 |
Search Options | |||
| Index | Site Map | FAQ | Facility Info | Reading Rm | New | Help | Glossary | Contact Us |  |
|||
Home > Electronic Reading Room > Document Collections > Commission Documents > Commission Meetings, Slides, Transcripts, Meeting SRMs, and Full Written Explanation for Closed Meetings > 1997
>
02/18/1997
1
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
***
BRIEFING ON BPR PROJECT ON REDESIGNED
MATERIALS LICENSING PROCESS
***
PUBLIC MEETING
***
Nuclear Regulatory Commission
Commission Hearing Room
11555 Rockville Pike
Rockville, Maryland
Tuesday, February 18, 1997
The Commission met in open session, pursuant to
notice, at 1:02 p.m., the Honorable SHIRLEY A. JACKSON,
Chairman of the Commission, presiding.
COMMISSIONERS PRESENT:
SHIRLEY A. JACKSON, Chairman of the Commission
KENNETH C. ROGERS, Member of the Commission
GRETA J. DICUS, Member of the Commission
EDWARD McGAFFIGAN, JR., Member of the Commission
NILS J. DIAZ, Member of the Commission
(SECY NOTE - SLIDES FOR THIS MEETING ARE IN POWERPOINT FORMAT IN FILE
M970218A.VG). 2
STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
JOHN C. HOYLE, Secretary of the Commission
KAREN D. CYR, General Counsel
HUGH THOMPSON, Deputy EDO
BRUCE MALLETT, Director DNMS, Region II
DAVID FOGLE, Chief, Industrial Licensing Project,
State of Texas
CARL PAPERIELLO, Director, NMSS
DONALD COOL, Director, Division of Industrial &
Medical Nuclear Safety, NMSS
PATRICIA RATHBUN, BPR Core Team Leader, NMSS
. 3
P R O C E E D I N G S
[1:02 p.m.]
CHAIRMAN JACKSON: Good afternoon, ladies and
gentlemen. Today the staff and a representative from the
State of Texas, an agreement State, will brief the
Commission on the Business Process Redesign Project. The
staff last briefed the Commission on BPR in July of 1996,
and as a result of that briefing, the Commission directed
the staff through a staff requirements memorandum to take
three actions.
First, to arrange for Commissioner visits to the
BPR laboratory in 2 White Flint North. Second, to address
the directives in a 1995 SRM. And third, to provide a
briefing on the initial trial of the BPR pilot program to
reform the materials licensing process.
The staff has acted on the first two items, and
the purpose of today's briefing is to provide the Commission
with the results of the BPR pilot program.
Today's presentation also provides the Commission
with its first formal briefing since the staff addressed the
1995 SRM directives in a September Commission paper. In
that regard, the commission may have questions for the staff
regarding the overarching materials licensing BPR program in
a broader context than just the pilot program and what the
results are that have been realized through the BPR relative
. 4
to the amount of resources expended.
We appreciate the attendance of the agreement
State representative and look forward to hearing your views
on the BPR licenses pilot program. We also look forward to
hearing from the staff both from headquarters and the
region.
I understand that the staff's paper, SECY-97-034,
describing the progress of the BPR pilot program, and the
staff and the agreement States viewgraphs are available at
the entrances to the meeting room.
If my fellow Commissioners have nothing to add,
Mr. Thompson, please proceed.
MR. THOMPSON: Thank you, Chairman Jackson,
Commissioners. Good afternoon. With me at the table, as
you said, from my far left, is Dave Fogle, from the State of
Texas; Bruce Mallett, the Region II Division of Nuclear
Materials; Carl Paperiello, who is the Office Director from
NMSS; Don Cool, who is the Division Director for the
materials licensing activities; and Pat Rathbun, who is the
head of the BPR activities and the team, I believe is, most
of the team members are in the back. So we probably have
people who really can answer any of the questions that may
come up today.
As you know, the Material Licensing Business
Process Redesign Project began about 2-1/2 years ago, and
. 5
the goal was to design a new licensing process that would
maintain or improve the public safety, yet give us an order-
of-magnitude improvement in the speed, and that's what we
have been working on for all these years, and obviously part
of the process was to insure that we understood the process
before we went to automate it.
As you mentioned earlier, we -- the Commissioners,
most of the Commissioners I think have viewed the test lab
for the prototype, the BPR lab, and I think we have only one
Commissioner that we are currently making the arrangements
for final visits, but after that the team conducted a small
focus pilot exercise in the BPR lab using the computer-
assisted licensing prototype. The headquarters pilot
exercise was followed by a second phase of the pilot test
conducted in Region II using actual portable gauge license
applications. In today's briefing we will describe the
results from the pilot test and lay out our plans for the
next steps in this project.
In addition, Dr. Bruce Mallett, from the Region
II, will give you the regional perspective, as we'll hear
from Dave Fogle from the State of Texas, as their desire to
see how it would work for the agreement States.
The staff is very pleased with the progress to
date, but we still have lots of things to do, and with that
I'll turn it over to Dr. Paperiello for a few opening
. 6
remarks.
DR. PAPERIELLO: Donald Cool's going to present
most of the, make most of the presentation today, but I'd
like to remind people of how we got started into this
program. The problem we were out to solve with the
licensing backlog in the regions was a half a year's work.
The budget at FTE was shrinking, and it is shrinking, for
this activity.
The licensing guides and the standard review plans
that we had available for licensing had been last written in
the mid-eighties, and there was no provision in the budget
for revising or updating them, and they were out of date,
and in fact we had changed regulations since they were
written and never changed the licensing guides. And a
substantial portion, almost 50 percent of the licensing of
the FTE expended for licensing of the FTE expended for
licensing was actually in the renewal area. So with the
needs and to bring the program into line with the resources,
we launched this effort. That's kind of how we got started.
I would note that since we started this effort a
couple of years ago, the Commission a year ago initiated
strategic assessment, and somewhere this year we're going to
have to incorporate the direction from strategic assessment
into BPR, because one of the lessons you learn when you do
BPR is one way to save resources is to find things you don't
. 7
have to do.
For example, basically changing the frequency of
renewal from 5 years to 10 years is essentially one way of
saving resources by not doing something. We have an
opportunity when we revise -- if we revise regulations based
on Commission direction and strategic assessment -- to look
for things, requirements that we just don't provide any
added safety. And by altering our requirements, we may be
able to save resources there, both on our part and on the
part of licensees. So somewhere this year we're going to
have to incorporate the strategic assessment directions into
the direction we're going on BPR. I'd like to just take
notice of that.
With that I will turn it over to Don Cool, who
will discuss what we achieved in the pilot we ran.
DR. COOL: Thank you, Carl. Chairman Jackson,
Commissioners.
Go ahead and put the first slide up. My daughters
contributed their cold to me over the weekend, so I hope my
voice holds up through this.
I wanted to start very briefly with a little bit
of history, and we've touched on most of the points here in
this slide. We have briefed the Commission on a couple of
occasions, and you did indeed provide us several specific
tasks to go off and do back last July. We're here today to
. 8
focus principally on that third task, which was to go do a
pilot program of the licensing program.
Go ahead and go to the next slide.
The BPR project was actually started back in
September of 1994, and the staff created a vision of the new
licensing process which it presented to the Commission in
1995. Since that time we have been working on each of the
three principal areas within that vision, and have in fact
accomplished a number of things in each of those areas to
date.
For example, in the area of working in teams, that
area with the map of the United States, we have created the
redesign center. We have created some systems for working
in teams, a methodology for working in teams. Contrary to
what you might suspect, while this agency is very good at
using a team in an emergency situation or a AIT or an IIT
type of situation, it has not been common practice for the
staff to use a team approach in approaching more routine
problems. Rather we tend to be individualized experts, go
off and attack something.
So in fact it was not the normal way of doing
business for the staff to get together and just suddenly be
able to work harmoniously in a team. We have had to develop
methodologies, facilitation, and computer support systems to
enable us to work efficiently in developing teams.
. 9
In the area of guidance consolidation we have
looked at and developed a methodology for consolidating
guidance. We have in fact done the first of the
consolidations doing portable gauges, that being the largest
single class of materials licensees which we have, and doing
that in terms of a risk uniform performance-based approach,
trying to simplify that and move it to a performance
orientation. That was in fact part of what we were testing
in this pilot project.
We've also developed things related to our
technical assistance requests, making that electronic and
available so that now both in my office and in the regions
we can call up that data base of particular technical
systems actions, be able to determine whether or not we've
answered the question before, speed that particular process
along, as well as look at and change the license duration
with the Commission's approval just a few weeks ago to move
to 10-year license terms.
