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MODULE B - PROCESS

MODULE B - PROCESS. SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects B5. Consensus Process for Standards Development

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MODULE B - PROCESS

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  1. MODULE B - PROCESS SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects B5. Consensus Process for Standards Development B6. The Basics of Parliamentary Procedure B7. The Appeals Process B8. International Standards Development B9. ASME Conformity Assessment Programs ASME C&S Training Module B9

  2. REVISIONS ASME C&S Training Module B9

  3. B9. ASME Conformity Assessment Programs

  4. OBJECTIVES This submodule will • Describe ASME’s conformity assessment programs ASME C&S Training Module B9

  5. AGENDA • Introduction to Conformity Assessment • Board on Pressure Technology Programs • Board on Nuclear Codes & Standards Programs • Board on Safety Codes & Standards Programs • Board on Standardization Programs • Board on Conformity Assessment Programs ASME C&S Training Module B9

  6. I. INTRODUCTION TO CONFORMITY ASSESSMENT ASME C&S Training Module B9

  7. IMPORTANCE OF CONFORMITY ASSESSMENT PROCESS • Conformity Assessment Process ensures • Products, services, or systems have the required characteristics • Characteristics are consistent from product to product, service to service, or system to system • Individuals can be evaluated to determine whether they meet the qualification requirements of an ASME standard ASME C&S Training Module B9

  8. CONFORMITY ASSESSMENT • Definition (ISO/IEC Guide 2) “Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled” Examples: Sampling; testing and inspection; evaluation; verification and assurance of conformity (supplier’s declaration); certification; registration; accreditation; approval ASME C&S Training Module B9

  9. CONFORMITY ASSESSMENT • ASME Program Types • Accreditation • Certification • Registration ASME C&S Training Module B9

  10. ACCREDITATION • General definition (ISO/IEC Guide 2) “Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks” ASME C&S Training Module B9

  11. ASME ACCREDITATION • Applicability • Companies that supply a product or service covered by an ASME standard (not individuals) • Examples: • Manufacturers of boilers or pressure vessels (ASME Boiler and Pressure Vessel Code) • Organizations that certify elevator inspectors (ASME QEI-1 Standard for Qualification of Elevator Inspectors) ASME C&S Training Module B9

  12. ASME ACCREDITATION • Meaning of ASME accreditation • Supplier’s quality assurance program has been reviewed by ASME and meets the requirements of the relevant ASME standard [CSP-20] NOTE: ASME only accredits the quality management system; the supplier must certify the product. ASME C&S Training Module B9

  13. ASME ACCREDITATION • Accreditation process • ASME audit team on-site review • Formal recognition • Certificate of Authorization or Accreditation • Certificate valid for specified period ASME C&S Training Module B9

  14. ASME ACCREDITATION • Certificates • Certificate of Authorization • Organization may certify that their equipment conforms to the ASME standard • May stamp equipment with an ASME mark • Certificate of Accreditation • Varies from program to program ASME C&S Training Module B9

  15. ASME ACCREDITATION • Audits • Verify continued compliance • Typically annual • Types • Announced • Unannounced • Third-Party Inspection • Conducted by Authorized Inspection Agency, if one exists ASME C&S Training Module B9

  16. CERTIFICATION • General definition (ISO/IEC Guide 2) “Procedure by which a third party gives written assurance that a product, process, or service conforms to specified requirements” ASME C&S Training Module B9

  17. ASME CERTIFICATION • Applicability • An individual performing an activity whose qualifications are covered by an ASME standard • Example: hazardous waste incinerator operator • Meaning of ASME certification • Individual has met the qualification criteria specified in the standard • Doesnotlicense the individual to perform a specific task ASME C&S Training Module B9

  18. ASME CERTIFICATION • Certification process • Evaluation of education and/or experience requirements • Oral or written examinations • Formal recognition • Certificate or Certification Card • Valid for 3 to 5 years • Benefits of certification • Means of compliance with regulation • Confirmation of competence ASME C&S Training Module B9

  19. ASME REGISTRATION(ASME ISO 9000 Registration) • Applicability • Companies (“suppliers or organizations”) • Meaning of registration • Company’s quality management system meets International Organization for Standardization’s ISO 9000 standard ASME C&S Training Module B9

  20. POP QUIZ #1 For each of the following, what type of conformity assessment program is used: accreditation, certification or registration? • To assess the conformity of a boiler and pressure vessel manufacturer to the ASME Boiler and Pressure Vessel Code • To assess the conformity of a boiler and pressure vessel manufacturer to the ISO 9001 standard • To assess the qualifications of an individual to be a hazardous waste incinerator operator • To assess the conformity of a company that will provide boiler and pressure vessel inspection services ASME C&S Training Module B9

