Effective machinery compliance project management

NOW THAT the United Kingdom has left the EU, machinery end-users in the UK will slowly start to see a UKCA mark appearing on compliant products. Since the EU exit transition period came to an end on 31st December 2020, the UKCA marking is now required for new machinery placed on the market for the first time in Great Britain (England, Scotland and Wales), where the involvement of an independent certification body is required, but CE marking will continue to be accepted in Northern Ireland. However, machinery manufacturers do have 10 months’ grace in the form of a further transitional arrangement for the acceptance of CE marking until 1st January 2022. After this time any machinery sold in the UK, irrespective of when that model was first placed on the market, must carry a UKCA marking.

While references to 'harmonised standards' have changed to 'designated standards', for now the UK standards remain the same as EU harmonised standards and have simply been carried across as UK designated standards to maintain a single model. For example, within the EU, compliance with the Machinery Directive (2006/42/EC) is required, which is now the Supply of Machinery (Safety) Regulations 2008 in the UK.

In the UK, UKCA marking procedures have changed very little from the CE marking structure. However, while initially these requirements will align with the CE marking ones that they replace, overtime divergence is possible. The CE marking will of course remain in the EU. In both jurisdictions the same rules will apply - everyone must understand their legal duties and responsibilities.

This means that all machinery should meet all relevant essential health and safety requirements (EHSRs), which are detailed in the UKCA Regulations. Machinery must be able to satisfy the EHSRs for any corresponding hazard which may apply to it. The EHSR requirements are wide ranging, taking into account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide adequate warning labels where there are moving parts that might trap parts of the body of personnel using the machine. However, taking into account the state of art, it may not be possible to meet all the objectives set by EHSRs, as technologies often move more quickly than the standards trying to catch up with them. With this in mind, the machinery must be designed and constructed with the purpose of approaching these objectives.

A technical file for the machinery should also be available as it proves due diligence and provides evidence of compliance. It can be a traditional paper file, or stored electronically, with hyperlinks to documents. It must also be kept up to date as the product is adapted, which means that the technical file cannot be put away and forgotten.

The technical file must remain available for inspection by a competent national authority, such as the UK Health and Safety Executive, for a period of ten years. However, it does not have to include detailed information such as the sub-assemblies of the machine, unless a knowledge of them is essential for verification and compliance with the EHSRs.

Project management practicalities

When the Provision and Use of Work Equipment Regulations (PUWER) first came into force in 1992 it included a very simplistic view, as the end user only had to check that the equipment concerned carried a CE marking. If it did, they were able to presume conformity. PUWER was updated in 1998 and one of the more important but easily overlooked changes was that the onus was now put on the end-user to make sure that the equipment complies with all relevant legislation. These changes were re-enforced with further changes in June 2002.

When building machines, or when combining machines to produce an assembly of machines, it is easy to get things wrong and end up with a project that requires a lot of rework and ends up going over budget or overtime. To this end, it is vital to ensure that the CE/UKCA marking is considered from the start. If this is not done, common problems that occur include:

- Equipment being installed before a final layout is agreed so that machines have to be moved and rework is required.

- Consideration not given to a safety related control system at the start leads to a number of problems when linking different machines with different performance levels.

- Not considering control system functionality so that feed conveyors are not stopped when a process is stopped, resulting in damaged products at best and injury at worst.

- Machinery that is not inspected before installation subsequently reveal non-compliances, resulting in disagreements about who pays to put it right - the supplier, the contractor or the user.

- Control colours not being agreed means that different suppliers may use different colours, leading to confusion. The European Standard allows for green, white, black or grey for ‘start’ and red, white, black or grey for ‘stop’, so even if the supply chain complies with the standard, errors and confusion can occur.

Equipment is often designed and installed with no thought as to what happens either upstream or downstream, or who takes the responsibility for which parts, and who takes responsibility for the final assembly. This can be exacerbated when equipment is sourced from outside the European Economic Area, or existing equipment is linked to new equipment.

When starting a project, it is therefore vital to decide who is going to take the responsibility for the CE/UKCA marking and lay down the ground rules. Decide what Performance Level the machine will come under, using EN ISO 13849 and ensure all suppliers are aware of what is required. Make sure they all understand which EN Standards to follow, and that they have copies of the Standards. A good tip is to ask for sample declarations before deciding on suppliers, so that you can check to see if they contain the correct information.

When you issue purchase orders, ensure there is a clause about CE/UKCA compliance  which states whose responsibility it is. A solution to this is to use a User Requirement Specification (URS) when purchasing new equipment, which will outline your requirements for the equipment supplier. A URS should include statements such as:

- The machine must comply with all applicable European and UK legislation (list all applicable directives)

- Euro-norm or designated standards should be used to achieve compliance with the essential safety requirements of all applicable directives

- Documentary evidence demonstrating compliance with all applicable directives will be required

- A Declaration of Conformity will be required

- A CE/UKCA marking will be applied to the machine, preferably on the maker’s nameplate

- A full operation and maintenance manual that complies with EHSR 1.7.4 of the UK’s Supply of Machinery (Safety) Regulations 2008 will be required

Before accepting and paying for any machines, check that they meet the requirements of the order and also that they conform to the relevant directive. A pre-purchase audit is a useful system that can help machinery buyers ensure that equipment is both safe and correct.

Paul Taylor is head of industrial products (UK) at TÜV SÜD

http://www.tuvsud.com/uk