Failure Modes, Effects and Diagnostic Analysis

Project:
Primary Elements

Company:
Rosemount Inc.
Emerson Automation Solutions
Chanhassen, MN
USA

Contract Number: Q21/06-099

Report No.: ROS 13/04-008 R001
Version V2, Revision R1, June 17, 2021
Gregory Sauk

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 hardware assessment in the form of a Failure Modes,
Effects, and Diagnostic Analysis (FMEDA) of the Primary Elements. A Failure Modes, Effects, and
Diagnostic Analysis is one of the steps to be taken to achieve functional safety certification per IEC
61508 of a device. From the FMEDA, failure rates are determined. The FMEDA that is described in
this report concerns only the hardware of the Primary Element. For full functional safety
certification purposes all requirements of IEC 61508 must be considered.
A Flowmeter consists of a Primary Element that is attached to one of the following devices:
Rosemount 3051, Rosemount 3051S, Rosemount 3051S Multivariable, Rosemount 2051, and
Rosemount 3095 differential pressure transmitters. The specific Primary Element that were
considered are the 485 Annubar Primary Element, the 405 Compact Primary Element, and the
1195 Integral Orifice Plate.
Note:This report does not include the failure rates for the Rosemount Pressure Transmitter that the
Primary Element is attached to.
Table 1 gives an overview of the different versions that were considered in the FMEDA of the
Primary Element.

Table 1 Version Overview

Model Application
Process Connection for Flow – High Trip, Clean Service
485 Annubar Primary Element
Process Connection for Flow – Low Trip, Clean Service
Process Connection for Flow – High Trip, Clean Service
405 Compact Primary Element
Process Connection for Flow – Low Trip, Clean Service
Process Connection for Flow – High Trip, Clean Service
1195 Integral Orifice Plate
Process Connection for Flow – Low Trip, Clean Service

The Primary Element is classified as a device that is part of a Type A1 element according to IEC
61508, having a hardware fault tolerance of 0.
The failure rate data used for this analysis meets the exida criteria for Route 2H. See Section 5.2.
Therefore, the Primary Element can be classified as a 2H device when the listed failure rates are
used. When 2H data is used for all of the devices in an element, then the element meets the
hardware architectural constraints up to SIL 2 at HFT=0 (or SIL 3 @ HFT=1) per Route 2H. If Route
2H is not applicable for the entire sensor element, the architectural constraints will need to be
evaluated per Route 1H.
Based on the assumptions listed in 4.3, the failure rates for the Primary Element are listed in
section 4.4.
These failure rates are valid for the useful lifetime of the product, see Appendix A.

1
Type A element: “Non-Complex” element (using discrete components); for details see 7.4.4.1.2 of IEC 61508-2, ed2,
2010. / 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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The failure rates listed in this report are based on over 350 billion-unit operating hours of process
industry field failure data. The failure rate predictions reflect realistic failures and include site
specific failures due to human events for the specified Site Safety Index (SSI), see section 4.2.2.
A user of the Primary Element can utilize these failure rates in a probabilistic model of a safety
instrumented function (SIF) to determine suitability in part for safety instrumented system (SIS)
usage in a particular safety integrity level (SIL).

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Table of Contents
1 Purpose and Scope ........................................................................................................ 5
2 Project Management ...................................................................................................... 6
2.1 exida ................................................................................................................................. 6
2.2 Roles of the parties involved .............................................................................................. 6
2.3 Standards and literature used ............................................................................................ 6
2.4 Reference documents ....................................................................................................... 7
2.4.1 Documentation provided by Rosemount Inc. ............................................................. 7
2.4.2 Documentation generated by exida .......................................................................... 7
3 Product Description ........................................................................................................ 9
3.1 Rosemount Flowmeter Series ........................................................................................... 9
3.2 Annubar Flowmeter ........................................................................................................... 9
3.3 Compact Flowmeter .......................................................................................................... 9
3.4 Integral Orifice Flowmeter.................................................................................................. 9
4 Failure Modes, Effects, and Diagnostic Analysis .......................................................... 11
4.1 Failure categories description .......................................................................................... 11
4.2 Methodology – FMEDA, failure rates ............................................................................... 11
4.2.1 FMEDA ................................................................................................................... 11
4.2.2 Failure rates ............................................................................................................ 12
4.3 Assumptions .................................................................................................................... 12
4.4 Results ............................................................................................................................ 13
5 Using the FMEDA Results ............................................................................................ 15
5.1 PFDavg calculation Primary Element................................................................................. 15
5.2 exida Route 2H Criteria.................................................................................................... 15
6 Terms and Definitions................................................................................................... 17
7 Status of the Document ................................................................................................ 18
7.1 Liability ............................................................................................................................ 18
7.2 Version History ................................................................................................................ 18
7.3 Future enhancements...................................................................................................... 19
7.4 Release signatures .......................................................................................................... 19
Appendix A Lifetime of Critical Components ................................................................ 20
Appendix B Proof Tests to Reveal Dangerous Undetected Faults .............................. 21
B.1 Suggested Proof Test ...................................................................................................... 21
Appendix C exida Environmental Profiles ................................................................... 22
Appendix D Determining Safety Integrity Level ............................................................ 23
Appendix E Site Safety Index ...................................................................................... 27
E.1 Site Safety Index Profiles................................................................................................. 27

