Safe workplaces II – Changes in production and the importance of safety

In industry, development is fast, and changes of different magnitude occur almost continuously. The changes may concern new equipment, robotization, organizational design, etc. However, a change often affects the business more broadly than you think and more than the employees most directly affected are affected. Therefore, planned changes require a holistic approach to safety.

Risk analysis, concepts

Key standards:

  • ISO 10218-2:2011, Robot systems and integration
  • ISO TS 15066 (2016), Collaborative Robots
  • ISO 12100, Risk assessment and risk reduction
  • ISO-TR 14121-2, Risk assessment – Part 2: Practical guidance and examples of methods

For each identified hazard, the parameters A, S, O and F above are assessed. It is important that these parameters are assessed independently of each other.

Examples of hazards (mechanical) from ISO 12100, Annex B.1:

  • acceleration, deceleration
  • approach of a moving element to a fixed part
  • cutting parts, sharp edges
  • falling objects
  • height from the ground
  • kinetic energy
  • instability
  • machinery mobility
  • rough, slippery surface
  • rotating elements

Examples of risks to consider in risk analysis, according to ISO TS 15066:

  • Robot characteristics (e.g. load, speed, force, momentum, torque, power, geometry, surface shape and material)
  • Quasi-static contact conditions in the robot
  • Operator location with respect to proximity of the robot (e.g. working under the robot)
  • End-effector and workpiece hazards, including lack of ergonomic design, sharp edges, loss of workpiece, protrusions, working with tool changer
  • Operator motion and location with respect to positioning of parts, orientation of structures (e.g. fixtures, building supports, walls) and location of hazards on fixtures
  • Fixture design, clamp placement and operation, other related hazards

Risk index according to ISO TR 14121-2 is derived from the graph below, risk index greater than 2 means that risk mitigation measures are required:


The Machinery Directive – AFS 2008:3 Maskiner

Directive 2006/42/EC of the European Parliament and of the Council, also known as the Machinery Directive, has been transposed into Swedish law via the Swedish Work Environment Authority's regulation AFS 2008:3 Maskiner.

The term "Machinery Directive (MD)" is widely known and will continue to be used in this text and refers to AFS 2008:3 Maskiner.

  • The Machinery Directive is a manufacturer's directive, which is used during the design and production phase to meet the "Essential Health and Safety Requirements" specified in the Machinery Directive.
  • The Machinery Directive applies to each individual machine when it is first placed on the market.
  • The Machinery Directive applies as law as soon as the machine is placed on the market and until it is put into operation.
  • Only the organization regarded as the manufacturer can be held liable if the machine does not comply with applicable legal requirements when it is placed on the market.

A distinction is made between a completed machine and a partly completed machine.

Completed machinery:

  • Machinery that is complete for its purpose and must meet all relevant requirements set out in the Machinery Directive before it is placed on the market.

Partly completed machinery:

  • Incomplete machinery intended to be supplemented or joined with other machinery to form a completed machine.
  • Must have a declaration of conformity but not CE marked.

The "Essential Requirements" of the Machinery Directive is referred to as "Essential health and safety requirements for the design and construction of machinery". This is the main heading of Annex 1 of the Machinery Directive.

  • It is the requirements of Annex 1 that all products covered by the Machinery Directive must meet in order to be used in the European Union's common market.
  • It is these requirements that the manufacturer declares are met by drawing up a declaration of conformity and CE marking.

General principles of Annex 1

The manufacturer must always ensure that a risk assessment is carried out to determine the health and safety requirements applicable to the machinery. The manufacturer must carry out a hazard analysis in order to identify all hazards that may arise from the machinery. This risk analysis shall be carried out even if manufacturers use a harmonized standard. This is because it cannot be assumed that a harmonized standard covers all applicable requirements.

Anyone who puts a machine on the market under their own name or trademark - is the one who is considered MANUFACTURER. In addition, anyone who substantially modifies or rebuilds an existing CE-marked machine, may be considered a manufacturer.

Per Stålberg


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This article is categorised as Intermediate  |  Published 2023-06-27  |  Authored by Matilda Hurtig