Understanding and meeting compliance of statutory_ regulatory and by gyvwpsjkko

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									    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?

								
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