IEC 61508 Assessment

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IEC 61508 Functional Safety Assessment
Project:
DeltaV SIS
DeltaV SIS ETA Relay Module, KJ2231X1- BA1
DeltaV SIS DTA Relay Module, KJ2231X1- BB1
DeltaV SIS Relay Diode Module, KJ2231X1-BC1
DeltaV SIS Voltage Monitor, KJ2231X1 – EB1
Customer:
Emerson Process Management
Fisher Rosemount Systems
Austin, TX
USA
Contract No.: Q09/10-23
Report No.: FRS 09-10-23 R001
Version V1, Revision R1, May 13, 2010
Michael Medoff
The document was prepared using best effort. The authors make no warranty of any kind and shall not be liable in any
event for incidental or consequential damages in connection with the application of the document.
© All rights reserved.
Management summary
This report summarizes the results of the functional safety assessment according to IEC 61508
carried out on the:

DeltaV SIS


DeltaV SIS ETA Relay Module, KJ2231X1- BA1
DeltaV SIS DTA Relay Module, KJ2231X1-BB1

DeltaV SIS Relay Diode Module, KJ2231X1-BC1

DeltaV SIS Voltage Monitor, KJ2231X1 – EB1
The functional safety assessment performed by exida consisted of the following activities:
-
exida assessed the modifications performed by Emerson via two audits (one on-site) and
creation of a detailed safety case against the requirements of IEC 61508.
These products were previously certified to IEC 61508, SIL 3 (See [D10]). Based on this
certification, it can be concluded that the Emerson development process meets the requirements of
IEC 61508 for SIL 3. As a result this latest assessment focused on reviewing the changes made to
the product. The changes were assessed against section 7.8 of IEC 61508 part 2 (E/E/PES
Modification) and section 7.8 of part 3 (Software Modification). A partial IEC 61508 Safety Case
was prepared, focusing specifically on the modification process, and used as the primary audit tool.
Modification process requirements and all associated documentation were reviewed.
See section 3 of this document for details on which hardware and software versions have been
included in this assessment.
The results of the Functional Safety Assessment can be summarized by the following statements:
The DeltaV SIS, DeltaV SIS Relay Modules, DeltaV SIS Relay Diode Module, and DeltaV SIS
Voltage Monitor were found to meet the requirements of SIL 3, single use (HFT = 1/0).
© exida Certification
Michael Medoff
emerson 09-10-23 r001 v1 r1 iec 61508 assessment.doc, 5/13/2010
Page 2 of 25
Table of Contents
Management summary .................................................................................................... 2
1
Purpose and Scope ................................................................................................... 4
2
Project management .................................................................................................. 5
2.1
2.2
2.3
2.4
3
Product Description.................................................................................................. 12
3.1
3.2
3.3
3.4
4
exida ............................................................................................................................ 5
Roles of the parties involved ........................................................................................ 5
Standards / Literature used .......................................................................................... 5
Reference documents .................................................................................................. 5
2.4.1 Documentation provided by Emerson Process Management ............................. 5
2.4.2 Documentation generated by exida.................................................................. 11
DeltaV SIS Logic Solver ............................................................................................. 12
DeltaV SIS Relay Modules ......................................................................................... 12
DeltaV SIS Relay Diode Module ................................................................................. 12
DeltaV SIS Voltage Monitor ........................................................................................ 12
IEC 61508 Functional Safety Assessment ............................................................... 14
4.1 Methodology............................................................................................................... 14
4.2 Assessment level ....................................................................................................... 14
5
Results of the IEC 61508 Functional Safety Assessment ........................................ 15
5.1 Lifecycle Activities and Fault Avoidance Measures..................................................... 15
5.1.1 Functional Safety Management ....................................................................... 15
5.1.2 Safety Requirements Specification and Architecture Design ............................ 16
5.1.3 Hardware Design ............................................................................................. 16
5.1.4 Validation ......................................................................................................... 17
5.1.5 Verification ....................................................................................................... 17
5.1.6 Modifications.................................................................................................... 17
5.1.7 User documentation ......................................................................................... 21
5.2 Hardware Assessment ............................................................................................... 22
6
Terms and Definitions .............................................................................................. 24
7
Status of the document ............................................................................................ 25
7.1
7.2
7.3
7.4
Liability ....................................................................................................................... 25
Releases .................................................................................................................... 25
Future Enhancements ................................................................................................ 25
Release Signatures .................................................................................................... 25
© exida Certification
Michael Medoff
emerson 09-10-23 r001 v1 r1 iec 61508 assessment.doc, 5/13/2010
Page 3 of 25
1 Purpose and Scope
Generally four options exist when doing an assessment of sensors, logic solvers and/or final
elements.
Option 1: Hardware assessment according to IEC 61508
Option 1 is a hardware assessment by exida according to the relevant functional safety standard(s)
like IEC 61508 or EN 954-1. The hardware assessment consists of a FMEDA to determine the fault
behavior and the failure rates of the device, which are then used to calculate the Safe Failure
Fraction (SFF) and the average Probability of Failure on Demand (PFDAVG).
This option shall provide the safety instrumentation engineer with the required failure data as per
IEC 61508 / IEC 61511 and does not include an assessment of the development process.
Option 2: Hardware assessment with proven-in-use consideration according to IEC 61508 /
IEC 61511
Option 2 is an assessment by exida according to the relevant functional safety standard(s) like IEC
61508 or EN 954-1. The hardware assessment consists of a FMEDA to determine the fault
behavior and the failure rates of the device, which are then used to calculate the Safe Failure
Fraction (SFF) and the average Probability of Failure on Demand (PFDAVG). In addition, this option
includes an assessment of the proven-in-use demonstration of the device and its software including
the modification process.
