Results of the IEC 61508 Functional Safety Assessment Project: DeltaV SIS with Electronic Marshalling Customer: Emerson Process Management Fisher Rosemount Systems Austin, TX USA Contract No.: Q15/09-137 Report No.: FRS 11-03-091 R002 Version V1, Revision R5, June 14, 2016 Michael Medoff, John Yozallinas 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 with Electronic Marshalling and the addition of Local Safety Network Gateway (LSNG) and I/O CHARMs. The functional safety assessment performed by exida consisted of the following activities: - exida assessed the development process used by Emerson Process Management, Fisher Rosemount Systems, through an audit and creation of a detailed safety case against the requirements of IEC 61508:2010. - exida performed a detailed Failure Modes, Effects, and Diagnostic Analysis (FMEDA) of the devices to document the hardware architecture and failure behavior. This included detailed Markov models of the fault tolerant architectures done in order to show accurate average probability of failure on demand. - exida assessed the product features and capabilities according a series of Application Standards for the logic solver portion of a system. The Application Standards included: NFPA 72:2007, NFPA 85:2007, NFPA86:2011, NFPA87:2011, EN50156-1:2004, EN54-2-A1:2006, EN50402-1-A1:2004, and EN298:2012. The functional safety assessment was performed to the SIL 3 requirements of IEC 61508:2010. A full IEC 61508 safety case was prepared using the exida SafetyCase audit tools. Hardware and software process requirements and all associated documentation were reviewed. Also, the user documentation (safety manual) was reviewed. The results of the Functional Safety Assessment can be summarized by the following statements: The audited development process, as tailored and implemented by the Fisher Rosemount Systems DeltaV SIS with Electronic Marshalling development project, complies with the relevant safety management requirements of IEC 61508 SIL 3. The assessment of the FMEDA shows that the DeltaV SIS with Electronic Marshalling was found to meet the requirements of SIL 3, single use (HFT = 1 or 0). DeltaV SIS with Electronic Marshalling was found to meet the specific logic solver requirements of the listed system Application Standards. The Local Safety Network Gateway (LSNG) is limited to a maximum of SIL 2 with HFT =0. The manufacturer will be entitled to use the Functional Safety Logos. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 2 of 22 Table of Contents Management summary .................................................................................................... 2 1 Purpose and Scope ................................................................................................... 4 1.1 Tools and Methods used for the assessment ................................................................ 4 2 Project management .................................................................................................. 5 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 .................................................................... 9 2.5 Assessment Approach ................................................................................................... 9 2.1 2.2 2.3 2.4 3 Product Description .................................................................................................. 11 4 IEC 61508 Functional Safety Assessment ............................................................... 13 4.1 Assessment level ......................................................................................................... 13 5 Results of the IEC 61508 Functional Safety Assessment ........................................ 14 5.1 Lifecycle Activities and Fault Avoidance Measures ..................................................... 14 5.1.1 Functional Safety Management......................................................................... 14 5.1.2 Safety Requirements Specification and Architecture Design ............................ 15 5.1.3 Hardware Design............................................................................................... 15 5.1.4 Software (Firmware) Design.............................................................................. 16 5.1.5 Validation........................................................................................................... 