Presentation by: Dr. Arthur H. Carter COMPOSITES AFRICA 2009 Understanding and Meeting Compliance of Statutory, Regulatory and Mandatory Requirements for Materials Testing Certificates used in the Process of Manufacturing Pressure Equipment KEYWORDS • Legal requirements, Statutory, Regulatory, Mandatory • Identification and Tractability • Non-specific Inspection • Test Reports • Inspection Certificates • Quality NEW SPECIFICATIONS & REGULATIONS PER Gazetted 15 July 2009 SABS are currently in the process of adopting • EN 13121 parts 1 to 4 as SANS 53121 • EN 13923 as SANS 53923 • EN 13280 as SANS 53280 • ISO 14692 as SANS 14692 Part 1 & 2 RESPONSIBLE PARTIES • Manufacturers • Importers & Suppliers • Users • Inspection Authorities Non –Metallic Compliance with • OHSAct 1993 and PER • SANS 10227 • SANS 347 • EN 13121 • EN 13923 • EN 10204 Provision of identification and traceability • Certificates of Analysis (COA), • Certificates of Compliance (COC) • Materials Testing Certificates (MTC) • Certificates of Conformity (COC) The lack of comprehension by: • Manufacturers • Material suppliers • Quality controllers • Inspection authorities • Users can give rise to numerous possible legal, contractual time consuming and costly consequences. ISO 9001:2008 requirements: • Statutory and Regulatory requirements shall be given scale of importance as any other legal or customer’s requirements. • The Statutory and Regulatory requirements include the raw material and component Suppliers as well. • A purchased process is equivalent to any other product or raw material that the organization has purchased for the manufacturing process (product realization) if it affects the product. • The product, raw materials used in the process of manufacture (product realization) must be identifiable and have proven traceability typically as provided for in SANS 31-EN10204. Statutory, Regulatory & Mandatory Legal Requirements OHSAct, Mines Health & Safety, Minerals Act & ISO 9001:2008 Pressure Equipment Regulations (PER) Gazetted 15 July 2009 Pressure Vessels New Equipment & Piping Health & Safety Codes Regulation 44 SANS 347 SANS 10227 (Designers) (AIA & IPE’s) Typical Non-Metallic Health & Safety Codes Vessels & Tanks Piping BS 4994 BS 6464 & BS 7159 EN 13121 SANS 1748-2 EN 13923 ISO 14692 SANS 31-EN 10204 Certificates • Type 2.1 - Declaration of Compliance with order test results excluded • Type 2.2 - Test Report with non-specific test results • Type 3.1 - Inspection certificate inclusive of specific test results • Type 3.2 - Inspection certificate inclusive of specific test results validated by Manufacturer & Notifying Body Validation / Verification By Notifying Body’s IPE’s (employed by an AIA) Equipment Data Book Manufacturer’s Certificate of Manufacture & AIA’s Certificate of Conformity IMPORTANT SECTIONS OF ISO 9001:2008 INTRODUCTION 01 General Para 3 This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization’s own requirements. GENERAL This International Standard specifies requirements for a quality management system where an organisation: • Needs to demonstrate its ability to consistently provide product that meets customer, and applicable statutory and regulatory requirements; and • Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE: • In this International Standard the term “product” applies to the product intended for, or required by, a customer or the product realisation processes. This applies to any intended output resulting from product realization processes, including purchasing. • Statutory and regulatory requirements may be expressed as legal requirements. APPLICATION • All requirements of this international Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. • Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. • Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. MANAGEMENT COMMITMENT Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: • Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements. IDENTIFICATION AND TRACEABILITY • Where appropriate, the organization shall identify the product by suitable means throughout product realization. • The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. • Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records. CONTROL OF RECORDS • Records established to provide evidence of conformity to requirement and of the effective operation of the quality management system shall be controlled. IMPORTANT SECTIONS OF SANS 31-EN 10204 SCOPE • This document specifies the different types of inspection documents supplied to the purchaser, in accordance with the requirements of the order, for the delivery of all metallic products, e.g. plates, sheets, bars, forgings, castings, whatever their method of production. • This document may also apply to non- metallic products. • This document is used in conjunction with the product specifications which specify the technical delivery conditions of the products. TERMS AND DEFINITIONS For the purposes of this document, the following terms and definitions apply. 1. NON-SPECIFIC INSPECTION Inspection carried out by the manufacturer in accordance with his own procedures to assess whether products defined by the same product specification and made by the same manufacturing process, are in compliance with the requirements of the order or not. The products inspected are not necessarily the products actually supplied. 2. SPECIFIC INSPECTION Inspection carried out, before delivery, according to the product specification, on the products to be supplied or on test units of which the products supplied are part, in order to verify that these products are in compliance with the requirements of the order. 3. MANUFACTURER Organization that manufactures the respective products according to the requirements of the order and to the properties specified in the referenced product specification. 4. INTERMEDIARY Organization which is supplied with products by the manufacturers and which then in turn supplies them without further processing of after processing without changing the properties specified in the purchase order and referenced product specification. 