WORKING GROUP 2 – Conformity Assessment Practical Aspects of Conformity Assessment, Cooperation with Subsidiaries within New Member States Mikael Kuokkanen 2005-04-12

WORKING GROUP 2 – Conformity Assessment DNV in Brief: Objective is To Safeguard life, property, and the environment An independent foundation established in 1864 One of the world's major classification societies and certification bodies Global operations, in over 100 countries, with over 6.000 employees DNV Sweden, NoBo 0409, hub for DNV PED activities world wide Largest NoBo PED and ISI supplier in Nordic Countries 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment General impressions / trends: In Sweden and Western Europe manufacturing is continuously moving to new member states and Asia Design, manufacturing, erection and commissioning is performed in different places/countries by different actors Manufacturers expect NoBo to support, coordinate and manage all NoBo activities world-wide Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment General impressions / trends: Increasing demand on NoBo to simultaneously handle other directives than PED (ATEX, MD etc) Increasing demand on NoBo to simultaneously handle other national rules than PED Harmonised product standards (e.g. EN 13445 / EN 13480) in general use in nordic countries so far, but their use is growing elsewhere Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment Experienced practical issues/questions H module (or “h” modules?). What is the manufacturer´s production scope (different approaches from wide open to detailed)? Continuous dialogue with QA module (D/E/H) manufacturers is essential! Management for NoBo of D/E/H modules more demanding for overseas manufacturers Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment Experienced practical issues/questions Piping projects often create special issues: Pipings in an assembly where a different module and/or NoBo is involved, specially for welds connecting pipings Engineering companies often control design process and more or less the complete process, but are reluctant to bear manufacturers responsibility What statements/certificates shall be issued and to whom? The responsible manufacturer of pipings is often not decided in the contract phase of a project How shall pipings be divided in the context of manufacturer responsibility when several contractors are involved in the same pipings? Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment Experienced practical issues/questions Assemblies/Installation. At many large projects unclear which part takes responsibility for complete site/system, user or supplier National regulations still affects PED conformity assessment (Catch 22 situations occur) National authorities/inspectors involved in e.g. categorizing, definitions of assembly/installation, often late during site work, long time after contract phase is finished Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment Experienced practical issues/questions Risk or hazard analysis generally accepted but very different approaches with very different results can be noted. What is the minimum level? “Approved pipe classes” and components. How to handle? NoBo has to deal with various unofficial statements (”certificates”) issued by other NoBos and RTPOs Issues on how equivalent level of safety is ensured when non-harmonized codes are used, especially ASME Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Some practical aspects of Conformity Assessment Experienced practical issues/questions Mixing of standards. Common in some countries. “Cherry picking” must be avoided! How shall local NoBo act when the design is approved by other NoBo with a for the local NoBo unfamiliar or even mixed standard (e.g. under modules B1 + F)? Approved NDT-personnel (By NoBo or RTPO) hard to find in new member states P/T rating of CE-marked valves often unclear. Creates issues on assessment of assemblies and pipings Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Cooperation with subsidiaries in new member states DNV uses own network of locally stationed offices Also cooperation with other NoBos, and RTPOs Important task is to train, examine, audit and maintain approval system for personnel approved for PED work world wide DNV holds several notifications for PED in various countries for local market reasons. DNV Sweden (NoBo 0409), is appointed as the supporting unit within DNV for PED in terms of defining common procedures, providing personnel training, maintaining approval systems etc. Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment Cooperation with subsidiaries in new member states DNV has developed an intranet based solution to provide all necessary tools for subsidiaries to work with PED (e.g. checklists, reports, info on progress of guidelines, NB Forum etc.) To be on a local market for ISI sometimes means that a notification for PED in the country in question is necessary DNV holds notifications for many important directives such as MD, ATEX, EMC, LVD etc, to be able to provide full service with respect to product certification Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment FLOWSHEETS Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment FLOWSHEETS Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment FLOWSHEETS Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

WORKING GROUP 2 – Conformity Assessment FLOWSHEETS Picture 1: (Prestige) Extreme environmental focus. Compliance, or lack of compliance? A symbol of a shipping accident. Picture 2: (Enron USA) Expectations on ethical standards in business. Demonstrates consequences of poor ethics. A symbol of corporate failure. Picture 3: (illustration) Requirements on transparency from media and non-governmental organisations (NGO) on the rise. Picture 4: (September 11, 2001 – New York) A symbol of increased international terrorism. A part of the new risk reality. 01 December 2018

01 December 2018