Good Morning Ladies and Gentleman

Good Morning Ladies and Gentleman

Taiex (Technical Assistance Information Exchange) Office with

DG Enterprise, European Commission

organised in co-operation with

Slovak Office of Standards, Metrology and Testing

Workshop on the Implementation of the Pressure Equipment Directive

Bratislava 11-12-13 April 2005 – SLOVAK REPUBLIC

SUMMARY OF THE PROCEEDINGS OF WORKING GROUP 2

ON CONFORMITY ASSESSMMENT

ACHILLIDES Stephanos

Introduction

Good morning ladies and gentlemen,

My name is Stephanos Achillides and I represent the Department of Labour Inspection of the Ministry of Labour and Social Insurance of Cyprus. I will try my best to summarize what has been discussed in working group 2.

The main topic of working group 2 was to explain and give answers to matters related to conformity assessment.

To achive this task, we had the pleasure to receive four interesting presentations from the following speakers, whom are experts in the field:

Mr. Mikael Kuokkanen of Det Norske Veritas on the subject of “Practical Aspects of Conformity Assessment and Cooperation with subsidiaries within the new member states”,

Mr. Hans Verschuren, Chairman of the PED European Notified Body Forum on the subject of “Hazard analysis-practical example”,

Ms. Hannelore Wessel of the German Society of NDT on the subject of “Non destructive testing”, and

Ms. Anja-Leena Tyry of Technology Industries of Finland on the subject of “PED modules and guidelines”.

PRESENTATIONS

1. Presentation on “Practical Aspects of Conformity Assessment and Cooperation with subsidiaries within the new member states”

Mr. Mikael Kuokkanen, after a short introduction of Det Norske Veritas the Notified Body (NB) for which he works for, proceeded with the identification of a the following general impressions and trends that relate to conformity assessment.

  • There is a tendency in Sweden and other Western countries to move their manufacturing processes to new European member states and in countries of Asia, thus creating some problems to NBs since products are designed in one country, manufactured in another, and installed in a third.

This creates the need for NBs to visit different countries in order to assess and verify compliance procedures. The manufacturers expect from NBs to undertake the support and coordination of all conformity assessment procedures irrespective where design or manufacture is taking place.

  • For large projects, which are offered as a complete package and usually involve other product categories that fall within the scope of other directives, such as ATEX and Machinery, there is a demand on NBs to handle those other directives, as well as national legislation and practice other than PED.
  • Harmonized standards in Nordic countries are often used and their use is growing in other countries also.

Mr Kuokkanen went on and identified a number of practical issues and questions that relate to the application of conformity assessment procedures.

He stated that the manufacturer’s scope, in relation to the application of the quality assurance module, is not very clear and that it was necessary to establish a continued dialogue between manufacturers using quality assurance modules and the NBs in order to collect information and understand better how these modules are applied in practice. This issue is particularly important for overseas manufacturers who do not find easily contact persons within the Community.

He also expressed his views on how piping projects create special issues related to conformity assessment, by flagging up some of them, for example:

  • In an assembly, where piping is present, another NB and/or module is involved in the process specially for welds connecting pipes.
  • Engineering companies, which are involved in the design process and more or less in the complete process, are reluctant to undertake the responsibilities of the manufacturer.
  • The selection of the piping contractor is not decided in the contract phase of the project.

Another issue was the fact that National authorities get involved at a late stage during work, usually after the contract phase is finished. This late intervention may result in a change of categorization or change of item classification.

Other issues that interfere with the effective application of conformity assessment are:

  • The shortage of qualified non destructive testing personnel,
  • the tendency to mix standards in a attempt to use the easiest and best parts of them,
  • local NBs are not always familiar with a particular harmonised standard used in the design process, which has been approved by another NB, and
  • how an equivalent level of safety is ensured in cases where non harmonized standards are applied, for example ASME.

Mr. Kuokkanen then emphasized the importance of cooperation of Det Norske Veritas with subsidiaries in new member states. This cooperation is achieved through the use of the network of locally stationed offices and cooperation with other NBs and Recognized Third Party Organizations. He also stressed the importance of training, examination, audit and maintaining an approval system for personnel on PED work.

The various subsidiaries are kept up to date and given the necessary tools to carry out PED related work with information available on the DNV intranet, for example checklists, guidelines, report, etc.

Finally, Mr. Kuokkanen expressed his opinion that in order to carry out in-service inspections in a specific country, it is important that notification for PED in that country should be obtained.

