Results of the IEC Functional Safety Assessment. ABB, Inc. Baton Rouge, LA USA

Transcription

1 Results of the IEC Functional Safety Assessment Project: MT5000, MT5100 and MT5200 Level Transmitter Customer: ABB, Inc. Baton Rouge, LA USA Contract No.: Q Report No.: ABB R001 Version V3, Revision R1, November 1, 2016 Gregory Sauk - David Butler 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.

2 Management Summary The Functional Safety Assessment of the ABB, Inc. MT5000, MT5100 and MT5200 Level Transmitter development project, performed by exida consisted of the following activities: - exida assessed the development process used by ABB, Inc. through an audit and review of a detailed safety case against the exida certification scheme which includes the relevant requirements of IEC The assessment was executed using subsets of the IEC requirements tailored to the work scope of the development team. - exida reviewed and assessed a detailed Failure Modes, Effects, and Diagnostic Analysis (FMEDA) of the devices to document the hardware architecture and failure behavior. - exida reviewed field failure data to verify the accuracy of the FMEDA analysis. The functional safety assessment was performed to the SIL 3 requirements of IEC 61508:2010. A full IEC Safety Case was created using the exida Safety Case tool, which also was used as the primary audit tool. Hardware and software process requirements and all associated documentation were reviewed. Environmental test reports were reviewed. The user documentation and safety manual also were 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 ABB, Inc. MT5000, MT5100 and MT5200 Level Transmitter development project, comply with the relevant safety management requirements of IEC SIL 3. The assessment of the FMEDA, done to the requirements of IEC 61508, has shown that the MT5000, MT5100 and MT5200 Level Transmitter can be used in a low demand safety related system in a manner where the PFD AVG is within the allowed range for SIL 2 (HFT=0), according to table 2 of IEC The assessment of the FMEDA also shows that the MT5000, MT5100 and MT5200 Level Transmitter meets the requirements for architectural constraints of an element such that it can be used to implement a SIL 2 safety function (with HFT = 0) or a SIL 3 safety function (with HFT = 1). This means that the MT5000, MT5100 and MT5200 Level Transmitter is capable for use in SIL 3 applications in Low demand mode when properly designed into a Safety Instrumented Function per the requirements in the Safety Manual and when using the versions specified in section 3.1 of this document. T-034 V5R1 80 N. Main St, Sellersville, PA Page 2 of 21

3 The manufacturer will be entitled to use the Functional Safety Logos. Manufacturing Facilities are located in Prairieville, LA and Shanghai, China. T-034 V5R1 80 N. Main St, Sellersville, PA Page 3 of 21

4 Table of Contents Management Summary Purpose and Scope Tools and Methods used for the assessment Project Management exida Roles of the parties involved Standards / Literature used Reference documents Documentation provided by ABB, Inc Documentation generated by exida Assessment Approach Product Description Hardware and Software Version Numbers IEC Functional Safety Assessment Scheme Product Modifications Results of the IEC Functional Safety Assessment Lifecycle Activities and Fault Avoidance Measures Functional Safety Management Safety Requirement Specification Change and modification management Hardware Design and Verification Hardware Design Hardware Design / Probabilistic properties Software Design Verification Safety Validation Safety Manual IEC Functional Safety Surveillance Audit Roles of the parties involved Surveillance Methodology Documentation provided by ABB, Inc Surveillance Documentation generated by exida Surveillance Results Procedure Changes Engineering Changes Impact Analysis Field History T-034 V5R1 80 N. Main St, Sellersville, PA Page 4 of 21

5 6.3.5 Safety Manual FMEDA Update Previous Recommendations Terms and Definitions Status of the document Liability Version History Future Enhancements Release Signatures T-034 V5R1 80 N. Main St, Sellersville, PA Page 5 of 21

