QUALITY ASSURANCE TRAINING DOE O 414'1C AND 10 CFR 830, SUBPART A

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QUALITY ASSURANCE TRAINING DOE O 414.1C AND10
CFR 830, SUBPART A

• Instructor

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LEARNING OBJECTIVES

• Articulate the Underlying Principles of Quality
  Assurance
• Discuss the interrelationships between Quality
  Assurance, Integrated Safety Management, and the
  Price-Anderson Amendments Act
• List Basic Quality Assurance Requirements
• Apply Quality Assurance to Your Work

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PRESENTATION OUTLINE

• Introduction
• History
• Definitions
• DOE Quality Assurance Program
• Responsibilities
• Total Management System Overview
• DOE Quality Assurance Culture
• QA Rule and Order Integration
• Total Management System Underlying Principles
  of
• Quality Assurance
• Integrated Safety Management
• Price-Anderson Amendments Act
• QA Program Basic Requirements Criteria
• Summary

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INTRODUCTION

• Brief History of Quality Assurance
• 1954 AEC issued QC-1, Weapons Quality Policy
• 1969 AEC issued QAP standard for AEC reactors
• 1970 AEC published 18 QA criteria 10 CFR 50, App.
  B
• 1971 AEC industry begin developing ANSI/ASME
  standards QAP requirements, guidance, work
  practices for nuclear power plant design
  construction
• 1972 ANS issued standard for admin controls
  during power plant operation
• 1975 ASME NQA committee established
• 1975 2004 Successive revisions to ASME QA
  requirements, ASME NQA-1-2004 most recent
  revision.
• 1980-2004 Successive revisions to DOE QA
  requirements, DOE O 414.1C (2004) most recent
  revision.
• 1994 DOE issued 10 CFR 830, Nuclear Safety
  Management

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INTRODUCTION (continued)

• The Quality Assurance Program is part of a Total
  Management System
• Programmatic, but bottom line is its about
• People
• The work they perform, and
• Common sense

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DEFINITIONS

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QUALITY DEFINITIONS

• Quality
• The condition achieved when an item, service or
  process meets or exceeds the users requirements
  or expectations.
• Quality Assurance (QA)
• All those actions that provide confidence that
  quality is achieved.
• Quality Assurance Program (QAP)
• A management system established to assign
  responsibilities and authorities, define policies
  and requirements, and provide for the performance
  and assessment of work.

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QUALITY DEFINITIONS (continued)

• Graded Approach
• The process of ensuring that actions used to
  comply with a requirement are commensurate with
• The relative importance to safety, safeguards,
  and security
• The magnitude of any hazard involved
• The life cycle stage, mission and characteristics
  of a facility
• The relative importance of hazards and
• Any other relevant factor.

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QUALITY DEFINITIONS (continued)

• System
• An integrated composite of people, products, and
  processes that provide a capability to satisfy a
  stated need or objective.
• Management System
• A set of interrelated processes that provides
  personnel what they need to effectively perform
  work which results in a product or service
  consistently meeting requirements and
  expectations.

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DOE QUALITY ASSURANCE PROGRAM

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RESPONSIBLITIES FOR QUALITY ASSURANCE
MANAGERS RESPONSIBLE AND ACCOUNTABLE FOR ALL
ASPECTS OF QUALITY OF PERFORMANCE, INCLUDING
PLANNING, ORGANIZATION, DIRECTION, CONTROL, AND
SUPPORT
PERFORMERS RESPONSIBLE FOR ACHIEVING QUALITY OF
PERFORMANCE SO AS TO ENSURE SAFETY AND
RELIABILITY

• ASSESSORS
• RESPONSIBLE FOR EVALUATING EFFECTIVENESS
• TO ACHIEVE QUALITY OF PERFORMANCE,
• IDENTIFY DEFICIENCIES, AND
• ENSURE CORRECTIONS

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TOTAL MANAGEMENT SYSTEM EXPECTATION

• Total Management System integrates systems,
  programs, and processes utilizing Rules, Orders,
  other applicable Standards and Guides, and Best
  Industry Practices to achieve safe, reliable
  results.