  21. POP QUIZ #2(Extra Credit) Which program(s) review the applicant’s quality management system? • Accreditation • Certification • Registration ASME C&S Training Module B9

  22. CA PROGRAM MANAGEMENT Council on Codes and Standards • Board on Conformity Assessment • Supervises all ASME conformity assessment activities Board on Conformity Assessment ASME C&S Training Module B9

  23. CA PROGRAM MANAGEMENT Council on Codes and Standards • CA Committees • Report directly to Board on Conformity Assessment Board on Conformity Assessment CA Committee (e.g. ISO 9000 Registration) ASME C&S Training Module B9

  24. CA PROGRAM MANAGEMENT Council on Codes and Standards • CA Subcommittees • Dual reporting Board on Conformity Assessment Board on Pressure Technology CA Committee (e.g. ISO 9000 Registration) Standards Committee* (e.g. Boiler and Pressure Vessel Code) CA Subcommittee (e.g. Boiler and Pressure Vessel Accreditation) * Note: Proposed alternative requirements shall be reviewed jointly by the relevant Supervisory Board and Board on Conformity Assessment. ASME C&S Training Module B9

  25. Accreditation Programs (Quality control system, ASME standards) Certification Programs (Qualifications of individuals, ASME standards) Registration Programs (Quality management system, ISO standards) CURRENT ASME CA PROGRAMS Council on Codes and Standards Board on Pressure Technology Board on Nuclear C&S Board on Safety C&S Board on Standard-ization Board on Performance Test Codes Board on Conformity Assessment Boiler and Pressure Vessel (BPV) Nuclear Components (N-type) Elevator Inspector Certification Organizations (QEI) ISO 9000 Registration Note: PTC-25 is an integral part of PRD accreditation Geometric Dimensioning and Tolerancing Professionals (GDTP) Reinforced Thermoset Plastic Vessels (RTP) Nuclear Material Organizations (QSC) Authorized Inspection Agencies (AIA) Resource Recovery Facility Operator (QRO) Pressure Relief Device Laboratory (PRD) Hazardous Waste Facility Operator (QHO) High Capacity Fossil-Fuel-Fired Facility Operator (QFO) ASME C&S Training Module B9

  26. POP QUIZ #3 Look at the chart of ASME Conformity Assessment programs. To which Board(s) is (are) the program for Elevator Inspector Certification Organizations (QEI) accountable? _____ ASME C&S Training Module B9

  27. ACCREDITED COMPANIESSeptember 1, 2003 ASME C&S Training Module B9

  28. CONFORMITY ASSESSMENT ADMINISTRATION • Confidentiality and Conflict of Interest • Statements must be signed by all staff, committee members, and designees • Access to meetings • Limited to members, staff, internal auditors and BCA Chair • Records • Confidential, except accreditation/certification status and scope • Applicant information not released • Records only maintained for life of Certificate ASME C&S Training Module B9

  29. shop review survey assessment audit audit surveillance (for cause or audit unannounced) team leader team leader lead auditor team member team member auditor ASME TERMINOLOGY BPV Nuclear, AIA (Non-Nuclear) QEI, FAP ISO 9000 ASME C&S Training Module B9

  30. II. BOARD ON PRESSURE TECHNOLOGY PROGRAMS ASME C&S Training Module B9

  31. BOARD ON PRESSURE TECHNOLOGY PROGRAMS • Accreditation programs • Boiler and Pressure Vessel (BPV) • Pressure Relief Device Laboratory (PRD) • Reinforced Thermoset Plastic Vessels (RTP) ASME C&S Training Module B9

  32. BOILER AND PRESSURE VESSEL ACCREDITATION (BPV) • History • 1916 Accreditation program started • 1968 Program changed to be based on QA/QC requirements • 1972 Accreditation offered internationally • Today • ASME’s largest program • 4400+ Certificate Holders • Companies in 60+ countries • Referenced in laws and regs. of nearly all US States, Canadian Provinces, and other countries ASME C&S Training Module B9

  33. Accredits Inspection Agencies • Issues BPV Certificate Authorized Inspection Agencies (AIA) Inspectors Inspectors ROLES AND RESPONSIBILITIES ASME • Develops Code Jurisdiction (Regulatory Authority) Insurance Company (BPV insurance) Manufacturer ASME C&S Training Module B9

