ida Certification Services IEC Functional Safety Assessment Project: Series 20/30 Butterfly Valves Customer: Bray International, Inc.

Transcription

1 e ida Certificatin Services IEC Functinal Safety Assessment Prject: Series 20/30 Butterfly Valves Custmer: Bray Internatinal, Inc. Hustn, Texas USA Cntract Number: Q07/12-19 Reprt N.: BRA R008 Versin V2, Revisin R1, April 22, 2013 Steven Clse The dcument was prepared using best effrt. The authrs make n warranty f any kind and shall nt be liable in any event fr incidental r cnsequential damages in cnnectin with the applicatin f the dcument. All rights reserved.

2 Management summary This reprt summarizes the results f the functinal safety assessment accrding t IEC carried ut n the: Bray Series 20/30 Butterfly Valves The functinal safety assessment perfrmed by exida cnsisted f the fllwing activities: - exida assessed the develpment prcess used by Bray Internatinal, Inc. by an n-site audit and creatin f a safety case against the requirements f IEC exida perfrmed a detailed Failure Mdes, Effects, and Diagnstic Analysis (FMEDA) f the devices t dcument the hardware architecture and failure behavir. - exida reviewed field failure data t ensure that the FMEDA analysis was cmplete. - exida reviewed the manufacturing quality system in use at Bray Internatinal, Inc.. The functinal safety assessment was perfrmed t the requirements f IEC 61508, SIL 3 fr mechanical cmpnents. A full IEC Safety Case was prepared, using the exida SafetyCase tl, and used as the primary audit tl. Hardware prcess requirements and all assciated dcumentatin were reviewed. Envirnmental test reprts were reviewed. Als the user dcumentatin (safety manual) was reviewed. The results f the Functinal Safety Assessment can be summarized as: The Bray Internatinal, Inc. Series 20/30 Butterfly Valves were fund t meet the requirements f IEC fr up t SIL 3 (SIL 3 Capable). The PFD AVG and Safe Failure Fractin requirements f the standard must be verified fr a cmplete final element design using these final element cmpnents. The manufacturer will be entitled t use the Functinal Safety Lg. The manufacturer may use the mark: T-023 V2R1, August, Page 2 f 15

3 Table f Cntents Management summary Purpse and Scpe Prject management exida Rles f the parties invlved Standards / Literature used Reference dcuments Dcumentatin prvided by Bray Internatinal, Inc Dcumentatin generated by exida Prduct Descriptins IEC Functinal Safety Assessment Methdlgy Assessment level Results f the IEC Functinal Safety Assessment Open Issues Lifecycle Activities and Fault Avidance Measures Functinal Safety Management Safety Requirements Specificatin and Architecture Design Hardware Design Validatin Verificatin Prven In Use Mdificatins User dcumentatin Hardware Assessment Terms and Definitins Status f the Dcument Liability Releases Future Enhancements Release Signatures T-023 V2R1, August, Page 3 f 15

4 1 Purpse and Scpe This dcument shall describe the results f the IEC functinal safety assessment f the Bray Internatinal, Inc. Series 20/30 Butterfly Valves by exida accrding t the requirements f IEC 61508: ed2, The results f this prvides the safety instrumentatin engineer with the required failure data as per IEC / IEC and cnfidence that sufficient attentin has been given t systematic failures during the develpment prcess f the device. T-023 V2R1, August, Page 4 f 15

