training workshop: doe qa framework, application to doe

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

Overview

Ruben Sanchez, MA-63

May 14, 2015

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


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



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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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Highlights

Bud Danielson, CNS

May 14, 2015

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.

2

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: Vessel Head

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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

Rule, Order, Guides, and the Standard

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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

3

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title10/10cfr830_main_02.tpl

https://www.directives.doe.gov/directives/0414.1-BOrder-d/view

https://www.directives.doe.gov/directives/0414.1-EGuide-2Badmchg1/view

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.

10


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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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.

12


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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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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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.

15


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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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.

17


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

19


https://www.directives.doe.gov/directives/0232.2-BOrder/view

http://www-pub.iaea.org/MTCD/publications/PDF/te_1169_prn.pdf

https://www.directives.doe.gov/directives/0221.01-BOrder-a/view

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.

21

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.

3

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

4


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.

5


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.

6


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.

7


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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Questions? 9

HQ QA Resources Office of Chief of Nuclear Safety

Bud Danielson, CNS

May 14, 2015

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.

2

Footprint of EM Hazard Category 2 and 3 Nuclear Facilities

3

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.

4

Relative Risk Ranking(Prioritize Operational Awareness)

5

-

-

-

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

6

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


(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

10


(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)

11








9:00 a.m. – 9:30 a.m.


and Expectations

Duli Agarwal, AU-33










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


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



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


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


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


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


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-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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


Requirement 16 – Corrective Action o Other

– Sp 3.1, NMA 16A-1, Guidance on Corrective Action

32


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


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


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


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


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


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


Part III and Part IV since 2008

39


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


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

NQA-1 Discussions and Q&A

May 14, 2015








9:00 a.m. – 9:30 a.m.


and Expectations

Duli Agarwal, AU-33










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


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


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


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


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

NQA-1 and Oversight Programs

Jeffry Roberson, NA-51

May 14, 2015

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

DOE Oversight Documents (Cont’d)

DOE G 414.1-1, Management and Independent Assessment Guide

6

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

Lessons to be Learned

Bud Danielson, CNS

May 14, 2015

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

Supply-Chain Issues to Look Out For (Example: Suspect/Counterfeit Items)

11

Supply-Chain Issues to Look Out For (S/CI Example: Hoisting & Rigging)

12








9:00 a.m. – 9:30 a.m.


and Expectations

Duli Agarwal, AU-33


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







Critical Decision (CD) Process – DOE Order 413.3B

Bud Danielson, CNS

May 14, 2015

DOE Order 413.3B – Critical Decision (CD) Process for Nuclear Projects

(QA is an integral element.)

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

Specific SRPs

6

Performance Status & Verification Handbook

7

Sample Key Questions to be Asked by Senior Management and

Federal Project Directors (FPDs)

8

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

Case Study

Case Study Welding QA Issue

10

Vessel Head

11

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

QA Role in the CD Process, DOE O 413.3B

Ruben Sanchez

May 14, 2015

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


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


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


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

Case Studies

May 14, 2015

NNSA Project Lessons Learned

Jeffry Roberson, NA-51

May 14, 2015

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


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


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

DOE Project Case Studies Lessons Learned NQA-1 Deficiencies

Ruben Sanchez

May 14, 2015

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

Closing/Summary

Ruben Sanchez, MA-63 Bud Danielson, CNS

May 14, 2015

Resources to Assist You

2

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

http://energy.gov/em/standard-review-plan-srp-modules

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

http://energy.gov/sites/prod/files/2013/06/f1/G414_1-4_&-2B.pdf

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


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


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


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


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


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


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


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


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


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


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


41

Natural Phenomena and Structural Engineering,


6


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


Assurance

42 Fire Protection,


43 Criticality,


44 Mechanical Engineering,


45

Electrical Engineering, Engineering SRP LOI Set 7,

December 2012 (draft)

46 Instrumentation and Control,


47 Radiation Protection,


48 Chemical Engineering,


49 Hazardous Materials,


7


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


Assurance

50 Sustainability,


51 Human Factors Engineering, Engineering SRP LOI Set 13,


52 Safeguards and Security,


53 Pressure Safety,


54 Environmental Protection, Engineering SRP LOI Set 16,


55 Emergency Preparedness, Engineering SRP LOI Set 17,


56 Technology Readiness,


57 Waste Management,


8


As of April 2015

SRP


Project Management


Nuclear and

Facility Safety


Assurance

58

D&D Considerations during Design,


59 Systems Engineering,


60 Configuration Management, Engineering SRP LOI Set 22,


61

Nuclear Maintenance Management Program,


9