thursday, may 14, 2015 - us department of energy · thursday, may 14, 2015 . one-day...
TRANSCRIPT
THURSDAY, May 14, 2015
One-Day Workshop/Training
“Understanding DOE Quality Assurance Requirements and ASME NQA-1 for Application in DOE Nuclear Projects”
8th floor, CNF-AR-Franklin-Center Main – 950 L’Enfant Plaza SW Washington, DC 20024
Time Discussion/Activity Speaker/Presenter
8:15 a.m. – 8:30 a.m. Opening / Introductions /Learning Objectives Ruben Sanchez, MA-63
8:30 a.m. – 9:00 a.m. Highlights Bud Danielson, CNS
9:00 a.m. – 9:30 a.m.
Overview of DOE QA Regulatory Framework • Rules, Directives, and Standards• Requirements, Program Elements,
and Expectations
Duli Agarwal, AU-33
9:30 a.m. – 10:00 a.m. DOE-HQ QA Resources, AU/CNS Duli Agarwal, AU-33 Bud Danielson, CNS
10:00 a.m. – 10:30 a.m. Break/Networking — 10:30 a.m. – 11:45 a.m. Overview of NQA-1 Requirements, Part I Ron Schrotke, CNS 11:45 a.m. – 12:00 p.m. NQA-1 Discussions and Q/A Group 12:00 p.m. – 1:00 p.m. Lunch —
1:00 p.m. – 2:00 p.m. Overview of NQA-1 Requirements, Part II Ron Schrotke, CNS
2:00 p.m. – 2:30 p.m. Line Management QA Oversight /Assessment Practices Jeff Roberson, NNSA
2:30 p.m. – 3:00 p.m. QA Lessons Learned Bud Danielson, CNS 3:00 p.m. – 3:15 p.m. Break/Networking —
3:15 p.m. – 4:30 p.m. • QA role in the DOE Critical Decision
(CD) Process, DOE O 413.3B• Project Case Studies
Bud Danielson, CNS Duli Agarwal, AU-33 Ruben Sanchez, MA-63 Ron Schrotke, CNS
4:30 p.m. – 5:00 p.m. Closing/Summary Ruben Sanchez, MA-63 Bud Danielson, CNS
Agenda
Time Discussion/Activity Speaker/Presenter 8:15 a.m. – 8:30 a.m. Opening / Introductions / Learning Objectives Ruben Sanchez, MA-63 8:30 a.m. – 9:00 a.m. Highlights Bud Danielson, CNS
9:00 a.m. – 9:30 a.m. Overview of DOE QA Regulatory Framework • Rules, Directives, and Standards • Requirements, Program Elements, and Expectations
Duli Agarwal, AU-33
9:30 a.m. – 10:00 a.m. DOE-HQ QA Resources, AU/CNS Duli Agarwal, AU-33 Bud Danielson, CNS
10:00 a.m. – 10:30 a.m. Break/Networking — 10:30 a.m. – 11:45 a.m. Overview of NQA-1 Requirements, Part I Ron Schrotke, CNS 11:45 a.m. – 12:00 p.m. NQA-1 Discussions and Q&A Group 12:00 p.m. – 1:00 p.m. Lunch — 1:00 p.m. – 2:00 p.m. Overview of NQA-1 Requirements, Part II Ron Schrotke, CNS 2:00 p.m. – 2:30 p.m. Line Management QA Oversight / Assessment Practices Jeff Roberson, NNSA 2:30 p.m. – 3:00 p.m. QA Lessons Learned Bud Danielson, CNS 3:00 p.m. – 3:15 p.m. Break/Networking —
3:15 p.m. – 4:30 p.m. • QA role in the DOE Critical Decision (CD) Process,
DOE O 413.3B • Project Case Studies
Bud Danielson, CNS Duli Agarwal, AU-33 Ruben Sanchez, MA-63 Ron Schrotke, CNS
4:30 p.m. – 5:00 p.m. Closing/Summary Ruben Sanchez, MA-63 Bud Danielson, CNS
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Objectives
One-day QA orientation training and awareness workshop. Focus is on DOE nuclear projects. Ultimate goal: Sensitize the urgency and the need to ensure integration of
QA, early on, throughout project lifecycle and management processes— e.g., o Design, engineering, construction, commissioning, operation,
post-operation. o Procurement, supply chain, training and qualification, assessments, etc.
Interactive format – o Questions and discussion of real-life examples are encouraged.
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What you will become familiar with by the end of this workshop
Why QA is relevant o Affects the mission: Project cost, schedule, safety, and reliability o Affects ability to meet commitments: contractual, regulatory, and stakeholders. DOE QA framework o The Directives and requirements o Application of ASME NQA-1 standard What to do if you need assistance with QA issues –
whom to call or resources to leverage for: o Policy questions and interpretation of requirements o Specialized skill sets for programmatic or on-site assessments
(e.g., Safety SQA, CGD, S/CI) QA role in acquisition and management of capital projects o Critical Decision (CD) process DOE lessons learned and QA observations
associated with major design and construction projects o Legacy QA issues o Construction project reviews, assist visits
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Why QA is Relevant: It reduces risk…
Provides management with confidence and assurance that people, processes, and implementation will meet requirements and performance expectations.
Risk is reduced by a process of verifying some or all aspects of an activity, e.g.: o Plan or design o Materials used o Attention to detail during construction o Thoroughness of testing o Conduct of maintenance and operations o Control of procurement spare parts o Document control
Each interrelated control and check performed along the way increases the confidence that the final product, system, and facility will meet performance expectations.
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Why QA is Relevant: QA has a substantive effect on
the execution of nuclear projects.
What’s at risk? Significant cost overruns and project delays! A simple example of “welding quality” to illustrate the point…
o In June 2010, the DOE Office of Inspector General (OIG) received allegations regarding the lack of quality assurance records on the fabrication of the Waste Treatment Plan (WTP) “black cell” vessels at the Project.
o OIG Audit focused on the process vessels received and/or installed prior to June 2005 because additional vessels had not been received since that time.
o In April 2012, OIG published an audit report about the Project’s welding issues.
o In September 2013, OIG published a parallel audit report on the Project’s design control issues.
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WTP Welding Example
WTP is expected to be world’s first chemical waste processing facility capable ofboth separating highly radioactive liquid waste and turning it into a stable glassform suitable for permanent, safe disposal.
Classified as a DOE Hazard Category 2 nuclear facility, it consists of 15 “black cells” and one hot cell that contains equipment necessary for preparing the Low-Activity Waste and High-Level Radioactive Waste feeds for vitrification.
Once waste is being processed, the “black cells” are inaccessible areas (for thelife of the plant) for inspection, maintenance, repair, or replacement of systemsand components due to extremely high radiation levels.
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WTP Welding Example (Continued)
Located in the “black cells,” processing vessels must last the expected 40-year design life without requiring in-service inspection and maintenance.
A safety basis analysis determined that these vessels are safety-class equipment, requiring higher-level safety and quality assurance.
ASME NQA-1-2000 and ASME Boiler and Pressure Vessel Code Section VIII, Rules for Construction of Pressure Vessels, applied via procurement documents for fabrication and installation. Section VIII is not a nuclear code. NQA-1 was imposed on a shop that does not apply it to Section VIII.
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WTP Welding Example – OIG Findings
Inadequate record keeping of Nondestructive Examination (NDE) Non-traceability of pressure-vessel fabrication records Positive Material Identification (PMI) requirements not met Contractor and subcontractors deviated from contractor requirements
without securing appropriate DOE authorization Inadequate source verification of welding quality by contractor at the
subcontractors’ fabrication facilities Inadequate contractor receipt verification of pressure vessel from
subcontractors
Project Impact: Cost Escalation – Schedule Delays
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WTP Welding Example (Continued)
Conducted welding deficiencies reviews and published Project Issues Evaluation Reports (PIERs).
Review indicated that the sampled pressure vessel had been fabricated and released by subcontractor with nozzle welds that failed to meet contractor’s Purchase Order requirements.
48 of the 53 nozzle welds have excessive undercut (figures, left); 6 welds are undersized.
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WTP Welding Example – What it Took to Respond
1. Revise Project procedures. 2. Provide training and/or refresher training to contractor’s Project team, include
Responsible Engineer, Buyers, Expeditors, Supplier Quality Representatives, and procurement staff.
3. Enforce the use of Independent Peer Review. 4. Revise the QA form to confirm that the Supplier Quality Representative
contacted the Project Supplier Quality Supervisor during final visit and received concurrence prior to release shipment.
5. Provide the Project Supplier Quality Supervisor with adequate resources. 6. Send a qualified team as necessary to the subcontractor’s facility to augment
Supplier Quality function.
Extensive Rework Vessels scrapped to use in FSVT
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DOE QA Framework (Integrated)
Corporate QA Program
Integrated Work
Management System
ISMSD EMS QAP
Specialty Programs
Governing Requirements
Federal Regulations
DOE Requirements
Industry Standards
10 CFR 830 Subpart A, QA
DOE O 414.1D DOE
O 226.1 Oversight
ASME NQA-1, 2004 with 2007 Addenda ANSI/ASQ
Z 1.13
WIPP QA Program
*
Site-Specific Graded
QA Program
Federal QAP/QIP
Contractor QAP/QIP
Implementation guidance: DOE G 414.1-1C Management and Independent
Assessments DOE G 414.1-2B QA Management System Guide DOE G 414.1-4 Safety Software Guide
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DOE O 414.1D Performance Criteria NQA-1 Requirement Section
Criterion 1 – Program Requirement 1 (Organization) Requirement 2 (Quality Assurance Program)
Criterion 2 – Personnel Training & Qualification Requirement 2 (Quality Assurance Program)
Criterion 3 – Quality Improvement Requirement 16 (Corrective Action)
Criterion 4 – Documents & Records Requirement 5 (Instructions, Procedures & Drawings) Requirement 6 (Document Control) Requirement 17 (Quality Assurance Records)
Criterion 5 – Work Processes Requirement 8 (Identification & Control of Items) Requirement 9 (Control of Special Processes) Requirement 10 (Inspection)
Criterion 6 – Design Requirement 3 ( Design Control)
Criterion 7 – Procurement Requirement 4 (Procurement Document Control) Requirement 7 (Control of Purchased Items & Services)
Criterion 8 – Inspection & Acceptance Testing
Requirement 10 (Inspection) Requirement 11 (Test Control) Requirement 12 (Control of Measuring & Test Equipment) Requirement 14 (Inspection, Test & Operating Status) Requirement 15 (Control of Nonconforming Items)
Criterion 9 – Management Assessment Requirement 2 (Quality Assurance Program) Criterion 10 – Independent Assessment Requirement 18 (Audits)
Close Alignment Between DOE QA Order Criteria and ASME NQA-1 Requirements
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Use a Graded Approach – Common-Sense Application of
Requirements on a Project-Specific Basis
Factors to consider Relative importance to safety, safeguards, and security Magnitude of any hazard involved Life-cycle stage of a facility or item Programmatic mission of a facility/project Potential radiological or industrial safety impact on the public and worker Potential to impact the environment Potential to impact the acceptability to the customer Regulatory significance
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Overview of Quality Assurance Requirements
Duli C. Agarwal, PE Office of Quality Assurance (AU-33)
Chair, NQA Subcommittee on Applications Chair, IAEA TEC-DOC-1169 Revisions
Chair, S/CI Focus Group May 14, 2015
Hierarchy of Quality Assurance Requirements Framework
10 CFR 830: Nuclear Safety Management Rule –
Subpart A, Quality Assurance
DOE Order 414.1D, Quality Assurance
DOE Guide 414.1-2B, Quality Assurance Program Guide
ASME, NQA-1-2008 with NQA-1a-2009 Addenda, Quality Assurance Requirements
for Nuclear Facility Applications
DOE Headquarters Program Office QA Programs (EM, Weapons, HLW, WIPP)
Approved Quality Assurance Program, Processes and Procedures
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DOE Quality Assurance (QA)Regulatory Framework
10 CFR Part 830, Nuclear Safety Management (QA and Safety Basis) o 10 QA Criteria using a graded approach o Use voluntary consensus standards o Integrate the quality assurance criteria
with the safety management system
DOE Order 414.1D, Quality Assurance (All work, nuclear & non-nuclear facilities) o 10 QA Criteria using a graded approach o Suspect/Counterfeit Items (S/CI) o Nuclear Safety Software o Requires NQA-1 for nuclear facilities o Use of National and International Standards
DOE G 414.1-2B, Quality Assurance Program Guide
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QA Rule At-A-Glance 10 CFR 830 Subpart A
Establishes quality assurance requirements for contractors conducting activities, including providing items or services, affecting the nuclear safety of DOE facilities.
