Version: V1.1 Previous Update: 21-09-2026

Project Engineer–Playbook

Part 3

Safety – Risk Assessment

Figure - Risk Assessment

Version

Version
Date
Initials
Description
1.0
04-08-2026
PJH
Document Created








Machinery Safety Review Guide

From Hazard to Validated Safety Function

Machinery safety can become difficult when the risk assessment, design, calculations, software, and testing develop separately.

This guide connects them through one practical process. It helps the machine builder identify the risk, define the safety function, determine the required Performance Level, verify the design, and validate the result.

This guide supports the application of ISO 12100 and ISO 13849-1. It does not replace the standards, applicable legislation, machine-specific standards, or review by a competent person.

Understand the risk. Define the function. Prove the result.

The Safety Review Process

The safety review begins with the machine and the people who interact with it. It ends when the machine builder can trace every required safety function to approved validation evidence.

The process follows the automation project phases.

Project phase
Safety activity
Result
P1 Concept and Analysis
Establish the machine and safety scope
Safety scope agreed
P2 User Requirements
Identify hazards and required risk reduction
Safety requirements agreed
P3 Functional and System Design
Define safety functions and required Performance Level
Safety concept approved
P4 Detailed Design and Implementation
Design the safety-related control system
Safety design verified
P5 Factory Acceptance Testing
Test safety functions before delivery
FAT results approved
P6 Installation and Site Acceptance
Validate the installed safety functions
Validation approved
P7 Handover and Evaluation
Transfer the safety file and continued responsibilities
Safety ownership transferred

Changes can occur in every phase. Each change must be assessed for its effect on the risk assessment, safety functions, design, calculations, and validation evidence.

Understand the Risk

Begin with the Machine

A risk assessment starts by defining what is being assessed.