5 2 Prject management 2.1 exida exida is ne f the wrld s leading accredited Certificatin Bdies and knwledge cmpanies specializing in autmatin system safety and availability with ver 300 years f cumulative experience in functinal safety. Funded by several f the wrld s tp reliability and safety experts frm assessment rganizatins and manufacturers, exida is a glbal cmpany with ffices arund the wrld. exida ffers training, caching, prject riented system cnsulting services, safety lifecycle engineering tls, detailed prduct assurance, cyber-security and functinal safety certificatin, and a cllectin f n-line safety and reliability resurces. exida maintains a cmprehensive failure rate and failure mde database n prcess equipment. 2.2 Rles f the parties invlved Bray Internatinal, Inc. exida Manufacturer f the Series 20/30 Butterfly Valves Perfrmed the IEC Functinal Safety Assessment and Surveillance audit. Bray Internatinal, Inc. cntracted exida in July 2009 fr the IEC Functinal Safety Assessment f the abve mentined devices. 2.3 Standards / Literature used The services delivered by exida were perfrmed based n the fllwing standards / literature. [N1] IEC (Parts 1-7): 2010 Functinal Safety f Electrical/Electrnic/Prgrammable Electrnic Safety-Related Systems 2.4 Reference dcuments Dcumentatin prvided by Bray Internatinal, Inc. [D1] QM, Rev 9; 5/9/2012 Bray Quality System Manual [D2] BOP-04-01, Rev 2; 5/8/2010 Design Cntrl [D3] BOP-04-02, rev 1; 3/1/2013 Design and Develpment [D4] BOP-04-06; Rev 1; 3/1/2013 Preparatin, Cntrl and Issue f Engineering Prjects [D5] BOP-04-07; Rev 5; 3/1/2013 Preparatin, Issue And Cntrl Of Engineering Revisin Ntices [D6] BOP-04-08,rev 1; 3/1/2013 Impact Analysis [D7] BOP-08-02, rev 2; 12/30/2011 Traceability Of Prducts [D8] BOP-11-01, rev 2; 2/2/2012 Identificatin And Registratin Of Measuring Equipment T-023 V2R1, August, Page 5 f 15

6 [D9] BOP-11-02, rev 2; 12/30/2011 Frequency Of Measuring And Test Equipment [D10] BOP-11-03, rev 2; 12/30/2011 [D11] BOP-11-04; rev 8; 1/5/2012 [D12] BOP-13-01; rev 7; 1/9/2012 Out Of Calibratin Evaluatin Recrding Of Calibratin Results Identificatin And Reviewing Of Nn-Cnfrming Prducts [D13] BOP-13-02; rev 5; 8/23/2012 Preparatin, Issue And Cntrl Of Prduct Nn - Cnfrmance Reprts [D14] BOP-13-03; rev 4; 7/26/2010 [D15] BOP-13-04; rev 4; 8/23/2012 [D16] BOP-14-01, Rev 1, Jan 1997 [D17] BOP-14-03; rev 2; 3/5/2012 [D18] BOP-18-01, rev 2; 6/6/2012 [D19] BOP-02-01; rev. 1; 12/19/2011 [D20] BOP-05-02; rev. 1; 12/19/2011 [D21] BOP-01-01; Rev 1; 11/21/2011 [D22] BOP-02-02; rev. 1; 11/23/2011 [D23] BOP-02-03; rev. 1; 11/23/2011 [D24] BOP-05-01, Rev 0, Aug 1995 [D25] BOP-05-04, Rev 0, Feb 1997 [D26] BOP-06-01; rev 5; 12/28/2011 [D27] BOP-11-02, rev 2; 12/30/2011 [D28] BOP-11-03, rev 2; 12/30/2011 [D29] BOP-11-04; rev 7; 6/13/2002 [D30] BOP-17-01; rev 3; 6/20/2012 [D31] FRM0402A [D32] FRM 1801B, Feb 1996 [D33] FRM 1801A, Apr 2004 [D34] WI-10-01, Rev 2, Aug, 2010 [D35] Test Standards, Jan 2004 [D36] Inspectin Reprt, Oct 2009 [D37] Bray NCR, Jan 2010 Handling, Registratin Of Return Shipments Registratin And Cntrl Of Custmer Cmplaints Preparatin Issue And Implementatin Of Crrective Actin On Nncnfrmances Preventive Actin Training Prcedure Technical CV; Training plans & recrds f individuals Quality Prcedure: Cntrl And Issue Of The Quality Assurance Manual Quality Prcedure: Dcument And Data Cntrl Quality Prcedure: Management Review Quality Prcedure: Preparatin, Cntrl, Issue And Use Of Operating Prcedures Quality Prcedure: Preparatin, Cntrl, Issue And Use Of Wrk Instructins Cntrl Of Standards Specificatins And Cdes Cntrl And Issue Of The Sales And Engineering Manual Preparatin And Cntrl Of Apprved Suppliers List Frequency Of Measuring And Test Equipment Out Of Calibratin Evaluatin Recrding Of Calibratin Results Internal Quality Audits Design and Develpment Plan Training Recrd Frm Blank Training Frm Sample Apprval Prcess Bray List Of Applicable Test Standards Sample Inspectin Reprt Ncr Screen Sht T-023 V2R1, August, Page 6 f 15