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1 Purpose and Scope
This document shall describe the results of the hardware assessment in the form of the Failure
Modes, Effects and Diagnostic Analysis carried out on the Primary Element. From this, failure rates
for each failure mode/category, useful life, and proof test coverage are determined.
The information in this report can be used to evaluate whether an element meets the average
Probability of Failure on Demand (PFDavg) requirements and if applicable, the architectural
constraints / minimum hardware fault tolerance requirements per IEC 61508 / IEC 61511.
A FMEDA is part of the effort needed to achieve full certification per IEC 61508 or other relevant
functional safety standard.

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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, availability, and cybersecurity with over 500-person years
of cumulative experience in functional safety, alarm management, and cybersecurity. Founded by
several of the world’s top reliability and safety experts from manufacturers, operators and
assessment organizations, exida is a global corporation with offices around the world. exida
offers training, coaching, project-oriented consulting services, safety engineering tools, detailed
product assurance and ANSI accredited functional safety and cybersecurity certification. exida
maintains a comprehensive failure rate and failure mode database on electronic and mechanical
equipment and a comprehensive database on solutions to meet safety standards such as IEC
61508.

2.2 Roles of the parties involved

Rosemount Inc. Manufacturer of the Primary Element
exida Performed the hardware assessment
Rosemount Inc. contracted exida with the hardware assessment of the above-mentioned device.

2.3 Standards and literature used

The services delivered by exida were performed based on the following standards / literature.

[N1] IEC 61508-2: ed2, 2010 Functional Safety of Electrical/Electronic/Programmable

Electronic Safety-Related Systems
[N2] Mechanical Component exida LLC, Electrical & Mechanical Component
Reliability Handbook, 4th Reliability Handbook, Fourth Edition, 2016 (pending
Edition, 2016 publication, not publicly available at the time of this report)
[N3] Safety Equipment Reliability exida LLC, Safety Equipment Reliability Handbook,
Handbook, 4th Edition, Fourth Edition, 2015, ISBN 978-1-934977-13-2
2015
[N4] Goble, W.M., 2010 Control Systems Safety Evaluation and Reliability, 3rd
edition, ISA, ISBN 97B-1-934394-80-9. Reference on
FMEDA methods
[N5] IEC 60654-1:1993-02, Industrial-process measurement and control equipment –
second edition Operating conditions – Part 1: Climatic condition
[N6] O’Brien, C. , Stewart, L., & exida LLC., Final Elements in Safety Instrumented
Bredemeyer, L., 2018 Systems IEC 61511 Compliant Systems and IEC 61508
Compliant Products, 2018, ISBN 978-1-934977-18-7
[N7] Scaling the Three Barriers, http://www.exida.com/Webinars/Recordings/SIF-
Recorded Web Seminar, Verification-Scaling-the-Three-Barriers
June 2013

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 [N8] Meeting Architecture http://www.exida.com/Webinars/Recordings/Meeting-
Constraints in SIF Design, Architecture-Constraints-in-SIF-Design
Recorded Web Seminar,
March 2013
[N9] Random versus Systematic http://www.exida.com/Resources/Whitepapers/random-
– Issues and Solutions, versus-systematic-failures-issues-and-solutions
September 2016
[N10] Bukowski, J.V. and Assessing Safety Culture via the Site Safety IndexTM,
Chastain-Knight, D., April Proceedings of the AIChE 12th Global Congress on
2016 Process Safety, GCPS2016, TX: Houston
[N11] Bukowski, J.V. and Stewart, Quantifying the Impacts of Human Factors on Functional
L.L., April 2016 Safety, Proceedings of the 12th Global Congress on
Process Safety, AIChE 2016 Spring Meeting, NY: New
York
[N12] Criteria for the Application exida White Paper, Sellersville, PA
of IEC 61508:2010 Route www.exida.com
2H, December 2016
[N13] Goble, W.M. and Using a Failure Modes, Effects and Diagnostic Analysis
Brombacher, A.C., (FMEDA) to Measure Diagnostic Coverage in
November 1999, Vol. 66, Programmable Electronic Systems, Reliability
No. 2 Engineering and System Safety, Vol. 66, No. 2,
November 1999.