This option for pre-existing (programmable electronic) devices shall provide the safety
instrumentation engineer with the required failure data as per IEC 61508 / IEC 61511 and justify the
reduced fault tolerance requirements of IEC 61511 for sensors, final elements and other PE field
devices.
Option 3: Full assessment according to IEC 61508
Option 3 is a full assessment by exida according to the relevant application standard(s) like IEC
61511 or EN 298 and the necessary functional safety standard(s) like IEC 61508 or EN 954-1. The
full assessment extends option 1 by an assessment of all fault avoidance and fault control
measures during hardware and software development.
This assessment shall be done according to option 3.
This document shall describe the results of the IEC 61508 functional safety assessment of the
DeltaV SIS, DeltaV SIS Relay Module, and DeltaV SIS Voltage Monitor.
© exida Certification
Michael Medoff
emerson 09-10-23 r001 v1 r1 iec 61508 assessment.doc, 5/13/2010
Page 4 of 25
2 Project management
2.1 exida
exida is one of the world’s leading knowledge and certification companies specializing in
automation system safety and availability with over 300 years of cumulative experience in
functional safety. Founded by several of the world’s top reliability and safety experts from
assessment organizations and manufacturers, exida is a global company with offices around the
world. exida offers training, coaching, project oriented consulting services, internet based safety
engineering tools, detailed product assurance and certification analysis and a collection of on-line
safety and reliability resources. exida maintains a comprehensive failure rate and failure mode
database on process equipment.
2.2 Roles of the parties involved
Emerson Process Management
Manufacturer of the DeltaV SIS, DeltaV SIS Relay Modules,
DeltaV SIS Relay Diode Module, and DeltaV SIS Voltage
Monitor
exida
Performed the IEC 61508 Functional Safety Assessment
according to option 3 (see section 1)
Emerson Process Management contracted exida with the IEC 61508 Functional Safety
Assessment of the above mentioned devices.
2.3 Standards / Literature used
The services delivered by exida were performed based on the following standards / literature.
[N1]
IEC 61508 (Parts 1 - 7):
2000
Functional Safety of Electrical/Electronic/Programmable
Electronic Safety-Related Systems
2.4 Reference documents
2.4.1 Documentation provided by Emerson Process Management
[D1]
ImpactAnalysis_080318_10_3_SLS.doc
DeltaV SIS Impact Analysis 03/27/200
Report
8
[D2]
Reduced Status Boolean Design.docx
Design for Reduced Status
Booleans
[D3]
SIS_LSDVC_RevN.xls
DeltaV SIL_LSDVC_Block Rev N
Test Plan and Results
[D4]
HighDensity_
SIS_SLS_Fault_Detection_RevJ.xls
DeltaV
SIS_SLS_Fault_Detection
Test Plan and Results
Rev J
[D5]
SIS_SLS_Fault_Detection_RevI.xls
DeltaV
SIS_SLS_Fault_Detection
Rev I
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Michael Medoff
02/15/200
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Test Plan and Results
[D6]
SIS_Validation_Blocks_RevO.xls
DeltaV
SIS_Validation_Blocks
Test Plan and Results
Rev O
[D7]
Incident_90431.txt
Incident Report 90431
4/22/2008
[D9]
SIS_Validation_System_RevL.xls
SIS_Validation_System
Test Plan
Rev L
[D10] FRS 06-05-30 R001
IEC
61508
Functional V1R1
Safety Assessment Report
for DeltaV SIS.
[D11] Incident_90899.txt
Incident Report 90899
[D12] Review_3597.pdf
SIS – Reduced Status 1/16/2008
Boolean Concept Design
Review Minutes
[D13] Review_3639.pdf
Reduced Status Booleans 2/7/2008
– SLS Design Review
Minutes
[D14] Review_3657.pdf
Code Review Minutes
[D15] Review_3739.pdf
Software Impact Analysis 3/28/2008
Review Minutes
[D16] V210x_Formal_Module_Tests.docx
Module Test Results
5/21/2008
[D17] V210x_Informal_Module_Tests.docx
Module Test Results
5/21/2008
[D18] V210x_Lint_Results
PC Lint Results
3/13/2008
[D19] ControlDevice_FMT.doc
Module Test Results
2/13/2008
[D20] ControlIOBlock_FMT.doc
Module Test Results
3/13/2008
[D21] ControlMsgRouter_FMT.doc
Module Test Results
2/13/2008
[D22] ControlSecureWrite_FMT.doc
Module Test Results
2/13/2008
[D23] FMT_DiagSSMonitor.doc
Module Test Results
2/13/2008
[D24] Review_3657.bmp
Code Review Minutes
2/18/2008
[D25] DS Delta V SIS – Simulate
enhancements As-built.doc
for
SIS Direction
release
Statement
4/22/2008
2/18/2008
for 3/18/2008
[D26] V2105_SIS_Integration_Test_Results_080424.x
ls
Integration Test Results
6/6/2008
[D27] v11_SIS_Changes.pdf
SIS Changes for V11
1/12/2010
[D28] MultipleSISNetArchitecture.pdf
Delta V Technology
Multiple SISNet
1.0
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Architecture
[D29] MultipleSISNetDesign.pdf
DeltaV Technology Run
Time Design for SISNet
Domains
5/27/2009