5. PRODUCT SPECIFICATION Complete detailed technical requirements relevant for the order, stated in written form, e.g. referenced regulations, standards and other specifications. INSPECTION DOCUMENTS BASED ON NON-SPECIFIC INSPECTION 1. DECLARATION OF COMPLIANCE WITH ORDER “TYPE 2.1” Document in which the manufacturer declares that the products supplied are in compliance with requirements of the order, without inclusion of test results. 2. TEST REPORT “TYPE 2.2” Document in which the manufacturer declares that the products supplied are in compliance with the requirements of the order and in which he supplies test results based on non- specific inspection. INSPECTION DOCUMENTS BASED ON SPECIFIC INSPECTION 1. INSPECTION CERTIFICATE 3.1 “TYPE 3.1” 1.1 Document issued by the manufacturer in which he declares that the products supplied are in compliance with requirements of the order and in which he supplies test results. 1.2 The test unit and the tests to be carried out are defined by the product specification, the official regulation and corresponding rules and/or the order. 1.3 The document is validated by the manufacturer’s authorized inspection representative, independent of the manufacturing department. It shall be permissible for the manufacturer to transfer on to the inspection certificate 3.1 relevant test results obtained by specific inspection on primary or incoming products he uses, provided that the manufacturer operates traceability procedures and can provide the corresponding inspection documents required. 2. INSPECTION CERTIFICATE 3.2 “TYPE 3.2” 2.1 Document prepared by both the manufacturer’s authorized inspection representative, independent of the manufacturing department and either the purchaser’s authorized inspection representative or the inspector designated by the official regulations and in which they declare that the products supplied are in compliance with the requirements of the order and in which test results are supplied. 2.2 It shall be permissible for the manufacturer to transfer on to the inspection certificate 3.2 relevant test results obtained by specific inspection on primary or incoming products he uses, provided that the manufacturer operates traceability procedures and can provide the corresponding inspection documents required. VALIDATION AND TRANSMISSION OF INSPECTION DOCUMENTS • The inspection document shall be validated by the responsible person(s) (name and position) • The retention and transmission of documents shall be either in electronic data or paper form. TRANSMISSION OF INSPECTION DOCUMENTS BY AN INTERMEDIARY An intermediary shall only pass on either an original or a copy of the inspection documents provided by the manufacturer without any alteration. The documentation shall be accompanied by suitable means of identification of the product, in order to ensure the traceability between the product and the documentation. Copying of the original document is permitted, provided that: • Traceability procedures are operated; • The original document is available on request. When producing copies it is permissible to replace the information on the original delivered quantity by the actual delivered partial quantity. FIGURE ZA.1 – CONFORMITY WITH ANNEX I SECTIONS 4.3 OF DIRECTIVE 97/23/EC Type of Documentation for materials for pressure equipment Main Pressure-bearing Main pressure-bearing parts in category I, Other Parts parts in category II, III & IV pressure parts other than main pressure- Resin, Reinforcements, bearing in categories I to IV, attachments Backing Rings & Plastic to category II, III & IV parts Liner Materials Specific inspection Non-specific inspection¹ Non-specific inspection¹ Appropriate quality management system ² Inspection Inspection Inspection Inspection document type 3.1 document type 3.2 document type 2.2 document type 2.1 ¹ Non-specific inspections may be replaced by specific inspection if specified in the material standard or the order. ² Quality management system of the material manufacturer certified by a competent body established within the Community and having undergone a specific assessment for materials. Figure ZA.1 Generally complies with the requirements for the production and validation of the following: • Certificates of Analysis (COA); Typically “type 3.1” • Certificates of Compliance (COC) ; Typically “type 2.1 and type 2.2” • Materials Testing Certificates (MTC); Typically “type 3.1 and type 3.2” • Manufacturer’s Certificate of Compliance (MCOC) Typically “type 3.2”. The contents of AIA / Independent Third Party Inspection Authorities Certificates of Conformity is typically structured in accordance with “type 3.2” Inspection Certificate and the requirements of the Health & Safety Code. These certificates, test reports, and inspection documents will meet the OHSAct, PER, PED EC 97/23 and the following Health & Safety Codes requirements: TANKS & VESSELS: • BS 4994 up to 31 December 2009 when it will be superseded by EN 13121 (SANS 53121) parts 1 – 4, • EN13923 (SANS 53923) • ASME X, RTP-1, ASTM D4097, ASTM D3299 PIPING: • BS 7159, BS 6464 • ASTM D 2996, ASME B 31.3, ASME B31.8, API 15 LR, AWWA M45 • SANS 1748-2, SANS 1748-3 • ISO 14692, DVS 2210-1 SUMMARY OF INSPECTION DOCUMENTS EN 10204 Designation of the Document Content Document validated by Ref document type Type 2.1 Declaration of Statement of compliance with The Manufacturer compliance with the the order order Type 2.2 Test report Statement of compliance with The Manufacturer the order, with indication results of non-specific inspection Type 3.1 Inspection Certificate Statement of Compliance with The manufacturer’s authorized the order, with indication of inspection representative results of specific inspection independent of the manufacturing department Type 3.2 Inspection certificate Statement of compliance with The manufacturer’s authorized 3.2 the order, with indication of inspection representative results of specific inspection independent of the manufacturing department and either the purchaser’s authorized inspection representative or the inspector designated by the official regulations TYPICAL SANS 31-EN10204 TYPE 3.1 CERTIFICATE OF ANALYSIS (COA) Thank You QUESTIONS?
Pages to are hidden for
"Understanding and meeting compliance of statutory_ regulatory and "Please download to view full document