Conformity with Relevant Standards and CE Marking

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1 SELECTION Suitability for Task and Environment The Provision and Use of Work Equipment Regulations 1998 (PUWER), Regulation 4, requires the employer to ensure that work equipment is designed or adapted for the purpose for which it is used or provided. To do so, the employer must ensure that employees are supplied with relevant information and training. The selection of suitable work equipment for particular tasks and processes makes it possible to reduce or eliminate many risks to the health and safety of people in the workplace. This applies both to the use and maintenance of the equipment. Equipment must be suitable, by design, construction or adaptation, for the actual work it is provided to do. This means that work equipment provided must be suitable for the work to be undertaken and used in accordance with the manufacturer s specifications and instructions. The location in which the work equipment is to be used should be reviewed, to account for any risks that may arise from particular conditions. For example, electrically powered equipment is not suitable for use in wet or flammable atmospheres unless it is designed for this purpose, i.e. suitably protected; alternative pneumatically or hydraulically powered equipment might be more suitable alternatives. Work equipment should also be installed, located and used in such a way as to reduce risks to users of work equipment and to other workers; e.g. ensuring that there is sufficient space to work, or there is sufficient satisfactory air to breathe. Account should always be taken of the fact that work equipment itself can sometimes cause risks to health and safety in particular locations which would otherwise be safe; e.g. a petrol engine generator discharging exhaust fumes into an enclosed space, such as in a garage. Individual examples of unsuitability for the task often occur in more than one piece of legislation and the laws appear to overlap. Equipment must be suitable for the process and conditions of use and must not be misused. For example, a forklift is not suitable for lifting people unless it is specially adapted. Another of the factors to be considered when studying the equipment is the man/machine interface, i.e. the ergonomics. Ergonomic design takes account of the size and shape of the human body. Operating positions, working heights, reach distances, etc., can be adapted to accommodate the intended operator. Operation of the equipment should not place undue strain on the user. Conformity with Relevant Standards and CE Marking When an employer selects suitable piece of work equipment, there is a heavy reliance on information and assurances provided by the manufacturer or supplier. Under the Supply of Machinery (Safety) Regulations 2008 (SMSR) clearly the manufacturer and/or supplier of machinery for use in the workplace is required to ensure that the machinery supplied is safe. These regulations implement into UK law the EU Machinery Directive 2006 (2006/42/EC). This builds on the requirements of Regulation 6 of HSWA RRC Training Element C5 Work Equipment 5-3

2 SMSR state that a manufacturer or distributor may not supply relevant machinery for use within the European Community (Union) unless it is safe and, in particular: It satisfies the essential health and safety requirements (see later). The technical file is compiled and made available (see later) Information required to operate it safely is provided e.g. operating instructions The appropriate conformity assessment procedure is followed (see later). An EC Declaration of Conformity is drawn up (see later). The CE marking is properly affixed to the machinery. It is in fact safe (that is to say, safe when properly installed, maintained and used for its intended purpose). The requirements are similar but slightly different for partly completed machinery (i.e. parts of machines designed to be used with or incorporated into other machinery). Partly completed machinery must have a declaration of incorporation instead of a declaration of conformity. In practice, when an employer is selecting work equipment, you should check that adequate operating instructions have been provided, that there is information about residual hazards such as noise and vibration and that the machinery is CE marked. The CE mark is marked on the machinery by the manufacturer in a distinct, visible, legible and indelible manner. The CE marking is therefore supposed to be a readily identifiable logo that indicates that the machine satisfies the essential health and safety requirements. But, remember, it is (in most cases) simply an assessment by the manufacturer that the machine is safe. It shouldn t therefore be relied upon completely. Employers also need to satisfy themselves that the machine is safe before it is put into use. The CE marking itself should conform to the following design: CE Mark Requirements for Maintenance In order to ensure, as far as possible, that the equipment remains reliable throughout its planned useful life it is important to ensure that it is regularly maintained. This will entail a planned maintenance schedule carried out by competent maintenance personnel. Availability of Expertise/Skills Required of Operators and Maintenance Personnel The Provision and Use of Work Equipment Regulations 1998 (PUWER) state that if the use of work equipment is likely to involve a specific risk to health and safety, every employer 5-4 Element C5 Work Equipment RRC Training