Applicable irrespective of contract. Requires contractors to conduct work in accordance with the 10 QA Criteria
in 10 CFR 830.122. Requires Contractors Responsible for a DOE Nuclear Facility to
o develop a QA Program in accordance with QA criteria. o submit their QA program to DOE for approval. o describe how they ensure that subcontractors and suppliers satisfy the QA
criteria. o integrate the QA criteria with the Safety Management System.
Civil and Criminal Enforcement is established via the Price-Anderson Amendments Act and 10 CFR 820.
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QA Order At-a-Glance: O 414.1D
Establishes quality assurance requirements for DOE and contractors conducting any activities, including providing items or services.
Applicable to feds and contractors when imposed via contract. Requires feds and contractors to
o conduct work in accordance with the 10 QA Criteria (= rule). o Develop a QA Program in accordance with QA criteria and perform
work to the QAP. o submit their QA program to DOE for approval. o describe how they ensure that contractors, subs, and suppliers satisfy the
QA criteria. o integrate the QA criteria with the Safety Management System.
Enforcement is established via the contract.
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The Rule and Order require development of a QA program
addressing 10 QA criteria.
Performance-Based and Outcome-Oriented 1. Program (organization structure, interfaces, planning, scheduling) 2. Personnel training and qualification 3. Quality improvement (Identify problems, causes, correction, and
improvements.) 4. Documents and Records (Use documents to define work; maintain records.) 5. Work Processes (Perform work correctly; control items/material.) 6. Design (Incorporate requirements; verify/validate adequacy.) 7. Procurement (Buy proper material; check the adequacy of suppliers.) 8. Inspection and Acceptance Testing (and calibrate equipment) 9. Management Assessment (Check for problems that hinder work.)
10. Independent Assessment (Perform an unbiased check of quality.) 6
Close Alignment Between DOE QA Order Criteria
and ASME NQA-1 Requirements
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DOE O 414.1D Performance Criteria NQA-1 Requirement Criterion 1 – Program Requirement 1 – Organization
Requirement 2 – Quality Assurance Program Criterion 2 – Personnel Training & Qualification
Requirement 2 – Quality Assurance Program
Criterion 3 – Quality Improvement Requirement 16 – Corrective Action, Part II Subpart 2.22 Criterion 4 – Documents & Records Requirement 5 – Instructions, Procedures & Drawings
Requirement 6 – Document Control Requirement 17 – Quality Assurance Records
Criterion 5 – Work Processes Requirement 8 – Identification & Control of Items Requirement 9 – Control of Special Processes Requirement 10 – Inspection
Criterion 6 – Design Requirement 3 – Design Control Criterion 7 – Procurement Requirement 4 – Procurement Document Control
Requirement 7 – Control of Purchased Items & Services Criterion 8 – Inspection & Acceptance Testing
Requirement 10 – Inspection Requirement 11 – Test Control Requirement 12 – Control of Measuring & Test Equipment Requirement 14 – Inspection, Test & Operating Status Requirement 15 – Control of Nonconforming Items
Criterion 9 – Management Assessment Requirement 2 – Quality Assurance Program, Part II Subpart 2.22 Criterion 10 – Independent Assessment Requirement 18 – Audits
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Application of DOE QA Criteriaand NQA-1 Requirements
All DOE QA Criteria and NQA-1 Requirements may apply to some organizations, but certain Criteria and Requirements may not apply to other organizations. Examples: o An architect-engineer-constructor for a nuclear facility would likely need to
implement all 10 DOE QA Criteria and all 18 NQA-1 Requirements because they perform activities that are within the scope of those requirements.
o A calibration laboratory would likely not require the DOE and NQA-1 “design” criterion.
o A safety software development company would include “design” but may not require “Item Identification and Control” or “Control of Measuring and Test Equipment”.
Each nuclear organization’s quality program must address all the DOE QA Criteria and NQA-1 Requirements for which they perform related activities.
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Details of Each QA Criterion
Criterion 1—Management/Program a. Establish an organizational structure, functional responsibilities,
levels of authority, and interfaces for those managing, performing, and assessing the work.
b. Establish management processes, including planning, scheduling, and providing resources for the work.
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Details of Each QA Criterion (Cont’d)
Criterion 2—Management/Personnel Training & Qualification a. Train and qualify personnel to be capable of performing their assigned
work. b. Provide continuing training to personnel to maintain their job proficiency.
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Details of Each QA Criterion (Cont’d)
Criterion 3—Management/Quality Improvement a. Establish and implement processes to detect and prevent quality
problems. b. Identify, control, and correct items, services, and processes that do
not meet established requirements. c. Identify the causes of problems, and include prevention of
recurrence as a part of corrective-action planning. d. Review item characteristics, process implementation, and other
quality-related information to identify items, services, and processes needing improvement.
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Details of Each QA Criterion (Cont’d)
Criterion 4—Management/Documents and Records a. Prepare, review, approve, issue, use, and revise documents to prescribe
processes, specify requirements, or establish design. b. Specify, prepare, review, approve, and maintain records.
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Details of Each QA Criterion (Cont’d)
Criterion 5—Performance/Work Processes a. Perform work consistent with technical standards, administrative
controls, and other hazard controls adopted to meet regulatory or contract requirements using approved instructions, procedures, or other appropriate means.
b. Identify and control items to ensure proper use. c. Maintain items to prevent damage, loss, or deterioration. d. Calibrate and maintain equipment used for process monitoring or
data collection.
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Details of Each QA Criterion (Cont’d)
Criterion 6—Performance/Design a. Design items and processes using sound engineering/scientific
principles and appropriate standards. b. Incorporate applicable requirements and design bases in design work
and design changes. c. Identify and control design interfaces. d. Verify or validate the adequacy of design products using individuals
or groups other than those who performed the work. e. Verify or validate work before approval and implementation of
the design.
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Details of Each QA Criterion (Cont’d)
Criterion 7—Performance/Procurement a. Procure items and services that meet established requirements and
perform as specified. b. Evaluate and select prospective suppliers on the basis of specified
criteria. c. Establish and implement processes to ensure that approved suppliers
continue to provide acceptable items and services.
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Details of Each QA Criterion (Cont’d)
Criterion 8—Performance/Inspection and Acceptance Testing a. Inspect and test specified items, services, and processes,
using established acceptance and performance criteria. b. Calibrate and maintain equipment used for inspections/tests.
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Details of Each QA Criterion (Cont’d)
Criterion 9—Assessment/Management Assessment Ensure that managers assess their management processes and identify and correct problems that hinder the organization from achieving its objectives.
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Details of Each QA Criterion (Cont’d)
Criterion 10—Assessment/Independent Assessment a. Plan and conduct independent assessments to measure item and
service quality, to measure the adequacy of work performance, and to promote improvement.
b. Establish sufficient authority and freedom from line management for independent assessment teams.
c. Ensure persons who perform independent assessments are technically qualified and knowledgeable in the areas to be assessed.
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QA Requirements & Guidance for Counterfeit Items
DOE Order 414.1D, Attachment 3, Suspect/Counterfeit Items Prevention o Program, responsibilities, inspection, control o Once adopted, civil/criminal/contract penalties for
noncompliance DOE O 232.2, Occurrence Reporting and Processing of Operations
Information International Atomic Energy Agency IAEA-TECDOC-1169 DOE Awareness Training Manual, 2007 DOE Order 221.1A, Reporting Fraud Waste & Abuse to the
Office of the Inspector General
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QA Requirements for Nuclear Safety Software
DOE Order 414.1D, Attachment 4, Safety Software QA Requirements for Nuclear Facilities o Safety Software must be acquired, developed, and implemented using
ASME NQA-1 Part 1 and Subpart 2.7 or other national or international consensus standards that provide equivalent level of quality assurance requirements of ASME NQA-1
o Must involve facility design authority for specification, acquisition, design, development, verification, and validation
o Must identify, document, control and maintain Safety Software inventory, which includes: software description; software name; version identifier; safety software designation
o Establish and document grading levels for Safety Software using the graded approach
DOE Guide G 414.1-4, SQA Guide 20
Quality Assurance Requirementsand Project Management
DOE O 413.3B, Appendix C, Topical Areas Quality Assurance (QA) begins at project inception and continues through
all phases of the project. The FPD is responsible for a Quality Assurance Program (QAP) for the
project and all applicable QA requirements must be addressed. Apply ASME NQA-1-2008 (Edition) and NQA-1a-2009 (Addenda) for Hazard Category 1, 2, or 3 nuclear facilities.
The key elements of a QAP are provided in DOE O 414.1D and 10 CFR Part 830, Subpart A.
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New DOE QA Initiatives
Prevention and detection of Suspect / Counterfeit Items (S/CI) in the DOE supply chain. In 2012, DOE formed S/CI Focus Group to address new S/CI risks, tactics, and sources.
Reporting of S/CI. U.S. Federal Acquisition Regulation (FAR) 46 is being revised to expand reporting of nonconforming items and require higher-level contract quality requirements.
