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

QUALITY ASSURANCE TRAINING DOE O 414.1C AND 10 CFR 830, SUBPART A. Instructor:. LEARNING OBJECTIVES. Articulate the Underlying Principles of Quality Assurance Discuss the interrelationships between Quality Assurance, Integrated Safety Management, and the Price-Anderson Amendments Act

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

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  1. QUALITY ASSURANCE TRAINING DOE O 414.1C AND10 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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  5. 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 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  13. TOTAL MANAGEMENT SYSTEM ISM Orders/Guides Rules PAAA NQA-1ISOINPO QC-1 Lessons LearnedANSI ASQ Best Practices Other Standards 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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 10/24/05 Revision 0

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

  18. 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. 10/24/05 Revision 0

  19. 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. 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  21. 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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  23. QA CRITERIA/ISM PRINCIPLES AND FUNCTION CROSSWALK TABLE 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  27. 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) QA RULE & ORDER REQUIREMENTS AND APPLICABILITY 10/24/05 Revision 0

  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 10/24/05 Revision 0

  29. NQA - 1 - 2004 Requirements 5. Instructions, Procedures 12. Control of Measuring & 8. Identification & Control 13. Handling, Storage, & 7. Control of Purchased 14. Inspection, Test, & Nonconforming Items 16. Corrective Action 9. Control of Special 6. Document Control 4.Procurement Doc. Operating Status` 3. Design Control Items & Services 11. Test Control Test Equipment 17. QA Records 1. Organization 2. QA Program 15. Control of 10. Inspection & Drawings DOE QA Criteria Processes 18. Audits Shipping of Items Control 1. Program X X 2. Training & Qualification X 3. Quality Improvement X X X 4. Documents & Records X X X 5. Work Processes X X X X X X 6 Design X 7. Procurement X X 8. Inspect & Accept. Test X X X X 9. Management Assess. X X 10. Independent Assess. X X X X X X X DOE QA CRITERIA/NQA-1-2004 REQUIREMENTS CROSSWALK 10/24/05 Revision 0

  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. 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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) 10/24/05 Revision 0

  33. 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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  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 10/24/05 Revision 0

  36. QUALITY ASSURANCE CRITERIA BASIC REQUIREMENTS MANAGEMENT PERFORMANCE ASSESSMENT • PROGRAM • PERSONNEL TRAINING & QUALIFICATION • QUALITY IMPROVEMENT • DOCUMENTS & RECORDS • WORK PROCESSES • DESIGN • PROCUREMENT • INSPECTION & ACCEPTANCE TESTING • MANAGEMENT ASSESSMENT • INDEPENDENT ASSESSMENT More detail on each of the 10 criteria to follow. 10/24/05 Revision 0

  37. QUALITY ASSURANCE CRITERIA

  38. 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 10/24/05 Revision 0

  39. 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 10/24/05 Revision 0

  40. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  41. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  42. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  43. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  44. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  45. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  46. QA CRITERIA (continued) • Assessment/Criterion 9—Management 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 10/24/05 Revision 0

  47. QA CRITERIA (continued) • 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 10/24/05 Revision 0

  48. 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 10/24/05 Revision 0

  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 10/24/05 Revision 0

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