6 1 Purpose and Scope This document shall describe the results of the IEC functional safety assessment of the: Model Descriptions MT5000 Guided Wave Radar Level Transmitter MT5100 MT5200 Guided Wave Radar Level and Interface Transmitter Guided Wave Radar Bulk Solids Level Transmitter by exida according to the accredited exida certification scheme which includes the requirements of IEC 61508:2010. The purpose of the assessment was to evaluate the compliance of: - the MT5000, MT5100 and MT5200 Level Transmitter with the technical IEC and -3 requirements for SIL 3 and the derived product safety property requirements and - the MT5000, MT5100 and MT5200 Level Transmitter development processes, procedures and techniques as implemented for the safety-related deliveries with the managerial IEC , -2 and -3 requirements for SIL 3. and - the MT5000, MT5100 and MT5200 Level Transmitter hardware analysis represented by the Failure Mode, Effects and Diagnostic Analysis with the relevant requirements of IEC 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 per IEC / IEC 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 out using the exida Safety Case tool. The Safety Case tool contains the exida scheme which includes all the relevant requirements of IEC 61508:2010. 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. All assessment steps were continuously documented by exida (see [R3]) T-034 V5R1 80 N. Main St, Sellersville, PA Page 6 of 21

7 2 Project Management 2.1 exida 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 100 billion hours of field failure data. 2.2 Roles of the parties involved ABB, Inc. Transmitters exida exida Manufacturer of the MT5000, 5100 and MT5200 Level Performed the hardware assessment [R3] Performed the Functional Safety Assessment [R1] per the accredited exida scheme. ABB, Inc. contracted exida with the IEC 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 (Parts 1-3): 2010 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems 2.4 Reference documents Documentation provided by ABB, Inc. [D1] QM-0001D, Rev D, 10/13/2011 [D2] QMP-0003K, Rev K, 8/19/2011 [D3] QMP-0008D, Rev D, 1/17/2012 [D4] QMP-0010D, Rev D, 9/13/2012 [D5] QMP-0018C, Rev C, 11/27/2012 [D6] QMP-0023G, Rev G, 9/13/2012 K-TEK Corporation Quality Manual Quality Management Plan Procedure, Control of Documents Quality Management Plan Procedure, Design & Development Quality Management Plan Procedure, Supplier Selection and Evaluation Quality Management Plan Procedure, Control and Monitoring of Measuring Devices Quality Management Plan Procedure, Control of Nonconforming Products T-034 V5R1 80 N. Main St, Sellersville, PA Page 7 of 21

8 [D7] QMP-0026, Rev A, 3/26/2007 [D8] PRC0077, Rev A, 4/3/2008 [D9] PRC0078, Rev A, 5/6/2008 [D10] PRC0079, Rev A, 4/29/2008 [D11] PRC0080, Rev A, 3/28/2008 [D12] PRC0081, Rev NC, 4/22/2008 [D13] PRC0082, Rev A, 4/7/2009 [D14] FRM-0708, Rev B, 5/2/2008 [D15] PNP , Rev NC, 4/15/2008 [D16] FRM-0008, Rev NA, 2/26/2008 [D17] PNP PL, Rev NC, 4/15/2008 [D18] PNP , Rev NC, 4/22/08 [D19] PNP , Rev NC, 4/24/2008 [D20] PNP , Rev NC, 4/24/08 [D21] PNP , Rev NC, 5/6/2008 [D22] PNP , Rev NC, 4/29/2008 [D23] PNP A, Rev A, 5/6/2008 [D24] PNP , Rev NC, 4/22/2008 [D25] PNP , Rev NC, 4/21/2008 [D26] PNP , Rev NC, 4/29/2008 [D27] PNP , Rev NC, 4/29/2008 [D28] PNP , Rev NC, 4/2/2008 [D29] PNP , Rev NC, 3/31/08 [D30] PNP , Rev NC, 4/2/2008 [D31] PNP , Rev NC, 4/24/2008 [D32] PNP , Rev NC, 4/22/2008 [D33] FRM-0708B , 8/6/2010 Quality Management Plan Procedure, Corrective and Preventive Action Quality Procedure, Software Coding & Style Guidelines Quality Procedure, Software Design & Development Procedure Quality Procedure, Functional Safety Management Plan Quality Procedure, Safety Requirements Review Checklist Quality Procedure, Safety Critical Tools Qualification Quality Procedure, R&D Group Qualification Record Design Project Records Template for General Arrangement Drawings New Product Release Checklist Top Level Parts List Construction Table Template Template for Safety Requirements Specifications Template for Integration & Validation Test Plan Template for Functional Safety Documentation Checklists Template for Impact Analysis Template for Modification & Change of Design Project Records Template for Architecture Design Overview High Level UML & Sub Assemblies Template for Hardware Design Template for Software Configuration Record Template for Software Design Review Template for Software & Critical Code Review Template for Architecture Design & SW HW Interface Review Template for Safety Requirements Review per PRC0080 Checklist Template for Safety Integration & Validation Test Plan Review Template for Safety Manual Review Template for Integration & Validation Testing MT5000 Design Project Records T-034 V5R1 80 N. Main St, Sellersville, PA Page 8 of 21