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TOTAL MANAGEMENT SYSTEM
ISM Orders/Guides Rules PAAA
NQA-1 ISO INPO QC-1 Lessons
Learned ANSI ASQ Best Practices
Other Standards
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QUALITY ASSURANCE PROGRAM IS PART OF A TOTAL
MANAGEMENT SYSTEM

• Objectives/goals are to
• Ensure requirements expectations are met
• Provide confidence in achieved results
• Comply with applicable regulations requirements
• Fundamental to Total Management System
• Applies to all work

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DOE QA CULTURE REFLECTED IN TOTAL MANAGEMENT
SYSTEM

• Quality is everyone's responsibility
• All contribute to quality in a concerted cost
  effective manner
• Achieving quality products services is the
  measure of success
• Quality achievement is verified or validated by
  either individuals or groups other than those who
  performed the work.
• Quality is "built in" by providing every person
• Correct training, resources, and motivation
• Focus to safely do the job right the first time
• Assessors of work are
• Technically knowledgeable and performance
  oriented
• Focused on improving quality

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The QA RULE, QA ORDER, PAAA

• 10 CFR 830, Nuclear Safety Management
• Subpart A applies to all contractors at DOE
  nuclear facilities (including radiological
  facilities)
• DOE O 414.1 applies to DOE elements and
  contractors
• Price-Anderson Amendments Act establishes
  requirements, indemnification and enforcement

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UNDERLYING PRINCIPLES

• QUALITY ASSURANCE
• INTEGRATED SAFETY MANAGEMENT
• PRICE-ANDERSON AMMENDEMENTS ACT

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QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES

• Define policies and objectives. Ensure they are
  understood and accepted.
• Specify roles, responsibilities, authorities.
  Ensure they are understood and accepted.
• Specify and communicate expectations. Identify
  allocate resources to achieve them.
• Establish a culture that is conducive to quality
  achievement and continuous improvement.

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QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES
(continued)

• Ensure people are competent at the work they do.
• Ensure the right people have the right tools and
  information at the right time.
• Seek and use relevant experience.
• Plan and control the work.
• Use the right materials, tools, and processes.
  Control any changes to them.

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QUALITY ASSURANCE (QA)UNDERLYING PRINCIPLES
(continued)

• Assess work to ensure it meets expectations.
• Identify and remedy errors and deficiencies.
• Periodically review management processes to
  improve effectiveness and efficiency.

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INTEGRATED SAFETY MANAGEMENT (ISM) - UNDERLYING
PRINCIPLES

• Line management responsibility for safety
• Clear roles and responsibilities
• Competence commensurate with responsibilities
• Balanced priorities
• Identification of safety standards and
  requirements
• Hazard controls tailored to work being performed
• Operations Authorization

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INTEGRATED SAFETY MANAGEMENT (ISM) CORE
FUNCTIONS

• Define the Scope of Work
• Analyze the hazards
• Develop and implement hazard controls
• Perform work within controls
• Provide feedback and continuous improvement

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QA CRITERIA/ISM PRINCIPLES AND FUNCTION CROSSWALK
TABLE
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PRICE-ANDERSON AMENDMENTS ACT (PAAA) - PURPOSE

• Promotes protection of the environment, health,
  and safety of the public and workers
• Indemnifies (insures) DOE contractors against
  public liability due to a nuclear incident
• Establishes nuclear safety requirements
• Provides DOE enforcement authority

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QUALITY ASSURANCE PROGRAM

• BASIC REQUIREMENTS
• AND
• CRITERIA

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BASIC QA PROGRAM REQUIREMENTS

• Rule Order Requirements and Applicability
• Consensus Standards
• Integration of Requirements
• Responsibilities for a Documented Approved
  Management System
• Flow-down of QA Program Requirements
• QA Criteria

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QA RULE ORDER REQUIREMENTS AND APPLICABILITY

• Order
• Enforceable by contract
• Applicability/Scope
• Responsibilities
• Definitions (consistent)
• Graded Approach
• Consensus Standards
• Integration of Requirements
• Flow-down of Requirements
• Criteria (same)
• Safety Software Requirements
• S/CI Prevention Requirements
• CAMP (Feds)

• Rule
• Enforceable by law
• Applicability/Scope
• Responsibilities
• Definitions (consistent)
• Graded Approach
• Consensus Standards
• Integration of Requirements
• Flow-down of Requirements
• Criteria (same)

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CONSENSUS STANDARDS

• Consensus Standards must be used to develop and
  implement the QA Program
• Appropriate standards include ASME NQA-1, ISO
  9001, ANSI/ASQ Z1.13
• Must be practicable and consistent with
  contractual or regulatory requirements
• ASME NQA-1, Quality Assurance Requirements for
  Nuclear Facility Applications
• Key national consensus standard for nuclear
  quality safety
• Unique focus on nuclear facilities activities
• Single most rigorous and comprehensive standard
• First choice for DOE nuclear facility
  applications
• Supports compliance with DOE QA Requirements
• Establishes criteria for the performance of work

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DOE QA CRITERIA/NQA-1-2004 REQUIREMENTS CROSSWALK
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CONSENSUS STANDARDS - Continued

• ISO 9001-2000, Quality Management System
• Applies to all types of organizations that are
  involved in non-nuclear activities
• Based on 8 quality management principles
• ISO chose these principles because they can
  be used to improve organizational performance and
  achieve success
• ANSI/ASQ Z1.13, Quality Guide for Research, 1999
• Applies to non-nuclear research activities
• This document can be used in the development of a
  quality system for basic and applied research.