7 [D38] Bray S20/30 Safety Manual R2 [D39] Bray S20/30 SRS R2 [D40] RMA Data Bray Valves [D41] WI-09-01, Jan. 29, 2010 [D42] WI rev 2, Aug. 14, 2002 [D43] Varius dates in 2010 [D44] BC110100, 11/29/2009 Bray S20/30 Safety Manual Bray S20/30 SRS Rma Data Bray Valves Resilient Seated Butterfly Valve Hydrstatic Test Prcedure Resilient Seated Butterfly Valve Shell Hydrstatic Test Prcedure Prductin Test Reprts Crrective Actin Reprt Dcumentatin generated by exida [R1] BRA R004, V2R1, April 3, 2013 [R2] BRA 07/12-19 R001, V1R1, Oct 29, 2009 [R3] Bray_ SafetyCaseDB IEC 61508R1.esc, April 2013 [R4] BRA R008 V2R1 Series IEC Assessment.dc, April 22, 2013 FMEDA reprt, Bray Series 20/30 Butterfly Valves IEC Prcess Gap Analysis Reprt, Bray Internatinal, Inc. IEC SafetyCaseDB fr Series 20/30 Butterfly Valves IEC Functinal Safety Assessment, Bray Internatinal, Inc. Series 20/30 Butterfly Valves (this reprt) T-023 V2R1, August, Page 7 f 15

8 3 Prduct Descriptins Bray Series 20/30 Butterfly Valves descriptin: The Bray Series 20/30 Butterfly Valves supprt up t ANSI Class 150. Valve bdies are available in wafer, lug and full flanged cnfiguratins frm 2 t 96 sizes. The basic valve mvement, seats and ther cmpnents are similar between the varius bdy fferings and valve series. All f these valves are classified as Type A 1 devices accrding t IEC 61508, having a hardware fault tlerance f 0. This reprt is applicable t the valves series listed in Table 1. Table 1 Bray Series 20/30 Butterfly Valves Descriptins Valve Series Series 20 Series 21 Series 22 Series 23 Series 30 Series 31 Series 32 Series 33 Series 35 Series 36 Series 3A Descriptin Wafer Bdy Butterfly Valve rated at 50 t 150 psi depending n applicatin Lug Bdy Butterfly Valve rated at 50 t 150 psi depending n applicatin Wafer Bdy Butterfly Valve rated at 150 psi Lug Bdy Butterfly Valve rated at 150 psi Wafer Bdy Butterfly Valve rated at 150 psi Lug Bdy Butterfly Valve rated at 150 psi Wafer Bdy Butterfly Valve rated at 75 psi Wafer Bdy Butterfly Valve rated at 150 psi Full Flange Bdy Butterfly Valve rated at 75 psi Full Flange Bdy Butterfly Valve rated at 150 psi Duble Flange Bdy Butterfly Valve 1 Type A device: Nn-Cmplex element (using discrete elements) fr details see f IEC T-023 V2R1, August, Page 8 f 15

