EED Nuclear QA Auditor Training Handbook The Vital...
Transcript of EED Nuclear QA Auditor Training Handbook The Vital...
EED Nuclear QA Auditor Training
Handbook
The Vital Qualification Tool
Karen M. Douglas
13 October 2017
Applications of Nuclear Quality Assurance
• Domestic Commercial Nuclear Power Operations - US NRC Regulated,
10CFR50
– 99 Operating Nuclear Reactors
– Spent Nuclear Fuel – 10CFR72 Storage, 10CFR71 Transport, Disposal,
10CFR72 Casks
– Service Providers (ISI, Welding, Fabrication, Testing, Maintenance,
Calibration) follow ASME Section III, V, IX, XI
• Defense Nuclear Applications – US DOE Regulated, 10CFR830
– Radioactive Waste Management
– Nuclear Facilities and Nuclear Research
• Suppliers of Systems, Structures, Components & Services for Nuclear Safety
Applications
• International Nuclear Applications – ASME NQA-1, IAEA-GS-R3
– 449 Operating Nuclear Reactors in 30 Countries
– 66 New Reactors under Construction (2015)
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Evaluation of Nuclear Quality Assurance compliance
• ASME NQA-1 Quality Assurance Requirements for Nuclear Facility
Applications
– Dominant Standard for Domestic and International Nuclear Industry
– 4 Parts, 18 Criteria (2008 Standard)
– Specific Auditing Techniques Applicable
– Standardized Nuclear QA Auditor Training & Qualification
• Nuclear QA Auditor Qualification and Maintenance of Proficiency
– Specific Training, Examination, Experience for Nuclear Applications
(Figures 4.7, 4.8, 4.9)
– Tools and Learning Methods Essential to Nuclear QA Auditor
Proficiency
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ASME NQA-1 QA Requirements for Nuclear Facility Applications
2008 with 2009 Addenda 18 elements
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ASQ EED Nuclear Quality Assurance Auditor Training Handbook
• ASQ EED Nuclear QA Auditor Training Handbook – History (Contents)
– 1986 Quality Systems Auditor Training Handbook, ASQC Education and
Training Committee of the Energy Division
• Practical Examples for Nuclear QA Auditing Applications
– 2 Blank and 14 Completed Forms
– 4 Diagrams
– 4 Completed Tables
• 4 Case Studies
– Illustrate typical Nuclear Audit Scenarios
– Feature conversations between Auditor and Auditee
– Case Study Solutions and Audit Deficiencies with Criteria included
– 1999 Revision incomplete
– 2016 EED Handbook Requested for Auditor Training in China; previously
IAEA expressed interest
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EED Nuclear Quality Assurance Auditor Training Handbook
2018 Revision
• Retains Practical Approach used for 1986 Auditor
Handbook
• Revises and Supplements Standards, Figures, and
Examples
• Incorporates new Programs instituted since 1986
– Section 7.1 Commercial Grade Dedication and
Commercial Grade Dedication of Software
– Section 7.2 Suspect/Counterfeit Items
– Section 7.3 Software Verification and Validation
– Section 7.4 Control of Electronic Records
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EED Nuclear QA Auditor Training Handbook Supplements
(cont’d)
• 2017 Case Study Supplements
– Case Study #5 External – Subcontractor Readiness
Audit
– Case Study #6 Source Verification for Commercial
Grade Item Dedication (Method 3)
– Case Study #7 Suspect/Counterfeit Items
– Case Study #8 Software Use in Nuclear Applications
– Case Study #9 Software Verification and Validation
– Case Study #10 Control of Electronic Records
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EED Nuclear Quality Assurance Auditor Training Handbook
Sample Figures
• Figures 4.5, 4.6 Example of Audit Plan Form &
Completed Audit Plan
• Figures 4.7, 4.8, 4.9
– Example of ASME NQA-1 Lead Auditor Qualification Form
– Completed ASME NQA-1 Record of Lead Auditor Qualification
(1993 & 2014)
• Case Study #3 Nuclear Utility Construction (1986
Handbook with Worksheet identifying Deficiencies)
• Case Study #6 Commercial Grade Dedication (Nuclear
Application & Figures)
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Audit Plans – Blank and Completed
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AUDIT NOTIFICATION
AND
AUDIT PLAN
AUDIT NO.:
#####
NOTIFICATION OF AUDIT
DATE:
TO: LOCATION:
FROM: LOCATION:
DATE OF AUDIT: CC:
An audit has been scheduled to be performed as indicated below. If there is a problem concerning the plan, or a conflict with the
schedule, please contact the team leader. Any changes to the plan or date of audit must be confirmed in writing.
