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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. IEC 61508 Functional Safety Assessment Project: Rosemount 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter Device Label SW 2.A1 2.J0 Customer: Rosemount Tank Radar (an Emerson Process Management company) Gothenburg, Sweden Contract No.: Q16/06-042 Report No.: ROS 13-06-005 R002 Version V1, Revision R4, 31-October-2016 John Yozallinas

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Page 1: IEC 61508 Assessment - · PDF fileThe functional safety assessment performed by exida consisted of the following activities: ... and SIL 3@HFT=1 and the Systematic Capability requirements

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.

IEC 61508 Functional Safety Assessment

Project:

Rosemount 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

Device Label SW 2.A1 – 2.J0

Customer:

Rosemount Tank Radar (an Emerson Process Management company)

Gothenburg, Sweden

Contract No.: Q16/06-042 Report No.: ROS 13-06-005 R002

Version V1, Revision R4, 31-October-2016

John Yozallinas

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Management Summary

This report summarizes the results of the functional safety assessment according to IEC 61508 carried out on the:

5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

The functional safety assessment performed by exida consisted of the following activities:

- exida assessed the development process used by Rosemount Tank Radar through an audit and creation of a detailed safety case against the requirements of IEC 61508.

- 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 ensure that the FMEDA analysis was complete.

The functional safety assessment was performed to the requirements of IEC 61508: ed2, 2010, SIL

3. A full IEC 61508 Safety Case was prepared, using the exida Safety Case Workbook as the primary audit tool. Hardware process requirements and all associated documentation were reviewed. Environmental test reports 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 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter was found to meet the Random Capability requirements for a Type B element of SIL 2@HFT=0 and SIL 3@HFT=1 and the Systematic Capability requirements for SC 3 (SIL 3 Capable).

The manufacturer will be entitled to use the following Functional Safety Logos.

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Table of Contents

Management Summary ................................................................................................... 2

1 Purpose and Scope ................................................................................................... 5

2 Project management .................................................................................................. 6

2.1 exida ............................................................................................................................ 6

2.2 Roles of the parties involved ........................................................................................ 6

2.3 Standards / Literature used .......................................................................................... 6

2.4 Reference documents .................................................................................................. 7

2.4.1 Documentation provided by Rosemount Tank Radar ......................................... 7

2.4.2 Documentation generated by exida ................................................................... 7

3 Product Description ................................................................................................... 9

4 IEC 61508 Functional Safety Assessment ............................................................... 10

4.1 Methodology .............................................................................................................. 10

4.2 Assessment level ....................................................................................................... 11

5 Results of the IEC 61508 Functional Safety Assessment ........................................ 11

5.1 Lifecycle Activities and Fault Avoidance Measures .................................................... 11

5.1.1 Functional Safety Management ....................................................................... 12

5.1.2 Safety Requirements Specification and Architecture Design ............................ 12

5.1.3 Design ............................................................................................................. 12

5.1.4 Validation ......................................................................................................... 12

5.1.5 Verification ....................................................................................................... 13

5.1.6 Proven In Use .................................................................................................. 13

5.1.7 Modifications ................................................................................................... 13

5.1.8 User Documentation ........................................................................................ 13

5.2 Hardware Assessment ............................................................................................... 14

6 Terms and Definitions .............................................................................................. 15

7 2016 IEC 61508 Functional Safety Surveillance Audit ............................................. 16

7.1 Roles of the parties involved ...................................................................................... 16

7.2 Surveillance Methodology .......................................................................................... 16

7.2.1 Documentation provided by Rosemount Tank Radar ....................................... 17

7.2.2 Surveillance Documentation generated by exida............................................. 17

7.3 Surveillance Results ................................................................................................... 17

7.3.1 Procedure Changes ......................................................................................... 17

7.3.2 Engineering Changes ...................................................................................... 17

7.3.3 Impact Analysis ............................................................................................... 17

7.3.4 Field History .................................................................................................... 18

7.3.5 Safety Manual.................................................................................................. 18

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7.3.6 FMEDA Update ............................................................................................... 18

7.3.7 Previous Recommendations ............................................................................ 18

8 Status of the document ............................................................................................ 19

8.1 Liability ....................................................................................................................... 19

8.2 Releases .................................................................................................................... 19

8.3 Future Enhancements ................................................................................................ 19

8.4 Release Signatures .................................................................................................... 19

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1 Purpose and Scope

This document shall describe the results of the IEC 61508 functional safety assessment of the Rosemount Tank Radar:

5300 4-20mA HART Guided Wave Radar Level and Interface Transmitter

by exida according to the requirements of IEC 61508: ed2, 2010.