9 4 IEC Functinal Safety Assessment The IEC Functinal Safety Assessment was perfrmed based n the infrmatin received frm Bray Internatinal, Inc. and is dcumented in this reprt. A surveillance audit was cnducted in April f This reprt was revised t reflect the results f the surveillance audit. In Summary the surveillance audit did nt reveal any nn-cnfrmances. 4.1 Methdlgy The full functinal safety assessment includes an assessment f all fault avidance and fault cntrl measures during hardware develpment and demnstrates full cmpliance with IEC t the end-user. The assessment cnsiders all requirements f IEC Any requirements that have been deemed nt applicable have been marked as such in the full Safety Case reprt, e.g. sftware develpment requirements fr a prduct with n sftware. The assessment als includes a review f existing manufacturing quality prcedures t ensure cmpliance t the quality requirements f IEC As part f the IEC functinal safety assessment the fllwing aspects have been reviewed: Develpment prcess, including: Functinal Safety Management, including training and cmpetence recrding, FSM planning, and cnfiguratin management Specificatin prcess, techniques and dcumentatin Design prcess, techniques and dcumentatin, including tls used Validatin activities, including develpment test prcedures, test plans and reprts, prductin test prcedures and dcumentatin Verificatin activities and dcumentatin Mdificatin prcess and dcumentatin Installatin, peratin, and maintenance requirements, including user dcumentatin Manufacturing Quality System Prduct design Hardware architecture and failure behavir, dcumented in a FMEDA The review f the develpment prcedures is described in sectin 5. The review f the prduct design is described in sectin Assessment level The Series 20/30 Butterfly Valves have been assessed per IEC t the fllwing levels: SIL 3 capability The develpment prcedures have been assessed as suitable fr use in applicatins with a maximum Safety Integrity Level f 3 (SIL3) accrding t IEC T-023 V2R1, August, Page 9 f 15

10 5 Results f the IEC Functinal Safety Assessment exida assessed the develpment prcess used by Bray Internatinal, Inc. fr these prducts against the bjectives f IEC parts 1 and 2. The assessment was dne n-site at the Bray Internatinal, Inc. facility n Octber 27, 2009 and dcumented in the SafetyCase [R3]. 5.1 Open Issues The verall prcess is strng and the designs have extensive prven field experience, sufficient fr SIL 3 capability. Sme areas f imprvement were identified in the design prcess and sme f the design prcedures and frms were upgraded during the prject. All f the imprvements were evaluated and included in the final versin f the SafetyCase. 5.2 Lifecycle Activities and Fault Avidance Measures Bray Internatinal, Inc. has a defined prduct lifecycle prcess in place. This is dcumented in the Quality Management System Manual [D2] and varius Quality Prcedures [D2-D28]. A dcumented mdificatin prcess is als cvered in the Quality Manual and BOP N sftware is part f the design and therefre any requirements specific frm IEC t sftware and sftware develpment d nt apply. The assessment investigated the cmpliance with IEC f the prcesses, prcedures and techniques as implemented fr prduct design and develpment. The investigatin was executed using subsets f the IEC requirements tailred t the SIL 3 wrk scpe f the develpment team. The defined prduct lifecycle prcess was mdified as a result f the audit which shwed sme areas fr imprvement. Hwever, given the simple nature f the safety functin and the extensive prven field experience fr existing prducts Bray Internatinal, Inc. was able t demnstrate that the bjectives f the standard have been met. The result f the assessment can be summarized by the fllwing bservatins: The audited Bray Internatinal, Inc. design and develpment prcess cmplies with the relevant managerial requirements f IEC SIL Functinal Safety Management FSM Planning Bray Internatinal, Inc. has a defined prcess in place fr prduct design and develpment. Required activities are specified alng with review and apprval requirements. This is primarily dcumented in sectin 7 f their Quality System Manual [D2] and in greater detail in prcedures BOP t BOP Templates and sample dcuments were reviewed and fund t be sufficient. The mdificatin prcess is cvered by BOP This prcess and the prcedures referenced therein fulfill the requirements f IEC with respect t functinal safety management fr a prduct with simple cmplexity and well defined safety functinality. Versin Cntrl BOP specifies what dcuments must be under dcument cntrl and lists the applicable BOP prcedures t be fllwed. Use f this t cntrl revisins was evident during the audit. T-023 V2R1, August, Page 10 f 15