AUDIT TEAM LEADER / TELEPHONE NO.:
AUDIT TEAM:
TENTATIVE SCHEDULE:
PRE AUDIT:
POST AUDIT:
AUDIT PLAN
ORGANIZATION / ACTIVITY TO BE AUDITED:
PURPOSE / SCOPE:
PROGRAM REQUIREMENTS / APPLICABLE PROCEDURES:
Quality Program:
Departmental Procedures:
Project Procedures:
Other:
CHECKLIST REFERENCE:
PREVIOUS AUDIT:
Audit No: Date:
AUDIT TEAM LEADER SIGNATURE
Findings: Yes: [ ] No: [ ]
AUDIT NOTIFICATION
AND
AUDIT PLAN
AUDIT NO.:
2017- Nuc –PF8
NOTIFICATION OF AUDIT
DATE: June 6, 2017
TO: John Harmen, QA Manager, Pennsylvania Forge LOCATION: 5401 1st St. NW, Pittsburgh, PA
FROM: Josephine Kemp, QA Manager, Rodey Fabrication LOCATION: Charlotte, NC
DATE OF AUDIT: July 11-13, 2017 CC: Edith Talbot, Technical Manager
An audit has been scheduled to be performed as indicated below. If there is a problem concerning the plan, or a conflict
with the schedule, please contact the team leader. Any changes to the plan or date of audit must be confirmed in writing.
AUDIT TEAM LEADER / TELEPHONE NO.:
Carla Thomas/(807) 295- 6186
AUDIT TEAM:
Robert Wilmot
Peter Jenkins
Bernadette Diaz
TENTATIVE SCHEDULE: July 11 – 13, 2017
PRE AUDIT: Tuesday, July 11 9 :00 am
POST AUDIT: Thursday, July 13 3 :00 pm
AUDIT PLAN
ORGANIZATION / ACTIVITY TO BE AUDITED:
Pennsylvania Forge Supplier qualification/Machining and QC inspection of component for 10CFR72 Dry Cask Storage
of Nuclear Material
PURPOSE / SCOPE: Addition to Rodey Fabrication Qualified Supplier List/ASME NQA-1 2008 with 2009 Addenda
PROGRAM REQUIREMENTS / APPLICABLE PROCEDURES:
Quality Program: Pennsylvania Forge Quality Assurance Program, April 2016
Departmental Procedures: Pennsylvania Forge procedures controlling:
Training and Qualification, Receiving Inspection, Identification and Control of Items, Mechanical Inspection, Control of
Measuring and Test Equipment, Procurement, QA Records
Project Procedures: Rodey Manufacturing Control Drawing #2015- UCL33267, Rev. G; Rodey Material Specification
#CS-4J275, Rev. B, 2/15/14
Other:
CHECKLIST REFERENCE: N/A
PREVIOUS AUDIT: N/A
Audit No: Date:
AUDIT TEAM LEADER SIGNATURE
Carla Thomas
Findings: Yes: [ ] No: [ ]
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Figure 4.7 ASME NQA-1 Lead Nuclear Auditor Certification
(blank)
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Lead Auditor Qualification Record
Name: _____________
Sheet 1 of ___
Qualification Requirements Credits
Education - University / Degree / Date Maximum Credits - 4
Associate Degree (1 or 2 Credits)
Bachelor Degree (2 or 3 Credits)
Masters Degree (1 Credit)
Experience - See Resume Maximum Credits - 9
Technical (0 to 5 Credits) and
Nuclear Industry/ (0-1 Credit) or ISO 9000
Quality Assurance (0 to 3 Credits) or
Auditing (0 to 4 Credits)
Professional Accomplishment - Certificate / Date Maximum Credits - 2
Professional Engineer
Society
Rights of Management Maximum Credits - 2
Justification:
Evaluated By: Title: Date:
Credits Assigned By: Title: Date: Total Credits
Audit Communications Skill
Evaluated By: Title: Date:
Audit Training: See Training Records
Audit Participation: See Audit Participation
Examination
Written: (Grade)
Oral: (Evaluation)
Practical: (Evaluation)
Evaluator Title Date
Qualification Certified By: Title: Date:
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Figure 4.8 ASME NQA-1 Lead Nuclear QA Auditor Recertification
2014
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{Graphic}