Implementation of the Commercial-Grade Dedication Process requirements. The AU Office is working with EFCOG to develop a DOE Handbook with examples.
Purchasing Practices. National Defense Authorization Act (NDAA) revision emphasizes purchase from Original Component Manufactures or authorized distributors.
Guidance for procuring from Foreign Sources/Suppliers and distributors.
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HQ QA ResourcesDuli C. Agarwal, PE
Office of Quality Assurance (AU-33)Chair, NQA Subcommittee on Applications
Chair, IAEA TEC-DOC-1169 RevisionsChair, S/CI Focus Group
May 14, 2015
AU-33’s Mission
The Office of Quality Assurance (QA) establishes and maintains the QA and Technical standards policies, requirements and guidance for the Department and serves as DOE’s corporate resource to ensure that products and services meet or exceed the Department’s quality objectives. The Office provides assistance to
Departmental elements and contractors in the interpretation and implementation of DOE QA requirements and in the resolution of QA-related issues.
—AU-33 Director, Debbie Rosano
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AU-33’s Roles and Responsibilities
Policy Delivers clear requirements and expectations for QA. Identifies clear expectations for roles and responsibilities for DOE and its
contactors related to QA. Provides technical assistance and collaboration with GC for maintaining
the QA rule. Provides interpretations for the QA Order and for QA guides and technical
standards and supports technical interpretations of the QA rule by the GC. Currently working on development of a series of new initiatives and
supplemental guidance to improve implementation ofo Suspect/counterfeit items (S/CI).o Commercial Grade Dedication.o Training and Qualification.
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AU-33’s Roles and Responsibilities (Cont’d)
Assistance AU-33 provides assistance to DOE headquarters, program and field in
assuring the quality of operations, activities, and products through clarification of implementation of DOE QA Requirements, expectations, and periodic assessments.
Support to EM QA site visits Recent assist visits to DOE-RL and DOE-SRS
o Focus on Commercial Graded Dedication (CGD) Practiceso Planned visit to Albuquerque, NM in June 2015 timeframe
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AU-33’s Roles and Responsibilities (Cont’d)
Internal Interface/Interactions AU-33 interfaces and interacts with various programs and
organizations within AU and throughout the DOE complex to meet DOE’s missions.
Interfaces with the Energy Facility Contractors Group (EFCOG) on DOE-wide QA activities.
Works with AU-20 on the ORPS, the suspect/counterfeit items process (S/CI), the Lessons Learned Program, and the Operation Experience (OE) Program.
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AU-33’s Roles and Responsibilities (Cont’d)
Internal Interface/Interactions Participates on efforts to support the Integrated Safety Management
process to ensure that QA is fully integrated into all work activities. Chairs DOE Quality Council. Provides input to AU-1.1 in the development of the DOE Annual
Report to Congress on DNFSB related activities.
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AU-33’s Roles and Responsibilities (Cont’d)
External Interface/Interactions Interface with, and provide technical support to, groups and
organizations outside of the Department to learn from external organizations and develop standards and programs to support successful implementation of QA at DOE.
Support technical responses to external organizations such as Congressional staff, the DNFSB, the GAO, the IG, the Environmental Protection Agency, and other Federal and local government entities regarding QA requirements and implementation at DOE.
Actively participates as committee and subcommittee members on nongovernment and industry standards efforts, such as ASME, ASQ ASCE, and AISC to continuous improvement.
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AU-33’s Roles and Responsibilities (Cont’d)
External Interface/Interactions (cont.) Provides technical responses for DOE to inquiries from external
organizations, such as Congressional staff, the DNFSB, the GAO, the IG, and other Federal and local government entities regarding QA requirements and implementation.
Solicits new information relating to QA from external organizations addressing QA issues.
Provides resources and staff to the International Atomic Energy Agency (IAEA) intergovernmental forums for scientific and technical collaboration, preparing white papers, briefing materials, and presentations.
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CTA’s Roles and Responsibilities
DOE Order 410.1, Center Technical Authority Responsibilities regarding Nuclear safety requirements, August 28, 2007 describes requirements and responsibilities.
Established in 2005 to provide independent analysis, advice, and recommendations to DOE senior management, program offices, field offices, and contractors on the health of the oversight and practices associated with nuclear facility safety.
In 2011, EM CTA responsibilities was delegated to Richard (Chip) Lagdon, the Chief of Nuclear Safety (CNS).
CNS functions consists of a full range of policy, implementation, and executive decision-making activities that bear directly on nuclear safety, quality, engineering, and overall project performance.
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CTA’s Roles and Responsibilities
Concur with determination of applicability of directives included in contracts.
Concur with nuclear safety requirements in contracts. Concur with exemptions to nuclear safety requirements in contracts. Recommend to the Office of Environment, Health, Safety and Security
(AU) issues and proposed resolutions concerning safety requirements, and concur in adoption or revision of nuclear safety requirements.
Maintain operational awareness of implementation of nuclear safety requirements.
Assess whether EM and site offices maintain adequate numbers of technically competent personnel.
Provide input to, and concur with, DOE-wide nuclear safety-related research and development activities.
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-
-
Planned 2015 Operational Awareness
(Partial) 2015
Facility (Site Office) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
(ORP) [New design & construction] Integrated Control Network
ORP QA MA Mini-CPR QA ETGs CPR OA OA
SWPF (SRS) [New Construction] OA CPR OA
IWTU (ID) [New Startup & operations] Start-up RA SQA H Canyon (SRS) OA OA OA OA 235F PuFF (SRS) OA CSTF (SRS) OA OA OA 3019/2026 (ORO) OA OA PFP (RL) OA
Tank Farm (ORP) OA & CGD
HB Line (SRS) OA OA OA OA TRU WPF SWAS 5 (ORO) OA OA X 326 (PORT) ISMS OA OA X705 (PORT) SRNL (SRS) OA TRU WPF (ORO) C 400 (PAD) OA OA Liq. Waste Facility (ORNL) OA OA CPP 666 IFMS (ID) OA AMWTP (ID) OA OA K27 (ORO) OA OA GDP (PAD) OA OA
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CNS and Staff Participation in CPRs
The CNS and staff have led/participated in nearly every CPR since their inception in 2009
April 2009 – June 2014 5
4
3
2
1
0
CNS Staff CNS 7
Site-Specific POCs
Office of Environmental Management (EM) Site Lead /Backup
Savannah River Site Office WDED/SRR and SWPF/Parsons Sparkman, Garzon, Berg
Savannah River NMSP/SRNS Berg Idaho Berg Richland McDuffie Office of River Protection (ORP) – Waste Treatment and Immobilization Plant Garzon & Danielson
ORP/Tank Farms Garzon & Berg Carlsbad McDuffie ORO Weaver PPPO Weaver LANL Weaver
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CNS Staff – Subject Matter Experts
McDuffie, Steve
NPH SMiRT Scientific Committee Operations Facility representative program
SSO engineer Maintenance Integrated Safety Management Operational readiness reviews
Danielson, Bud
ASME Committee on Nuclear Quality Assurance Alternate EM Quality Assurance board
member ISO TC 85, WG4 –
Nuclear Quality Systems QA Construction quality control Integrated Safety Management
Nuclear safety regulation PAAA and enforcement CNS Technical Standards
Manager and directives system point of contact International Conformity
Assessment Committee IAEA Management Systems
for Nuclear Facility Safety
Staff involved in national and international activities related to their area of expertise 9
CNS Staff – Subject Matter Experts
(Continued)
Lagdon, Chip
Nuclear Operations EM Quality Assurance board member EM/NE/SC Software Quality
Assurance Support Group sponsor Nuclear Safety research and
development member ANS/ASME Joint Committee for
Nuclear Risk Management
FTCP member Tank Waste corporate board EPWOG sponsor Authorization Bases Unreviewed Safety Questions Operational readiness reviews Accident investigations Construction Project Reviews
Sparkman, Debra
Commercial-Grade Dedication Alternate Nuclear Safety research
and development member EM/NE/SC Software Quality
Assurance Support Group CNS Lead EFCOG SQA sub-team sponsor Safety instrumented systems
ASME Subcommittee on Software QA, Nuclear Quality Assurance Committee Software QA Software engineering &
development and real-time control systems
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CNS Staff – Subject Matter Experts
(Concluded)
Weaver, Bill
Safety Design Strategy Alternate FTCP member NTC instructor Risk assessments Authorization Bases Operational readiness reviews
Tritium handling and storage Member, ASTM Subcommittee
for Deactivation and Decommissioning Activities
Operations Integrated Safety Management
Berg, Larry
ANS N16 and 8 Committee member Criticality safety Nuclear materials handling
USQ SDS AB Reactor assessment
Garzon, Caroline
Environmental engineering Alternate Nuclear Safety research
and development member CNS/ EM Standard Review Plan
Modules
Environmental law Nuclear safety analysis Radiological risk assessment
(including MACCS2 and risk ranking)
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THURSDAY, May 14, 2015
One-Day Workshop/Training
“Understanding DOE Quality Assurance Requirements and ASME NQA-1 for Application in DOE Nuclear Projects”
8th floor, CNF-AR-Franklin-Center Main – 950 L’Enfant Plaza SW Washington, DC 20024
Time Discussion/Activity Speaker/Presenter
8:15 a.m. – 8:30 a.m. Opening / Introductions /Learning Objectives Ruben Sanchez, MA-63
8:30 a.m. – 9:00 a.m. Highlights Bud Danielson, CNS
9:00 a.m. – 9:30 a.m.
Overview of DOE QA Regulatory Framework • Rules, Directives, and Standards• Requirements, Program Elements,
and Expectations
Duli Agarwal, AU-33
9:30 a.m. – 10:00 a.m. DOE-HQ QA Resources, AU/CNS Duli Agarwal, AU-33 Bud Danielson, CNS
10:00 a.m. – 10:30 a.m. Break/Networking — 10:30 a.m. – 11:45 a.m. Overview of NQA-1 Requirements, Part I Ron Schrotke, CNS 11:45 a.m. – 12:00 p.m. NQA-1 Discussions and Q/A Group 12:00 p.m. – 1:00 p.m. Lunch —
1:00 p.m. – 2:00 p.m. Overview of NQA-1 Requirements, Part II Ron Schrotke, CNS
2:00 p.m. – 2:30 p.m. Line Management QA Oversight /Assessment Practices Jeff Roberson, NNSA
2:30 p.m. – 3:00 p.m. QA Lessons Learned Bud Danielson, CNS 3:00 p.m. – 3:15 p.m. Break/Networking —
3:15 p.m. – 4:30 p.m. • QA role in the DOE Critical Decision
(CD) Process, DOE O 413.3B• Project Case Studies
Bud Danielson, CNS Duli Agarwal, AU-33 Ruben Sanchez, MA-63 Ron Schrotke, CNS
4:30 p.m. – 5:00 p.m. Closing/Summary Ruben Sanchez, MA-63 Bud Danielson, CNS
Ron Schrotke Member, ASME NQA-1 Main Committee and ASME Board of Nuclear Codes and Standards
History, Evolution and Content of NQA-1
May 14, 2015
Session Objectives
Provide overview of NQA-1 history. Discuss NQA-1 Structure, and usage.
o Describe the Part I requirements of NQA-1’s QA program. o Discuss graded approach. o Overview Parts III and IV.
