Transcript Overview of a New Training Program Produced by LeBlond

Training Program Overview
Produced by
LeBlond & Associates, LLC
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© November, 2001
LeBlond and Associates, LLC
Response to “Conditions Adverse to Quality”
Developed and Presented by LeBlond and Associates, LLC
© November, 2001
LeBlond and Associates, LLC
Contents of This Presentation
(color coded by topic)
• Why has this course been developed?
• How will the course be structured?
• What course materials will be provided?
• Is on-site instruction available?
• What is the current delivery schedule?
© November, 2001
LeBlond and Associates, LLC
Why Has This Course Been Developed?
• NRC has revised the guidance for these activities twice in recent
years
– NRC Inspection Manual Chapter 326 was issued January, 2014
• Update of Regulatory Issue Summary 2005-20
– Revision reflects a number of issues developed in the last few years
• Use of Maintenance Rule
• Differing treatment of SSCs controlled, or not controlled, by TS
LCOs
• Separation of Corrective Action from “Change”
But more importantly…
• Classroom experience over the last few years has demonstrated
that students typically struggle with these concepts
– The “Typical Student Questions” on the next slide are indicative.
© November, 2001
LeBlond and Associates, LLC
Typical Student Questions
• Exactly how, and when, do I perform an Operability
Determination?
– What are the main features of an Operability Determination?
• Operability versus “Change”?
– How do Operability Determinations fit in with 10 CFR 50.59?
• How does Corrective Action relate to:
– Operability?
– Change/10 CFR 50.59/Temporary Alterations?
– Maintenance Rule Risk Assessment/Management?
• Can I run my plant with a defect that would require NRC
approval under 10 CFR 50.59?
• Can a SSC be Inoperable (or Operable) if there is no
associated Technical Specification?
– How does “Functionality” fit in?
• When are Temporary Changes treated as Maintenance?
• and other similar questions.
© November, 2001
LeBlond and Associates, LLC
Overall Course Objective
• To provide an understanding of the:
– Goals
and
– Interrelationships
of the following five processes.
• Identification of Conditions Adverse to Quality
• Corrective Action
• Ensuring Public Health and Safety (Pervasive, of course)
• Operability Determination/Interim Operation
• Maintenance Rule Risk Assessment and Management
The actual course’s slide introducing the Major Course
Objectives is next.
© November, 2001
LeBlond and Associates, LLC
Major Course Objectives
The student shall Define and Identify:
1. Conditions Adverse to Quality in Accordance with Industry Standards
2. The Elements of a Corrective Action Program as described in as described
in NRC Inspection Manual Chapter 326 (update of Regulatory Issue
Summary (RIS) 2005-20) and industry standards
3. Inoperable versus Operable SSCs in Accordance with Inspection Manual
Chapter 326 (update of RIS 2005-20) and Industry Guidance
4. The Assessment and Management of Risk Increases Associated with
Maintenance Activities in Accordance with Regulatory Guide 1.182 and 10
CFR 50.65
5. The Interrelationships of the Processes Defined Above
• with the Overall Goal of Protecting the Public Health and Safety
6. The Use of Site-specific Procedures to Implement these Processes
Click to Advance to
© November, 2001
LeBlond and Associates, LLC
“How is this course structured?
How Is This Course Structured?
• Five processes are be covered
–
–
–
–
–
Identification of Conditions Adverse to Quality
Corrective Action
Ensuring Public Health and Safety (Pervasive, of course)
Operability Determination/Interim Operation
Maintenance Rule Risk Assessment and Management
• For each process:
– The legal background is be provided
then
– the concepts associated with each process are illustrated
• Illustrated? … How is that presented?
© November, 2001
LeBlond and Associates, LLC
To see more about the illustration of
these concepts, click here
Use of Five Illustrative Examples
• Five examples are introduced at the beginning of the
course
– The examples are based upon actual UFSAR material from
a variety of sites
More importantly …
• They have been selected to illustrate patterns of
defects commonly encountered
–
–
–
–
–
–
Defect in QA documentation
Material property deficiency
Support equipment degradation
Discovery of a design deficiency
Failure of non-safety related equipment
Defect potentially resulting in a serious safety concern
© November, 2001
LeBlond and Associates, LLC
Procedure Customization
• The course is intended to be “customized” to each
site’s procedures
– The site-specific procedures are compared against the
guidance and regulations
– An option is available to allow a site to conduct an procedure
improvement cycle prior to incorporation into the class
material
• Option includes a report examining current procedures
• Intended to allow student to relate their procedures to
the underlying regulations
• Each process will follow this instructional sequence:
1. The site’s implementing procedure will be identified
2. The class will cover the associated rules/guidance
3. The procedure will be compared to the course’s content
Click here for more detail on the course’s characteristics
© November, 2001
LeBlond and Associates, LLC
Additional Course Characteristics
• Two days in length
– 16 hours of instruction with 2 hours for review/exam
• Attendance by a wide variety of students is appropriate,
but…
– Intended for “10 CFR 50.59 and Related Processes” graduates
• All reference material is located in a separate book
– No flipping back and forth
• Main presentation file proceeds “front to back”, with
each slide in sequence
• A Master Flowchart will be used to orient the class
• A few simple course slides from “Identification” follow
Click here to view a few simple, selected course slides
© November, 2001
LeBlond and Associates, LLC
Identification
• What is a “Condition Adverse to Quality?”
