You are on page 1of 100

Sicurezza Funzionale per lindustria di processo

24 Novembre 2011 CROWNE PLAZA Via K. Adenauer, 3 20097 San Donato Milanese (MI) ( )

Ledizione 2010 della norma IEC 61508 Carlo Tarantola CTAI S.r.l.
mcT Petrolchimico Milano 2011 1

La nuova edizione 2010 della norma IEC 61508

IEC 61508-1/7 61508 1/7 Tempi e modalit di applicazione

mcT Petrolchimico Milano 2011

IEC 61508-1/7: 2010 61508Tempi e modalit di applicazione


IEC 61508: Aprile 2010 Part 17 Functional Safety of Electrical/Electronic/Programmable Electronic Safety Related Systems (uscita la versione CENELEC Maggio 2010) CENELEC, IEC 61511: 2003 Part 13 Functional Safety Safety Instrumented Systems for the process industry sector IEC / EN 62061: 2004 Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems IEC / EN 61800 5 2: 2007 Adjustable speed electrical power drive 61800-5-2: systems - Part 5-2: Safety requirements Functional (Norme Armonizzate per Direttiva Macchine)
mcT Petrolchimico Milano 2011 3

IEC 61508 e IEC 61511 Modalit di applicazione


NORME PER SISTEMI STRUMENTATI DI SICUREZZA PER IL SETTORE DELLINDUSTRIA DI PROCESSO OC SSO

Costruttori e fornitori di dispositivi IEC 61508

Progettisti, integratori e utilizzatori di Sistemi Strumentati di Sicurezza IEC 61511


mcT Petrolchimico Milano 2011 4

La nuova edizione 2010 della norma IEC 61508

IEC 61508-1/7: 2010 61508 1/7: Generalit

mcT Petrolchimico Milano 2011

IEC 61508-1/7: 2010 61508Generalit


1. Chiarisce, in maniera migliore rispetto alla edizione 2000, che la focalizzazione sulla Funzione di Sicurezza espletata, non sulla sicurezza tout court, che pur importante pu essere compito di tout court che, importante, altre norme (ad esempio, quelle sulla Sicurezza Elettrica o PED) 2. Resta applicabile per safety-related systems when one or more of such systems incorporates electrical/electronic/programmable electronic devices elements, ma si applica anche ad elementi non E/E/PE, da incorporare i sistemi E/E/PE E/E/PE d i in i i E/E/PE. 3. Modifica in maniera anche significativa alcune definizioni, e quindi g , q tutti gli aspetti connessi ad esse

mcT Petrolchimico Milano 2011

IEC 61508-1/7: 2010 61508Generalit


4. Mantiene i requisiti fondamentali per la progettazione di Sistemi di Sicurezza:
a. b. c. Management of Functional Safety Safety Life Cycle Requisiti per guasti casuali (Failure Rates dellHW) e sistematici (HW e SW) combinati con requisiti di architettura e diagnostica

5. 5 Al tempo stesso modifica in alcuni casi in maniera significativa le stesso, strade per la conformit 6. Introduce il concetto di Systematic Capability e di element di un Sistema di Si Si t Sicurezza 7. Introduce requisiti per ASICs e on-chip redundancy 8. Introduce requisiti obbligatori per il Safety Manual q g p y 9. Introduce metodi per la valutazione di SW pre-esistente 10. Introduce un metodo di dettaglio per la valutazione del SW 11. 11 Introduce requisiti pi specifici per il personale coinvolto nella Sicurezza Funzionale
mcT Petrolchimico Milano 2011 7

Contenuti della IEC 61508/61511


Gestione della Sicurezza Funzionale Safety Lif C l S f t Life Cycle

SIL
Eliminazione guasti sistematici HW/SW Architettura (HFT)

Controllo guasti HW/SW

Probabilit guasto casuale (PFD/PFH)

Orientamento guasto (SFF)

mcT Petrolchimico Milano 2011

IEC 61508-1/7: 2010 61508Argomenti trattati


Il seminario tratta in particolare le modifiche principali (tralasciando le modifiche cosmetiche o poco pi) relative alle prime 4 parti della norma, norma quelle normative Il seminario dedica solo un cenno alle ultime tre parti, che sono in pratica delle guide Indice IEC 61508-4 IEC 61508-2 61508 2 IEC 61508-3 IEC 61508-1 IEC 61508 5/7 (C 61508-5/7 (Cenni) i) Al termine delle Sezioni sulle Parti 2, 3, e 1, un riassunto degli effetti (per gli utilizzatori della norma) delle modifiche introdotte.
mcT Petrolchimico Milano 2011 9

La nuova edizione 2010 della norma IEC 61508

IEC 61508-4: 2010 61508 4: Le nuove definizioni e modifiche a definizioni attuali

mcT Petrolchimico Milano 2011

10

Definizioni - Software
3.2.10 software on-line support tool software tool that can directly influence the safety-related system during its run time 3.2.11 software off-line support tool software tool that supports a p pp phase of the software development lifecycle p y and that cannot directly influence the safety-related system during its run time. Software off-line tools may be divided into the following classes: T1: generates no outputs which can directly or indirectly contribute to the executable code (including data) of the safety related system; T2: supports the test or verification of the design or executable code, where errors in the tool can fail to reveal defects but cannot directly create errors in the executable software; T3: generates outputs which can directly or indirectly contribute to the executable code of the safety related system system.
mcT Petrolchimico Milano 2011 11

Definizioni - Software
3.2.15 application specific integrated circuit ASIC integrated circuit designed and manufactured for specific function, where its functionality is defined by the product developer The term ASIC covers all types of the following integrated circuits: Full custom ASIC Core based ASIC C ll b Cell based ASIC d Gate array Field programmable gate array (FPGA) Programmable logic device (PLD) Complex programmable logic device (CPLD)

mcT Petrolchimico Milano 2011

12

Definizioni - Sistema
3.4.2 other risk reduction measure measure to reduce or mitigate risk that is separate and distinct from, and does not use, E/E/PE safety-related systems 3.4.5 element part of a subsystem comprising a single component or any group of components that performs one or more element safety functions. 3.5.2 overall safety function means of achieving or maintaining a safe state for the EUC, in respect of a specific hazardous event 3.5.3 element safety function y that part of a safety function (see 3.5.1) which is implemented by an element mcT Petrolchimico Milano 2011

13

Definizioni Safety Function and Safety Integrity


3.5.9 systematic capability measure (expressed on a scale of SC 1 to SC 4) of the confidence that the systematic safety integrity of an element meets the requirements of the specified SIL, in respect of the specified element safety function, when the element is applied in accordance with the instructions specified in the system manual for compliant items. 3.5.10 software safety integrity level y g y systematic capability of a software element that forms part of a subsystem of a safety-related system

mcT Petrolchimico Milano 2011

14

Definizioni Safety Function and Safety Integrity


3.5.11 E/E/PE system safety requirements specification 3.5.12 E/E/PE system safety functions requirements specification 3.5.13 3 5 13 E/E/PE system safety integrity requirements specification 3.5.14 E/E/PE system design requirements specification specification containing the design requirements for the E/E/PE safetyrelated system in terms of the subsystems and elements

mcT Petrolchimico Milano 2011

15

Definizioni Safety Function and Safety Integrity


3.5.16 mode of operation way in which a safety function operates, which may be either low demand mode: where the safety function is only performed on demand, in order to transfer the EUC into a specified safe state, and where the frequency of demands is no g q y greater than one p y per year; or
NOTE The E/E/PE safety-related system that performs the safety function normally has no influence on the EUC or EUC control system until a demand arises. However, if the E/E/PE safety-related system fails in such a way that it is unable to carry out the safety function then it may cause the EUC to move to a safe state (see 7.4.6 of IEC 61508 2). 61508-2).