9 [D34] MT , Rev F, February 2009 [D35] MT , Rev F, February 2009 [D36] MT , Rev E, January 2008 [D37] MT , Rev A, April 2009 Data Sheet, MT5000 Data Sheet, MT5100 Data Sheet, MT5200 Installation and Operational Manual, MT5000 [D38] MT f, Rev E, 4/1/2010 MT5000 Series IOM/Safety Manual (Draft) [D39] MT , Rev NC, September 2005 [D40] MT , Rev A, March 2009 [D41] MT , Rev NC, 5/3/2010 [D42] MT , Rev A, 6/14/2010 [D43] MT , Rev NC, 5/25/2010 [D44] MT , Rev NC, 3/8/2010 [D45] MT , Rev NC, 6/10/2010 [D46] MT , Rev NC, 6/22/2010 [D47] MT , 8/11/2010 [D48] MT , Rev NC, 6/8/2010 [D49] MT , Rev NC, 5/20/2010 [D50] MT , Rev NC, 2/20/2010 [D51] MT , Rev NC, 6/20/2010 [D52] MT , Rev NC, 5/24/2010 [D53] MT , Rev NC, 5/5/2010 [D54] MT , Rev NC, 6/20/2010 Installation and Operational Manual, MT5100 Installation and Operational Manual, MT5200 MT5000 Series General Specifications Requirements MT5000 Series Safety Requirements Specification MT5000 Series Level Transmitters Integration and Validation Test Plan MT5000 Series SIL 2 Project Plan (Phase 1) MT5000 Series Modification Impact Analysis MT5000 Series Modification Impact Analysis - BBTC3 MT5000 Series Architecture UML Design Overview MT5000 Software Configuration Record MT5000 Software Design Review MT5000, MT5100,& MT5200 Series Software & Safety Critical Code Review MT5000, MT5100 & MT5200 Architecture Design & SW/HW Interface Review MT5000 Series Requirements Review per Checklist - Completed MT5000 Series SIL 2 Safety Integration and Validation Test Plan Review MT5000 Integration and Validation Testing Results T-034 V5R1 80 N. Main St, Sellersville, PA Page 9 of 21

10 [D55] MT A, Rev A, 6/22/2010 [D56] MT B, 6/24/2010 [D57] ELE1032, Rev B, November 7, 2005 [D58] MT , Rev B, 11/11/2005 [D59] Field_failure_analysis_KTEK_ABB_ MT_ _Update.xls, 8/19/2013 [D60] SPM efm, October 15, 2008 [D61] MT jcg after FI.efm, 9/1/09 [D62] MT jcg after FI with added diagnostics.efm, 8/5/10 [D63] SPM C.efm, October 15, 2008 [D64] SPM B.efm, October 15, 2008 [D65] Probe_Assembly FMEDA R3-gps, 9/3/09 [D66] TAB, 8/4/2010 [D67] PMU 10, Rev G, March 5, 2013 [D68] ITP , Rev 0 [D69] Production Doc Package, Rev01 [D70] Engineering Change Documentation MT5000 Integration and Validation Testing Results Addendum MT5000 BBTC3 RAM tests after code correction Block Diagram, MT5000, MT5100, MT5200, /M6 /M7 /M7A /M7B Intrinsically Safe Modules MT5000, MT5100, MT5200 Series General Assembly and Options Field Failure Analysis PIU spreadsheet Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series EPROM / Connector Board Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series Radar Transmit/Receive Module Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series uprocessor Board Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series HART Interface Board Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series SPM201 Electronics Failure Modes, Effects, and Diagnostic Analysis MT5x00 Transmitter Series Probe Assembly IEC Tables, document shows all tables from IEC Annex A and B from part 2 and part 3 along with a description as to how ABB, Inc. meets each of the requirements Supply Management Procedure Inspection Test Plan, Magnetic Level Gauge Production Document Package Form Engineering Changes, including impact analysis documentation Documentation generated by exida [R1] [R2] [R3] KTEK R001 V1 R3 FMEDA Report MT5x00.doc, 8/6/2010 MT5000_Fault_Injection_report_ xls, 6/17/10 K-TEK MT5x00 SafetyCase DB IEC61508 R2.esc, August 2010 FMEDA Report MT5000 Series Guided Wave Radar Level Transmitters Fault Injection Test report for MT5x00 Series IEC SafetyCaseDB for MT5000, 5100 and MT5200 Level Transmitters T-034 V5R1 80 N. Main St, Sellersville, PA Page 10 of 21

