quality assurance training doe o 414.1c and 10 cfr 830, subpart a

QUALITY ASSURANCE QUALITY ASSURANCE TRAINING TRAINING

DOE O 414.1C DOE O 414.1C ANDAND

10 CFR 830, SUBPART A10 CFR 830, SUBPART AInstructor:

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LEARNING OBJECTIVESLEARNING 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 OUTLINEPRESENTATION 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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INTRODUCTIONINTRODUCTION

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)INTRODUCTION (continued)

• The Quality Assurance Program is part of a Total Management System

• Programmatic, but bottom line is it’s about:– People– The work they perform, and– Common sense

DEFINITIONSDEFINITIONS

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QUALITY DEFINITIONSQUALITY 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)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)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.

DOE QUALITY ASSURANCE DOE QUALITY ASSURANCE PROGRAMPROGRAM

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RESPONSIBLITIES FOR RESPONSIBLITIES FOR QUALITY ASSURANCEQUALITY ASSURANCE

MANAGERSMANAGERSRESPONSIBLE AND ACCOUNTABLE FOR ALL ASPECTS OF

QUALITY OF PERFORMANCE, INCLUDING PLANNING, ORGANIZATION, DIRECTION, CONTROL, AND SUPPORT

ASSESSORSASSESSORS RESPONSIBLE FOR EVALUATING EFFECTIVENESS

TO ACHIEVE QUALITY OF PERFORMANCE, IDENTIFY DEFICIENCIES, AND

ENSURE CORRECTIONS

PERFORMERSPERFORMERSRESPONSIBLE FOR ACHIEVING QUALITY OF

PERFORMANCE SO AS TO ENSURE SAFETY AND RELIABILITY

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TOTAL MANAGEMENT SYSTEM TOTAL MANAGEMENT SYSTEM EXPECTATIONEXPECTATION

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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ISM Orders/Guides Rules PAAA NQA-1 ISO INPO QC-1 Lessons Learned ANSI ASQ Best Practices Other Standards

TOTAL MANAGEMENT SYSTEMTOTAL MANAGEMENT SYSTEM

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QUALITY ASSURANCE PROGRAM IS QUALITY ASSURANCE PROGRAM IS PART OF A TOTAL MANAGEMENT PART OF A TOTAL MANAGEMENT

SYSTEMSYSTEM

• 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 DOE QA CULTURE REFLECTED IN TOTAL MANAGEMENT SYSTEMTOTAL 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, & PAAAThe 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

UNDERLYING PRINCIPLESUNDERLYING PRINCIPLES

QUALITY ASSURANCEINTEGRATED SAFETY MANAGEMENT

PRICE-ANDERSON AMMENDEMENTS ACT

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QUALITY ASSURANCE (QA) QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES UNDERLYING PRINCIPLES

1. Define policies and objectives. Ensure they are understood and accepted.

2. Specify roles, responsibilities, & authorities. Ensure they are understood and accepted.

3. Specify and communicate expectations. Identify & allocate resources to achieve them.

4. Establish a culture that is conducive to quality achievement and continuous improvement.

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QUALITY ASSURANCE (QA) QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES UNDERLYING PRINCIPLES

(continued)(continued)5. Ensure people are competent at the

work they do.6. Ensure the right people have the

right tools and information at the right time.

7. Seek and use relevant experience.8. Plan and control the work.9. Use the right materials, tools, and

processes. Control any changes to them.

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QUALITY ASSURANCE (QA)QUALITY ASSURANCE (QA)UNDERLYING PRINCIPLES UNDERLYING PRINCIPLES

(continued)(continued)

10. Assess work to ensure it meets expectations.

11. Identify and remedy errors and deficiencies.

12. Periodically review management processes to improve effectiveness and efficiency.

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INTEGRATED SAFETY INTEGRATED SAFETY MANAGEMENT (ISM) - MANAGEMENT (ISM) -

UNDERLYING PRINCIPLESUNDERLYING PRINCIPLES1. Line management responsibility for safety2. Clear roles and responsibilities3. Competence commensurate with

responsibilities4. Balanced priorities5. Identification of safety standards and

requirements6. Hazard controls tailored to work being

performed7. Operations Authorization

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INTEGRATED SAFETY INTEGRATED SAFETY MANAGEMENT (ISM) – CORE MANAGEMENT (ISM) – CORE