The third area, dealing with the actual licensing
process, was the focus of this particular pilot, and in
particular, testing the computer-assisted reviews of the
licensing applications.
CHAIRMAN JACKSON: How much have we actually
expended resource-wise in terms of dollars and people to
this point?
. 10
DR. COOL: 2.8 million in terms of dollars net
total, and I'm not sure, I don't have an FTE number right in
front of me. We can get that for you, if you'd like. For
that we've bought actually a large number of things and
developed a fair number of ideas, including the laboratory
product center, a lot of the infrastructure and software
systems, business practice facilitation support, a great
deal of training in those activities, groupware. So a
variety of things go into that. It's not all spent in one
particular place or location.
COMMISSIONER McGAFFIGAN: On the FTE's, an order
of magnitude, is it 10, 15, what number of FTE?
DR. RATHBUN: Just kind of estimating roughly I
would say it's about between 12 and 17.
CHAIRMAN JACKSON: And as you go along, I'd be
interested in hearing to what extent the software you've
developed is applicable beyond that relating to portable
gauges. That's number 1. But more importantly and more
broadly, to what extent is it compatible with either
existing systems or systems the agency is developing, and in
particular I'm thinking about ADAMS, and I'm interested in
to what extent that is a bottleneck or not or to what extent
what you've developed is compatible with that or not, and
what is being done both within your organization and with
the CIO to address this. These are very important issues,
. 11
particularly if you're telling us that you've already spent
$3 million on a pilot, and 12 to 17 FTE have been involved.
DR. COOL: We will certainly do that.
If I can go ahead and have the next slide.
Those questions I particularly hope to get to when
we get close to the end of the briefing and where we're
going in next steps.
This is a slightly different way of looking at
some of the things that we've done. Racked out in terms of
the amount of automation that was necessary or desirable to
do these. Some of the actions that we took didn't need any
automation to accomplish them, such as the license extension
changes to duration.
Some of the actions, such as consolidating
guidance, making guidance available on the Internet of
technical assistance data base, required some automation.
You could do guidance consolidation and do a paper copy, and
in fact we did that. That's a published NUREG. You can
take it a step farther and make it more useful by having it
available on-line on the Internet, which that document is,
and by using the software systems that are now available
today to facilitate group development processes.
On the other hand, considerable more computer
assistance and expertise is needed if you go to a computer-
assisted license review process, which is what we were
. 12
piloting.
CHAIRMAN JACKSON: What have we spent the $3
million on?
DR. COOL: I'm sorry?
CHAIRMAN JACKSON: You went through some things
that really didn't involve much automation, and I guess I'm
curious as to what we spent the 2.8, that is circa $3
million on.
DR. COOL: Okay. That breaks down into a couple
of large categories. One is IT systems, the development of
the BRP laboratory, the associated computers and systems
which are in there, the purchase of the software systems,
both Lotus Notes, which this is the software package we use
to facilitate group interactions and development of
products, and the various software packages that were
necessary to develop the licensing application that we
piloted down in Region II.
The other big category, the sort of a broad block,
was contractor support services in terms of facilitation of
my staff in developing the BPR ideas, facilitation of the
process of developing what we sometimes refer to as the
business diamond, the things of values and goals and jobs
and skills and metrics that go along with these activities.
The support systems for the servers, we have used
contractors to support and maintain our Lotus Notes server,
. 13
our development server, some of the activities, in
particular training, that went along with getting our staff
to use these software packages, to learn how to put
materials onto the Internet, do the HTML, the hypertext
coding, which is associated with that.
So there are two blocks. One was hardware, if you
will, and in that I'm going to include things like the
software packages, and the other was the facilitation
support and assistance and us working our way through the
process, because when we embarked on this process, BPR was
an idea you read about in the trade literature. We had no
way of just starting to walk down the path for ourselves.
So part of what we went out and purchased was
someone to walk us down the path who has been down that
path, done that for other both government organizations and
private industry in terms of business process redesign
philosophy, the kinds of approaches, the kinds of pitfalls.
Now that doesn't mean that we managed to avoid all of the
potholes. You have to sort of fall into some of them on
your own. But a fair amount of that money actually went
into the support to help us walk down that path and know
what path we were generally trying to walk down.
CHAIRMAN JACKSON: How many people are involved in
the kind of licensing actions that you hope the BPR
ultimately will cover?
. 14
DR. COOL: I would say virtually all of my staff
and in the regions.
CHAIRMAN JACKSON: So how many people are we
talking about?
DR. COOL: The net budget for my materials program
is slightly over 100 FTE's. Of that actual reviewers is in
the regions probably something on the order of 25 to 30
reviewers in the four regions who are the actual reviewers.
Then there are associated with that people like the
administrative assistants, the licensing assistants, who
receive the application, have to docket it, have to forward
it to fees. You get a variety of people who end up having
to touch that application at some point in the process.
CHAIRMAN JACKSON: I guess -- so the natural
question becomes should I apply a linear or a multiplicative
factor to figure out what it would take to expand a BPR to
all these people in your organization. You say 100, and
you've used 12 to 17 FTE's, so you're talking a factor of 6
to 8. And so is that what we have to look forward to, six
to eight times the 3 million that's already been spent? I
mean, and I'm not trying to give you a hard time, I'm
really --
DR. COOL: I would say no, very frankly.
CHAIRMAN JACKSON: Okay.
DR. COOL: Because a lot of it has to go in on the
. 15
front end, looking at the idea, generating the idea, testing
whether the idea will in fact work, developing the
underlying system. We're now to the point where we can
start to implement things, build on it, expand it, as you
mentioned. And we believe that it is expandable, both up in
terms of more complex licenses and to the potentials for
registration, as we discussed with the general license
program.
And once you have the underlying system, then you
can create another set of screens. It doesn't come free,
but it doesn't, I believe, scale linearly.
CHAIRMAN JACKSON: If I look on viewgraph 5, the
one that has the BPR recommendations, where are we exactly
with respect to the three areas that are on that slide?
DR. COOL: Area 1, no automation. License
extension is done. The duration is done. The move to
performance-based licensing and implementation of strategic
assessment obviously ongoing.
In terms of the consolidate and revising guidance,
the first document was portable gauges. The draft is done,
public comment completed. We anticipate to move very
quickly to make that a final document.
From there the additional subject areas, such as
fixed gauge, self-shielded irradiators, radiography, well
logging, the whole suite of those and right now we have
. 16
about 19 or so topical areas laid out, have been made part
of my division operating plan over the next three years. It
will be an ongoing operation over that period of time.
The fully automation portion, as you mentioned,
that we'll have to pace with the development of the agency's
infrastructure.
Our anticipation is that we will move to create
the automation screens that can be associated with each of
the licensee types as we develop the consolidated guidance
document that goes along with that particular licensee type.
CHAIRMAN JACKSON: Dr. Paperiello, you were going
to make a comment?
DR. PAPERIELLO: Yes. I would point out that the
tools, all the automation tools to do the guidance revision,
we have. Nothing other than actually writing the things --
we don't have to do any -- you know, we actually have the
right text but we do not have to add any more in terms of
computer hardware or software.
I would point out we talked about writing
software. In fact, we used all off-the-shelf software. We
did not, you know, write programs ourselves, so there was
nothing like that.
Most of the money was spent on contractors.
CHAIRMAN JACKSON: That's my impression. Okay.
COMMISSIONER McGAFFIGAN: Could I just follow up?
. 17
The contractor-facilitator part of the $2.8 million, could
you tell me what percentage of that was?
DR. RATHBUN: Let me try this with a little more
accurate numbers. I've never broken it this way
specifically, but the first part of BPR, just getting us
through to the vision and laying out -- you know, the
interviews, the vision, that was $350,000, so if you want to
just sit down and conceptualize something and actually take
it to a vision of the future, that is what it cost us to do
this, and we conducted about 75 interviews in all regions.
Now it becomes more complex after that because
normally you would go on in the BPR and then automate what
you visioned. Because we had a number of tasks we had to
accomplish -- the 10-year license, the one-time license
extension, and the guidance consolidation -- that moves us
out into this other part, and I am going to say that we
probably spent close to a million dollars in both buying the
Lotus Notes, getting the Staff accustomed to that, setting
up the templates, and, frankly, having one false start,
which we told you about last time.
Now that you would not have to account for in
future projects. Presumably we learned our lesson on that,
because now that we are down to it, it only took us six
weeks to do that portable gauge.