[D30] MultipleSISNetRingsConcept.pdf
DeltaV Technology
Concept for Multiple
SISNet Domains
4/16/2009
[D31] DS DeltaV SIS – Protected SIS Composite DS DeltaV SIS - Protected
Template.html
SIS Composite Template
3/11/2010
[D32] DS DeltaV SIS – Multiple SISNet Rings.html
DS DeltaV SIS - Multiple
SISNet Rings
3/11/2010
[D33] Additional_SLS_Changes.doc
Changes for 3.1.0.7 Logic
Solver
4/16/2010
[D34] Incident Repair information
Detailed change
descriptions for multiple
incident repairs
1/22/2010
&
3/24/2010
[D35] Module Test Reports
Reports on Formal and
Informal Module Testing
Various
[D36] Review Documentation
Detailed review minutes for
design, code, and impact
analysis reviews
Various
[D37] Delta V SIS Safety Manual.pdf
DeltaV Safety
Instrumented System
Safety Manual
August
2005
[D38] SIS_Validation_System_RevO.xls
DeltaV
SIS_Validation_System
Test Plan
Revision O
[D39] SIS_LSDVC_RevN.xls
SIS_LSDVC_Block Test
Plan
Revision N
[D40] SIS_SLS_Fault_Detection_RevJ.xls
SIS_SLS_Fault_Detection
Test Plan
Revision J
[D41] SIS_Validation_Blocks_RevR.xls
SIS_Validation_Blocks
Test Plan
Revision R
[D42] SIS_Validation_SecureWrite_RevR.xls
SIS_Validation_SecureWrit
e Test Plan
Revision R
[D43] SIS_MultipleSISNetDomains.xls
SIS_Multiple SISNet
Domains Test Plan
Revision A
[D44] DeltaV SIS Safety Requirements
Specification.pdf
DeltaV SIS Safety
Requirements Specification
5/20/2005
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[D45] ImpactAnalysis_09_09_05_11_3_SLS_RevB
DeltaV SIS Impact Analysis
Report
8/10/2009
[D46] ImpactAnalysis_100120_11_3_part2
DeltaV SIS Impact Analysis
Report
1/20/2010
[D47] DeltaV PM – 2003.6.12.pdf
Delta V Project
Management Plan
6/12/2003
[D48] DeltaV SIS SafetyCaseDB
DeltaV SIS SafetyCaseDB,
documenting the IEC
61508 compliance of the
DeltaV SIS system and the
Fisher-Rosemount
Systems, Inc. development
process
March 08,
2005
[D49] SIS Acc SRS.doc
DeltaV SIS Accessories,
Safety Requirements
Specification
February
21, 2007
[D50] SIS Accessories WPP.doc
SIS Accessories, Hardware
Work Package Plan
February
23, 2007
[D51] Safety Relay Schem 12P3963A
Electronic Schematics,
DeltaV SIS Safety Relay
November
14, 2006
[D52] VM Schem 12P3966A
Electronic Schematics,
DeltaV SIS Voltage Monitor
November
14, 2006
[D53] Safety Relay revised.xls
FMEDA, Safety Relay,
KJ2231X1-EA1, 1.01
February
23, 2007
[D54] V_MON_Acc revised.xls
FMEDA, Voltage Monitor,
KJ2231X1-EB1, 1.01
February
23, 2007
[D55] VMA and SRM Fault Injection Results.xls
Fault Injection Test results
for Safety Relay and
Voltage Monitor, tests
performed by FisherRosemount Systems, Inc.
February
23, 2007
[D56] Safety Relay FMEDA Review Supporting
Documentation.xls
PFDAVG and PFH
calculations for DeltaV SIS
Safety Relay
February
23, 2007
[D57] Voltage Monitor FMEDA Review Supporting
Documentation
PFDAVG and PFH
calculations for DeltaV SIS
Voltage Monitor
February
23, 2007
[D58] FGES21B15, REV B
SIS Accessories – Safety
Relay and Voltage Monitor
Product Hardware
Specification
February
13, 2007
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[D59] 07238-10_Emerson_DeltaV System_Report
Emerson Process
Management Delta V
System, Electromagnetic
Compatibility and
Environmental Test Report
February
16, 2007
[D60] SafetyManual
SIS Accessories,
Installation and Safety
Manual
April
2007
[D61] FMEDA Review for Safety Relay and Voltage
Monitor
FMEDA Review for Safety
Relay and Voltage Monitor
February
23, 2007
[D62] HW Design Review - Safety Relay.doc
HW Design Review Safety
Relay
February
22, 2007
[D63] HW Design Review - Voltage Monitor.doc
HW Design Review
Voltage Monitor
February
22, 2007
[D64] Validation Plan - Safety Relay.doc
Validation Plan Safety
Relay
March 04,
2007
[D65] Validation Plan - Voltage Monitor.doc
Validation Plan Voltage
Monitor
March 24,
2007
[D66] Safety Relay Module Hardware Testplan.doc
KJ2231-EA1 Safety Relay
Module, Hardware Test
Plan
September
14, 2006
[D67] Safety Relay Module Hardware Testplan
Results.doc
KJ2231-EA1 Safety Relay
Module, Hardware Test
Plan Results
September
14, 2006
[D68] Voltage Monitor Accessory Hardware
Testplan.doc
KJ2231-EB1 Voltage
Monitor Accessory,
Hardware Test Plan
September
14, 2006
[D69] Voltage Monitor Accessory Hardware Testplan
Results.doc
KJ2231-EB1 Voltage
Monitor Accessory,
Hardware Test Plan
Results
September
14, 2006
[D70] KJ2231X1 EA1 Safety Relay Module CSA 1010
report 17Feb107.doc
Test Report, IEC 61010-1/
EN 61010-1 for KJ2231X1
EA1 Safety Relay Module
February
17, 2007
[D71] KJ2231X1 EB1 Voltage Monitor Accessory CSA
1010 report 17Feb.doc
Test Report, IEC 61010-1/
EN 61010-1 for KJ2231X1
EB1 Voltage Monitor
Accessory
February
17, 2007
[D72] Review DB 3229_3238_3239.doc
Screenshots of Review DB
indicating documentation of
review and impact analysis