2
NQA-1 History Overview
Atomic Energy Commission (AEC) issued 10 CFR 50 Appendix B, Quality Assurance (Appendix B) o Developed to address AEC concerns about insufficiently experienced
organizations, leading to errors and omissions resulting in startup problems and delays in nuclear power plant construction
AEC determined most desirable method to develop implementation methods for Appendix B use government, industry, national laboratories, and other public institutions to develop consensus standards to define and practices (technical and administrative).
3
NQA-1 History Overview
Committee made up of ANSI steering committee, representatives of ASME, and other technical societies identified 7 quality-assurance–related standards for the construction phase of nuclear power plants:
1. Pressure System Cleaning 2. Packaging, Shipping, Receiving, Handling, Storage 3. Housekeeping (total plant) 4. Installation, Inspection and Testing – Electrical and
Instrumentation 5. Inspection and Testing – Structural Steel and Structural Concrete 6. Qualification of Personnel 7. Quality Assurance Program Requirements
4
The topic on quality assurance program requirements was to cover the total scope of activities affecting the quality of nuclear power plant structures, systems, and components, from initial design through construction and operation, exclusive of those structures, systems, and components covered by the ASME Boiler and Pressure Vessel Code.
Applicable to plant owner and major participating contractors at every level of the plant design & construction project.
Essentially consistent with and would amplify the 18 criteria of Appendix B.
ANSI N45.2 standard issued in early 1972.
5
NQA-1 History Overview
NQA-1 History Overview
Daughter Standards were developed, and were of two basic types: o Those that amplified the programmatic aspects of the parent
N45.2 standards, and o Those that focused on quality-related work practices.
During the mid 1970s, the ASME NQA Committee was formed.
6
NQA-1 History Overview
The NQA Committee adopted the following approach to consolidation of the N45.2: 1) The 18-criteria structure of Appendix B would be preserved as
basic requirements. 2) These 18 basic requirements would provide an overview of the
quality assurance program logic and would be sufficiently general to have wide applicability.
3) More detailed requirements would be contained in Supplements. 4) Requirements would be clearly separated from guidance, which
would be contained in Appendices.
7
NQA-1 History Overview
The NQA Committee adopted the following approach to consolidation (continued): 5) The full expertise of ASME and other standards writing societies
would be employed in developing, coordinating, and maintaining the standard.
6) The standard would provide for flexibility in its application as well as growth or reduction of supplementary requirements and guidance.
7) Redundancy and conflicts in programmatic requirements would be minimized.
8) The standard would not be as limited as was Appendix B to safety-related structures, systems, components, and associated activities but would be applicable also to those items and activities that were essential to the achievement and assurance of reliable operation.
8
NQA-1 History Overview
ANSI/ASME NQA-2-1983 standard, Quality Assurance Requirements for Nuclear Facility Applications, incorporated these separate work-practices standards in the following parts: o N45.2.1-1980, Cleaning of Fluid Systems and Associated Components
for Nuclear Power Plants (NQA-2 Part 2.1) o N45.2.2-1978, Packaging, Shipping, Receiving, Storage, and Handling
of Items for Nuclear Power Plants (NQA-2 Part 2.2) o N45.2.3-1973, Housekeeping During the Construction Phase of Nuclear
Power Plants (NQA-2 Part 2.3)
9
NQA-1 History Overview
ANSI/ASME NQA-2-1983 standard, Quality Assurance Requirements for Nuclear Facility Applications, incorporated ANSI Daughter Standards, the separate work practices standards, in the following parts:
N45.2.5-1978, Supplementary Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete, Structural Steel, Soils, and Foundations During the Construction Phase of Nuclear Power Plants (NQA-2 Part 2.5)
N45.2.8-1975, Supplementary Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems for the Construction Phase of Nuclear Power Plants (NQA-2 Part 2.8)
N45.2.15-1981, Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants (NQA-2 Part 2.15) N45.2.20-1979 Supplementary Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants (NQA-2 Part 2.20) .
10
NQA-1 History Overview
NQA-2 also included new topics not in the Daughter standards: o Part 2.4, Installation, Inspection, and Testing Requirements for Power,
Instrumentation, and Control Equipment at Nuclear Facilities o Part 2.7, Quality Assurance Requirements of Computer Software for
Nuclear Facility Applications o Part 2.16, Requirements for Calibration and Control of Measuring and
Test Equipment Used in Nuclear Facilities o Part 2.18, Quality Assurance Requirements for Maintenance of
Nuclear Facilities
11
NQA-1 History Overview
In 1989, ASME’s NQA Committee established a Subcommittee on Nuclear Waste Management.
Developed NQA-3-1989, Quality Assurance Program Requirements for the collection of Scientific and Technical Information for Site Characterization of High-Level Nuclear Waste Repositories.
12
NQA-1 History Overview
Early in the 1990s, NQA Committee leadership perceived that the NQA-1, NQA-2, and NQA-3 were not structured in a way that enabled users to understand and apply them easily.
Committee determined to consolidate the NQA-1 and NQA-2 standards into a single multi-part document that was intended to allow a more rapid response to varied applications of the nuclear quality-assurance requirements and guidance.
Result was NQA-1-1994.
13
NQA-1 History Overview
Committee once again restructured the consolidated ASME NQA-1 standard in the 1997 edition.
Continued to evolve to address new issues, applications. During the late 1990s and beyond, NQA-1 began to incorporate changes
that provided better alignment with DOE Regulation 10 CFR 830, and Order O 414.1.
14
NQA-1 Structure, and usage
NQA-1 now is a multipart standard to establish and implement a quality-assurance program for any nuclear facility application. o Part I contains requirements for developing and implementing a Quality
Assurance Program for nuclear facility applications. o Part II contains additional quality-assurance requirements for the
planning and conduct of specific work activities under a Quality Assurance Program developed in accordance with Part I.
16
NQA-1 Structure, and usage
Part III contains guidance for implementing the requirements of Parts I and II.
Part IV contains guidance for application of NQA-1 and comparisons of NQA-1 with other quality requirements.
17
NQA-1 Structure, and usage
Requirement 1 – Organization o Document the following for activities affecting quality:
– Organizational structure – Functional responsibilities – Levels of authority – Lines of communication
o Establish organizational structure and responsibilities such that: – Senior management establishes overall expectations for effective QAP
implementation, and is responsible for obtaining desired end result. – Quality is achieved and maintained by those performing work. – Quality achievement is verified by those not directly responsible for
performing work. Guidance on Organization, see Part III, 1A-1
18
NQA-1 Structure, and usage
Requirement 2 – QA Program o The QAP shall be
– Planned. – Implemented. – Maintained.
o Management shall regularly assess the adequacy and effective implementation of the QAP.
o The QAP shall – Identify the activities and items to which it applies. – Provide control over activities affecting quality consistent with their
importance. – Monitor activities against acceptance criteria. – Be established in accordance with scheduled activities.
Guidance on the Qualifications of Inspection and Test Personnel; see Part III, 2A-1. Guidance on Quality Assurance Programs; see Part III, 2A-2. Guidance on the Education and Experience of Lead Auditors; see Part III, 2A-3. Guidance on Surveillance for Use in Assessment of Processes and Activities; see
Part III, 2A-4.
19
NQA-1 Structure, and usage
Graded Approach (SP 3.1 NMA 2A-2) o Items and services may require varying degrees of control and
verification to ensure compliance with requirements. Some factors that should be considered in determining appropriate levels of control and verification are: (a) the hazards associated with doing the work or using the results of
the work (b) the consequences of malfunction or failure of the item, or
inappropriate use of the results of services provided
20
NQA-1 Structure, and usage
Graded Approach (SP 3.1 NMA 2A-2) o Items and services may require varying degrees of control and
verification to ensure compliance with requirements. Some factors that should be considered in determining appropriate levels of control and verification are: (c) the probability of the occurrence of the postulated consequences (d) the design and fabrication complexity or uniqueness of the item,
or difficulty to perform services (e) the need for special controls and oversight of processes,
equipment, and performance (f) the degree to which functional compliance can be demonstrated by
inspection, test, or performance verification
21
NQA-1 Structure, and usage
Graded Approach (SP 3.1 NMA 2A-2) (continued) o Items and services may require varying degrees of control and
verification to ensure compliance with requirements. Some factors that should be considered in determining appropriate levels of control and verification are: (g) the quality history and degree of standardization of items and
services (h) the difficulty of repair, replacement, or replication of the items and
services
22
NQA-1 Structure, and usage
Requirement 3 – Design Control o Design Input o Design Process o Design Verification
– Design Reviews – Alternate Calculations – Qualification Testing
o Change Control o Interface Control o Software Design Control o Documentation and Records Guidance on Design Control, see Part III, 3A-1.
23
NQA-1 Structure, and usage
Requirement 4 – Procurement Document Control o Content of Procurement Documents Guidance on Procurement Document Control, see Part III, 4A-1.
Requirement 7 – Control of Purchased Items and Services o Supplier Evaluation and Selection o Supplier Nonconformance o Commercial Grade Items and Services Guidance on Control of Purchased Items and Services, see Part III, 7A-1.
24
NQA-1 Structure, and usage
Requirement 8 – Identification and Control of Items o Controls established to assure only correct and accepted items are used
or installed. o Identification shall be maintained on items or documents traceable to
the items. Requirement 9 – Control of Special Processes
o Processes that require a high degree of skill, cannot be verified after completion (heat treating, welding, etc.)
25
NQA-1 Structure, and usage
Requirement 10 – Inspection o Verify conformance of an item or activity to specified requirements or
continued acceptability of items in service. Guidance on Inspection, see Part III, 10A-1.
Requirement 11 – Test Control o Tests required to collect data or design input, to verify conformance of
an item or computer program to specified requirements, or demonstrate satisfactory performance for service shall be planned and executed
Guidance on Test Control, see Part III, 11A-1.
26
NQA-1 Structure, and usage
Requirement 12 – Control of Measuring and Test Equipment o Tools, o gages, o instruments, and other measuring and test equipment used for activities affecting quality shall be controlled, calibrated at specific periods, adjusted, maintained to required accuracy limits.
27
NQA-1 Structure, and usage
Requirement 13 – Handling, Storage, and Shipping o Handling, storage, cleaning, packaging, shipping, and preservation of
items shall be controlled – prevent damage – prevent loss – minimize deterioration
28
NQA-1 Structure, and usage
Requirement 14 – Inspection, Test, and Operating Status o Status of inspection and test activities shall be
– identified either on the items/ in documents traceable to the items where it is necessary to ensure that required o inspections and tests are performed o to ensure that
– items that have not passed the required inspections – tests are not inadvertently installed, used, or operated.