Then you have the development of the -- well, wait
. 18
a minute. In doing these tasks, we had to -- we used the
contractors. They went with us on the interviews. They
designed templates. They wrote reports and they also
facilitated every team session and team met daily for a
period of a year and contractors were with us during that
entire process.
The IT development, then, is probably at least
another $1.2 million just in building that system, and I
would have to go to CSC and ask them to --
CHAIRMAN JACKSON: This is not a budget hearing.
DR. RATHBUN: I understand. It's just -- so you
have got, those are your big chunks and then we have
training.
CHAIRMAN JACKSON: Well, I'll just say that, and I
don't want to preempt whatever you are planning to discuss
as we go along, you know, my concern is less a detailed,
specific breakdown, because this is not a budget hearing,
but rather how to have a better sense of exactly where you
are, did you accomplish everything that was in the previous
SRM, where you are going from here and how quickly, and how
this ties into -- and back to the compatibility issues with
other ongoing efforts in terms of information technology and
automation in the agency.
I mean I think you can separately provide detailed
breakdowns --
. 19
DR. RATHBUN: Okay.
CHAIRMAN JACKSON: I am not interested in hearing
about $350,000.
DR. RATHBUN: Okay.
CHAIRMAN JACKSON: But rather what are we
accomplishing and where do we expect to go and how quickly
for the dollars expended. Okay?
DR. COOL: Okay, and our anticipation was to get
to that in just a little while, after we had walked through
the pilot.
We can jump to that if you would like
immediately --
CHAIRMAN JACKSON: No, let's just work our way
through it.
DR. COOL: Okay.
CHAIRMAN JACKSON: I mean I guess I am looking at
the full automation and you are saying that we haven't
gotten there, even relative to portable gauges?
DR. PAPERIELLO: No. We have.
CHAIRMAN JACKSON: Oh, you have. Okay.
MR. THOMPSON: Let me just say, we are automated
but we are not fully-automated in our infrastructure and we
have tested out in the pilot and we'll discuss that, but it
is not in the system where we can just dial up right now and
I think that is what we are really talking about.
. 20
Either you would have to have I think a stand-
alone machine to be able to do it like we set up the pilot
down in Region II, and it was automated. It was fully
automated in the region but it is not integrated, fully
integrated -- maybe it is fully automated but not fully
integrated.
CHAIRMAN JACKSON: That sounds good.
DR. PAPERIELLO: Fundamentally the agency's
information management system is still paper.
CHAIRMAN JACKSON: No, I understand that and I'm
sure the CIO is listening very carefully.
[Laughter.]
CHAIRMAN JACKSON: And if he is not, he should be
listening very carefully.
MR. THOMPSON: I'm sure he is. Okay, Don, I want
you to move forward on it.
DR. COOL: Okay. Let's go ahead and then quickly
walk through the pilot.
Our objective was to see whether or not the system
could in fact work.
We picked portable gauges because they are
relatively simple devices. There are two spaced reviews so
there is an inherent degree of safety built into them, and
at 19 percent of the licensees they were by far the biggest
single chunk, so we could take a big chunk out with this
. 21
particular challenge.
We were looking at the test in terms of the
technical review and QA review. We boxed off other things
like exactly how you do all of the incoming receipt of
electronic applications, how you might fire back out
electronically a finished license, and a variety of those
sorts of activities so we constrain the system, and that
introduces some artificialities when you get to how long did
it take and how confident you are about how long it took.
We did use the consolidated guidance documents
that had been developed.
We can go ahead and go to the next slide, very
quickly.
The development process --
CHAIRMAN JACKSON: Let me just take you back.
DR. COOL: I'm sorry.
CHAIRMAN JACKSON: You mentioned new portable
gauge license applications only, but in the opening remarks
you mentioned that the bulk of what you have to deal with
are license renewals.
How close are you to being able to handle renewals
and/or amendments for the portable gauges?
DR. COOL: Renewals will be very quick to be able
to take in because they look exactly like the new
application so you can roll the renewals right in.
. 22
The amendments should also come very easily as you
have an electronic system, calling up the file, seeing which
change, and authorizing that also then comes much more
quickly because you with the system can click on the screen
as opposed to having to go off and find the text file, pull
it out of the docket file, flip it open, flip through the --
CHAIRMAN JACKSON: What is your target date for
that, for having that piece of it relative to portable
gauges tied up?
DR. COOL: I don't have a date for you at the
moment, ma'am.
CHAIRMAN JACKSON: Okay. You should think about
doing this. See, this is the classic kind of thing where
somebody calls up -- "Chairman Jackson, please come downtown
and see Senator So-and-So --"
You know, he has the licensees who are upset
because of how long it takes to renew a license or amend a
license.
"Ah, but Senator, you know, we have a redesign
materials process." "Right. How long is it going to take
then to review my constituent's license amendment? "
That is the kind of thing from a practical point
of view, you know, that is really helpful to us. Okay?
Thanks.
DR. COOL: When we come back to the "where do we
. 23
go from here" at the end, I would like to talk a little bit
more about why I gave you the answer I did.
CHAIRMAN JACKSON: Okay, fine. I think I know
part of the reason.
DR. COOL: The iterative development process,
working through the development of the application screens
in Headquarters and our regions; go ahead and go to the
next slide.
The Information Technology Management Reform Act a
couple years ago, one of the things that directed the
Federal Government to do was to develop and build IT systems
in a modular fashion. That is exactly what we tried to do
in this particular case, building a structure and a module
with the technical staff sitting side by side with the
people who were actually doing the screen development, so
you build a little, test a little, build a little, test a
little -- refine the process -- say, no, that doesn't quite
get us where we need to go -- in a very efficient process
actually over a relatively small number of weeks last Fall.
In a matter of months they had the working model
that could be tested within the laboratory and headquarters.
CHAIRMAN JACKSON: What is rapid application
development?
DR. COOL: Build and test, build and test, build
and test with the people sitting side by side.
. 24
CHAIRMAN JACKSON: Okay. Go ahead and go to the
next slide, the Headquarters testing.
We used as the feed material for that some
licenses that have already been issued, pulled that
information out of the docket files to test it, tested the
system, looked at in terms of going out and grabbing the
guidance process flow, kinds of screens, what works, what
didn't work -- a variety of things, and as you might
suspect, found a number of things that needed to be refined,
needed to be debugged.
Developed no fatal flaws from that -- the thing
did what we wanted it to do, identified a number of areas to
be improved.
It also validated to the extent we could the kinds
of jobs reviewer, quality assurance person, and some of
those activities. That proved out very nicely also.
So we refined the system and moved on to the
region.
COMMISSIONER DICUS: What were some of the things
that you found that you needed to fix, to redo?
DR. COOL: Well --
COMMISSIONER DICUS: I think in the paper noted
some major issues and some minor issues.
DR. COOL: There were a number of work flow issues
that came out of this.
. 25
How does the license reviewer hand it off and how
does the QA person know to pick it up? Some of those
things, which caused us to go back and look at what we refer
to as business rules.
The old system that we are all very used to -- it
takes it, carries it over, puts it on the desk. The next
person has it sitting in his pile, does things.
Well, it's a little bit different with the
electronic system in terms of, oh, I now have it, it's now
in my queue, for example.
Some of the things about how to go and pick up and
correlate activities in the IT space, depending on the level
of complexity some of them are minor debuggings. It's
calling the wrong place on the code. Some of them, more
major in terms of the logic train of the relational
database.
CHAIRMAN JACKSON: How much did you interact with
IRM on this can how helpful were they to you?
DR. COOL: We had a person from IRM on our core
team interacting with us on an almost daily basis and they
were quite useful to us.
We had those folks participating with us, although
most of the rapid development activity was the contractor
developing the screens with my reviewers from the region
sitting there talking about this particular application.
. 26
CHAIRMAN JACKSON: Who helped you with the work
flow issues?
DR. COOL: The contractor. My reviewers. My
licensing assistants from the regions.
We tried to go out and to pick the people who do
this job on a routine basis in the old process and say,
okay, now it does this -- where would it next go logically
under the old system? How do I make sure that I manage to
get all the steps done, all the buttons touched -- so we
have used a variety of people within the regions and
headquarters.
COMMISSIONER DICUS: Do you think all the problems
are resolved or do you still have some with regard to what
you have identified to date?
DR. COOL: I would venture to say that no computer
system ever has all of the problems resolved. I think all
of the major ones we're certainly there.
We are down to things like it calls the data up in
the wrong format. It doesn't quite print it on the standard
license page at the moment. There's formatting issues and
some of those sorts of things --
CHAIRMAN JACKSON: I would like to put the
question this way. Relative to portable gauges, do you have
a product that you are using today, so that if someone sends
in a new license application relative to a portable gauge
. 27
that you will use this system as opposed to your paper-
intensive system?