February
23, 2007
[D73] SIS VMon Diagnostic.doc
SIS Voltage Monitor, Fault
February
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5,
Diagnostic Performance
19, 2007
[D74] VM SR Preliminary Test Plan.doc
SLS Accessory Module
Test Plan Proposal
April
2007
16,
[D75] Validation Plan Summary- Safety Relay
16Apr2007.doc,
Validation Plan SummarySafety Relay
April
2007
16,
[D76] Validation Plan Summary- Voltage Monitor
16Apr2007.doc
Validation Plan SummaryVoltage Monitor
April
2007
16,
[D77] Validation Plan Test Log - Safety Relay.doc,
Validation Plan Test Log Safety Relay
April
2007
16,
[D78] Validation Plan Test Log - Voltage Monitor.doc,
April 16, 2007
Validation Plan Test Log Voltage Monitor
April
2007
16,
© exida Certification
Michael Medoff
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Page 10 of 25
2.4.2 Documentation generated by exida
[R1]
DeltaV Change Audit.xls
Detailed safety case documenting results of first
assessment (internal document)
[R2]
DeltaV V11 Change
Audit.xls
Detailed safety case documenting results of second
assessment (internal document)
[R3]
Emerson 07-11-05 R002
V1 R1 IEC 61508
Assessment.doc
IEC 61508 Functional Safety Assessment, DeltaV SIS
(Previous version of this report)
[R4]
Emerson 09-10-23 R001
V0 R1 IEC 61508
Assessment.docx
IEC 61508 Functional Safety Assessment, DeltaV SIS
(This report)
[R5]
FRS 04-09-22 R001 V3R3
FMEDA DeltaV SIS.pdf,
April 6, 2010
Emerson FRS 06-11-27
R002 V1 R1 FMEDA
Voltage Monitor Module,
April 4, 2007
Failure Modes Effects and Diagnostic Analysis: DeltaV SIS
Safety PLC
[R7]
FRS Voltage Monitor and
Safety Relay Fault
Injection Tests, March 26,
2007
FRS Voltage Monitor and Safety Relay Fault Injection
Tests performed at Fisher-Rosemount Systems, Inc. on
February 23, 2007.
[R8]
FRS 06-05-30 R002 v10
SafetyCase Review, April
9, 2007
Fisher-Rosemount Systems, Inc. IEC 61508 Compliance
Assessment, SafetyCaseDB Review
[R6]
© exida Certification
Michael Medoff
FMEDA report, Fisher-Rosemount Systems, Inc. DeltaV
SIS Voltage Monitor
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3 Product Description
The DeltaV SIS SLS1508 is a safety logic solver. The DeltaV SLS1508 is classified as a Type B1
device according to IEC 61508, with an advanced hybrid architecture having a hardware fault
tolerance of 1-detected failures / 0 – undetected failures. DeltaV SIS Relay Modules, DeltaV SIS
Relay Diode Module, and DeltaV SIS Voltage Monitor are accessories that can be used with the
DeltaV SLS1508 logic solver. The DeltaV SIS Relay Modules, DeltaV SIS Relay Diode Module,
and DeltaV SIS Voltage Monitor are classified as Type A2 devices according to IEC 61508, having
a fault tolerance of 0. Fisher-Rosemont Systems, Inc. is the original designer and manufacturer of
the DeltaV SIS, DeltaV SIS Relay Modules, DeltaV SIS Relay Diode Module, and DeltaV SIS
Voltage Monitor modules.
3.1 DeltaV SIS Logic Solver
The DeltaV SIS Logic Solver is a compact logic solver that can handle up to 16 I/O channels in any
combination of HART AI, HART AO, DI and DO including line fault detection on all I/O. The DeltaV
SLS1508 hardware version assessed is 4.0 and the software versions assessed are 2.1.0.5 and
3.1.0.7. The versions covered by this assessment include 4.0 and higher for hardware, and 2.1.0.5
and higher for software.
3.2 DeltaV SIS Relay Modules
The DeltaV SIS Relay Modules are suitable for use in both high and low demand safety
applications, to extend the voltage and current capability of the DeltaV SLS1508 discrete output
and to provide logic inversion for energize to trip applications. The modules are capable of
switching up to 2.5A at 250VAC or 2.5A at 24VDC for safety applications.
3.3 DeltaV SIS Relay Diode Module
The DeltaV SIS Relay Diode Module allows monitoring of field wiring when the output is not
actuated.
3.4 DeltaV SIS Voltage Monitor
The DeltaV SIS Voltage Monitor (model number KJ2231X1 – EB1) provides two independent sets
of voltage monitoring circuitry in one device where each is suitable for use in both high and low
demand de-energize to trip applications to extend the voltage input monitoring capability of the
SLS1508. It also supplies a secondary output for non-safety critical monitoring for each input.
1
Type B sub(system): “Complex” sub(system) (using microcontrollers or programmable logic); for details
see 7.4.3.1.3 of IEC 61508-2
2
Type A sub(system): “Non-complex” sub(system) with well defined failure modes; for details see 7.4.3.1.2
of IEC 61508-2
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Page 12 of 25
The state of both outputs for an associated input is controlled by the voltage level of the input with
the outputs going to the de-energized state when the input goes below a specified value.
