Ispe_glchriskbasedcommqualbnchmrkg

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Risk-Based Commissioning & Qualification Benchmarking Educational Track #1 Agenda  Part • • 1 ISPE Baseline ® Guide Volume 5: ommissionin! " #uali$i%ation &s' S* E+500 – *r' ,o-ert .e/ &er&ie/ o$ "# aroa%.es – --ott2 ill42 P$ier   Brea6  Part • (8:30 – 10:00) – Vendor areas oen + (10:30 – 7oon) Panel #"  ra9u (10:00 – 10:30) Agenda  Part • • 1 ISPE Baseline ® Guide Volume 5: ommissionin! " #uali$i%ation &s' S* E+500 – *r' ,o-ert .e/ &er&ie/ o$ "# aroa%.es – --ott2 ill42 P$ier   Brea6  Part • (8:30 – 10:00) – Vendor areas oen + (10:30 – 7oon) Panel #"  ra9u (10:00 – 10:30) ISPE Baseline Guide Volume ! Commissioning and Qualification" #s$ AS% E'(( ,o-ert E' .e/2 PE President2 ommissionin! ommiss ionin! !ents2 !ents2 In%' ) Background in Su*+ect • $$i%ial trainer $or ISPE Baseline ommissionin! and #uali$i%ation Guide • *em-er o$ team t.at /rote S* E+500 ,e) Points to Comare • • • • • erminolo!4 #uali$i%ation ra%ti%es o%usin! t.e e$$ort ,oles and resonsi-ilities *ana!in! %.an!es durin! t.e ro;e%t %erminolog) • "# Baseline !uide • • ommissionin! #uali$i%ation •  S* E+500 • Veri$i%ation Qualification Practices • "# Baseline Guide • <o meet t.e demands o$ t.e re!ulators= •  S* E+500 • 7ot mentioned .ocusing the Effort • "# Baseline Guide • Ima%t assessments • >ire%t ima%t s4stems and %riti%al %omonents • V9model •  S* E+500 • ,is6 assessment 9? %riti%al ase%ts Roles and Resonsi*ilities • "# Baseline Guide • #ualit4 re and ost aro&es roto%ols@ Aualit4 %ontrol role •  S* E+500 • • #ualit4 in&ol&ed in ro%ess reAuirements2 ris6 assessments2 %riti%al ase%ts2 and a%%etan%e and release Su-;e%t matter eerts used t.rou!.out anaging Change • "# Baseline Guide • # re9aro&ed %.an!e %ontrol imlemented at start o$ I#C# •  S* E+500 •  # re9aro&ed %.an!e %ontrol imlemented at start o$ manu$a%ture o$ rodu%t $or distri-ution Common Elements • • • • • • Good en!ineerin! ra%ti%es Plannin! ,eAuirements de$inition En!ineerin! desi!n re&ie/s Pro;e%t %.an!e mana!ement >o%umented inse%tions and testin! Risk-Based Commissioning & Qualification Aroach  Abbott Laboratories Global Pharmaceutical Operations Steve Connelly  /#er#ie0  .ere --ott Is oda4  "# roa%.  ommissionin! "  Do/ #uali$i%ation %ti&ities e *ana!e ost  essons earned 1here A**ott is %oda) ,is6 Based *aturit4 *odel dated $rom +00F ISPE ama on$eren%e Presentation Commissioning & Qualification Aroach  C&Q Aroach! • • •  li%ation o$ ISPE Baseline ® Guide Volume 5: ommissionin! " #uali$i%ation (last + 4ears) ittle to no imlementation o$ S* E+50090F e&el 3 (,is69-ased *aturit4 *odel)  Imlementation! • • • • ororate oli%ies suort S%ien%e " #ualit4 ,is6 *ana!ement and in%ludes Good En!ineerin! Pra%ti%e (GEP) re$eren%e rainin! ( ,B2 GEP2 E*' ommissionin!2 ,is6 ssessments) ools and emlates >is%retion o$ t.e Validation ,e&ie/ Board (V,B) S* E+50090F:  Standard Guide $or t.e Se%i$i%ation2 >esi!n2 " Veri$i%ation o$ P.arma%euti%al and Bio.arma%euti%al *anu$a%turin! S4stems and EAuiment Science & Qualit) Risk anagement Qualification Process .lo0 Good Engineering Practices  ormal a%6no/led!ement o$ GEP in %ororate oli%4  >i&isional GEP !uideline %onsists o$ minimum reAuirements    dditional di&isional !uidelines are in de&eloment $or li$e9 %4%le mana!ement – ali-ration – *aintenan%e – En!ineerin! %.an!e mana!ement rainin! to aid site suort (imlementation) Re2uirements Based /n Imact Categor) %hree methods!  –ISPE9St4le S4stem Ima%t ssessment #uestionnaire  –,is6 ssessment /it. an4 standard met.od (*E2 DHP2 et%')  –e%.ni%al E&aluation -4 S*Es •>o%umented and V,B aro&ed •>eterminin! ima%t ≠ to identi$4in! %riti%al elements Qualit) Risk Control  –,is6 ssessment (i'e' *E2 et%) used to ena-le: •#uali$i%ation $o%us on %riti%al $un%tions andCor %omonents •e&era!e limited %ommissionin! testin! (CS) and •Eliminate some redundant a%ti&ities (i'e' alarms2 et%) S4stem  eAuiment2 $a%ilit42 utilit4 Commissioning  1hen suorting Qualification" Commissioning must include or address! • Engineering Change anagement 3EC4  – $ter oint %ommissionin! data intended to suort #uali$i%ation • %esting *et.ods des%ri-ed in su$$i%ient detail $or reeata-ilit4 >o%umentation %on$irms %riti%al elements met %riteria  %%etan%e %riteria do%umented rior to ee%ution riteria -ased on ser ,eAuirements >o%umentation o$ o-ser&ed results – – – – –  Commissioning & Qualification 3C&Q4 Plans t)icall) contain run rules for ro+ect Qualification 5 E2uiment  6ser re2uirements • •  Commissioning (in suort o$ Auali$i%ation) • •  Produ%t and Pro%ess ser ,eAuirement (P,S) General ser ,eAuirements (G,S) est it on%e (or one set o$ multile test reetitions2 /.ere aroriate)@ do%ument it %orre%tl4 Primaril4 installation a%ti&ities2 oerational testin! le&era!ed in some instan%es (V,B dis%retion)@%omile2 summarie test results $or V,B aro&al Qualification • .en aro&ed2 %ommissionin! reorts %omlete t.e I#C# .ase o$ #uali$i%ation /it. no additional <roto%ol= testin! Qualification 5 Soft0are 3APC78I79CS4   Categori:ation (-ased on rodu%t Aualit4 ima%t) • *ana!in! %ontrol issues $or %riti%al elements • Sulier ssessments $or dire%t ima%t s4stems onl4 • V,B dis%retion /it. te%.ni%al ad&isor4 $rom Su-;e%t *atter Eert 8olistic Aroach • • Inte!rated #uali$i%ation do%ument (I# $or eAuimentC%ontrols@ as ali%a-le)  P se%i$i% Auali$i%ation reAuirements  – ra%ea-ilit4 matri  >esi!n #uali$i%ations (>#)  – ommissionin!  #uali$i%ation e%et %riti%al items Qualification 5 .acilities  Indirect Imact .acilities 9 ommission – –  >esi!n and %onstru%tion %on$ormin! to GEP  --ott En!ineerin! Standards 9irect Imact .acilities – ommissionC#uali$4 – *eet Aualit4 se%i$i%ations (i'e' seti% $a%ilit42 et%) – >esi!n and %onstru%tion %on$ormin! to GEP –  --ott En!ineerin! Standards Qualification 5 8VAC  Categori:ation • Interdeendent /it. $a%ilit4 Aualit4 attri-utes – – or eamle: ontinuous monitorin! $or %riti%al en&ironmental ase%ts@ t.ere$ore $a%ilit4 and DV %an -e Indire%t Ima%t (DV %ontrols /ould t.en -e Auali$ied) or eamle: emerature2 ,D2 and room ressure di$$erentials t4i%all4 %riti%al elements /.i%. are monitored and re%orded %ontinuousl42 alarmin! /.en arameters e%eed se%i$i%ations@ V,B dis%retion as to Auali$4 Qualification 5 6tilities  Ima%t ate!ories 9 4i%all4 %riti%al or non9%riti%al  tilit4 s4stems t4i%all4 not -i! sour%e o$ Validation .an!e ,eAuest (V,) sour%es  