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Functional safety
assessment
Part 1 - Setting the boundaries of the FSA,
defining the scope and planning the FSA.
CONTENTS
1.0
Introduction
Page 3
2.0
Page 4
3.0
Page 6
4.0
Page 8
5.0
Planning of FSAs
Page 9
Appendices
Page 13
References
Page 24
Page 25
For more information, contact Stuart Nunns, UK Safety Lead Competency Centre at
stuart.nunns@gb.abb.com
1.0 INTRODUCTION
To many readers, Functional Safety
Assessments (FSAs) will be a new topic in the
area of functional safety. Even those who have
read and understand the key features of IEC
61508 [1] and IEC 61511 [2] may not be fully
conversant with the specific details of the FSA
activity, aware that it is a mandatory (shall)
requirement if one wishes to claim compliance
to IEC 61508 or have actually implemented
FSAs and reaped the benefits.
Review
Report
Review
Review
Develop
Functional Design
Specification
D
Review
Test Plan
M
Software
Configuration
Production Log
D
Safety Lifecycle
Management
Plan
D
Review
Report
Stage 9 - Verification
Review
Report
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Review
Review
Review
Report
Review
Project Lifecycle
Tools (Process
Navigator)
A
Review
Report
Develop
Module Design
Specification
Review
Module Test
Specification
D
Review
Technique and
Measures
Specification
Review
Report
M
Review
Review and
Configuration
Management
Review
Report
Audit Point
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Module Failure
Modes Analysis
Review
Report
O
Review
Review
Report
Query/Change
Procedure
M
A
M
Optional
Review
Report
Review
Report
Review
Factory
Acceptance Test
M
Review
Factory Acceptance
Test Specification
Integrated Test
Review
M
Audit
Report
Report
Optional
M
Audit
Report
Project
Competency
Assessments
Review
Report
Site Acceptance
Test Specifications
M
Review
Review
Report
Review
Review
Report
Review
Site Acceptance
Test
M
Operation and
Maintenance
M
Review
Review
Report
Review
D
Functional Safety
Audit Procedure
M
Manual
Audit Point
Review
Report
SIL Achievement
Report
M
Review
Review
Report
Review
Report
Review
Review
Develop
Functional Design
Specification
D
Review
Test Plan
M
Review
Report
Stage 9 - Verification
Review
Report
Activity
Deliverable
Mandatory
Optional
Review
Review
Review
Plan
M
Project
Competency
Assessments
Review
Report
Review
Report
Review
Report
Navigator)
Develop
Module Design
Specification
Review
Module Test
Specification
D
Review
Technique and
Measures
Specification
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Audit Point
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Module Failure
Modes Analysis
Review
Report
O
Query/Change
Procedure
M
A
M
Optional
Review
Report
Review
Report
Review
Factory
Acceptance Test
M
Review
Factory Acceptance
Test Specification
Integrated Test
Review
M
Audit
Report
Report
Project Lifecycle
Tools (Process
M
Review
A
Optional
M
Audit
Report
Safety Lifecycle
Management
Develop Boundary
Diagrams
O
Review
Site Acceptance
Test Specifications
M
Review
Review
Review
Review
Report
Review
Review
Report
Review
D
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Site Acceptance
Test
M
SIL Achievement
Report
M
Audit Point
Review
Report
Review
Report
Software
Configuration
Production Log
D
Review
Report
the assessment
The means by which any follow-up
recommendations shall be progressed
The stage(s) within the safety life cycle when
the FSA(s) will occur
Degree of Independence in accordance with
IEC 61508
Schedule and estimated duration of the
assessment
Documents referenced at each FSA stage
Checklist utilised at each FSA stage
Findings and recommendations from each
FSA stage
The plan is approved by the local SEC Manager
and issued to all parties prior to the
assessment-taking place. Only one plan is
developed for the specific project FSA and this
plan is effectively a living document in that as
each stage is completed the evidence reviewed,
findings, conclusions and recommendations are
added to the plan.
10
Review
Report
Review
Review
Develop
Functional Design
Specification
M
D
Review
Test Plan
M
Software
Configuration
Production Log
D
Safety Lifecycle
Management
Plan
D
Review
Report
Stage 9 - Verification
Review
Report
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Review
Review
Review
Report
Review
Report
Review
Report
Project Lifecycle
Tools (Process
Navigator)
A
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Project
Competency
Assessments
Review
Report
Module Test
Specification
D
Review
Technique and
Measures
Specification
Review
Report
M
Review
Review and
Configuration
Management
Review
Report
Review
Audit Point
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Module Failure
Modes Analysis
Review
Report
O
Review
Review
Report
Query/Change
Procedure
M
A
M
Optional
Review
Report
Review
M
Review
Report
Review
Factory
Acceptance Test
M
Audit
Report
Review
Factory Acceptance
Test Specification
Integrated Test
Review
Review
Report
Review
Review
Report
Site Acceptance
Test Specifications
M
SIL Achievement
Report
M
Review
Review
Report
Review
Review
Report
Review
Review
Report
Operation and
Maintenance
Manual
M
Software
Configuration
Production Log
D
Safety Lifecycle
Management
Plan
D
Functional Safety
Audit Procedure
A
Audit Point
Review
Report
Review
Site Acceptance
Test
M
Review
Report
Review
Review
Develop
Functional Design
Specification
D
Review
Test Plan
M
Review
Report
Stage 9 - Verification
Review
Report
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Review
Review
Report
Project Lifecycle
Tools (Process
Navigator)
M
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Review
Module Test
Specification
D
Review
Technique and
Measures
Specification
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Audit Point
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Module Failure
Modes Analysis
Review
Report
O
Query/Change
Procedure
M
A
M
Optional
Review
Report
Review
Report
Review
Review
Factory
Acceptance Test
M
Audit
Report
Factory Acceptance
Test Specification
Integrated Test
Review
Site Acceptance
Test Specifications
M
Review
Review
Review
Review
Report
11
Review
Review
Report
Review
D
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Site Acceptance
Test
M
SIL Achievement
Report
M
Audit Point
Review
Report
Review
Report
Project
Competency
Assessments
M
Review
Report
ALSO AVAILABLE
This document is the first of a two part series focusing on planning creating and implementing a
Functional Safety Assessment programme. The second part is also available, covering:
PART 2: Performing the Functional Safety Assessment, reporting and follow-up.
