1. © November, 2001 LeBlond and Associates, LLC Training Program Overview Produced by LeBlond & Associates, LLC Thanks for taking the time to view this presentation –It’s about ten minutes long This presentation will advance automatically until you see this symbol –which means “click to advance” Click on this when you are ready to proceed

2. © November, 2001 LeBlond and Associates, LLC Response to “Conditions Adverse to Quality” Developed and Presented by LeBlond and Associates, LLC

3. © 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?

4. © 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.

5. © 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.

6. © 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.

7. © 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 “How is this course structured?

8. © November, 2001 LeBlond and Associates, LLC 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? To see more about the illustration of these concepts, click here

9. © November, 2001 LeBlond and Associates, LLC 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

10. © 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

11. © 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

12. © 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 No discussion of procedure at this point. That occurs at the end of each process.

13. © November, 2001 LeBlond and Associates, LLC 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?

14. © 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.

15. © November, 2001 LeBlond and Associates, LLC Graphical Summary of Identification Process This flowchart is part of the Master Flowchart and is used to summarize each process and orient the students as the class proceeds.

16. © November, 2001 LeBlond and Associates, LLC 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

17. © 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.

18. © 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? 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. Need to “click once” to view the answer.

19. © 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?”

20. © 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?”

21. © 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?”

22. © 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

23. © 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 –LeBlond@Prodigy.net Just click anywhere to end the show