3 must restrict the use of that equipment to those persons given the task of using it. Any repairs, modifications, maintenance or servicing carried out on that equipment must only be undertaken by people who have been specifically designated to perform the work. Designated persons must receive adequate training in respect of any operations to which they have been designated. (Regulation 7). All users of work equipment must be provided with adequate health and safety information. The employer must make it available and may have to provide written instructions on the use of work equipment. This means the workforce should have easy access to such information and be able to understand it. Users must be trained to use equipment safely and supervisors must also receive adequate training on potential risks and precautions. (Regulations 8 and 9). RRC Training Element C5 Work Equipment 5-5

4 ? Revision Questions 1. Identify the factors an employer should consider when deciding on the suitability of work equipment. 2. With regard to conformity with CE standards, what duty is placed on the end user? (Suggested Answers are at the end of Unit C.) 5-6 Element C5 Work Equipment RRC Training

5 RISK ASSESSMENT AND USE Work Equipment Risk Assessment The requirement in the Management of Health and Safety at Work Regulations 1999 (MHSWR) to carry out a risk assessment for all work activities applies equally to the maintenance and use of work equipment. As the general risk assessment requirements in the MHSWR apply, there is no specific regulation requiring a risk assessment in PUWER. You might find the HSE booklet 5 Steps to Risk Assessment useful. When undertaking a risk assessment, some risks may seem obvious and others less so. A list of some hazards are shown in the Appendix of PUWER, as well as in BS EN ISO (Safety of Machinery), which we will cover later in the element. One of the first steps in the design or purchase of machinery is to analyse the risks. Risk assessment formalises the intuitive process by which designers and safety engineers use their experience to identify hazards, assess risks and select the appropriate safety measures. It determines, to a large extent, the level of safety precautions which are necessary. Risk assessment covers risk analysis and risk evaluation and includes: Hazard identification. Risk estimation. Limits of the machinery. Requirements for the life phases of the machinery. Design drawings or other means of establishing the nature of the machinery. Information concerning power supply. Any accident and incident history. Any information about damage to health. Two factors should be taken into account: The severity of foreseeable injuries. The probabilities of their occurrence. The identification of the various hazards should be followed by a careful study of the possible failures or combination of failures which might lead to those hazards causing injury. In any system where equipment failure may adversely affect safety, each component within the system should be considered in turn. The likely types of failure and their consequences for the system as a whole should be taken into account. When examining machines you should take account of the frequency of access to or beyond a danger point during each phase of machine life, e.g. machine operation and breakdown, commissioning, maintenance, setting and process changeover. By considering foreseeable human behaviour at each phase, we can assess the probable total frequency of access to the danger points. Next, estimate the proportion of each type of access likely to be injurious. This may call for a reliability assessment of safety or other RRC Training Element C5 Work Equipment 5-7

6 features, and on assessment of the degree of injury in each case. Note that the degree of injury may vary because of variations in the position of access for different reasons. The greater the risk, the greater the need to protect against it. The greater the probability or severity of injury resulting from failure of the safety measure, the greater the reliability of the measure should be. This applies to safeguards and controls in general, to interlocks, braking systems, over-run devices, work-holding devices, emergency stop systems, etc. Systematic methods of assessing these devices and systems are available. The absence of injury from machinery used without safeguards over a period of time does not in itself mean that the machine is completely safe. Guards and safeguarding systems for machinery should achieve their safety function with minimal downtime and the least reduction in productivity. We have to recognise that production pressures, incentive schemes, or well-intentioned zeal can lead to safeguards being defeated. Safeguards should be designed and constructed to make bypassing or defeating them, whether deliberately or by accident, as difficult as is reasonably possible. In addition, the elements of safeguarding systems should be reliable, since poor reliability will encourage attempts to defeat them. A machine should be installed with due regard to its interaction with other machines and the requirements of the process. Space should be provided around each machine to allow clear separation from passing traffic and for the storage of tools and work-in-progress. All phases of machine life should be considered, including cleaning, maintenance, etc., as well as normal operation. Platforms, safe means of access and lifting appliance suspension points should be built-in, where practicable, to facilitate cleaning and maintenance work without causing interference to adjacent machinery. In such circumstances, it may be necessary to safeguard moving parts which would otherwise be out of reach. Local lighting on the machine for the illumination of the work area should be provided when the construction of the machine and/or its guards renders the normal lighting inadequate for the safe and efficient operation of the machine. The controls should be so positioned relative to the machinery that the operator has adequate vision for control of the process being undertaken. The operator should have adequate room in his working position and have all controls placed within comfortable range. Where it is necessary for an operator to stand or sit on machinery when it is being operated, a platform or seat should be provided and designed and situated so as to protect an operator from any fixed or moving part which may cause injury. Seats should be designed to provide adequate support and should be fitted with back rests or shaped to protect an operator against slipping from the seat. Suitable footrests should be provided, where necessary. Risk Control Measures Risk control measures follow the same principle as for all risk control strategies. For work equipment, a hierarchy of control measures exists: Remove all risk by design, i.e. introduce intrinsic safety. 5-8 Element C5 Work Equipment RRC Training

