BaltimoreWash DC ISA 2008 3-08

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    email: [email protected]

    Mnchen, Germany+49-89-49000547

    Sellersville, PA., USA+1-215-453-1720

    Tales from the inside the instrument -

    IEC 61508 Certification

    excellence in dependable automation

    Copyright exida2001..2008

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    Introduction

    William Goble

    William Goble has over 30 years of professionalexperience. His areas of expertise include safetyand high availability automation systems,automation probabilistic analysis, new product

    development and market analysis. He developedmany of the techniques used for probabilisticevaluation of safety and high availabilityautomation systems. He was formerly Director,Critical Systems at Moore Products where jobduties included marketing, design and

    development and engineering projectmanagement. He has written three books ontopics of safety and reliability modeling. He is afellow member of ISA. He has published manypapers and magazine articles. Dr. Goble has aBSEE from Penn State, a MSEE from Villanovaand a PhD from Eindhoven University of

    Technology in Eindhoven, Netherlands.

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    Functional Safety Standards

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    1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

    Year

    Is your company implementing or planning onimplementing the ISA 84.01 Functional SafetyStandard?

    ISA S84.01-1996 Published

    IEC 61508 Parts 1,2,4

    IEC 61508 Parts 3,5,6,7

    IEC 61511

    ANSI/ISA 84.01-2004

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    IEC 61511 EquipmentJustification

    Application Fit JustificationMake sure that the equipment performs the

    needed functions and is fully compatible

    with the environment and process.Safety Integrity JustificationEquipment used in safety instrumented

    systems must be chosen based on either

    IEC 61508 certification to the appropriateSIL level orjustification based on prioruse criteria

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    Copyright exida 2001..2008

    Prior Use ??? Prior use generally means:

    a user company has many years of documentedsuccessful experience (no dangerous failures)with a particular version of a particular instrument

    this can provide justification for using thatinstrument even if it is not safety certified.Operating conditions must be recorded and mustbe similar to the proposed safety application.

    We do not have the failure data!

    I do not want to take responsibility forequipment justification!

    We do not take the time to record allinstrument failures!

    This is a new instrument!

    I cannot justify PRIOR USE!

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    Alternative for safety integrity justification -IEC 61508 Full Certification

    The end result of the certificationprocess is a certificate listing theSIL level for which a product isqualified and the standards thatwere used for the certification.

    A good certification assessmentwill demonstrate high designquality for hardware, softwareand high manufacturing quality.

    A good certification assessmentwill check to see that proper enduser documentation is provided The Safety Manual

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    Trend toward 61508 certified instruments

    IEC 61508 Certification is a measure of design quality.IEC 61508 Certification provides fully justifiable equipment

    selection without safety integrity documentation created by the

    end user.

    More and more products are getting IEC 61508 Certification:

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    Number of IEC 61508 Certified Sensors

    From exida Process

    MeasurementInstrument Marketreport

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    What does an instrument manufacturer have to do?

    1. Hardware - meet PFDavg

    expectations for target SIL via:

    Low failure rates, fail-safe design

    High diagnostic coverage

    2. Hardware - Meet SFF

    requirement for target SIL.3. Software - Meet software

    process requirements for target

    SIL, systematic fault avoidance

    4. Product - Meet design process

    requirements for target SIL,systematic fault avoidance

    5. Produce Safety Manual for UserHardware 1,2

    Certify theprocess 3,4

    UserDocumentation - 5

    Full Product

    Certification

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    Hardware Analysis

    Industry

    Product

    Database

    FMEDA

    Compare

    COMPONENT

    DATABASE

    Draft

    Component

    s

    Failure Mode

    Distribution

    ProductFailure

    Modes

    Product

    Diagnostic

    Coverage

    Feedback

    to update

    database

    Based of warranty data analysis

    or field failure data analysis

    An FMEDA is an analysis technique used in IEC 61508 Certification. Itis a detailed, systematic review of the design looking at every part in thedesign.

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    Failure Rates:lS(Failure rate of all safe failures)

    l

    SD

    (Failure rate of all safe detected failures)

    lSU(Failure rate of all safe undetected failures)

    lD(Failure rate of all dangerous failures)

    lDD(Failure rate of all dangerous detected failures)

    lDU(Failure rate of all dangerous undetected failures)

    Calculation of SFF

    What are the results of the FMEDA ?

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    Product Failure Data Example from FMEDA

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    FMEDA Fault Insertion Test

    Simulate component failures andtest that diagnostics perform asexpected.

    Verify software contribution tofault handling

    F.I.T. suites driven from FMEDA totest each diagnostic andfunctional failure mode.

    Fault Insertion Tests (F.I.T.) verify the theoreticalFMEDA with actual product reactions to faults

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    exidaSafety Case DatabaseRequirements Arguments Assessment

    Evidence

    Audit Lists

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    Copyright exida2001..2008

    IndependentAssessment Process

    FMEDA & Fault Insertion TestsTest SpecificationSafety Manual

    Review FSM Plan + Procedures

    Define Scope

    Assess System & SoftwareArchitecture

    Assess Safety Case

    On-site AuditsComplete Safety Case

    Checklist

    Complete Safety CaseChecklist

    Complete Safety CaseChecklist

    Review Design documentation

    Review Testing

    Problems?

    Assessment report

    CertificateIndependent Audit

    Assessment Plan Application Safety RequirementsMilestones

    System FMEAPartitioning + Safety CriticalitySoftware + IC On-Chip Redundancy Physical & Logical Independence

    Common CauseRequirements Tracking

    Safety Manual

    Test execution

    Role allocation + Competence

    Implementation of proceduresCompetence

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    Experience

    Design Quality? Does everyone pass?

    NO a majority fail initial auditsHardware A transmitter has shipped over 25,000 units and has beenshipping for nearly 5 years. The FMEDA analysis quickly showed that whenthe microprocessor clock stops, the 4 20 mA output freezes!

    Hardware A valve has been shipping for nearly two years. The tool

    verification check showed that mechanical tolerances were incorrectlytranslated by a CAD tool revision such that the valve would bind at hightemperatures!

    Hardware A transmitter has shipped over 200,000 units and has beenshipping for nearly 3 years. A Fault Injection Test showed that diagnosticssimply did nothing. Component failures in the transmitter could cause

    drifting outputs and this situation would not be revealed.Hardware A valve manufacturer has been making a particular ball valvedesign for thirty years. The product is clearly field proven. A purchasing

    agent changed vendors on a critical part. The new part was not quite thesame material and many field failures resulted. IEC 61508 requires that thedesign specify exact parts with a qualification procedure needed for allchanges including a new vendor.

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    Are IEC 61508 Products Available?

    IEC 61508 Certified Products:Pressure Transmitters

    Temp. Transmitters

    Flow Transmitters

    Level Transmitters

    PLCs

    Trip Amps, modules

    ActuatorsSolenoids

    Valves

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    IEC 61508PLC

    Certification

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    IEC 61508Pressure

    TransmitterCertification

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    IEC 61508Solenoid Valve

    Certification

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    ISA and othershave several bestsellers for

    automation safetyand reliability

    Read more about Funct ional Safety

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    excellence in dependable automation

    Questions?