Functional Safety. Presented by Matthias Ramold and Stewart Robinson from TÜV SÜD. 07/05/2014 Functional Safety

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1 Functional Safety Presented by Matthias Ramold and Stewart Robinson from 07/05/2014 Functional Safety

2 Your Presenters Matthias Ramold Team leader Safety components for Rail in Germany Many years experience in different Safety applications Technical Certifier for machinery directive and Safety components Member of the working group DKE/AK IEC Stewart Robinson MIET MInstMC Functional Safety Consultant for Product Service in the UK Many years Experience Industry Member of the IET BSI Committee Member for MCE/3 Safeguarding of machinery Chair of the Safety Panel of the Institute of Measurement and Control 2

3 UK Machinery Division Assistance in meeting the requirements of machinery legislation CE marking for Machinery, Low Voltage & EMC Directives PUWER Assessments for the Work Equipment Directive Comprehensive machinery risk assessments Guidance on technical file construction and declaration of conformity/incorporation Pre-purchasing CE audits Safety related control system verification/validation Seminars, workshops and university accredited five day training courses 3

4 Machinery Safety Engineering Services Engineering design Site survey and function design specification Factory acceptance test Installation and commissioning Machine guarding Design, manufacture and installation of machine guarding and Safety Related Control Systems Solutions include perimeter guarding, light curtains, scanners, interlocking etc. 4

5 Products in FS Safety-related generic components Scope of Embedded Systems Application PS HOUSE, Machinery (EN ISO13849, IEC 60335) AT Drive-by-wire systems (ISO 26262) PLC Sensors, drives, valves Operating systems Tools. (IEC 61508, EN ISO 13849, IEC 62061) IS i.e Pipeline, turbine, (IEC61511) Rail Signalling, Rolling stock (EN50128, EN 50129) 5

6 Certification Mark for Safety&Security Safety according to IEC main focus in the project Safety & Security analysis for our customers certification mark for Safety&Security IEC IEC IEC security and penetration testing check of development process according to IEC and IEC Security handbook (secured architecture) & Gap-Analysis according to IEC

7 Accreditations - Functional Safety Deutsche Akkreditierungsstelle Technik (DATech) e.v., DAR DTI-P-G 001/91-02: Competence according to DIN EN ISO/IEC Die Zentralstelle der Länder für Sicherheitstechnik (ZLS): Accreditation as Notified Body according to 2006/42/EC (Machinery Directive) EU NR and DIN EN ISO/IEC

8 Involved in Qualification and Research is member of i.e. IEC committee IEC committee IEC maintainance group EN ISO maintainance group ISO committee IEC working group Several Network associations (i.e. PNO, Foundation Fieldbus, Safety over EtherCat, Safety alliance) 8

9 Certificate: Example 9

10 Introduction to Functional Safety..in order to protect... people and machines Safety has to be an integrated part of every automation 10

11 Definitions Safety = Free from unacceptable risks Risk = Combination of probability of occurrence of harm and the severity of that harm Goal is to reduce risk to a acceptable extent (see IEC Part 4 and 5, Annex A) 11

12 Risk Reduction Residual risk Acceptable risk EUC Risk Increasing Risk Necessary Risk Reduction Actual Risk Reduction Partial Risk covered by E/E/PE safety related systems Partial risk covered by other technology safety related systems Partial risk covered by external risk reduction facilities 12

13 Aspects for Risk reduction The combination of probability of occurrence and severity of hazardous events may not exceed the tolerable risk. Requirements of reliability of safety related functions necessary to sustain or fulfil the required safety = Functional Safety Control of dangerous failures during operation robust design Avoidance of systematic failures during design, production and operation of the system robust development process 13

14 Aim of Functional Safety The avoidance of systematic failures as well as the control of systematic and random failures in safety related functions reduces the expected risk to a tolerable extent, thereby the following will be prevented: injury or death of people catastrophic effects on the environment, destruction or damage of production facilities and producer goods, inclusive production deficit (optional) 14