At the end of his presentation, he was asked to comment why the use of harmonized standards is not so widespread among member states and he explained that some countries still prefer their own national standards, because they are more familiar and experienced with them. Another reason is because the application of harmonized standards is not mandatory. Moreover, due to errors in the translated harmonized standards in some languages, manufacturers are discouraged from applying them.

2. Presentation on “Hazard analysis-practical example”

Mr. Hans Verschuren delivered the second presentation on the subject of PED hazard analysis. Following a short introduction on Loyds Register Netherlands, he stated that the manufacturer is responsible to design and manufacture pressure equipment products that conform to the essential health and safety requirements of PED. In doing so, the manufacturer should apply hazard analysis to enable him to identify potential hazards, known and foreseeable, foreseeable misuse and intended use whilst taking into consideration the applicable essential health and safety requirements. All these should be put onto paper as user instruction and safety information.

The relevant method for applying hazard analysis is described in harmonized standard EN 1050. The manufacturer must take all necessary measures to either eliminate the hazards, or if not possible, to reduce them to an acceptable level and finally if the latter is not entirely possible to warn the end user accordingly.

The essential health and safety requirements are obligatory for all categories (1 – 4). The manufacturer has to provide a description of his solution in cases where no harmonized standards have been used or because the applied harmonized standards may not confer the presumption of conformity to all essential health and safety requirements but only to some of them.

Furthermore, he mentioned that the application of national standards, instead of harmonized standards is acceptable provided that the manufacturer can prove that the essential health and safety requirements are satisfied.

Mr. Verschuren emphasized that pressure equipment should be accompanied by user instruction containing information related to assembling and mounting, putting into service, use and maintenance as prescribed in clause 3.3 of annex I. It is also important to identify other relevant safety information and any other hazards, which were unable to be prevented either by design or safety measures.

The hazard analysis procedure was then explained in more detail, via an example of a hazard followed by the necessary steps that need to be taken in order to reduce the risk either in the design or the use stage.

At the end of his presentation a question was raised regarding the various approaches used by manufacturers in terms of hazard analysis. Mr. Verschuren commented that he has come across different approaches of hazard analysis from various manufacturers. Nevertheless, the content of the hazard analysis, whether complete or not, is affected by the information given by the end user to the manufacturer on the specifics of the particular product.

3. Presentation on “Non destructive testing”

The third Speaker, Ms. Hannelore Wessel, presented useful information about Non-Destructive Testing (NDT), a method of detecting and analyzing defects without destroying the examined item, on its relation to PED.

NDT is carried out either during manufacturing, or during in-service inspection.

There are various NDT methods, starting with simple ones such as visual inspection and penetrant testing followed by some more sophisticated ones, such as magnetic particle inspection, ultrasonic flaw detection, radiography, infrared thermography, etc. These tests should only be carried out by suitably qualified personnel, whose training and accreditation should be in accordance to standard EN 473. There are 3 levels of qualified NDT personnel. The relation between NDT and PED is laid down in Article 13 and annexes I and IV of the Directive.

The German Society of Non-Destructive Testing, with more than 2000 associates, provides not only NDT but also training, education, and accreditation globally.

It was interesting to hear from Ms. Wessel that manufacturers are complaining about the unavailability of NDT personnel and quoted humorously, ¨here is a good chance for those of you who want to get rid of your employer and start a new career ¨.

She also stressed the importance of experienced and knowledgeable NDT personnel in the discharge of their duties for installations with critical and time based operations.

The last part of the presentation was focussed on the European Federation for NDT, a non profit organization with legal entity and activities including co-ordination of NDT Accreditation Bodies, etc.

Answering to questions, the speaker pointed out the big differences between the American and the European standards regarding the accreditation of suitably qualified NDT personnel.

4. Presentation on “PED modules and guidelines”.

The last, but not the least of the speakers, Ms. Anja-Leena Tyry, dealt with the difficulties arising from the complexity of PED, the non user-friendly text and the possible misinterpretation of its provisions.

For the above-mentioned reasons, the conformity assessment procedures are of vital importance.

A reflection of the complexity of PED is the 200 (and still rising) number of Guidelines, giving answers to questions related to the provisions of PED.

The speaker expressed concerns on the responsibilities undertaken by the persons placing pressure equipment on the Community Market, when neither the manufacturer, nor the authorized representative, exists in the Community.

Rounding up, Ms. Tyry commented about the fact that PED is a relatively new directive and suggested that National Authorities should be patient with is implementation. Commenting on the same matter, Mr. Brekelmans reminded the participants that in the past, before the introduction of PED, the European countries had “stacks and stacks” of pressure equipment legislation, something that was eliminated with the adoption of PED.

This concludes the summary of this working group’s presentations and discussions.

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