Implementation of Technical Regulations on Company Level

1
Implementation of Technical Regulations on
Company Level
Chamber of Commerce and Industry, Ljubljana

• 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 doesnt 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 not lead 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. Troubleshooting
  9. Cleaning and maintenance10. Overhaul11. Disma
  ntling 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 instructions
Additional information (not in the Machinery
Directive)

• structured texts
• visual algorithms
• flow charts
• questionnaires
• illustrations and (line) drawings
• photographs
• quick reference guide