Technical collection The use of conformity certification for product validation 2007 - Conferences publications P. Migaud M. Vittoz J-F. Rey Schneider Electric 2007 - Conferences publications THE USE OF CONFORMITY CERTIFICATION FOR PRODUCT VALIDATION Pierre MIGAUD, EDF R&D, (France), Pierre.migaud@edf.fr Marc VITTOZ, AREVA T&D, (France), marc.vittoz@areva-td.com J.-F. REY, SCHNEIDER ELECTRIC, (France), jean-francois.rey@schneider-electric.com ABSTRACT For MV and HV switchgear, Utilities (and generally speaking Users) most often request a reliable demonstration of safety and performances. The purpose of this paper is to describe a way to adapt the concept of Product Certification to electrical equipment for Transmission and Distribution networks. The main features of this certification scheme are : o Independence based on the strong involvement of each party : Manufacturers, End Users, Testing Laboratories and independent experts, o Competence based on Testing Laboratories, o Certification scope limited to the conformity of the type of product, o International recognition through accreditation. The main advantages of this system are : o The organisation is cost effective, o The organisation is time effective and flexible, o Responsibilities are clearly split between stakeholders, o Certificates are well accepted. the KEYWORDS Conformity Assessment, Testing, Laboratory, Certification, Accreditation. INTRODUCTION Testing is only part of conformity assessment Assessing the conformity of a product is part of the relationship between the Manufacturer and the possible Users of a product. For Medium Voltage and High Voltage electrical equipment, assessment is based on the results of tests in most cases. However, it is not only the result of a single type test that allows to decide that a product fulfils all the requirements of a specification. Tens of type tests have to be performed, addressing various sharp technical competences. Several samples of equipment may be required to perform the complete list of type tests. And when a range of products is concerned, it is often cost effective to combine different tests with various options of equipment in order to cover the whole range of rated values with the minimum set of tests. Some tests may fail (it is part of the game, otherwise testing would be useless), leading to adjustments or improvements of the product design. In such a case it is important to avoid repeating the whole test series if possible, in order to minimize costs and delays. Then technical competences are needed to decide which tests have to be repeated according to the necessary design adjustments. Last but not least, identification of the product (or range of products) is part of the conformity assessment. This is not the less complicated task if the design has been updated in the course of the testing process. Consequently, assessing the conformity of a piece of equipment is not only performing type tests, but also defining the list of tests to be performed (or repeated), interpreting test results with regards to the test conditions, checking that drawings adequately represent the objects under tests. The complexity of this activity is well described by ISO/IEC Guide 67 (see table 1 in [1]). For the sake of simplicity, we can split this bunch of tasks in two parts : performing tests on one hand, and making a decision about conformity on the other hand. There are many responsibilities ways to split the As far as Testing is concerned, tests may be performed in the Laboratories of the Manufacturer (called First Party) or in the Laboratories of the User (called Second Party), assuming such facilities are available. They are also often performed by commercial Laboratories which are belonging neither to the Manufacturer nor to the User (called Third Party Laboratories). As far as the decision is concerned, various situations may be encountered : o The Manufacturer may supervise the testing process himself and finally attests the conformity of the object This is First Party assessment. o Some Utilities may demand to be involved in the assessment process (witnessing tests, reviewing the test results, attending the final expertise of the object after tests, and so on…). A given Utility may also rely on an external consultant of his choice, or an assessment panel made of several Utilities interested in the same pieces of equipment. Those two cases are Second Party assessment. o Third Party Bodies may also offer services such as supervising tests and reviewing test results. Amongst these bodies, we may find Certification Bodies or Inspection Bodies, as well as equivalent or alike bodies. Some of these bodies may operate their own testing facilities, while others may resort to separate Laboratories to have tests performed (either Third Party Laboratories, or Firsts or Second Party Laboratories in some cases). Schneider Electric 2007 - Conferences publications Moreover, any combination of these various means of assessment is also possible. There is no right or wrong recipe. All is a matter of equilibrium between parameters such as : the financial amount at stake (price per unit X number of pieces), the possible impact of the piece of equipment on the reliability of the network, the availability of testing facilities, the availability of human resources