Implementation of Technical Regulations on Company Level

1. Chamber of Commerce and Industry, Ljubljana Implementation of Technical Regulations on Company Level Breakout session Safety of Machinery Directive Expert: Robert Huigen

2. Community Policy (I) Main goals: • safety of equipment • environmental acceptability • economic efficiency

3. Community policy (II) Tools: • European regulations • Machinery directive (98/37/EC) • Workers’ safety directive (89/655/EEC) • supplementary: European standards (CEN & CENELEC) • national regulations

4. New Approach European Directives • mandatory through national legislation • give essential safety- and health requirements • provide certification procedures

5. Compliance of products with applicable European Directives by : • common Essential requirements • common certification procedures • using European standards • verification tests by (no)tified (bo)dies • appropriate measures by member states

6. European standards • implemented nationally as: BS EN, DIN EN, NF EN, SIST EN, etc. same content, different language • technical implementation (requirements & test methods) of essential requirements of the relevant New Approach directive • Compliance with standards is voluntary

7. Types of machinery standards • type A: deals with basic safety concepts applicable to all types of machinery • type B: deals with one safety aspect that can be applied to wide range of machinery • type C: deals with detailed safety requirements for specific (or group of) machines or safety components

8. New Approach Directives and European standards The use of European standards gives the presumption of conformity with the essential requirements of the relevant directive

9. Useful definitionsfrom the view of the Machinery directive • Machine: ready to usee.g. turning machine, hydraulic excavator, compressor, hydraulic jack, wood working machine • Safety component: primary function contributes to safety machine and placed on the market separately e.g. lightscreens, emergency stop devices, roll bars • Component: all other machinery partse.g. frames, vessels & piping, bolts & nuts, driving components & gearboxes, wheels & borders

10. Machinery: definition (I) Three cumulative requirements : • an assembly of linked parts or components, at least one of which moves, • with the appropriate actuators, control and power circuits etc., • joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material

11. Machinery: definition (II) Definition put in a different way : “Machinery can only be marked with CE if : • the product is ready for use by the end user • the final product can function independently without the help of any other machinery or component in order to fulfil its function, apart from the supply of energy”

12. Machinery: definition (III) Also considered as machinery are : • an assembly of machines or complex installation (e.g. production line) • interchangeable equipment (e.g. all machinery towed by a tractor) • safety components (e.g. emergency stop device) • all lifting accessories (specific form of interchangeable equipment)

13. Declarations of conformity (I) Three types of declarations : • II A : declaration of conformity for machinery within the scope of the Machinery directive (mandatory) • II C : declaration of conformity for safety components within the scope of the Machinery directive (mandatory)

14. Declarations of conformity (II) II B : free declaration in which the manufacturer states that the product does NOT comply with the Machinery directive (not mandatory) (meant for business-to-business purposes only, content of II B declaration often already part of the quotation)

15. Declarations of conformity (III) • business name of the manufacturer or name of the authorized representative established in the EEA • full address, place and country • description of the machinery (make, type, serial number etc.) • applicable directive(s) • applicable standard(s) or other such specifications • name and address of the notified body involved • Identification of the person signing

16. Certification procedure (I)

17. Notified bodies (I) A Notified body is : • Designated by a member state and notified to the Commission • A third party with the competence to evaluate the conformity of the products referred to the directive concerned • Only notified for machinery and safety components listed in Annex IV (one or more of the items listed) • Meets the requirements laid down in annex VII

18. Notified bodies (II) A Notified body : • Carries out EC-type examinations as described in annex VI • Draws up EC-type examination certificates • Keeps a copy of the technical file

19. Competent bodies • Meets the criteria in a harmonized standard, e.g. en 45001 • Shall have a quality system • Do not have to be approved by member states • can be used when a manufacturer doesn’t have the skills or resources to verify the requirements of a standard • provides testing and/or measurements

20. CE marking (I) • Always CE: on machines • Never CE: on safety components falling within the scope of the Machinery directive • Choice of CE: equipment showed at trade fairs • CE marking always possible on the basis of other directives

21. CE marking (II) Excluded from the obligation of CE marking machinery on trade fairs, exhibitions, etc. but : • keep visitors at a safe distance • take care of adequate safety measures during demonstrations (e.g. authorized operators) • provide in a visible sign that clearly indicates that such machinery or safety components do not conform and that they are not for sale in the showed form

22. CE marking (III)

23. How to prove conformity? By • inventory of all hazards emanating from the machine • risk-analysis (which hazards can turn into risks?) • risk-evaluation (comparising of risks) • risk-reduction (in this given order : by redesign, protection measures, information to user)

24. Dealing with safety in this imperative order: • integrate safety (built-in safety by design) • reduce residual risks by shielding and/or guarding • warn and inform in case of inevitable risks (indicate whether specific training and/or personal protective equipment are required)

