A new look at safety.

European conformity

The single market is one of the great achievements of our time. This economic space, where goods, services, capital and labour can circulate freely, provides a foundation for prosperity in the European Union as we move towards the 21st century.

Since 1987 more than 20 directives, adopted on the basis of the New Approach and the Global Approach, have progressively come into force. The operation of any innovative system inevitably raises questions.

Background on the Provision and Use of Work Equipment Regulations 98

PUWER requires users of work equipment to carry out regular risk assessments which are documented and kept on file. Most importantly, those risk assessments must address each of the Regulations under PUWER.

The regulations require that all provided work equipment is suitable for its intended task and can be used without putting persons at risk.

In general terms, the Regulations require that equipment provided for use at work is:

Suitable for the intended use;

Safe for use, maintained in a safe condition and, in certain circumstances, inspected to ensure this remains the case;

Used only by people who have received adequate information, instruction and training.

Accompanied by suitable safety measures, e.g. protective devices, markings, and warnings.

If you are an employer or self-employed person and you provide equipment for use at work, or if you have control of the use of equipment, then the Regulations will generally apply to you.

The Regulations cover places where the HSW Act applies – these include factories, offshore installations, offices, shops, hospitals, hotels, places of entertainment etc. PUWER also applies in common parts of shared buildings and temporary places of work such as construction sites. While the regulations cover equipment used by people working from home, they do not apply to domestic work in a private household.

Machinery inspections

Most companies carry out risk assessments for processes that use machinery, unfortunately that doesn’t always mean that the correct risk assessments have been carried out on the machinery itself. The PUWER approved code of practice (ACOP) L22 specifically refer to the competence of the person carrying out the assessment or inspection.

Engineers should carry out thorough inspections, focusing on safety critical components that could affect the ability of the equipment being operated safely. You should consider the design and installation of the equipment and bring any problems to your attention. For example, if an item has a non-compliant Safety Related Control Circuit, inadequate guarding or requires CE marking and is not at present, you should check it.

• Risk Assessments -Satisfying the requirements of the Provision and Use of Work Equipment Regulations, and will be carried out in accordance with EN 14121-1

• Assessment of electrical systems and safety related control circuitry in accordance with EN13849, EN954-1 or EN62061 as required.

• A Report on compliance of your equipment in respect to each of the sections of the Provision and Use of Work Equipment Regulations.

• Where non-conformances are identified, we will give detailed help with solutions which reference the Harmonised or other EN Standards.

Competent sign off

When making safety upgrades to machinery, it is important that they are compliant. Whether your upgrades are completed by the Original Equipment Manufacturer, a third party sub-contractor or by your own staff, a competent [person should inspect your equipment and provide certification for physical compliance with the Regulations.

It makes sense to involve experts before upgrades are started as we can advise on the scope and design of those upgrades before money is spent on your machinery. Remember that even if you employ an outside resource to complete the safety improvements, you are legally responsible for inspection before putting that machine back into service.

Incident investigation

The main purpose of investigating incidents is to find the reason why harm was caused to employees, other people or resources such as equipment or facilities. The investigation should not be used to allocate blame, but to identify what went wrong and to prevent a similar incident happening again. Accidents are costly events, besides pain and sufferings there are costs arising from accident, such as human cost, loss of time from work, claim for injury, business disruption and clearers time, therapists time, investigation time, ambulance time, fire brigade, police and other hidden costs such as disruption to family and society.

An expert consultant can provide an independent, third party assessment of the root cause and practical advice on corrective measures to prevent a recurrence and attend meetings and correspond with Authorities on your behalf. They should work for you, to protect your business and your employees.

CE Marking

Background to European Conformity.

To supply products on the market in the European Economic Area (EEA), CE Marking is mandatory.

With the CE marking on a product the manufacturer ensures that the product conforms to the essential requirements of the applicable EC directives.

Most new products placed on the European market must be CE marked. This will include products which are “new” to Europe, second-hand products from outside Europe and which are put into service or placed on the market in Europe for the first time, and existing products which are so substantially modified as to be considered “new”.

CE marking is the responsibility of the person who places the product on the market, or puts it into service, for the first time. In law this duty rests with the Responsible Person, which in most cases is either the manufacturer or the manufacturer’s authorised (in writing) representative, but can also include those who import non CE marked products into Europe, any user in Europe who makes a product for their own use, and those who modify existing products already in use to such an extent they must be considered “new” products.

CE marking is the final stage of the conformity assessment process as specified in the relevant Directive for the product. The conformity assessment process (sometimes referred to as the CE marking process) is concerned with:

Assessing the risks presented by a product throughout its lifecycle

Meeting safety objectives by design and construction

Taking account of the current best practice to ensure the safety for that product, known as the state of the art

in some cases the supply Directive will require the use of third parties to verify compliance, collecting and retaining information about the design, testing and construction process and the means by which the product complies with the essential requirements of all relevant product safety.

Declaring the product’s conformity with all relevant product safety law by means of a document (the Declaration of Conformity), which in most cases must accompany the product down the supply chain to the end user and the preparation and provision of comprehensive product User Instructions, in the language of the end user.

Directives likely to be encountered with your machinery include:

• The Supply of Machinery ( Safety ) Regulations 2008 as amended. SI 1597.