11 [R4] [R5] KTEK R001 V2R1 MT5x00 IEC Assessment.doc, 11/11/2013 Field_failure_analysis_KTEK_ABB_ MT_ _Update.xls IEC Functional Safety Assessment for MT5000, MT5100 and MT5200 Level Transmitter (This document) Field failure analysis. 2.5 Assessment Approach The certification audit was closely driven by requirements of the exida scheme which includes subsets filtered from IEC The assessment was planned by exida and agreed with ABB, Inc.. The following IEC objectives were subject to detailed auditing at ABB, Inc.: FSM planning, including o o o o o o Safety Life Cycle definition Scope of the FSM activities Documentation Activities and Responsibilities (Training and competence) Configuration management 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. T-034 V5R1 80 N. Main St, Sellersville, PA Page 11 of 21

12 3 Product Description The MT5000 Series Level Transmitters are a series of two-wire 4 20 ma smart devices. It contains self-diagnostics and is programmed to send its output to a specified failure state, either high or low, upon internal detection of a failure. For safety instrumented systems usage it is assumed that the 4 20 ma output is used as the primary safety variable. Figure 1 shows an overview of the main parts of the MT5000 Series Level Transmitters and the boundary for the Failure Modes, Effects, and Diagnostic Analysis. SIGNAL CONDITIONING PROCESSOR OUTPUT CURRENT GENERATION, POWER SUPPLY 4-20mA USER INTERFACE HART (optional) PROBE EXTENT OF FMEDA Figure 1 MT500, MT5100, and MT5200 SIS Assembly Table 1 gives an overview of the different versions that were considered in this assessment of the MT5000, MT5100 and MT5200 Level Transmitters. Table 1 Models Overview MT5000 MT5100 MT5200 Guided Wave Radar Level Transmitter Guided Wave Radar Level and Interface Transmitter Guided Wave Radar Bulk Solids Level Transmitter The MT5000 Series Level Transmitters are classified as a Type B device according to IEC 61508, having a hardware fault tolerance of Hardware and Software Version Numbers This assessment is applicable to the following hardware and software versions of MT5000, 5100 and MT5200 Level Transmitters: T-034 V5R1 80 N. Main St, Sellersville, PA Page 12 of 21

13 MT5000 Series Level Transmitters Options: 4-20mA output, single output Hardware Processor board #: MT Revision Level: G Signal conditioning board #: MT Display board #: MT Connector board #: SPM Hart Board #: SPM Software/Firmware Revision Level: E Revision Level: C Revision Level: E Revision Level: F 4 IEC Functional Safety Assessment Scheme exida assessed the development process used by ABB, Inc. for this development project against the objectives of the exida certification scheme. The results of the assessment are documented in [R3][R1]. All objectives have been successfully considered in the ABB, Inc. development processes for the development. exida assessed the set of documents against the functional safety management requirements of IEC 61508:2010. An evaluating assessor created a safety case, to argue that the relevant requirements of IEC to -3 have been met, based on documented the evidence provided. An independent certifying assessor then reviews the safety case to ensure coverage of the requirements and the validity of the arguments. Additionally, an audit is performed to witness development and manufacturing environments and techniques to ensure procedures are being followed and that certain testing is carried out successfully. The detailed assessment evaluated the compliance of the processes, procedures and techniques, as implemented for the ABB, Inc. MT5000, 5100 and MT5200 Level Transmitters, with IEC The assessment was executed using the exida certification scheme which includes subsets of the IEC requirements tailored to the work scope of the development team. The result of the assessment shows that the MT5000, 5100 and MT5200 Level Transmitters are capable for use in SIL 3 (Systematic Capability is SC3) applications, when properly designed into a Safety Instrumented Function per the requirements in the Safety Manual. 4.1 Product Modifications The modification process has not yet been assessed and audited, so modifications are not currently covered by this assessment. No modifications are permitted to the certified versions of the MT5000, 5100 and MT5200 Level Transmitters without reassessment. 5 Results of the IEC Functional Safety Assessment exida assessed the development process used by ABB, Inc. during the product development against the objectives of the exida certification scheme which includes IEC parts 1, 2, & 3 [N1]. The development of the MT5000, 5100 and MT5200 Level Transmitters was done per this IEC SIL 3 compliant development process. The Safety Case was updated with project specific design documents. T-034 V5R1 80 N. Main St, Sellersville, PA Page 13 of 21