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CONSENSUS STANDARDS - Continued

• Standards for Specific Applications
• Address unique/specific work activities such as
• Development and use of safety software ASME
  NQA-1-2000 (Required by DOE O 414.1C)
• Establishing the competence of a testing and
  calibration laboratory ISO 17025

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INTEGRATION OF REQUIREMENTS

• Quality Assurance requirements as defined in
  Rule and/or QA Order must be integrated with
  Safety Management System including
• Suspect/Counterfeit Items (S/CI)
• Corrective Action Management Program (CAMP)
• Safety Quality Assurance (SQA)

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ROLES AND RESPONSIBILITIES

• EH roles and responsibilities for a documented
  and approved Management System
• DOEs independent element responsible for safety
  of the public, worker and environment
• Develops and maintains QA policy requirements,
  guides, and standards for all DOE work
• Provides advise and assistance to DOE elements
  and contractors implementing DOE QA policy
• Identifies and proposes resolutions for
  crosscutting QA issues
• Develops and maintains the EH QAP

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ROLES AND RESPONSIBILITIES - Continued

• PSO roles and responsibilities for a documented
  and approved Management System
• Ensure HQ, field elements, and contractors
  implement the requirements in the QA Order
• Set priorities and schedule for compliance
• Provide direction and resources, including
  prioritization, for implementing the QA
  requirements
• Review and approve QAPs or other documents that
  include implementation approaches for the QA
  requirements
• Design and implement line management oversight
  programs

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FLOWDOWN OF QA PROGRAM REQUIREMENTS

• Quality Assurance Program must
• Flow-down requirements to subcontractors and
  suppliers to ensure criteria are satisfied
• Flow-down should employ graded approach so that
  subcontractor requirements are commensurate with
  subcontractor scope of work
• Requirement in both the QA Rule and Order

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QUALITY ASSURANCE CRITERIA
BASIC REQUIREMENTS
PERFORMANCE
MANAGEMENT
ASSESSMENT

• WORK PROCESSES
• DESIGN
• PROCUREMENT
• INSPECTION ACCEPTANCE TESTING

• PROGRAM
• PERSONNEL TRAINING QUALIFICATION
• QUALITY IMPROVEMENT
• DOCUMENTS RECORDS

• MANAGEMENT ASSESSMENT
• INDEPENDENT ASSESSMENT

More detail on each of the 10 criteria to follow.
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QUALITY ASSURANCE CRITERIA

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QA CRITERIA

• Management/Criterion 1Program
• Establish an organizational structure, functional
  responsibilities, levels of authority, and
  interfaces for those managing, performing, and
  assessing work.
• Establish management processes, including
  planning, scheduling, and providing resources for
  work.
• Key Elements
• Senior management ownership
• Performance objectives established
• Responsibilities, authorities, and interfaces
  established
• Individuals empowered
• Application based on graded approach

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QA CRITERIA (continued)

• Management/Criterion 2Personnel Training and
  Qualification
• Train and qualify personnel to be capable of
  performing assigned work.
• Provide continuing training to personnel to
  maintain job proficiency.
• Key Elements
• Affects all personnel
• Stimulate professional development
• Designed to address specific needs
• Maintain proficiency and promote improvement
• Conduct on-going review of training effectiveness

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QA CRITERIA (continued)

• Management/Criterion 3Quality Improvement
• Establish implement processes to detect and
  prevent quality problems.
• Identify, control, and correct items, services,
  and processes that do not meet established
  requirements.
• Identify the causes of problems, and include
  prevention of recurrence as a part of corrective
  action planning.
• Review item characteristics, process
  implementation, other quality-related
  information to identify items, services,
  processes needing improvement.
• Key Elements
• Standards and measures for performance
• Problem identification, control, resolution, and
  follow-up
• Cause analysis
• Continuous improvement
• Prevent problems

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QA CRITERIA (continued)