7 Use fixed enclosed guards; fixed guards have no moving parts which can fail or be abused. Use other guards, including movable guards, adjustable guards, automatic guards and fixed guards which are not fully enclosing. Use protection devices which do not prevent access but do prevent motion of the work equipment when close, e.g. pressure mats, infra-red beams. Use protection appliances which hold or manipulate the workpiece, keeping the operator away from danger, e.g. a push stick on a circular saw. Use Personal Protective Equipment. Provide information, instruction, training and supervision, which is always important and a requirement no matter what guarding arrangements are in place. It is particularly important when the risk cannot be adequately eliminated by the above, e.g. a hand-held electric drill. Training Statutory Requirements for Training/Certification/Authorisation Here we shall look at the requirements for training in the operation and maintenance of equipment, as detailed in PUWER, the Lifting Operations and Lifting Equipment Regulations 1998 (LOLER) and the Power Press ACoP. PUWER makes specific requirements regarding health and safety training related to the provision and use of work equipment. Other health and safety legislation contains general requirements relating to training, such as the HSWA and Regulation 13 of MHSWR 99, which requires employers to provide employees with health and safety training. For example, in PUWER it states that self-propelled work equipment, including any attachments or towed equipment, is only to be driven by workers who have received appropriate training in the safe driving of such work equipment. There is also specific mention of certain jobs, such as chainsaw operators, where it is stated that all workers who use a chainsaw should be competent to do so, and specifically that: Before using a chainsaw to carry out work on or in a tree, a worker should have received appropriate training and obtained a relevant certificate of competence or national competence award, unless they are undergoing such training and are adequately supervised. The Power Press ACoP also gives requirements which specifically state that the person appointed for the purpose of inspection of guards must receive suitable and sufficient training before being allowed to inspect and test a guard and/or protection device unsupervised. People training for inspection and final assessment should always work under the immediate supervision of a named competent person until their training is finished. The level of supervision should be appropriate to the stage in the training they have reached, competency demonstrated, and also to the particular job being carried out. The ACoP also states that an appointed person who is undergoing training may carry out inspections, providing they are acting under the immediate supervision of a person already RRC Training Element C5 Work Equipment 5-9

8 appointed. In addition, they should have the competence, maturity and authority appropriate to the circumstances. Before a person can be allowed to carry out inspection and testing on their own, it must be ensured for each class or description of power press, guard and protection device on which they will work that they: Have been adequately trained. Are competent to carry out the duties. Have been appointed in writing. In addition to being technically competent to carry out inspection and testing of guards and protection devices, people should also have maturity and authority. In Regulation 8 of LOLER there are requirements that the person planning the operation should have adequate practical and theoretical knowledge and experience of planning lifting operations. The plan will need to address the risks identified by the risk assessment and identify the resources required, the procedures and the responsibilities so that any lifting operation is carried out safely. Statutory Restrictions on Use of Work Equipment There are numerous restrictions laid down in legislation regarding the use of work equipment. Specifically, the Management of Health and Safety at Work Regulations require young persons (under the age of 18 years), undergoing training, to be closely supervised by a competent person in addition to the general requirement to provide suitable information and training. PUWER endorses this point in stating that all persons who use work equipment should receive adequate training, including the health and safety implications, on the equipment they are expected to use. Young persons should be given special consideration due to their inexperience and immaturity Element C5 Work Equipment RRC Training