It is designed to be used with DeltaV SLS1508 to drive a logic solver’s discrete input channel or a
series 2 DI dry contact channel based on the output of the SIS Relay Module. The Voltage Monitor
has the following connections:
• Two four pin connection blocks, one for each voltage monitoring channel for
connection to DC or AC power source being monitored.
• Two four pin connection blocks , one for each voltage monitoring channel for
connecting the output to a SLS monitored DI channel and a DI, dry contact channel.
The DeltaV SIS Voltage Monitor hardware revision covered by this assessment is revision A or
higher.
© exida Certification
Michael Medoff
emerson 09-10-23 r001 v1 r1 iec 61508 assessment.doc, 5/13/2010
Page 13 of 25
4 IEC 61508 Functional Safety Assessment
The IEC 61508 Functional Safety Assessment was performed based on the information received
from Emerson and is documented here.
4.1 Methodology
As part of the IEC 61508 functional safety assessment the following aspects have been reviewed:
•
•
Development process, including:
o
Functional Safety Management, including training and competence recording, FSM
planning, and configuration management
o
Specification process, techniques and documentation
o
Validation activities, including development test procedures, test plans and reports,
production test procedures and documentation
o
Verification activities and documentation
o
Modification process and documentation
o
Installation, operation, and maintenance requirements, including user documentation
Product design
o
•
Hardware architecture and failure behavior, documented in a FMEDA
A representative subset of all changes made in comparison to the modification requirements
of IEC 61508 (Section 7.8 of part 2 and 7.8 of part 3).
4.2 Assessment level
The DeltaV SIS, DeltaV SIS Relay Module, DeltaV SIS Relay Diode Module and DeltaV SIS
Voltage Monitors have been assessed per IEC 61508 to Safety Integrity Level 3.
The development procedures have been assessed as suitable for use in applications with a
maximum Safety Integrity Level of 3 (SIL3) according to IEC 61508 (see [D10])
© exida Certification
Michael Medoff
emerson 09-10-23 r001 v1 r1 iec 61508 assessment.doc, 5/13/2010
Page 14 of 25
5 Results of the IEC 61508 Functional Safety Assessment
exida-certification assessed the development process used by Fisher-Rosemount Systems, Inc.
during the DeltaV SIS logic solver IEC 61508 certification against the objectives of IEC 61508 parts
1, 2, and 3, see [D48]. The development of the DeltaV SIS, DeltaV SIS Relay Modules, DeltaV SIS
Relay Diode Module and, DeltaV SIS Voltage Monitor modules was done per this IEC 61508 SIL 3
compliant development process. The Safety Case created for the DeltaV SIS logic solver was
updated with DeltaV SIS Safety Relay and DeltaV SIS Voltage Monitor design documents, see
[R8]. The main difference between the DeltaV SIS logic solver Safety Case and the DeltaV SIS
Safety Relay and DeltaV SIS Voltage Monitor Safety Case, apart from different design documents,
is that the DeltaV SIS Safety Relay and DeltaV SIS Voltage Monitor are simple electrical devices
that do not comprise of any software. Consequently software development specific objectives of
IEC 61508 are ruled not applicable.
In addition, exida assessed a representative subset off changes made by Fisher-Rosemount
Systems, Inc. for recent releases against the modification procedures of IEC 61508 parts 2 and 3.
These assessments were done remotely in May and June of 2008 and then again in March and
April of 2010. Additionally, a detailed modification safety case was completed for the modifications
(See [R2]).
5.1 Lifecycle Activities and Fault Avoidance Measures
Fisher-Rosemount Systems, Inc. has an IEC 61508 compliant development process as assessed
during the IEC 61508 certification of the DeltaV SIS logic solver. This compliant development
process is documented in [D48]. For the DeltaV SIS Safety Relay and DeltaV SIS Voltage Monitor
no software is part of the design and therefore any requirements specific from IEC 61508 to
software and software development do not apply.
This functional safety assessment has shown that the process sufficiently meets the requirements
of IEC 61508 SIL 3. The assessment investigated the compliance with IEC 61508 of the processes,
procedures and techniques as implemented for the Fisher-Rosemount Systems, Inc. development.
The investigation was executed using subsets of the IEC 61508 requirements tailored to the SIL 3
work scope of the development team. The result of the assessment can be summarized by the
following observations:
The audited Fisher-Rosemount Systems, Inc. development process complies with the
relevant managerial requirements of IEC 61508 SIL 3.
5.1.1 Functional Safety Management
FSM Planning
The functional safety management of any DeltaV development is governed by the DeltaV PMP
(Project Management Plan). For each development Fisher-Rosemount Systems, Inc. creates a
Work Package Plan (WPP), see [D50], with specific deliverables, reviews and approvals. This
process and procedures referenced herein fulfill the requirements of IEC 61508 with respect to
functional safety management.
Version Control
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All documents as called out for in the Delta V PMP and the Work Package Plan are under version
control as documented in [D48]. Design drawings and documents are also under version control.
Fisher-Rosemount Systems, Inc. uses SourceSafe for its version control.
Training, Competency recording
Personnel training records are kept in accordance with IEC 61508 requirements as documented in
[D48]. Fisher-Rosemount Systems, Inc. hired exida-certification to be the independent assessor per
IEC 61508.