11 Training, Cmpetency recrding BOP requires that each department retain n file training recrds and / r training attendance lists. Filing shall be dne as described in BOP It is the respnsibility f the department managers t establish the training needs f individuals and a training recrd fr individuals wh perfrm activities that culd affect quality within their department. The prcedures and frms were examined and fund up-t-date and sufficient. A sample f a training attendance recrd was placed in evidence in the SafetyCase. Bray Internatinal, Inc. hired exida Cnsulting t be the independent assessr per IEC and t prvide specific IEC knwledge Safety Requirements Specificatin and Architecture Design A Safety Requirements Specificatin (SRS) fr the Bray Internatinal Series 20/30 Butterfly Valves was submitted as evidence in the SafetyCase. The SRS must be frmatted and cntrlled per BOP prir t certificatin renewal. As the Bray Series 20/30 Butterfly Valves designs are simple and are based upn standard designs with extensive field histry, n semi-frmal methds are needed. General Design and testing methdlgy is dcumented and required as part f the design prcess. This meets SIL Hardware Design The design prcess is dcumented in Sectin 7.1 thrugh 7.3 f [D2]. Items frm IEC , Table B.2 include bservance f guidelines and standards, (EU Directives, API, EN29001) prject management, dcumentatin (design utputs are dcumented per quality prcedures), structured design, mdularizatin, use f well-tried cmpnents / materials, and cmputer-aided design tls. This meets SIL Validatin As the Bray Internatinal Series 20/30 Butterfly Valves are purely mechanical devices with a simple safety functin, there is n separate integratin testing necessary. The Bray Series 20/30 Butterfly Valves perfrm nly 1 Safety Functin, which is extensively tested under varius cnditins during validatin testing. Validatin testing is cnducted n 100% f prductin fr bth pressure and trque. Items frm IEC , Table B.3 include functinal testing, prject management, dcumentatin, and black-bx testing (fr the cnsidered devices this is similar t functinal testing). Field experience and statistical testing via regressin testing are nt applicable. This meets SIL 3. Items frm IEC , Table B.5 included functinal testing and functinal testing under envirnmental cnditins, prject management, dcumentatin, failure analysis (analysis n prducts that failed), expanded functinal testing, black-bx testing, and fault insertin testing. This meets SIL Verificatin The develpment and verificatin activities are defined in Sectin 7.3 f [D2]. Fr each design phase the bjectives are stated, required input and utput dcuments and review activities. This meets SIL 3. T-023 V2R1, August, Page 11 f 15

12 5.2.6 Prven In Use In additin t the Design Fault avidance techniques listed abve, a Prven in Use evaluatin was carried ut n the Bray Internatinal, Inc. Bray Series 20/30 Butterfly Valves during the surveillance activities in April Shipment recrds were used t determine that the actuatrs have >2 billin perating hurs and they have demnstrated a field failure rate less than the failure rates indicated in the FMEDA reprts. This meets the requirements fr Prven In Use fr SIL Mdificatins Mdificatins are initiated per BOP [D5] Preparatin, Issue and Cntrl f Engineering Revisin Ntices. Engineering Revisin Ntices are cntrlled thrugh an engineering data base. All changes are first reviewed and analyzed fr impact befre being apprved. Measures t verify and validate the change are develped fllwing the nrmal design prcess. This meets SIL User dcumentatin Bray Internatinal, Inc. creates the fllwing user dcumentatin: prduct catalgs and a Safety Manual. The Safety Manual was fund t cntain all f the required infrmatin given the simplicity f the prducts. The Safety Manual references the FMEDA reprts which are available and cntain the required failure rates, failure mdes, useful life, and suggested prf test infrmatin. Items frm IEC , Table B.4 include peratin and maintenance instructins, user friendliness, maintenance friendliness, prject management, dcumentatin, limited peratin pssibilities (Bray Internatinal Series 20/30 Butterfly Valves perfrm well-defined actins) and peratin nly by skilled peratrs (peratrs familiar with type f valve, althugh this is partly the respnsibility f the end-user). This meets SIL Hardware Assessment T evaluate the hardware design f the Series 20/30 Butterfly Valves a Failure Mdes, Effects, and Diagnstic Analysis was perfrmed by exida. This is dcumented in [R1]. A Failure Mdes and Effects Analysis (FMEA) is a systematic way t identify and evaluate the effects f different cmpnent failure mdes, t determine what culd eliminate r reduce the chance f failure, and t dcument the system in cnsideratin. An FMEDA (Failure Mde Effect and Diagnstic Analysis) is an FMEA extensin. It cmbines standard FMEA techniques with extensin t identify nline diagnstics techniques and the failure mdes relevant t safety instrumented system design. Frm the FMEDA, failure rates are derived fr each imprtant failure categry. All failure rate analysis results and useful life limitatins are listed in the FMEDA reprt [R1]. Tables in the FMEDA reprt list these failure rates fr the Bray Series 20/30 Butterfly Valves under a variety f applicatins. The failure rates listed are valid fr the useful life f the devices. Nte, as the Bray Internatinal Series 20/30 Butterfly Valves are nly ne part f an element, the SFF shuld be calculated fr the entire final element cmbinatin. T-023 V2R1, August, Page 12 f 15

