At a CE audit, (often carried out at the same time as a Factory Acceptance Test), the documentation should be checked to make sure it is available, and the CE marking is adequate. The file should include the following, (wording in italics is from the Machinery Directive, non-italic is comments).
- a general description of the machinery, (Often not in place).
- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,
- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, (Test results include things like lifting tests, noise, vibration, Electro Magnetic Compatibility, electrical safety tests. There should also be a validation report on the safety related control system, demonstrating it meets the relevant Performance Level or Safety Integrity Level).
- the documentation on risk assessment demonstrating the procedure followed, (Often the method is not explained), including:
(i) a list of the essential health and safety requirements (EHSR) which apply to the machinery, (This is critical, and is often the report that is missing. It should explain how each EHSR has been addressed, and how the machine complies).
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery, (Risk Assessment report).
- the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, (The standards used should be current, the Europa website lists current harmonised standards on the Machinery pages).
- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
- a copy of the instructions for the machinery,
- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,
- where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,
- a copy of the EC declaration of conformity. (The original should be in the Technical File, a copy supplied with the machine).
For series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive. (Details of any Quality System).
The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
There are costs in ensuring CE marking is done correctly. However, these fade into insignificance compared to the cost of an accident due to poor machinery safety, and the hidden costs such as the responsibility for someone else’s injury or death, the increased insurance premiums, the loss of reputation and the loss of morale within a workforce.
It is not difficult to check the documentation, it is unlikely that all will be available, however a decision has to be made as to whether the company supplying the equipment has done sufficient to give confidence that they understand their responsibility with regard to CE marking, and primarily, is the machinery SAFE.
CE Audit Checklist
The CE Audit checklist in COMPLIANCE Risk Software enables a machine and documentation to be reviewed.