and competences of each Party, the sale strategy of the Manufacturer, the purchase strategy of the Utility, and so on… To the end, the responsibility always lies on the shoulders of the Manufacturer who guarantees the rated performances, and on the shoulders of the Utility who intends to operate the equipment on its network for tens of years hopefully. This is why it is often important for them to keep an eye on the assessment process, being able to make sure the Laboratories in charge of testing and the Body in charge of deciding are correctly fitted to the interests at stake. An example of assessment system dedicated to MV and HV products The purpose of this paper is to describe an original solution for conformity assessment, based on the general concepts of certification and accreditation, involving each Party, and tuned to fit the specific requirements of MV and HV equipment. Such a solution that has been implemented in France for ten years, may be chosen each time a Third Party assessment is required. FEW RECALLS ABOUT GENERAL CONCEPTS The concept of Product Certification has been first developed for mass products in order to remove technical trade barriers. Accreditation is also intended on the same purpose since it is a way to get international recognition. The basis of both concepts is briefly recalled hereunder. Product Certification Product Certification is described by EN 45011 [2] that is identical to ISO/IEC Guide 65 [3]. It is a broad concept that encompasses all kinds of “products” (including processes and services) and may be implemented in different ways, including or not including : initial testing, assessment of the suppliers’ quality systems, surveillance of the factory quality system, subsequent surveillance testing of samples from the factory, and son on… (see Introduction in [2] or [3]). It is important to keep in mind that the concept of Product Certification ranges from certification systems based on type testing, to certification systems including type testing and surveillance of the manufacturing process. The choice of a given system within this range depends of product specificities and market needs. It is important also to note that the scope of the standards [2] and [3] is so broad that each Certification Body is responsible to adapt the general requirements of the standard to its specific domain of activity. But in any case, all certification systems exhibit a common feature that is to be operated by Third Party Bodies (being both independent from the Manufacturer and from the User). The outcome of a Product Certification system is usually called a “certificate of conformity”. It is important to avoid confusion with look alike wordings that may be used for designation of documents that do not result from a Product Certification system. Accreditation According to the International Vocabulary [4], Accreditation is a “third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks”. It is described by EN ISO/CEI 17011 [5]. According to European Regulation, Accreditation is a non profit activity that is “operated in each Member State by a single national accreditation body” (see article 4 in [6]). Following these principles : o a Laboratory that complies with ISO/IEC 17025 [7] may be accredited according to this standard by an Accreditation Body, o a Certification Body that complies with EN 45011 [2] may be accredited according to this standard by an Accreditation Body. In both cases, it is important to note the difference between “complying with…” and “being accredited according to…” that means “providing an evidence of compliance with…”. Only Accreditation provides a formal evidence of compliance. It is to be noted that Quality Requirements of ISO 9001:2000 are fully covered by ISO/IEC 17025:2005, as stated in [8] : “The management system requirements in ISO/IEC 17025 (Section 4) […] meet the principles of ISO 9001:2000 Quality Management systems – Requirements and are aligned with its pertinent requirements”. As a consequence a Laboratory has no need for ISO 9001 certification if it is already accredited against ISO/IEC 17025. On the contrary, it is important to mention that ISO/IEC 17025 goes further than ISO 9001, with additional requirements for technical competence and metrology that are specific to Laboratories. SPECIFIC FEATURES OF MV/HV EQUIPMENT The assessment schemes that have been tailored for mass domestic products may not fit MV and HV network equipment that have specific features. Amongst these specific features, let us consider the main ones as follows : o The ratio between the cost for testing (including the cost of the object under tests) and the number of manufactured products may be much higher for network equipment than for domestic products. As a consequence, it is more of all important to avoid useless test repetitions. Schneider Electric 2007 - Conferences publications o Due to the investment amount requested for testing facilities (especially facilities for power testing), few Third Party Laboratories are available over the world. Apart from the few Third Party Laboratories, the competence is mostly available in the Manufacturers and the Utilities. As a matter of fact, it is the case in France for instance, as far as HV switchgear is concerned. o Utilities are very much involved in the technical assessment