2.4 Reference documents

2.4.1 Documentation provided by Rosemount Inc.

[D1] 00813-0100-4485, Rev EB, May 2013 Product Data Sheet
[D2] 00809-0100-4809, Rev CB, March 2012 Annubar Reference Manual
[D3] 00809-0100-4686; Rev HA, April 2006 Integral Orifice Flowmeter Series
[D4] 01195-1002, Rev AE, 15-Feb-2010 MODEL 1195 INTEGRAL ORIFICE PLATE /
FLOWMETER Drawing
[D5] 00405-1001, Rev AO, 9-Mar-2012 MODEL 405 COMPACT FLOWMETER
Drawing
[D6] 00485-1011, Rev AF, 15-Feb-2010 MODEL 485 ANNUBAR FLOWMETER SZ 1
FLANGED Drawing
[D7] 00813-0100-4001, Rev MA, May 2012 Rosemount 3051 Pressure Transmitter,
Product Data Sheet

2.4.2 Documentation generated by exida

[R1] Rosemount 3051 Flow Failure Modes, Effects, and Diagnostic Analysis –
Adders R2.xls, 12-Feb-2013 Primary Element (internal document)
[R2] ROS 13/04-008 R001, FMEDA report, Primary Element (this report)

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 V2R1, 17-Jun-2021

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3 Product Description
A Flowmeter consists of a Primary Element that is attached to one of the following devices:
Rosemount 3051, Rosemount 3051S, Rosemount 3051S Multivariable, Rosemount 2051, and
Rosemount 3095 differential pressure transmitters. The purpose of this report is to consider the
additional failure rates between these elements when attached to a pressure transmitter.
These elements have the ability to attach onto numerous devices such as a Rosemount 2051,
Rosemount 3051, Rosemount 3051S, etc. A user may visit the supplier’s website for the
technical specifications. A flowmeter measures flow and comes in numerous ways.
A Rosemount Pressure Transmitter can be combined with primary elements to offer fully
assembled flowmeters. The direct mount flowmeter capability eliminates troublesome impulse
lines associated with traditional installations. With multiple primary element technologies
available, Rosemount flowmeters offer a flexible solution to meet the performance, reliability,
and installation needs of nearly any flow measurement application.
Note:This report does not include the failure rates for the Rosemount Pressure Transmitter that the
Primary Element is attached to.

3.1 Rosemount Flowmeter Series

Rosemount Flowmeters combine the proven pressure transmitter and the latest Primary Element
technology: Annubar Averaging, Compact Conditioning Orifice Plate, and Integral Orifice Plate.
Flowmeters are factory configured to meet your application needs. Direct or remote mount
configurations are available, but only the Direct mount configurations have been included in this
analysis. The direct mount flowmeter capability eliminates troublesome impulse lines associated
with traditional installations. With multiple primary element technologies available, Rosemount
flowmeters offer a flexible solution to meet the performance, reliability, and installation needs of
nearly any flow measurement application.

3.2 Annubar Flowmeter

Annubar flowmeters reduce permanent pressure loss by creating less blockage in the pipe. They
are ideal for large line size installations when cost, size, and weight of the flowmeter are concerns.
This analysis includes the Rosemount Model 485 Sensor and a 3-way Valve Manifold. Not
included in this analysis are the ‘Flo-tap’ models that can be installed and removed from service
while the process is running.

3.3 Compact Flowmeter

Compact Conditioning flowmeters reduce straight piping requirements to 2D upstream and 2D
downstream from a flow disturbance. These models feature simple installation of the Compact
Flowmeter between any existing raised-face flanges. This analysis includes the Rosemount Model
405 Conditioning / Orifice Plate and a 3-way Valve Manifold.

3.4 Integral Orifice Flowmeter

These feature precision honed pipe sections for increased accuracy in small line sizes, and self-
centering plate design prevents alignment errors that magnify measurement inaccuracies in small
line sizes. This analysis includes the Rosemount Model 1195 Sensor and a 3-way Valve Manifold

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Table 3 gives an overview of the different versions that were considered in the FMEDA of the
Primary Element.

Table 2 Version Overview

Model Application
Process Connection for Flow – High Trip, Clean Service
485 Annubar Primary Element
Process Connection for Flow – Low Trip, Clean Service
Process Connection for Flow – High Trip, Clean Service
405 Compact Primary Element
Process Connection for Flow – Low Trip, Clean Service
Process Connection for Flow – High Trip, Clean Service
1195 Integral Orifice Plate
Process Connection for Flow – Low Trip, Clean Service

The Primary Element is classified as a device that is a part of a Type A2 element according to IEC
61508, having a hardware fault tolerance of 0.

2
Type A element: “Non-Complex” element (using discrete components); for details see 7.4.4.1.2 of IEC 61508-2, ed2,
2010.
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4 Failure Modes, Effects, and Diagnostic Analysis
The Failure Modes, Effects, and Diagnostic Analysis was performed based on the documentation
listed in section 2.4.1 and is documented in [R1].
When the effect of a certain failure mode could not be analyzed theoretically, the failure modes
were introduced on component level and the effects of these failure modes were examined on
system level.