high demand mode: where the safety function is only performed on demand, in order to transfer the EUC into a specified safe state, and where the frequency of demands is greater than one per year; or continuous mode: where the safety function retains the EUC in a safe state as part of normal operation

mcT Petrolchimico Milano 2011

16

Definizioni Guasti
3.6.7 dangerous failure failure which has the potential to put the safety-related system in a hazardous or fail-to-function state
NOTE Whether or not the potential is realised may depend on the channel architecture of the system; in systems with multiple channels to improve safety, a dangerous hardware failure is less likely to lead to the overall dangerous or fail to function state fail-to-function state.

failure of an element and/or subsystem and/or system that plays a part in implementing the safety function that: prevents a safety function from operating when required (demand mode) or causes a safety function to fail (continuous mode) such that the EUC is put into a hazardous or potentially hazardous state; or decreases th probability th t th safety f d the b bilit that the f t function operates correctly when ti t tl h required

mcT Petrolchimico Milano 2011

17

Definizioni Guasti
3.6.8 safe failure failure which does not have the potential to put the safety-related system in a hazardous or fail-to-function state
NOTE Whether or not the potential is realised may depend on the channel architecture of the system; in systems with multiple channels to improve safety, a safe hardware failure is less likely to result in an erroneous shut down shut-down.

failure of an element and/or subsystem and/or system that plays a part in implementing the safety function that: a) results in the spurious operation of the safety function to put the EUC (or part thereof) into a safe state or maintain a safe state; or b) increases the probability of the spurious operation of the safety function to t th t put the EUC ( part thereof) into a safe state or maintain a safe state (or t th f) i t f t t i t i f t t

mcT Petrolchimico Milano 2011

18

Definizioni Guasti
3.6.12 soft-error erroneous changes to data content but no changes to the physical circuit itself 3.6.13 no part failure failure of a component that plays no part in implementing the safety function 3.6.14 no effect failure failure of an element that plays a part in implementing the safety function but has no direct effect on the safety function

mcT Petrolchimico Milano 2011

19

Definizioni Guasti
3.6.15 safe failure fraction SFF property of a safety related element that is defined by the ratio of the average failure rates of safe plus dangerous detected failures and safe plus dangerous failures. This ratio is represented by the following equation: g p y g q SFF = (S avg + Dd avg)/(S avg + Dd avg+ Du avg) when the failure rates are based on constant failure rates the equation can be simplified to: SFF = (S + Dd)/(S + Dd + Du)

mcT Petrolchimico Milano 2011

20

Definizioni Guasti
3.6.18 average probability of dangerous failure on demand PFDavg mean unavailability (see IEC 60050-191) of an E/E/PE safety-related system to perform the specified safety function when a demand occurs from the EUC or EUC control system
NOTE 2 Two kind of failures contribute to PFD and PFDavg: the dangerous undetected failures occurred since th l t proof test and genuine on d d i the last ft t d i demand f il d failures caused b th d d by the demands ( d (proof f tests and safety demands) themselves. The first one is time dependent and characterized by their dangerous failure rate DU(t) whilst the second one is dependent only on the number of demands and is characterized by a probability of failure per demand (denoted by ). NOTE 3 As genuine on demand failures cannot be detected by tests, it is necessary to identify them and take them into consideration when calculating the target failure measures.

3.6.19 3 6 19 average f frequency of a dangerous failure per hour PFH f d f il h average frequency of a dangerous failure of an E/E/PE safety related system to perform the specified safety function over a given period of time
mcT Petrolchimico Milano 2011 21

Definizioni Guasti
3.6.21 mean time to restoration MTTR expected time to achieve restoration 3.6.22 mean repair time MRT Expected overall repair time Formula per il calcolo PFDAVG(1oo1(D)) secondo Ed. 2010: PFDAVG(1oo1(D))=DU(TI/2+MRT)+ DD(TID/2+MRT)

mcT Petrolchimico Milano 2011

22

Definizioni Confirmation of safety measures


3.8.5 proof test periodic test performed to detect dangerous hidden failures in a safetyrelated system so that, if necessary, a repair can restore the system to an as new condition or as close as practical to this condition 3.8.8 detected in relation to hardware, detected by the diagnostic tests, proof tests, operator intervention (for example physical inspection and manual tests) or tests), through normal operation
EXAMPLE These adjectives are used in detected fault and detected failure. g y g NOTE A dangerous failure detected by diagnostic test is a revealed failure and can be considered a safe failure only if effective measures, automatic or manual, are taken.

mcT Petrolchimico Milano 2011

23

Definizioni Confirmation of safety measures


3.8.17 safety manual for compliant items document that provides all the information relating to the functional safety of an element, in respect of specified element safety functions, that is required to ensure that the system meets the requirements of IEC 61508 series 3.8.18 proven in use demonstration based on an analysis of operational experience for a demonstration, specific configuration of an element, that the likelihood of dangerous systematic faults is low enough so that every safety function that uses the element achieves its required safety integrity level

mcT Petrolchimico Milano 2011

24

La nuova edizione 2010 della norma IEC 61508

IEC 61508-2: 2010 61508 2: Progettazione HW Le modifiche sostanziali

mcT Petrolchimico Milano 2011

25

Figure 2 E/E/PE system safety lifecycle (in realisation phase)

mcT Petrolchimico Milano 2011

26

Figure 3 ASIC development lifecycle (the V-Model) V-

mcT Petrolchimico Milano 2011

27

Requisiti di progettazione
7.4.2.2 The design of the E/E/PE safety-related system (including the overall hardware and software architecture, sensors, actuators, programmable electronics, ASIC ( ) embedded software, application software, d l i ASICs (75), b dd d f li i f data etc.), ) see figure 4 shall meet all of the requirements a) to c) e) as follows: a) the requirements for hardware safety integrity comprising: the architectural constraints on hardware safety integrity (see 7.4.3.1 7.4.4), and the requirements for the probability of dangerous random hardware q p y g failures (see 7.4.3.2) quantifying the effect of random failures (see 7.4.5); b) the special architecture requirements for ICs with on-chip redundancy (see Annex E), where relevant, unless justification can be given that the same level of independence between different channels is achieved by applying a different set of measures;

mcT Petrolchimico Milano 2011

28

Requisiti di progettazione
b c) the requirements for systematic safety integrity (systematic capability), which can be met by achieving one of the following compliance routes: the requirements for the avoidance of failures (see 7.4.4), and the requirements for the control of systematic faults (see 7.4.5), or evidence that the equipment is "proven in use" ( q p p (see 7.4.7.6 to 7.4.7.12); ) Route 1S: compliance with the requirements for the avoidance of systematic faults (see 7.4.6 and IEC 61508-3) and the requirements for the control of systematic faults (see 7.4.7 and IEC 61508-3), or y ( ), Route 2S: compliance with the requirements for evidence that the equipment is proven in use (see 7.4.10), or Route 3S (pre-existing software elements only): compliance with the requirements of IEC 61508-3, 7.4.2.12; c d) the requirements for system behaviour on detection of a fault (see 7.4.6 7.4.8). 7 4 8) e) the requirements for data communication processes (see 7.4.11).
mcT Petrolchimico Milano 2011

