CE auditing and the need for specifications and documentation

I have recently assisted a number of companies with CE marking of assemblies of machinery, supplied mainly by European organisations, and I am concerned about the high number of incorrect CE markings provided by machinery suppliers. Declarations listing out-of-date Directives and standards, more than one to the original Machinery Directive 89/392/EEC which came into force on 1 January 1993 and was superseded by 98/37/EC in 1998, when declarations should have been updated to use the new number. On 29 December 29 2009, Directive 2006/42/EC came into force, and declarations again should have been updated. Six and a half years later, many companies are still not meeting its minimum requirements. CE can be taken to mean Check Everything.

It is not all the supplier's fault. When buying machinery, many organisations do not provide an adequate Universal Requirement Specification (URS) detailing what they expect and require. Many organisations do not check that what they are buying is compliant with existing legal requirements, assuming that manufacturers will provide suitable CE marked equipment that is safe.

When things go wrong, particularly when someone gets hurt because the machine is unsafe, it is usually the end user who is prosecuted, not the manufacturer of the machinery. In the UK, the HSE prosecutes far more companies under the Provision and Use of Work Equipment Regulations (PUWER) than they do under the Supply of Machinery (Safety) Regulations.

Regulation 10 of PUWER states:

(1) Every employer shall ensure that an item of work equipment conforms at all times with any essential requirements, other than requirements which, at the time of its being first supplied or put into service in any place in which these Regulations apply, did not apply to work equipment of its type.

(2) In this regulation "essential requirements", in relation to an item of work equipment, means requirements relating to the design and construction of work equipment of its type in any of the instruments listed in Schedule 1 (being instruments which give effect to Community directives concerning the safety of products).

(3) This regulation applies to items of work equipment provided for use in the premises or undertaking of the employer for the first time after 31st December 1992.

The Approved Code of Practice (ACOP) explains this as the following:

Employers providing work equipment for use in the workplace should ensure that it has been made to the requirements of the legislation implementing any product Directive that is relevant to the equipment. This means that in addition to specifying that work equipment should comply with current health and safety legislation, you should also specify that it should comply with the legislation implementing any relevant EC Directive. You can check to see that the equipment bears a CE marking and is accompanied by the relevant certificates or declarations (ask for a copy of the EC Declaration of Conformity), as required by relevant product Directives.

You will need to check that appropriate operating instructions have been provided with the equipment and that there is information about residual hazards such as noise and vibration. You should also check the equipment for obvious faults. Your supplier should be able to give further advice about what the equipment is designed for and what it can and cannot be used for, or alternatively, make further enquiries with the manufacturer.

Universal requirement specification

In any specification or URS the purchaser should specify what the machine should do, to make sure there is no doubt - whether this is to produce a certain number of parts in a given time, or pack a certain number of items, or for a hydraulic power pack to provide a certain flow and pressure, the goals should be reasonable and achievable. These will often be derived from sales literature but should be realistic and agreed with the supplier in advance of any order being placed.

The URS should specify things such as access times onto sites, how and when installation can be carried out, and things such as space, services (power, air, water, etc). These may be quite simple for a small, simple machine, but more in-depth on a larger long-term project. Health and safety requirements should be specified, such as any requirement for risk assessment and method statements before any work is carried out. Other requirements such as Construction (Design and Management) Regulations may be necessary, depending on the complexity of the project. The CDM Guidance does not mention CE marking, so do not assume that the Principal Designer or Principal Contractor will deal with it, if CDM applies.

Most importantly, the URS should specify who has responsibility for CE marking, and the means for checking the CE marking is correct. Every situation is different; if there is a single supplier, it is their responsibility to ensure everything is CE marked correctly, and this should be clear. If there is a prime contractor supplying most of the equipment, they may take the responsibility for all equipment, but they need to understand their obligations and what is expected - for example, a Declaration of Conformity for an assembly of machines, some of which they may not have supplied. It may be that the end user has the responsibility for the CE marking of the assembly and provides a URS to a number of suppliers, and compiles its own Technical File and provides a Declaration of Conformity (or appoints a consultant to work with them).

The URS should specify that the end user, or someone acting on his behalf, has the right to visit each supplier's premises to review the Technical File, ensure it exists and contains the correct information. The end user has no right to a copy of the Technical File, it has intellectual property rights, and information that is not necessary for the end user to have. The supplier has no legal obligation to make available a copy of the Technical File. However, if a supplier refuses to allow an end user to review a Technical File at the supplier's premises, there has to be a suspicion that it is either incomplete or does not exist, casting doubt on the validity of the CE marking.

The URS should also specify things like colours of controls. The EN standard covering control colours (EN 60204-1) states that the preferred colour for start is white and the preferred colour for stop is black. Manufacturers of new machinery should be providing these colours as their standard, normal colours. However, many existing machines have green for start and red for stop, so an inconsistency arises. Under PUWER, the end user needs to ensure that their staff can operate all machines safely, so should aim at consistency in control colours across each site. This may mean specifying new machines with green start and red stop controls, or whatever colours the end user normally uses. (If inconsistent, the end user should start to ensure consistency is applied throughout the existing facility!)

Another important item for the URS is the payment terms, and these should always require that the final payment is only due when installation and commissioning is complete, AND that ALL documentation is in place. This at least gives some bargaining power in the event that the correct documentation is not supplied. In too many cases, the final payment is made and the supplier moves on to the next project without completing the documentation.

Documentation review

If possible, request a copy of a Declaration and draft instructions in the early stages of the project; the Machinery Directive 2006/42/EC explains what needs to be in these documents, with the Declaration requirements found in Annex II and the instructions requirements in EHSR (essential health and safety requirement) 1.7.4.2. Check the documentation supplied, and make sure that on the Declaration the machine is clearly identified, and that all documentation uses the same terminology. I have seen machines where the designations on the Declaration, Manufacturers Plate and Technical File are all different, making it difficult to determine what documentation goes with which machine.

Make sure the Declaration lists current Directives - these can be checked on the Europa website Machinery pages - and check that current EN standards are being used; also check that the Declaration does actually declare conformity. If you do not understand, do not be afraid to ask the supplier to explain it.

Check the Instructions, even if only the index is supplied, to make sure that all relevant requirements of the EHSR 1.7.4.2. have been addressed. Make sure before the machine goes into service that there is a completed instruction manual.

CE audit

At the CE audit, which is often carried out at the same time as a Factory Acceptance Test, the documentation should be checked to make sure it is available and adequate. The file should include the following, (wording in italics is from the Machinery Directive, non-italic is my 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
• {i=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~~~ electromagnetic compatibility and 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 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 and 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.

Conclusion

There are costs involved 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?

Follow the link for more information about CE audits and other machinery safety services from Safe Machine Ltd.