Eight years ago I worked with a manufacturer of oilfield machinery in Texas. They wanted to CE Mark their equipment to comply with the Machinery Directive for use on oil pumping platforms in the North Sea. They also wanted to use DNV as well as EN harmonized standards, where appropriate, to satisfy the Annex I Essential Health and Safety Requirements. In addition to the Machinery Safety Requirements, the UK and Norway imposed additional safety requirements for use on the platforms.
To say that the equipment was rugged would be an understatement. In addition to the Machinery Directive, we had to satisfy the Low Voltage Directive, EMC Directive, Equipment and Protective Systems for Use in Potentially Explosive Atmospheres Directive (ATEX) and for one of the machines, the Pressure Equipment Directive. Altogether we had four large machines to CE Mark.
For each machine, I met with the manager and key personnel of that division and walked them through the requirements of the different directives. I had anticipated that possibly one or two individuals would be assigned the responsibilities for CE Marking the machines as had happened in my work with other manufacturers. I discovered, however, that the different divisions didn’t feel that they could free up an individual to follow through on CE marking their specific machine.
Therefore, I decided to write a detailed report identifying each step needed to satisfy the Machinery Directive and other Directives relevant to each machine. First, we went over the Annex I Essential Health and Safety Requirements to create a checklist. Next we identified the EN and DNV standards to demonstrate conformity with the requirements and reviewed the specific standards requirements and EMC testing for each machine. Following that we walked step-by-step through the EN1050 Risk Assessment Standard, the creation of a Technical File, EC Declaration of Conformity and identification of their Authorized Representative. Fortunately, the manufacturing plant was certified to ISO 9001, which answered Annex V 3 (b) For series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.
While the company was happy with the detailed report for each machine, I was not convinced that the company would successfully follow through on each step. I had been in too many plants prior to this experience where a bright young engineer would create a matrix to identify the elements relevant to a Risk Assessment. When one of his or her colleagues was asked to explain the rationale of the matrix, they often failed. It was idiosyncratic to the engineer.
I explained that the matrix had to stand on its own merits when called upon in the future by an EU member state government or in a US courtroom in a product liability lawsuit. The creator of the matrix and writer of the documents likely would have been promoted, moved to another company at that time. I decided as a preventive law measure that in the future I was going to draft the documents myself and submit them to the company for editing. The legal consequences were too great to risk non-apparent reasoning and poor writing.
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