECR
committee (your signature is one that's needed
on the ECR) , but also at the component selection
and/or approval stage. That is, be one of the
sign offs for a part. If you ever get into
Bellcore, this may be critical.
The ECO driven companies bypass the ECR process
and just cut right to the chase. I've seen this
have ill effects by jumping right in to changing
things. Personally, I didn't like the ECO process.
Anywho, that's still a pretty rough outline
of the two processes I've dealt with. Sorry
for the length if most of this was redundant.
Regards, Doug McKean
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