9 ? Revision Question 3. When considering machinery hazards, identify the hierarchy of control measures. (Suggested Answer is at the end of Element C5.) RRC Training Element C5 Work Equipment 5-11

10 DUTIES IN RESPECT OF MACHINERY, PRESSURE SYSTEMS AND ELECTRICITY ON MANUFACTURERS AND SUPPLIERS There are a number of UK regulations which impose specific requirements on manufacturers/suppliers to make sure that what they are supplying is safe. These implement EU Directives and tend to be of a similar general format, requiring adherence to essential health and safety requirements, conformity assessment, CE marking etc. Examples include the Supply of Machinery (Safety) Regulations 2008, the Simple Pressure Vessels (Safety) Regulations 1991 (as amended), the Pressure Equipment Regulations 1999 (as amended) and the Electrical Equipment (Safety) Regulations These are just a few examples. As we shall see later, essential health and safety requirements are goal-setting; they set legal safety objectives to be met. They are supported by harmonised European standards (denoted by EN. codes) which give detailed guidance on how to comply.. Of general relevance to all machinery are BS EN ISO (Machinery Safety Principles) and BS EN ISO (Machinery Risk Assessments). Though the use of such standards is voluntary, there is a presumption (which can be challenged) that design/construction to a relevant published harmonised European standard implies conformity with the relevant essential health and safety requirements. Published means that they have been printed in the Official Journal of the European Union. As an example we will look at some aspects of the Supply of Machinery (Safety) Regulations (which implement the Machinery Directive). They only apply to Relevant Machinery, i.e. all machinery except that which is specifically excluded (identified in the regulations). As we discussed earlier, there are a number of basic requirements of this legislation which can be summarised as: Machinery must satisfy the relevant Essential Health and Safety Requirements (implied risk assessment here). Conformity assessment: Different procedures depending on category of machine: Technical file. Type examination by an approved body. Declaration of conformity/incorporation. CE mark. Machinery must in fact be safe. Duties Under Section 6, Health and Safety at Work, etc. Act 1974 You will have looked at Section 6, HSWA in your studies of Unit A; you may wish to look back at your study material to remind yourself of the detail Element C5 Work Equipment RRC Training

11 Section 6 specifies the duties of anyone who designs, manufactures, imports or supplies any article for use at work; which are: So far as reasonably practicable, to ensure the article is designed and constructed so as to be safe when set, used, cleaned and maintained. To carry out/arrange for testing and examination to support this. To supply adequate information about the use for which the article has been designed and about any conditions required to ensure its safe use, dismantling or disposal (e.g. manuals, data, etc.). To provide revisions of information when he becomes aware of any serious risk to health and safety arising from use, etc. of the article, e.g. recall notices. Additionally, manufacturers (but not suppliers) have the duty to carry out research in order to discover, eliminate and minimise, so far as is reasonably practicable, any health and safety risks arising from the design, erection or installation of the article. Risk Assessment We looked at risk assessment for machinery earlier. You will find the flowchart in the following figure useful to refer to, as you read on. RRC Training Element C5 Work Equipment 5-13

12 Determine limits: intended use, space limits, time limits. Identify hazards and assess all hazardous situations, considering: The various aspects of the operator-machine relationship. The possible states of the machine. Foreseeable misuse. Then for each hazardous situation, proceed as below: no yes Are other hazards generated? Is hazard avoidable? yes no GOAL REACHED Is risk reducible? yes Risk reduction by design no Is safety adequate? yes GOAL REACHED Is safeguarding possible? yes Safeguarding techniques no no Is safety adequate? yes GOAL REACHED no Information for use no Is safety adequate? yes GOAL REACHED Schematic Representation of the Strategy for Selecting Designed-In Safety Measures (after BS EN ISO 12100, Part 1) 5-14 Element C5 Work Equipment RRC Training

