More Information on CE Compliance Audits
When the Provision and Use of Work Equipment Regulations (PUWER) first came into force in 1992 it included a very simplistic view on CE Marking: the enduser only has to check that the equipment concerned carried a CE Mark. 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 such as CE Marking. These changes were re-enforced with further changes in June 2002.
This point has been further backed up in other guidance from HSE including Information sheet FIS 25. Even though this is specifically for flat bed conveyors for the food industry, the outlook is clear. This sheet states: “Even when a machine is supplied CE Marked, users should not assume that it is safe. Users should check for themselves that all relevant Essential Requirements are met and that the machine supplied is in fact safe”. If this is the case, and the end-user should now check more thoroughly regarding the CE Marking of new equipment, what is the best way to do this?
PUWER - The Problem
To fully comply with PUWER, any new equipment should be inspected after installation and before it is put into use to make sure it is safe. This inspection, if carried out correctly, will highlight any safety issues, which may have an affect on the CE Marking of the equipment. Any issues that appear to relate to the CE Marking of the equipment should be raised with the manufacturer or supplier of the equipment. Hoever, as the equipment has been installed it may be more difficult to deal with.
CE Audits - The Solution
A solution to this is to use a User Requirement Specification (URS) when purchasing new equipment. This specification 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 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 Mark will be applied to the machine, preferably on the makes nameplate.
- A full operation and maintenance manual that complies with EHSR 1.7.4 of the Machinery Directive will be required.
The above is not a complete list, but is indicative of the type of information you should be asking for.
To ensure compliance with the URS, the equipment may need to be inspected or CE Audits performed before it is shipped from the manufacturer or supplier. But this inspection need not be limited to only safety issues. Often a purchaser may want to inspect his equipment to ensure the product he is receiving is indeed the product he believes he is buying. These inspections are both engineering and quality based. Often a company may lack the skill or resources to carry out an inspection of this type in one visit.
Combining the two inspections into one is a cost effective method of ensuring the machine you receive is both safe and meets your specification. Any potential issues can be raised with the manufacturer and either dealt with before it is shipped or at least be planned into the installation process once the equipment has been shipped. Retrofitting is the more difficult method of compliance; it is always advisable to deal with safety as early as possible in the purchasing process, the design stage being preferable.
So, if as a company, you decide to include such an audit in your equipment purchasing policy, what would you need to look at and who should carry out the audit? Dealing with the person first, they should have a good knowledge of the equipment type itself as well as competent understanding of PUWER and CE Marking legislation and have a sound engineering background to understand the latest developments in machine manufacture. Whilst the auditor may not go through the EHSRs as in-depth as the manufacturer, the same areas need to be covered. It may be beneficial for the auditors to create a generic checklist that can be used so that all people who are carrying out an audit for the company are looking at the same points.
Areas to look at include:
- Documentation, manuals etc.
- Drawings, electrical pneumatic, hydraulic etc.
- Electrical wiring and termination checks
- Hardware checks
- Utilities
- Environmental checks
- Control Systems
- Software
- Calibration, machine parameters
- Safety CE, PUWER as applicable
- Safety related control systems, interlocks etc.
- Safety, manual handling, COSHH etc.
- Safety, hazards etc.
- Ergonomic Assessments
- Maintenance and cleaning procedures
- Training requirements It may also be beneficial at this stage to collate all the relevant documentation such as manuals, drawings etc so that a file is in place when the equipment arrives on site.
External Assistance.
There may be many reasons why a company feels that a pre-purchasing audit is not feasible. It may be manpower, time, competence or a mixture of the three.Laidler Associates currently carry out this kind of audit for a number of major blue chip companies, both in the UK and abroad. Following the audit, the client will receive a full report highlighting any problem areas with a recommended corrective action. Laidler can also carry out an inspection to enable compliance with PUWER and Project Manage any retro engineering that needs to be carried out.
Laidler Associates also have experience of writing URS’ for clients from amongst others, pharmaceutical and automotive companies. Laidler can also tailor the mCom Machinery Compliance software system, to include the URS.
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