ASME PTB-10-2015 pdf download
ASME PTB-10-2015 pdf download.Guide for ASME Section VIII Division 1 Stamp Holders.
(1) The procedures are divided into a design phase and a production phase. (2) In each phase, the roles and responsibilities of the Manufacturer and the NB are detailed. (3) Some procedures are better adapted to single production (procedures G, H). Others are better adapted to production type (procedures B+C, B+E, B+F, B+D). In this case the procedure is divided in two modules covering separately the design phase and the production phase. (4) The Manufacturer always has the choice between (i) Conformity Assessment Procedure without a QA system: the NB will check the product itself. (ii) Conformity Assessment Procedure requiring a QA system: the NB will check the QA system more than the product itself. (5) The seven Conformity Assessment Procedures of Figure 5-1 of this Guide imply an increasing involvement of the NB from procedure A to procedure H, depending on the level of hazard presented by the Equipment covered by the Directive. (6) Each Manufacturer must select a Conformity Assessment Procedure among these seven procedures. Their application is mandatory for affixing the CE Marking (Article 14 of the PED). 6.2 General Concept (a) The PED uses these seven conformity assessment procedures (A to H) plus six additional ones (which are identified in Figure 5-3 of this Guide), making a total of 13 procedures. The multiplicity of these procedures results from the consensus between 15 countries and is justified by (1) the diversity of types of Pressure Equipment (2) the diversity of means of production (unit production, series production, with or without QA system) (3) the diversity of hazard levels presented by these Equipment, which has led to four Hazard Categories in the PED. Figure 5-3 of this Guide shows a general overview of these Conformity Assessment Procedures. (b) In each Hazard Category one or several Conformity Assessment Procedures, of equivalent stringency, are proposed to the Manufacturer, depending on production (single or series) and if there is a QA system (see Figure 5-2).
(i) draw up the Technical Documentation (ii) ensure conformity to the ESR by drawing up a Declaration of Conformity (Annex IV of the PED) (iii) affix the CE Marking (iv) affix the identification number of the NB. (2) the NB must check the conformity of the Equipment with the ESR by applying the specifications of the Procedure. This check will differ according to whether the manufacturer uses a QA procedure. (b) For the six Conformity Assessment Procedures without QA (A, A2, B+C, B+F, B2+F, G), the NB must examine the Design and the Fabrication of each Equipment, and perform appropriate tests, so as to check its conformity to the ESR, except for the following procedures. (1) Procedure A. Self-certification by the Manufacturer. (2) Procedure A2. Self-certification by the Manufacturer and surveillance by an NB that takes the form of unexpected visits. (c) For the seven Conformity Assessment Procedures with QA (D1, E1, B+E, B+D, B1+D, H, H1), the involvement of the NB on the Equipment itself is reduced, and the NB concentrates on the QA system. The NB (1) assesses the adequacy of the QA system to the production (2) carries out periodic audits to ensure that the Manufacturer applies the QA system (3) applies the surveillance by unexpected visits to check that the QA systems works correctly. (d) Six procedures are devoted to unit production (A, A2, D1, E1, G, H, H1). (e) Seven procedures are devoted to series production (B+C2, B+D, B+E, B+F, B+D, B+F). They consist of a design module covering the design phase (modules B) and a production module covering the production phase (modules C2, D, E, and F). 6.4 Review of Conformity Assessment Modules 6.4.1 Conformity Assessment Modules Module A Internal Production Control Module A2 Internal Production Control Plus Supervised Pressure Equipment Checks at Random Intervals Module B EC type examination – Production Type Module B EC type examination – Design Type Module C2 Conformity to Type Based on Internal Production Control Plus Supervised Pressure Equipment Checks at Random Intervals Module D Conformity to Type Based on Quality Assurance of the Production Process Module D1 Quality Assurance of the Production Process Module E Conformity to Type Based on Pressure Equipment Quality Assurance Module E1 Quality Assurance of Final Pressure Equipment Inspection and Testing Module F Conformity to Type Based on Pressure Equipment Module G Conformity Based on Unit Verification Module H Conformity Based on Full Quality Assurance Module H1 Conformity Based on Full Quality Assurance Plus Design Examination Appendix F Declaration of Conformity Appendix G Activities of Manufacturers and Notified Bodies in Accordance with Conformity Assessment Procedures