DR. COOL: We have a system which is ready to do
that when I make the guidance final and make that the way
that we license portable gauges, then based out of Region II
we will be using this system for at least some of those
applications because I do not have underlying infrastructure
in other systems ready to make that a network application
for all of my reviewers, but we will be issuing -- I expect
us to be using it to review and issue licenses.
CHAIRMAN JACKSON: Do you want to give us a target
date? That is the date you can't give us yet? All right.
DR. COOL: Stand-alone, we'll be doing that before
the end of the fiscal year.
COMMISSIONER DICUS: For portable gauge.
DR. COOL: For portable gauges -- and I think that
is the issue we are going to discuss later on, integrating
this in ADAMS and the platforms that are going to be
compatible is the key element.
DR. PAPERIELLO: I'd like to go back to a
question, a question of IRM involvement.
We in NMSS are not experts on information
technology and I would say depending upon when you start
dealing with the technical analyses we do, and I am talking
about numerical analyses, modelling, and things like that on
. 28
computers, we are quite knowledgeable.
When it comes to information technology, we are
not, and we have to heavily rely on contractor support and
some support from IRM.
If there is a lessons learned, at least the lesson
I learned, in any future project like this, I will not get
involved with it without full partnership with now it would
be the CIO organization, which I would say IRM was not.
I am not saying -- if it was anybody's fault it
was my own fault for having gotten into this without
realizing maybe all of the resources I would have needed,
that kind of resources, but I would say that is a lessons
learned out of this.
CHAIRMAN JACKSON: No, that's -- and I appreciate
your making that comment, Dr. Paperiello, because I think
where we want to go, and I think you have already spoken to
it, is that if we have a resource here or a putative
resource in IRM-CIO, that on the one hand in the working
organizations, you know, we have to be willing to go there
and make use of what resources exist. On the other hand,
that organization has to be working with you to see what in
fact can be offered by that organization to help not only
purchase technology but to optimize information flow, work
flow, and you mentioned that.
Of course, you know, you have people who are
. 29
technical reviewers who do this, who do that, and one has to
ask where are the resources best deployed in which ones --
but I think you have essentially spoken to it in the comment
you made, and that is a good lessons learned out of this.
MR. THOMPSON: I might want to add, because I
obviously was dealing with IRM at the same time, there
are -- this is probably the first big BPR effort this agency
has undertaken, and there was limited IRM experience and IRM
often is subject to doing a lot of work by contractors, as
opposed to that, so it wasn't that they weren't prepared and
willing to assist.
I think it is a kind of a combination of the right
mix and skills and as I think Carl said, I think they were
there in and their heart was there. I am not sure they
didn't have much more than a body and mind to go with it
because I think they put one of their better IRM liaison
people to work with the contractors.
There wasn't I don't think an IRM lack of desire.
I think what they found both in budget space and other space
is the fact that it was a -- the program offices had more of
the capital and they were focused on other activities, and
supported them as best they could.
CHAIRMAN JACKSON: Okay. Commissioner McGaffigan.
COMMISSIONER McGAFFIGAN: Could I ask on Lotus
Notes, whose advice was it to use Lotus Notes? It is a very
. 30
good program. A lot people use it around the country in the
business community. Was that from your contractor? Was
there --
DR. PAPERIELLO: It was the contractor.
COMMISSIONER McGAFFIGAN: And did IRM happily go
along with that or unhappily or what was the --
DR. PAPERIELLO: They approached it, I think, with
skepticism, as we did.
It was suggested. We said we will go ahead and
try it. We got into it and it has proven to be pretty
effective.
There are with any sort of system the potential
drawbacks. The earlier version of Notes, when we started
this, did not have any way to interface with the Internet.
That almost killed it for us at one point. The
new version of Notes does, so as the systems grow,
capabilities change.
COMMISSIONER McGAFFIGAN: My experience with
software systems in a totally different setting is that the
perfect is oftentimes the enemy of the good.
Software people oftentimes tend to try to say, you
know, give us enough money and enough time and we'll come up
with the perfect system. They never get it and meanwhile
you miss the benefits of the good enough system for many,
many years in between.
. 31
CHAIRMAN JACKSON: Well, to me the ultimate metric
is can you process an application? Not can you process it
in the way that if we all had this perfect world would do
it, but can you do it, because in the end that is what the
job is, right? That is what the regulatory function is, and
that is what we want to get to.
MR. THOMPSON: And I think that's what our pilot
program I think did.
DR. COOL: I can jump five pages --
CHAIRMAN JACKSON: We have got to hear about the
regions and the states --
[Laughter.]
DR. COOL: All right.
CHAIRMAN JACKSON: I can't let Dr. Mallett and Mr.
Fogle sit at this table and not have their say.
DR. COOL: Yes, ma'am. Okay, then mushing forward
with all undue speed so we can get to them in a moment.
We ran the test in Region II. We had participants
from almost every region, Headquarters staff and several
states, Georgia, Illinois and Texas all had individuals
participating. We provided training to these individuals,
the adult learning concept, quote on quote, just in time
where you provide them some training, you immediately get
them on the system and let them use it to reinforce it.
That proved, in fact, to be very effective through that
. 32
process.
CHAIRMAN JACKSON: Well, before you even go
further, I do want to give you cudos on that one. I think
that you did truly follow what the '95 SRM asked you to do
in involving the regions and the states, the agreement
states, and that is, you know, a kind of a model and so I
commend you on that.
DR. COOL: Thank you.
The regional test used the information system as
we had revised it and improved it from the Headquarters. We
used the guidance in an on-line system. That particular
version, we were pulling off the NRC intranet. However, the
same version is on the Internet outside on our external
page.
For the regional test, we did real reviews, real
applications. For real applications and for dummy
applications from each of the major portable gauge vendors
who participated with us.
CHAIRMAN JACKSON: So the vendors did participate?
DR. COOL: We had all four major portable gauge
vendors participate and we had four actual applications that
participated.
CHAIRMAN JACKSON: All right.
DR. COOL: We performed both a computer-assisted
review and a paper-based review. We did those in parallel
. 33
at the same time on different floors of the building down in
Atlanta so that we could check to see whether we were
getting the same product, same result. We ran stopwatches
on it to see how long different segments lasted, how long it
took to do various pieces.
We tested various roles, the reviewer role,
handing it off to the QA reviewer. A customer service
person, the person in the licensing assistance type role,
bringing the application in, getting it queued up, a manager
assigning it to somebody so that they knew they had it. So
we tested a variety of job roles and hand-offs.
We also during that same week had people play in
various roles, pretending to be an applicant testing the
system, doing applications, being a reviewer doing a QA
review, a variety of those things during the course of the
week.
Going ahead on to the next slide, then.
In terms of the results, first in terms of the
consolidated guidance, we received very positive feedback on
both the consolidated guidance document, NUREG-1556, and on
the electronic licensing system. The gauge vendors and the
four applicants were asked to and did both fill out a paper
application and an electronic application and we
specifically solicited their feedback on how that worked
down to and including were you able to load it up, what kind
. 34
of problems did you have installing it, how did the screens
work, were you able to get out, printing issues, a variety
of those things and we provided and we got a great deal of
feedback on that.
That feedback was almost unanimously positive in
terms of the guidance, the performance orientation of that
guidance, its usefulness and on the electronic system
associated with this particular app.
CHAIRMAN JACKSON: Now, I don't want to keep
beating the same horse but I guess I'm interested. To the
extent, then, that you used off-the-shelf software, how
quickly adaptable is it to other applications than portable
gauges?
DR. COOL: I believe as quickly adaptable as
someone can sit down with a reviewer and create the set of
screens that goes along with that particular kind of
licensee type. So that if and in fact, as I will mention in
a moment, we are working on the consolidated guidance for
radiography to implement the rule which the Commission
approved in October. We will write that to the new form.
When that consolidated document is ready and out for
comment, my intention is to have a couple people sit down
with some of the IT folks and develop a set of screens that
goes along with that.
CHAIRMAN JACKSON: All right.
. 35
DR. COOL: The next slide.
In terms of the system itself, the computer-
assisted review and the paper review were technically
equivalent and provided the same level of safety. Meaning
they generated the exact same license, they generated it at
the same conditions in the same order. There were some
formatting glitches. It didn't pull up the date in quite
the right format, for example. It turned out that, through
all of this, we had managed to forget to have it assign the
docket number and print it on the top of the license, for
example. Some things like that, you go how did we manage to
miss those.
