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Step 01 — Identification & Assessment
Establishing visibility before risk becomes disruption.
Context
Product risks arise from both external pressures and internal capability gaps. Supplier dependencies, lifecycle constraints, regulatory change, and technology shifts often remain hidden until they affect availability, compliance, or business continuity.
Effective risk management starts with visibility. Organizations cannot manage risks they cannot see.
Focus
What It Enables
→ Identify critical components, technologies, and dependencies
→ Visibility across products and supply chains
→ Assess lifecycle, supply chain, compliance, and ESG exposure
→ Understanding of risk exposure and dependencies
→ Prioritize risks based on business impact
→ Risk-informed decision-making
→ Establish a structured product risk baseline
→ Preparedness for change
Component & Technology Visibility
Understand what matters most and where critical dependencies exist.
Lifecycle Assessment
Identify gaps between product lifetimes and technology availability.
Dependencies & External Risk Exposure
Reveal dependencies, constraints, and external risks.
Compliance & ESG
Understand regulatory and sustainability exposure.
Product Risk Assessment
Prioritize risks based on business impact and criticality.
Core Elements
Author
Nathan Eldridge
Head of Service Data & Information, Elekta
20 years across aerospace, transport, energy, and medical technology.
What is the main objective of Step 01?
01.
To establish visibility across products, components, suppliers, and associated risk factors.
What information should be captured?
02.
Lifecycle, supply chain, compliance, ESG, and technology-related information relevant to product availability and continuity.
How often should risks be reassessed?
03.
Regularly throughout the product lifecycle and whenever significant changes occur.
Why is this the first step?
04.
Because visibility is required before risks can be understood, prioritized, and managed.
Which functions should be involved?
05.
Engineering, procurement, quality, regulatory affairs, operations, and product management.
Which standards support this step?
06.
Primarily IEC 62402, SD-22, and related lifecycle, risk, and obsolescence management guidance.
Frequently Asked Questions
Standards Traceability
Theme
Standard & Clause
Component Data (MPN, lifecycle,
compliance)
IEC 62402 §8.10 • SD-22 §3.2 • SD-19 §3.3
BOM Alignment
IEC 62402 §7.2 • SD-19 §3.2
Risk Assessment (likelihood × impact)
IEC 62402 §9.1–§9.3 • SD-22 §3.3
Technology Grouping
IEC 62402 §9.1 • SD-22 §3.3
Software & Firmware
IEC 62402 §8.2, §8.9 • SD-22 §4.2
Supply Chain Resilience
SD-22 §3.4 • SD-19 §3.4
Regulatory Compliance
IEC 62402 §4.1, §8.10 • SD-22 §4.3
Lifecycle Fit (YTEOL vs. Product Life)
IEC 62402 §4.1, §10.3 • SD-22 §4.4
Implementation Guidance
Practical considerations and implementation details for this step.