13 The risk assessment process for machinery starts with the determination of limits of the assessment in terms of use, space and duration and requires the identification of these hazards from the machinery within these limits. BS EN ISO , clauses 5.3 to 5.5, give three options for control in preferred order: By design. By safeguarding. By supply of information. The process outlined in the previous figure is then followed until a GOAL REACHED box is achieved. Let us consider the effectiveness of the process. In Unit A of the course, we discussed the hierarchy of risk controls. Does the imposition of only three risk control options (design, safeguarding and information) restrict the opportunity to manage the risk effectively, or can the options be incorporated in order within the description laid down of what each of the three are? Clear definitions are given for hazard and risk in Part 3 of BS EN ISO Hazard is defined as a source of possible injury or damage and risk as a combination of the probability and the degree of the possible injury or damage to health in a hazardous situation. Both have distinct meanings. Note how the change from hazard to risk occurs in the flowchart in the previous figure as the process is followed. As a result of the need for risk assessment, a standard was developed for the evaluation of the risk and was issued initially as BS EN 1050: now BS EN ISO The function of this standard is to describe principles for a consistent systematic procedure for risk assessment as introduced in Clause 6 of BS EN ISO This standard gives guidance on the information required to allow risk assessment to be carried out. Procedures are described for identifying hazards and estimating and evaluating risk. The purpose of the standard is to provide advice for decisions to be made on the safety of machinery and the type of documentation required to verify the risk assessment performed. Risk assessment is a series of logical steps which enable, in a systematic way, the examination of the hazards associated with machinery. Risk assessment is followed, whenever necessary, by risk reduction as described in Clause 5 of BS EN ISO When this process is repeated it gives the process for eliminating hazards as far as possible and for implementing safety measures. As we saw earlier, risk assessment includes risk analysis and risk evaluation. Included as an Appendix to the standard is a table giving examples of hazardous situations and hazardous events, grouped under various headings such that they would assist any person carrying out a risk assessment. The headings include details on hazards in the categories: Mechanical, Electrical, Noise, Vibration, Materials and Substances, and Ergonomics. Essential Health and Safety Requirements To ensure that all machinery throughout the European Community was constructed to the same standards regarding safety, the Machinery Directive imposed compliance with the essential health and safety requirements. These are set out in Annex I to the directive, RRC Training Element C5 Work Equipment 5-15

14 reproduced as Part 1 of Schedule 2 of the Supply of Machinery (Safety) Regulations 2008 (SMSR)). The pre-amble (general principles) to the annex contains two points of specific note: It makes mandatory the principles of safety integration, CE marking (discussed earlier) and the need for instructions; otherwise the actions required in the annex are only to be introduced on the machinery in question if the hazard exists which the actions were introduced to control. This, therefore, requires decisions to be made by the manufacturer as to the presence or otherwise of the hazard. It recognises that it may not be possible to meet all the requirements because technical development may not be to the necessary level. In these cases there is a requirement to meet as far as possible the objectives set by the various essentials. The annex is divided into the following sections: 1. Essential health and safety requirements. 2. Supplementary essential health and safety requirements for certain categories of machinery. 3. Supplementary essential health and safety requirements to offset hazards due to the mobility of machinery. 4. Supplementary essential health and safety requirements to offset hazards due to a lifting operations. 5. Supplementary essential health and safety requirements for machinery intended for underground work. 6. Supplementary essential health and safety requirements for machinery presenting particular hazards due to the lifting of persons. Looking at selected, specific points from section 1 (essential health and safety requirements): 1.1 General Remarks Definitions: note that two groups of people are defined, exposed person" and operator", and that the definition for operator is wider than would normally be expected Principles of safety integration: this sets out the basic principles of safety for any machinery. Subsection (a) requires the basic assumption that it is fit for purpose and can be adjusted and maintained without putting the operator at risk. The manufacturer therefore has to consider carefully the operational limits in usage of the machinery and include this information in the instructions. Subsection (b) gives a hierarchy of control of any risks of elimination or reduction by design, introducing protection to others and informing the user of residual risks. Subsection (c) requires that the design and construction take into account abnormal use and misuse as well as normal use. Subsection (d) considers constraints that the operator will be subject to by wearing PPE. This will show itself in the design and size of openings, the layout of controls, etc Element C5 Work Equipment RRC Training

