Safety Risk Analysis supports incremental enhancement of safety during product development, going on to set out the evidence of safety (once established) in the form of a rigorous Safety Case. During this process:
· the safety assessment is scoped in terms of the product, its manufacture and its usage
· the hazards to which the product may be subject, and the accidents to which these may lead, are identified and characterised
· risk is quantified in terms of the probability of the hazards and the degree of severity of the accidents threatened
· targets are set for the risk, and a gap analysis performed for each hazard leading to the formulation of a set of control actions needed to achieve the targets
· progress with the control actions is monitored and the outcome captured and accounted for in the analysis
· these steps are reiterated until the risk is reduced to acceptable levels
· throughout, evidence is documented and included within a structured body of evidence
· an analysis report is written (based on this evidence) setting out the reasons why the product should be regarded as safe
· this report and the body of evidence is the Safety Case.
MMA has broad experience of implementing this process (primarily in respect of products with an explosive element, but we can contribute in any product area).
MMA’s role is to facilitate the process described above. We will not be part of your design team, but we can:
· guide the design team in implementing the process described above, the team working with manufacturing and user stakeholders
· lead the necessary meetings through what they need to achieve, step by step, providing detailed briefing material and capturing a comprehensive record
· prepare the safety documentation (on your behalf), including the Hazard Log
· press for, assemble and structure the Safety Case body of evidence
· challenge the completeness and rigour of the evidence
· draft the Safety Case Report on your behalf (using the information you provide), including helping to construct the logical argument that your product is safe
· act as your mentor in constructing the Safety Case – and as an ‘honest broker’ between the various stakeholders involved.
We’d be delighted to talk to you about how we can help in your circumstances.
Identification SAFETY CASE PHASES
Assessment
Reduction/Control
Endorsement
Implementation
Safety Case