29
NQA-1 Structure, and usage
Requirement 15 – Control of Nonconforming Items o Items that do not conform to specified requirements shall be controlled
to prevent inadvertent installation or use. o Controls shall provide for:
– identification – documentation – evaluation – segregation (when practical) – disposition of nonconforming items – notification to affected organizations.
30
NQA-1 Structure, and usage
Requirement 16 – Corrective Action o Conditions adverse to quality;
– identified promptly – corrected as soon as practicable
o Significant condition adverse to quality; – cause of the condition shall be determined – corrective action taken to preclude recurrence – identification – cause – corrective action
o documented o reported to appropriate levels of management
– Completion of corrective actions shall be verified. 31
NQA-1 Structure, and usage
Requirement 16 – Corrective Action o Other
– Sp 3.1, NMA 16A-1, Guidance on Corrective Action
32
NQA-1 Structure, and usage
Requirement 17 – Quality Assurance Records • Control established consistent with the schedule for accomplishing
work activities • Furnish documentary evidence that items/activities meet specified
quality requirements. • Shall be identified:
– Generated – Authenticated – Maintained
• Final disposition specified • Record control requirements and responsibilities shall be documented Guidance on Quality Assurance Records, see Part III, 17A-1. Guidance for Electronic Records, see Part III, 17A-2. 33
NQA-1 Structure, and usage
Requirement 18 – Audits o Audits performed to verify
– compliance to quality assurance program requirements – performance criteria are met – to determine the effectiveness of the program.
o Performed – in accordance with written procedures/checklists – by personnel who do not have direct responsibility for performing
the activities being audited. o Audit results shall be
– documented – reported to/reviewed by responsible management.
o Follow-up action shall be taken where indicated.
Guidance on Audits, see Part III, 18A-1.
34
NQA-1 Structure, and usage
Part III: Nonmandatory Appendices o Provides nonmandatory guidance on approaches and methods to
implement and satisfy the requirements of Parts I and II. – Reflects insights into the intent of the NQA Committee in
formulating Parts I and II. – User may use alternate methods/activities that can be
proven to provide results consistent with Parts I and II. o Consistent with its intent to provide nonmandatory guidance,
the terms “must”, “require”, and “shall” are not used.
35
NQA-1 Structure, and usage
Part III: Nonmandatory Appendices o Subpart 3.1, Nonmandatory Guidance on Quality Assurance Programs for
Nuclear Applications o 1A-1 Guidance on Organization o 2A-1 Guidance on the Qualifications of Inspection and Test Personnel o 2A-2 Guidance on Quality Assurance Programs o 2A-3 Guidance on the Education and Experience of Lead Auditors o 2A-4 Guidance on Surveillance for Use in Assessment of Processes
and Activities o 3A-1 Guidance on Design Control o 4A-1 Guidance on Procurement Document Control o 7A-1 Guidance on Control of Purchased Items and Services o 10A-1 Guidance on Inspection o 11A-1 Guidance on Test Control o 16A-1 Guidance on Corrective Action o 17A-1 Guidance on Quality Assurance Records o 17A-2 Guidance for Electronic Records o 18A-1 Guidance on Audits 36
NQA-1 Structure, and usage
Part III: Nonmandatory Appendices o Subpart 3.2, Nonmandatory Guidance on Quality Assurance Programs for
Nuclear Applications – 2.1, Guidance on Cleaning of Fluid Systems and Associated Components for Nuclear Power Plants – 2.15, Recommendations for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants – 2.17, Guidelines for Transition From Construction to Operation for Nuclear Facilities – 2.18A, Guidance on Establishing and Maintaining Equipment Histories – 2.18B, Guidance on Performing Engineering Evaluations of Equipment
Failures – 2.20, Guidance on the Quality Assurance Requirements for Identification and Control of Samples Obtained for Subsurface
Investigations of Nuclear Power Plants – 2.21, Quality Assurance Guidelines for Decommissioning Nuclear Facilities 37
NQA-1 Structure, and usage
Part IV: Nonmandatory Appendices – Positions and Application Matrices o Subpart 4.1, Application Appendix: Guide on Quality Assurance
Requirements for Computer Software o Subpart 4.2, Guidance on Graded Application of Quality Assurance (QA)
for Nuclear-Related Research and Development o Subpart 4.3, Guide to Modification of an ISO 9001-2000 Quality
Program to Meet NQA-1-2000 Requirements o Subpart 4.4, Application Guide for Managing Electronic Information o Subpart 4.5, Application Guide on the Use of NQA-1-2000 for
Compliance With Department of Energy Quality Assurance Requirements 10 CFR 830, Subpart A and DOE O 414.1
o Subpart 4.6, Application Guidance on the Use of NQA-1-2000 for Compliance With 10 CFR 71 and/or 10 CFR 72 Requirements
38
NQA-1 Structure, and usage
Technical Inquiries Committee considers written requests for interpretations, revisions to NQA
Standards and develops new requirements, guidance if dictated by technological development.
Committee’s activities limited strictly to interpretations of requirements and guidance, or to the consideration of revisions to the present Standard on the basis of new data or technology.
40
NQA-1 Structure, and usage
Technical Inquiries Question: For an implementer, is choosing to apply only paragraph 100 of applicable requirements of Parts I and II of the standard an appropriate and sufficient method to implement a NQA-1 based Quality Assurance program? Response: No. With the exception of the Part I requirement areas 5 (Instructions, Procedures and Drawings), 14 (Inspection, Test and Operating Status), and 16 (Corrective Action), paragraph 100 is a summary and introductory paragraph for additional mandatory criteria contained in the requirement area. The application of only section 100 by an implementing organization is insufficient to claim credit for implementing Part I or Part II of an NQA-1–based Quality Assurance program. It is also insufficient for an invoking organization to invoke only section 100 of Part I or Part II and expect results equivalent to specifying all of Parts I or II. This response is applicable to NQA-1-2000, NQA-1-2004, NQA-1-2008, and the NQA-1b-2011 Addenda.
41
THURSDAY, May 14, 2015
One-Day Workshop/Training
“Understanding DOE Quality Assurance Requirements and ASME NQA-1 for Application in DOE Nuclear Projects”
8th floor, CNF-AR-Franklin-Center Main – 950 L’Enfant Plaza SW Washington, DC 20024
Time Discussion/Activity Speaker/Presenter
8:15 a.m. – 8:30 a.m. Opening / Introductions /Learning Objectives Ruben Sanchez, MA-63
8:30 a.m. – 9:00 a.m. Highlights Bud Danielson, CNS
9:00 a.m. – 9:30 a.m.
Overview of DOE QA Regulatory Framework • Rules, Directives, and Standards• Requirements, Program Elements,
and Expectations
Duli Agarwal, AU-33
9:30 a.m. – 10:00 a.m. DOE-HQ QA Resources, AU/CNS Duli Agarwal, AU-33 Bud Danielson, CNS
10:00 a.m. – 10:30 a.m. Break/Networking — 10:30 a.m. – 11:45 a.m. Overview of NQA-1 Requirements, Part I Ron Schrotke, CNS 11:45 a.m. – 12:00 p.m. NQA-1 Discussions and Q/A Group 12:00 p.m. – 1:00 p.m. Lunch —
1:00 p.m. – 2:00 p.m. Overview of NQA-1 Requirements, Part II Ron Schrotke, CNS
2:00 p.m. – 2:30 p.m. Line Management QA Oversight /Assessment Practices Jeff Roberson, NNSA
2:30 p.m. – 3:00 p.m. QA Lessons Learned Bud Danielson, CNS 3:00 p.m. – 3:15 p.m. Break/Networking —
3:15 p.m. – 4:30 p.m. • QA role in the DOE Critical Decision
(CD) Process, DOE O 413.3B• Project Case Studies
Bud Danielson, CNS Duli Agarwal, AU-33 Ruben Sanchez, MA-63 Ron Schrotke, CNS
4:30 p.m. – 5:00 p.m. Closing/Summary Ruben Sanchez, MA-63 Bud Danielson, CNS
Ron Schrotke Member, ASME NQA-1 Main Committee
and ASME Board of Nuclear Codes and Standards
NQA-1 Part II
May 14, 2015
Purpose of NQA-1 Part II
Understand the purpose of Part II Identify the structure of Part II Overview of specific Part II Requirements
2
Purpose of Part II
Part II: Quality Assurance Requirements for Nuclear Facility Applications Contains amplifying quality assurance requirements for specific work
activities at various stages of a facility Supplements the quality assurance requirements of Part I
3
Structure of Part II
Part II Subpart 2.1 – Quality Assurance Requirements for Cleaning of Fluid
Systems and Associated Components for Nuclear Power Plants (Facilities) o Guidance on Cleaning of Fluid Systems and Associated Components
for Nuclear Power Plants – Part III, Subpart 3.2, 2.1 Subpart 2.2 – Quality Assurance Requirements for Packaging, Shipping,
Receiving, Storage, and Handling of Items for Nuclear Power Plants (Facilities)
Subpart 2.3 – Quality Assurance Requirements for Housekeeping for Nuclear Power Plants (Facilities)
Subpart 2.4 – Installation, Inspection, and Testing Requirements for Power, Instrumentation, and Control Equipment at Nuclear Facilities
4
Structure of Part II (cont’d)
Part II Subpart 2.5 – Quality Assurance Requirements for Installation,
Inspection, and Testing of Structural Concrete, Structural Steel, Soils, and Foundations for Nuclear Power Plants (Facilities)
Subpart 2.7 – Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
Application Appendix: Guide on Quality Assurance Requirements for Computer Software – Part IV, Subpart 4.1
5
Structure of Part II (cont’d)
Part II Subpart 2.8 – Quality Assurance Requirements for Installation, Inspection,
and Testing of Mechanical Equipment and Systems for Nuclear Power Plants (Facilities) Guidance on Establishing and Maintaining Equipment Histories – Part III, Subpart 3.2, 2.18A Guidance on Performing Engineering Evaluations of Equipment Failures - Part III, Subpart 3.2, 2.18B
Subpart 2.14 – Quality Assurance Requirements for Commercial Grade Items and Services
Subpart 2.15 – Quality Assurance Requirements for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants
Recommendations for Hoisting, Rigging, and Transporting of Items for Nuclear Power Plants – Part III, Subpart 3.2, 2.15 Subpart 2.16 – Requirements for the Calibration and Control of Measuring
and Test Equipment Used in Nuclear Facilities
6
Structure of Part II (cont’d)
Part II Subpart 2.18 - Quality Assurance Requirements for Maintenance of
Nuclear Facilities Guidance on Establishing and Maintaining Equipment Histories – Part III, Subpart 3.2, 2.18A Guidance on Performing Engineering Evaluations of Equipment Failures - Part III, Subpart 3.2, 2.18B
Subpart 2.20 - Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants (Facilities) Guidance on the Quality Assurance Requirements for Identification and Control of Samples Obtained for Subsurface Investigations of Nuclear Power Plants – Part III, Subpart 3.2, 2.20
Subpart 2.22 - Quality Assurance Requirements for Management Assessment and Quality Improvement for Compliance With 10 CFR 830 and Department of Energy (DOE) Order 414.1 for DOE Nuclear Facilities
7
Overview of Part II
Subpart 2.2 – Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Power Plants Measures shall be established/implemented for
o packaging o shipping o receiving o storage o handling
of specified items to be incorporated in the nuclear power plant, for the inspection, testing, documentation to verify conformance to specified requirements.