29

Requisiti di progettazione
7.4.3.1 To meet the requirements for systematic safety integrity, the designated safety related E/E/PE system may, in the circumstances described in this section, be partitioned into elements of different systematic capability capability. 7.4.3.2 For an element of systematic capability SC N (N=1, 2, 3), where a systematic fault of that element does not cause a failure of the specified safety function but does so o y combination t only in co b at o with a seco d syste at c fault of another e e e t o syste at c second systematic au t o a ot e element of systematic capability SC N, the systematic capability of the combination of the two elements can be treated as having a systematic capability of SC (N + 1) providing that sufficient independence exists between the two elements ( see 7.4.3.4). 7.4.3.3 The systematic capability that can be claimed for a combination of elements each of systematic capability SC N can at most be SC (N+1). A SC N element may be used in this way only once. It is not permitted to achieve SC (N+2) and higher by successively building assemblies of SC N elements elements. 7.4.3.4 Sufficient independence, in the design between elements and in the application of elements, shall be justified by common cause failure analysis to show that the likelihood of interference between elements and between the elements and the environment is sufficiently low in comparison with the safety integrity level of the safety function under consideration.
mcT Petrolchimico Milano 2011

30

Limitazioni di Architettura (HW)


7.4.4 In the context of hardware safety integrity, the highest safety integrity level that can be claimed for a safety function is limited by the hardware safety integrity constraints which shall b achieved b i l i i i hi h h ll be hi d by implementing one of two i f possible routes (to be implemented at system or subsystem level): Route 1H based on hardware fault tolerance and safe failure fraction concepts; or, Route 2H based on component reliability data from feedback from end users, increased confidence levels and hardware fault tolerance for specified safety integrity levels. Application standards based on the IEC 61508 series may indicate the preferred Route (i.e. Route 1H or Route 2H).

mcT Petrolchimico Milano 2011

31

Elementi di Tipo A e Tipo B


7.4.4.1.2 An element can be regarded as type A if, for the components required to achieve the safety function a) the failure modes of all constituent components are well defined; and b) the behaviour of the element under fault conditions can be completely determined; and c) there is sufficient dependable failure data from field experience to show that the claimed rates of failure for detected and undetected dangerous failures are met 7.4.4.1.3 An element shall be regarded as type B if, for the components required to achieve the safety function, a) the failure mode of at least one constituent component is not well defined; or b) b) the behaviour of the element under fault conditions cannot be completely determined; or c) there is insufficient dependable failure data from field experience to support claims for rates of failure for detected and undetected dangerous failures
mcT Petrolchimico Milano 2011

32

SFF, Diagnostica e Intervalli di Test


7.4.4.1.4 When estimating the safe failure fraction of an element, intended to be used in a subsystem having a hardware fault tolerance of 0, and which is implementing a safety f i l i f function, or part of a safety function, operating i hi h i f f f i i in high demand mode or continuous mode of operation, credit shall only be taken for the diagnostics if: the sum of the diagnostic test interval and the time to perform the specified action to achieve or maintain a safe state is less than the process safety time; or, when operating in high demand mode of operation, the ratio of the diagnostic test rate to the demand rate equals or exceeds 100. NOTA: Le stesse regole valgono anche per la valutazione dei guasti in diagnosticati e non.

mcT Petrolchimico Milano 2011

33

SFF, Diagnostica e Intervalli di Test


7.4.4.1.5 When estimating the safe failure fraction of an element which, has a hardware fault tolerance greater than 0, and which is implementing a safety function, or part of a safety function, operating in high demand mode or continuous mode of operation; or, is implementing a safety function, or p of a safety function, operating in p g y part y p g low demand mode of operation, credit shall only be taken for the diagnostics if the sum of the diagnostic test interval and the time to perform the repair of a detected failure is less than the p p MTTR used in the calculation to determine the achieved safety integrity for that safety function.

mcT Petrolchimico Milano 2011

34

Route 1H Progettazione secondo norma


7.4.4.2.1 To determine the maximum safety integrity level that can be claimed, with respect to a specified safety function, the following procedure shall be followed: f ll d
1. Define the subsystems making up the E/E/PE safety-related system. 2. For each subsystem determine the safe failure fraction for all elements in the subsystem separately (i.e. on an individual element basis with each element having a hardware fault (i e tolerance of 0). In the case of redundant element configurations, the SFF may be calculated by taking into consideration the additional diagnostics that may be available (e.g. by comparison of redundant elements). 3. 3 For each element, use the achieved safe failure fraction and hardware fault tolerance of 0 to element determine the maximum safety integrity level that can be claimed from column 2 of Table 2 (for Type A elements) and column 2 of Table 3 (for Type B elements). 4. Use the method in 7.4.4.2.3 and 7.4.4.2.4 for determining the maximum safety integrity level that th t can b claimed f th subsystem. be l i d for the b t 5. he maximum safety integrity level that can be claimed for an E/E/PE safety-related system shall be determined by the subsystem that has achieved the lowest safety integrity level.

mcT Petrolchimico Milano 2011

35

Route 2H Proven in use


7.4.4.3.1 The minimum hardware fault tolerance for each subsystem of an E/E/PE safety-related system implementing a safety function of a specified safety integrity l f i i level shall b as f ll l h ll be follows:
NOTE In the following clauses, unless otherwise specified, the safety function may be operating in either a low demand mode of operation or a high demand or continuous mode of operation.

a) a hardware fault tolerance of 2 for a specified safety function of SIL 4 unless the conditions in 7.4.4.3.2 apply. b) a hardware fault tolerance of 1 for a specified safety function of SIL 3 unless th conditions i 7 4 4 3 2 apply. l the diti in 7.4.4.3.2 l c) a hardware fault tolerance of 1 for a specified safety function of SIL 2, operating in a high demand or continuous mode of operation, unless the conditions i 7 4 4 3 2 apply. diti in 7.4.4.3.2 l d) a hardware fault tolerance of 0 for a specified safety function of SIL 2 operating in a low demand mode of operation. e) a hardware fault tolerance of 0 for a specified safety function of SIL 1.
mcT Petrolchimico Milano 2011 36

Requisiti per elementi Proven in use


7.4.10.1 An element shall only be regarded as proven in use when it has a clearly restricted and specified functionality and when there is adequate documentary evidence to d d id demonstrate that the lik lih d of any d h h likelihood f dangerous systematic faults is low enough that the required safety integrity levels of the safety functions that use the element is achieved. Evidence shall be based on analysis of operational experience of a specific configuration of the element together with suitability analysis and testing.
NOTE Suitability analysis and testing focuses on the demonstration of the elements performance within the intended application. The results of existing analysis and testing should be taken into application account. This includes functional behaviour, accuracy, behaviour in the case of a fault, time response, response to overload, usability (e.g., avoidance of human error) and maintainability.

mcT Petrolchimico Milano 2011

37

Valutazione guasti casuali HW


7.4.9.5 The estimated failure rates, due to random hardware failures, for subsystems elements can be determined either a. by a failure modes and effects analysis of the design using component element failure data from a recognised industry source; or b. from experience of the p p previous use of the subsystem element in a similar y environment. NOTE 1 Any failure rate data used should have a confidence level of at least 70 %. The statistical determination of confidence level is defined in reference [9] of the Bibliography. (ISO 14224, NDR)

mcT Petrolchimico Milano 2011

38

Route 1H SFF e HFT Tipo A


Safe Failure Fraction (SFF) N=0 Hardware Fault Tolerance (HFT) Tipo A Sottosistemi semplici N=1 N=2

< 60% 60% < 90% 90% < 99% >= 99%

SIL 1 SIL 2 SIL 3 SIL 3

SIL 2 SIL 3 SIL 4 SIL 4

SIL 3 SIL 4 SIL 4 SIL 4

La tolleranza ai guasti N significa che il guasto N+1 pu causare una perdita della funzione di sicurezza

mcT Petrolchimico Milano 2011

39

Route 1H SFF e HFT Tipo B


Safe Failure Fraction (SFF) N=0 Hardware Fault Tolerance (HFT) Tipo B sottosistemi complessi N=1 N=2