15 Subsection (e) requires machinery supplied to be equipped with any special tools needed for its operation, maintenance, adjustment, etc. without risk Material and products: materials of construction (or in the product or produced during use) shouldn t endanger people. This specifically also mentions fluids used in the machine Lighting: we will consider this in more detail later in this element Design of machinery to facilitate its handling: the requirement is that equipment must be capable of being handled safely, whether by hand or by mechanical means. Many of the requirements reflect good practice in the shape, weight and lighting arrangements, e.g. handles, as required by the Manual Handling Operations Regulations 1992 (as amended). 1.2 Control systems: we will consider this in more detail later in this element. 1.3 Protection Against Mechanical Hazards Risk of Loss of Stability: machinery should be stable in use or provided with anchor points Risk of break-up during operation: the machinery should not self-destruct! Risks due to falling or ejected objects: self-explanatory Risks due to surfaces, edges or angles: this is often actioned on the outside of machinery but sometimes forgotten for the inside, where access for maintenance is required Risks related to combined machinery: combined machinery is where the work undergoes a number of operations on one machine during which manual removal of the work is required at some stage. This requires that each element of the machine does not create risks to the operator Risks relating to variations in operating conditions: requires design to take into account that changes can be carried out without risk Risks related to moving parts: this requires guarding when the design cannot prevent the risk of contact which could lead to accident" Choice of protection against risks arising from moving parts: requires the choice of guard to be determined by the risk. 1.4 Required Characteristics of Guards and Protection Devices This section lists the general requirements of guards and then the special requirements for fixed, movable and adjustable guards and protection devices. More detail on this topic is included in Element C Risks due to Other Hazards The requirements set out in the directive to control these risks are summarised below: Electricity supply - designed for use within certain voltages and to be safe (see requirements of Electricity at Work Regulations 1989). Static electricity - machinery must prevent or limit build up of static electricity. RRC Training Element C5 Work Equipment 5-17

16 Energy supply other than electricity (e.g. hydraulic) - constructed so as to contain the type of energy and hazards associated with it. Errors in fitting - designed to prevent parts being incorrectly fitted, including connections to parts. Extreme temperatures - machinery or the work piece may be hot. Fire - risk to be avoided. Explosion - avoid risk of explosion from the machinery or from materials being processed. Noise - minimised ideally at source. Vibration - similar to noise. Radiation - to be limited to the extent that is required for the machinery s operation. External radiation - should not affect the safe operation of any machine. Laser radiation - lasers should be designed to prevent accidental radiation. Emission of hazardous materials and substances - design to avoid producing; if not, then to contain/evacuate. Risk of being trapped in a machine. Risk of slipping, tripping and falling. Lightning appropriate earthing where necessary to protect the machine against lightning strikes 1.6 Maintenance: we will consider this in more detail later in this element. 1.7 Information This sets out requirements for information on the machine, warning devices, warnings of residual risks (signage), etc Marking: this was covered earlier in this element under CE marking and will be covered in more detail later Instructions: these are required to be drawn up by the manufacturer in one of the languages of the Community (note that normally the manufacturer will produce the instructions in a number of languages, dependent upon where he or she intends to trade). Conformity Assessment Procedures There are three different possibilities, all with different options (the Annexes referred to are those in the Machinery Directive, being reproduced in Part 4 of Schedule 2 to SMSR): 1. Machinery that is listed in Annex IV (which pose special hazards, e.g. circular saws used for wood and meat), which are manufactured fully in accordance with published harmonised standards (and fully covered by those standards): Either a) Follow Annex VIII procedures 5-18 Element C5 Work Equipment RRC Training

17 Or - essentially, you draw up a technical file (see later). The manufacturer also ensures that there are internal checks carried out on the manufacturing process to make sure that manufactured machines comply with that technical file and also with the directive. b) Follow Annex IX procedures Or - essentially, submit a technical file to the approval body with an example of the machine for EC-type examination (see later). Internal manufacturing process checks must also be carried out as above. c) Follow Annex X procedures - essentially a full quality assurance programme i.e. the manufacturer operates an approved quality system covering design, manufacture, final inspection and testing. A technical file must be produced too as part of the application for approval of the quality system. 2. Annex IV machinery NOT manufactured fully in accordance with published harmonised standards or NOT fully covered by such standards: Either a) Follow Annex IX procedures (as already described above). Or b) Follow Annex X procedures (as already described). 3. Other machinery, i.e. most general machinery: The manufacturer follows Annex VIII conformity assessment procedures (as described above). EC Type Examination/Approval Procedure This is an examination of an example of the machine/component in order to ascertain whether it satisfies the relevant requirements of the directive. It is carried out by an approved national body. A certificate is issued by the approval body if successful. Technical File The technical file consists of all the relevant material upon which the manufacturer (or his/her representative) bases his or her decision as to whether to sign the CE declaration of conformity showing that the product conforms. The signature completes the declaration, allowing the CE marking to be affixed. Note that not all the information has to be kept together, but it must be made available within a reasonable time when requested. The technical file for machinery will consist of (as described in Annex VII): A general description of the machine. Drawings of the machine. Drawings of the control circuitry. RRC Training Element C5 Work Equipment 5-19