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Figure 4.9 ASME NQA-1 Lead Nuclear QA Auditor Recertification
1993
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Case Study #3 Nuclear Construction Supplier Assessment
1986 Handbook
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Case Study #6 – Commercial Grade Dedication
Source Verification (Method 3)
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Case Study #6 (Commercial Grade Dedication)
Application
Source Verification for Commercial Grade Item Dedication (Method 3) - see Figure 7.2
Source Verification
Scope
Compliance to ASME NQA-1, Part II, Subpart 2.14 QA Requirements for Commercial Grade
Items and Services, 2009; 604 Method 3 Source Verification
Setting
The Audit begins in the Conference room of Hanover Forge. Following presentation of Hanover
Forge History, Manufacturing Capabilities, and Industries Served by QA Manager, the NuCargo
Auditor/Source Inspector, Hanover Engineer and QA Manager proceed to QC Department,
where Hanover Quality Engineer initiates the tour of Manufacturing. The QA Manager departs,
requesting that she is informed when NuCargo is concluding the Source Verification, and will
join them later the same afternoon.
Main Characters
James T. Randall – NuCargo Auditor/Source Inspector
Jeanette Finlay – Quality Assurance Manager, Hanover Forge
Mark Sanders – Quality Engineer assigned by Hanover Forge as a guide
“James, Hanover has a long history dating back to 1974 with customers in the Defense industry,
Automotive industry, farm equipment manufacturing, and Energy producers. Although this is
our first item produced for NuCargo, we anticipate additional orders from Nuclear Power Plants
in the future. Defense industries were our initial customer base and our QA Program has been
audited annually for compliance to Defense Standards. We expect you will be pleased with our
personnel qualification, measurement capabilities, and records retention.”
“Mark, NuCargo reviewed some of Hanover’s records including prior products to ensure
manufacturability as the component you are processing for NuCargo, the Nuclear Fuel Shipping
Cask Inner Shield Lid, is both expensive and requires compliance to rigorous Nuclear Safety
provisions specified in the Code of Federal Regulations. Please include the equipment used to
finish the Inner Shield Lid during Hanover Forge tour.”
“You just viewed the fabrication equipment used to finish the NuCargo Cask Lid, and these are
the Training Records for Jay Watson, indicating he was initially qualified to operate this
equipment in March 2011 and requalified to production using current Hanover procedure #HF-
M13 Rev B on 10/12/16.”
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Completed Handbook Figures Demonstrate Application
• Section 7.1 Commercial Grade Dedication of
Items and Processes
– 4 Methods (Inspection and Test, Commercial Grade
Survey, Source Verification, and Supplier/Item
Performance record)
– Figure 7.1 Commercial Grade Item Technical Evaluation
– Figure 7.2 Source Verification for Commercial Grade
Item Dedication
– Figure 7.3 Acceptance of Commercial Grade Item
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Section 7.1 Commercial Grade Dedication
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Procurement Considerations
As CGD applies only to Safety Items, the SSC must reliably perform its intended safety function.