  34. ASME Insurance Company (BPV insurance) • Adopts ASME Code • Licenses insurance companies • May lead Shop Review Team Manufacturer ROLES AND RESPONSIBILITIES Authorized Inspection Agencies (AIA) Jurisdiction (Regulatory Authority) ASME C&S Training Module B9

  35. Jurisdiction (Regulatory Authority) Insurance Company (BPV insurance) • Trains & commissions Inspectors • May lead Shop Review Team • May register stamped equipment Manufacturer ROLES AND RESPONSIBILITIES ASME Authorized Inspection Agencies (AIA) National Board of BPV Inspectors ASME C&S Training Module B9

  36. ROLES AND RESPONSIBILITIES ASME • Develops Code • Accredits Inspection Agencies • Issues BPV Certificate Authorized Inspection Agencies (AIA) Jurisdiction (Regulatory Authority) Insurance Company (BPV insurance) • Adopts ASME Code • Licenses insurance companies • May lead Shop Review Team National Board of BPV Inspectors • Trains & commissions Inspectors • May lead Shop Review Team • May register stamped equipment Manufacturer ASME C&S Training Module B9

  37. BOILER AND PRESSURE VESSEL ACCREDITATION (BPV) • Applicability • Manufacturers of boilers and pressure vessels (non-nuclear) • Defining Code or Standard • ASME Boiler and Pressure Vessel Code ASME C&S Training Module B9

  38. BOILER AND PRESSURE VESSEL ACCREDITATION (BPV) • Accreditation requirements • A subscription to relevant Code sections • A contract with an Authorized Inspection Agency (in most cases) • An implemented, documented QC system ASME C&S Training Module B9

  39. BOILER AND PRESSURE VESSEL ACCREDITATION (BPV) • Shop Review • Review of QC manual and QC system implementation (1-2 days) • Team • Leader: ASME Designee (Jurisdiction, National Board, or ASME Consultant) • AIA (where required) ASME C&S Training Module B9

  40. BOILER AND PRESSURE VESSEL ACCREDITATION (BPV) • Certificate • H (Cast iron) and UM Certificates valid for one year • All others valid for three years • Audits • Only when required by Subcommittee ASME C&S Training Module B9

  41. POP QUIZ #4 Who can lead a BPV Shop Review team? • The ASME Subcommittee on BPV Accreditation • The ASME Committee on Authorized Inspection Agency accreditation • An ASME Consultant • The local regulatory authority (Jurisdiction) • The insurance company providing BPV insurance to the applicant • A National Board Consultant ASME C&S Training Module B9

  42. BPV CODE SYMBOL STAMPS Heating boilers Stamps (for non-nuclear code sections) • Each applies to specific product type • Requirements for Certificate of Authorization vary Power Boilers Pressure Vessel Safety Valves ASME C&S Training Module B9

  43. BPV ACCREDITATION PROCESS Initial Preparation Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

  44. BPV ACCREDITATION PROCESS Initial Preparation Before review, applicant must: • Ensure all accreditation requirements are in place • Complete review checklist by adding QC Manual references Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

  45. BPV ACCREDITATION PROCESS Initial Preparation Shop Review • On-site evaluation including • Review of QC manual • Demonstration of QC system • Demonstration includes demo of • QC admin functions • Product manufacturing, fabrication and testing • Demonstration conducted on • In-process work and/or mock-up • Past job documentation Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

  46. (cont’d) CONDUCT OF SHOP REVIEW • Activities • Review of QC Manual • Opening meeting (introductions, shop tour) • Report on QC Manual review ASME C&S Training Module B9

  47. CONDUCT OF SHOP REVIEW • Activities (cont’d) • Implementation demonstration • Review Team Executive Session (Private) • Review and document deficiencies • Formulate recommendation • Exit Meeting with Applicant • By Team Leader • Report deficiencies and recommendation ASME C&S Training Module B9

  48. BPV ACCREDITATION PROCESS Initial Preparation Deficiencies may be • Corrected and verified during Shop Review • Corrected after Shop Review; verified by AIA • Corrected after Shop Review; verified by additional Shop Review Note: method determined by severity of deficiency Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

  49. BPV ACCREDITATION PROCESS Initial Preparation Accreditation decision • Responsibility of ASME Subcommittee on BPV Accreditation • Based on Review Team report and recommendation Applicant may: • Request re-consideration • Initiate formal appeal Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

  50. BPV ACCREDITATION PROCESS Initial Preparation Certificate • Issued by ASME staff • Issued when required fees paid Shop Review Deficiency Correction Accreditation Decision Issuance of Certificate ASME C&S Training Module B9

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