13 These results must be cnsidered in cmbinatin with PFD AVG values f ther devices f a Safety Instrumented Functin (SIF) in rder t determine suitability fr a specific Safety Integrity Level (SIL). The architectural cnstraints requirements f IEC , als need t be evaluated fr each final element applicatin. It is the end users respnsibility t cnfirm this fr each particular applicatin and t include all cmpnents f the final element in the calculatins. The analysis shws that the design f the Bray Internatinal Series 20/30 Butterfly Valves can meet the hardware requirements f IEC 61508, SIL 3. The Hardware Fault Tlerance, PFD AVG, and Safe Failure Fractin requirements f IEC must be verified fr each specific design. T-023 V2R1, August, Page 13 f 15

14 6 Terms and Definitins Fault tlerance FIT FMEDA HFT Lw demand mde PFD AVG PVST SFF SIF SIL SIS Type A element Type B element Ability f a functinal unit t cntinue t perfrm a required functin in the presence f faults r errrs (IEC , 3.6.3) Failure In Time (1x10-9 failures per hur) Failure Mde Effect and Diagnstic Analysis Hardware Fault Tlerance Mde, where the demand interval fr peratin made n a safety-related system is greater than twice the prf test interval. Average Prbability f Failure n Demand Partial Valve Strke Test It is assumed that the Partial Strke Testing, when perfrmed, is autmatically perfrmed at least an rder f magnitude mre frequent than the prf test, therefre the test can be assumed an autmatic diagnstic. Because f the autmatic diagnstic assumptin the Partial Valve Strke Testing als has an impact n the Safe Failure Fractin. Safe Failure Fractin summarizes the fractin f failures, which lead t a safe state and the fractin f failures which will be detected by diagnstic measures and lead t a defined safety actin. Safety Instrumented Functin Safety Integrity Level Safety Instrumented System Implementatin f ne r mre Safety Instrumented Functins. A SIS is cmpsed f any cmbinatin f sensr(s), lgic slver(s), and final element(s). Nn-Cmplex element (using discrete cmpnents); fr details see f IEC Cmplex element (using cmplex cmpnents such as micr cntrllers r prgrammable lgic); fr details see f IEC T-023 V2R1, August, Page 14 f 15

15 7 Status f the Dcument 7.1 Liability exida prepares reprts based n methds advcated in Internatinal standards. exida accepts n liability whatsever fr the use f this reprt r fr the crrectness f the standards n which the general calculatin methds are based. 7.2 Releases Versin: V2 Revisin: R1 Versin Histry: V2, R1: Surveillance audit update, S. Clse, April 2013 V1, R1: Released t Bray, Nvember 9, 2010 V0, R1: Draft; July 1, 2010 Authrs: Steven Clse Review: V2, R1: William Gble, exida, April 19, 2013 V0, R1: William Gble, exida Release status: Released 7.3 Future Enhancements At request f client. 7.4 Release Signatures Steven F. Clse, Safety Engineer Dr. William M. Gble, Principal Partner T-023 V2R1, August, Page 15 f 15