Performance in this safety application is essential, therefore, procurement requires that Critical
Characteristics for Acceptance (CCFA) must be verified. This CCFA Verification may employ
these methods:
• Inspection and Test
• Commercial Grade Survey
• Source Verification, and
• Supplier/Item Performance record
The selection of dedication method(s) is based on the type of critical characteristics to be
verified for acceptance (derived from item form, fit, and function in actual service conditions),
available supplier information, quality history, and degree of standardization. Commercial
Grade Item acceptance criteria for the verification method selected should be consistent with the
plant-specific application and most severe conditions.
1) Inspection and Testing require supplier data regarding material pedigree (e.g.,
drawings/specifications, material composition and processing history). Supplier
acceptance method and selection of a sampling plan requires adequate review and
justification.
2) Commercial grade Surveys may be performed to ensure supplier processes and controls
are adequate for item production/service performance. Survey frequency should be
selected to ensure uniformity of controls for additional item/services. A supplier
Certificate of Conformance may be submitted verifying programs and processes
utilized during CGI production remained the same as evaluated during survey and adhere
to provisions of the procurement contract. Documentation/certification is acceptable only
from a sub-tier supplier that has been surveyed or audited by the dedicating entity and
when the basis for acceptability and validity of the supplier’s documentation has been
established and documented, as sub-tier suppliers may not be familiar with the part’s
design or intended function in the component. Surveys may not qualify items procured
from distributors where handling includes warehousing or repackaging of items.
3) During Source Verification, sampling plans selected for items must ensure homogeneity
and lot traceability is maintained. Services may be verified during performance or at
conclusion of service performance with identification of manufacturing or test phase
Figure 7.2 and Case Study #6). Additional supplier documentation and records examined
may include design, procurement, calibration and material processes and controls.
Objective evidence of information examined during the dedication process and activities
observed must be retained including verification method for CCFA and hold points
stipulated for witness of in-process measurements (Figure 7.2).
4) Supplier/Item Performance Record may supplement the previous 3 acceptance
methods but does not suffice for CGD approval of suppliers. Performance records
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Figure 7.1 CGD Technical Evaluation (select Critical Characteristics)
ASME NQA-1 Requirements: #3 Design Control, #7 Control of Purchased Items and Services, #11 Test Control,
#12 Control of Measuring and Test Equipment
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Figure 7.1 Commercial Grade Item Dedication - Technical Evaluation
Section A) Item Description
FuelPac International – UNF 385 Spent Nuclear Fuel Cask #67-1014
• Storage Overpack – Concrete Lid
• Inventory Control #FP-276
Section B) End-Use/Parent/Host Equipment Information
1. Safety Related Yes X No
2. Passive X Active
3. Basic Safety Function
a. Structural Integrity- Maintain Confinement (Retain Spent Nuclear Fuel within Cask),
Ensure Retrievability
b. Radiation Shielding – Radiation Protection to the Public and On-site Worker i/a/w
10CFR72.104, 10CFR72.106, 10CFR20
Section C) Eligibility for Dedication
1. Commodity or Standard Item Yes No X
2. Codes Applicable – Plain Concrete/American Concrete Institute Code #349-85; ASME Code
1995 Edition with Addenda through 1997
Section D) Failure Modes and Effects Analysis
1. Credible Failure Modes:
a. Thermal – Burial in soil with blockage of air inlets and without potential for cooling
b. Immersed in Flame – Modeled by ANSYS Computer Code; Risk accepted by NUREG
2943
2. Basis for Selection: 6/1/2000 NRC Safety Analysis Report, Section 9.1 Accident Analysis
Section E) Critical Characteristics
1. Dimensions: D- _85’ 11.125”____ Thickness- 8.624”______
2. Concrete Testing – ASTM C39 Test Specimens
a. Compressive Strength – ASTM C1107: Pass
b. Volume Change – ASTM C1107: Pass