5.1.2 Safety Requirements Specification and Architecture Design
The first step for any new development is the creation of a Design Specification per the Work
Package Plan [D50]. The creation of the design specifciation is a combined effort by marketing and
engineering. This ensures that the design requiremetns are understood correctly by engineering.
For IEC 61508 developments the requirements document, Safety Requirements Specification see
[D49], is reviewed by exida-consulting. During the assessment, exida-certification reviewed the
content of the specification for completeness per the requirements of IEC 61508.
As the DeltaV SIS Safety Relay and DeltaV SIS Voltage Monitor are simple electrical devices, there
is no need for a separate architecture design phase, although design concepts where created as
required by the Work Package Plan [D50].
Requirements as specified in the Design Specification are tracked through all development phases,
simply by the fact that the DeltaV SIS Relay Modules, DeltaV SIS Relay Diode, and DeltaV SIS
Voltage Monitor are very simple electrical devices. The Safety Requirements are part of the
hardware design review checklist to ensure that designs comply with the Safety Requirements
Specification.
Items from IEC 61508-2, Table B.1 include project management, documentation, separation of
safety requirements from non-safety requirements, structured specification, and inspection of the
specification. As the functions of the DeltaV SIS Relay Modules, DeltaV SIS Relay Diode, and
DeltaV SIS Voltage Monitor are simple and clearly defined there is no need for semi-formal
methods such as functional block diagrams. The application is considered when specifying the
requirements; the devices may be required to meet specific applications standards. This meets SIL
3.
5.1.3 Hardware Design
The hardware design process consists of two distinct phases: design phase and pilot phase. During
the design phase all possible solutions are reviewed and the most promising is detailed, see [D58].
At this time Circuit Description and Component Drawings are created, 3rd Party Certification is
decided on and Prototype Test Planning is performed. The prototype testing is considered part of
the verification activities per IEC 61508.
In the pilot phase, the design is further detailed and testing is performed on prototype units. Design
reviews are performed per the Work Package Plan [D50], see also [D62] and [D63]. FisherRosemount Systems, Inc. has standards for documentation with specified output documents.
Development tools to be used are documented in the DeltaV PMP as documented in [D48].
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Items from IEC 61508-2, Table B.2 include observance of guidelines and standards, project
management, documentation (design outputs are documented per the Work Package Plan and
other quality guidelines), structured design, modularization, use of well-tried components, and
computer-aided design tools. This meets SIL 3.
5.1.4 Validation
Validation Testing is done via a set of documented tests. The DeltaV SIS Safety Relay and DeltaV
SIS Voltage Monitor Work Package Plan [D50] requires a validation plan for both the DeltaV SIS
Relay Modules and the DeltaV SIS Voltage Monitor, see [D64] and [D65]. The validation tests are
traceable to the Safety Requirements Specification [D49], see [D77] and [D78]. In addition to
standard Test Specification Documents third party testing may be included as part of agency
approvals. As the DeltaV SIS Relay Modules, DeltaV SIS Relay Diode, and DeltaV SIS Voltage
Monitor are simple electrical devices with a straightforward safety function, there is no separate
integration testing necessary. The DeltaV SIS Relay Modules, DeltaV SIS Relay Diode, and DeltaV
SIS Voltage Monitor perform only 1 safety function, which is extensively tested under various
conditions during validation testing.
Procedures are in place for corrective actions to be taken when tests fail as documented in [D48].
Items from IEC 61508-2, Table B.3 include functional testing, project management, documentation,
and black-box testing (for the considered devices this is similar to functional testing). Field
experience and statistical testing via regression testing are not applicable. This meets SIL 3.
Items from IEC 61508-2, Table B.5 included functional testing and functional testing under
environmental conditions (see also [D70] and [D71]), fault insertion testing, project management,
documentation, failure analysis (analysis on products that failed), and expanded functional testing
and black-box testing. This meets SIL 3.
5.1.5 Verification
The development and verification activities are defined in the Work Package Plan [D50]. For each
phase the objectives are stated, required input and output documents and review activities. Several
checklists are included in the Work Package Plan to ensure completeness of the verification
activities. All verification activities are documented. Given the DeltaV SIS Relay Modules, DeltaV
SIS Relay Diode, and DeltaV SIS Voltage Monitor only perform a single safety function, this meets
SIL 3.
5.1.6 Modifications
5.1.6.1 Detailed Specification of the Modification or Change (Part 2, Section 7.8.2.1a)
Detailed specifications of all modifications are included in the impact analysis document and in the
Issue Tracking Database.
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5.1.6.2 Impact Analysis (Part 2, Section 7.8.2.1b)
All changes include a detailed safety impact analysis. The impact analysis details which phases of
the development process need to be repeated and what output is required from each phase. The
impact analysis is documented in multiple independent documents (See [D1], [D45], and [D46]). A
listing of all changed software modules is included in the review database (See [D24] and [D36]).
5.1.6.3 Approvals for changes (Part 2, Section 7.8.2.1c)
Approvals for all changes are documented in the issue tracking database.
5.1.6.4 Progress of Changes (Part 2, Section 7.8.2.1d)
Progress of all changes is documented via the change history in the issue tracking database.
5.1.6.5 Test Cases Including Revalidation Data (Part 2, Section 7.8.2.1e)
Integration test cases are documented in the issue tracking database. Validation test cases are
documented in the validation test plans.
5.1.6.6 E/E/PES configuration management history (Part 2, Section 7.8.2.1f)
Configuration Management history is documented via the version control system for all changes. In
addition, all documents include the configuration management history within the document.