< 60% 60% < 90% 90% < 99% >= 99%

Non permesso SIL 1 SIL 2 SIL 3

SIL 1 SIL 2 SIL 3 SIL 4

SIL 2 SIL 3 SIL 4 SIL 4

La tolleranza ai guasti N significa che il guasto N+1 pu causare una perdita della funzione di sicurezza

mcT Petrolchimico Milano 2011

40

Route 2H Proven in use Minimum HFT


Maximum SIL Minimum Hardware Fault Tolerance (HFT) Low Demand Mode of f Operation 1 2 3 4 0 0 1 2 Continuous High Demand or C Mode of Operation 0 1 1 2

La tolleranza ai guasti N significa che il guasto N+1 pu causare una perdita della funzione di sicurezza

mcT Petrolchimico Milano 2011

41

SIL e PFD/PFH
Safety Integrity Level (SIL) Average Probability of Failure on Demand (PFDAVG) 10-5 a <10-4 10-4 a <10-3 10-3 a <10-2 10-2 a <10-1 Probability of Failure per Hour (PFH) Risk Reduction Factor (RRF)

SIL 4 SIL 3 SIL 2 SIL 1

10-9 a <10-8 10-8 a <10-7 10-7 a <10-6 10-6 a <10-5

>10000 a 100000 >1000 a 10000 >100 a 1000 >10 a 100

PFDAVG utilizzata per sistemi Low Demand Mode PFH utilizzata per sistemi High Demand or Continuous Mode

mcT Petrolchimico Milano 2011

42

Systematic safety integrity


A.3 Tables give recommendations for techniques and measures to: control failures caused by hardware design (Table A.15); control failures due to environmental stress or influences (Table A.16); control failures during operation (see Table A.17). In Tables A.15 to A.17, recommendations are made and requirements are A 15 A 17 given by safety integrity level, stating firstly the importance of the technique or measure and secondly the effectiveness required if it is used. Annex B (normative) - Techniques and measures for E/E/PE safety-related systems avoidance of systematic failures during the different phases of the lifecycle In Tables B.1 to B.5, recommendations are made and requirements are given by safety integrity level, stating firstly the importance of the technique or measure and secondly th effectiveness required if it i used d dl the ff ti i d is d
mcT Petrolchimico Milano 2011 43

Systematic safety integrity


The importance is signified as follows: M: the technique or measure is required (mandatory) for this safety integrity level; HR: the technique or measure is highly recommended for this safety integrity level. If this technique or measure is not used then the rationale g y q behind not using it shall be detailed; R: the technique or measure is recommended for this safety integrity level; ; -: the technique or measure has no recommendation for or against being used; NR: the technique or measure is positively not recommended for this safety integrity level; If this technique or measure is used then the rationale behind using it shall be detailed.

mcT Petrolchimico Milano 2011

44

Systematic safety integrity


The required effectiveness is signified as follows: Mandatory: the technique or measure is required for all safety integrity levels and shall be used as effectively as possible (i.e. giving high effectiveness). Low: if used, the technique or measure shall be used to the extent q necessary to give at least low effectiveness against systematic failures; Medium: if used, the technique or measure shall be used to the extent necessary to give at least medium effectiveness against systematic y g g y failures; High: if used, the technique or measure shall be used to the extent necessary to give high effectiveness against systematic failures.

mcT Petrolchimico Milano 2011

45

Esempio - Tecniche e misure per evitare errori nella Specifica dei Requisiti di Sicurezza

mcT Petrolchimico Milano 2011

46

Special architecture requirements for Ics with on-chip redundancy ona) The highest safety integrity level that can be claimed for a safety function using an IC as described above is limited to SIL 3. b) The systematic capability shall not be increased by combination of elements. c) To avoid common cause failure(s), the effects of increasing temperature, for example due to random hardware fault(s), shall be considered. At least one of the measures listed in Table E 2 no 6 shall be applied In a design where a local fault E.2, no. applied. can cause a safety critical temperature increase, appropriate measures shall be taken. d) Separate physical blocks on substratum of the IC shall be established for each channel and each monitoring element such as a watchdog. The blocks shall include bond wires and pin-out. Each channel shall have its own separated inputs and outputs which shall not be routed through another channel/block. e) Appropriate measures shall be taken to avoid dangerous failure caused by faults of the power supply including common cause failures. f) The minimum distance between boundaries of separate physical blocks shall be sufficient to avoid short circuit and cross talk between these blocks.
mcT Petrolchimico Milano 2011 47

Special architecture requirements for Ics with on-chip redundancy ong) Short circuit and/or cross-talk between adjacent lines of separate physical blocks shall not lead to a loss of a safety function or an undetected loss of a monitoring function (Table E.2, no. 5). ( ) h) substratum shall be connected to ground whatever the IC design process used (nwell or p-well); i) The susceptibility of an IC with on-chip redundancy to common cause failures shall on chip be estimated by determining a -factor according to E.3. This -factor called IC shall be used when estimating the achieved safety integrity of the E/E/PE safetyrelated system according to 7.4.5.1 and will be used for the IC instead of the factor -factor determined for example according to Annex D of IEC 61508-6. j) The detection of a fault (by diagnostic tests, proof tests or by any other means) in an IC with on-chip redundancy shall result in a specified action to achieve or on chip maintain a safe state. k) The minimum diagnostic coverage of each channel shall be at least 60 %. Where a monitoring element is implemented only once the minimum diagnostic coverage once, for this element shall also be at least 60 %.
mcT Petrolchimico Milano 2011 48

Special architecture requirements for Ics with on-chip redundancy onl) If it is necessary to implement a watchdog, for example for program sequence monitoring and/or to guarantee the required diagnostic coverage or safe failure fraction one channel shall not be used as a watchdog of another channel, except g p when functionally diverse channels are used. m) When testing for electromagnetic compatibility without additional safety margin, y (for p performance the function carried out by the IC shall not be interfered ( example p criterion A as described in EMC immunity standards). n) When testing for electromagnetic compatibility with additional safety margins, the safety function (including IC) shall comply with the FS criterion in IEC 61326-3-1 FS 61326 3 1 o) Appropriate measures shall be taken to avoid dangerous failure caused by oscillations of digital input ports connected to external asynchronous digital signals, e.g. introduction of respective multiple clock synchronization stages. p) The common cause potential of common resources such as boundary scan circuitries and arrays of special function registers shall be analyzed. q) The requirements a) to p) list common cause initiators specific to ICs with on chip on-chip redundancy. Other relevant common cause initiators shall be considered as 49 specified in this Standard. mcT Petrolchimico Milano 2011

Ics with on-chip redundancy on-factor


The susceptibility of the IC with on-chip redundancy to common cause failures shall be estimated by determining the -factor IC, which is special to ICs with on-chip redundancy ( hi d d (see also E 1 i)) Th estimation shall b b l E.1, i)). The i i h ll be based upon the d h following: a) a basic -factor called B-IC of 33 %; b) estimation of the increase of the basic -factor, B-IC, by the design using Table E.1; and c) estimation of the decrease of the basic -factor, B-IC, by the design ) , y g using Table E.2. IC is estimated by adding B-IC and all scores from Table E 1 and afterwards E.1 subtracting all scores from Table E.2. The estimated final IC shall not exceed 25 %.