4.1 Failure categories description

In order to judge the failure behavior of the Primary Element, the following definitions for the failure
of the device were considered.
Fail-Safe State
High Trip State where the output exceeds the user defined threshold.
Low Trip State where the output is below the user defined threshold.
Fail Safe Failure that causes the device to go to the defined fail-safe state
without a demand from the process.
Fail Dangerous Failure that deviates the measured input state or the actual output by
more than 2% of span and that leaves the output within active scale.
Fail Dangerous Undetected Failure that is dangerous and that is not being diagnosed by
automatic diagnostics.
Fail Dangerous Detected Failure that is dangerous but is detected by automatic diagnostics.
No Effect Failure of a component that is part of the safety function but that
hasno effect on the safety function.
External Leakage Failure that causes process fluids to leak outside of the device;
External Leakage is not considered part of the safety function and
therefore this failure rate is not included in the Safe Failure Fraction
calculation.
The failure categories listed above expand on the categories listed in IEC 61508 in order to provide
a complete set of data needed for design optimization.

4.2 Methodology – FMEDA, failure rates

4.2.1 FMEDA
A FMEDA (Failure Mode Effect and Diagnostic Analysis) is a failure rate prediction technique
based on a study of design strength versus operational profile stress in each application. It
combines design FMEA techniques with extensions to identify automatic diagnostic techniques and
the failure modes relevant to safety instrumented system design. It is a technique recommended to
generate failure rates for each failure mode category [N13].

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4.2.2 Failure rates
The accuracy of any FMEDA analysis depends upon the component reliability data as input to the
process. Component data from consumer, transportation, military or telephone applications could
generate failure rate data unsuitable for the process industries. The component data used by
exida in this FMEDA is from the Electrical and Mechanical Component Reliability Handbooks [N2]
which were derived using over 350 billion-unit operational hours of process industry field failure
data from multiple sources and failure data from various databases. The component failure rates
are provided for each applicable operational profile and application, see Appendix C. The exida
profile chosen for this FMEDA was Profile 6 (Process Wetted Parts) as this was judged to be the
best fit for the product and application information submitted by Rosemount Inc.. It is expected that
the actual number of field failures will be less than the number predicted by these failure rates.
Early life failures (infant mortality) are not included in the failure rate prediction as it is assumed
that some level of commission testing is done. End of life failures are not included in the failure rate
prediction as useful life is specified.
The failure rates are predicted for a Site Safety Index of SSI=2 ([N10] & [N11]) as this level of
operation is common in the process industries. Failure rate predictions for other SSI levels are
included in the exSILentia® tool from exida.
The user of these numbers is responsible for determining the failure rate applicability to any
particular environment. exida Environmental Profiles listing expected stress levels can be found in
Appendix C. Some industrial plant sites have high levels of stress. Under those conditions the
failure rate data is adjusted to a higher value to account for the specific conditions of the plant.
exida has detailed models available to make customized failure rate predictions (Contact exida).
Accurate plant specific data may be used to check validity of this failure rate data. If a user has
data collected from a good proof test reporting system such as exida SILStatTM that indicates
higher failure rates, the higher numbers shall be used.

4.3 Assumptions
The following assumptions have been made during the Failure Modes, Effects, and Diagnostic
Analysis of the Primary Element.
 The worst-case assumption of a series system is made. Therefore, only a single component
failure will fail the entire Primary Element, and propagation of failures is not relevant.
 Failure rates are constant for the useful life period.
 Any product component that cannot influence the safety function (feedback immune) is
excluded. All components that are part of the safety function including those needed for
normal operation are included in the analysis.
 The stress levels are specified in the exida Profile used for the analysis limited by the
manufacturer’s published ratings.
 Materials are compatible with the environmental and process conditions.
 The device is installed and operated per the manufacturer’s instructions.
 Devices are installed such that the controlled substance will flow through the device in the
direction indicated by the flow arrow, located on the device body.

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  The devices are generally applied in relatively clean gas or liquid; therefore, no severe
service has been considered in the analysis.

4.4 Results
Using reliability data extracted from the exida Electrical and Mechanical Component Reliability
Handbook the following failure rates resulted from the FMEDA analysis of the Primary Element.
Table 3 lists the failure rates for the Primary Element according to IEC 61508 with a Site Safety
Index (SSI) of 2 (good site maintenance practices). See Appendix E for an explanation of SSI.

Table 3 Primary Element incremental Failure rates with Good Maintenance Assumptions in FIT @
SSI=2

Device λSD λSU λDD λDU # E

Primary Element – High Trip, Clean Service 0 8 0 11 51 93
Primary Element – Low Trip, Clean Service 0 10 0 9 51 93

Incremental failure rates are to be added to the failure rates listed in the transmitter’s FMEDA. This
analysis included consideration for parts of the Primary Element that replace the applicable
transmitter parts that are included in the transmitter FMEDA failure rates.