25. Nature of possible hazards • mechanical (moving parts) • energy source (electrical, hydraulical, thermical etc.) • ergonomical (physical stress, work position, man-machine-interface, noise etc.) • other (general work place safety)

26. Technical file • the manufacturer must be able to produce a technical file comprising all safety related information on request of the competent national authorities • it must be kept available for the authorities for at least 10 years following the date of manufacture of the machinery or of the last unit produced, in the case of a series manufacture

27. Contents of the technical file (I) The technical file contains at least : • an overall drawing of the machinery together with drawings of the control circuits, • full detailed drawings, accompanied by any calculation notes, test results etc. required to check the conformity of the machinery with the essential health and safety requirements,

28. Contents of the technical file (II) • a list of : • the essential health and safety requirements, • standards, • other technical specifications, which were used when the machinery was designed ; • a description of methods adopted to eliminate hazards presented by the machinery, • if he so desires, any technical report or certificate obtained from a competent body or laboratory,

29. Contents of the technical file (III) • if he declares conformity with a specified European standard which provides therefore, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory, • a copy of the instructions for the machinery, • for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

30. Safety related changes to machinery • changing performance (e.g. velocity, capacity, power) • other destination (e.g. excavator becomes lifting equipment) • new application (e.g. sawing of different product, aluminium on woodworking machine) • new combination (of production line)

31. Changing of machinery already put into service (I) Machinery with CE : • Any safety related change includes a new risk assessment of the whole machinery • performer of the change : • becomes manufacturer of a changed product: placing on the market starts again! • must draw up a new declaration of conformity, an additional technical file and manual

32. Changing of machinery already put into service (II) Machinery without CE : • Any safety related change includes a risk assessment of the whole machinery • performer of the change: • becomes manufacturer of a new product • must draw up a declaration of conformity, a technical file and a manual • must affix the CE marking

33. Production lines (I) Production line without the CE marking: • It is allowed to consider the replacing of separate modules (machines) as replacing of parts of the production line (spare parts must be comparible in design, performance, etc.) • spare parts must not (but advisable) bear the CE marking if applicable • safety related changes to one module do not lead to the CE marking of the whole production line

34. Production lines (II) Production line without the CE marking : • Notice ! Any other changes than replacing worn-out parts/machines can lead to the CE marking of the relevant module or even the complete line! • e.g. replacing the complete control system by a different type and/or lay-out leads to the CE marking of the whole line! • e.g. replacing one module by a CE marked module does notlead to the CE marking of the whole line! • always look at interacting risks!

35. Production lines (III) The production line as a whole is CE marked : • Any safety related change includes a new risk assessment of the whole line • performer of the change : • becomes manufacturer of a changed line: placing on the market starts again! • must draw up a new declaration of conformity, an additional technical file and manual

36. Production lines (IV) Changing activities by the user and possible loss of product liability : • the performer - as the new manufacturer - becomes first in liability • the original manufacturer of the complete line or separate module remains liable for those parts of his product not being influenced by any changes (now becomes second in liability)

37. Machinery directive and Workers’ safety directive • employer always responsible for the health and safety of the worker • employer responsible for the suitability of the work equipment put at the workers’ disposal • manufacturer responsible for the intrinsic safety of his products

38. Product liability (I)(85/374/EEC) • Definition of product liability • Addressees of product liability • Calling in of product liability • Expiration of product liability • CE and product liability

39. Product liability (II)(85/374/EEC) • Manufacturers/producers/importers/brand name owners: • Risk-based liability for safety of product • Reversal of the burden of proof • Trade: • Liable for product quality • burden of proof with purchaser

40. The basic manual structure (I) Title page Preface/foreword1. Introduction2. Description and process information3. Safety4. Transport and storage5. Mounting/assembling and installation

41. The basic manual structure (II) 6. Commissioning7. Operation8. Troubleshooting9. Cleaning and maintenance10. Overhaul11. Dismantling and disposal Index Appendices

42. How does a technical writer work Additional information (not in the Machinery Directive) • Find the essential source information • Design the text structure • Write the draft text • Prepare the final text • Validate

43. Different kinds of texts in manuals Additional information (not in the Machinery Directive) • General introductory texts • Texts that describe machinery parts • Texts that describe process information • Texts that describe working instructions- descriptive- imperative

44. Formulating technical instructions (I) Additional information (not in the Machinery Directive) A complete set of instructions consists of four parts : • number the action or use typographical symbols • use the imperative mood to formulate the action (e.g. ‘push button A’)

45. Formulating technical instructions (II) Additional information (not in the Machinery Directive) 3) give the why, the meaning of the action, the process that starts 4) indicate the possible check on correctness of the action or the cause of the action

46. Different ways to present instructionsAdditional information (not in the Machinery Directive) • structured texts • visual algorithms • flow charts • questionnaires • illustrations and (line) drawings • photographs • quick reference guide