They identified the same deficiencies. There was
one additional deficiency identified in the paper version
because, in fact, the electronic version prompted the
applicant to include his authorization for field sites. The
licensee didn't manage to get that same authorization
clipped to the paper copy so, in fact, the electronic
version may perhaps have indicated some additional benefits
because it does indicate to you whether or not you have
checked off all of the areas and edited all of the areas
that need to be part of the license. So there was one less
deficiency identified in the electronic review.
We demonstrated that we could print out the paper
that was necessary to document that particular application
. 36
and we demonstrated that the overall metric, goal, target of
this operation, which was to have the average turnaround
time of 12 days is obtainable.
Now these are simple devices.
Go ahead and go on to the next slide.
The average turnaround time for these is nowhere
close to 89 or 84 days. Rough estimate of the turnaround
time on a portable gauge under the old system, 18 days. We
turned four of them around in one day.
The majority of that, I believe, can be attributed
to the guidance, consolidated guidance, which provided all
the information which everyone needed. It resulted in very
good applications that had essentially no deficiencies
associated with it.
Within the constraints of the system that we had
which is a very artificial system, timing only certain
components of it, there was not a great deal of difference
between a paper reviewer who had a copy of the NUREG right
there and the electronic version where the copy of the
guidance could be brought up on the screen with very few
deficiencies, very little reason to go back and forth. Not
a whole lot of difference of time.
But as you move to other pieces, the input/output
processing or as you expand it toward more complicated ones,
those differences not sufficient here to be able to really
. 37
call them out for this simple class of licensees will, I
believe, become more evident or it becomes more complicated,
there's more pieces to look at, where there are more things
you would have to run around and do. Within the constraint
of this pilot test, we weren't looking at a system that
would allow us to really differentiate between those two.
CHAIRMAN JACKSON: Would you say, then, that in
some sense the pilot was less a test of the efficacy of
automation and more a test of the efficacy of process
reengineering for this class of licenses?
DR. COOL: it was a test of the electronic system
to the extent that we were testing to see whether or not it
would work. It, in fact, did work, it ran at a comparable
speed, perhaps a little bit faster if you click the
stopwatches, so it tested that. But it did, in fact, also
have a major component of testing process and, in
particular, I think it validated the value of the
consolidated guidance, having a document which, in one
place, is the standard format and content, the standard --
CHAIRMAN JACKSON: That's what I put in what I
call a process reengineering.
DR. COOL: Yes, yes, that's correct.
CHAIRMAN JACKSON: And that is an important point
because, from my perspective, I have been in various
technical organizations and the goal is not necessarily
. 38
automation, per se. It is automation as part of an
optimization of work process and so the fact that the two
both were roughly a day but you came down from an eight-day
current estimated average -- 18 day, I'm sorry -- is not
something to run away from. Because as we go forward with
constrained resources, we have to understand how automation
is part of an optimization process. It is part of it. But
an equally, probably as important part, has to do with the
guidance, other ways to optimize how the information is
handled. So don't back away from that, the fact that a lot
of it was due to the consolidated guidance.
Commissioner McGaffigan.
COMMISSIONER McGAFFIGAN: It's really on the same
point.
The consolidated guidance, what this chart tells
me is that that really, I don't know how many areas you set
at the outset, we have rules --
DR. PAPERIELLO: About 19.
COMMISSIONER McGAFFIGAN: Nineteen different areas
and in many cases we've changed rules and not changed
guidance documents and all of that. The payoff sounds like
getting all those guidance documents up to date, whether you
have electronics or paper.
DR. PAPERIELLO: It is getting them up to date,
it's consolidating them because unfortunately we put out
. 39
different kinds. Yes.
DR. COOL: That is exactly right.
CHAIRMAN JACKSON: What I would tell you is that
the IMTRA, the new law, essentially says that you should
look at work process and its optimization and understand
paper flow before you make a decision about automation and
that's why, in fact, this is not a trivial point.
COMMISSIONER McGAFFIGAN: The other point I would
make, and I filled out a soccer application this weekend for
a soccer tournament on the Internet, so it had a glitch. I
kept entering zero and it kept giving me one and I
couldn't -- but in any case, I honestly am a paper person.
It may reflect my generation. But I'm not so sure when you
get to the more complex licenses where you have to go back
and forth, that doing that on a computer screen is better
than doing it with a piece of paper on your desk.
I am from Missouri. As I have said in other
hearings, when it comes to something like that, it wouldn't
be for me.
CHAIRMAN JACKSON: Yes, but I think the way that
addresses all of the above, whatever the "above" is, is
again, and I hate to sound repetitive, although I am
obviously being that, is looking at work process because
that allows you to address where doing it by hand or with
paper still may be perfectly adequate but where automating
. 40
can actually help you do it better.
DR. COOL: I agree. And with that I am going to
turn to Bruce Mallett from Region II to give us perspectives
of the host of the pilot.
DR. MALLETT: Chairman Jackson, Commissioners,
thanks for letting me be here today.
CHAIRMAN JACKSON: Well, thank you for being here
today.
DR. MALLETT: I want to first, before I give you
comments specifically on the pilot, I wanted to give you
three general insights that we noticed and that we learned
part of out of the pilot process and Carl is looking at me
so I will be careful what I give you as insights.
CHAIRMAN JACKSON: We're looking at Carl.
[Laughter.]
DR. MALLETT: First of all, I think one of the
things we did with the pilot is we set a list of objectives
in place. There was a lot of gnashing of teeth but I think
you mentioned in your SRM in 1995, we should focus the work
on unique packets to complete and that's what we did. And I
believe in your Commission paper, those objectives are
spelled out. We also spelled out the scope and I think that
helped succeed in the project.
Another thing we did which you suggested in your
SRM, we put it out with the people that would use it. We
. 41
had regional people involved in the pilot and, as Mr. Fogle
will attest to, we had agreement state people involved in
the pilot.
But third, I'm not sure comes through. We also
established a sponsor at a senior manager level. Don Cool
and I co-sponsored this pilot and what that did was give
Carl a neck to wring if we didn't meet the schedule and
deadline. But I think it also showed us something.
You have been asking questions along where are you
and where are you going. One of the ways to get there is if
you put the person in charge that it is going to be their
project it seems to work. I believe that is how we
succeeded in the pilot or helped succeed, along with a lot
of work from other people.
Now let me give you some specific perspectives on
the pilot and what we think it did.
The first slide talks about improve the concept of
work. We took the design that the group had worked on that
Pat Rathbun talked about and we tested that out and we
proved that that design will work and we were quite pleased
with it. The key things in the design I thought were good
was the electronic referencing to the guidance as well as we
proved you could take a diskette, send it to an applicant,
receive that back and electronically load it into your
system and it works quite well.
. 42
As far as the second bullet there, efficiency
gains, we talked a little bit about that. I think,
Commissioner McGaffigan, you mentioned the benefits for
other type of licenses. Let me list a few that we observed
during the pilot that I think will help in the other
licenses. Some things I didn't believe that we would gain
out of it but we reserved and they are a very great benefit.
One is it focused the reviewer on a quick glance
of what the applicant had put in and where the applicant was
going to cause some procedure they need to look at in more
depth. You mentioned before to us how you tie this into
risk, into safety risk. If you pull up that screen, you
will see right away where the applicants deviated from what
is the key safety risk and we didn't figure on getting that
benefit but you can see it right away.
Another one was we heard from both applicants and
the reviewers. All the guidance was there. They didn't
have to go down the hall, ask by word of mouth, do you have
the latest guidance. They didn't have to call someone, they
didn't have to go look up some 14-volume set to find the
guidance. It was all there. A big benefit. I think it
will save you time over the long run, although not in this
application because it's so simple.
Another item that my administrative staff told me
is it will save time in retyping things. In the current
. 43
process now, we take an application from an applicant, type
it into a tracking system, pass it on to a reviewer who then
types it into some license document. With this process,
once you loaded the disk in, it filled in all those
documents. I think that has tremendous capabilities.
So the second bullet, I think the efficiency gains
were not so much seen in a turnaround time for portable
gauges but I think as a basic structure for other difficult,
complex cases you will see that.
And it was more efficient for applicants. I think
two things I would comment on that they told us was one is
the online guidance was much easier to follow but also that
it flagged items for them. If you look in the computer or
even in the hard copy of the NUREG, it flags things to watch
out for and that was a comment from them that they liked
that.
So if I could have the next slide?
