Essential requirements must be applied as a function of the hazard inherent to a pressure equipment. Therefore, pressure equipment manufacturers have to carry out a risk analysis to first identify all possible risks that the pressure equipment may pose and determine the essential requirements applicable to the pressure equipment. This analysis has to be documented and included in the technical documentation.
In addition, the pressure equipment manufacturer needs to document the assessment of how he is addressing the risks identified to ensure that the pressure equipment complies with the applicable essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all applicable essential requirements, then the way applicable essential requirements not covered by it are dealt with, should be documented.
PED requirements regarding hazards analysis and risk assessment
The third preliminary observation of Annex I of the PED requires that the manufacturer shall “… analyse the hazards and risks in order to identify those which apply to his equipment on account of pressure”. In addition, the modules of Annex III require that “The technical documentation…….shall include an adequate analysis and assessment of the risk(s).”. How shall this be carried out and documented?
How should the hazards analysis and risk analysis be carried out?
- The manufacturer shall determine and record the characteristics, extent, surrounding and circumstances of the intended use of the pressure equipment or the assembly.
- It is necessary to identify hazards and/or hazardous situations that could occur during the life cycle of the pressure equipment or the assembly in reasonably foreseeable conditions.
The manufacturer shall analyse each hazard and/or hazardous situation and evaluate the significance of the risk for each identified applicable hazard and/or hazardous situation and follow the mitigation measures as listed in Annex I section 1.2.
The goal of the risk assessment is the appropriate application of the relevant essential safety requirements (Annex I) of the PED and the implementation of associated measures. - The manufacturer shall record the risk assessment that has been carried out.
- The methods of the risk assessment, a list of the essential safety requirements applied to the equipment and the corresponding protective measures shall be included in the technical documentation.
Who is authorised to carry out the risk assessment?
The risk assessment may be carried out by the manufacturer himself, by his authorised representative or by another person acting on their behalf.
If the risk assessment is carried out on behalf of the manufacturer or by another person, the manufacturer remains responsible for the risk assessment and the implementation of the necessary protective measures during the design and manufacture of pressure equipment.
Can the manufacturer rely on harmonised standards when carrying out a hazards analysis and risk analysis process?
The hazard and risk analysis process may be facilitated by using harmonised standards but they do not relieve the manufacturer of his obligation to carry out the analysis.
The PED specify (see Annex I sect. 1.2) the principles to be applied for the hazards and risks analysis, choosing the most appropriate solutions:
- eliminate or reduce identified hazards as reasonably practicable;
- apply protection measures against hazards which cannot be eliminated;
- When relevant, inform the users of residual hazards and require to take special measures to reduce the risks at the time of installation and/or use.
Where the potential for misuse is known, the pressure equipment shall be designed to prevent the risks from such misuse or, if not possible, adequate warning to be provided to avoid the use of the relevant pressure equipment in the dangerous way.
For a consistent view on the terms, definitions and the inclusion of the safety aspects (hazard and risk analysis included) in the standards.
Even where the manufacturer uses a harmonised standard (where its reference is published in the OJ and which aims to cover certain risks) to satisfy essential requirements, the risk assessment has to be carried out and he must check whether the harmonised standard covers all risks of the pressure equipment. This is because it cannot be assumed that the harmonised standard covers all requirements of all legislative acts applicable to a given pressure equipment (or, indeed, all the requirements of the specific act under which it has been developed) or whether the pressure equipment in question introduces also other risks not considered in the harmonised standard.
Each harmonised standard related to PED contain an Annex Z about the relationship between the standard clauses and the Essential Safety Requirements of the PED.
Can the risk assessment include a quantitative approach with probabilistic analysis and/or assumptions about the possible extent of damage?
The risk assessment can include, but does not require, a quantitative approach with probabilistic analysis and/or assumptions of possible extents of damage.
It is up to the manufacturer to decide about the most appropriate method taking into account the pressure equipment technology used and current practice.
Read More
Hazard identification and the PED risk assessment processs
PED: Essential Safety Requirements (ESR)
What means? – Sound Engineering Practice (SEP) in acc. to PED