12
APPENDICES
APPENDICES
13
APPENDICES
Review
Report
Review
Review
Develop
Functional Design
Specification
M
D
Review
Test Plan
M
Stage 9 - Verification
Review
Report
A
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Review
Review
D
Review
Report
Review
Factory
Acceptance Test
M
Audit Point
Review
Report
Review
Site Acceptance
Test
M
14
Review
D
Factory Acceptance
Test Specification
Integrated Test
Review
M
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Audit Point
Review
Report
Audit
Report
Module Test
Specification
D
Site Acceptance
Test Specifications
M
Review
Review
Safety Lifecycle
Management
Plan
M
D
Technique and
Measures
Specification
Review
Report
M
Project
Competency
Assessments
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Review
Review
Review
Report
Query/Change
Procedure
Optional
Review
Report
SIL Achievement
Report
M
Review
Report
Review
Review
Report
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Report
Project Lifecycle
Tools (Process
Navigator)
M
A
Module Failure
Modes Analysis
Review
Report
Review
Software
Configuration
Production Log
M
D
Review
Report
Review
Review
Report
15
APPENDICES
Review
Report
Review
Review
Develop
Functional Design
Specification
M
D
Review
Test Plan
M
Stage 9 - Verification
Review
Report
A
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Review
Review
D
Review
Report
Review
Factory
Acceptance Test
M
Audit Point
Review
Report
Review
Site Acceptance
Test
M
16
Review
D
Factory Acceptance
Test Specification
Integrated Test
Review
M
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Audit Point
Review
Report
Audit
Report
Module Test
Specification
D
Site Acceptance
Test Specifications
M
Review
Review
Safety Lifecycle
Management
Plan
M
D
Technique and
Measures
Specification
Review
Report
M
Project
Competency
Assessments
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Review
Review
Review
Report
Query/Change
Procedure
Optional
Review
Report
SIL Achievement
Report
M
Review
Report
Review
Review
Report
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Report
Project Lifecycle
Tools (Process
Navigator)
M
A
Module Failure
Modes Analysis
Review
Report
Review
Software
Configuration
Production Log
M
D
Review
Report
Review
Review
Report
17
APPENDICES
Review
Report
Review
Review
Develop
Functional Design
Specification
M
D
Review
Test Plan
M
Stage 9 - Verification
Review
Report
A
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Review
Review
D
Review
Report
Review
Factory
Acceptance Test
M
Audit Point
Review
Report
Review
Site Acceptance
Test
M
18
Review
D
Factory Acceptance
Test Specification
Integrated Test
Review
M
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Audit Point
Review
Report
Audit
Report
Module Test
Specification
D
Site Acceptance
Test Specifications
M
Review
Review
Safety Lifecycle
Management
Plan
M
D
Technique and
Measures
Specification
Review
Report
M
Project
Competency
Assessments
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Review
Review
Review
Report
Query/Change
Procedure
Optional
Review
Report
SIL Achievement
Report
M
Review
Report
Review
Review
Report
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Report
Project Lifecycle
Tools (Process
Navigator)
M
A
Module Failure
Modes Analysis
Review
Report
Review
Software
Configuration
Production Log
M
D
Review
Report
Review
Review
Report
19
APPENDICES
Review
Report
Review
Review
Develop
Functional Design
Specification
M
D
Review
Test Plan
M
Stage 9 - Verification
Review
Report
A
Activity
Deliverable
Mandatory
Optional
Review
Develop Boundary
Diagrams
O
Optional
Review
Report
Develop
Module Design
Specification
Review
M
Audit
Report
Review
Review
D
Review
Report
Review
Factory
Acceptance Test
M
Audit Point
Review
Report
Review
Site Acceptance
Test
M
20
Review
D
Factory Acceptance
Test Specification
Integrated Test
Review
M
Review
Report
Integrated Test
Specification
Module Test
Review
M
Review
Audit Point
Review
Report
Audit
Report
Module Test
Specification
D
Site Acceptance
Test Specifications
M
Review
Review
Safety Lifecycle
Management
Plan
M
D
Technique and
Measures
Specification
Review
Report
M
Project
Competency
Assessments
Review
Report
M
Review
Review
Report
Review
Review
Report
Review and
Configuration
Management
M
Review
Review
Review
Report
Query/Change
Procedure
Optional
Review
Report
SIL Achievement
Report
M
Review
Report
Review
Review
Report
Functional Safety
Audit Procedure
M
Operation and
Maintenance
Manual
M
Report
Project Lifecycle
Tools (Process
Navigator)
M
A
Module Failure
Modes Analysis
Review
Report
Review
Software
Configuration
Production Log
M
D
Review
Report
Review
Review
Report
21
NOTES
22
23
REFERENCES
[1] IEC 61508 Functional safety of electronic/electrical/programmable electronic
Safety-Related Systems
[2] IEC 61511 Functional safety Safety instrumented systems for the process sector
[3] IEC 61131 Programmable controllers
24
25
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