15 Possible scenario Planning completed Industrial facilities under operation punching machine 15

16 Legal situation In case of an accident you will be asked: Has the development and planning been performed according to the state of the art? (not only with view to the company product liability, but with guilty causing of the developer [Germany: 823 BGB-Schadensersatzpflicht]) Safety related functions Legal requirements for the facility operation Requirements according to product liability (state of the art) 16

17 Legal requirements for production Laws and regulations have to be fulfilled to achieve and sustain the admission for operation Machinery directive 2006/42/EC Safety goal and elementary safety requirements Low Voltage Directive 2006/95/EC for devices within specific voltage ranges EMC Directive 2004/108/EC Electromagnetic compatibility 17

18 Fulfilling the directive (I) Technical realisation Requirements and the technical realisation are given in standards and have to be fulfilled. Presumption of conformity If a product complies with the relevant harmonized standards it may be presumed that the directive is fulfilled Harmonized standards are listed under the related directive. ( Deviation from standards Other technical solutions are allowed if equivalent safety is achieved. (Problem to show the evidence of compliance?) 18

19 Requirements resulting from product liability...state of the art at the point of installation (=commissioning).. is relevant in case of assessment of product liability IEC DIN EN IEC ISO Generic basic standard for functional safety of electric/ electronic systems Application specific standard of IEC for manufacturing industry 19

20 Definitions CEN CENELEC IEC ISO EN DIN VDE = European Committee for Standardization, Brüssel = European Committee for electrotechnical Standardization, Brüssel = International Electrotechnical Commission, Geneva = Internationale Organisation for Standardization, Geneva = European Standard = German Institute of Standardization (Deutsches Institut für Normung e.v.), Berlin = Verband der Elektrotechnik, Elektronik und Informationstechnik e.v., Frankfurt am Main Process of standardization: IEC EN DIN EN ISO EN ISO DIN EN ISO More: 20

21 Fulfilling the directive (II) Liability In case of compliance with the standards it is assumed that the manufacturer did not act grossly negligent. Thereby the legal consequences in case of damage will be reduced to a minimum. 21

22 Overview of valid key standards Harmonized under EU Machinery Directive: EN ISO Basic concepts, general principles for design and risk assessment EN Safety of machinery electrical equipment of machines Part 1: General requirements EN ISO Safety of machinery - Emergency stop Principles for design EN ISO /2 (EN 954-1) Safety of machinery - Safety-related parts of control systems EN Safety of machinery Functional safety of safety-related electrical, electronic and programmable electronic control systems EN Safety of machinery- Electro-sensitive protective equipment Part 1: General requirements and tests 22

23 Overview of valid key standards Not harmonized under any EU Directive: IEC Functional safety of electrical/electronic/programmable electronic safety-related systems IEC , -3, -4 Electro-sensitive protective equipment

24 Hierarchical Structure of EN Standards Basic Safety Standards TYPE A Basic design guidelines and basic terminology for machinery EN EN ISO EN ISO EN 954 (until 2011) EN Group Safety Standards B1 Standards General safety aspects TYPE B B2 Standards Reference to special protective devices EN ISO Emergency Stop Product standards TYPE C Specific safety features for individual machinery groups EN 692 Machine tools Mechanical presses 24

25 Link between FS Standards IEC Medical ISO Automobile ISO Agriculture DO-178B Aviation EN Railway IEC Nuclear Power IEC Furnaces IEC Generic IEC Household Appliances ISO IEC Machinery ISO Earth Moving M. IEC Process Ind. 25