• ANS-3.2-1994 definition
An all-inclusive term used in reference to any of the following: failures,
malfunctions, deficiencies, defective items, and nonconformances.
• In practice, this is a very broad term.
• Procedure ## controls this activity at XXX
© November, 2001
LeBlond and Associates, LLC
No discussion
of procedure at
this point. That
occurs at the
end of each
process.
Example #1
The vendor that provided the RHR pumps has discovered that
one of the pumps delivered was only tested up to seismic
accelerations of 1.9 g, rather than the specified value of 2.1 g.
The pump was purchased as Safety-Related, and the
Purchase Order did specify the testing specifications, which
included the required accelerations.
Is this a Condition Adverse to Quality (CATQ)? If so, why?
© November, 2001
LeBlond and Associates, LLC
Yes.
The Regulatory Issue Summary (RIS) guidance specifically
identifies “does not meet CLB requirements” as one example of
a Non-conforming condition. The UFSAR is specific in
identifying the testing’s acceleration of 2.1 g.
However, a CATQ does not have to be related back to the
UFSAR’s content or wording. The definition provided in ANSI
3.2, and RIS are consistent. A CATQ is “an all-inclusive term”.
In this case, note that Appendix B, Criterion 7 addresses this
general issue of ensuring that SSCs are received as specified
in purchase documents. This “Loss of Quality” is a CATQ.
Review the guidance provided in IMC 326, Sections 2.0, 3.2,
and 3.7. Note that the term “Fully Qualified” is defined in
Section 3.4. We will refer back to this significant concept in the
Corrective Action and Operability Determination processes.
© November, 2001
LeBlond and Associates, LLC
Graphical Summary of Identification Process
Conditions
Adverse to
Quality
Ø
Ÿ
Ÿ
Ÿ
Ÿ
Ø
All inclusive term
Failures
Malfunctions
Deficiencies
etc.
Not limited to
UFSAR
To Ensuring Public
Safety
This flowchart is part
of the Master
Flowchart and is
used to summarize
each process and
orient the students
as the class
proceeds.
© November, 2001
LeBlond and Associates, LLC
Significant
Condition
Adverse to
Quality?
No
Yes
To Corrective Action
Ø A condition, if
uncorrected, could
have a serious
effect on safety or
operability
Additional Illustrative Example
• The next two slides are from a continuation of
“Example #1”
• Illustrates the Inspection Manual Chapter 326
concept of “Reasonable Expectation of Operability”
– Part of the “Operability Determination” process
© November, 2001
LeBlond and Associates, LLC
Example #1
Residual Heat Removal Pump Purchase and Testing Requirements
The vendor that provided the RHR pumps has discovered that one of
the pumps delivered was only tested up to seismic accelerations of 1.9
g, rather than the specified value of 2.1 g.
The pump was purchased as Safety-Related, and the Purchase Order
did specify the testing specifications, which included the required
accelerations.
Investigation has determined the following:
1. The correct pump model was shipped. The error resulted from
another client who purchased the same model, but only tested to 1.9 g.
2. The other pumps received were successfully tested to 2.1 g.
© November, 2001
LeBlond and Associates, LLC
Question #1
Use the Specified Functions previously identified, and follow
the process summarized in the Master Flowchart.
Is there a “reasonable expectation” for believing the RHR pump
in question remains “capable of performing its specified
functions?” If so, what is the technical basis for this
expectation?
Need to “click once”
to view the answer.
Yes.
The pump in question is identical to the other pumps delivered.
Those pumps successfully passed the intended/required tests.
In addition, there may be historical test data that supports this
conclusion.
Note that this conclusion does not alter the potential Appendix
B, Criterion seven compliance issue.
© November, 2001
LeBlond and Associates, LLC
Summary of Course Structure
• Each of the five processes are handled in a similar
fashion.
• The “story” for the five illustrative examples is carried
throughout the class and is unfolded as the
processes are illustrated.
Click here to advance to “What course materials will be provided?”
© November, 2001
LeBlond and Associates, LLC
What Course Materials Will Be Provided?
• Same breadth of material provided for “10 CFR 50.59
and Related Processes”
– Three-day course
•
•
•
•
•
Master Presentation File
Learning Objectives
Lesson Plan
Posters, handouts, etc
Exambank cross-referenced to
– learning objectives
– location of instruction
• Hard copy master for student reference books
Click here to advance to “Is on-site instruction available?”
© November, 2001
LeBlond and Associates, LLC
Is On-Site Instruction Available?
• Yes
• Instruction may be acquired separately from the
Course Materials
Click here to advance to “What is the current delivery schedule?”
© November, 2001
LeBlond and Associates, LLC
What is the current delivery schedule?
• The course materials are complete and are ready for
site-specific procedure customization.
• It has been delivered over one hundred times at
numerous sites
– Student feedback has been overwhelming positive
– Site-wide training was part of NRC Corrective Actions at
many of the sites
• The site-specific class can be delivered at your site
within seven weeks or less from a decision to acquire
the Class Materials or Instructional Services
© November, 2001
LeBlond and Associates, LLC
Closure
• Thanks again for your interest and time
• For any questions or further details, contact Peter LeBlond at:
– 847-549-8775
or
– [email protected]
Just click anywhere to end the show
© November, 2001
LeBlond and Associates, LLC