of the products for two reasons. First, some pieces of equipment may have a strategic impact on the energy network. Second, purchasing equipment is a long term investment over at least 30 years and sometimes more. o Manufacturers of MV and HV equipment need to keep control on their development and assessment process and not depend on the availability of external Laboratories. A CERTIFICATION SYSTEM TAILORED FOR MV AND HV EQUIPMENT It is possible to design a certification system that takes advantages of the general concepts as described above (certification and accreditation) and that is tuned up to suit the specific features of MV and HV electrical equipment. For instance, such a solution has been implemented in France for years in the shape of a unique combination of partners, concepts, principles, and rules of operation. The legal frame of the French Certification Body that comes out of this combination is a non profit association involving Manufacturers, Utilities and Third Party stakeholders (Laboratories and Standardization Body). Let’s have a look at the main characteristics of the French Certification Body : Independence, impartiality and involvement o Independence of the French Certification Body is guaranteed by its constitution that grants a balanced influence to each Party. In this case, independence doesn’t mean this Body is operated on commercial purpose only and doesn’t care about the possible outcome of the certifications it performs. On the contrary, Manufacturer and Utility members of the French Certification Body, are very much concerned by the results of the certification if they manufacture the object under test, or if they intend to operate it for 30 years on their network. This involvement is the guarantee that each object under certification is thoroughly tested and that results are deeply examined. Nevertheless the equilibrium between the different Parties leads to a final decision that is impartial in any case. Thus, involvement and impartiality are the ground for independence. o From a practical point of view, it should be noted that the “Three Party System” exists at each level of this Body, and not only on the top of the pyramid. From the Technical Committee up to the Board of Directors, each part of the French Certification Body has a balanced management. Especially the Certification Committee is composed of the three Parties : it is in charge of granting or refusing certificates based on technical evaluation of test results. o There is a close relationship between this Body and the Laboratories where the tests are performed. This relationship is called homologation. The French Certification Body is responsible for granting homologation to a Laboratory for a limited period of time. Periodical reviews are made to keep up homologation. Accreditation according to ISO/IEC 17025 is one of the requirements for homologation. Other requirements are related to technical competence (for a given nature of tests, on a given category of products), and rules of operation that place the testing process under the control of the French Certification Body. o Homologated Laboratories may be Manufacturer’s Laboratories or Utility’s ones. But in any case, tests are supervised by the French Certification Body. Supervision includes test program, test planning, witnessing, identification of the objects under tests, and test reports. Technical observers are selected and appointed by the French Certification Body. Technical competence o Competence of the French Certification Body is made of the competence of the members forming the Body. And the core of the competence is located in their Laboratories. This is the reason why technical experts acting as observers and reviewers are chosen amongst the teams of experienced test engineers of the homologated Laboratories. This brings the guarantee that competence of observers and reviewers is kept up to date thanks to their everyday professional activity. o Observers never come from the laboratory which is performing the test. Observers always belong to a separate Company. Scope of activity in line with the needs of the market o The Product Certification System operated in France is limited to the conformity of the type of product. It corresponds to the column 1 in table 1 of ref [1]. It does not include Surveillance. The reason for it is that MV and HV are produced in small series (compared to domestic mass products). Most Utilities operates themselves their own schemes for Surveillance, taking into account their return of experience. o The scope of activity of the Body is not limited to IEC standards. It includes also national standards and specifications, not only French ones, but also German ones or Italian ones for instance. It is a matter of fact that large Utilities throughout Europe have their own specification. So there is no reason to limit the scope of activity to IEC. o It is possible to issue a partial certificate covering only a part of the requirements of a standard as far as the batch of tests performed is consistent to demonstrate a given performance (dielectric performance for instance). In Schneider Electric 2007 - Conferences publications such a case, the scope of the certification is clearly mentioned on the front page of the certificate. Once again, this answers to a requirement