18 Details of tests carried out to check conformity against essential health and safety requirements. List of applicable essential health and safety requirements. Description of methods adopted to eliminate hazards. The standards and other technical specifications used (indicate the essential health and safety requirements covered by these standards). Any technical reports/certificate giving the results of tests. A copy of the instructions for the machinery. Where appropriate, the declaration of incorporation for included partly completed machinery. Where appropriate, the EC declaration of conformity of machinery/products incorporated into the machine. A copy of the EC declaration of conformity. For series manufacture, the internal measures to be taken to ensure that production machinery is to the same standard (i.e. quality assurance and quality control). The technical file for partly completed machinery is similar but slightly different in the details. Declaration of Conformity/Incorporation Drawing up an EC declaration of conformity is the procedure whereby the responsible person declares in respect of each item of relevant machinery which he or she supplies in the Community that it complies with all the essential health and safety requirements applying to it. An EC declaration of conformity (as described in Annex II) must: State the business name and full address of the manufacturer and, where appropriate his authorised representative. Name and address of the person authorised to compile the technical file. Contain a description and identification of the machinery to which the declaration relates, including its: Generic denomination (i.e. Make). Function. Model. Type. Serial number. Commercial name. A sentence expressly declaring that the machinery fulfils all relevant provisions of the directive (and other directives, as appropriate). Where an EC type examination has been carried out (as per Annex IX), the name, address and identification number of the approved body which carried it out and the number of the issued certificate Element C5 Work Equipment RRC Training

19 Where a full quality assurance has been approved (as per Annex X procedures), the name, address and identification number of the approving body. Specify (as appropriate) the published harmonised standards used. Specify (as appropriate) any technical standards and specifications used. Place and date of declaration. Identity and signature of the person authorised to draw up the declaration on behalf of the responsible person. The declaration of conformity is issued with the finished machine. Where the machinery is intended for incorporation into other machinery, the responsible person can draw up a declaration of incorporation. This declaration, without a CE mark being applied, is applicable to partly completed machinery that: Is almost machinery. Is intended for incorporation into other machinery. Cannot function independently. Is to be assembled with other machinery. CE Marking and Other Marking The Machinery Directive, Annex 1, Essential Requirements indicates that all machinery meeting the requirements must be marked with the following information in such a way that it is indelible: The CE Marking (described earlier). Name and address of the manufacturer. Designation of machinery. Designation of series or type. Serial number, if any. Year of construction (i.e. when it was actually completed). If designed for such, information regarding its use in an explosive atmosphere. Any safety-related information regarding the machinery in use (e.g. maximum speed of rotating parts). Mass of any part where it must be handled by lifting equipment during use. The CE marking can only be applied when a declaration of conformity is supplied. It consists of a CE mark (described earlier) which must be visible, legible, indelible and distinct. The full specification of a CE mark is described in Annex III to the Machinery Directive. Note that where an Annex X conformity procedure has been followed (i.e. full quality assurance), the CE mark is followed by the identification number of the notified body. RRC Training Element C5 Work Equipment 5-21

20 ? Revision Questions 4. Under what circumstances can a CE mark be applied to a machine? 5. Where would the Essential Health and Safety Requirements for machinery be found? 6. What are the three options for risk control of machinery hazards identified in BS EN ISO 12100? 7. What information must be provided in the technical file required by the Supply of Machinery (Safety) Regulations? 8. What information is required to be marked on machinery in accordance with the Supply of Machinery (Safety) Regulations? (Suggested Answers are at the end of Unit C.) 5-22 Element C5 Work Equipment RRC Training

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