8
Overview of Part II
Subpart 2.5 – Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete, Structural Steel, Soils, and Foundations for Nuclear Power Plants applies to the following:
o formwork o steel reinforcement o embedded items o foundation preparation o concrete o structural steel o soils and earthwork o special foundations o foundation underpinning
9
Overview of Part II
Subpart 2.7 – Quality Assurance Requirements for Computer Software for Nuclear Facility Applications o Provides requirements for the life cycle:
– Acquisition – Development – Operation – Maintenance – Retirement of software
o Appropriate requirements implemented through policies, procedures, plans, specifications, or work practices, that provide the framework for software engineering activities.
10
Overview of Part II
Subpart 2.7 – Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
General Requirements o General requirements apply to the software engineering elements:
– Documentation – Review – Software Configuration Management – Problem Reporting and Corrective Action
11
Overview of Part II
Subpart 2.14 – Quality Assurance Requirements for Commercial-Grade Items and Services
The development of this work practice was necessary to address the o shrunken nuclear-grade manufacturing base in the United States. o increased employment of non-United States manufacturing/suppliers –
suppliers whose QA Program is not compliant with the requirements of NQA-1.
This subpart is critical to DOE Project success to assure that items (services) that are performing a safety function that was not designed and manufactured as an item in accordance with the requirements of NQA-1, or commercial-grade item which has successfully completed the dedication process.
12
Overview of Part II
Subpart 2.14 – Quality Assurance Requirements for Commercial-Grade Items and Services
DEFINITIONS important to DOE Projects Commercial-grade item: an item satisfying the following: o not subject to design or specification requirements that are unique to those
facilities or activities o used in applications other than those facilities or activities o to be ordered from the manufacturer/supplier on the basis of specifications
set forth in the manufacturer’s published product description (e.g., a catalog) Commercial-grade service: a service that was not provided in accordance
with the requirements of this Standard
13
Overview of Part II
Subpart 2.14 – Quality Assurance Requirements for Commercial-Grade Items and Services o Critical characteristics: important design, material, and performance
characteristics of a commercial-grade item or service that, once verified, will provide reasonable assurance that the item or service will perform its intended safety function
14
Overview of Part II
Subpart 2.14 – Quality Assurance Requirements for Commercial-Grade Items and Services
Methods Dedication method(s) provide means to ensure the commercial-grade
item/service meets the acceptance criteria specified for the selected critical characteristics
Selection of dedication method(s) based on the type of critical characteristics to be verified for acceptance, available Supplier information, quality history, and degree of standardization
Supplemental dedication methods planned and completed prior to delivery of the item or performance of the service
15
Overview of Part II
Subpart 2.14 – Quality Assurance Requirements for Commercial Grade Items and Services
Methods Dedicating entity verify the commercial-grade item or service meets
the acceptance criteria for the identified critical characteristics by one or more of the dedication methods
Four methods o Inspections, tests, or analyses performed after delivery o Commercial-grade survey of the supplier o Source verification of the item or service o Acceptable supplier/item performance record
16
Overview of Part II
Subpart 2.20 – Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants o Apply to work of any organization/individual participating in subsurface
geotechnical investigations, such as: – drilling – coring – sampling – trenching – logging – geophysical methods – testing – or in interpreting results of subsurface investigations
17
Overview of Part II
Subpart 2.22 (2012) – Quality Assurance Requirements for Management Assessment and Quality Improvement for Compliance With 10 CFR 830 and Department of Energy (DOE) Order 414.1 for DOE Nuclear Facilities o Supplements requirements of Part I: 2, 4, 7, 15, 16, and 18, which do not
fully address DOE Management Assessment and Quality Improvement criteria.
– Management Assessment Requirements – Quality Improvement
18
Path to NQA-1
Paragraph 17 of DOE O 413.3B identifies the requirements for a Quality Assurance Program and references DOE O 414.1D, Quality Assurance, and 10 CFR 830, Subpart A, Quality Assurance Requirements.
DOE O 413.3B and DOE O 414.1D identify NQA-1-2008, with the 2009 addenda as the national standard for Hazard Category 1, 2, and 3 nuclear facilities.
2
Path to NQA-1 (Cont’d)
DOE G 413.3-2, Quality Assurance Guide for Project Management, identifies the guidance for project management activities to implement quality assurance requirements.
3
Oversight Process
Assessments, including NQA-1 audits. are conducted on activities other than for projects.
Assessments can be conducted as contractor internal/self-assessments, or external assessments conducted by DOE, DNFSB, GAO, IG, etc.
DOE has established orders and guides to address how assessments are to be conducted.
4
DOE Oversight Documents
DOE P 226.1B, Department of Energy Oversight Policy DOE O 226.1B, Implementation of Department of Energy Oversight Policy DOE G 226.1-2A, Federal Line Management Oversight
of Department of Energy Nuclear Facilities DOE O 227.1, Independent Oversight Program
5
Quality Assurance Assessment Definitions
A management assessment is a periodic introspective self-analysis, conducted by management, to evaluate management systems, processes, and programs, ensuring the organization’s work is properly focused on achieving desired results.
Independent assessments are conducted by individuals within the organization or company but independent from the work or process being evaluated, or by individuals from an external organization or company, such as an NQA-1 audit.
7
NNSA Implementation
A Three-Tiered Process NNSA Biennial Review – field/Federal-focused
o HQ Lead o Field process and implementation
Site integrated assessment planning – Field/HQ partnership o Required reviews (IPRs, TIPRs) o Ad hoc (trends, CAS flags, events)
Contractor Assurance System o Self-monitoring o Corporate monitoring
Assessment Results
Assessments, whether NQA-1 related or not, project related or not, may generate information that is useful to your project.
Results of other assessments may also impact your activities as lessons learned. These results may improve activities on your project.
Look at assessments as potential for improvement opportunities to improve your project results.
9
Legacy Quality-Assurance Issues: Institutional–Federal Level
Field offices typically did not have a specific QA organization or an individual designated as a QA manager.
Project QA documentation had not been established or was inadequate. Field offices had not performed a QA program audit of the project that
included all the QA criteria invoked on the project. QA & SQA personnel staffing to perform effective oversight of projects
was insufficient. There was no NQA-1 program to certify lead auditors, auditors, and
technical specialists. Integrated Project Teams (IPTs) relied heavily on the ability to matrix
needed expertise from site personnel, often resulting in insufficient resources to adequately support FPDs.
Most oversight activities occurred as a result of events that had already occurred and were reactive rather than proactive in nature.
2
Legacy Quality Assurance Issues: Program Management–Contractor Level
Contractor QA organizations did not have a direct line of access to responsible levels of management. Non-nuclear QA standards were selected by the contractor and approved by DOE. Graded Approach was incorrect and eliminated applicable NQA-1 requirements. Projects had not documented and executed adequate internal or external interface
control plans for the execution of work between multiple organizations. Documentation and technical basis for commercial-grade items/services were
insufficient. Software quality-level determination process was site-specific and inconsistent
across the complex. QA professionals lacked organizational freedom from cost and schedule to
independently perform their function. Software configuration management was lacking.
3
Observations From Construction Project Reviews
(CPRs)
Major design and construction project issues and their tie to quality assurance requirements
4
Comparison of Technical Approach for Two Projects
Project A DOE is the Design Authority. Established testing program. Inputs defined (low solids). Aggressive issue resolution. Utilizes existing technologies in
design.
Project B Contractor is the Design Authority. The testing program takes place in
starts and stops. Inputs are uncertain (high solids). Issues arise with culture /
corrective-action programs. First-of-a-kind technologies are
being employed for key processes.
5
Construction Project Challenges
Technical Challenges Welding programs Seismic design Supplier quality /
commercial-grade dedication Technical authority QA/SQA Safety in design Startup and commissioning Standards interpretations
Project Management Issues CD-4 requirements
for nuclear facilities Definitions of construction complete,
systems turnover Funding profiles consistent with
efficient execution of project Defining special considerations
for nuclear facilities Managing technical / safety
documents through design and construction
6
Observations (Including Good Practices)
Design is incomplete or design errors found. Requirements were missing, vague, or not linked. This led to overstating
requirements, incorrect scopes, and design omissions and errors. Safety basis documents were incomplete or unreviewed for stage of project. Design, construction, or operating alternatives were not sufficiently
considered. Design/construction documents were not clear; contractor expected to
perform final design. Design changes late in life-cycle led to increased costs and discovery of
errors. Project team operational safety board was used from early in design to
evaluate and monitor changes in design and fabrication associated withspecific safety features.
7 7
Observations (Design)
A project-specific process for dealing with requests for information, field technical questions, and resultant design change notices was established early.
Late evolution of safety requirements (and corresponding design solutions) significantly impacted the facility’s design, construction, procurement, readiness, and start-up.
In some instances, site standards and procedures and DOE Orders exceeded industry requirements and the basis for those positions was not clear.
Design practices were poor. The design team and Project execution team were poorly managed.
8 8
Observations (Project Reviews)
The review process throughout the project was inadequate. Management self-assessments were self-initiated and conducted during
the life of the project. Constructability reviews were conducted too late; they were not allowed
enough time for completion and lacked depth and specificity. Contractor lacks a mature self-assessment program, leading to late
discovery of construction quality issues. DOE should require peer reviews for first-of-a-kind and technically
complex projects at CD-1. Planning of project reviews is not well-coordinated.
9 9
Observations (Project Management)
Project Management – PM requirements are not consistently followed. Project execution and work control processes are poor.
o Requirements are spread out and poorly integrated. o Work and controls are not adequately defined.
10 10
THURSDAY, May 14, 2015
One-Day Workshop/Training
“Understanding DOE Quality Assurance Requirements and ASME NQA-1 for Application in DOE Nuclear Projects”
8th floor, CNF-AR-Franklin-Center Main – 950 L’Enfant Plaza SW Washington, DC 20024
Time Discussion/Activity Speaker/Presenter
8:15 a.m. – 8:30 a.m. Opening / Introductions /Learning Objectives Ruben Sanchez, MA-63
8:30 a.m. – 9:00 a.m. Highlights Bud Danielson, CNS
9:00 a.m. – 9:30 a.m.