FUNCTIONSFUNCTIONS1. Define the Scope of Work2. Analyze the hazards3. Develop and implement hazard

controls4. Perform work within controls5. Provide feedback and continuous

improvement

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QA CRITERIA/ISM PRINCIPLES AND QA CRITERIA/ISM PRINCIPLES AND FUNCTION CROSSWALK TABLEFUNCTION CROSSWALK TABLE

QA Criteria

ISM Requirements Pro

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Line Management Responsibilities X X X

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Competence Commensurate Responsibilities

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Define Work X X X X X X X

Analyze Hazards X X X X X X X

Identify Safety Standards, Requirements & Develop & Implement Controls

X X X X X X X

Operations Authorization/ControlsX X X X X X

Feedback & Improvement X X X X X X

QA Criteria


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Competence Commensurate Responsibilities

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Feedback & Improvement X X X X X XFeedback & Improvement X X X X X X

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PRICE-ANDERSON AMENDMENTS PRICE-ANDERSON AMENDMENTS ACT (PAAA) - PURPOSEACT (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

QUALITY ASSURANCE PROGRAMQUALITY ASSURANCE PROGRAM

BASIC REQUIREMENTSAND

CRITERIA

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BASIC QA PROGRAM BASIC QA PROGRAM REQUIREMENTSREQUIREMENTS

• 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 QA RULE & ORDER REQUIREMENTS AND APPLICABILITYAND 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 • 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 DOE QA CRITERIA/NQA-1-2004 REQUIREMENTS CROSSWALKREQUIREMENTS CROSSWALK

X X X X X X X 10. Independent Assess.

X X 9. Management Assess.

X X X X 8. Inspect & Accept. Test

X X 7. Procurement

X 6 Design

X X X X X X 5. Work Processes

X X X 4. Documents & Records

X X X 3. Quality Improvement

X 2. Training & Qualification

X X 1. Program

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DOE QA Criteria

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CONSENSUS STANDARDS - CONSENSUS STANDARDS - ContinuedContinued

• 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 - CONSENSUS STANDARDS - ContinuedContinued

• 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 REQUIREMENTSINTEGRATION 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:– DOE’s 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 FLOWDOWN OF QA PROGRAM REQUIREMENTSREQUIREMENTS

• 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 CRITERIAQUALITY ASSURANCE CRITERIA

BASICBASIC

REQUIREMENTSREQUIREMENTS

PERFORMANCEMANAGEMENT

5. WORK PROCESSES

6. DESIGN 7. PROCUREMENT 8. INSPECTION &

ACCEPTANCE TESTING

9. MANAGEMENT ASSESSMENT

10.INDEPENDENT ASSESSMENT

1. PROGRAM2. PERSONNEL

TRAINING & QUALIFICATION

3. QUALITY IMPROVEMENT

4. DOCUMENTS & RECORDS

ASSESSMENT

More detail on each of the 10 criteria to follow.

QUALITY ASSURANCE CRITERIAQUALITY ASSURANCE CRITERIA

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QA CRITERIA QA CRITERIA

• Management/Criterion 1—Program– 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 QA CRITERIA (continued)

• Management/Criterion 2—Personnel 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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• Management/Criterion 3—Quality 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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• Management/Criterion 4—Documents 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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• Performance/Criterion 5—Work 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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• Performance/Criterion 6—Design– 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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• Performance/Criterion 7—Procurement– 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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• Performance/Criterion 8—Inspection 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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• Assessment/Criterion 9—Management AssessmentEnsure 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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• Assessment/Criterion 10—Independent 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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SUMMARYSUMMARYAPPLYING QA TO YOUR WORKAPPLYING 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 SOURCESDOE 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

BACKUP SLIDESBACKUP SLIDES

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SUPPLEMENTAL HIGH-RELIABILITY SUPPLEMENTAL HIGH-RELIABILITY PRINCIPLESPRINCIPLES

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

quality assurance training doe o 414.1c and 10 cfr 830, subpart a

Documents

quality of performance

quality assurance qa

aspects of quality

quality definitionsquality

quality assurance program

weapons quality policy1969

recent revision

work102405 revision