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QUALITY ASSURANCE TRAINING DOE O 414.1C AND 10 CFR 830, SUBPART A

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Title: QUALITY ASSURANCE TRAINING DOE O 414.1C AND 10 CFR 830, SUBPART A


1
QUALITY ASSURANCE TRAINING DOE O 414.1C AND 10
CFR 830, SUBPART A
  • Instructor

2
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

3
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

4
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

5
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

6
DEFINITIONS

7
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.

8
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.

9
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.

10
DOE QUALITY ASSURANCE PROGRAM

11
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

12
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.

13
TOTAL MANAGEMENT SYSTEM
ISM Orders/Guides Rules PAAA
NQA-1 ISO INPO QC-1 Lessons
Learned ANSI ASQ Best Practices
Other Standards
14
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

15
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

16
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

17
UNDERLYING PRINCIPLES
  • QUALITY ASSURANCE
  • INTEGRATED SAFETY MANAGEMENT
  • PRICE-ANDERSON AMMENDEMENTS ACT

18
QUALITY ASSURANCE (QA) 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.

19
QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES
(continued)
  1. Ensure people are competent at the work they do.
  2. Ensure the right people have the right tools and
    information at the right time.
  3. Seek and use relevant experience.
  4. Plan and control the work.
  5. Use the right materials, tools, and processes.
    Control any changes to them.

20
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.

21
INTEGRATED SAFETY MANAGEMENT (ISM) - UNDERLYING
PRINCIPLES
  1. Line management responsibility for safety
  2. Clear roles and responsibilities
  3. Competence commensurate with responsibilities
  4. Balanced priorities
  5. Identification of safety standards and
    requirements
  6. Hazard controls tailored to work being performed
  7. Operations Authorization

22
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

23
QA CRITERIA/ISM PRINCIPLES AND FUNCTION CROSSWALK
TABLE
24
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

25
QUALITY ASSURANCE PROGRAM
  • BASIC REQUIREMENTS
  • AND
  • CRITERIA

26
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

27
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)

28
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

29
DOE QA CRITERIA/NQA-1-2004 REQUIREMENTS CROSSWALK
30
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.

31
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

32
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)

33
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

34
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

35
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

36
QUALITY ASSURANCE CRITERIA
BASIC REQUIREMENTS
PERFORMANCE
MANAGEMENT
ASSESSMENT
  1. WORK PROCESSES
  2. DESIGN
  3. PROCUREMENT
  4. INSPECTION ACCEPTANCE TESTING
  1. PROGRAM
  2. PERSONNEL TRAINING QUALIFICATION
  3. QUALITY IMPROVEMENT
  4. DOCUMENTS RECORDS
  1. MANAGEMENT ASSESSMENT
  2. INDEPENDENT ASSESSMENT

More detail on each of the 10 criteria to follow.
37
QUALITY ASSURANCE CRITERIA

38
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

39
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

40
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

41
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

42
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

43
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

44
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

45
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

46
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

47
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

48
SUMMARY APPLYING 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

49
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

50
BACKUP SLIDES

51
SUPPLEMENTAL HIGH-RELIABILITY PRINCIPLES
  • Highly-Reliable Operational Performance
  • Individual Attitude and Responsibility
  • Performance Assurance
  • Organizational Performance Improvement
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