16 5.1.6 Verification......................................................................................................... 17 5.1.7 Modifications ..................................................................................................... 17 5.1.8 User documentation .......................................................................................... 18 5.2 Hardware Assessment ................................................................................................. 19 6 Terms and Definitions .............................................................................................. 20 7 Status of the document ............................................................................................ 21 7.1 7.2 7.3 7.4 Liability ......................................................................................................................... 21 Releases ...................................................................................................................... 21 Future Enhancements .................................................................................................. 21 Release Signatures ...................................................................................................... 22 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 3 of 22 1 Purpose and Scope This document shall describe the results of a full safety assessment and renewal surveillance audit by exida according to the necessary functional safety standard IEC 61508:2010, parts 1-7. It also includes relevant application standards: NFPA 72:2007, NFPA 85:2007, NFPA86:2011, NFPA87:2011, EN50156-1:2004, EN54-2-A1:2006, EN50402-1-A1:2004, and EN298:2012. The full safety assessment includes an assessment of all fault avoidance and fault control measures during hardware and software development. Supporting documents are listed in section 2.4.1. The assessment has been carried out based on the quality procedures and scope definitions of exida The results of this assessment provide the safety instrumentation engineer with the required failure data as per IEC 61508 / IEC 61511 and confidence that sufficient attention has been given to systematic failures during the development process of the device. 1.1 Tools and Methods used for the assessment This assessment was carried by using the exida Safety Case tool. The Safety Case tool contains the exida scheme which includes all the relevant requirements of IEC 61508. For the fulfillment of the objectives, expectations are defined which builds the acceptance level for the assessment. The expectations are reviewed to verify that each single requirement is covered. Because of this methodology, comparable assessments in multiple projects with different assessors are achieved. The arguments for the positive judgment of the assessor are documented within this tool and summarized within this report. The assessment was planned by exida agreed with Emerson Process Management by proposal. All assessment steps were continuously documented by exida (see [R4] and [R20]). © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 4 of 22 2 Project management 2.1 exida is one of the world’s leading accredited Certification Bodies and knowledge 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 system consulting services, safety lifecycle engineering tools, detailed product assurance, cyber-security and functional safety certification, and a collection of on-line safety and reliability resources. exida maintains a comprehensive failure rate and failure mode database on process equipment based on 150 billion hours of field failure data. 2.2 Roles of the parties involved Emerson Process Management Manufacturer of the DeltaV SIS with Electronic Marshalling exida Performed the Functional Safety Assessment 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 61508:2010 (Parts 1 - 7) Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems 2.4 Reference documents 2.4.1 Documentation provided by Emerson Process Management Reference Number Document Name ( [Dxxx] =SCDB log entry in [R4] ) Revision; Date [D01] Functional Safety Management Plan: DeltaV CHARMs SIS 3.2; 11/26/2012 [D100] Safety Measures Integration Test Results NA; 11/23/2012 [D110] EMC Test Results 0; 12/13/2012 [D111] Validation Test Results 7; 1/11/2013 [D119a] DeltaV CHARMs SIS SRS Validation Test Plan Review Checklist NA; 11/7/2012 [D160] DeltaV SIS Charms Safety Manual November 2012: Draft 1; 11/11/2012 [D180] Emerson