2 TÜV SÜD UK Ltd in the UK 500+ Employees 18 UK Locations Nuclear Technologies TÜV NEL Wallace Whittle Worldwide, there are over 16,000 staff at over 600 locations
3 TÜV Machinery SÜD Product Service Safety legal requirements and responsibilities
4 Responsibilities The Manufacturer The User
5 Single European Market 27 different countries 27 different legal systems All countries introduce the same laws into their own legal systems The Directives are adopted as Laws and must be complied with before supplying equipment into the European Economic Area (EEA).
6 Directives that could apply to machinery The Machinery Directive 2006/42/EC. The Low Voltage Directive 2006/95/EC. The EMC Directive 2004/108/EC. The Pressure Equipment Directive 97/23/EC.
7 Why do we have to comply? Because all of the European directives are brought into UK law by the issue of Regulations that make it a criminal offence punishable by fines and imprisonment not to comply.
8 What are these Regulations? The Supply of Machinery ( Safety ) Regulations 2008 as amended. SI The Electrical Equipment ( Safety ) Regulations 1994 as amended. SI The Electromagnetic Compatibility Regulations 1992 as amended. SI The Pressure Equipment Regulations 1999 as amended. SI 2001.
9 Definitions of Machinery An assembly fitted with or intended to be fitted with a drive system other than directly applied manual or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application. Lifting apparatus whose only power source is directly applied manual effort.
10 Definitions of Machinery An assembly of machines and/or partly completed machinery which, in order to achieve the same end are arranged and controlled to function as an integral whole.
11 Definitions of Machinery Interchangeable equipment is a device which, after placing into service of machinery or tractor is assembled with that machinery or tractor by the operator himself in order to change its function.
12 Definition of a Safety Component Definition of a Safety Components Which serves to fulfil a safety function, which is independently placed on the market, the failure and/or malfunction of which endangers the safety of persons.
13 Definition of a Safety Component Safety devices that fall under the scope of the Directive Annex V Indicative list: Extraction systems. Guards and protection devices. Control devices for calling lifting appliances and anti fall devices for hoists. Protective devices designed to detect the presence of a person. Safety belts and seat harnesses. Hydraulic non return valves where they are used to prevent falls.
14 Definition of a Safety Component
15 Scenarios where the MD applies If you are creating a complex assembly by interlinking a series of existing machines you are in effect creating something new. Therefore who ever is carrying out the work must ensure that the whole assembly complies with the Directive. Regardless of the age of the machines. If you are altering the function or performance of a machine or complex assembly you are again creating something new and must ensure that the Directive is complied with.
16 Scenarios where the MD applies These regulations also applies to in-house machinery. a) where the manufacturer of relevant machinery himself puts that machinery into service. b) having imported machinery from a country or territory outside the EEA, puts that machinery into service.
17 The Four Steps to Compliance 1. Complying with the EHSR s 2. Compiling the Technical Construction File (TCF) 3. Raising the Declaration of Conformity 4. Affixing the CE Mark
18 How to Comply EHSR s The Essential Health and Safety Requirement s laid down in the Directives are mandatory. They are split into six sections: 1. General. 2. Foodstuffs, Medical. 3. Mobile Machinery. 4. Lifting Equipment. 5. Underground Machinery. 6. Lifting or Moving of Persons.
19 How to Comply EHSR s The first EHSR asks us to carry out a risk assessment. First we must identify all the hazards, that is any thing that has the potential to cause harm. Then we must access the risk, that is the likelihood of a person or persons coming into contact with the hazard and how much damage it would cause.
20 How to Comply EHSR s Stability; Machinery and its components must be designed and constructed that they are stable enough for use without risk of overturning, falling or unexpected movement. This requirement also applies during transportation, assembly, dismantling, scrapping and any other action involving machinery.
21 How to Comply EHSR s Fixed guards; Must be fixed with systems that can be opened only with tools. Their fixing systems must remain attached to the guards when removed. Where possible guards must be incapable of remaining in position without their fixings.