mcT Petrolchimico Milano 2011

50

ASICs - Techniques and measures for avoidance of systematic failures


Annex F - For the design of Application Specific Integrated Circuits (ASICs) the following techniques and measures for the avoidance of failures during the ASICdevelopment should be applied. a) All design activities and test arrangements, and tools used for the functional simulation and the results of the simulation, should be documented. b) All tools libraries and manufacturing procedures should be proven in use tools, use. c) All activities and their results should be verified, for example by simulation, equivalence checks, timing analysis or checking the technology constraints. d) M Measures f the reproducibility and automation of th d i i l for th d ibilit d t ti f the design implementation t ti process (script based, automated work and design implementation flow) should be used. e) For 3rd party soft-cores and hard-cores, only validated macro blocks should be used and these should comply with all constraints and proceedings defined by the macro core provider if practicable. Unless already proven in use, each macro block h ld be treated bl k should b t t d as newly written code, for example it should b f ll l itt d f l h ld be fully validated.
mcT Petrolchimico Milano 2011 51

ASICs - Techniques and measures for avoidance of systematic failures


f) For the design, a problem-oriented and abstract high-level design methodology and design description language should be used. g) Adequate testability (for manufacturing test of the full and semi-custom ASIC) should be achieved. h) Gate and interconnection (wire) delays should be considered during test and ) ( ) y g ASIC verification steps. i) Internal gates with tristate outputs should be avoided. If internal tristate outputs are used these outputs should be equipped with p p q pp pull-ups/downs or bus-holders. p j) Before manufacturing, an adequate verification of the complete ASIC (i.e., including each verification step carried out during design and implementation to ensure correct module and chip functionality) should be carried out.

mcT Petrolchimico Milano 2011

52

Safety manual for compliant items - HW


7.4.9.4 The following information shall be available for each safety-related element 7.4.9.6 Suppliers shall provide a safety manual for compliant items, in accordance with Annex D, for each compliant item that they supply and for which they claim compliance with IEC 61508 series. C 7.4.9.7 The supplier shall document a j pp justification for all the information that is provided in each safety manual for compliant items.
NOTE 1 It is essential that the claimed safety performance of an element is supported by sufficient evidence. Unsupported claims do not help establish the correctness and integrity of the safety function to which the element contributes contributes. NOTE 2 There may be commercial or legal restrictions on the availability of the evidence. These restrictions are outside the scope of this standard. If such restrictions deny the functional safety assessment adequate access to the evidence, then the element is not suitable for use in E/E/PE safety-related systems. f t l t d t mcT Petrolchimico Milano 2011 53

Safety manual for compliant items - HW


a. a functional specification of the functions capable of being performed; b. identification of the hardware and/or software configuration of the compliant item to enable configuration management of the E/E/PE safety-related system in accordance with 6.2.1 of IEC 61508-1. c. constraints on the use of the compliant item and/or assumptions on which p p analysis of the behaviour or failure rates of the item are based. d. d any limit on the lifetime of the element that should not be exceeded in order to maintain the validity of the estimated rates of failure due to random hardware failures; NOTA: questultimo punto stato dimenticato nellAllegato D ma riportato quest ultimo dimenticato nell Allegato D, al punto 7.4.9.4.

mcT Petrolchimico Milano 2011

54

Safety manual for compliant items - HW


D.2.2 For every function, the safety manual shall contain: e. the failure modes of the compliant item (in terms of the behaviour of its outputs), due to random hardware failures, that result in a failure of the function and that are not detected by diagnostics internal to the compliant item; f. for every failure mode in e), an estimated failure rate; g. the failure modes of the compliant item (in terms of the behaviour of its outputs), due to random hardware failures, that result in a failure of the p ), , function and that are detected by diagnostics internal to the compliant item; h. the failure modes of the diagnostics, internal to the compliant item (in terms of the behaviour of its outputs), due to random hardware failures, that result in a failure of the diagnostics to detect failures of the function; i. for every failure mode in g) and h), the estimated failure rate; j. j for every failure mode in g) that is detected by diagnostics internal to the compliant item, the diagnostic test interval;
mcT Petrolchimico Milano 2011 55

Safety manual for compliant items - HW


k. for every failure mode in e) the outputs of the compliant item initiated by the internal diagnostics; NOTE 1 The outputs of the internal diagnostics could be b used to i i i d initiate additional measures ( h i l/ ddi i l (technical/procedural) to the E/E/PE d l) h safety-related system, subsystem or element to achieve or maintain a safe state of the EUC. l. any periodic proof test and/or maintenance requirements; m. for those failure modes, in respect of a specified function, that are capable of being detected by external diagnostics, sufficient information shall be provided to facilitate the development of an external diagnostics capability. The information shall include details of failure modes and for those failure modes the failure rates; n. the hardware fault tolerance; o. the classification as type A or type B of that part of the compliant item that p provides the function
mcT Petrolchimico Milano 2011 56

Safety manual for compliant items - HW


D.2.3 For every function of the compliant item that is liable to systematic failure, the manual shall contain: p. the systematic capability of the compliant item or that part of the element that provides the function; q q. any instructions or constraints relating to the application of the compliant y g pp p item, relevant to the function, that should be observed in order to prevent systematic failures of the compliant item. NOTE The systematic safety integrity indicated by the systematic capability y y g y y y p y can be achieved only when the instructions and constraints are observed. Where violations occur, the claim for systematic capability is partially or wholly invalid. D.2.4 For additional requirements relating to software compliant items see 7.4.2.12 and Annex D of IEC 61508 3. 61508-3.
mcT Petrolchimico Milano 2011 57

IEC 61508-2: 2010 - Conclusioni 615081. Quasi tutti i requisiti (Funzione di Sicurezza, Systematic Capability, HFT, SFF, Classificazione Tipo A e Tipo B) sono attribuibili a partire dallElemento (a parte la SIL, che assegnata alla Funzione di Sicurezza) ( p g ) 2. La norma prevede due strade ben distinte per la dimostrazione della conformit per elementi:
1. Progettazione secondo norma g 2. Proven in use

3. La Classificazione in Tipo A non prevede pi una esperienza di campo 4. Deve essere predisposta FMEDA dell elemento seguendo le nuove dellelemento classificazioni di guasti (Safe, Dangerous, No Effect, No Part) 5. Sono inseriti requisiti specifici per ASICs 6. Item 6 Item conformi alla norma devono essere accompagnati da un Safety Safety Manual dal contenuto definito, e da adeguata documentazione comprovante la conformit

mcT Petrolchimico Milano 2011

58

La nuova edizione 2010 della norma IEC 61508

IEC 61508-3: 2010 61508 3: Progettazione SW Le modifiche sostanziali

mcT Petrolchimico Milano 2011

59

Figure 3 E/E/PES system safety lifecycle (in realisation phase)

mcT Petrolchimico Milano 2011

60

Software systematic capability and development lifecycle (the V-model) model)

mcT Petrolchimico Milano 2011

61

SW Safety Requirements Specification


7.2.2.4 In order to address independence, a suitable common cause failure analysis shall be carried out. Where credible failure mechanisms are identified, effective defensive measures shall b taken. ff i d f i h ll be k
NOTE See Annex F for techniques for achieving one aspect of independence of software.

