CE Marking and the Responsibility of an Engineer to the Company He Is Working For - Essay Example

CE Marking Introduction The project is on CE Marking and the role and responsibility of an engineer towards the company or the employer he is working for. CE marking is a conformity mark which is essential for all manufacturers and authorised representatives to meet all the basic requirements of European Directives in the European Union. As it is very crucial to acquire CE marking, it becomes necessary for the firms to seek the help of some consultancy or engineer to guide them to do so and to ensure that their product complies with all European Directives. The professional engineers have various responsibilities towards the employers and know how should they act and respond while carrying out the procedures of CE marking. Whenever in a conflict between any of the social responsibility and their responsibility to their employer they are quite clear about the strategy they should opt. The project too suggests a few guidelines to resolve any such conflict. Among various responsibilities of the engineers a few are to look into the EU Documentation and Standards, technical consultation, compliance testing, technical documentation, product registration, company-internal self-certification process and many more. Then there are various CE marking related issues, its objectives and the difficulties faced by the manufacturers in the process or due to any of the discrepancies. So, the project caters to all the above mentioned issues as well as the role of engineers employed by the manufacturers in the whole procedure. CE Marking CE Marking, also known as CE mark, is a mandatory conformity mark to be put on the products which are placed on the single market in European Economic Area (EEA). The affixation of the CE Marking on the product which is placed on the market or put into service means that the product meets all the necessary requirements of the relevant European Directives. But it should be noted that CE Marking doesn't mean that the product certifies EU consumer safety, health or environmental requirements. It is considered a kind of trade passport for the European marketplace which allows the manufacturer to freely circulate their product throughout 28 countries of EEA. A few examples of European Directives requiring CE Marking include toy safety, low-voltage equipment, machinery, terminal equipment and EM compatibility. And there are about 25 directives requiring CE Marking. If you are planning to export a product to one or more markets in any member states of EU or EEA then it becomes essential to apply for CE Marking of your products. "CE Marking is a mandatory mark for most (around 70%) of the products sold on the EU market (totalling 28 countries.)"1 it can be crucial to your success if the new product directives apply to your product and you also want to continue exporting it to the European market. It becomes very necessary to seek the professional help and advice to assist the manufacturers in conforming and acquiring the CE Marking. It is very essential for business and is a very swift and straightforward process if you seek genuine advice. It is very important to understand the amount of resources and the time that companies spend on a product and to obtain a smooth approach for CE Marking. And if your company is outside the EU, the process becomes all the more challenging but the capable engineers can do the job well. And as the process is essential for business it is better to have knowledgeable engineers to do the job and to ensure that your products comply with all basic requirements. They know well how to get the products CE marked understanding all the safety issues that are important to address.2 Responsibility and Actions taken by Engineer for CE Marking As it is very crucial to acquire CE marking, it becomes necessary for the firms to seek the help of some consultancy or engineer to guide them to do so and to ensure that their product complies with all European Directives. For CE Marking there are several things to be taken into account which can be left to the responsibility of the engineers hired by the employers. The foremost responsibility is to make sure that the product conforms to certain health and safety requirements. He should look into the aspect that the product has the capability to undergo any hazard identification and risk analysis. Before the product is offered for sale in EU country all the documentations should be completed and accompanied. A few products may even require a third party certification which should also be checked by the engineer if their product needs any such certification. Most of the products can be self-assessed by the manufacturers. It is his duty to document the proof regarding the relevant requirements of the item. Sometimes he may have to use the external test house to get the item evaluated and for product documentation. Either be the case, it is his responsibility to get an EC-Declaration of Conformity (EC-DoC) issued. It is his responsibility to identify the EU Directives and standards applicable to their product. He should evaluate the existing market and the available products for conformity with the Directives and standards. He should also modify or design a new product as per the market demands and to attain the conformity. It is his duty to complete all the necessary Technical File and documentation required to meet EU legal requirements. It is very crucial for the engineer to understand the relationship between CE Marking requirements, U.S. safety requirements and U.S. products liability laws.3 The New Approach Directives provide a range of available compliance routes for your product, usually in a modular format. And now it becomes your engineer's responsibility to choose the best fir for your company. He may also have to use a Notified Body for the compliance route to assist you with the certification process. It may differ from directive to directive and item to item. He should go by the set of laws and regulations for entire market place and design label and manufacture the products as per the guidelines. This would in-turn help in acquiring CE marking easily. His responsibility is to affix CE marking as authorised by the manufacturer. Manufacturer indicates that he is responsible for product conformity with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.4 He