Where:
λSD = Fail Safe Detected
λSU = Fail Safe Undetected
λDD = Fail Dangerous Detected
λDU = Fail Dangerous Undetected
# = No Effect Failures
E = External Leaks
As the External Leak failure rates are a subset of the No Effect failure rates, the total No Effect
failure rate is the sum of the listed No Effect and External Leak rates. External leakage failure rates
do not directly contribute to the reliability of the device but should be reviewed for secondary safety
and environmental issues.
These failure rates are valid for the useful lifetime of the product, see Appendix A.
According to IEC 61508-2 the architectural constraints of an element must be determined. This can
be done by following the 1H approach according to 7.4.4.2 of IEC 61508-2 or the 2H approach
according to 7.4.4.3 of IEC 61508-2, or the approach according to IEC 61511:2016 which is based
on 2H (see Section 5.2).
The 1H approach involves calculating the Safe Failure Fraction for the entire element.
The 2H approach involves assessment of the reliability data for the entire element according to
7.4.4.3.3 of IEC 61508.

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The failure rate data used for this analysis meets the exida criteria for Route 2H which is more
stringent than IEC 61508. Therefore, the Primary Element meets the hardware architectural
constraints for up to SIL 2 at HFT=0 (or SIL 3 @ HFT=1) when the listed failure rates are used.
The architectural constraint type for the Primary Element is A. The hardware fault tolerance of the
device is 0. The SIS designer is responsible for meeting other requirements of applicable
standards for any given SIL.

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5 Using the FMEDA Results
The following section(s) describe how to apply the results of the FMEDA.

5.1 PFDavg calculation Primary Element

Using the failure rate data displayed in section 4.4, and the failure rate data for the associated
element devices, an average Probability of Failure on Demand (PFDavg) calculation can be
performed for the entire sensor element.
Probability of Failure on Demand (PFDavg) calculation uses several parameters, many of which are
determined by the particular application and the operational policies of each site. Some parameters
are product specific and the responsibility of the manufacturer. Those manufacturer specific
parameters are given in this third-party report.
Probability of Failure on Demand (PFDavg) calculation is the responsibility of the owner/operator of
a process and is often delegated to the SIF designer. Product manufacturers can only provide a
PFDavg by making many assumptions about the application and operational policies of a site which
may be incorrect. Therefore, the use of pre-calculated PFDavg numbers requires complete
knowledge of the assumptions and a match with the actual application and site.
Probability of Failure on Demand (PFDavg) calculation is best accomplished with exida’s
exSILentia tool. See Appendix D for a complete description of how to determine the Safety Integrity
Level for the sensor element. The mission time used for the calculation depends on the PFDavg
target and the useful life of the product. The failure rates for all the devices in the sensor element
and the proof test coverage for the sensor devices are required to perform the PFDavg calculation.
The proof test coverage for the suggested proof test for the Primary Element is listed in Table 5.
This is combined with the dangerous failure rates after proof test for other devices in the sensor
element to establish the proof test coverage for the sensor element.

5.2 exida Route 2H Criteria

IEC 61508, ed2, 2010 describes the Route 2H alternative to Route 1H architectural constraints. The
standard states:
"based on data collected in accordance with published standards (e.g., IEC 60300-3-2: or ISO
14224); and, be evaluated according to
 the amount of field feedback; and
 the exercise of expert judgment; and when needed
 the undertaking of specific tests,
in order to estimate the average and the uncertainty level (e.g., the 90% confidence interval or
the probability distribution) of each reliability parameter (e.g., failure rate) used in the
calculations."
exida has interpreted this to mean not just a simple 90% confidence level in the uncertainty
analysis, but a high confidence level in the entire data collection process. As IEC 61508, ed2, 2010
does not give detailed criteria for Route 2H, exida has established the following:
1. field unit operational hours of 100,000,000 per each component; and
2. a device and all of its components have been installed in the field for one year or more; and
3. operational hours are counted only when the data collection process has been audited for
correctness and completeness; and
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4. failure definitions, especially "random" vs. "systematic" are checked by exida; and
5. every component used in an FMEDA meets the above criteria.
This set of requirements is chosen to assure high integrity failure data suitable for safety integrity
verification.

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6 Terms and Definitions
Automatic Diagnostics Tests performed online internally by the device or, if specified,
externally by another device without manual intervention.
Device A device is something that is part of an element; but, cannot perform
an element safety function on its own.
Element A collection of devices that perform an element safety function such as
a final element consisting of a logic solver interface, actuator and valve.
exida criteria A conservative approach to arriving at failure rates suitable for use in
hardware evaluations utilizing the 2H Route in IEC 61508-2.
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
High demand Mode Mode, where the demand interval for operation made on a safety-
related system is less than twice the proof test interval.
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
Random Capability The SIL limit imposed by the Architectural Constraints for each
element.
Severe Service Condition that exists when material through the device has abrasive
particles, as opposed to Clean Service where these particles are
absent.
SFF Safe Failure Fraction, summarizes the fraction of failures which lead to
a safe state plus the fraction of failures which will be detected by
automatic 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).
SSI Site Safety Index (See Appendix E)
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

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7 Status of the Document
7.1 Liability
exida prepares FMEDA reports based on methods advocated in International standards. Failure
rates are obtained from exida compiled field failure data and 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.
Due to future potential changes in the standards, product design changes, best available
information and best practices, the current FMEDA results presented in this report may not be fully
consistent with results that would be presented for the identical model number product at some
future time. As a leader in the functional safety market place, exida is actively involved in evolving
best practices prior to official release of updated standards so that our reports effectively anticipate
any known changes. In addition, most changes are anticipated to be incremental in nature and
results reported within the previous three-year period should be sufficient for current usage without
significant question.
Most products also tend to undergo incremental changes over time. If an exida FMEDA has not
been updated within the last three years, contact the product vendor to verify the current validity of
the results.