Another thing we felt the pilot showed us is that
the consolidated guidance was useful and saved time. I
mentioned before not having to search the some -- one time
we looked, I think there's about 14 different sources of
references for reviewers. What the beauty of this system
showed us is you don't have to go out and look for them.
Once we reviewed them and put them all together in one
document, you can just point and click, so to speak, in the
. 44
computer and it's right there. Very handy for the
applicants as well as the reviewers.
COMMISSIONER McGAFFIGAN: Could I ask, what do you
do for the other 18 categories today, some of which have
guidance documents that don't even reflect the rule?
DR. MALLETT: There are basically three steps.
One is, the reviewer looks at the standard review plan that
is out for those and then they go down the hall and talk to
other reviewers to find out who knows is there anything new
in this area, plus they also looked at -- Don Cool mentioned
the TAR database, the technical assistant request database,
to see if there was anything in that subject area. Plus you
usually turn around behind your desk to some 14 volumes of
things and leaf through them.
Now, the reviewers that are experienced, of
course, they can do it fairly quickly. But the risk is you
miss something. The beauty of this process is consolidating
all the guidance now and keeping it updated in one location.
Did that answer your question?
COMMISSIONER McGAFFIGAN: Yes, thank you.
COMMISSIONER DIAZ: Isn't it possible, maybe I
missed something, that as you -- as the process gets more
complex, all you have to do is, you know, change your
protocol and as you change your protocol you will be able to
address more and different issues. I don't see where that
. 45
would be much more different from where you are now.
DR. MALLETT: Well, there is a particular guidance
document out there that says, for this type use that they
want to use, these are some things that we have asked them
for in the past. You might want to look at that.
For example, on a portable gauge user, you have a
simple leak test that they can or cannot elect to do because
most of those things are fairly straightforward radioactive
materials. At a research facility, like a large broad
scope, you might have something that's an alpha emitter that
is a significant difficulty in leak testing. You might have
a special procedure for that and so, for that, you might
have that further guidance in that area.
COMMISSIONER DIAZ: So you will just bring in an
additional protocol?
DR. MALLETT: That's right. You can add to the
basic, that's correct.
The second bullet I had there was there was a
built-in benefit for consistency. What was -- we heard was
both the applicants and reviewers had the same guidance
looking at it at the same time, so you didn't have to deal
with a difference in do you have the latest version, do I
not have the latest version and so forth. And that was
quite comforting.
And then last, I put a bullet of access to
. 46
guidance. I think a benefit we will gain from this we
didn't realize is now when somebody calls in and says, I
want to apply for a portable gauge application, we have a
person go down the hall, collect that particular document,
come back, have somebody put a label on it and mail it to
them. With this system now, you can tell them, go to the
home page, it's listed in the home page, and pull it up.
And that was -- we see a great benefit from that in savings
of administrative resources.
I guess I would summarize up by saying that from
the regional perspective, the users liked it, the system, we
proved it works, and we want it.
[Laughter.]
DR. MALLETT: I think Don Cool's going to talk
about that date you've been asking her for.
But before he does that, I would like to turn it
over to Mr. David Fogle from the State of Texas. Okay.
MR. FOGLE: It is an interesting segue to what I
have. I appreciate that. Thank you.
CHAIRMAN JACKSON: Please speak into the
microphone.
MR. FOGLE: To give you a better idea.
Good afternoon. Thank you. Chairman,
Commissioners. To give you a better perspective from where
I come from, I am, as the plate says, chief of the
. 47
Industrial Licensing Project for the Texas Department of
Health, the Bureau of Radiation Control, where I've been
doing materials licensing for the last 7 years. And a year
and a half out, I was given a staff of four license
reviewers to assist me. But my first bullet -- what I mean
by participation barometer is that I've been involved
whenever the NRC has asked for agreement-State participation
in different events, several times. Back in 1992 in dose
radiography, new rules were being altered at that time, and
agreement-State input was sought at that time. Basically
NRC said this is what we have, what do you think? Two years
later in dose radiography it was still around, and they said
well, we think this is what we want to do, what do you
think?
Well, to say that what I did three weeks and a day
ago is unprecedented, I don't think is taking it lightly.
Basically what happened is that I showed up along with the
other agreement-State participants to the Atlanta Region II
headquarters, and within an hour of my arrival I was
actually doing application entry into the relicensing
program. Within an hour and a half to two hours I was
completely knowledgeable on how to do entry review, QA
review, and then also customer service. So I would venture
to say that that is an unprecedented level of agreement-
State input at that level.
. 48
My comment on performance base draft reg guide --
pardon me, draft NUREG-1556, is that when it was first being
authored there was agreement-State input represented from
North Carolina, represented from Illinois, New Hampshire,
and Washington were all involved in either the authoring or
the editing of that NUREG. And many States have gone to the
performance base guidance. Texas has not. This is supposed
to be something I'm supposed to do with my copious free time
is to produce guidance of this nature. It is an excellent
idea, and the agreement States that were represented at the
pilot do believe that this is the way to go.
On to the electronic licensing information. What
did you say, yes, I want it. We're also very interested in
seeing this adapted to gas chromatography, fixed gauging,
and perhaps even in some medical applications. Most readily
we're thinking of bone mineral analyzers, eye applicators,
high-rate dose afterloaders.
This day and age I think we're all asked
certainly, all asked to do more with less, and a good
example of that is, and I have hard numbers, not with me,
but back at the office, to indicate that from 1993 to
current the number of licensing actions in the State of
Texas has gone up 40 percent, while staff remain the same.
Well, what really gives there is time. It takes
much more time to review the work that you have, and a
. 49
system like this would be not only a great benefit to the
license reviewers, to the people who pay our -- the citizens
of Texas -- but also to the licensee, our customer, because
you're getting the product to them much faster, and
certainly in the application of new license applications,
they're waiting to hear from you so they can order their
material, they can receive their material, they can use the
radioactive material.
COMMISSIONER McGAFFIGAN: Madam Chairman.
CHAIRMAN JACKSON: Please.
COMMISSIONER McGAFFIGAN: This really goes back to
our staff, I think, that technically if agreement States,
individually or -- it would have to be individually, with
their different computer systems, were to come to us and say
I want this, is that going to be a big problem, or, since
Lotus Notes underlies this, will that be relative -- perhaps
be relatively easy? I mean, did we do this at all from
the -- and are there any restraints in terms of any
contracts we signed that limits our use of this to this
agency? Or is it something that we can propagate to
agreement States if there's compatible computer systems?
DR. COOL: I think there's a couple of pieces to
those couple different parts -- parts of the question.
The infrastructure is standard system built on
Powerbuilder and SY base. Lotus Notes doesn't actually
. 50
underlie this particular application set of screens. From a
transferability standpoint to put it on a machine in Texas
technologically should not be a problem.
I'm not sure this agency has ever actually thought
through the steps that would be necessary to migrate out a
system like this, but -- and someone from the CIO's office
would probably be better placed to specifically answer this.
I would not see a reason why when the system was developed
and hardened, and I'm going to talk about where we have to
go in a minute, that it could not be placed out. It might
be that the optimal path would be to have the States who
wish to do it work with the contractor perhaps with their
own small contract to the same contractor to develop the
right set of cross-references to the State's regulations and
the State's version of the guidance document, because so
many of this keys in and the Texas regs don't number the
same way as the NRC regs or the Illinois regs, so there
would be some tailoring to that, but conceptually it should
not be a problem.
COMMISSIONER McGAFFIGAN: It just strikes me as
this could be a tremendous benefit to the agreement States
where, you know, we've done most of the up-front pothole-
riding-through, whatever -- and they get a fairly smooth
product at the end of it.
DR. COOL: Exactly.
. 51
MR. FOGLE: To help answer that, I did take a copy
of the entry application back with me to show some
individuals that work with me where the NRC is going, and
they were very excited, to say the least. So it's not a
hardware issue at all.
CHAIRMAN JACKSON: You know, the possibility
probably exists, either in the context of meetings of the
Organization of Agreement States or perhaps through the
regional offices for the NRC to conduct mini-workshops to
perhaps not only share the information but let us say
proselytize a little bit, so before I get to my closing
remarks I urge you to consider.
DR. COOL: We are in fact scheduled to have a
booth in the poster session at the conference of radiation
control programs.
[Laughter.]
DR. COOL: We weren't calling it by quite those
same terms, but in fact we intended to set up the system,
show it, and run it on a longer basis than you can get one
of those wonderful little 15-minute segues on the front
stage.
CHAIRMAN JACKSON: Right. Very good.