Overview of DOE QA Regulatory Framework • Rules, Directives, and Standards• Requirements, Program Elements,
and Expectations
Duli Agarwal, AU-33
9:30 a.m. – 10:00 a.m. DOE-HQ QA Resources, AU/CNS Duli Agarwal, AU-33 Bud Danielson, CNS
10:00 a.m. – 10:30 a.m. Break/Networking — 10:30 a.m. – 11:45 a.m. Overview of NQA-1 Requirements, Part I Ron Schrotke, CNS 11:45 a.m. – 12:00 p.m. NQA-1 Discussions and Q/A Group 12:00 p.m. – 1:00 p.m. Lunch — 1:00 p.m. – 2:00 p.m. Overview of NQA-1 Requirements, Part II Ron Schrotke, CNS
2:00 p.m. – 2:30 p.m. Line Management QA Oversight /Assessment Practices Jeff Roberson, NNSA
2:30 p.m. – 3:00 p.m. QA Lessons Learned Bud Danielson, CNS 3:00 p.m. – 3:15 p.m. Break/Networking —
3:15 p.m. – 4:30 p.m. • QA role in the DOE Critical Decision
(CD) Process, DOE O 413.3B• Project Case Studies
Bud Danielson, CNS Duli Agarwal, AU-33 Ruben Sanchez, MA-63 Ron Schrotke, CNS
4:30 p.m. – 5:00 p.m. Closing/Summary Ruben Sanchez, MA-63 Bud Danielson, CNS
Strategy to Strengthen Technical Basis for CD Review
and Approval Process
Ensure more comprehensive, integrated, and standardized project reviews performed at project Critical Decision (CD) points.
Develop consistent, predictable, and rigorous review framework to support major design and construction projects.
Ensure that DOE performance expectations are reflected clearly through project life-cycle activities as defined in DOE O 413.3B, DOE-STD-1189, and PSO requirements.
Develop SRP in a series of stand-alone Review Modules (RMs) addressing the following project areas: o Project Management o Engineering and Design o Nuclear and Facility Safety o Worker Safety o Environment o Security o Quality Assurance
3 3
SRP Overview
Promotes transparency, clarity, and consistency in corporate decision-making. Framework for comprehensive, integrated, and standardized project reviews
that support day-to-day efforts as well as project-applicable Critical Decision (CD) points, for both federal and contractor personnel
Tailored to each Critical Decision (CD) phase Many SRP modules were piloted at major construction projects—i.e., Salt
Waste Processing Facility (SWPF), Waste Treatment Plant (WTP), Sodium Bearing Waste / Integrated Waste Treatment Unit (IWTU), Oak Ridge U233, Depleted Uranium Hexafluoride (DUF6)—to capture lessons-learned from field implementation.
Leverage best practices and lessons learned from past Office of Engineering and Construction Management (OECM) / Office of Science (SC) / National Nuclear Security Administration (NNSA), and EM-HQ field reviews, review guides/protocols, and consensus standards.
4 4
Over 60 SRP Review Modules Have Been Developed to Date to Support
Technically Defensible Implementation of CD Review and Approval Process
555
CD-0 Approval
on Mission Need
Pr o ject Mana gement
Engineer ing and Design
Nuclear and Faci l i ty Safety
Envi r onment
Wor ker Safety
Qual i ty Assur ance
Secur i ty
CD-1 Approval
on Alternative
CD-2 Approval on Performance
Baseline
CD-3 Approval
on Start of Construction
CD-4 Approval
on Start of Operations
5
Emerging QA Opportunity/Challenge: Nuclear Facility Commissioning Process
Opportunity: Proactively influence project success Challenge: Establish/ensure a functioning QA framework for each major project
9
Contractor and Subcontractors
Findings
Inadequate record keeping of Nondestructive Examination (NDE) No records traceability of pressure vessel fabrication Positive Material Identification (PMI) requirements not met Deviated from contract requirements without DOE authorization Inadequate weld quality source verification at the subcontractors’
fabrication facilities Inadequate receipt verification of pressure vessel from subcontractors
12
Description of a Selected OIG Finding
Traceability of Pressure Vessel Fabrication Quality assurance records were incomplete because all material, welding
procedures, welders, and NDEs were not traceable to the associated item. Contractor’s QA program requires all vessel subcontractors to submit a weld
map identifying the specific location of each weld used in the fabrication of the vessel as well as information on the welding procedures, the welder, material used, and the location of the NDE.
Contractor was unable to provide the records, which further indicated the records were not available from the subcontractors.
OIG audit confirmed DOE’s earlier review of the missing records.
13
OIG Findings on DOE Oversight
Ineffective DOE oversight of contractor’s quality assurance processes, including: o Overseeing contract requirements o Assuring a higher level of quality assurance for safety-class
equipment o Assuring use of appropriate personnel during receipt inspection
process o Assuring contractor has safeguards to place to identify contract
specification deviations o DOE reviews not comprehensive enough to detect inadequacies in
contractor’s source verification program and to identify the missing quality assurance documentation.
DOE did not take aggressive action on contractor to retrieve the incentive fee payment after the vessel QA issues were identified.
14
Contractor Root Cause Analysis
A Root Cause Analysis (RCA) Team was formulated to review the PIER welding defect issues.
Review why the ASME Section VIII vessel fabricated under an NQA-1 program was released for shipment with undercut and undersized welds.
The Team concluded that: o Primary reason for the fabrication deficiencies was the subcontractor’s failure
to fabricate the vessel in accordance with the Purchase Order requirements. o The subcontractor’s Quality Assurance program failed to identify and correct
welding issues since the subcontractor, as an ASME U-Stamp Holder, is responsible for ASME code compliance.
15
Root Cause Analysis (Concluded)
Root Causes for Welding Deficiencies o Weld changes were not adequately communicated throughout the
entire engineering and procurement cycle as well as lack of adherence to contractor’s processes and procedures.
o The Supplier Quality Representative’s lack of performance allowed release of pressure vessel which was non-conforming to the Purchase Order requirements.
The extent of condition includes all the Project’s Black Cell vessels, hard-to-reach vessels, or materials and equipment with higher safety and quality assurance classifications.
16
CD-0 Requirements, Mission Need
No project-specific QA program is required. Prior to CD-1, a Risk Management Plan should be developed.
Recommendations (based on lessons learned) Include NQA-1 in the Risk Management Plan. Correct the poor/inadequate implementation of requirements
o by contractor. o by subcontractors.
Ensure that qualified suppliers are available. o Suppliers of components, parts, and services o Suppliers of personnel
Ensure that records are properly controlled.
2
CD-1 Quality Requirements
Establish a Quality Assurance Program (QAP) . (Refer to 10 CFR Part 830, Subpart A; DOE O 414.1D, and DOE G 413.3-2). For Nuclear Facilities, the applicable national consensus standard shall be NQA-1-2008 (Edition) and NQA-1a-2009 (Addenda).
Recommendations Ensure that the initial submitted QAP is aligned with the Acquisition
Strategy and quality levels associated with scope. Ensure that the QAP builds quality into the design activities. Ensure that the Human Resource Plan will acquire qualified individuals,
maintain their skills, and retain them throughout the project lifecycle.
3
CD-2 Quality Requirements
Determine that the Quality Assurance Program is acceptable and continues to apply. (Refer to 10 CFR 830, Subpart A; DOE O 414.1D; and DOE G 413.3-2.)
Recommendations Ensure that the Oversight/Contract Admin/QA/QC organization structure and
plan are resource loaded and estimated. This is or will be directly affected by the quality of design and the final construction specs / drawing package.
Ensure that the design philosophy (identification and flow-down of requirements into the design/performance specifications) is coordinated with the acquisition strategy and QA strategy.
In addition to a flow-down of requirements, it is essential that contractors and vendors clearly understand the requirements. This is especially true for such activities as nuclear-grade construction and design, where the contractor pool may not truly understand the costs for implementing an effective QA program, one that includes an oversight function.
4
CD-3 Quality Requirements
Update the Quality Assurance Program for construction, field design changes, and procurement activities. (Refer to 10 CFR 830, Subpart A; DOE O 414.1D; and DOE G 413.3-2.)
Recommendations Ensure that acquisition documents (such as the construction RFP)
include appropriate QA/QC requirements. Ensure the use of qualified vendors. Ensure that in-depth oversight of the QA program(s) of the prime
contractor and key subcontractors (if applicable) is conducted.
5
CD-4 Quality Requirements
No specific QA requirements are specified.
Recommendations Prior to CD-4, ensure, use observation oversight, QA representatives,
and independent assessments to ensure that quality is being incorporated into work processes and activities (e.g., design, construction) – not “inspected in.”
Provide an updated QA program plan and lessons learned to operations as a source for updating existing operational QA program plans and other operational-related documentation.
Ensure that records are validated, authenticated, and turned over, consistent with applicable codes, regulations, and directives.
6
NA-APM QA Case Studies
The challenge: a non-nuclear, straightforward project The QA issue: Obvious quality issues were regularly identified: concrete,
pole heights, pole alignments, civil elevation misalignments. The real issue: While these items were identified, they were not
corrected immediately; when they were not corrected immediately,adequate actions were not taken to escalate the issue in the M&O andNNSA chain of command.
The result: Months of rework; replacement of the FPD and ContractorPM; a delay in the CD-4 date.
2
NA-APM QA Case Studies
The challenge: a nuclear project with the attendant NQA-1 paperworkpedigree requirements
The QA issue: There was a lack of deliberateness in ensuring that thepaperwork was considered as important as the construction.
The real issue: While construction completion is always important, NQA1 paperwork is almost equally important; when certifications weren’treceived, no priority was placed in remedying the situation; as time passed,the project had incorrect, incomplete, and missing documentation; yearsafter the due date made it nearly impossible to recover.
The result: A much longer certification period, with attendant cost growthdue to alternate certifications being required; a delay in the CD-4 date.
3
NA-APM QA Case Studies
The challenge: a nuclear project with the attendant NQA-1 specificationsfor Gloveboxes (GBs)
The QA issue: Shop drawings were approved that did not meet thespecifications.
The real issue: Once the issue was revealed that the GBs that weredelivered on-site did not meet the specifications, months were spent intrying to: 1) determine if the GBs could be used as-is and 2) determiningwho was liable for the incorrect GBs that were provided.
The result: An unnecessary delay to the critical path.
4
HEUMF Issues
Based on several documented nonconforming reinforcing steel conditions,BWXT Y-12 Senior Management and HEUMF Project Management issueda work suspension on February 2, 2006 for CBJV on-site work untileffective corrective actions were satisfactorily implemented.
Report on Deficiencies QA/QC Execution deficiencies resulted in the incorrect installation of
reinforcing steel during early construction activities at HEUMF. Concrete placement activities were suspended because of incorrectly placed
or missing rebar and wall dowels.