7.2.2.10 The software safety requirements specification shall express the required safety properties of the product, but not of the project as this is covered by safety planning (see Clause 6 of 61508-1). With reference to 7.2.2.1 to 7.2.2.10 7.2.2.9, the following shall be specified as appropriate: a) the requirements for the following software safety functions: 1) ) 11) safety-related communications (see 7.4.11 of IEC 61508-2). b) the requirements for the software safety integrity systematic capability: 1) 2) independence requirements between functions.
mcT Petrolchimico Milano 2011

62

SW Safety Requirements Specification


7.2.2.11 Where software safety requirements are expressed or implemented by configuration data, the data shall be: c) consistent with the system safety requirements; d) expressed in terms of the permitted range and authorized combinations of its operational parameters; p p e) defined in a manner which is compatible with the underlying software (for example sequence of execution, run time, data structures, etc.). 7.2.2.12 7 2 2 12 Where data defines the interface between software and external systems, the following performance characteristics shall be considered in addition to 7.4.11 of IEC 61508-2: f) the need for consistency in terms of data definitions; g) invalid, out of range or untimely values; h) response time and throughput, including maximum loading conditions; i) best case and worst case execution time, and deadlock; j) overflow and underflow of Petrolchimico Milano 2011 mcT data storage capacity. 63

SW Design and Development


7.4.2.7 The software design shall include, commensurate with the required safety integrity level, self-monitoring of control flow and data flow. On failure detection, appropriate actions shall b taken. d i i i h ll be k 7.4.2.10 Where the systematic capability of a software element is lower than y p y the safety integrity level of the safety function which the software element supports, the element shall be used in combination with other elements such that the systematic capability of the combination equals the safety integrity level of the safety function. 7.4.2.11 Where a safety function is implemented using a combination of software elements of known systematic capability, the systematic capability requirements of 7.4.3 of IEC 61508-2, shall apply to the combination of elements.
mcT Petrolchimico Milano 2011 64

SW Design and Development PrePre-existing SW


7.4.2.12 Where a pre-existing software element is reused to implement all or part of a safety function, the element shall meet both requirements a) and b) below f systematic safety i b l for i f integrity: i a) meet the requirements of one of the following compliance routes: Route 1S: compliant development. Compliance with the p p p requirements of this standard for the avoidance and control of systematic faults in software; Route 2S: proven in use. Provide evidence that the element is p proven in use. See 7.4.10 of IEC 61508-2; Route 3S:assessment of non-compliant development. Compliance with 7.4.2.13. b) provide a safety manual (see Annex D of IEC 61508-2 and Annex D of this standard) that gives a sufficiently precise and complete description of the element to make possible an assessment of the integrity of a specific safety function that depends wholly or partly on the pre-existing software element. mcT Petrolchimico Milano 2011 65

SW Design and Development PrePre-existing SW


7.4.2.13 To comply with Route 3s a pre-existing software element shall meet all of the following requirements a) to i): a) The software safety requirements specification for the element in its new application shall be documented to the same degree of precision as would be required by this standard for any safety related element of the same systematic capability. The software safety requirements specification shall cover the functional and safety behaviour as applicable to the element in its new application and as specified in 7.2. See Table A.1. A1 b) The justification for use of a software element shall provide evidence that the desirable safety properties specified in the referenced subclauses (i.e. 7.2.2, 7.4.3, 7.4.4, 7.4.5, 7.4.6, 7.4.7, 7.5.2, 7.7.2, 7.8.2, 7.9.2, and Clause 8) have been considered, taking account of the guidance in Annex C.
mcT Petrolchimico Milano 2011 66

SW Design and Development PrePre-existing SW


c) The elements design shall be documented to a degree of precision, sufficient to provide evidence of compliance with the requirement specification and the required systematic capability. S 7.4.3, 7.4.5 and ifi i d h i d i bili See 4 3 4 d 7.4.6, and Tables A.2 and A.4 of Annex A. d) The evidence required in 7.4.2.13 a) and 7.4.2.13 b) shall cover the softwares integration with the hardware. See 7.5 and Table A.6 of Annex A. e) There shall be evidence that the element has been subject to verification and validation using a systematic approach with documented testing and review of all parts of the elements design and code. See 7.4.7, 7.4.8, 7.5, 7.7 and 7.9 and Tables A.5 to A.7 and A.9 of Annex A as well as related tables in Annex B.
NOTE 1 Positive operational experience may be used to satisfy black-box and probabilistic testing requirements [see Tables A.7 and B.3].

mcT Petrolchimico Milano 2011

67

SW Design and Development PrePre-existing SW


f) Where the software element provides functions which are are not required in the safety related system, then evidence shall be provided that the unwanted f h d functions will not prevent the E/E/PE system from meeting i ill h f i its safety requirements. g) There shall be evidence that all credible failure mechanisms of the software element have been identified and that appropriate mitigation measures have been implemented. h) The planning for use of the element shall identify the configuration of the software element, the software and hardware run-time environment and if necessary the configuration of the compilation / linking system. i) The justification for use of the element shall be valid for only those applications which respect the assumptions made in the compliant item safety manual for the element (see Annex D of IEC 61508-2 and Annex D).
mcT Petrolchimico Milano 2011 68

Requisiti per on-line e off-line onoffsupport tools


7.4.4.1 A software on-line support tool shall be considered to be a software element of the safety-related system 7.4.4.2 Software off-line support tools shall be selected as a coherent p part of the software development activities p La norma fissa i requisiti per Support tools: Se on-line, deve essere trattato secondo la norma on line Se off-line, deve essere gestito come parte dellattivit di sviluppo, per quello che riguarda i Support tool di tipo T2 e T3:
T2: T2 supports the test or verification of th d i or executable code, where errors i th t l t th t t ifi ti f the design t bl d h in the tool can fail to reveal defects but cannot directly create errors in the executable software; T3: generates outputs which can directly or indirectly contribute to the executable code of the safety related system.

mcT Petrolchimico Milano 2011

69

Requisiti per on-line e off-line onoffsupport tools


7.4.4.4 All off-line support tools in classes T2 and T3 shall have a specification or product documentation which clearly defines the behaviour of the tool and any i f h l d instructions or constraints on i use. S 7.1.2 f i i its See 1 2 for software development lifecycle requirements, and 3.2.11 of IEC 61508-4 for categories of software off-line support tool 7.4.4.5 An assessment shall be carried out for offline support tools in classes T2 and T3 to determine the level of reliance placed on the tools, and the potential failure mechanisms of the tools that may affect the executable software. Where such failure mechanisms are identified, appropriate mitigation measures shall be taken

mcT Petrolchimico Milano 2011

70

Requisiti per on-line e off-line onoffsupport tools


7.4.4.6 For each tool in class T3, evidence shall be available that the tool conforms to its specification or documentation. Evidence may be based on a suitable combination of hi i bl bi i f history of successful use i similar environments f f l in i il i and for similar applications (within the organisation or other organisations), and of tool validation as specified in 7.4.4.7 7.4.4.7 The results of tool validation shall be documented covering the following results:
a. b. c. d. d e. f. g. a chronological record of the validation activities; the version of the tool product manual being used; the tool functions being validated; tools d t l and equipment used; i t d the results of the validation activity; the documented results of validation shall state either that the software has passed the validation or the reasons for its failure; q y ; test cases and their results for subsequent analysis; discrepancies between expected and actual results. mcT Petrolchimico Milano 2011 71

Annex A - Techniques and measures


HR the technique or measure is highly recommended for this safety integrity level If level. this technique or measure is not used then the rationale behind not using it should be detailed with reference to Annex C during the safety planning and agreed with the assessor. the technique or measure is recommended for this safety integrity level as a lower recommendation to a HR recommendation. the technique or measure has no recommendation for or against being used. q g g the technique or measure is positively not recommended for this safety integrity level. If this technique or measure is used then the rationale behind using it should be detailed with reference to Annex C during the safety p g y planning and g agreed with the assessor.