DR. COOL: We'll move along to the next steps, and
I want to try and address two areas here, first in terms of
the guidance consolidation itself. As I mentioned a little
. 52
bit earlier, we see great benefit in this, and as you
mentioned, Madam Chairman, there is a huge jump to be gained
by having that guidance consolidated. There are a whole
series of actions to get us to the point where the guidance
will be consolidated for all of the various classes of
licensees.
Step number 1 obviously is to go ahead and
finalize the portable-gauge document. The public comment
period has been completed. We've gotten public comments on
it. We've subjected it to a test. I think we can move
forward very rapidly within the next month or two to make
that a final document and make that the basis for doing the
portable-gauge licenses.
Immediately after that you can start to attack
some of the very similar things, things like fixed gauges,
self-shielded irradiators, a number of places that use
sealed sources where devices are designed in already which
are very similar for which this application can very quickly
in terms of guidance development. A number of the
applications are very similar to the sorts of things you
would see in guidance are very similar, to move those very
quickly during the first half of this year, by the end of
the fiscal year have those drafts on the street.
We are moving forward already with radiography,
using this approach to write the guidance that will be used
. 53
to implement the rule, which is still under OMB clearance
and so yet has not even become effective. Our intention is
to implement the new rule with the new approach to guidance,
to move from there then into other areas where the
regulations are relatively stable, they've undergone a more
recent revision such as irradiators, well logging, some of
those issues.
And then a little bit later in the cycle, down the
line a year and a half, two years, to be bringing on the
guidance associated with broad-scope applications, medical
applications, for which we have ongoing contemplated
significant changes to the regulatory structure such that
you write the consolidated guidance document to go along
with the new rulemaking rather than pumping resources into a
consolidated document for something which we are undergoing
simultaneous change. And to do that in the process where we
would be looking at developing application screens from
electronic systems to implement that which can be relatively
readily facilitated by an electronic assistance during the
comment period associated with each of those consolidated
guidance documents.
So those pace along as you schedule them out, and
we've in fact laid out a schedule within my operating plan
to look at doing those taking into account those factors.
We plan to move forward with that, adjust that as necessary
. 54
to respond to assessment directions. We're looking at that
same system, underlying information, as being part of the
basis for the generally licensed devices where we might go
in a registration system.
This fundamental set of information is the exact
same set of information you would want a registrant or
someone else to have available to them. So we believe there
is a great deal of crossover to that.
In terms of the electronic system, this gets back
to some of the points that you brought up, in terms of
portable gauges itself, continue to refine the application
through what in the industry is referred to as beta testing.
Yes, we identified some other glitches that need to be
fixed.
There are some things that need to be done to make
this a system that you have confidence in. There's
essentially no security password controls, backups, that you
build into it in the three or four-month developmental
window that you want to have in place if you're using it as
your processing system. Those need to be accomplished.
You need to continue to work through the process,
let reviewers continue to use it. In a week's time you
identify some things; you'll continue to find those sorts of
things. As Bruce mentioned, we plan to use the sponsor
approach. Region II will be the sponsor for this activity.
. 55
It'll reside in Region II. It'll be used in Region II to
review applications that come in. We may send applications
from the other regions down there to run them through that
particular system.
We will have to have some workarounds. What do we
do to make sure that we generate the right kind of
documentation to put in the licensing file in order to
accommodate the present system, the present requirements for
having files and backups that meet archive requirements. We
will continue to do those things over the next few months.
So one answer to your question is we will be
processing applications. Once the document is final and
that becomes the baseline for licensing portable gauges, we
will be doing at least some of them that way as we continue
to harden-down the system.
As I mentioned with other types of licenses,
develop the associated application screens as you bring each
one of those consolidated documents along. As you
mentioned, it makes no sense to electrify that which you
haven't already gone through and consolidated and pulled the
information together, looked at what the questions are that
you really have to ask. So that's our process, our plan to
bring each one of those along as we run through that
guidance system.
In terms of bringing it on line as a network
. 56
application, that obviously has to pace along with where the
agency is and the CIO is in terms of the underlying
information management system, document control systems,
electronic document systems, code name ADAM. Our
understanding, we've been meeting with the CIO, Carl met
with Mr. Gallante this morning, is that the CIO will be
selecting the fundamental software packages probably in the
next 90 days or so. I'm not sure how firm a number that is.
DR. PAPERIELLO: I won't hold him to that number,
but we had a discussion, it's in that time frame, that I
believe they're going to have the underlying software that's
going to support ADAM identified.
DR. COOL: Once we have that software identified,
we can look and see whether we have to make any changes in
order to be able to be compatible with the infrastructure.
And then as those systems are brought on line, we can also
bring on line to a greater extent the system that we have
developed. And so that will be a hand-in-hand process which
we will need to walk down with them as the infrastructure is
available to use it, as the network capabilities are
available, as we have hardened and secured it such that it
meets the standards, it has the proper kinds of backups that
we don't lose the information, that it becomes an online
system. And so the answer to that question is I can't
really give you a date for being able to do that, because
. 57
that will be a hand-in-hand process as we select software
test systems, validate systems out, and move in that
direction.
CHAIRMAN JACKSON: Okay. I have a followup
comment and a couple of questions.
I agree with you, when you talk about refinement
of the information system from the point of view, you
mentioned no security, no password controls, no backup.
Those are very serious issues that one has to deal with as
up-front as one can.
But there's a difference, I would think, between
that and what I'll call iterative performance improvements,
where you may have an already usable or good system, and it
strikes me that that kind of iterative performance
improvement is something that IRM or the CIO ought to be
doing for you, and not necessarily have it done by the
resources of people who are materials licensing people. It
just strikes me that it's a question of how resources get
used.
I had a couple of followup questions on your SECY.
You had an attachment to that SECY that showed that as far
as training plans are concerned the staff intends to conduct
a BPR of the administrative support functions within NMSS,
and NMSS was mentioned also in SECY 96-205 last September.
And this is a good, may be a good idea, but now my
. 58
understanding though is that the regions perform basically
the materials licensing function, not the headquarters. And
so the question is, how will this new effort relative to BPR
of administrative support and NMSS affect continued progress
toward licensing process reform, which is what our goal was
here, and it was the original objective.
You mentioned a kind of pacing in terms of dealing
with fixed-gauge, self-shielded irradiators, radiography
licensing, well-logging, and broad-scope applications. And
so the real issue becomes one of, if it's a question of
expenditure of resources, that you keep the momentum going
in the licensing area, not that it's, you know, that you
don't want to obviously streamline administrative support
functions as much as you can, but what the Commission has
supported you in doing is streamlining the licensing,
materials licensing process.
And so -- but my questions are not meant to
question the wisdom net net of streamlining or BPRing
secretarial or administrative support functions, but given
the bumpy road we've gone along to get to where we are, it's
important that we don't lose that momentum, and that we
don't divert resources that could be used to help the
regions do their regulatory function, you know, unless this
is all part of an integrated picture. And so that's my one
caveat about that.
. 59
Commissioner Rogers, you have some questions.
COMMISSIONER ROGERS: Well, we had a lot of good
words said today and a lot of wisdom --
[Laughter.]
COMMISSIONER ROGERS: -- folks, and I'm not going
to add to that. I think that they're all good things,
they're all things that have to be kept in mind as you
proceed. I'd just like to say that I, in reflecting on this
project, I really want to compliment NMSS and Dr. Paperiello
for getting started on it, and this was really the first
major BPR effort at NRC, and I think that it so far looks
like it's being successful and being very carefully and well
executed. And I hope we can learn lessons from it that will
allow us to take the same kind of critical review of all of
our other licensing activities in other areas.
Thank you very much.
CHAIRMAN JACKSON: Commissioner Dicus.
COMMISSIONER DICUS: It follows up a bit I think
on the Chairman's question or statement about overall
resources. The comment is made in the SECY paper I believe
it is that the verification of the information that's
presented in this format, together perhaps with other
formats, but is going to have to be done in the inspection
part of the program.
And some of the language would imply, or perhaps
. 60
suggest, that while there may be a savings for the agency,
not to mention licensees, et cetera, but a savings for the
agency, perhaps in FTE, time, whatever, at some point, it
could be lost because it's going to overload the inspection
part of the program. And I just want to raise this to make
you aware of it, and if you had any thoughts on it.