2
HEUMF Investigation of Issue – Causes
Inspections of concrete pre-placements were inadequately performed,utilized inappropriate drawings, and were not documented as required byprocedure.
Design change processes were not effective in ensuring that changes wereclearly communicated and controlled.
Nuclear requirements were not understood at the worker level; quality wasnot being built-in.
QA oversight of subcontractors by BWXT Y-12 was inadequate. Field inspection activities by BWXT Y-12 were lacking. BWXT Y-12 and subcontractor documented project QA Programs were
inadequate.
3
HEUMF Conclusions: Effect
As concluded by the corporate review team, “… project’s processes andquality programs as implemented do not fully support the rigor, oversightand controls needed for effective nuclear construction quality.”
Estimates indicate that the costs of lost project time, investigation, andrecovery will amount to approximately $10 million dollars.
Outcomes Y-12’s Quality Assurance Program was retooled to strengthen the site’s
nuclear culture. Increased project and corporate level of knowledge concerning Nuclear
Design/Construction Quality Program implementation. Improved contractor assurance system implementation, including better
procedures, metrics, trends, assessments, process improvements, andlessons learned.
4
MOX Quality Issues
Vendors’ lack of understanding of NQA-1 concerns documentation andrecords. They focused heavily on the hardware, ignoring documentation.Consequence: Project didn’t accept shipped equipment until alldocumentation was done properly that supported the “pedigree” of thematerials used and resulted in delays of the installation of the equipment.
The main contractor purchased steel through a subcontractor but was notdoing quality inspections upon receipt. Records kept were incomplete orhad errors when the steel was delivered.Result: Upon further review, it was discovered that some of the productdimensions were not right. The main contractor wasn’t conducting thechecks that were required by the contract.
5
CGD Example
May 14, 2015
Duli C. Agarwal, PEOffice of Quality Assurance (AU-33)
Chair, NQA Subcommittee on ApplicationsChair, IAEA TEC-DOC-1169 Revisions
Chair, S/CI Focus Group
Example of CGD
2
Item Information: Safety Bearing Labyrinth Seal, Split Type Safety Classification: Safety Significant Description: Seal is used for exhaust fan that maintains building negative
pressure. The seal is triple labyrinth type, 4-7/16″ diameter, made from non-metal synthetic material, flexible.
Procured From: Supplier has NO NQA-1 Program. Requirements: NQA-1, Part II, Subpart 2.14, QA Requirements for CGD
Items and Services
2
General Observations on CGD Packages Reviewed
3
Safety Function descriptions are system-level rather than how the item contributes to the safety function.
Failure Mechanisms and Failure Modes are used interchangeably. Inconsistent documentation of critical characteristics for design
(CCFD) (e.g., Performance Characteristics, Environmental and NPH are missing).
Use of “N/A” rather blank entries on CGD forms.
3
General Observations on CGD Packages Reviewed
4
Mixed usage of English and Metric units. Dimensions and tolerances as critical characteristics not specified. When referencing national standards, not provided the specific critical
characteristic elements that are required for acceptance. CCFAs do not contain details to verify the critical characteristics
documented in a Certificate of Conformance.
4
QA Resources
Policy, requirements interpretation, and SME support Office of Quality Assurance, AU-33 Office of Chief of Nuclear Safety, CNS
Leverage the existing body of knowledge Ongoing assessments and reviews by HQ and Field elements –
e.g., Construction Project Reviews (CPRs), topical reviews –e.g., commercial-grade dedication), operational awareness reports,and line-management audits.
EM Corrective Actions Hub (EMCAP Hub) – contains the status ofsite-specific QA findings and associated corrective actions.
3
Recommended Reading List
Standard Review Plan (SRP)o Performance requirements and expectations in support of Critical Decision
(CD) Review and Approvalo Lines Of Inquiry (LOI) in support of DOE Order 413.3B, Program and
Project Management for the Acquisition of Capital Assets, and DOE-STD1189-2008, Integration of Safety into the Design Process
o SRP review modules are organized per following categories (http://energy.gov/em/standard-review-plan-srp-modules):
– Critical Decision Handbook– Project Management– Engineering and Design– Safety– Environment– Security– Quality Assurance
4
Recommended Reading List (Cont’d)
DOE Directiveso 10 Code of Federal Regulations (C.F.R.) 830, Nuclear Safety Managemento DOE Order 414.1D, Quality Assuranceo DOE Guide 414.1-2B, Quality Assurance Program Guideo DOE G 414.1-4, Software Quality Assurance Guideo DOE Order 413.3B,
Program and Project Management for the Acquisition of Capital Assets Industry Codes and Standards
o ASME, NQA-1-2008 with NQA-1a-2009 addenda,Quality Assurance Requirements for Nuclear Facility Applications
Self-Study Guideo NNSA Self-Study Program, DOE G 414.1-4, Safety Software Guide, and
DOE G 414.1-2B, Quality Assurance Program Guide(http://energy.gov/sites/prod/files/2013/06/f1/G414_1-4_%26-2B.pdf)
5
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
Standard Review Plan (SRP) Technical Basis for Critical Decision (CD) and Nuclear Projects Review
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
SRP - Critica Decision Review and Approval Handbook
1 Senior Management SRP
Handbook, Jan 2013
SRP Volumes 1 and 2 - Performance Expectations of Implementation of DOE Order 413.3A and DOE-STD-1189
2 Overview, SRP Volume 1, Mar 2010
3 Project Execution Plan,
SRP Volume 1, Tab A, Mar 2010
4 Risk Management,
SRP Volume 1, Tab B, Mar 2010
5 Integrated Project Team, SRP Volume 1, Tab C, Mar
2010
6
Earned Value Management System (EVMS),
SRP Volume 1, Tab D, Mar 2010
1
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
7 Acquisition Strategy,
SRP Volume 1, Tab E, Mar 2010
8 Decommissioning Plan,
SRP Volume 1, Tab F, Mar 2010
9 Site Transition,
SRP Volume 1, Tab G, Mar 2010
10 Conceptual Design,
SRP Volume 1, Tab H, Mar 2010
11 Preliminary Design,
SRP Volume 1, Tab I, Mar 2010
12 Final Design,
SRP Volume 1, Tab J, Mar 2010
13 Construction Readiness,
SRP Volume 1, Tab K, Mar 2010
14
Checkout, Testing, and Commissioning Plan,
SRP Volume 1, Tab L, Mar 2010
2
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
15 Readiness Review,
SRP Volume 1, Tab M, Mar 2010
16 Seismic Design,
SRP Volume 1, Tab N, Mar 2010
17
Technology Readiness Assessment,
SRP Volume 1, Tab O, Mar 2010
18 External Technical Review, SRP Volume 1, Tab P, Mar
2010
19 Safety Design Strategy,
SRP Volume 2, Tab A, March 2010 (see Item 33 for update)
20 Conceptual Safety Design,
SRP Volume 2, Tab B, March 2010
21 Preliminary Safety Design,
SRP Volume 2, Tab C, March 2010
22
Facility Disposition Safety Strategy,
SRP Volume 2, Tab D, March 2010
3
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
23
Construction Project Safety and Health Plan,
SRP Volume 2, Tab E, March 2010
24
Review of SAR for Packaging, SRP Volume 2, Tab F, March
2010
25 NEPA,
SRP Volume 2, Tab G, March 2010
26
High Performance Sustainable Building Design, SRP Volume 2, Tab H, March
2010
27
Safeguards and Security and Cyber Security,
SRP Volume 2, Tab I, March 2010
28 Quality Assurance,
SRP Volume 2, Tab J, March 2010
29
Protocol for QAP/QIP, SRP Volume 2, Tab K, March
2010
4
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
SRP - Preparation for Facility Operations
30 Preparation for Facility
Operations, August 2013
SRP - Code of Record
31 Code of Record May 2014
SRP - Commercial Grade Dedication
32 Commercial Grade
Dedication August 2013
SRP – Safety Design Strategy
33 Safety Design Strategy
November 2014 (update of Item 19)
SRP - Safety Basis (SB) Program Review
34
Safety Basis (SB) Overview and Management Oversight, SB SRP Volume 1, February
2015
35
Safety Basis Review during Design
SB SRP Volume 2, February 2015
5
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
36
Safety Basis Review during Operations and Transition SB SRP Volume 3, February
2015
37
Safety Basis Review during Decommissioning and
Environmental Restoration SB SRP Volume 4, February
2015
38
Safety Basis Review of TSRs, USQs, and SERs
SB SRP Volume 5, February 2015
SRP - Engineering
39 Siting Criteria,
Engineering SRP LOI Set 1, December 2012 (draft)
40 Nuclear Engineering
Engineering SRP LOI Set 2, December 2012 (draft)
41
Natural Phenomena and Structural Engineering,
Engineering SRP LOI Set 3, December 2012 (draft)
6
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
42 Fire Protection,
Engineering SRP LOI Set 4, December 2012 (draft)
43 Criticality,
Engineering SRP LOI Set 5, December 2012 (draft)
44 Mechanical Engineering,
Engineering SRP LOI Set 6, December 2012 (draft)
45
Electrical Engineering, Engineering SRP LOI Set 7,
December 2012 (draft)
46 Instrumentation and Control,
Engineering SRP LOI Set 8, December 2012 (draft)
47 Radiation Protection,
Engineering SRP LOI Set 9, December 2012 (draft)
48 Chemical Engineering,
Engineering SRP LOI Set 10, December 2012 (draft)
49 Hazardous Materials,
Engineering SRP LOI Set 11, December 2012 (draft)
7
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
50 Sustainability,
Engineering SRP LOI Set 12, December 2012 (draft)
51 Human Factors Engineering, Engineering SRP LOI Set 13,
December 2012 (draft)
52 Safeguards and Security,
Engineering SRP LOI Set 14, December 2012 (draft)
53 Pressure Safety,
Engineering SRP LOI Set 15, December 2012 (draft)
54 Environmental Protection, Engineering SRP LOI Set 16,
December 2012 (draft)
55 Emergency Preparedness, Engineering SRP LOI Set 17,
December 2012 (draft)
56 Technology Readiness,
Engineering SRP LOI Set 18, December 2012 (draft)
57 Waste Management,
Engineering SRP LOI Set 19, December 2012 (draft)
8
Chief of Nuclear Safety (CNS) Office of the Undersecretary
As of April 2015
SRP
Applicable Review Areas
Project Management
Engineering and Design
Nuclear and
Facility Safety
Worker Safety Environmental Security Quality
Assurance
58
D&D Considerations during Design,
Engineering SRP LOI Set 20, December 2012 (draft)
59 Systems Engineering,
Engineering SRP LOI Set 21, December 2012 (draft)
60 Configuration Management, Engineering SRP LOI Set 22,
December 2012 (draft)
61
Nuclear Maintenance Management Program,
Engineering SRP LOI Set 23, December 2012 (draft)
9