R --NR

Appropriate techniques/measures shall be selected according to the safety integrity level. Alternate or equivalent techniques/measures are indicated by a letter following the number. Only one of the alternate or equivalent techniques/measures has to be satisfied. Other measures and techniques may be applied p q y pp providing that the g requirements and objectives have been met. See Annex C for guidance on selecting techniques. mcT Petrolchimico Milano 2011 72

Annex C - Properties for software systematic capability


Technique/Measure * 1a 1b 2 Semi-formal methods Formal methods Forward traceability between the system safety requirements and the y y q software safety requirements Backward traceability between the safety requirements and the perceived safety needs Computer-aided specification tools to support appropriate techniques/measures above t h i / b Ref. Table B.7 B.2.2, C.2.4 C.2.11 SIL 1 R --R SIL 2 R R R SIL 3 HR R HR SIL 4 HR HR HR

C.2.11

HR

HR

B.2.4

HR

HR

1) Si p ) parte da una delle tabelle dellAllegato A ( esempio la Tabella A.1 sopra g (ad p p riportata, per le SW Safety Requirements Specification).
mcT Petrolchimico Milano 2011 73

Annex C - Properties for software systematic capability

2) Lallegato C Table C.1 (Properties for systematic safety integrity Software safety requirements specification) definisce che la software safety requirements specification caratterizzata dalle propriet sopra riportate.

mcT Petrolchimico Milano 2011

74

Annex C - Properties for software systematic capability


R1 without objective acceptance criteria, or with limited objective acceptance criteria. E.g., black-box testing based on judgement, field trials. trials with objective acceptance criteria that can give a high level of confidence that the required property is achieved (exceptions to be identified & justified); e.g., test or analysis techniques with coverage metrics eg metrics, coverage of checklists. with objective, systematic reasoning that the required property is achieved. hi d E.g. formal proof, demonstrated adherence to architectural constraints that guarantee the property. this technique is not relevant to this property.

R2

R3

3) Viene definito uno score qualitativo per lefficacia della tecnica / misura.

mcT Petrolchimico Milano 2011

75

mcT Petrolchimico Milano 2011

76

Annex D - Contents of the safety manual for a software element


D.2.3 Element configuration: a) The configuration of the software element, the software and hardware run-time environment and if necessary the configuration of the compilation / link system shall be documented in the safety manual. b) The recommended configuration of the software element shall be ) g documented in the safety manual and that configuration shall be used in safety application. c) The safety manual shall include all the assumptions made on which the ) y p justification for use of the element depends.

mcT Petrolchimico Milano 2011

77

Annex D - Contents of the safety manual for a software element


D.2.4 The following shall be included in the safety manual: a) Competence: The minimum degree of knowledge expected of the integrator of the element should be specified, i.e. knowledge of specific application tools. b) Degree of reliance p ) g placed on the element: Details of any certification of y the element, independent assessment performed, integrity to which the integrator may place on the pre-existing element. This should include the integrity to which the element was designed, the standards that were followed during the design process, and any constraints passed to the integrator which shall be implemented in support of the systematic capability claimed. (depending on the functionality of the element, it is conceivable that some requirements may only be met at the integration phase of a system. In such circumstances, these requirements shall be identified for further progression by the integrator. Requirements pertaining to t response times and performance are two such examples). ti d f t h l )
mcT Petrolchimico Milano 2011 78

Annex D - Contents of the safety manual for a software element


c) Installation instructions: Details of, or reference to, how to install the preexisting element into the integrated system. d) The reason for release of the element: Details of whether the preexisting element has been subject to release to clear outstanding anomalies, or inclusion of additional functionality. e) Outstanding anomalies: Details of all outstanding anomalies should be given, with explanation of the anomaly, how it occurs and the mechanisms that the integrator shall take to mitigate the anomaly should the particular functions be used. f) Backward compatibility: Details of whether the element is compatible with previous releases of the sub-system, and if not, details of the process providing the upgrade path to be followed.

mcT Petrolchimico Milano 2011

79

Annex D - Contents of the safety manual for a software element


g) Compatibility with other systems: A pre-existing element may be dependent upon a specially developed operating system. In such circumstances, d il of the version of the specially d i details f h i f h i ll developed operating l d i system should be detailed. The build standard should also be specified incorporating compiler identification and version, tools used in creation of the pre-existing element (identification and version), and test pre-existing element used (again identification and version). h) Element configuration: Details of the pre-existing element name(s) and description(s) should be given, including the version / issue / modification state. i) Change control: The mechanism by which the integrator can initiate a change request to the producer of the software.

mcT Petrolchimico Milano 2011

80

Annex D - Contents of the safety manual for a software element


k) Design safe state: In certain circumstances, upon controlled failure of the system application, the element may revert to a design safe state. In such circumstances, the precise d fi i i of d i safe state should b h i h i definition f design f h ld be specified for consideration by the integrator. l) Interface constraints: Details of any specific constraints, in particular user interface requirements shall be identified. m) Details of any security measures that may have been implemented against listed threats and vulnerabilities. n) Configurable elements: details of the configuration method or methods available for the element, their use and any constraints on their use shall be provided.

mcT Petrolchimico Milano 2011

81

Justification of claims in the safety manual for compliant items


D.3.1 All claims in the safety manual for compliant items shall be justified by adequate supporting evidence. See 7.4.9.7 of IEC 61508-2.
NOTE 1 It is essential that the claimed safety performance of an element is supported by sufficient evidence. Unsupported claims do not help establish the correctness and integrity of the safety function to which the element contributes. NOTE 2 The supporting evidence may be derived from the element suppliers own documentation and records of the element suppliers development process, or may be created or supplemented by additional qualification activities by the developer of the safety related system or by third parties. NOTE 3 There may be commercial or legal restrictions on the availability of the evidence (e g (e.g. copyright or intellectual property rights). These restrictions are outside the scope of this standard.

mcT Petrolchimico Milano 2011

82

IEC 61508-3: 2010 - Conclusioni 61508Anche per il SW viene definita la Systematic Capability Viene definito come trattare il pre-existing SW Vengono definiti requisiti per on-line e off-line support tools stato inserito un allegato (Allegato C Informativo) per guidare nella scelta e nell efficacia di tecniche e misure per raggiungere la Systematic nellefficacia Systematic Capability desiderata 5. Item conformi alla norma devono essere accompagnati da un Safety Manual Manual dal contenuto definito, e da adeguata documentazione definito comprovante la conformit, anche per quello che riguarda il SW 1. 2. 3. 4.

mcT Petrolchimico Milano 2011

83

La nuova edizione 2010 della norma IEC 61508

IEC 61508-1: 2010 61508 1: Management of Functional Safety Safety Life Cycle Le modifiche sostanziali

mcT Petrolchimico Milano 2011

84

Management of Functional Safety


6.1.1 The first objective of the requirements of this clause is to specify the management and technical activities during the overall, E/E/PES and software safety lifecycle phases which are necessary f the achievement f f lif l h hi h for h hi of the required functional safety of the E/E/PE safety-related systems. the responsibilities in the management of functional safety of those who have responsibility f an E/E/PE safety-related system, or f one or more ibilit for f t l t d t for phases of the overall E/E/PE system and software safety lifecycles. 6.1.2 The second objective of the requirements of this clause is to specify the responsibilities of the persons, departments and organizations responsible for each overall, E/E/PES and software safety lifecycle phase or for activities within each phase activities to be carried out by those with responsibilities in the management of functional safety.

mcT Petrolchimico Milano 2011

85

Management of Functional Safety


6.2.12 Those individuals who have responsibility for one or more phases of the overall, E/E/PE system or software safety lifecycles shall, in respect of those phases f which they h h h for hi h h have responsibility and i accordance with the ibili d in d ih h procedures, specify all management and technical activities that are necessary to ensure the achievement, demonstration and maintenance of functional safety of the E/E/PE safety-related systems, i l di f ti l f t f th f t l t d t including:
a. b. the selected measures and techniques used to meet the requirements of a specified clause or subclause (see IEC 61508-2, IEC 61508-3 and IEC 61508-6); the functional safety assessment activities, and the way in which the achievement of functional safety will be demonstrated to those carrying out the functional safety assessment (see Clause 8); the procedures for analysing operations and maintenance performance, in particular for recognising systematic faults that could jeopardise functional safety, including safety procedures used during routine maintenance that detect recurring faults; assessing whether the demand rates and failure rates during operation and maintenance are in accordance with assumptions made during the design of the system. mcT Petrolchimico Milano 2011 86

c.