• Management/Criterion 4Documents and Records
• Prepare, review, approve, issue, use, and revise
  documents to prescribe processes, specify
  requirements, or establish design.
• Specify, prepare, review, approve, and maintain
  records.
• Key Elements
• Scope of documents and records defined
• Documents identified and controlled
• Records identified and controlled

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QA CRITERIA (continued)

• Performance/Criterion 5Work Processes
• Perform work consistent with technical standards,
  administrative controls, and hazard controls
  adopted to meet regulatory or contract
  requirements using approved instructions,
  procedures, etc.
• Identify and control items to ensure their proper
  use.
• Maintain items to prevent their damage, loss, or
  deterioration.
• Calibrate and maintain equipment used for process
  monitoring or data collection.
• Key Elements
• Management provides training, resources, and
  direction
• Employees are responsible for their work
• Review and improve processes

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QA CRITERIA (continued)

• Performance/Criterion 6Design
• Design items and processes using sound
  engineering/scientific principles and appropriate
  standards.
• Incorporate applicable requirements and design
  bases in design work and design changes.
• Identify and control design interfaces.
• Verify/validate the adequacy of design products
  using individuals or groups other than those who
  performed the work.
• Verify/validate work before approval and
  implementation of the design.
• Key Elements
• Design based on sound engineering/scientific
  principles
• Changes must be justified
• Interfaces must be identified and coordinated
• Verification must be conducted

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QA CRITERIA (continued)

• Performance/Criterion 7Procurement
• Procure items and services that meet established
  requirements and perform as specified.
• Evaluate and select prospective suppliers on the
  basis of specified criteria.
• Establish and implement processes to ensure that
  approved suppliers continue to provide acceptable
  items and services.
• Key Elements
• Procured items and services must perform as
  specified and meet requirements
• Use qualified suppliers
• Acceptance of procured items and services in
  accordance with specified methodology

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QA CRITERIA (continued)

• Performance/Criterion 8Inspection and Acceptance
  Testing
• Inspect and test specified items, services, and
  processes using established acceptance and
  performance criteria.
• Calibrate and maintain equipment used for
  inspections tests.
• Key Elements
• Inspection
• Conducted by, or for, the line organization
• Inspection criteria specified
• Acceptance Testing
• Conducted by or for the line organization
• Test and acceptance criteria specified

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QA CRITERIA (continued)

• Assessment/Criterion 9Management Assessment
• Ensure that managers assess their management
  processes and identify and correct problems that
  hinder the organization from achieving its
  objectives.
• Key Elements
• Focuses on broad categories of management issues
• Addresses how well integrated management system
  is working
• Management responsibility and participation

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QA CRITERIA (continued)

• Assessment/Criterion 10Independent Assessment
• Plan and conduct independent assessments to
  measure item and service quality and the adequacy
  of work performance to promote improvement.
• Establish sufficient authority and freedom from
  line management for independent assessment teams.
• Ensure that persons conducting independent
  assessments are technically qualified and
  knowledgeable in the areas to be assessed.
• Key Elements
• Implemented by independent organization
  representing senior management
• Performance-based approach
• Technically knowledgeable personnel
• Focus on improving performance
• Scheduling based on performance

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SUMMARYAPPLYING QA TO YOUR WORK

• Quality Assurance for all work is based on the
  development and maintenance of a single,
  integrated, effective Total Management System
• Each manager and worker must review and comply
  with QA requirements in planning and executing
  work
• Each employee is responsible for
• Achieving and maintaining quality
• Maximizing reliability and performance of work
  products, while
• Minimizing environmental, safety, and health
  risks and impacts

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DOE QA INFORMATION SOURCES

• DOE G 414.1-1A, 05/31/2001, Management Assessment
  and Independent Assessment Guide
• DOE G 414.1-2A, 06/17/2005, Quality Assurance
  Management System Guide for Use with 10 CFR 830
  Subpart A, Quality Assurance Requirements, and
  DOE O 414.1C, Quality Assurance
• DOE G 414.1-3, 11/03/2004, Suspect/Counterfeit
  Items Guide for Use with 10 CFR 830 Subpart A,
  Quality Assurance Requirements
• DOE G 414.1-4, 06/17/2005, Safety Software Guide
  for Use with 10 CFR 830, Subpart A, Quality
  Assurance Requirements, and DOE O 414.1C, Quality
  Assurance

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BACKUP SLIDES

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SUPPLEMENTAL HIGH-RELIABILITY PRINCIPLES

• Highly-Reliable Operational Performance
• Individual Attitude and Responsibility
• Performance Assurance
• Organizational Performance Improvement