The result of this assessment provides 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.

Table 1: Revisions in Assessment Scope

5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

Hardware Model 5301HxxxxxxxxxxxxxxZZ Model 5302HxxxxxxxxxxxxxxZZ Model 5303HxxxxxxxxxxxxxxZZ (Note: transmitters will be marked with “QS” or “QT” at the end of the model number in place of ZZ above)

Software/Firmware 2.A1 – 2.J0

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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.

2.2 Roles of the parties involved

Rosemount Tank Radar

Manufacturer of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

exida Performed the IEC 61508 Functional Safety Assessment

Rosemount Tank Radar 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): 2010 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems

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2.4 Reference documents

2.4.1 Documentation provided by Rosemount Tank Radar

(Doc IDs are references to the documents within the Safety Case; also see Surveillance Update section 7 in this report.)

Doc ID Generic Document Name

D001 Quality Manual

D003 Overall Development Process - RPD process

D004b Configuration Management Process - in SW Development Process

D006 Field Return Procedure

D007 Manufacturer Qualification Procedure

D008 Part Selection Procedure

D010 Quality Management System (QMS) Documentation Change Procedure

D012 Non-Conformance Reporting procedure

D013 Corrective Action Procedure

D016 Action Item List Tracking Procedure - Design Review Guidelines

D019 Customer Notification Procedure – DOP1440

D023 Modification Procedure – Product Change Process

D023b Modification Procedure - Impact Analysis Template

D023d Modification Procedure - Failure Analysis Review Procedure

D023e Modification Procedure - Change Control Board Charter

D030 Shipment Records

D031 Field Returns Records

D033 Training and Competency Records

D036 ISO 900x Cert or equivalent

D040 Safety Requirements Specification

D074 Validation Test Results

D075 Environmental Test Results

D076 EMC Test Results

D077 Fault Injection Test Results

D078 Operation / Maintenance Manual

D079 Safety Manual

D079b Software Release Notes

D081 Engineering Change Documentation

D082 List of Diagnostics from FMEDA

D087 Digital Signature

D088 Impact Analysis Record

2.4.2 Documentation generated by

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[R1] Q13-06-005 - Rosemount 5300 Series Assessment V0R5

Safety Case file for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

[R2] ROS 13-06-005 R002 V1_R4 Assessment Report 5300.Docx

IEC 61508 Functional Safety Assessment for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface

Transmitter (This document)

[R3] Q1306005 5300 FMEDA V1R5 Report

IEC 61508 FMEDA for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

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3 Product Description The 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter is a smart, two-wire continuous level transmitter based on Time Domain Reflectometry (TDR) principles. Low power nano-second-pulses are guided along an immersed probe. When a pulse reaches the surface, part of the energy is reflected back to the transmitter, and the time difference between the generated and reflected pulse is converted into a distance which calculates the total level or interface level.

It contains self-diagnostics and is programmed to send its output to a specified failure state upon internal detection of a failure. For safety instrumented systems usage, the 4 – 20 mA output is used as the primary safety variable. The 5300 Series Level Transmitter is classified as a type B1 element according to IEC 61508, having a hardware fault tolerance of 0.

1 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.

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4 IEC 61508 Functional Safety Assessment

The IEC 61508 Functional Safety Assessment was performed based on the information received from Rosemount Tank Radar and is documented in the safety case database [R1].

4.1 Methodology

The full functional safety assessment includes an assessment of all fault avoidance and fault control measures during hardware and software modifications to achieve SIL 3 capability. Other product development aspects prior to these modifications were assessed according to Proven-In-Use requirements (see section 5.1.6). The combination of these assessments demonstrates full compliance with IEC 61508 to the end-user. The assessment considers all requirements of IEC 61508. Any requirements that have been deemed not applicable have been marked as such in the full Safety Case report, e.g. software development requirements for a product with no software.

Additionally, for designs that have been in service for several years and have demonstrated themselves in a variety of applications and conditions, consideration of a proven in use assessment may be used as a substitute if a product didn’t follow a fully 61508 compliant design process.