7.2 Version History

Contract Report Number Revision Notes
Number
Q21/06-099 ROS 1304008 R001 V2R1 Revised Useful life and updated to latest template,
GPS, 17-Jun-21
Q13/04-008 ROS 1304008 R001 V1R0 Incorporated Rosemount comments; 6/16/13, Ted
Stewart
Q13/04-008 ROS 1304008 R001 V0R2 Removed Level per customer request. Only doing
Flowmeter
Q13/04-008 ROS 1304008 R001 V0R1 Draft; FMEDA for Flowmeter and Level per
customer request

Reviewer: Ted Stewart, exida, June 17, 2021

Status: Released, June 17, 2021

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7.3 Future enhancements
At request of client.

7.4 Release signatures

Gregory Sauk, CFSE, Senior Safety Engineer

Ted E. Stewart, CFSP, exidaCSP

Program Development & Compliance Manager

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Appendix A Lifetime of Critical Components
According to section 7.4.9.5 of IEC 61508-2, a useful lifetime, based on experience, should be
determined and used to replace equipment before the end of useful life.
Although a constant failure rate is assumed by the exida FMEDA prediction method (see section
4.2.2) this only applies provided that the useful lifetime3 of components is not exceeded. Beyond
their useful lifetime the result of the probabilistic calculation method is therefore meaningless, as
the probability of failure significantly increases with time. The useful lifetime is highly dependent on
the subsystem itself and its operating conditions.
This assumption of a constant failure rate is based on the bathtub curve. Therefore, it is obvious
that the PFDavg calculation is only valid for components that have this constant domain, and that
the validity of the calculation is limited to the useful lifetime of each component.
It is the responsibility of the end user to maintain and operate the Primary Element per
manufacturer’s instructions. Furthermore, regular inspection should show that all components are
clean and free from damage.
Based on field failure data a useful life period for Primary Elements used in Emerson Application
checked non-erosive/abrasive and non-corrosive process environments of 20 years can be
expected. When plant experience indicates a shorter useful lifetime for normal service than
indicated in this appendix, the number based on plant experience should be used.
When site experience indicates a shorter useful lifetime than indicated in this appendix, the number
based on site experience should be used.
A useful life period for Primary Elements in severe service should be based on plant specific failure
data. The exida’s SILStat™ software from exida is recommended for this data collection.

3
Useful lifetime is a reliability engineering term that describes the operational time interval where the failure rate of a
device is relatively constant. It is not a term which covers product obsolescence, warranty, or other commercial issues.
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Appendix B Proof Tests to Reveal Dangerous Undetected Faults
According to section 7.4.5.2 f) of IEC 61508-2, proof tests shall be undertaken to reveal dangerous
faults which are undetected by automatic diagnostic tests. This means that it is necessary to
specify how dangerous undetected faults which have been noted during the Failure Modes,
Effects, and Diagnostic Analysis can be detected during proof testing.

B.1 Suggested Proof Test

The suggested proof test described in Table 4 can be used as a Proof Test for the attached
Pressure Transmitter and the Primary Element. This test will detect 95% of the possible DU failure
rate adders for high or low trip clean service applications of the Primary Element. Consult the
Safety Manual of the Pressure Transmitter for any additional steps needed to fully test the
transmitter and for the Transmitter’s Proof Test Coverage

Table 4 Suggested Proof Test – Flow Transmitter

Step Action
1. Bypass the safety function and take appropriate action to avoid a false trip.
2. Inspect the Primary Element for any leaks, visible damage or contamination.
3. Perform a three-point calibration check of the Flow Transmitter by varying the Flow
through the Primary Element.
4. Remove the bypass and otherwise restore normal operation.

