Impact of Safety Standards to
Processes and Methodologies
Impact to Processes, Methodologies, Products
IEC 61508 /
ISO 26262
Requirement
Processes
+ New/changed role descriptions (e.g. safety manager) + Assignments to competent persons
+ Enrichment of process with safety plan
+ Enrichment of document flow with new documents + Process tailoring wrt SIL / ASIL …
Methodologies
+
Documentation & configuration mmgt (safety case) + Change management with safety label+ Failure Modes, Effects and Diagnostic coverage Analysis + Common Cause Analysis
+ Requirement Traceability for safety requirements…
Products
+ Safety concept with safety product requirements + Safety manual as user manual
+ Element safety function: product architecture + Additional / changed IP on µC or power IC + Monitor software, watchdog IC, …
Impact to processes and methodologies
IEC 61508 and ISO 26262 require certain processes and
methodologies to prevent systematic faults.
ISO explicitely requires an audit of functional safety processes
for ASIL B, C, D (see ISO 26262-2.6.4.6, Table 1).
ISO proposes to check the safety management including the
functional safety audit in frame of the functional safety
assessment of the item (see ISO 26262-2 Annex E).
1. Setup a safety audit project to prepare your processes and
methodologies according safety requirements.
2. Rollout it out for product development projects.
3. Pass the external safety audit.
4. Product assessments refer to safety audit
Example of a Safety audit project (1 of 2)
Scope of process audit(draft)
Selection of stakeholders
Stakeholder requirements
Methodologies to + cope with 2 standards + avoid overengineering
for < SIL3, < ASIL D
Selection of
lead customers Selection of auditor Interface to other process adaptations Align on Tier1 - Tier 2
process interface Align scope of audit
Scope of process audit Project setup,
Contract with auditor
I1
I2
Example of a Safety audit project (2 of 2)
Gap analysisCompany process vs standards
I4
1. Internal reviewImprovement plan to close gaps 1. Audit by auditor
Enrich improvement plan by + audit findings
+ changes in standards
I5
2. Internal review
2. Audit by auditor: Compliant! Rollout release
I6
I7
Implement Improvements Rollout to Projects CR against ISO 26262 till 08.12.09Example: Scope of process audit
Informative overviewNo
Guideline on ISO 2626226262-10
All companies affected.
Yes *
ASIL- & safety-oriented analysis
26262-9
All companies affected.
Yes *
Supporting processes
26262-8
OEM (car), Tier1 (ECU), Tier2 (µC)
Yes *
Production & operation
26262-7
Tier1 (appl. SW) & Tier 2 (FW, drivers, monitors,..)
Yes *
Product dev: software level
26262-6
ISO part
ISO topic
Scope Arguments
26262-1
VocabularyNo
No work product defined26262-2
Management offunctional safety
Yes *
All companies in the automotive safety market have to do it.26262-3
Concept phaseNo
OEM & Tier1 topic26262-4
Product dev.:system level
No
Tier1 & OEM topic26262-5
Product dev.:hardware level
Yes *
Tier1 (board) & Tier2 (µC)Example: How to cope with 2 standards
Differences
ISO 26262
IEC 61508
Evaluation
Information
structure
FSM in one part:
ISO 26262-2 FSM in IEC 61508-1.6 and other parts Risk not to find all relevant IEC information
FSM structure
1. Overall FSM 2. During development3. After release for production
ISO structure does not exist but most ISO requirements covered ISO structure clearer – no contradiction to IEC found
Concepts
Safety culture Does not exist ISO asks for moreTerminology
Safety plan, Safety case, Item, Work product,Confirmation measure
Terms not defined but content
implicitely available
ISO more precise
Roles
1. Organization, 2.PJM, 3. Safety Mgr 1. Organization, 2. Responsible persons
ISO more detailled