As part of the IEC 61508 functional safety assessment, the following aspects have been reviewed:

Documents:

FMEDA

Safety manual

Instruction manual

SRS

HW fault inject test plan and results verification

EMC and Environmental test results

Validation test results

Corrective Action and prevention action plan/process

Modification Process

Impact Analysis Records

One ASIC is used in this product. As part of the Proven In Use analysis, it is considered as a standard component in the FMEDA due to the number of operational hours.

No safety related communications are used in this product.

Proven-In-Use (PIU) data assessment [D030] and [D031] provides for the prevention of systematic failures for pre-existing devices with a proven history of successful operation. As part of the IEC 61508 PIU assessment, the following aspects have been reviewed:

PIU data and Operational excellence calculation/report (Evidence that the equipment is proven-in-use; Analysis of field failure rates to ensure that no systematic faults exist in the product)

A number of functional safety lifecycle assessment aspects are not required when relying on PIU assessment:

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o SW design specification

o Configuration management

o Validation of development tools

o Validation test plan

o Architecture design

o Integration and Unit test plans

Product design

o Hardware architecture and failure behavior, documented in a FMEDA

The review of the development procedures is described in section 5. The review of the product design is described in section 5.2. When changes are made, appropriate design documentation will be reviewed and updated for the scope of the change.

4.2 Assessment level

The 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter has been assessed per IEC 61508 to the following levels:

Systematic Capability SC3 (SIL 3 capability) suitable for use in applications with a maximum Safety Integrity Level of 3 (SIL 3) according to IEC 61508.

Architecture Constraint limitations of SIL 2 for a single device and SIL 3 for multiple devices in safety redundant configurations with a Hardware Fault Tolerance of 1.

5 Results of the IEC 61508 Functional Safety Assessment

exida assessed a detailed Failure Modes, Effects, and Diagnostic Analysis (FMEDA) [R3] of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter to document the hardware architecture and failure behavior. The Safety Case created for the 5300 Series Level Transmitter documents this assessment.

exida assessed failure and operational history of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter [D030, D031] and performed a detailed analysis of the data provided. This PIU assessment is done in place of a detailed functional safety assessment for systematic failures. The Safety Case created for the 5300 Series Level Transmitter documents this assessment.

The requirements of SIL 3 have been met in this area.

5.1 Lifecycle Activities and Fault Avoidance Measures

This functional safety assessment investigated the compliance with IEC 61508 of the processes, procedures and techniques as implemented for the product development. The investigation was executed using subsets of the IEC 61508 requirements tailored to the SIL 3 work scope of the development team. The assessment is supplemented by the PIU analysis. The result of the assessment can be summarized by the following observations:

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The audited development process complies with the relevant managerial requirements of IEC 61508 SIL 3 for Route 2s.

5.1.1 Functional Safety Management

Version Control All documents are under version control as required by [D004b]

Training and Competency recording Competency is ensured by the maintenance of a competency and training list for the project. The competency document [D033] lists all of those on the project who are working on any of the phases of the safety lifecycle.

5.1.2 Safety Requirements Specification and Architecture Design

As defined in [D003], a requirements specification is created for all products. For the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter, the requirements specification [D040] contains a system overview, safety assumptions, and safety requirements sections. During the assessment, exida reviewed the content of the specification for completeness per the requirements of IEC 61508:2010.

Requirements from IEC 61508-2, Table B.1 that have been met by Rosemount Tank Radar include project management, documentation, structured specification, and inspection of the specification.

5.1.3 Design

Hardware design, including both electrical and mechanical design, was reviewed as part of the Failure Modes, Effects and Diagnostic Analysis (FMEDA), electrical unit testing, fault injection testing, and review of modifications during the product lifetime.

Requirements from IEC 61508-2, Table B.2 that have been met by Rosemount Tank Radar include observance of guidelines and standards, project management, documentation, structured design, modularization, use of well-tried components, computer aided design tools, simulation, and inspection of the specification. This meets the requirements of SIL 3.

5.1.4 Validation

Validation Testing results were reviewed via a set of documented functional tests [D074]. As the 5300 Series Level Transmitter consists of simple electrical devices with a straightforward safety function, there is no separate integration testing necessary.