22 Step 2: The Technical Construction File
23 Technical File Should Consist of a) a construction file including: - a general description of the machinery, - 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, - 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,
24 Technical File Should Consist of Overall drawing
25 Technical File Should Consist of Detailed Drawings
26 Technical Construction File Circuit Diagram
27 Technical File Should Consist of - the documentation on risk assessment demonstrating the procedure followed, including: - a list of the essential health and safety requirements which apply to the machinery, means explaining how the machine complies with the requirement.
28 Technical Construction File EHSR Checklist
29 Technical File Should Consist of - the description of 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). - standards and technical specifications used, detailing Essential Health and Safety Requirements covered by such standards, - technical reports giving the results of the tests carried out either by the manufacturer or a body chosen by the responsible person,
30 Technical File Should Consist of
31 Technical File Should Consist of
32 Technical File Should Consist of a copy of the instructions for the machinery, where appropriate, the EC 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,
33 Technical File Should Consist of - a copy of the EC declaration of conformity; - for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive. (Quality System).
34 Changes to Declaration of Conformity Name and address of the person who is authorised to compile the Technical File, who must be established in the European Community. Where appropriate a statement confirming declaration of conformity with other applicable directives. The place and date of the declaration. Must be typewritten or handwritten in capital letters. It is illegal to affix the CE mark to a machine unless it complies with all applicable Directives.
35 Declarations Step 3 Declaration of Conformity or Incorporation. This has to accompany the machine.
36 Declarations The Declaration of Incorporation is used with a machine which is specifically designed to be incorporated into a complex assembly and not capable of independent work.
37 PUWER 98 Implementing the Work Equipment Directive 89/655/EEC. Provision and Use of Work Equipment Regulations 1998 APPLIES TO ALL WORK EQUIPMENT NOW REGARDLESS OF AGE INCLUDING CE MARKED EQUIPMENT.
38 PUWER 98 Made under the Health & Safety at Work Act Only applies where the HSWA applies. Does not require a CE mark, Technical File or Declaration of Conformity. Mobile work equipment. Lifting equipment. The inspection of work equipment. APPLIES TO ALL WORK EQUIPMENT, REGARDLESS OF AGE INCLUDING CE MARKED EQUIPMENT
39 If You Don t Comply It could result in prosecution and penalties, on conviction, of a fine of up to a) On summary conviction 20,000 fine and or 3 Months in prison. b) On conviction on indictment unlimited fine and or two years imprisonment c) Many more prosecutions under PUWER than other Regulations
40 Layout of PUWER 98 Part I Introduction. Part II General. Regs 1 to 24 Part III Mobile Work Equipment. Regs 25 to 30 Part IV Power Presses. Regs 31 to 35 Part V Miscellaneous. Regs 36 to 39 Regulations 1 to 9 with the exception of regulation 6 are to do with Policies and Procedures and look at Policies and Procedures, Maintenance, Operating Information, Training, Health and Safety Policies, etc.
41 Regulation 6 - Inspection Where the safety of work equipment depends on installation it must be inspected (a) After installation and before being put into service for the first time or (b) After assembly at a new site or in a new location. Work Equipment exposed to conditions causing deterioration liable to result in a dangerous situation must be inspected
42 Regulation 6 - Inspection (a) At suitable intervals, and (b) Each time circumstances liable to jeopardise the safety have occurred. The results of any inspection made under this regulation must be recorded. These records must be kept until the next inspection is recorded.
43 Regulation 6 - Inspection
44 Regulation 6 - Inspection The persons who determine the nature of the inspections required and who carry out the inspections are competent to do so. The competent person deciding the nature of the inspection should have the necessary knowledge and experience to decide what the inspection should include, how and when it should be carried out. The competent person carrying out the inspection should have the necessary knowledge and experience to know what to look at what to look for how and who to report to. Covers things like Testing of Light Guards and Scanners etc.
