Functional Safety Lifecycle Implementation

Hazard and Risk Assessment

Initial H&RA identifying hazardous events and required risk reduction per IEC 61511-1 Cl.8

Strategic context

What this element is — and why it matters

Phase 1 of the IEC 61511 lifecycle is the Hazard and Risk Assessment — the systematic identification of hazardous events and the determination of required risk reduction. It uses HAZOP, LOPA, fault trees, and event trees to establish a defensible scenario set and risk profile before any SIS allocation decisions are made.

Hazard and Risk Assessment

Individual significance for organisations

Without rigorous Phase 1, all downstream SIL allocations rest on incomplete hazard understanding. Sites that invest in deep H&RA catch the credible-worst-case scenarios that drive SIF design.

Contribution to Functional Safety Lifecycle Implementation

Phase 1 produces the hazard register that Phase 2 (Allocation) consumes. It also feeds back to Process Safety Information (PSI) and connects to the broader PHA cycle through 5-year revalidation triggers.

Key requirements

What compliant execution looks like

HAZOP / LOPA / Fault-Tree / Event-Tree per IEC 61511-1 Cl.8
Initiating event and consequence definition
Tolerable risk target setting per site-specific risk criteria
5-year revalidation cycle integrated with MOC
Implementation methodology

How we implement this element

A focused 6-step methodology calibrated to deliver hazard and risk assessment as a working capability — not a documented compliance artefact.

Scope & PSI Baseline

Define unit boundary and gather PSI per OSHA 1910.119(d); align with operating envelope and PHA records.

Hazard Identification

Run HAZOP per IEC 61882; supplement with What-If / Checklist where appropriate; document hazardous events.

Consequence Analysis

Quantify consequence severity per safety / environment / asset tolerable thresholds; align with corporate risk matrix.

Risk Estimation

Estimate frequency-consequence pairs; identify scenarios requiring further risk reduction beyond existing IPLs.

Tolerable Risk Comparison

Compare residual risk against site-specific tolerable frequency; identify SIF candidates per Cl.9 allocation.

H&RA Report & Phase 2 Hand-off

Issue H&RA report with hazard register, required risk reduction, and inputs for Phase 2 SIF allocation.

Implementation flow

Element-implementation flow chart

Decision-gated workflow showing the actual sequence of activities — from initiation through steady-state operation — with key decision points highlighted.

Start
PSI gathered; HAZOP team assembled
HAZOP Node Review
Per node and guideword per IEC 61882
Decision
Hazardous Event Identified?
Decision gate
Consequence Estimation
Severity per safety / env / asset
Frequency Estimation
Initiating event + enabling factors
Decision
Tolerable?
Decision gate vs corporate risk matrix
SIF Candidate Identified
Hand-off to Phase 2 allocation
H&RA Report Issued
Documented hazard register + risk reduction
Deliverables

What we produce

  • Hazard register with hazardous events and consequences
  • Risk reduction requirements per SIF candidate
  • Phase 1 H&RA report
Common pitfalls

Where execution fails

  • HAZOP team missing operator perspective
  • Tolerable risk targets not calibrated to site context
  • Revalidation cycle slipping past 5 years
Related elements

Explore related elements in this framework

All elements in this framework

Functional Safety Lifecycle Implementation — full element index

Implement this element

Talk to us about implementing Hazard and Risk Assessment

We can scope this element implementation against your facility, regulatory context, and existing management-system maturity — and integrate it with the other Functional Safety Lifecycle Implementation elements you already operate.