5.1.6.7 Deviation from normal operations and conditions (Part 2, Section 7.8.2.1g)
Deviations from normal operations and conditions is discussed in the impact analysis for all
changes
5.1.6.8 Necessary changes to system procedures (Part 2, Section 7.8.2.1h)
Any changes to system procedures are documented in the impact analysis.
5.1.6.9 Necessary changes to documentation (Part 2, Section 7.8.2.1i)
All necessary documentation changes are included in the impact analysis
5.1.6.10 Modifications shall be performed with at least the same level of expertise,
automated tools (see 7.4.4.2 of IEC61508-3), and planning and management as the
initial development of the E/E/PE safety-related systems (Part 2, Section 7.8.2.3)
Management assures that changes are carried out by qualified engineers. For this project, all
engineers had been involved in the initial development. The Project Plan documents which fixes
will be assigned to each release. The issue tracking system is used to track work assignments.
Identical tools to the original development were used.
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5.1.6.11 Evidence that Change was re-verified (Part 2, Section 7.8.2.4)
All changes had appropriate verification steps carried out. Verification included inspection, testing,
and static analysis. Action items from inspections were tracked to closure.
5.1.6.12 For SIL 3, Entire System Must be validated (Table A.8)
Complete validation test plan was run successfully after the changes were made (See [D3] through
[D9], and [D38] through [D43] )
5.1.6.13 A modification shall be initiated only on the issue of an authorized software
modification request under the procedures specified during safety planning (Part 3,
Section 7.8.2.1)
All software changes are submitted to the issue tracking system and authorized by the
development manager.
5.1.6.14 All modifications which have an impact on the functional safety of the
E/E/PE safety-related system shall initiate a return to an appropriate phase of the
software safety lifecycle. All subsequent phases shall then be carried out in
accordance with the procedures specified for the specific phases in accordance with
the requirements in this standard. Safety planning (see clause 6) should detail all
subsequent activities (Part 3, Section 7.8.2.5)
The impact analysis documents which phases need to be repeated and the phases are carried out
according to standard procedures.
5.1.6.15 The safety planning for the modification of safety-related software shall
include identification of staff and specification of their required competency. (Part 3,
7.8.2.6a)
This identification of staff is documented in the issue tracking system. Required competency is not
specifically documented, but the changes were made by experienced developers from the original
development team.
5.1.6.16 The safety planning for the modification of safety-related software shall
include a detailed specification for the modification (Part 3, Section 7.8.2.6b)
This information was included in the issue tracking system and the impact analysis document.
5.1.6.17 The safety planning for the modification of safety-related software shall
include verification planning (Part 3, Section 7.8.2.6c)
This information was included in the impact analysis document.
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5.1.6.18 The safety planning for the modification of safety-related software shall
include the scope of re-validation and testing of the modification to the extent
required by the safety integrity level. For SIL 3 entire system must be revalidated.
(Part 3, Section 7.8.2.6d)
The impact analysis stated that the entire system would be revalidated.
5.1.6.19 Modification shall be carried out as planned (Part 3, Section 7.8.2.7)
Documentation in the issue tracking system showed that all of the work was carried out as planned.
5.1.6.20 Details of all modifications shall be documented, including references to
the modification/retrofit request (Part 3, Section 7.8.2.8a)
The impact analysis references the modification request via the issue ID from the issue tracking
system (Unique identifier for each software change request).
5.1.6.21 Details of all modifications shall be documented, including references to
the results of the impact analysis which assesses the impact of the proposed
software modification on the functional safety, and the decisions taken with
associated justifications; (Part 3, Section 7.8.2.8b)
The impact analysis documentation contains this information.
5.1.6.22 Details of all modifications shall be documented, including references to
software configuration management history (Part 3, Section 7.8.2.8c)
The software configuration management history is documented and stored in the version control
system.
5.1.6.23 Details of all modifications shall be documented, including references to
deviation from normal operations and conditions (Part 3, Section 7.8.2.8d)
This was documented in the impact analysis.
5.1.6.24 Details of all modifications shall be documented, including references to all
documented information affected by the modification activity (Part 3, Section
7.8.2.8e)
The impact analysis included a listing of all documents that would be updated based on this
change.
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5.1.6.25 Information (for example a log) on the details of all modifications shall be
documented. The documentation shall include the re-verification and revalidation of
data and results. (Part 3, Section 7.8.2.9)
Details of all modifications are included in the impact analysis and the issue tracking system.
Documentation exists for re-verification (test reports, review reports, and static analysis results) and
re-validation (test reports).
5.1.6.26 The assessment of the required modification or retrofit activity shall be
dependent on the results of the impact analysis and the software safety integrity
level. (Part 3, Section 7.8.2.10)
The assessment of the modifications was based on the results of the impact analysis
5.1.7 User documentation
Fisher-Rosemount Systems, Inc. created a combined Installation and Safety Manual for the DeltaV
SIS Safety Relay and DeltaV SIS Voltage Monitor modules, see [D60]. This safety manual was
assessed by exida-certification. The final version is considered to be in compliance with the
requirements of IEC 61508. The document includes all required reliability data and operations,
maintenance, and proof test procedures.
Items from IEC 61508-2, Table B.4 include operation and maintenance instructions, user
friendliness, maintenance friendliness, project management, documentation, limited operation
possibilities (the DeltaV SIS Relay Modules, DeltaV SIS Relay Diode, and DeltaV SIS Voltage
Monitor perform well-defined actions) and operation only by skilled operators (operators familiar
with type of devices, although this is partly the responsibility of the end-user). This meets SIL 3.