14 5.1 Lifecycle Activities and Fault Avoidance Measures ABB, Inc. has an IEC compliant development process as assessed during the IEC certification. This compliant development process is documented in [D3]. This functional safety assessment evaluated the compliance with IEC of the processes, procedures and techniques as implemented for the product development. The assessment was executed using the exida certification scheme which includes subsets of IEC 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 development process complies with the relevant managerial requirements of IEC SIL Functional Safety Management FSM Planning The functional safety management of any ABB, Inc. Safety Instrumented Systems Product development is governed by QMP-0008B Quality Management Plan Procedure, Design & Development [D3]. ABB, Inc. has a Functional Safety Management Plan Quality Procedure, PRC0079A [D10] which is fixed but requires the creation of Design Project Records per FRM-0708 [D14] for each development which defines all of the tasks that must be done to ensure functional safety as well as the person(s) responsible for each task. These processes, and the procedures referenced herein, fulfill the requirements of IEC with respect to functional safety management. Version Control All documents are under version control as documented in [R3] and required by the Control of Documents Quality Management Plan Procedure [D2]. Design drawings and documents are also under version control, using a version control software application. Training, Competency recording Personnel training records are kept in accordance with IEC requirements as documented in [R3] and PRC0082 the R&D Group Qualification Record Quality Procedure [D13]. ABB, Inc. hired exida as an independent assessor, per IEC Safety Requirement Specification As defined in [D10] and [D14], a safety requirements specification (SRS) is created for all products that must meet IEC requirements. The requirements specification contains a scope and safety requirements section. For the MT5000, 5100 and MT5200 Level Transmitters, the SRS [D42] has been assessed. Safety requirements are tracked, throughout the development process, by the creation of derived requirements. Safety requirements are mapped to the design, and to the appropriate validation tests in the validation test plan [D53]. Requirements from IEC , Table B.1 that have been met by ABB, Inc. include project management, documentation, separation of safety requirements from non-safety requirements, structured specification, inspection of the specification, semi-formal methods and checklists. [D66] documents more details on how each of these requirements has been met. This meets the requirements of SIL 3. T-034 V5R1 80 N. Main St, Sellersville, PA Page 14 of 21

15 5.3 Change and modification management The modification process has been successfully assessed and audited for IEC 61508:2000, but has not yet been assessed for IEC 61508:2010 requirements. ABB, Inc. may not make modifications to this product until that assessment is successfully completed. 5.4 Hardware Design and Verification Objectives The main objectives of the related IEC requirements are to: - Create E/E/PE safety-related systems conforming to the specification for the E/E/PES safety requirements (comprising the specification for the E/E/PES safety functions requirements and the specification for the E/E/PES safety integrity requirements). - Ensure that the design and implementation of the E/E/PE safety-related systems meets the specified safety functions and safety integrity requirements. - Demonstrate, for each phase of the overall, E/E/PES and software safety lifecycles (by review, analysis and/or tests), that the outputs meet in all respects the objectives and requirements specified for the phase. - Test and evaluate the outputs of a given phase to ensure correctness and consistency with respect to the products and standards provided as input to that phase. - Integrate and test the E/E/PE safety-related systems Hardware Design As defined in [D10] and [D14], a safety requirements specification (SRS) is created for all products that must meet IEC requirements. The requirements specification contains a scope and safety requirements section. For the MT5000, 5100 and MT5200 Level Transmitters, the SRS [D42] has been assessed. Safety requirements are tracked, throughout the development process, by the creation of derived requirements. Safety requirements are mapped to the design, and to the appropriate validation tests in the validation test plan [D53]. Requirements from IEC , Table B.1 that have been met by ABB, Inc. include project management, documentation, separation of safety requirements from non-safety requirements, structured specification, inspection of the specification, semi-formal methods and checklists. [D66] documents more details on how each of these requirements has been met. This meets the requirements of SIL Hardware Design / Probabilistic properties To evaluate the hardware design of the MT5100 Series Level Transmitters, a Failure Modes, Effects, and Diagnostic Analysis was performed by exida for each component in the system. This is documented in [R1]. The FMEDA was verified using Fault Injection Testing as part of the development, see [R2], and as part of the IEC assessment. T-034 V5R1 80 N. Main St, Sellersville, PA Page 15 of 21