Procedures are in place for corrective actions to be taken when failures occur as documented in [D006, D012].

Items from IEC 61508-2, Table B.5 include project management, documentation, and black-box functional testing. Field experience and proven-in-use data are included for systematic capability. This meets SIL 3.

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Items from IEC 61508-2, Table B.5 included functional testing [D074] and functional testing under environmental conditions [D075], Interference surge immunity testing [D076], fault insertion testing [D077], project management, documentation, static analysis, dynamic analysis, and failure analysis. This meets SIL 3.

5.1.5 Verification

Verification activities are built into the standard development process as defined in [D003] and [D0088]. Verification activities include the following: Fault Injection Testing, FMEDA, and peer reviews. This meets the requirements of IEC 61508 SIL 3.

Requirements from IEC 61508-2, Table B.3 that have been met by Rosemount Tank Radar include functional testing, project management, documentation, and black-box testing.

Requirements from IEC 61508-3, Table A.5 that have been met by Rosemount Tank Radar include dynamic analysis and testing, data recording and analysis, functional and black-box testing, and performance testing.

Requirements from IEC 61508-3, Table A.6 that have been met by Rosemount Tank Radar include functional and black box testing, and performance testing.

Requirements from IEC 61508-3, Table A.9 that have been met include static analysis, dynamic analysis and testing.

This meets the requirements of SIL 3.

5.1.6 Proven In Use

In addition to the Design Fault avoidance techniques listed above, a Proven in Use evaluation was carried out on the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter. Shipment and field failure records [D030 and D031] were used to determine that the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter have >100 million operating hours and they have demonstrated a field failure rate less than the predicted failure rates indicated in the FMEDA reports. This meets the requirements for Proven In Use for SIL 3.

5.1.7 Modifications

Future modifications that do not affect the safety functions are permitted to the certified versions of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter without reassessment.

5.1.8 User Documentation

Rosemount Tank Radar created a safety manual for the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter [D079] which addresses all relevant operation and maintenance requirements from IEC 61508. This safety manual was assessed by exida. The final version is considered to be in compliance with the requirements of IEC 61508.

Requirements from IEC 61508-2, Table B.4 that have been met by Rosemount Tank Radar include operation and maintenance instructions, maintenance friendliness, project management, documentation, and limited operation possibilities.

This meets the requirements for SIL 3.

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5.2 Hardware Assessment

To evaluate the hardware design of the 5300 Series Level Transmitter, a Failure Modes, Effects,

and Diagnostic Analysis was performed by Rosemount and reviewed by exida for each component in the system. This is documented in [R3]. The FMEDA was verified using Fault Injection Testing as part of the development [D077] and as part of the IEC 61508 assessment.

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.

Failure rates are for each important failure category. All failure rate analysis results and useful life limitations are listed in the FMEDA report [R3]. Tables in the FMEDA report list these failure rates for the various configurations of the 5300 Series Level Transmitter. The failure rates listed are valid for the useful life of the devices.

These results must be considered in combination with PFDAVG 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 for each defined safety instrumented function (SIF) to verify the design of that SIF.

The FMEDA analysis shows that the 5300 Series Level Transmitter has a Safe Failure Fraction > 90% (assuming that the logic solver is programmed to detect over-scale and under-scale currents) and therefore these models meet Route 1H hardware architectural constraints for up to SIL 2 as a single device and up to SIL 3 with Hardware Fault Tolerance of 1.

The failure rate data used for this analysis meets the exida criteria for Route 2H and the diagnostic coverage is ≥60%. Therefore, all of the reviewed 5300 Series Level Transmitter meets the Route 2H hardware architectural constraints for up to SIL 2 as a single device when the listed failure rates are used.

If the 5300 Series Level Transmitter is one part of an element, the architectural constraints should be determined for the entire sensor element.

The architectural constraint type for the 5300 Series Level Transmitter is B. The required SIL determines the level of hardware fault tolerance that is required per requirements of IEC 61508 or IEC 61511. The SIS designer is responsible for meeting other requirements of applicable standards for any given SIL as well.

The analysis shows that the design of the 5300 Series Level Transmitter meets the hardware requirements of IEC 61508, SIL 2 @HFT=0 and SIL 3 @ HFT=1.

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6 Terms and Definitions

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.