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5.2 Hardware Assessment
To evaluate the hardware design of the DeltaV SIS, DeltaV SIS Relay Modules, DeltaV SIS Relay
Diode Module, and DeltaV SIS Voltage Monitor, a Failure Modes, Effects, and Diagnostic Analysis
was performed. This is documented in [R5], and [R6]. The FMEDA was verified using Fault
Injection Testing as part of the development, see [D55], and as part of the IEC 61508 assessment,
see [R7].
A Failure Modes and Effects Analysis (FMEA) is a systematic way to identify and evaluate the
effects of different component failure modes, to determine what could eliminate or reduce the
chance of failure, and to document the system in consideration. An FMEDA (Failure Mode Effect
and Diagnostic Analysis) is an FMEA extension. It combines standard FMEA techniques with
extension to identify online diagnostics techniques and the failure modes relevant to safety
instrumented system design.
From the FMEDA failure rates are derived for each important failure category. Table 1 lists these
failure rates as reported in the FMEDA reports. The failure rates are valid for the useful life of the
devices, which are defined as in the FMEDA reports [R5] and [R6] as approximately 10 years. This
information is listed in the Safety Manual, see [D60].
Table 1: Failure rates for Simplex Safety PLC according to IEC 61508
(*Note that the SD and SU category includes failures that do not cause a spurious trip)
λsd
λsu3
λdd3
λdu
Common (DET)
1,343 FIT
761 FIT
932 FIT
3.4 FIT
Common (ET)
1,091 FIT
694 FIT
1,251 FIT
4.0 FIT
AI Channel
31 FIT
45 FIT
20 FIT
0.006 FIT
DI Channel
39 FIT
49 FIT
13 FIT
0.0 FIT
AO Channel
31 FIT
45 FIT
20 FIT
0.006 FIT
DO Channel (DET)
26 FIT
15 FIT
10 FIT
0 FIT
DO Channel (ET)
16 FIT
12 FIT
17 FIT
0.3 FIT
Relay Module
21 FIT
93 FIT
10 FIT
40 FIT
Relay Diode Module
6 FIT
6 FIT
10 FIT
11 FIT
Voltage Monitor Module
1 FIT
134 FIT
0 FIT
0.72 FIT
Failure Categories
NOTE: SD = SD + AD, SU = SU + AU + NE, DD = DD, DU = DU
.
3
Note that the SD and SU category includes failures that do not cause a spurious trip
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These results must be considered in combination with PFDAVG or PFH values of other devices of a
Safety Instrumented Function (SIF) in order to determine suitability for a specific Safety Integrity
Level (SIL). The Safety Manual states that the application engineer should calculate the PFDAVG or
PFH for each defined safety instrumented function (SIF) to verify the design of that SIF.
The architectural constraints requirements of IEC 61508-2, Table 2 are also reviewed. The DeltaV
SIS Safety PLC is classified as a Type B device according to IEC 61508, having a
hardware fault tolerance of 1 for detected failures (99%+) and a hardware fault tolerance of 0 for
undetected failures (1%-). The analysis shows that the system has a safe failure fraction > 99%
and therefore per even worst case assumptions, the non-redundant unit may be used up to SIL
3 based on architecture constraints. For redundant use, common cause failures between the Relay
Modules and the Voltage Monitors have to be considered. The user of the DeltaV SIS Relay
Modules and DeltaV SIS Voltage Monitor needs to determine the application specific common
cause factor β.
The analysis shows that design of The DeltaV SIS, DeltaV SIS Relay Modules, DeltaV SIS
Relay Diode Module, and DeltaV SIS Voltage Monitor meets the hardware requirements of
IEC 61508 SIL 3 when used as a single element (HFT = 0).
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6 Terms and Definitions
DET
De-energize to trip
ET
Fault tolerance
Energize to trip
Ability of a functional unit to continue to perform a required function in the
presence of faults or errors (IEC 61508-4, 3.6.3)
Failure In Time (1x10-9 failures per hour)
Failure Mode Effect and Diagnostic Analysis
Hardware Fault Tolerance
Mode, where the frequency of demands for operation made on a safetyrelated system is no greater than twice the proof test frequency.
Average Probability of Failure on Demand
Safe Failure Fraction summarizes the fraction of failures, which lead to a
safe state and the fraction of failures which will be detected by diagnostic
measures and lead to a defined safety action.
Safety Instrumented Function
Safety Integrity Level
FIT
FMEDA
HFT
Low demand mode
PFDAVG
SFF
SIF
SIL
SIS
Safety Instrumented System – Implementation of one or more Safety
Instrumented Functions. A SIS is composed of any combination of
sensor(s), logic solver(s), and final element(s).
Type A (sub)system
“Non-Complex” (sub)system (using discrete elements); for details see
7.4.3.1.2 of IEC 61508-2
“Complex” (sub)system (using micro controllers or programmable logic); for
details see 7.4.3.1.3 of IEC 61508-2
Type B (sub)system
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7 Status of the document
7.1 Liability
exida prepares reports based on methods advocated in International standards. Failure rates are
obtained from a collection of industrial databases. exida accepts no liability whatsoever for the use
of these numbers or for the correctness of the standards on which the general calculation methods
are based.
7.2 Releases
Version:
Revision:
Version History:
Authors:
Review:
Release status:
V1
R1
V0, R1:
Draft; April 22, 2010
Michael Medoff
V0, R1: Dr. William Goble; May 5, 2010
Draft
7.3 Future Enhancements
At request of client.
7.4 Release Signatures
Dr. William M. Goble, Principal Partner
Michael Medoff, Senior Safety Engineer
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