of the market since Utilities are not always interested in getting the same level of guarantee for the whole batch of tests of a standard. Utilities may accept mere tests reports for some tests, and focus their attention on the tests that are the most strategic for them according to their application. Recognition The competence and independence of the French Certification Body is recognized through its accreditation by COFRAC (the French Accreditation Body) according to EN 45011 [2], [3]. It is a voluntary choice of the French Certification Body to go through the accreditation process to demonstrate its transparency and competence, and to enter into a continuous improvement process. Flexibility Although it is made of very strict procedures, the whole certification system that is operated by the French Certification Body, remains flexible : o The Body is opened to new members (Manufacturers, Users, Laboratories) as soon as they fulfil membership requirements, o The French Certification Body offers services to any client (not only members), o The scope of accreditation may be extended to new references, including specifications of Utilities, o The amount of activity may be easily adjusted to the yearly needs by calling skilled technical resources in the Laboratories of the members, o Personal involvement of the experts is an actual reality since all technical experts involved in the certification process are active in the Company members, o The possibility to take into account the results of tests in the Manufacturer’s Laboratory (assuming the whole testing process in under control of the French Certification Body) avoids tests repetition, o Costs are restricted to the minimum since French Certification Body is a non profit organisation, o Additional cost related to supervision of tests, review of test results, review of identification and impartial decision process are justified by the added value of the Conformity Certificate that is issued. Results and experience Such a Certification System has been existing for about ten years in France. It runs for Low Voltage, Medium Voltage and High Voltage equipment, but only MV and HV domains are addressed within the scope of this paper. Over the last ten years, the average number of issued certificates for the sole MV and HV domains is about 25 per year, and there is an increasing tendency up to 40 certificates some years. About 1/3 is strictly related to IEC standards, while 2/3 are related to specifications based on IEC. Certified products are MV switchgear, HV circuitbreakers and HV cable systems. The End Users for these products are located both in Europe and outside Europe. All these certificates have always been well accepted by the Users and no reclamation has been addressed to the Certification Body up to now. FUTURE TENDENCIES Although Certification is not the only way for assessing the conformity of a product, Manufacturers and Utilities may tend to rely more and more on Third Party assessment in order to clarify the border lines of their responsibilities. But the French example shows that this does not prevent them from being involved in the process of assessment to keep competence, impartiality and transparency at a high level. What is important for a Utility is to get choice between different offers in order to select the solution that fits the best his need. This is true also for assessment schemes. The development of Third Party assessment is a complement to First Party assessment and Second Party assessment. It allows the Utility to select the assessment profile according to the stake. As far as Certification is requested, there is not a unique solution to erect a Third Party Certification System and the French example is just one possibility. Other systems do exist and may give also good results. But whatever the organisation may be, it seems important that it fulfils the deep needs of the market. On that purpose, more the Utilities’ requirements will be stated clearly (in terms of competence, transparency, scope of activity…), more will be the possibility to harmonize the different existing schemes into a Mutual Recognition Agreement. Such an Agreement is useful to avoid test repetition and minimize cost and delay for assessment. It is also useful to clarify the status of the various “assessment documents” that are circulated on the marketplace. REFERENCES [1] ISO/CEI Guide 67, 2004, "Conformity assessment — Fundamentals of product certification”, [2] EN 45011, 1998, "General requirements for bodies operating product certification systems”, [3] ISO/CEI Guide 65, 1996, "General requirements for bodies operating product certification systems”, [4] ISO/IEC 17000, 2004, “Conformity assessment — Vocabulary and general principles”, [5] EN ISO/CEI 17011, 2005, “General requirements for accreditation bodies accrediting conformity assessment bodies” (cancels and replaces EN 45010, 1998). [6] Commission of the European Communities, 2007/0029, 14/02/2007, “Proposal for a regulation of the European Parliament and of the council setting out the requirements for accreditation and market surveillance relating to the marketing of products” [7] ISO/CEI 17025, 2005, "General requirements for the competence of testing and calibration laboratories”. [8] 601946.2005-08, August 2005, Joint ISO ILAC IAF Communiqué