DR. COOL: Well, we're certainly aware of that
particular issue. It's been an issue that we spent actually
a lot of time talking about where do we go and what is the
tradeoff, because there are two kinds of touches. There are
inspection touches, and there are licensing touches. We in
fact as part of the routine program can do an initial
inspection of each license that we issue. This would change
the list of things that they look for. But fundamentally I
don't believe it would change significantly the amount of
time we would actually spend, because we put a great deal of
priority on having an initial inspection out there shortly
after they've had the material to make sure that the set of
commitments they've given, whether it's old system or new
system, have actually been translated into a program. And
that becomes equally important irrespective of whether
they're doing it under this particular guidance, 1556, or
whether it's under the older guidance.
CHAIRMAN JACKSON: Do you have a question,
Commissioner Diaz?
. 61
COMMISSIONER DIAZ: Yes. Follow along these same
comments, but it seems to me like you have taken two big
steps already. One is develop the consolidated guidance
document, that was certainly good, and then going to the
electronic processing. But we don't want to let you off so
easy, so we'll ask the next question. What provisions have
you made or have you been considering in taking the next
step in making this into a true expert system and providing
full Internet access to handle licensing.
DR. COOL: Let me answer that in two halves, the
latter first. We spent a great deal of time thinking about
Internet access. That's very much the way we would like to
be able to go as the infrastructure allows the acceptance of
an application from that mode and we can process it, handle
it correctly, retrieve it and archive it. We have already
taken the steps and plan to have the steps of having the
documents available on the Internet for someone to use and
download. So it is a logical next step as we have the
infrastructure availabilities to allow them to fill it out
as Commissioner McGaffigan was dealing with soccer, or
buying tickets from American Airlines or whomever.
[Laughter.]
DR. COOL: The second question, we have also
thought about some, although not as much yet. We are still
at this point putting the reviewer in the loop looking at
. 62
the application.
Now, a logical step is, as we gain some more
confidence, letting the computer look and see if they have
clicked that they have committed to the standard condition,
letting the computer only flag those pieces for which they
have requested a special provision or otherwise. We have
not taken that step yet but the system does not preclude
adding to it, probably relatively simply, a quick scan by
the system saying, check, check, check, check, go look at
items 5 and 26.
COMMISSIONER DIAZ: That's precisely the point.
It seems to be a very simple thing to do. Why not take a
risk and go and do it while you're taking these steps?
CHAIRMAN JACKSON: It's a question of where you
start, where they're coming from.
COMMISSIONER McGAFFIGAN: Could I just ask, as you
go down, in this case, you don't have any technical diagrams
that would be part of a normal license application for a
portable gauge but in the other 18 areas, I am sure in the
reactor world we have very, very complex documents that are
volumes and lengths at times. But in your world, what is
the worst? Of the 18 categories yet to be done, which will
be the hardest to apply this paradigm to?
DR. COOL: Probably the big, broad-scope programs
where the license is covering licensee programs of radiation
. 63
protection and bioassay and for which there are very few
things you can just say, I commit to do X. Because the
license is issued for programs.
And in between that are a variety of things in
medical areas where you need to look at certain procedures
or some of the more complex isotope productions, things like
the productions of sealed sources or devices -- sealed
source device reviews, for example, where you've got a lot
of detailed technical drawings and have to go through a lot
of specifications still require a great deal of interaction
where you can't simply check some things off. So you've got
a whole range. We picked that on the bottom end and there
are several other categories. Even though they may be more
risky like radiography, for which this approach covers
virtually all of it.
COMMISSIONER McGAFFIGAN: Right. But is your
intent to be flexible? I mean, as you go through the other
18 categories and this paradigm doesn't work perfectly
you'll say, okay, it doesn't work and we're going to do
something -- we'll stick with paper, we'll get the
consolidated guidance done but we'll stick with paper? Or
what is the intent as you go forward?
DR. COOL: The intent is to apply it as it works.
So even for those pieces of program where you may need to do
detailed reviews in certain areas, there are probably other
. 64
areas for which this can assist. Name, address, contact and
some other things still always come up; you might as well
use the system to the extent you can use it but without
being slavish to it.
DR. MALLETT: Don, let me add to that, I think
what you'll find, though, what I learned this morning,
something new, is there is a section of this now that allows
the reviewer to comment on their basis for why they made a
certain decision and it is documented right into the record
as something we've been trying to achieve for a long time
and I think you'll find reviewers will like the ease of
doing that and will gain benefit in those more complicated
cases having that in there.
COMMISSIONER McGAFFIGAN: Well, my final comment
is only that I don't know how we got into the situation
where our guidance was as you described it when this process
started but I commend every effort to fix it and use
whatever flexibility you need to fix it. It strikes me we
should not do new rules if we can't see within a finite
period of time a way to get reg guides out and standard
review plans and all that sort of stuff to implement the
rule. And the resources have to be there. You know, you
have to come to us as a commission and say the resources,
you know, there is a mismatch here and we have to fix it.
And so I don't want to revisit the past but where
. 65
you guys started from is obviously not an acceptable place
to start from and I am glad you are trying to get out of it
as rapidly as possible.
CHAIRMAN JACKSON: I think, if I can speak, they
are starting from a point of, particularly in the materials
area, you know, there is a lot out there that has to be
fixed and within the last year-and-a-half to two years the
Commission has given the staff explicit guidance that is
they bring forward new rules. They should be bringing
forward the regulatory guidance, as well as standard review
plans that go along with those rules so as to not end up in
this kind of lead/lag situation. So the guidance from the
Commission is already there in that particular context.
MR. THOMPSON: That's right and that has been the
practice. It is the old rules that were there, probably
from the time I started working for the NRC, that have
created a lot of the problems that we find today that we are
addressing.
CHAIRMAN JACKSON: I think Dr. Paperiello had an
itch?
DR. PAPERIELLO: We can consolidate the guidance
within this framework. There is no problem there. For the
complicated receipts, where we have shielding that we have
to calculate or structural issues that way, yes, that's
going to be. But the computer helps you. The computer
. 66
forces people to walk through every step that has to be
submitted and make sure the applicant, not only that we re-
dot the "i" and cross the "t" but by providing it to the
applicant who sees exactly what the reviewer is going to
look at forces the applicant to do the same thing, so it is
a discipline in the process.
CHAIRMAN JACKSON: Thank you.
The Commission would like to thank the staff and
Mr. Fogle, the representative from the Texas Agreement State
Program, for this briefing. It has been very informative
and useful and the Commission particularly appreciates the
agreement states' perspectives as we reform our licensing
processes because any improvements or efficiencies that the
staff makes in NRC's business practices we hope could be
easily adapted and accepted by the agreement state programs
with appropriate modifications. And particularly if we can
resolve issues once in a manner that is agreeable to both
the federal and state regulators, we will end up minimizing
the cost to our citizens and to our licensees as the case
may be.
But what the staff has shown today though is that
through the successful results of the BPR pilot program, the
materials licensing processes can be reformed to provide
greater efficiencies without a loss that you've told us of
technical quality or safety and, in fact, the pilot program
. 67
seems to demonstrate the license applicants' satisfaction
with the process, which is a significant achievement for a
regulatory agency. So I am cautiously optimistic that the
improved efficiencies and customer satisfaction can be
propagated and continued over longer time periods if the
program is implemented NRC wide as well as within your
particular area, Dr. Paperiello.
And so I think we are all urging the staff to
proceed rapidly particularly with the implementation phase
to the greatest extent you can. But aside from the
program's, the pilot program's success, there has been a
fair amount of resources invested and -- and the issue
becomes what the scale factor is in terms of going. What do
we take away as lessons learned? And so the next year will
be a critical time for this project and it's important to be
able to report some tangible results to the Commission. And
so in that case, then, there has to be a movement beyond
process and a focus on implementation and there was
something that Dr. Mallett mentioned that I think are good,
overarching metrics. We have talked a lot about them. One
is consolidation of guidance, consistency and resource
savings.
I think falling out of this, and I would also say
customer satisfaction. And you can think of customers both
in the sense of license applicants, licensees as well as
. 68
agreement states and our own regional offices. I mean, they
are our internal customers. And I would just urge you to
focus particularly on the issue of the role of what I call
work process optimization as we are making or as a
prerequisite to information technology investments. And
also that we move along to creating, as Commissioner Diaz
has said, a truly more expert system but particularly one,
and you spoke to this, that provides the appropriate
Internet access.
We know we have to deal with things like security
and controls of various kinds as we do that. But it is
important if we really want to move beyond mailing out
diskettes but actually have people do it on line.
So again, the Commission commends the staff and
the agreement states on the success of the pilot program and
we thank you for the briefing. And so unless there are
further comments by the commissioners, we are adjourned,
just on time.
[Whereupon, at 2:32 p.m., the briefing was
concluded.]
|
Privacy Policy |
Site Disclaimer |