PFDAVG Average Probability of Failure on Demand (low demand mode)

PFH Probability of dangerous Failure per Hour (high demand mode)

PIU Proven In Use

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).

Systematic Capability The SIL limit imposed by the robustness of the design process and the methods used to avoid systematic faults in the design as described in the IEC 61508 tables.

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

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7 2016 IEC 61508 Functional Safety Surveillance Audit

7.1 Roles of the parties involved

Rosemount Tank Radar Manufacturer of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

exida Reviewed the FMEDA hardware assessment and changes

exida Performed the IEC 61508 Functional Safety Surveillance

Audit per the accredited exida scheme.

Rosemount Tank Radar contracted exida in August 2016 to perform the surveillance audit for the above 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter. The surveillance audit was conducted remotely in October 2016.

7.2 Surveillance Methodology

As part of the IEC 61508 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 any of the changes could affect the safety function of the 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter.

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 61508 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 61508 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.

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7.2.1 Documentation provided by Rosemount Tank Radar

[D1] 5300 exida - database file field returns analysis.xlsx

Field Failure History

[D2] 00809-0100-4530_RevDD.pdf Reference Manual Update, including Safety Manual

[D3] SME-8368_01.pdf Engineering Change

[D4] SME-8372_01.pdf Engineering Change

[D5] SME-8197_01.pdf Engineering Change

[D6] RTR ISO 9001 14001 Certificate 2015_2018.pdf

Update for company ISO 9001 certification

[D7] RE 5300 recert.msg Shipping History and EC clarifications

7.2.2 Surveillance Documentation generated by

[R4] Q16-06-042 - Rosemount 5300 Series Assessment V1R2.xlsm, Oct.2016

IEC 61508 Safety Case update for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

[R5] ROS 16-06-042 R002 V1R1 FieldFailureAnalysis.xls

Field Failure Analysis for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

[R6] ROS 16-06-042 R001 V1R1 5300 Recert Change Audit.xls

EC Change Audit for 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter

7.3 Surveillance Results

7.3.1 Procedure Changes

Changes and improvements to the Engineering Development Procedures were reviewed as part of other ongoing projects and were found to be consistent with the requirements of IEC 61508.

7.3.2 Engineering Changes

Engineering changes to the 5300 series products were submitted [D3-5] by Rosemount Tank Radar and reviewed during this audit. The changes were made according to well-established and compliant procedures. Changes that do not affect the safety functions are permitted without re-assessment. Only non-critical hardware changes were made. Relevant design drawings were updated as needed. Internal review and approvals are cited in the engineering change files.

7.3.3 Impact Analysis

A compliant Impact Analysis template is used. It was not required for the scope of the changes made during this period.

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7.3.4 Field History

Field failure and shipping history for the 5300 Series Level Transmitter [D1] were submitted by Rosemount Tank Radar and reviewed during this audit. The actual failure rate compares favorably to and is lower than the prediction of the FMEDA data.

7.3.5 Safety Manual

Although the Reference Manual has been updated several times, no safety manual changes (in section 8) were made during this period.

7.3.6 FMEDA Update

The 5300 Series Level Transmitter changes [D3-5] made during this period did not require a change in the FMEDA.

7.3.7 Previous Recommendations

Rosemount Tank Radar took action to resolve several recommendations made during the previous certification assessments. These changes improve the processes used to both develop and maintain products.

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Main Offices Service Centers

Sellersville, PA, USA Munich, Germany Switzerland United Kingdom Houston, TX, USA

Calgary, AB, Canada South Africa Singapore Mexicothe Netherlands New Zealand/Australia Brazil

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 Releases

Version: V1

Revision: R4

Version History: V1, R4: Updated for surveillance audit; JCY, 31-Oct-2016

V1, R3: Updated the revision of the FMEDA Report; JCY, 16-Apr-2015

V1, R2: Updated the revision of the FMEDA Report; DEB 3/31/2014

V1, R1: Internal review completed 14-Oct-13 JCY

V1, R0: Generated from Safety Case and revised per comments after review;

Authors: John Yozallinas

Review: V1,R4; Dave Butler

Release status: Released

8.3 Future Enhancements

At request of client.

8.4 Release Signatures

John Yozallinas, CFSE, Senior Safety Engineer

Dave Butler, CFSE, Senior Safety Engineer