Review and Approval
Prepared by: James Hoffman Date: 7/12/15
Reviewed by: Robert Barkley Date: 7/14/15
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Figure 7.2 CGD Source Verification (Method 3)
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Figure 7.2 Source Verification of Supplier for Dedication of Commercial Grade Item
Date: 12/21/16
Component: NuFab International – Shielded Shipping Cask for Irradiated PWR Fuel Assemblies
Transportation Cask Inner Steel Lid/Inventory Control #NuFab-27
Type 304 Stainless Steel product for further processing
Safety Application: Spent Nuclear Fuel Storage - Structural Integrity; Containment Boundary
Safety Specification: NRC CoC #9235 Rev. 11 Package ID USA/9235/B(U)F-96
_____________________________________________________________________________________
Supplier Identification: Hanover Forge, 1406 Longview Road, Pittsburgh, PA
Critical Characteristics for Acceptance:
Dimensions:
1. Diameter (86.700’ +/_ 0.500 “ required/ 85’ 11.125 “ actual)
2. Thickness (9.000” +/- 0.125” required/ 8.946”actual)
Fabrication Process: Form and Finish (grind, polish to #7 finish, buff) Disc from NuFab Stock provided
to final specification per Procedure #HF-M13 Rev B 10/14/12 as specified on NuFab Drawing #9235-
423G Rev C 3/17/09
Raw Material: Type 304SS
Operator JNW Procedure #HF-M13 Rev B Training Records of Operator: Recertified 10/12/16
Calibration:
Records Critical Characteristics Attributes Inspection: 12/4/16 Calibration of Instruments used for
Mechanical Inspection
Sub-Tier Suppliers for CGI: Viking Instruments – Qualified for instrument calibration by NuFab
Corporate QA 11/7/16
Qualification Method: NuFab Corporate QA Assessment of Viking Instruments (ASME NQA-1 2008
with 2009 Addenda)
NuFab Source Inspector James T. Randall________ Date ____2/23/17____
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Figure 7.3 CGID Acceptance (Critical Characteristics credited for Nuclear Safety)
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Figure 7.3 Commercial Grade Item Acceptance Record
Date Received: 11/6/2016
Commercial Grade Item: FuelPac 125 Ton TranSNF Transfer Cask (for use in FuelPac
360 Cask System)
Safety Application: The function of the transfer cask is to provide radiation and structural
protection of the Spent Nuclear Fuel during loading, unloading, and transfer operations.
(The TranSNF transfer cask is used for various plant operations, such as, normal onsite
transport of spent nuclear fuel. In the event of a postulated accident, the transfer cask
must not suffer permanent deformation to the extent that the ready retrievability or
confinement integrity of the Spent Nuclear Fuel is compromised. Structural characteristics
as specified in 10 CFR 72.24).
Supplier: Atlas Fabrication Corporation Date Qualified: 2/17/16
Specification Stress Limits per ASME Code, Section III, Subsection NF, Class 3; TranSNF
transfer cask is a carbon steel, lead, steel layered cylinder (steel structural material, SA-516
Grade 70) which possesses sufficient fracture toughness to preclude brittle fracture.
Critical Characteristics for Acceptance: Fracture Toughness to ensure intact following
drop accident
Acceptance Method: Charpy V-Notch Test at minimum Service Temperature
Critical
Characteristic
Test
Method
Specification Acceptance Criteria Accept
Y/N
Fracture
Toughness for
Side-Drop Test
Charpy
V-Notch
Testing
at 0 F
ASME Code,
Section III,
Subsection NF,
Articles
NF-2300 and
NF-2430
TranSNF: Horizontal
(side) drop; meet level
D TranSNF
stress limits for NF
Class 3 components:
Shell - 3.4.9.1 away
from the impacted
zone; show lids stay
in-place.
Transfer Lid-
3.4.4.3.3.3
Show primary and
secondary impact
Slapdown - 3.4.9.2
decelerations are
within design basis.
(This case is only
applicable to
TranSNF)
Y
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EED Nuclear QA Auditor Training Handbook
Path Forward
• Review and Update Codes and Standards
• Validate and Supplement Figures
• EED Nuclear Committee Review for Consistency and Style
• Editing and EED Council Review
• ASQ Audit Division Review
• Quality Press Publication 2018 (English)
• Translation for Emerging Markets (e.g., China, Korea,
MEA, UAE, India)
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EED Nuclear Committee
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Questions?
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