nl4 re!ulator4 reAuirement %on%ern is t4i%all4 Pota-le ater $eed to uri$i%ation – Purose o$ retreatment usuall4 to reser&e li$e o$ uri$i%ation eAuiment rat.er t.an dire%t ima%t o$ /ater Aualit4 8o0 1e anage Cost; J In '((<" re#ie0ed C&Q costs for se#eral caital ro+ects to! Esta-lis. a -aseline  – omare %osts $or t.e e$ines aroriate %ost <-u%6et= $or %onsisten%4 a%ross ro;e%ts E=GI=EERI=G :EP 193 ser ,eAuirements :un%tional Se%i$i%ation (>ra$t) Preliminar4 >esi!n >etailed >es i!n onstru%tion oo unin! EAuiment InstallationC li!nment C/&&ISSI/=I=G ,is6 ssessment :ailure *ode E$$e%t nal4sis IC0 %.e%6out ali-ration :un% tional S e% i$i% ation (,e&is ions ) :a%tor4 %%etan%e estin! Startu rou-le S.ootin! SeAuen%e estin!  s 9Buil ts (7on #uali $ied S 4s tems) Q6A>I.ICA%I/= 3CER%I.ICA%I/=4 Validation Plan >esi!n #uali$i%ation EAuiment Installation #uali$i%ation EAuiment 0erational #uali$i%ation om uter Dard/are Ins tallat ion #uali$i% at ion omuter So$t/are Installation #uali$i%ation ontroller *odi$i%ation #uali$i%ation DV  InstallationC0erational #uali$i% ation tilit4 Installation #uali$i%ation Pro% ess #uali$i% ation Validated >ra/in!s SamlesCestin! leanin!CPassi&ation Inse%tions   s    t   %   a   r    t   n   o        C   s   r   e    d   r    0    6   r   o    8   !   n    i   r   e   e   n    i   !   n    E >essons >earned Risk-Based C&Q is an iterati#e rocess 3one tin) ste at a time4  ororate " di&isional oli%ies in la%e2 tools de&eloed2 alt.ou!. su%%ess $or &arious sites2 %on%ern a-out %ororate " re!ulator4 audits  Sites /ant to maintain autonom4 /it. !uidan%e@ %ommon elements2 not same aroa%. (i'e' all en!ineers %oml4 .o/e&er &ariations due to se%ialt4)  li%ation: Site readiness tools 9 identi$4in! oortunities $or %losin! !as >essons >earned >isten" Seak" 9eli#er$ Communication is ke)$  #ualit4 ma4 /onder: .at i$ en!ineerin! doesnKt do its ;o-L@ensure %omlian%e  En!ineerin! ma4 /onder: #ualit4  oli%e " sell %.e%6ers@ essons >earned Sustaina*le Paradigm Shift  Sites: Imlementation2 a%%ounta-ilit4 " o/ners.i a must $or sustaina-ilit4  ,esour%es: Peole2 time " mone42 site retainin! te%.ni%al 6no/led!e  li%ation: rainin! " suort imlementation as ali%a-le %hank )ou? • #uestions /ill -e addressed durin! t.e Panel #" session (a$ter -rea6) Eli >ill) & Coman) Commissionin and !uali"ication  Approach Eli >ill) & Coman) Aroach to Commissioning & Qualification • "# >eli&er4 Strate!4 • "# *etri%s • "# essons earned • Imro&ed "# >eli&er4 Strate!4 Recent G.9 C&Q 9eli#er) Strateg) @ Baseline Guide aroach (K0+ – M0F) • • • • >e&eloed ro%edures !o&ernin! "# a%ti&ities ull4 %ommissioned all assets N GEP ,eser&ed Auali$i%ation $or %riti%al ase%ts o$ >I s4stems onl4 e&era!ed %ommissionin! do%umentation to suort Auali$i%ation – %ommissionin! su-;e%t to G>Ps • In&ol&ed #ualit4 at "# strate!4 le&el • In addition2 • • Simulation .as -een used to %ommission automation ase%ts SV testin! .as -een inte!rated /it.in "# test do%uments .undamental C&Q 9eli#er) Strateg) @ for  Glo*al .acilities 9eli#er) 3G.94 Caital Pro+ects C&Q 9eli#er) Strateg) @ Results .is strate!4 .as resulted in: • Earlier resolution o$ issues • ortunit4 to understand s4stems • ,edu%ed #uali$i%ation