IECEx: Certified Equipment Scheme
20 January 2017
One of the most important benefits of the IECEx Certified Equipment Scheme is the global availability of safety products for hazardous areas with a certificate issued by a recognized competent certification body. This creates a certain amount of flexibility, which is very important both for internationally acting manufacturers and end customers.
For certain products like terminal boxes or control stations, the markets need an even greater flexibility. Typically such products are customised at a very late stage of the supply chain. If the manufacturer is situated at a remote location it is not easy, if not impossible, to establish such flexibility. A possible solution is to perform the final assembly steps by an accredited agent of the certified manufacturer. What about the manufacturers general responsibility for the final product in this case? Among explosion protection experts it is common sense that even simple final assembling steps can be critical for the final protection level of the product. Wrong selection or mounting of cables, cable glands or terminals, too much built-in power dissipation and too small air and creepage distances are only some examples of such potential faults.
To solve this conflict, in summer 2013 IECEx established a working group consisting of experts from manufacturers and certification bodies which produced an operational document dealing with that issue. After the endorsement by IECEx MC, the OD 203 was published in April 2014. It consists of two parts:
* Part 1 deals with the issue of IECEx Certificates of Conformity covering a distributor or agent who does not actually manufacture the equipment. This is not relevant to the issue mentioned above.
* Part 2 however deals with the use of a local assembler for final assembly and despatch of a product made from fully defined parts supplied by the manufacturer. All parts of the final product must be fully defined by the manufacturer and have to be listed in the certification documentation of the product.
Furthermore, there are some very important requirements in this document concerning the role of the manufacturer, the Certification Body (CB) and the local assembler (LA). In all cases where the LA is envisaged, the manufacturer shall make an application to the ExCB that is responsible for the issue and maintenance of the Quality Assessment Report (QAR). This means that a general permission for any independent company to carry out the final assembly steps is not permitted!
The CB shall process the application as an extension of scope of the QAE, seeking sufficient information that the proposed procedure can be correctly implemented.
The manufacturer shall set up a written procedure which includes at least the following:
• A statement of how the contract is drawn up between the manufacturer and the assembler to ensure that the assembler accepts responsibility for its part in the process
• The process used to ensure that the assembler is issued with all appropriate assembly instructions.
• The process used to transfer identified components of the permitted assemblies to the assembler, including evidence that the assembler has correctly received undamaged components and retains any necessary identification of the components prior to assembly
• The processes used to ensure that the assembler applies correct final marking and of the final inspection to be employed by the assembler and the transmission of appropriate records to the manufacturer.
The CB shall monitor the operation of the procedure along with all other relevant aspects as part of routine surveillance and assessment of the manufacturer, at which time evidence of correct operation of the agreed procedure shall be obtained. Where a manufacturer uses more than one LA, the CB assessment shall confirm that the interval audit process of the manufacturers audits the operation of procedures with every assembler.
The OD203 contains a lot more requirements and limitations and their deep consideration would go too far for this article. My recommendation as an IECEx representative is that every manufacturer and every candidate assembly partner should study this document very carefully. As a conclusion we have to accept that the manufacturer remains responsible for the final product regardless if he is delegating the final modification of the product to an assembly partner or not, and every delegation of assembly activities to an independent partner needs the permission of the responsible CB.
The OD has been valid now for almost two years and it enables us, step by step, to improve the quality of the final assembly processes in the IECEx world. Other certification systems such as ATEX are increasingly recognising the relevance of clear rules for that issue and are preparing similar documents.
About the author
Prof. Dr. Thorsten Arnhold is VP Technology and Chief Strategic Officer at Stahl AG and and Chairman of IECEx
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