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Appendix C exida Environmental Profiles
Table 5 exida Environmental Profiles
exida Profile 1 2 3 4 5 6
Description Cabinet Low General Subsea Offshore N/A
(Electrical) mounted/ Power Field
Climate Field Mounted
Controlled Mounted
no self- self-heating
heating
Description Cabinet General General Subsea Offshore Process
(Mechanical) mounted/ Field Field Wetted
Climate Mounted Mounted
Controlled
IEC 60654-1 Profile B2 C3 C3 N/A C3 N/A
also also also
applicable applicable applicable
for D1 for D1 for D1
Average Ambient
30 C 25 C 25 C 5C 25 C 25 C
Temperature
Average Internal Process
60 C 30 C 45 C 5C 45 C
Temperature Fluid Temp.
Daily Temperature
5C 25 C 25 C 0C 25 C N/A
Excursion (pk-pk)
Seasonal Temperature
Excursion 5C 40 C 40 C 2C 40 C N/A
(winter average vs.
summer average)
Exposed to Elements /
No Yes Yes Yes Yes Yes
Weather Conditions
Humidity4 0-95%
0-100% 0-100% 0-100% 0-100%
Non- N/A
Condensing Condensing Condensing Condensing
Condensing
Shock5 10 g 15 g 15 g 15 g 15 g N/A
Vibration6 2g 3g 3g 3g 3g N/A
Chemical Corrosion7 Compatible
G2 G3 G3 G3 G3
Material
Surge8
Line-Line 0.5 kV 0.5 kV 0.5 kV 0.5 kV 0.5 kV
N/A
Line-Ground 1 kV 1 kV 1 kV 1 kV 1 kV
EMI Susceptibility9
80 MHz to 1.4 GHz 10 V/m 10 V/m 10 V/m 10 V/m 10 V/m
1.4 GHz to 2.0 GHz 3 V/m 3 V/m 3 V/m 3 V/m 3 V/m N/A
2.0Ghz to 2.7 GHz 1 V/m 1 V/m 1 V/m 1 V/m 1 V/m
ESD (Air)10 6 kV 6 kV 6 kV 6 kV 6 kV N/A

4
Humidity rating per IEC 60068-2-3
5
Shock rating per IEC 60068-2-27
6
Vibration rating per IEC 60068-2-6
7
Chemical Corrosion rating per ISA 71.04
8
Surge rating per IEC 61000-4-5
9
EMI Susceptibility rating per IEC 61000-4-3
10
ESD (Air) rating per IEC 61000-4-2
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Appendix D Determining Safety Integrity Level
The information in this appendix is intended to provide the method of determining the Safety
Integrity Level (SIL) of a Safety Instrumented Function (SIF). The numbers used in the examples
are not for the product described in this report.
Three things must be checked when verifying that a given Safety Instrumented Function (SIF)
design meets a Safety Integrity Level (SIL) [N4] and [N7].
These are:
A. Systematic Capability or Prior Use Justification for each device meets the SIL level of the SIF;
B. Architecture Constraints (minimum redundancy requirements) are met; and
C. a PFDavg calculation result is within the range of numbers given for the SIL level.
A. Systematic Capability (SC) is defined in IEC 61508:2010. The SC rating is a measure of design
quality based upon the methods and techniques used to design and development a product. All
devices in a SIF must have a SC rating equal or greater than the SIL level of the SIF. For example,
a SIF is designed to meet SIL 3 with three pressure transmitters in a 2oo3 voting scheme. The
transmitters have an SC2 rating. The design does not meet SIL 3. Alternatively, IEC 61511 allows
the end user to perform a "Prior Use" justification. The end user evaluates the equipment to a given
SIL level, documents the evaluation and takes responsibility for the justification.
B. Architecture constraints require certain minimum levels of redundancy. Different tables show
different levels of redundancy for each SIL level. A table is chosen, and redundancy is incorporated
into the design [N8].
C. Probability of Failure on Demand (PFDavg) calculation uses several parameters, many of which
are determined by the particular application and the operational policies of each site. Some
parameters are product specific and the responsibility of the manufacturer. Those manufacturer
specific parameters are given in this third-party report.
A Probability of Failure on Demand (PFDavg) must be done based on a number of variables
including:
1. Failure rates of each product in the design including failure modes and any diagnostic
coverage from automatic diagnostics (an attribute of the product given by this FMEDA report);
2. Redundancy of devices including common cause failures (an attribute of the SIF design);
3. Proof Test Intervals (assignable by end user practices);
4. Mean Time to Restore (an attribute of end user practices);
5. Proof Test Effectiveness; (an attribute of the proof test method used by the end user with an
example given by this report);
6. Mission Time (an attribute of end user practices);
7. Proof Testing with process online or shutdown (an attribute of end user practices);
8. Proof Test Duration (an attribute of end user practices); and
9. Operational/Maintenance Capability (an attribute of end user practices).
The product manufacturer is responsible for the first variable. Most manufacturers use the exida
FMEDA technique which is based on over 350 billion hours of field failure data in the process
industries to predict these failure rates as seen in this report. A system designer chooses the
second variable. All other variables are the responsibility of the end user site. The exSILentia®
SILVerTM software considers all these variables and provides an effective means to calculate
PFDavg for any given set of variables.