Management of Functional Safety


6.2.14 The appropriateness of competence shall be considered in relation to the particular application, taking into account all relevant factors including: a. a the responsibilities of the person; b. the level of supervision required; c. the potential consequences in the event of failure of the E/E/PE safety-related systems the greater the consequences, the more rigorous shall be the specification of competence; d. the safety integrity levels of the E/E/PE safety-related systems the higher the safety integrity levels, the more rigorous shall be the specification of competence; e. the novelty of the design, design procedures or application the newer or more untried these are, the more rigorous shall be the specification of competence; f. previous experience and its relevance to the specific duties to be performed and the technology being employed the greater the required competence, the closer the fit shall be between the competences developed from previous experience and those required for the specific activities to be undertaken; g. the type of competence appropriate to the circumstances (for example qualifications, experience, relevant training and subsequent practice, and leadership and decision-making abilities); h. engineering knowledge appropriate to the application area and to the technology; i. safety engineering knowledge appropriate to the technology; j. knowledge of the legal and safety regulatory framework; mcT Petrolchimico Milano 2011 87 k. relevance of qualifications to specific activities to be performed.

Safety LifeCycle
A parte alcune modifiche cosmetiche e/o comunque derivanti dalle modifiche alle definizioni (ad esempio quella relativa a other risk reduction measure, che va a modificare di conseguenza il Safety Life C l ) la modifica pi h difi S f Lif Cycle), l difi i significativa quella relativa al livello minimo di indipendenza di chi svolge lassessment (si vedano le slides successive). Vengono definite due tabelle: 1. Una per tutte le fasi di assessment, eccettuate quelle di definizione delle Specifiche del Sistema di Sicurezza (fase 9) e di realizzazione del Sistema di Sicurezza (fase 10) 2. Una seconda per le fasi 9 e 10 NOTA: altre modifiche sono meno rilevanti, in quanto relative pi al ruolo dellintegratore di sistema / utilizzatore finale, per i quali la norma pi appropriata da utilizzare nellindustria di processo la IEC 61511 nell industria 61511.
mcT Petrolchimico Milano 2011 88

Safety LifeCycle Lif C l

mcT Petrolchimico Milano 2011

89

Livello minimo di indipendenza


8.2.15 The minimum level of independence of those carrying out a functional safety assessment shall be as specified in Tables 4 and 5. Product and application sector i P d d li i international standards may specify, with i l d d if ih respect to compliance to their standards, different levels of independence to those specified in Tables 4 and 5. The tables shall be interpreted as follows: f ll
X: the level of independence specified is the minimum for the specified consequence (Table 4) or safety integrity level/systematic capability (Table 5). If a lower level of independence is adopted, then the rationale for using it shall be detailed. p g X1 and X2: see 8.2.16. Y: the level of independence specified is considered insufficient for the specified consequence (Table 4) or safety integrity level/ systematic capability (Table 5).

mcT Petrolchimico Milano 2011

90

Livello minimo di indipendenza Fasi 1-8; 12-16 1- 12-

mcT Petrolchimico Milano 2011

91

Livello minimo di indipendenza Fasi 9-10 9-

mcT Petrolchimico Milano 2011

92

IEC 61508-1: 2010 - Conclusioni 61508Management of Functional Safety Viene data maggiore importanza alla competenza e qualifica del personale coinvolto Safety LifeCycle Viene maggiormente chiarito (e leggermente modificato) il livello minimo di indipendenza richiesto per la fase di assessment

mcT Petrolchimico Milano 2011

93

IEC 61508-1: 2010 - Conclusioni 61508La seguente documentazione (almeno) deve essere predisposta per elementi conformi alla norma (per dettagli vedere Allegato A della IEC 61508-1): 1. Safety Plan 2. Safety Requirements Specification (requisiti di integrit e funzionalit); Specifiche di Progetto p g 3. Verification and Validation Plan (con riferimento ai requisiti di integrit e funzionalit, HW e SW) 4. 4 Documentazione di progetto (HW e SW) 5. Analisi guasti sistematici e di causa comune (con riferimento a tabelle IEC 61508-2/3) 6. 6 Analisi guasti casuali 7. Reports in conformit al Verification and Validation Plan 8. Documento di validazione 9. Safety Manual (HW e SW)
mcT Petrolchimico Milano 2011 94

La nuova edizione 2010 della norma IEC 61508

IEC 61508-5/7: 2010 61508 5/7: Le modifiche sostanziali

mcT Petrolchimico Milano 2011

95

IEC 61508-5: 2010 Examples of 61508methods for the determination of SIL


Premesso che questa Parte totalmente informativa, e che risulta essere un po un doppione della Parte 3 della IEC 61511, queste sono le modifiche pi importanti: i i 1. Introduzione dei concetti di Rischio Individuale e Rischio Sociale 2. Gestione dei guasti di modo comune g 3. Allineamento del testo, in alcuni punti (ad esempio per Risk Graph e LOPA) alla IEC 61511 4. 4 Introduzione di uno schema pi completo per la LOPA

mcT Petrolchimico Milano 2011

96

IEC 61508-5: 2010 Examples of 61508methods for the determination of SIL

mcT Petrolchimico Milano 2011

97

IEC 61508-6: 2010 - Guidelines on 61508the application Part 2 and Part 3


Premesso che questa Parte totalmente informativa, queste sono le modifiche pi importanti: 1. Inserimento di una introduzione dettagliata sulla valutazione della probabilit di guasto 2. Correzione delle formule errate per 1oo1(D) e di conseguenza p tutte le p ( ) g per altre architetture (come gi visto in precedenza) 3. Correzione di tutta una serie di esempi in cui, senza motivo, ledizione 2000 assumeva D=S= /2, inducendo in errore. Ora gli esempi si basano su: , g p

4. 4 Correzione di tutta una serie di errori di cut and paste nelle tabelle di esempio 5. Piccole modifiche alla tabella per la stima del fattore dei guasti di causa comune
mcT Petrolchimico Milano 2011 98

IEC 61508-7: 2010 - Overview of 61508techniques and measures


Premesso che questa Parte totalmente informativa, comunque utile per una descrizione pi dettagliata delle tecniche / misure da applicare per raggiungere l S i la Systematic C i Capability (HW e SW) queste sono le modifiche bili SW); l difi h pi importanti: 1. Identificazione delle tecniche adeguate per i soft-errors 2. Requisiti di tracciabilit per la documentazione SW 3. Tabella con suggerimenti per standard di codifica SW (par. C.2.6.2) 4. 4 Criteri per pre-existing SW (C.2.10.2) pre existing (C 2 10 2) 5. Inclusione di tecniche di generazione automatica del codice 6. Inclusione di allegato per tecniche e misure per ASICs 7. Rimando alle norme IEC 61326-3-1/2 per il requisito di increased immunity per elementi di sistemi di sicurezza

mcT Petrolchimico Milano 2011

99

Domande?

mcT Petrolchimico Milano 2011

100

You might also like