Notified Body Problem Solving Warsaw, Poland 24/26 June 2004 Presented by Peter Hanmore For the benefit of business and people TAIEX Workshop on the Pressure Equipment Directive

2 SUMMARY 2 Difficulties 1 Introduction

3 Taiex - Warsaw June 2004 The New Approach Sets “safety” objectives Offers harmonised standards as one means of conformity Considerable scope for “interpretation” notified bodies are in a unique position to influence the consistent application of the directive 1 Introduction

4 Taiex - Warsaw June 2004 The main challenge to the Commission, Member States and Notified Bodies! Achieving consistency of application Consistency 1 Guidelines Member States Competence & Co-ordination of Notified Bodies, Guide to the New Approach & Global approach

5 Taiex - Warsaw June 2004  Main Aim of NBF  Consistency of application of PED  Achieved by: Adherence to Guidelines Raising queries with peers for agreement at notified body level and passing appropriate agreements to WPG for agreement and submission to WGP  Dissemination to all notified body personnel  Internal monitoring by notified body management Consistency 1

6 Taiex - Warsaw June 2004  Represent agreement of Enforcement authorities of ALL Member States  Purpose: to provide guidance on application of PED  Not mandatory BUT Represents best interpretation of Directive without going to European Court Consistency 1 WGP Guidelines

7 Taiex - Warsaw June 2004 ? Scope What’s included, what’s excluded ? Responsibilities Who signs the declaration of conformity ? Use of Standards Harmonized Standards v Established ? Materials Particular Material Appraisal, Technical Requirements 1 Main areas of difficulties ? Conformity Assessment NoBo activities,

8 Taiex - Warsaw June 2004 Scope  Heat Exchangers 1/47  Sub sea equipment 1/37 and TRG 010  Discharge lines 1/42  Flare tips 1/50 Technical Requirements 1 notified bodies have been the instigators of guidelines that clarified:

9 Taiex - Warsaw June 2004 Responsibilities Technical Requirements 1 Oil refinery needs to provide new processing equipment Purchases design to local design company, obtains design approval (B1 Certificate) Design manufactured by separate local fabricator arranges local inspection (F)

10 Taiex - Warsaw June 2004 Responsibilities Technical Requirements 1 Problem How to issue B1 Certificate when manufacturer not known? B1 requires review of welding procedures Proposed solution to NBF Detailed proposal for NB associated with production to check WPs Result Rejected!!! TRG re drafted to reflect comments from NBF Revised doc submitted to WGP = 4/10

11 Taiex - Warsaw June 2004 The “manufacturer” is the person responsible for design, manufacture and conformity assessment of a product Responsibility # Must always retain overall control # Have necessary competence to take responsibility Declaration of Conformity Signed by; Manufacturer Most responsible person ? # May subcontract some or all of the activities N.B. May use more than one Notified Body but only one “manufacturer” Technical Requirements 1

12 Taiex - Warsaw June 2004 Conform to: Essential Safety Requirements Legal Requirement: Using recognized Code/Standard, e.g. PD 5500, CODAP, or ASME Achieved by: Use Harmonized Standards for “Presumption of Conformity” Use of Standards Technical Requirements 1

13 Taiex - Warsaw June 2004  Many users wish to continue to use standards which have been used for most of their existing equipment.  Many manufacturers wish to continue to use standards with which they are familiar.  Guideline 7/17 – Impact testing  Guideline 6/12 – Welding  Both started as agreements of NBF that were adopted by WGP (with some modification) Use of Standards Technical Requirements 1 7/17 6/12

14 Taiex - Warsaw June 2004 Materials Harmonized Standard European Approval of Material Particular Material Appraisal Provide list of materials that demonstrates source: Technical Requirements 1

15 Taiex - Warsaw June 2004 PMA Notified Body reviews the manufactures appraisal for equipment in Cats III & IV PMA is the manufacturer’s assessment that the material is suitable for particular” application and meets applicable ESRs Decisions made concerning one material do not have to repeated PMAs – No guidance as how should be performed notified body prepared guidance document: Technical Requirements 1 WPM used this document as basis for (PE 03-28) now submitted to WGP

16 Taiex - Warsaw June 2004

17 For further information, please contact: Peter Hanmore Technical Manager Bureau Veritas