Impact Analysis Process Template NA; 9/15/2011 [D189] exida Modification Phase Verification Checklist NA; 10/12/2012 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 5 of 22 [D23] C/C++ Software Coding Standards 1.0; 4/25/2011 [D30] DeltaV CHARTMs SIS Safety Requirements Specification 2.6; 01/08/2013 [D35] SIS CHARMs SRS Validation Test Plan 4; 11/29/2012 [D36] Emerson Safety Validation Test Plan Review Checklist A; 11/7/2012 [D39] Safety Measures Module Test Results Template 0.0; 11/6/2012 [D40] DeltaV CHARMs SIS System Description 1.19; 11/21/2012 [D41.1] Integration Test Plan/Results - Delta V CHARMs SIS - Inc 4 NA; 8/17/2012 [D41] Integration Test Plan Overview 0.2; 11/15/2012 [D43] Derived Requirements Document - included in [D30] [D49] Emerson System Architecture Review Checklist - Delta V SIS CHARMs [D50] Detailed Design Description - Documented in many documents duch as D50a [D50a] KL2001X1 CSLS / SZ Controller Hardware Specification A; 9/27/2012 [D51] CSLS Secure Data Item Safety Communications Analysis V1R2; 4/16/2011 [D53] Fault Injection Test Plan - stored in multiple documents such as D53a. [D53a] CSLS Product Fault List [D55] Schematics [D56] Emerson Integration Test Overview Template 0.0; 4/27/2011 [D57] Emerson Safety Requirments Specificaton Template 0.01; 5/17/2011 [D58] DeltaV CHARMs SIS Project Support Tools 2.0; 12/3/2012 [D59] Technology Program Management Plan (PMP) NA; 11/8/2012 [D60] IEC 61508 Tables 2.2; 11/12/2012 [D61] Fault Injection Test Results NA; 11/29/2012 [D70] DeltaV CHARMs SIS Software Architecture Description 2.9; 6/27/2011 [D71] Detailed Software Design Specification - documented in many documents [D71a] CSLS Common Subsystem Design 1.5; 11/12/2012 [D77] QMS0539: Report on C Compiler Validation for the Neutrino RTOS Safe Kernel 3.0; 10/24/2012 [D79a] Delta V Charms SIS software architecture and design verification checklist NA; 11/20/2012 [D81] Code Review and Module Test Verification Report NA; 12/19/2012 [D82] Module Testing Overview 1.0; 11/26/2012 [D83] QCC Toolchain Qualification Report 1.1; 11/30/2012 © exida Michael Medoff, John Yozallinas NA; 11/20/2012 NA; 11/7/2012 frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 6 of 22 [D84] Microsoft Visual Studio CL Compiler Tool Chain Qualification Report 1..0; 11/30/2012 [D85] LS DVC Hardware Desing Checklist 1.0; 12/3/2012 [D86] LS DOUT HW Design Checklist 1.0; 12/3/2012 [D87] CSLS Hardware Design Review Checklist 1.1; 12/3/2012 [D91] Module Test Records - various records reviewed during on-site audit [D92] DeltaV SIS CHARMs On-site Assessment Summary NA; 12/5/2012 [D94] Verification Plan NA; 01/10/2013 [D95] Detailed Integration Test Procedures [D96] Detailed Validation Test Procedures [D161a] Delta V CHARMs SIS Safety Manual Review Checklist (Completed) 0.1; 7/31/2012 [D107] Delta V Technology Incident Management Guidelines D; 11/1/2011 2.4.1.1 Updated Documentation provided by Emerson Process Management Reference Number Document Name ( [Dxx] =SCWB log entry in [R20] ) Revision; Date D200 Functional Safety Management Plan: DeltaV CHARMs SIS [D26] 3.14; 4/8/2015 D201 DeltaV SIL2 Verification Plan [D29] For v13.3; Apr.2015 D202 DeltaV CHARMs SIS Safety Requirements Specification [D40] 3.7; SEP.2014 D203 Overall Traceability [D56] NA; Mar.2015 D204 Software Test Coverage Analysis [D57] 1.3; Dec.2014 D205 LSNG Code Review Example [D58] ID 1835; Nov.2014 D206 SIS Design And Coding Standard [D60] 2; Apr.2015 D207 SIS Standard Lint Results [D62] NA; Mar.2015 D208 LSNG Software Module Test Results [D66] 1.3; 4/9/2015 D209 LSNG Safety Integration Test Results [D68] 1.0.0.62; 1/23/2015 D210 SRS Validation Test Plan Review [D70] G; 3/31/2015 D211 SRS Validation Test Results [D74] 14; 3/30/2015 D212 DeltaV SIS Charms Safety Manual [D79] NA; Dec.2014 D213 Safety Manual Review [D80] D214 ECRN 22282.pdf [D81] NA; Dec.2014 NA; May.2014 D215 ECRN 22108.pdf [D81b] NA; Jul.2013 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 7 of 22 D216 ECRN 22180.pdf [D81c] NA; Jan.2014 D217 D218 ECRN 22282.pdf [D81d] Impact Analysis ECRN 22082 22083.pdf [D88] NA; May.2014 NA; May.2013 D219 Impact Analysis ECRN 22108.pdf [D88b] NA; Jun.2013 D220 Impact Analysis ECRN 22180.pdf [D88c] NA; Jan.2014 D221 Impact Analysis ECRN 22282.pdf [D88d] NA; Apr.2014 D222 DeltaV SIS with Electronic Marshalling.xlsx [D30] NA; Jun.2016 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 8 of 22 2.4.2 Documentation