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Simplified equations often account for only the first three variables. The equations published in IEC
61508-6, Annex B.3.2 [N1] cover only the first four variables. IEC 61508-6 is only an informative
portion of the standard and as such gives only concepts, examples and guidance based on the
idealistic assumptions stated. These assumptions often result in optimistic PFDavg calculations and
have indicated SIL levels higher than reality. Therefore, idealistic equations should not be used for
actual SIF design verification.
All the variables listed above are important. As an example, consider a high-level protection SIF.
The proposed design has a single SIL 3 certified level transmitter, a SIL 3 certified safety logic
solver, and a single remote actuated valve consisting of a certified solenoid valve, certified scotch
yoke actuator and a certified ball valve. Note that the numbers chosen are only an example and
not the product described in this report.
Using exSILentia with the following variables selected to represent results from simplified
equations:
 Mission Time = 5 years
 Proof Test Interval = 1 year for the sensor and final element, 5 years for the logic solver
 Proof Test Coverage = 100% (ideal and unrealistic but commonly assumed)
 Proof Test done with process offline
This results in a PFDavg of 6.82E-03 which meets SIL 2 with a risk reduction factor of 147. The
subsystem PFDavg contributions are Sensor PFDavg = 5.55E-04, Logic Solver PFDavg = 9.55E-06,
and Final Element PFDavg = 6.26E-03 (Figure 1).

Figure 1: exSILentia results for idealistic variables

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If the Proof Test Interval for the sensor and final element is increased in one-year increments, the
results are shown in Figure 2.

3.50E-02

3.00E-02

PFDavg 2.50E-02

2.00E-02
Series1
Sensor
1.50E-02
Final
Series2
1.00E-02 Element

5.00E-03

0.00E+00
1 2 3 4 5
Proof Test Interval (Years)

Figure 2: PFDavg versus Proof Test Interval

If a set of realistic variables for the same SIF are entered into the exSILentia software including:

 Mission Time = 25 years

 Proof Test Interval = 1 year for the sensor and final element, 5 years for the logic solver
 Proof Test Coverage = 90% for the sensor and 70% for the final element
 Proof Test Duration = 2 hours with process online.
 MTTR = 48 hours
 Maintenance Capability = Medium for sensor and final element, Good for logic solver

with all other variables remaining the same, the PFDavg for the SIF equals 5.76E-02 which barely
meets SIL 1 with a risk reduction factor of 17. The subsystem PFDavg contributions are Sensor
PFDavg = 2.77E-03, Logic Solver PFDavg = 1.14E-05, and Final Element PFDavg = 5.49E-02 (Figure
3).

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 Figure 3: exSILentia results with realistic variables
It is clear that PFDavg results can change an entire SIL level or more when all critical variables are
not used.

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Appendix E Site Safety Index
Numerous field failure studies have shown that the failure rate for a specific device (same
Manufacturer and Model number) will vary from site to site. The Site Safety Index (SSI) was
created to account for these failure rates differences as well as other variables. The information in
this appendix is intended to provide an overview of the Site Safety Index (SSI) model used by
exida to compensate for site variables including device failure rates.

E.1 Site Safety Index Profiles

The SSI is a number from 0 – 4 which is an indication of the level of site activities and practices
that contribute to the safety performance of SIF’s on the site. Table 6 details the interpretation of
each SSI level. Note that the levels mirror the levels of SIL assignment and that SSI 4 implies that
all requirements of IEC 61508 and IEC 61511 are met at the site and therefore there is no
degradation in safety performance due to any end-user activities or practices, i.e., that the product
inherent safety performance is achieved.
Several factors have been identified thus far which impact the Site Safety Index (SSI). These
include the quality of:
Commission Test
Safety Validation Test
Proof Test Procedures
Proof Test Documentation
Failure Diagnostic and Repair Procedures
Device Useful Life Tracking and Replacement Process
SIS Modification Procedures
SIS Decommissioning Procedures
and others
Table 6 exida Site Safety Index Profiles

Level Description
Perfect - Repairs are always correctly performed, Testing is always done correctly and on
schedule, equipment is always replaced before end of useful life, equipment is always
selected according to the specified environmental limits and process compatible materials.
SSI 4
Electrical power supplies are clean of transients and isolated, pneumatic supplies and
hydraulic fluids are always kept clean, etc. Note: This level is generally considered not
possible but retained in the model for comparison purposes.
Almost perfect - Repairs are correctly performed, Testing is done correctly and on schedule,
equipment is normally selected based on the specified environmental limits and a good
SSI 3 analysis of the process chemistry and compatible materials. Electrical power supplies are
normally clean of transients and isolated, pneumatic supplies and hydraulic fluids are mostly
kept clean, etc. Equipment is replaced before end of useful life, etc.
Good - Repairs are usually correctly performed, Testing is done correctly and mostly on
SSI 2
schedule, most equipment is replaced before end of useful life, etc.
Medium – Many repairs are correctly performed, Testing is done and mostly on schedule,
SSI 1
some equipment is replaced before end of useful life, etc.
None - Repairs are not always done, Testing is not done, equipment is not replaced until
SSI 0
failure, etc.

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