IEC 62061-2021 Safety of machinery – Functional safety of safety-related electrical, electronic and programmable electronic control systems.
4 Management of functional safety
This Clause specifies management and technical activities that are necessary for the achievement of the required functional safety of the SRECS.
4.2.1 A functional safety plan shall be drawn up and documented for each SRECS design project, and shall be updated as necessary. The plan shall include procedures for control of the activities specified in Clauses 5 to 9.
NOTE 1 The content of the functional safety plan should depend upon the specific circumstances, which can include:
– size of project;
– degree of complexity;
– degree of novelty of design and technology;
– degree of standardization of design features;
– possible consequence(s) in the event of failure.
In particular the plan shall:
a) identify the relevant activities specified in Clauses 5 to 9.
b) describe the policy and strategy to fulfil the specified functional safety requirements.
c) describe the strategy to achieve functional safety for the application software,
development, integration, verification and validation.
d) identify persons, departments or other units and resources that are responsible for
carrying out and reviewing each of the activities specified in Clauses 5 to 9.
e) identify or establish the procedures and resources to record and maintain information relevant to the functional safety of a SRECS.
NOTE 2 The following should be considered:
– the results of the hazard identification and risk assessment;
– the equipment used for safety-related functions together with its safety requirements;
– the organization responsible for maintaining functional safety;
– the procedures necessary to achieve and maintain functional safety (including SRECS modifications).
f) describe the strategy for configuration management (see 9.3) taking into account relevant organizational issues, such as authorized persons and internal structures of the organization.
g) establish a verification plan that shall include:
− details of when the verification shall take place;
− details of the persons, departments or units who shall carry out the verification;
− the selection of verification strategies and techniques;
− the selection and utilization of test equipment;
− the selection of verification activities;
− acceptance criteria; and
− the means to be used for the evaluation of verification results.
h) establish a validation plan comprising:
− details of when the validation shall take place;
− identification of the relevant modes of operation of the machine (e.g. normal operation,setting);
− requirements against which the SRECS is to be validated;
− the technical strategy for validation, for example analytical methods or statistical tests;
− acceptance criteria; and
− actions to be taken in the event of failure to meet the acceptance criteria.
NOTE 3 The validation plan should indicate whether the SRECS and its subsystems are to be subject to
routine testing, type testing and/or sample testing.
4.2.2 The functional safety plan shall be implemented to ensure prompt follow-up and
satisfactory resolution of issues relevant to a SRECS arising from:
– activities specified in Clauses 5 to 9;
– verification activities; and
– validation activities.IEC 62061 pdf download.