ISO 21448: Setting Up a SOTIF Process in Your QMS — Roles, Tailoring, and the Project Safety Plan

Date
2027-01-26
Location
Online
Host
Zach L
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About this event

A live 30-minute expert session on Setting Up a SOTIF Process in Your QMS — Roles, Tailoring, and the Project Safety Plan (ISO 21448 — Safety of the Intended Functionality). What We'll Cover: What process-level expectations ISO 21448 carries despite being less prescriptive than ISO 26262 Part 2, and where they anchor in the QMS The setup method step by step: process mapping to clauses, RASIC for SOTIF roles, tailoring criteria by automation level, and template rollout How the process maps to ISO 21448 and produces the SOTIF process description, project safety plan section, and tailoring records Common mistakes: SOTIF bolted on as a checklist after design freeze, no named owner for the scenario database, tailoring decisions undocumented The evidence assessors check: the planned-versus-performed comparison, competence records for key roles, and tailoring justifications per project Related topics: sotif process setup · quality management system · safety plan · process tailoring · rasic roles · aspice integration · apqp · process architecture · competence management · template rollout · organizational capability · process audit · planned vs performed · sotif governance Critical Systems Analysis provides embedded functional safety consulting for ISO 21448 — Safety of the Intended Functionality. Learn more: https://criticalsystemsanalysis.com Partner with us: https://meetings.hubspot.com/benjamin-twombly/strategic-partnerships

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About Functional Safety Foundations

This online session delivers expert-led instruction on the regulatory landscape and implementation approach for Functional Safety Foundations.

The cross-sector fundamentals underlying every functional safety standard: risk as severity × likelihood, the safety function concept, integrity levels, the safety lifecycle, and the split between random and systematic failures.

What it regulates

Shared vocabulary and reasoning: hazard → risk → risk reduction allocation → safety requirement → verified implementation → maintained integrity in operation.

Who must comply

Everyone entering the field — the conceptual base of the entire catalog.

Key requirements of Functional Safety Foundations

  • Hazard and risk fundamentals
  • Safety function anatomy: sensor-logic-actuator with defined safe state
  • Integrity ladders (SIL/PL/ASIL/DAL) as risk-reduction currencies
  • Random vs systematic failure treatment
  • Lifecycle and management of functional safety incl. competence

Key concepts: Functional Safety Foundations

Functional safety management
Planning, competence, documentation and assessment wrapped around technical work.
Random vs systematic
Hardware wear-out/chance failures quantified statistically versus design/process errors controlled by rigor.
Risk reduction allocation
Distributing required risk reduction among mechanical design, safeguards, control functions and procedures.
Safe state
The defined condition a function drives the equipment to on demand or fault.

Frequently asked questions: Functional Safety Foundations

Why can't testing alone prove safety?

Rare-event targets (like 1e-7/h) are unverifiable by test duration, and systematic errors evade random testing — hence the standards' dual machinery of quantified hardware analysis plus process rigor and independent assessment.

Standard information based on the published text of Functional Safety Foundations. Event content is provided by the host. For authoritative guidance, consult the official standard body.