generated by Reference Document Name Number Revision; Date [R1] FRS 11-03-091 R002 V1R5 IEC 61508 Assessment DeltaV SIS ElecMarsh.doc (This Report) [R2] Item Deleted [R3] DeltaV SIS Failure Modes, Effects and Diagnostics Analysis (FMEDA) Report V1R4; 3/14/2013 [R4] DeltaV SIS CHARMs IEC 61508 SafetyCaseDB NA; 1/11/2013 [R5] exida Configuration Management Checklist NA; 7/18/2011 [R6] exida Software Tool Checklist for DeltaV v12 project NA; 12/5/2012 [R7] exida Integration Test Execution Phase Checklist NA; 12/5/2012 [R8] exida Validation Test Execution Phase Checklist NA; 12/21/2012 [R9] exida FSM Planning Phase Verification Checklist for Emerson Systems DeltaV CHARMs SIS NA; 12/3/2012 [R10] exida Functional Safety Assessment Phase Verification Checklist NA; 12/6/2012 [R11] exida Safety Manual Checklist NA; 12/3/2012 [R12] exida SRS Document Checklist NA; 11/13/2012 [R13] exida Integration Test Plan Checklist NA; 12/5/2012 [R14] exida Derived Requirements Document Checklist NA; 7/19/2011 [R15] exida Hardware Development Phase Verification Checklist NA; 12/21/2012 [R16] exida System Architecture Phase Verification Checklist NA; 11/8/2012 [R17] exida Software Architecture and Design Phase Checklist NA; 12/21/2012 [R18] exida Implementation Phase Verification Checklist NA; 12/5/2012 [R19] FRS11-03-091 R001 V3R3 FMEDA DeltaV SIS™ with Electronic Marshalling (updated) V3R3; 11/13/2015 [R20] DeltaV SIS CHARMs IEC 61508 Safety Case WB V2R1; 6/9/2016 [R21] FRS 1509137 R001 V1R0 DeltaV SIS Field Failure Analysis Sheet V1R0, 6/7/2016 V1R5; 6/14/2016 2.5 Assessment Approach The certification audit was closely driven by requirements of the exida scheme which includes subsets filtered from IEC 61508. The assessment was planned by exida and agreed with Fisher Rosemount Systems. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 9 of 22 The following IEC 61508 objectives were subject to detailed auditing at Fisher Rosemount Systems: FSM planning, including o Safety Life Cycle definition o Scope of the FSM activities o Documentation o Activities and Responsibilities (Training and competence) o Configuration management o Tools and languages Safety Requirement Specification Change and modification management Software architecture design process, techniques and documentation Hardware architecture design - process, techniques and documentation Hardware design / probabilistic modeling Hardware and system related V&V activities including documentation, verification o Integration and fault insertion test strategy Software and system related V&V activities including documentation, verification System Validation including hardware and software validation Hardware-related operation, installation and maintenance requirements The project teams, not individuals, were audited. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 10 of 22 3 Product Description DeltaV SIS with Electronic Marshalling is a safety critical control system for general safety market use. It consists of a simplex or redundant CSLS controller and one or more single-channel I/O CHARMs. Up to 96 CHARMs can be connected to a controller. The parts included in the assessment are those in the blocks “CSLS”, “LSNG”, and “I/O Charms” in Figure 1. Figure 1 DeltaV SIS with Electronic Marshalling System Parts included in the Assessment The Local Safety Network Gateway (LSNG) is a SIL 2 gateway that allows the DeltaV SIS with Electronic Marshalling System to connect to third party Modbus devices to read safety critical data. It resembles a Local Safety Network Bridge (LSNB) in some operations, but is specific to Fire and Gas applications. The LSNG will read data from a pair of Modbus devices that are each reading the same sensor data. It will then compare the data and form secure parameters from it and transmit them on the Local Safety Network for use by CSLSs. The secure parameters it chooses to transmit are configured by the user and the DeltaV Database. Table 1 gives an overview of the different components that were considered at the time of the Assessment of DeltaV SIS with Electronic Marshalling. Contact the manufacturer for the latest versions of these components. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 11 of 22 Table 1 Component Overview Product Type Number Description HW Revision SW/FW Revision KL2001X1-BA1 CHARMS Smart Logic Solver (CSLS) 1.x 1.1.x.x KL3001X1-LS1 LS DI NAMUR CHARM 1.x 1.x 1.x KL3003X1-LS1 LS DI 24 VDC low-side sense (Dry 1.x Contact) CHARM KL3005X1-LS1 LS DI 24 VDC Isolated CHARM 1.x 1.x KL3011X1-LS1 LS DI 120 VAC Isolated 1.x 1.x KL3012X1-LS1 LS DI 230 VAC Isolated 1.x 1.x KL3302X1-BA1 LS DO 24 VDC DTA CHARM 1.x 1.x Redundant 1.x 1.x KL3302X1-BB1 LS DO CHARM KL3302X1-BC1 LS DO 24 VDC ETA CHARM 1.x 1.x Redundant 1.x 1.x KL3302X1-BD1 LS DO CHARM KL3322X1-BA1 LS DVC HART DTA CHARM 1.x 1.x Redundant 1.x 1.x KL3322X1-BB1 LS DVC CHARM KL3021X1-LS1 LS AI 4-20 mA HART CHARM 1.x 1.x KL3032X1-LS1 LS Thermocouple/mV CHARM 1.x 1.x KL3031X1-LS1 LS RTD CHARM 1.x 1.x KL3023X1-LS1 LS AI 0-10 VDC Isolated CHARM 1.x 1.x KL3103X1-LS1 IS LS DI NAMUR CHARM 1.x 1.x KL3101X1-LS1 IS LS AI 4-20 mA HART CHARM 1.x 1.x KL3007X1-LS1 LS 24 VDC Power CHARM 1.x 1.x KL3105X1-LS1 IS LS CHARM THERMOCOUPLE mV 1.x 1.x KL3106X1-LS1 IS LS CHARM RTD Resistance 1.x 1.x KL2001X1-BC1 Local Safety Network Gateway (LSNG) 1.x 1.x 24 VDC 24 VDC HART DTA ETA DTA DeltaV SIS with Electronic Marshalling is classified as a Type B1 element according to IEC 61508, having a hardware fault tolerance of 0. Type B element: “Complex” element (using micro controllers or programmable logic); for details see 7.4.4.1.3 of IEC 61508-2, ed2, 2010. 1 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 12 of 22 4 IEC 61508 Functional Safety Assessment The IEC 61508 Functional Safety Assessment was performed based on the information received from Fisher Rosemount Systems and is documented here. 4.1 Assessment level The DeltaV SIS with Electronic Marshalling has 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 (SIL 3) according to IEC 61508. The Local Safety Network Gateway (LSNG) is limited to a maximum of Safety Integrity Level 2 (SIL 2) according to IEC 61508. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 13 of 22 5 Results of the IEC 61508 Functional Safety Assessment exida assessed the development process used by Fisher Rosemount Systems during the DeltaV SIS with Electronic Marshalling product development and maintenance against the objectives of the exida certification scheme which includes IEC 61508 parts 1, 2, and 3. The development of the DeltaV SIS with Electronic Marshalling modules was done per this IEC 61508 SIL 3 compliant development process. A Safety Case [R4] and [R20] were created to show compliance with IEC 61508. 5.1 Lifecycle Activities and Fault Avoidance Measures Fisher Rosemount Systems has an IEC 61508 compliant development process as assessed during the IEC 61508 certification of the DeltaV SIS with Electronic Marshalling. This compliant development process is documented in [D01] and [D59]. 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 development. The assessment was executed using the exida certification scheme which includes subsets of 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 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 Functional Safety Management Team (FSMT). For each development Fisher Rosemount Systems creates a Functional Safety Management Plan (FSMP), see [D01] and D200, with specific deliverables, reviews and approvals. This process and procedures referenced herein fulfill the requirements of IEC 61508 with respect to functional safety management. Configuration Management Formal configuration control is defined and implemented for Change Authorization, Version Control, and Configuration Identification. A documented procedure exists to ensure that only approved items are delivered to customers. Master copies of the software and all associated documentation are kept during the operational lifetime of the released software. Formal configuration control of requirements only is started once those requirements have been approved (See section 2.2.6 of the FSM plan). Formal configuration control of all other deliverables occurs when the validation phase starts as defined in section 2.2 of FSM plan. The engineering design database (EDD) keeps track of all hardware drawings and versions including schematics and bills of material. For software, section 4.4 of the FSM plan discusses how a branch is made for each release of software. A version label is created for that branch and the constituent parts that make up the software (source code files) can be found on this branch. For hardware, items cannot be released to or from manufacturing without an ECRN, D214-D217, which must be approved. For software, © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 14 of 22 unauthorized changes will be flagged to the FSMT and to the person who made the change via email as described in section 2.2.5 of FSM plan. Training, Competency recording Section 6 of the FSM plan describes the procedures to ensure that all persons are competent relevant to the specific duties that they have to perform. Competency Assessment will occur at the beginning of each project and whenever there is a change in project staff. 