Guidance on whether a change constitutes a material change to a safety case
OEUK’s Guidance on whether a change constitutes a material change to a safety case.
Quoting from the introductory text in the L154 Guidance to The Offshore Installations (Offshore Safety Directive) (Safety Case etc.) Regulations 2015: Safety cases are intended to be ‘living’ documents, kept up to date and revised as necessary during the operational life of the installation. Changes to a safety case are covered under Regulation 24. If a change is a material, as per 24(2), then that change cannot be made until an updated safety case has been accepted by the regulator. Guidance paragraph 291 of L154 states that: A Material Change is likely to be one that changes the basis on which the original safety case was accepted. This would involve changes to the basis on which risk control decisions are made or which necessitate a review of the adequacy of major hazard control measures. It includes both physical modifications and operational management changes of sufficient significance.
However, the duty holder’s decision on what constitutes a material change to a safety case can be challenging. During this decision process consultation with the competent authority (HSE) is encouraged. This document provides example-based guidance as to whether a change is material. For each example, a “default” is given of whether the change would normally be considered material on a scale of: Yes, Likely, Possible, Unlikely, No. Factors are then given that influence the materiality of each example. The aim of the examples is to ease the discussion between operator and regulator on whether a change is material or not. This guidance covers production installations only. Prior to the examples, text is repeated from the regulations below on those changes, or types of changes that are mandated as material.
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