16 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. These results must be considered in combination with PFD AVG 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 PFD AVG for each defined safety instrumented function (SIF) to verify the design of that SIF. The objectives of the standard are fulfilled by the ABB, Inc. functional safety management system, FMEDA quantitative analysis, and hardware development guidelines and practices. 5.5 Software Design Software design is done according to [D3], [D10], [D14], [D8], and [D9]. The software design process includes software interface specification and detailed module design [D47], specification of configuration records [D48], design and critical code reviews [D49] and [D50], and UML specifications [D47]. Requirements from IEC , Table A.1 through A.5 that have been met by ABB, Inc. include observance of guidelines and standards, project management, documentation, structured design, modularization, use of well-tried components, checklists, semi-formal methods, computer aided design tools, simulation, and inspection of the specification, selection of suitable programming language, use of a defined subset of the language, and others. This meets the requirements of SIL Verification The development and verification activities are defined in [D10] and [D14]. Verification activities include the following: Fault Injection Testing, Code Review [D50] per [D27], Checklists embedded in [D14], and FMEDA [R1]. Further verification activities are documented in [D10] and [D14] for new product development projects. 5.7 Safety Validation Validation Testing is done via a set of documented tests (see [D10] and [D14]). The validation tests are traceable to the Safety Requirements Specification [D42] in the validation test plan [D43]. In addition to standard Test Specification Documents, third party testing may be included as part of agency approvals. As the MT5100 Series Level Transmitters consists of simple electrical devices with a straightforward safety function, integration testing has been limited to verifying that all diagnostics take the appropriate action when they find a problem (See [D54] and [R2] for more details on this testing). Procedures are in place for corrective actions to be taken when tests fail as documented in [R3] and [D7]. T-034 V5R1 80 N. Main St, Sellersville, PA Page 16 of 21

17 Requirements from IEC , Table B.3 that have been met by ABB, Inc. include functional testing, project management, documentation, and black-box testing. Field experience and statistical testing via regression testing are not applicable. [D66] documents more details on how each of these requirements has been met. This meets the requirements of SIL 3. Requirements from IEC , Table B.5 that have been met by ABB, Inc. 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 and black-box testing. [D66] documents more details on how each of these requirements has been met. This meets SIL Safety Manual ABB, Inc. updated the user manual for the MT5100 Series Level Transmitters and incorporated the requirements for the Safety Manual, see [D37] and [D38]. This (safety) manual was assessed by exida. The final version is considered to be in compliance with the requirements of IEC The document includes all required reliability data and operations, maintenance, and proof test procedures. Requirements from IEC , Table B.4 that have been met by ABB, Inc. include operation and maintenance instructions, user friendliness, maintenance friendliness, project management, documentation, limited operation possibilities, protection against operator mistakes, and operation only by skilled operators. [D66] documents more details on how each of these requirements has been met. This meets the requirements for SIL 3. T-034 V5R1 80 N. Main St, Sellersville, PA Page 17 of 21

18 IEC Functional Safety Surveillance Audit 6.1 Roles of the parties involved ABB, Inc. exida exida Manufacturer of the MT5000, 5100 and MT5200 Level Transmitters Performed the hardware assessment review Performed the IEC Functional Safety Surveillance Audit per the accredited exida scheme. ABB, Inc. contracted exida in October 2016 to perform the surveillance audit for the above MT5000, 5100 and MT5200 Level Transmitters. The surveillance audit was conducted remotely in October Surveillance Methodology As part of the IEC functional safety surveillance audit, the following aspects have been reviewed: Procedure Changes Changes to relevant procedures since the last audit are reviewed to determine that the modified procedures meet the requirements of the exida certification scheme. Engineering Changes The engineering change list is reviewed to determine if an of the changes could affect the safety function of the MT5000, 5100 and MT5200 Level Transmitters. Impact Analysis If changes were made to the product design, the impact analysis associated with the change will be reviewed to see that the functional safety requirements for an impact analysis have been met. Field History Shipping and field returns during the certification period will be reviewed to determine if any systematic failures have occurred. If systematic failures have occurred during the certification period, the corrective action that was taken to eliminate the systematic failure(s) will be reviewed to determine that said action followed the approved processes and was effective. Safety Manual The latest version of the safety manual will be reviewed to determine that it meets the IEC requirements for a safety manual. FMEDA Update If required or requested the FMEDA will be updated. This is typically done if there are changes to the IEC standard and/or changes to the exida failure rate database. Recommendations from Previous Audits If there are recommendations from the previous audit, these are reviewed to see if the recommendations have been implemented properly. T-034 V5R1 80 N. Main St, Sellersville, PA Page 18 of 21