26 Safety Reqiuerment Spec. (SRS) certification process FSM for all steps Einführung Checklist FSM IEC Safety plan Checklist Audit plan + reports Checklist V & V Plan Checklist Software Development Checklist SW Development Development guidelines Checklist Safety analysis Analysis guidelines Checklist Hardware Development Checklist HW Development Development guidelines Checklist Quotation Process Customer documents TÜV documents Technical Report (Concept Report) Hardware Spec. Hardware Design Hazard & Risk Analysis Safety goals with SIL X Checklist Risk Analysis Funktional Safety Concept Requirements for each function: SIL, operation mode/modi, process safety time, safe state, measure&method Technical Safety Concept HW-Test System-Analysis System-FMEA / FTA Checklist System Analysis HW/SW Interface SRS Safety Case Review Report Checklist Safety Case Validation System Test System Test Specification, System Test Reports HW-Verification Hardware SRS Test spec + report Software SRS Test spec. + report Checklist HW Spec. Checklist HW Verification Checklist Software Spec. Checklist SW Verification Hardware Analysis FMEDA, ZBD, Markov, SFF, PFH/PFD Checklist HW Analysis Checklist Safety Requirement Spec. (SRS) System architectur, interface, HFT, SFF goal, conditions of use, maintance, error handling & diagnosis Checklist Safety Requirement Spec. (SRS) System Design Hardware Integration Fault Insertion Tests Checklist HW Tests Certificate, Certificate Report Technical Report Software Spec. SW Design SW-Analysis Criticality Analysis Checklist SW-Analysis Validation Specification, Validation Reports Checklist Validation Checklist System Tests System Integration SW-Verification SW Modul-Integration SW-Tests SW-Modul Tests Checklist SW Tests 26

27 Certification: Necessary documentation from the manufacturer V&V Phase 2.1 Safety requirement specification SRS Document 2.2 Planning of validation Validation plan, safety plan 3.1 System plan System-Specification and system architecture (hard- and software) 3.2 System test concept System test plan System-FMEA and block diagrams 4.1 Hardware design and implementation Hardware description and schematics, part lists, layouts and information on the components and materials used Component FMEA (FMEDA) 4.2 Hardware test concept Hardware test plan MTTFd/DC/CC calculation according to ISO SFF/PFH/PFD calculation according to IEC

28 Certification : Necessary documentation from the manufacturer V&V Phase Document 5.1 Software design Software architecture and design specification (structured or semi-formal) (according to IEC ) Documentation of the software tool qualification Coding standards Software criticality analyse 5.2 Software test concept Software test plan 6 Realization: implementation / coding Graphical explanation, source code 7 Software test: verification of all SW Documentation of test results requirements 8 Hardware test / fault insertion tests Documentation of hardware fault insertion tests 9 System integration / integration test Documentation of system integration tests HW/SW 10 Validation of the safety Protocols of accredited test laboratories for EMC, environmental conditions and primary safety Available certificates of other competent bodies Safety - related user documentation 28

29 Certification : Test steps phase 1 Phase 1: Concept Review and functional safety management (FSM) The analysis of functional safety management (FSM) is mandatory to fulfil the requirements of EN part 1. Task Audit of the safety organisation and the functional safety management (FSM) according to EN Concept Review based on System specification SW architecture System FMEA Plan for Verification and Validation (V&V-Plan) 29

30 Certification : Test steps phase 2 Phase 2: Detail Following table gives an overview of the activities of TUV in the detail phase of a type testing. Task Hardware design and implementation Hardware design: architecture Review of component FMEDA (block level and component level incl. mechanical aspects) Probabilistic Review PFH/PFD- and SFF-Calculation Hardware tests / fault insertion tests Review test reports Execution of representative FITs 30

31 Certification : Test steps phase 2 Task Software design and module design Review software requirements Review software design Review software analysis Reviews tool qualification Software module test Review module test concept and module test report Execution of representative FIT tests Realization: implementation / coding Review design- and coding guidelines Coding review (spot-checks) External communication (if applicable) Review of probabilistic calculations and analysis of the qualitative error models ASIC Design (if applicable) Review ASIC design Review ASIC analysis Review tool qualification 31

32 Certification : Test steps phase 2 Task System integration / integrations test HW execution of representative fault insertion tests Review integration test report / system test report Audit safety life cycle Testing of electrical safety Review of EMC test reports Review of application tests results (if applicable) Validation of the safety review of Validation Requirement tracking Optional support for other test certificates (e.g. UL listing) Review of the user manual Factory inspection Technical report Certificate Generating the certificate Report to the certificate (if needed) 32

33 Conclusion: Advantage of certified products Third party assessment No evaluation by the end user necessary Conformity to the relevant standards Supervision of the production Comparability between products 33

34 Thank you for listening For more information please contact: Matthias Ramold: Stewart Robinson: Slide 34

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