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APPENDIX C. MANUFACTURING IMPLEMENTATION INTERVIEW #1 99
APPENDIX C. MANUFACTURING IMPLEMENTATION INTERVIEW #1
Manufacturing Implementation Interview
Interviewer: Interviewer
Interviewee: Subject E - Production Manager
Date: November 22, 1995
Interviewer:
Now, I have to do something. First of all this is Interviewer. The day is
November twenty-second Subject E and Interviewer. I understand that this
guideline exists, this manufacturing implementation guideline exists, and we
are going to refer to it and as you use it and ah what I would like to do is start
and say go through these questions "A." through "I."
Q: Interviewer:
What starts the implementation process?
A: Subject E:
Something is signed out from a ..if weve done an experiment, experiments go
through the line and we decide to make the final process change. That is when
the manufacturing implementation gets started.
Interviewer:
Okay, so you are talking about on an ECR there is block and soon as that is
signed off then you start ...
Subject E:
...before we make the final changes to the documents. Where we take the PCS
or whatever that's going to need, implementation checklist is filled out started.
Interviewer:
Okay. So
Subject E:
They will have to do this for an experiment to be run. Once the existing
process is changed. Any time you have to update the PCS or change the
process. Thats when this [implementation checklist] is done
Interviewer:
Now, I just want to be sure that I have got that right. There is this ECR right,
now there is the final check sign-off sheet, sign-off area, and you are saying that
the implementation
Subject E:
Far right-hand side
Interviewer:
The far right-hand side, the implementation starts when that is signed. That
starts this going through the checklist. I that right?
Subject E:
That's my understanding of it. 100
Interviewer:
Oh, okay. Alright.
Subject E:
Then you are going to be operating off the PCS instead of off an experimental
traveler or, or what have you.
Interviewer:
Oh, okay. You will have been doing something on experimental traveler..
Subject E:
Right. It will be traveling through the line on a different piece of paper,
different traveler. Designation of it outline the experiment. Whenever it
becomes a final process that is when this gets done.
Q: Interviewer:
Okay. What are the steps of manufacturing implementation? What do you do?
A: Subject E:
first thing is going to be to fill this out INAUDIBLE
Interviewer:
Yah, INAUDIBLE this is what you are filling ...
Subject E:
to be honest with you, I do not know where this goes, after I sign it. I have
never seen another one again
Interviewer:
Okay, so you go through and...
Subject E:
It goes with the ECR I know, document control takes it and it's basically just
saying who was responsible for each of these different areas. Depending on
what the, the change is, a lot of times there'll be non-applicable anyway.
Interviewer:
Oh, okay.
Subject E:
exactly where this thing goes and what document control does with it, I have
no idea.
Interviewer:
Okay. So you go through and you fill this out. Now when you fill this out, is
this just a piece of paper you fill out or what do you do. Let's say, let's say if it
is like in control process or take one that you would normally would have to do,
an action or something that gets somebody to sign this.
Subject E:
If it is a process change, then the screen shop for example they're changing
emulsion types, something that we have recently done. Quality impacts of the
change it is going to be the engineer that has done all the experimenting and is
agreeing yes this is the thing to do. That is going to be the engineer, in my
opinion, that is who I would put down there. John Nespor responsible for the,
all the quality impacts of it. 101
Interviewer:
How much time do spend when you fill out one of these check sheets?
Subject E:
Not long.
Interviewer:
Oh, okay. Does it cause you to do other actions?
Subject E:
anytime something is signed of as a final change, I go to notify all the people
that are involved in, in the case of an
Interviewer:
emulsion change
Subject E:
I am going to go down and go over it, you know just from notes that I would
make on my own, go over that with the screen shop. It is going to come out on
the PCS as far as who, you know which screens they are suppose to be using
when it goes to the printing area.
Interviewer:
Oh, okay. So at the time of the sign-off there is this PCS that is going to be
generated. Is that correct thats what changes? I mean, you mention the PCS
quite a bit.
Subject E:
Yes. This is going to be the PCS that is going to be changed.
Interviewer:
so you've got this thing and there's completely signed ECR, and then you take
notes from that ECR.
Subject E:
Telling them what the changes are going to be.
Interviewer:
Oh okay, and then you talk to the lead, the people ...
Subject E:
We come and say you know look it is coming. This is what is going to happen.
This is what changing on it, you know ... just to give them a heads up that they
better be watching for it, you know.
Interviewer:
Okay.
Subject E:
cost impacts, for a screen change I would put non-applicable. It is a wash
there. manufacturing impacts, usually myself and my leads I would put there.
Document changes is, document control, that is what I have always put there,
Becky Rocco. Ah, safety impacts depending on what the change is to change
the emulsions on the screens, that is no impact, not applicable. Uhm...
Interviewer:
In situations where you have an impact what would you do there? 102
Subject E:
Depends on what it is the engineer that is requesting the change,, myself, the
leads.
Interviewer:
You personally fill this out? and is anybody around when you fill it out, or you
just usually at your desk
Subject E:
Document control is standing there waiting for it.
Interviewer:
Waiting for it to get completely signed. Okay. Okay. So you put the people
that would be responsible for this, and so you, what you mentioned is that even
if there is somebody that is said to be accountable for something like this, you
don't know what the follow-up is because you have an accountability and a due
date and you are not aware of what the follow-up of this should be.
Subject E:
I don't know.
Interviewer:
Have you ever had a situation where you have put yourself responsible if
somebody came back and said so did you do it?
Subject E:
It's done? Nope never have.
Interviewer:
So, alright let's continue on through this thing because that was your next step
as you go through and fill this out. Let's talk about time line or environmental
impact.
Subject E:
again it depends on what it is. You know a lot of these things are going to be
non-applicable. For an emulsion change your environmental impact there's
there is no impact to it. traceability of the first of the lot would be the
engineer that is requesting the change, be watching for any data that is going to
be generated or anything coming from that. Customer impacts again the
engineer.
Interviewer:
Process engineer?
Subject E:
Process engineer. And other impacts, Ive never done anything with that.
Interviewer:
Monitor of effectiveness?
Subject E:
The engineer.
Interviewer:
Alright, so. you have gone through this stuff, then what's the next thing you do.
You hand this into Becky Rocco and your done 103
Subject E:
Becky Rocco takes that with the signed off ECR and the next thing you know,
couple hours later you get the documentation on the floor to implement the
process.
Interviewer:
Oh, you'll have like the PCS and whatever documentation that there is to the
process. Now ...
Subject E:
... the racks down on the floor, any time there is new documentation, there in
my office area, there is a mailbox for each department and each department gets
a new PCS or whatever the change is.
Interviewer:
Oh, okay. Whatever, whatever there is that is effected she will have a PCS and
it is always within a couple hours?
Subject E:
... she's pretty good.
Interviewer:
So what you are saying is that the implementation, essentially all the
documentation is done prior to the final sign-off ..
Subject E:
I wouldn't say, after the 1:30 meeting Becky or Ron will have come up and start
working through making whatever changes are
Interviewer:
Oh, to the documentation, they will make the changes
Subject E:
... shows up in the mailbox, the leads check it, they're suppose to