time • ,edu%ed #uali$i%ation %osts • e/er #uali$i%ation %ommentsCdis%rean%ies C&Q etrics • S%.edule *etri%s • ost *etri%s • >is%rean%4 *etri%s %)ical C&Q Schedule etrics @ 9urations • 10 mont.s $rom $a%ilit4 me%.ani%al %omletion to # %omletion • otal ommissionin! duration: +O mos' (1F+ da4sCs4stem) • otal I#C# duration:  mont.s •  durationCs4stem: O+ da4s • I# durationCs4stem: 11 da4s • # durationCs4stem: 1F da4s •  &era!e Q o$ da4s $rom * to # %omletion: ++F da4s 7ote: *etri%s $or ne/ o/der $illin! $a%ilit4 %onsistin! o$ aro' O0 s4stems C&Q Cost etrics @ 8istorical #ie0 "# ost as  I O0 +0 +5 10 10 5 7o "# ro! 1RR89 +001 Part' "# ro! +0019+003 5 ull "# ro! +00+9 res' 3 G C&Q Budget etrics @ caital ro+ects comleted in (< otal Installed ost "# ost ( I) $1%&& '()* 1+'&& 1+)&& 1/,&& 1/(,&& 11('&& 0(2&& 1(,* -comm( only. ,(,* ,(0* -incl( nonC! activities. /($* /($* 2(2*  Averae3 /(0* -C4! pro5ects only. C&Q deli#er) strateg) has resulted in a ste change in C&Q sa#ings?? >ill) C&Q 1ork Breakdo0n Structure ill4 -ud!etsCtra%6s "# eenses &ia O rimar4 BS %ate!ories: Plannin! " >esi!n • ommissionin! • #uali$i%ation •  dministration • 7e/ "# ost >ata se% re%entl4 aro&ed to ro&ide !uidan%e Planning & 9esign - Su*categor) • • • • • • • • • • • • "# lans and strate!4 Initial s%.edule de&eloment Estimatin! S4stem %lassi$i%ation omonent %lassi$i%ation S4stem "# lans Vendor assessments ser reAuirements >esi!n re&ie/2 se% re&ie/2 dra/in! re&ie/ re&ie/sCta! list En!ineerin! reAuirements >esi!n #uali$i%ation ra%ea-ilit4 *atri%es Commissioning - Su*categor) • • • • • • • • •  de&eloment  ee%ution ,e%eit Veri$i%ation de&eloment ,e%eit Veri$i%ation ee%ution Installation Veri$i%ation de&eloment Installation Veri$i%ation ee%ution S de&eloment S ee%ution onstru%tion turno&er a%6a!es • • • • • • • • Start9u roto%ol de&eloment Start9u roto%ol ee%ution un%tional testin! de&eloment un%tional testin! ee%ution ommissionin! a%6a!es "# lan summar4 reorts  tra&el Suortin! do%uments Qualification - Su*categor) • • • • • • I# de&eloment I# ee%ution # de&eloment # ee%ution P# de&eloment P# ee%ution Administration - Su*categor) rainin! • Pro;e%t mana!ement • "# resour%e tra&el •  dministrati&e assistan%e •  udits • SV suort • %)ical C&Q Budget etrics @ Cost Breakdo0n 34 7ote: nl4 in%ludes %ost data $or "# %ontra%tor  C&Q 9iscreanc) etrics @ Philosoh) "# deli&er4 strate!4 -ased on ris6 miti!ation aroa%. • >,C># redu%ed ris6 durin! onstru%tionCBuild2 ommissionin!2 #uali$i%ation • onstru%tion Aualit4 assuran%e a%ti&ities redu%ed ommissionin! ris6s • Simulation redu%ed ris6 durin! ommissionin! (Startu2 S2 ) • ommissionin! (,V2 IV2 2 S2 ) redu%ed ris6 durin! su-seAuent ommissionin! a%ti&ities and #uali$i%ation •  s ris6 de%reased2 t.e num-er num-er o$ dis%rean%ies also de%reased 9 resulted in %leaner Auali$i%ation do%umentation and -etter s%.edule ad.eren%e durin! Auali$i%ation %)ical C&Q 9iscreanc) etrics    1+30 dis%rean%ies resultin! $rom onstru%tion # a%ti&ities +800 dis%rean%ies durin! %ommissionin! 