5.1.2 Safety Requirements Specification and Architecture Design As defined in [D59] a safety requirements specification (SRS) is created for all products that must meet IEC 61508 requirements. For the DeltaV SIS with Electronic Marshalling, the requirements specification [D30] contains a system design requirements and constraints, user programming configuration constraints, safety subsystem interface constraints, and derived requirements for hardware and software. During the assessment, exida reviewed the content of the specification for completeness per the requirements of IEC 61508. All software safety requirements trace to software architecture, or software design or safety manual. Reverse traceability is achieved in the system architecture specification by listing the safety requirement for each that drives each safety measure. Requirements from IEC 61508-2, Table B.1 that have been met by Fisher Rosemount Systems include project management, documentation, structured specification, inspection of the specification, semi-formal methods, and checklists. Requirements from IEC 61508-3, Table A.1 that have been met by Fisher Rosemount Systems include semi-formal methods, forward traceability between the system safety requirements and the software safety requirements, and backward traceability between the safety requirements and the perceived safety needs. [D60] documents more details on how each of these requirements has been met. This meets the requirements of 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. 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 Functional Safety Management Plan [D01], using the hardware design checklist (see [D87] for example). Hardware changes to the DeltaV SIS with Electronic Marshalling system have been reviewed and there are no significant effects on the existing FMEDA [R19]. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 15 of 22 Items from IEC 61508-2, Table B.2 that have been met by Fisher Rosemount Systems include observance of guidelines and standards, project management, documentation, structured design, modularization, use of well-tried components, semi-formal methods, checklists, inspection of the hardware or walk-through of the hardware, and computer-aided design tools. This meets SIL 3. 5.1.4 Software (Firmware) Design Software (firmware) design is done according to [D59]. The software design process includes software architecture design and peer review, detailed design and peer review, critical code reviews, static source code analysis and module test. Software changes to the DeltaV SIS with Electronic Marshalling system have been reviewed and there are no significant effects on the existing safety functions. Requirements from IEC 61508-3, Table A.2 that have been met by Fisher Rosemount Systems include fault detection and diagnosis, error detecting and correcting codes, failure assertion programming, diverse monitor techniques, retry fault recovery mechanisms, graceful degradation, modular approach, use of trusted/verified software elements, forward and backward traceability between the software safety requirements specification and software architecture, semi-formal methods, computer-aided specification and design tools, cyclic behavior, with guaranteed maximum cycle time, time-triggered architecture, and static resource allocation. Requirements from IEC 61508-3, Table A.3 that have been met by Fisher Rosemount Systems include suitable programming language, strongly typed programming language, language subset, certified tools and translators, and tools and translators: increased confidence from use. Requirements from IEC 61508-3, Table A.4 that have been met by Fisher Rosemount Systems include semi-formal methods, computer aided design tools, defensive programming, modular approach, design and coding standards, structured programming, use of trusted/verified software modules and components, and forward traceability between the software safety requirements specification and software design. This is also documented in [D60]. This meets the requirements of SIL 3. 