45 Regulation 10 Community Requirements Requires that an Employer must ensure that any equipment that is subject to European Directives complies with all applicable Essential Health and Safety Requirements of the Directives that apply to it.
46 Regulations Regulation 11 Access to Dangerous Parts of Machinery Regulation 12 Specified Hazards, Fire, Heat etc Regulation 13 High/Low Temperatures Regulation 14 Start Controls Regulation 15 Stop Controls Regulation 16 E Stop Controls
47 Regulations Regulation 17 Operating Controls Regulation 18 Control Systems Regulation 19 Isolation of Energy Regulation 20 Stability Regulation 21 Lighting Regulation 22 Maintenance Regulation 23 Markings Regulation 24 Warnings
48 Regulations Regulation Mobile Work Equipment Other Regulations on Power Presses etc Revocation of Other Regulations
49 TÜV Machinery SÜD Product Service Safety Lifecycle from design to disposal
50 Responsibilities The Manufacturer The User
51 Risk Assessment Carried out across all phases of the lifecycle of the machine Design Prototype Installation Operations Process Maintenance
52 Risk Assessment The first EHSR asks us to carry out a risk assessment. First we must identify all the hazards, that is any thing that has the potential to cause harm. Then we must assess the risk, that is the likelihood of a person or persons coming into contact with the hazard and how much damage it would cause.
53 Identify the hazard Example; A manipulating robot is a hazard. A moving conveyor is a hazard. A pallet wrapper is a hazard. Because they have the potential to do harm! VR
55 Assess the Risk That is the likelihood of a person or persons coming into contact with the hazard and how much damage it would cause.
56 Risk Assessment Control Measures Design the hazard out. Remove the need for man machine interface. Design in safeguards. Reduce the possibility of occurrence. Reduce the degree of harm. Warn and inform (but only if you can achieve adequate safety).
57 The Role of EN Standards
58 EN Standards EuroNorm ( EN Standards ) Now we have decided on the control measures we must ensure that they will comply with the EHSR s. To do this we can use EuroNorm (EN Standards)
59 EN Standards The EHSR s are mandatory the EN Standards are not however: Machinery manufactured in conformity with specified published European Harmonised standards will be presumed to comply with Essential Health and Safety Requirements covered by those standards
60 BS EN ISO 12100:2010 Safety of machinery Basic concepts, general principles for design. Risk Assessment and risk reduction BS EN 414 Safety of machinery Rules for drafting and Presentation of safety standards BS EN Electrical Equipment BS EN Safety-related parts of control systems. BS EN PR ISO EN Emergency Stop SPECIFIC PROTECTIVE DEVICE STANDARDS 2 Hand Controls Light Curtains Safety Switches etc TYPE C STANDARDS for Machines
61 EN Standards Examples of B Type Standards BS EN 953 Relates to the selection and manufacturing of Guards. BS EN 349 Relates to minimum gaps to prevent Crushing of the whole body BS EN ISO Relates to the positioning of guards to protect the upper limbs and the lower limbs.
62 EN Standards Examples of C Type Standards BS EN 415 Series Safety of Packaging Machines in 9 parts part 4 applies to Palletisers and De-Palletisers. BS EN BS EN Industrial Robots Recommendations for Safety. Safety of Machine tools Machining Centres.
63 BS EN ISO 13857
64 Enclosing Fixed Guard
65 Suitability of guards
74 Functional Safety ISO EN &2 Is a replacement for EN can be used for any energy source.
75 Functional Safety ISO EN &2 Introduces Performance levels (probability of a dangerous failure per hour) a,b,c,d,e. Based on the Safety Related Parts of the control system (SRP/CS). Data to be obtained from manufacturer Mean Time To (dangerous) Failure MTTD.
76 Functional Safety Four stage approach: Perform a risk assessment For the identified risks, allocate the safety measure (Performance Level (PL)) Devise a system architecture that is suitable for the Performance Level Validate the design to check that it meets the requirements of the initial risk assessment
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