130 dis%rean%ies durin! Auali$i%ation %)ical C&Q 9iscreanc) etrics @ Categories C&Q >essons >earned 1' Proerl4 de$ine ser ,eAuirements  esta-le2 &eri$ia-le2 ali%a-le  7ot too res%riti&e2 no desi!n details2 no !uesses  In%lude "# en!ineers in re&ie/Caro&al ro%ess +' learl4 de$ine data and do%umentation reAuirements 3' .an!e mana!ement  >onKt imlement $ormal %.an!e %ontrol too soon  >onKt %on$use %.an!e %ontrol /it. &ersion %ontrol  Ensure %ommissionin! %.an!e ro%ess is /ell understood  Ensure %onstru%tion %.an!es are %ommuni%ated to team  Ensure automation %.an!es are re$le%ted in desi!n do%s Current G.9 C&Q 9eli#er) Strateg) @ Enhanced Baseline Guide aroach 3last ' )ears4 • ondu%ted se&eral si si!ma initiati&es to imro&e "# ro%esses • >e&eloed additional ro%edures and -est ra%ti%es ertainin! to "# • • • • G>P SP .an!e *ana!ement SP rans$er o$ are2 ustod4 and ontrol SP >is%rean%4 *ana!ement Best Pra%ti%e • >e&eloed ne/ se%i$i%ations !o&ernin! t.e $ollo/in! • • • Vendor data and do%umentation CS "# %ost data • >e$ined ne/ ro;e%t in$ormation mana!ement role • Imlementin! ne/ reAuirements de$inition ro%ess -ased on s4stems en!ineerin! rin%iles • Imlementin! $ormal onstru%tion # ro!ram Current G.9 C&Q 9eli#er) Strateg) @ Enhanced Baseline Guide aroach 3cont$4 • >e&eloed utomation i$e%4%le *ana!ement en!ineerin! standard to a%%ommodate inte!ration o$ SV and "# resultin! in: • • • Elimination o$ duli%ate reAuirements2 desi!n re&ie/s2 testin! Elimination o$ eader  Pfi:er Qualit) /erations ,alama:oo" I Agenda • Basis o$ "# Pra%ti%es • "# Pro!ram *ana!ement  roa%. • "# ost *ana!ement • Te4 essons Current C&Q Practices • Primaril4 -ased on "# Baseline® Guide 5 • ertain sites .a&e streamlined "# ro%ess • • • • "# <ite= &ersion $or small ro;e%ts and minor eAuiment %.an!es e&era!in! o$ ommissionin! tests into I#  l4in! some S* %on%ets – o%usin! I# on ris6 to rodu%t Aualit4Catient sa$et4 un%tional e&el Ima%t ssessment 9 ,ela%in! omonent e&el Ima%t ssessment • urrentl4 de&eloin! and ilotin! $ull S* E+500 -ased Veri$i%ation aroa%. at tar!eted sites C&Q Program anagement • "# suorted ;ointl4 -4 #ualit42 En!ineerin! and utomationCI • #ualit4 reAuirements de$ined in ororate #ualit4 Standards • "# roa%. de$ined in Glo-al Pra%ti%es • Sites de&elo t.eir o/n ro%edures and &alidation master lans -ased on t.e !lo-al do%uments C&Q Cost anagement • "# %osts t.at are asso%iated /it. eAuiment Auali$i%ation are in%luded in Pro;e%t aital -ud!ets' Pro%ess Validation and leanin! Validation are not in%luded in ro;e%t -ud!ets • "# %ost mana!ed -4 Pro;e%t team ,e) C&Q >essons >earned • $ront in&ol&ement -4 6e4 sta6e.olders in t.e  ssessment stes to de$ine t.e aroriate s%oe $or Auali$i%ation • I# s%oe s.ould -e $o%used on %riti%al ase%tsC$un%tions' ll ot.er testin! is GEP • estin! do%uments s.ould -e -ased on S*E ee%ution and le&era!ed2 /.ere ossi-le2 $rom &endors' e&el o$ do%umentation s.ould -e %ommensurate /it. ris6 to rodu%t Aualit4Catient sa$et4' • ,olesC,esonsi-ilities need to -e %learl4 de$ined at t.e outset o$ ro;e%ts Risk-Based Commissioning & Qualification Benchmarking Educational Track #1 Part 2  Agenda  Part • • 1 ISPE Baseline® Guide Volume 5: ommissionin! " #uali$i%ation &s' S* E+500 – *r' ,o-ert .e/ &er&ie/ o$ "# aroa%.es – --ott2 ill42 P$ier   Brea6  Part • (8:30 – 10:00) – Vendor areas oen + (10:30 – 7oon) Panel #"  ra9u (10:00 – 10:30)