5.1.5 Validation Validation Testing is done via a set of documented tests. Microsoft Test Manager is used to document all safety validation tests. These tests are exported to a spreadsheet which documents a snapshot of the safety validation test plan [D35]. An independent Verification and Validation team has confirmed that all safety requirements are covered by one or more tests (See [D94]). A number of validation tests were witnessed by the assessor during an on-site audit. Procedures are in place for corrective actions to be taken when tests fail as documented in [D01]. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 16 of 22 Items from IEC 61508-2, Table B.5 that have been met by Fisher Rosemount Systems include functional testing and functional testing under environmental conditions, interference surge immunity testing, fault insertion testing, project management, documentation, static analysis, dynamic analysis and failure analysis, expanded functional testing, black-box testing, “Worst-case” testing, and field experience. This meets SIL 3. Items from IEC 61508-3, Table A.7 that have been met by Fisher Rosemount Systems include process simulation, modelling, functional and black box testing, forward traceability between the software safety requirements specification and the software safety validation plan, and backward traceability between the software safety validation plan and the software safety requirements specification. 5.1.6 Verification The development and verification activities are defined in the Functional Safety Management Plan [D01]. For each phase the objectives are stated, required input and output documents and review activities. A number of checklists are referenced in the FSM Plan to ensure completeness of the verification activities. During the assessment it was verified that all of these checklists were completed. All verification activities are documented. This meets the requirements for SIL 3. 5.1.7 Modifications The modification process has been successfully assessed and audited, Fisher Rosemount Systems may make modifications to this product as needed. Modifications are done per the Fisher Rosemount Systems change management process as documented in the Functional Safety Management Plans. Impact analyses, D218-D222, are performed for all changes once the product is released for integration testing. The results of the impact analysis are used in determining whether to approve the change. The standard development process as defined in [D59] is then followed to make the change. The handling of hazardous field incidents and customer notifications is governed by [D107]. This procedure includes identification of the problem, ranking of the problem, analysis of the problem, identification of the solution, and communication of the solution to the field. This meets the requirements of IEC 61508 SIL 3. As part of the exida scheme a surveillance audit is conducted prior to renewal of the certificate. The modification documentation listed below is submitted as part of the surveillance audit. exida will review the decisions made by the competent person in respect to the modifications made. o List of all anomalies reported and failure analysis samples o List of all modifications completed o Safety impact analysis which shall indicate with respect to the modification: o The initiating problem (e.g. results of root cause analysis) The effect on the product / system The elements/components that are subject to the modification The extent of any re-testing List of modified documentation © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 17 of 22 Requirements from IEC 61508-3, Table A.8 that have been met by the Fisher Rosemount Systems modification process include impact analysis, re-verify changed software modules, reverify affected software modules, regression validation, software configuration management, data recording and analysis, and forward and backward traceability between the software safety requirements specification and the software modification plan (including re-verification and revalidation). This meets the requirements of SIL 3. 5.1.8 User documentation Fisher Rosemount Systems created a Safety Manual for the DeltaV SIS with Electronic Marshalling, see [D160]. This safety manual was assessed by exida. 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 operation only by skilled operators, and protection against operator mistakes. This meets SIL 3. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 18 of 22 5.2 Hardware Assessment To evaluate the hardware design of the DeltaV SIS with Electronic Marshalling a Failure Modes, Effects, and Diagnostic Analysis was performed. This is documented in [R3] and [R19]. The FMEDA was verified using Fault Injection Testing which has been automated as part of the safety validation testing, see [D53]. The fault injection testing was witnessed as part of the on-site audit performed by exida. 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. All failure rates are included in the exSILentia tool from exida. The failure rates are valid for the useful life of the devices, which are defined as in the FMEDA report as approximately 50 years. The architectural constraints requirements of IEC 61508-2, Table 2 are also reviewed. The DeltaV SIS with Electronic Marshalling is classified as a Type B device according to IEC 61508. The system can be configured with redundant CSLS modules as well as redundant CHARMS. Therefore, based on configuration the system can have a hardware fault tolerance (HFT) of 0 or 1. The analysis shows that the system has a safe failure fraction > 90% for all configurations and therefore per even worst case assumptions, the non-redundant unit may be used up to SIL 2 and a redundant unit may be used up to SIL 3 based on architecture constraints. Some configurations of the system will also result in a safe failure fraction > 99% which means that such a system may be used up to SIL 3 as a non-redundant unit, based on architectural constraints. For redundant use, common cause failures 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 with Electronic Marshalling, meets the hardware requirements of IEC 61508 SIL 3 when used as a single element (HFT = 0) in certain configurations. The Local Safety Network Gateway (LSNG) is limited to a maximum of SIL 2 with HFT =0. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 19 of 22 6 Terms and Definitions CHARM I/O CHARacterization Module Fault tolerance 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) FIT Failure In Time (1x10-9 failures per hour) FMEDA Failure Mode Effect and Diagnostic Analysis HFT Hardware Fault Tolerance Low demand mode Mode where the demand interval for operation made on a safety-related system is greater than twice the proof test interval. High demand mode Mode where the demand interval for operation made on a safety-related system is less than 100x the diagnostic detection/reaction interval, or where the safe state is part of normal operation. PFDAVG Average Probability of Failure on Demand PFH Probability of dangerous Failure per Hour SFF 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. SIF Safety Instrumented Function SIL Safety Integrity Level 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 element “Non-Complex” element (using discrete components); for details see 7.4.4.1.2 of IEC 61508-2 Type B element “Complex” element (using complex components such as micro controllers or programmable logic); for details see 7.4.4.1.3 of IEC 61508-2 © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 20 of 22 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: V1 Revision: R5 Version History: V1, R5: certification renewal, added Emerson documents supporting the reassessment and updated SCWB [R20] in doc list; updated contract number and [R21]; 14-Jun-2016, JCY V1, R4: added LSNG and 2 new I/O, added FMEDA report [R19] and SCWB [R20] in doc list; 1-May-2015, JCY V1, R3: updated [R3] FMEDA report in doc list and updated report per V4R1 type B template, 2-Oct-2014, JCY V1, R2: Updated product list and corrected errors, Feb. 25, 2013 V1, R1: Updated per final testing and witnessed validation test audit, Feb. 14, 2013 V0, R2: Updated document versions based on updated documents received from Emerson; January 11, 2013 V0, R1: Draft; December 26, 2012 Authors: Michael Medoff, John Yozallinas Review: V1, R5; Ted Stewart, exida, 6-10-2016 Release status: Released 7.3 Future Enhancements At request of client. © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 21 of 22 7.4 Release Signatures Michael Medoff, Senior Safety Engineer John Yozallinas, CFSE, Senior Safety Engineer Ted E. Stewart, CFSP, Program Development & Compliance Manager © exida Michael Medoff, John Yozallinas frs 11-03-091 r002 v1r5 iec 61508 assessment deltav sis elecmarsh.doc, Page 22 of 22