19 6.2.1 Documentation provided by ABB, Inc. [D71] MTs with M7A_2016 hours calculated [D72] OI_MT5000-EN_H. Failure return data and shipping records Safety Manual Surveillance Documentation generated by exida [R6] [R7] ABB R001 V1 R5 FMEDA Report MT5x00.doc, 10/27/2016 DRAFT - ABB R001 V3R Assessment Report - MT5x00.docx, 10/31/2016 [R8] ABB V1R Update Analysis MT 5x00.xlsx FMEDA Report MT5000 Series Guided Wave Radar Level Transmitters IEC Assessment Report (this file) Update from ed. 1 to ed. 2 Gap analysis. 6.3 Surveillance Results Procedure Changes There were no changes to the procedures during the previous certification period Engineering Changes There were no safety-related design changes during the previous certification period Impact Analysis There were no safety-related design changes during the previous certification period Field History The field history of the product has been analyzed and found to be consistent with the failure rates predicted by the FMEDA Safety Manual The safety manual was reviewed and found to be compliant with IEC 61508: FMEDA Update No FMEDA update was necessary as there were no safety-related design changes during the certification period. However, the FMEDA report was updated to reflect changes made in the 2010 version of the standard and to add Route 2 H Previous Recommendations There were no previous recommendations to be assessed at this audit. T-034 V5R1 80 N. Main St, Sellersville, PA Page 19 of 21

20 7 Terms and Definitions exida criteria A conservative approach to arriving at failure rates suitable for use in hardware evaluations utilizing the 2 H Route in IEC Fault tolerance FIT FMEDA HFT Low demand mode High demand mode PFD AVG PFH Random Capability SFF SIF SIL SIS Ability of a functional unit to continue to perform a required function in the presence of faults or errors (IEC , 3.6.3) Failure In Time (1x10-9 failures per hour) Failure Mode Effect and Diagnostic Analysis Hardware Fault Tolerance Mode where the demand interval for operation made on a safety-related system is greater than twice the proof test interval. 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. Average Probability of Failure on Demand Probability of dangerous Failure per Hour The SIL limit imposed by the Architectural Constraints for each element. 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 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). Systematic Capability Measure of the confidence that the systematic safety integrity of an element meets the requirements of the specified SIL. Type A element Non-Complex element (using discrete components); for details see of IEC Type B element Complex element (using complex components such as micro controllers or programmable logic); for details see of IEC T-034 V5R1 80 N. Main St, Sellersville, PA Page 20 of 21

21 8 Status of the document 8.1 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. 8.2 Version History Contract Number Report Number, version Q16/ ABB R001 V3R1 Q16/ ABB R001 V3R0 Q13/ KTEK R001 V2R1 Q13/ KTEK R001 V2R0 Q13/ KTEK R001 V1R2 Q10/ KTEK R001 V1R1 Q10/ KTEK R001 V0R1 Revision Notes Changed city to Baton Rouge, DEB, 31-Oct-2016 Revised for surveillance assessment, D. Butler, 31-Oct Revised for (minor) ABB comments, D. Butler, 11-Nov Revised for surveillance assessment, D. Butler, 29-Oct Added manufacturing locations, S. Close, 11-Mar Released to ABB, Inc.; 27-Aug-2010 Internal Draft; 25-Aug-2010 Review: V2, R0: Gregory Sauk; October 30, 2013 V0, R1: Iwan van Beurden (exida); August 27, 2010 Status: Released, 10/31/ Future Enhancements At request of client. 8.4 Release Signatures David Butler, CFSE, Safety Engineer Gregory Sauk, CFSE Senior Safety Engineer William M. Goble, Principal Partner T-034 V5R1 80 N. Main St, Sellersville, PA Page 21 of 21