should give the following data on the label: Name or the trade mark of the product. Address of the manufacture as well of the importer. Type and description of the product. Serial number and the batch code. Date by which the device or product should be used. Instructions and warnings for storage and usage of the product. He should understand the requirements and make all the possible modifications to the existing designs and equipments to avoid any complications later on. He should keep a strict eye on the developing standards and the upcoming Directives which are readily available. The set and decided standards are also published on Official Journals of European Union which should be given due consideration while forming the products to be launched in European markets. The engineer, on behalf of the companies needs to check any changes for new equipments being introduced in the market. CE marking is also important as it avoids any hassles caused at customs and he should make sure that it is listed on all the products, on the package and on the shipping documents as well. It is his duty to read all the appropriate directives and is also responsible for the integrity of any related certification documents and for making available supporting information upon request. He should also look into the standards and the approvals that apply to your product, obtain proof of the approvals for safety critical parts and manage compliance approval programs. The engineer, hired by the employer should take into account all the requirements and risks while designing the product so that there is no problem in acquiring CE marking. For this he should provide technical guidance, determine alternatives when the set standards can not be applied or used to verify product compliance and provide resting and design support.5 Resolutions of Conflicts between Engineer's Social responsibility and his Responsibility to the Employer Whenever someone works for some firm or person there comes various situations where he/she as to take the logical decision thus maintaining equilibrium between the social responsibility and the duty towards the employer. Similar is the case with the engineers working for the manufacturers eager to launch their product in European markets. They set all the responsibilities regarding the acquisition of CE marking on their engineers and expect then to go by it. Whereas there are various social and ethical issues which can not be ignored in any way. These are the situation where every engineer has to take his own decision while explaining the logic of his decisions and avoiding any serious conflict. Foremostly, sticking on the safety requirements of CE marking he should always prefer making the product safer for the consumers and thus reducing the damage claims and liability premiums. He can well explain the slight change in design of the products and increased costing stating that it will in-turn benefit the company retaining the goodwill as well as acquiring the CE marking easily and in a very smooth manner. This would also not create any document as well as conformity worries later on. Second conflict can arise between the engineer's social responsibility and the responsibility to the employer regarding the responsibility of the conformity of the product in accordance with various applicable requirements set out in the relevant Community harmonisation legislation for affixing CE marking. If the employer insists on ignoring any of the required standards set by European Directives the engineer should then try to understand the requirements and make all the possible modifications to the existing designs and equipments to avoid any complications later on. He should look for the standards and approvals that apply to the existing product or ones with little modification. He should always disregard the suggestions that suggest misleading third parties regarding the meaning or form of CE marking. He should make it clear that CE marking is not a marketing or promotional tool and nor is a quality mark in any sense; so there is no need for the employer to push in any of the matters of CE marking as it may lead problems with customs. He should make it clear by the words of quality engineer at Komo that, "if you want to sell your product in Europe, you have to comply with certain directives and there's not really much you can do about it." Even employers would understand that the engineers not only have to undergo CE marking process but also have to obtain the help of a notified body if the product has to be sold overseas.6 Different engineers are assigned different roles in the company to meet the social as well as employers' needs. To comply with the directives during risk assessment, the machinery may also have to make changes to the machines. For e.g.: if an electrical assembly had to be redesigned, the task would be assigned to the company's electrical engineer. And the engineers should be left free to do what ever they feel to comply with the directives. Code of Law - Fundamental Canons The few fundamental laws and canons need to be catered to while proceeding for CE Marking procedures. It is a kind of trade passport for European market which would allow you to circulate your product throughout 28 countries of EEA. These are ought to be followed by the manufacturers and their engineers for gaining uninterrupted and smooth CE marking. Complying with CE marking is a very critical issue if you want to launch your product on global market. Understanding this myriad of regulations that would affect your product in the market is the only key to success. Entire EEA has only one set of requirements and procedures to comply while designing and manufacturing the products. These have full impact on the mind of the manufacturers and the engineers who wish to launch their products in European marketplace. The few of the fundamental requirements of the directives are: General safety. Efficiency requirements. Special provisions in regard to chemical, physical and biological properties. Mentioning all the possible risks of infection and microbial contamination if any. Measuring properties and environmental properties. Protection against radiation, mechanical, electrical and thermal risks if any. Provision of the manual for the consumers of the product to use it safely. Apart from all these responsibilities of the manufacturer the conformity assessment of the