37 accordance with the limits and procedures established by the manufacturer does not, in itself, constitute a modification of the software. SAFETY AND RELIABILITY OF CONTROL SYSTEMS – EHSR 1.2.1 This is probably the requirement that will demand the greatest cultural change. The Regulation takes into account not only hardware failures, but also errors in the control system’s logic, foreseeable conditions of use and interventions that may alter its behaviour. It is, however, important to avoid confusion between different concepts. Modifying the software means altering the programme, the logic or its structure; configuring a parameter provided for by the software is normally a different activity. Not all parameters, however, are equally relevant to safety. A parameter must be set within the limits specified by the system and in a manner that prevents hazardous configurations. But this does not mean that every adjustment made by a technician must entail a new risk analysis: this would result in a procedural burden that would be difficult to sustain without necessarily improving safety. Particular attention must instead be paid to parameters that may affect a safety function or alter its operating limits. In such cases, the relationship between the parameter, the function and the risk must be clearly identified in the assessment. A distinction must also be made between software that directly performs a safety function and control software that does not perform a safety function but whose malfunction could nevertheless lead to a hazardous situation. The former clearly requires a greater level of detail; the latter must be considered to the extent that its behaviour may affect safety. This distinction is particularly important for the lift sector, where the choice to maintain, where possible, independent safety functions entrusted to dedicated devices can make it easier to demonstrate the safety of the system as a whole. Requirement 1.2.1 introduces the possibility of a tracing log of data generated in connection with an intervention and of the versions of the safety software loaded after placing on the market or putting into service. This log must be made available for five years after the software is loaded, solely for the purpose of demonstrating conformity, in response to a reasoned request from the competent national authority. This opens up a new perspective for the lift and lifting equipment sector: risk assessments will need to identify not only the mechanical, electrical or functional hazards traditionally taken into account, but also which hardware components, software, parameters and interfaces are relevant to safety, and what consequences any changes to them might have. LOSS OF POWER SUPPLY OR CONNECTION TO THE COMMUNICATIONS NETWORK – EHSR 1.2.6 A further new development is requirement 1.2.6, which considers not only the loss of power supply but also the loss of connection to the communication network. For traditional equipment, this may not have any particular consequences. However, where certain functions depend on communication with external systems, the loss of connection becomes, in itself, a condition that must be assessed. It is therefore necessary to identify which functions depend on the connection and to determine how the machine should behave when communication is lost. ACCESS TO WORKSTATIONS AND MAINTENANCE POINTS – EHSR 1.6.2 Requirement 1.6.2, relating to access to workstations and maintenance points, also places greater explicit emphasis on rescue and emergency response operations. The risk assessment should therefore consider not only normal maintenance activities, but also situby EN 81-41 and EN 81-42. Pending the revision of these two standards to take account of the new requirements of the Machinery Regulation, the aspects not covered must be the subject of a specific risk assessment, in order to demonstrate the machine’s compliance with the applicable essential health and safety requirements. ERGONOMICS – EHSR 1.1.6 The requirement relating to ergonomics is not entirely new, but the new Regulation reinforces its importance. The assessment must take into account the user’s physical and cognitive characteristics, postures, physical exertion, visibility, accessibility of controls and the conditions under which installation, maintenance, adjustment and rescue operations are carried out. For lifting equipment, therefore, it is not merely a matter of assessing the user during normal use, but also the activities carried out by personnel responsible for maintenance, adjustment and rescue. PROTECTION AGAINST TAMPERING – EHSR 1.1.9 The new requirement places particular emphasis on the possibility that hardware, software or safety-relevant data may be tampered with, either accidentally or deliberately. The assessment must, however, focus on alterations that may affect safety. It is necessary to identify which components, settings, software or data are actually safety-relevant and what measures prevent unauthorised intervention from creating a hazardous situation. Consideration must also be given to access methods – whether local or remote – and the requirements for protection and traceability of interventions. This does not mean that every maintenance operation must be treated as a modification to the machine. Replacing a component with an identical one or one specified by the manufacturer as compatible normally falls within the scope of maintenance. Similarly, configuring parameters already provided for by the software in 37
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