Directive 2006/42/EC applies to machinery, lifting accessories such as slings and chains, and safety components. A machine is defined as “an assembly of linked parts or components, at least one of which moves…”

• The Electrical Equipment ( Safety ) Regulations 1994 as amended. SI 3260.

It applies to all apparatus running on (or generating) an electrical supply in the range 50 – 1000 volts A.C. or between 75 and 1500 volts D.C.

• The Electromagnetic Compatibility Regulations 1992 as amended. SI 2372.

The Directive requires that products must not emit unwanted electromagnetic pollution (interference) and must be immune to a normal level of interference.

• The Pressure Equipment Regulations 1999 as amended. SI 2001.

Equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge including vessels, piping, safety accessories and pressure accessories.

Safety circuit validation

Only competent persons should carry out assessments of your control systems with reference to EN61508, EN62061, EN 954-1 and EN ISO 13849-1.

The new European Harmonised Standard, EN ISO 13849-1:2008 “Safety of machinery – Safety-related parts of control systems” replaces EN 954-1. Get an expert to assist you in selecting the appropriate standard for compliance of your plant, we firmly believe in cost effective safety, not blindly following trends.

A comprehensive analysis, in accordance with the Validation Plan, enables you to model the structure of your safety related control system based upon the components used and the designated architectures, thereby permitting calculation of the reliability values in detail, including relevant parameters such as the overall component reliability (MTTFd), the average test quality (DCavg) of components and blocks and probable common-cause failures (CCF), to determine Performance Level achieved (PL). This is in turn compared to the Performance Level required (PLr) for the level of risk posed by the machine.

Modified machinery

Many companies no longer have the budgets available to invest in new plant and machinery. This means that for many end users the only alternative is to upgrade or adapt existing plant. It is important however, to remember that modifications to existing machinery might fall under the scope of the new Machinery Directive 2006/42/EC. It is often a case that an existing declaration of conformity is rendered invalid if machinery undergoes a ‘significant’ change.

The term ‘significant’ is often misunderstood and can also include the linking of machinery together such as in a production line. One should exercise caution when linking old and new machinery.

Get an expert to give advice in ensuring compliance, especially at the design stage to ensure that a ‘significant’ change is not undertaken and exclude CE Marking altogether. This will provide a large cost saving to many capital projects.

Buying machinery CE audit

If you are an end user, or thinking of buying new machinery, or machinery first provided for use after January 1st 1995, then you have specific responsibilities in respect to the conformity of that equipment. Regulation 10 of PUWER (HASAWA 1974 Sec 2/2) states:

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.

In plain language, that means it is in breach of the Regulations for you to use equipment if it does not comply. So if the manufacturer does not CE Mark that equipment properly, you could be held responsible if you use it!!

When purchasing or hiring new or second-hand equipment, special care needs to be taken to ensure that any associated risks have been assessed and that you are complying with the law. You should check that any contract deals with health and safety and that there is no misunderstanding about the condition of the machine and its guards or safety measures. The law applies not only to guarding but also to other aspects, which may affect health and safety, such as noise generated by machinery, solvent vapour emission, and protection against fire and explosion.

Key stages in the purchase or acquisition of new equipment will be;

1. Defining a user requirement specification.

2. Pre-delivery CE Inspection

3. Post installation sign off and PUWER inspection

The purchase and acquisition of equipment for use within your organisation should comply with all National and International Regulatory requirements. In order for this provision to be complied with, a competent person should review the machine acquisition protocol existing within your organisation and, with the involvement of key stakeholders, provide a template User Requirement Specification document that covers the common requirements, industry standards, and organisational standards that apply to Equipment intended for use within European facilities.

It should be read together with the relevant organisational Machine Specification.

This practice will assist in ensuring equipment supplied shall comply with the statutory national, local, legal regulatory requirements, and internal Standards applicable to the equipment type, operating environment and operating site.

Systems Audits

It is important that any consultant communicates effectively to define the level of reduction of risk to the business that is required and how this is to be achieved. The legislation continually changes and new Standards are published with alarming regularity. It is possible that some of the remedial works is no longer compliant. We need to determine the company’s viewpoint of “compliant” and “safe” as they are not mutually dependent and there is no infinite pot of capital. This will define the “agreed adequate level of safety” in the business.

Following this process you can audit your HSE & Q Policy and procedure in respect to machinery and its use.

These are necessary to build up a picture of existing health and safety management controls and to determine their suitability. The audit procedure is designed to scrutinise policies, procedures and day-to-day activities from a which a comprehensive report is produced which compares ‘what is’ against ‘what should be’, again with practical suggestions for improvement.

Health and Safety Audits are best carried out by an external pair of eyes as nothing is overlooked.

An important part of an audit service is a “gap analysis” regarding competence of employees. You should look at your training records and systems to determine if improvements can be made that will have a positive effect on the behavioural safety of the safe use of your machines.

ATEX and DSEAR

An approved system demonstrates your legal responsibility in regard to the use of safety-related products, systems or services, wherever you are in the supply chain. Assessment and/or certification to IEC 61508 is either a pre-requisite or it can offer a significant advantage over the competition.

The assessment of the process plant will cover the relevant hardware and software lifecycle and how it is applied. The majority of the work entails detailed examination of the relevant documentary evidence and can therefore be conducted off site.

On completion of the full assessment, you should compile a detailed report, which provides the supporting evidence to enable the wording of the certificate to be framed accurately and appropriately.