products is the fundamental requirement to acquire CE marking. In some cases the Notified Body may also have to be involved. Other information that is required to be given as per the code of law includes the mane or the trade mark, address of the manufacturer, description of the product, serial number and batch code, the indication of the date by which the device should ultimately be used, important instructions and warnings for storage and use of the product. It should be noted that there is no other way to acquire CE mark for your product without complying with all the essential relevant European Directives. Related Issues and Difficulties It should be understood that the engineers not only have to undergo CE marking process but also have to obtain the help of a notified body and go through other related issues if the product has to be sold in European marketplace. A few such issues to be considered while proceeding for CE marking are: Declaration of Conformity. It is to obtain the certification for the regulated products. Sometimes the parts of the certification process for CE marking could be performed by third party test houses or certification bodies that would be identified by any of the Notified Body. Identification of the products is to be done along with mentioning the name and address of the manufacturer. European agents name and address has also to be mentioned if applicable. Operating instructions Test Reports. Vigilance and incident reporting. Design details, description of operation, components list, test rationale, circuits and diagrams are to be provided. Technical construction file is to be submitted. This is a special file for regulated products and high risk machines. Product registration. User manual and installation instructions.7 These were some of the related issues in CE marking procedure. All these issues give rise to various difficulties which should be dealt carefully right from the beginning. A few of the difficulties faced during the process of CE Marking are: - It has been seen that the new product Directives may sometimes exceed the present national laws and regulation. It may also levy some extra charges on the manufacturers to change or modify their designs or total production line. And there is no other option left for them than to make changes if they wish to continue working in the huge European market. - Extra costs may be also involved while acquiring product Certificate of Registration for CE Marking and also for testing certificate if needed. ( refer footnote 1) - Penalities are also put for infringements of the regulations of any of the applicable directives to your products. These penalties may also include criminal sanctions for serious infringements. (refer footnote 4) - If there is a non-compliance issue with a product, regulatory bodies in Europe blame the European counterpart of the U.S firm - the importer or distributor. The U.S. firms suffer due to a hold up or return of its machinery and the loss of sale and future business. The European company faces fines and possible imprisonment. (refer footnote 5) - Developing standards of CE marking can be hard to track because they are not published anywhere. If there is any complaint of your product from any of the dissatisfied competitor or customer it may result in harsh penalties. It can be the worst, damaging the business reputation and the product may even be suspended and banned from all EU member states. So, as you go by the procedure of CE marking be as cautious as possible and let your engineers decide the best for you to save your company and product from any unwanted fines or even the total exemption from the European market. Objectives of CE Marking CE Marking is ideally known as a passport to enter the market place of European member states. The most important goals and objectives of CE marking are: CE marking ensures that the product meets all the essential requirements of all the applicable directives. For this, most of the products are self-assessed by the manufacturers or their hired engineers except of some of the high-risk products. And it becomes wholly the declaration by the supplier. CE marking allows product to be placed on the market. It ensures free movement of the goods in all the EU member states. It also allows the withdrawal of the non-compliance products by customs and enforcement authorities. Its main aim is to symbolize the conformity of the product and to ensure that the product has gone through all the essential evaluation procedures set by the Community law applicable to the product. Conclusion CE marking no doubt has a great impact upon the manufactures while preparing their products and as they prepare to enter the European Union marketplace. It also ensures the liability implications of the manufacturers globally as well as the domestic ones more significantly and makes it difficult to ignore. The safety directives and the technical standards set also increases the faith of customers hence increasing the demand gradually. Although CE marking is in no way a promotional tool or quality check but still is very vital if you wish to launch your product in EU market. Manufacturers may hire various engineers to see through all the difficulties right from the beginning and to make relevant changes so that their products may not have to face any problems while the procedure of CE marking. Sources 1. bis.org. The CE Mark, CE Marking and CE Certification. November 29, 2008. 2. stewart-usa.com. CE Marking Service from Stewart technology Associates. November 29, 2008. 3. walaw.com. CE Marking Seminar. Obtaining the European CE Marking for your Product. November 29, 2008. 4. ce-marking.org What is CE Marking (CE Mark) November 29, 2008. 5. mitc.com Will. Smith. Maine International Trade Center. Maine Exporter's Guide to the European Union's CE Marking Requirements. July 27, 1999. November 29, 2008. 6. cemarkinfo.com Preparing For The DTI CE Mark. November 29, 2008. 7. ce-marking.com CE Marking. Questions and Answers. November 29, 2008 8. bis.org How do you benefit from CE November 29, 2008. 9. abmankar.gov MEDICAL DEVICES. November 29, 2008. 10. ablewisp.com. Compliance. November 29, 2008 11. cw-marking.com. CE Marking (CE mark): Manufacturer and its responsibilities (authorized representative, distributor, retailer, wholesaler, user, sub-contractor, own brand labeller, private labeller). November 29, 2008. Read More