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Compliant, Effective, Efficient.

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Best%Practices%for%Effectiveness%Checks%for%CAPA!

The! need! for! periodic! performance! and! effectiveness! checks! should! established! and!

documented!as!part!of!a!compliant!Corrective!Action!&!Preventive!Action!(CAPA)!process.!

This! is! a! practice! that! regulators! look! for! when! evaluating! a! firm’s! Quality! Management!

System! (QMS).! CAPAs! are! among! the! most! important! Quality! systems! and,! when! done!

properly,!enable!the!firm!to!show!due!diligence!and!commitment!to!Quality.!

Verifying! the! effectiven ess! of! corrective! and! preventive! actions! closes! the! loop! between!

identifying!a!problem!and!completing!the!actions! to!solve!a!problem.!Even!in!everyday!life,!

if! you! have! a! problem,! investigate! it! and! correct! it,! you! should! also! verify! that! the!

correction!actually!worked.!! Determining!the!best!verification!approach!and!deciding!when!

to!conduct!the!verification!for!the!wide!range!of!problems!that!could!occur!can!often!prove!

to!be!elusive.!!!In!many!instances,!these!problems!are!easy!to!fix,!but!some!require!more!

time!and!more!robust,!well-thought!out!remediation.!!!

After!a!deviation!or!non-conformance!occurs,!it!is!up!to!you,!the!investigator,!and!the!area!

impacted!to!develop!an!action!plan!to!fix !the!issue.!!But!what!if!you!couldn’t!find!a!true!root!

cause?! What! if! you! really! don’t! understand! the! problem! that! occurred?! What! happens! if!

you!deem!the!issue!a!minor!hiccup!as!opposed!to!a!critical!deviation!from!the!norm?!What!

if!the!team!begins!to!over!think!the!resolution?!!!These!are!all!common!roadblocks!when!

trying!to!establish!an!effective!verification!for!a!CAPA.!

Once!the!CAPA!has!been!established!and!the!details!have!been!determined!with!regard!to!

the!plan!of!action,!the!areas!responsible!and!the!due!date!for!implementation;!it !is!up!to!the!

Quality!Unit!to!develop!a!proper!effectiveness!check!to!ensure!that!the!CAPA!is!successful.!!!

Compliant, Effective, Efficient.

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The!basic!purpose!of!a!CAPA!is!to!identify!the!problem!and!make!certain!it!does!not!occur!

again.!!!

Some!firms!struggle!with!using!a!quantitative!approach!in!performing!effectiveness!checks,!

because! some! things! are! harder! to! measure! than! others.! However,! you! can! measure!

anything.!For!exa mple,!you!can!even!measure!entry!errors!for!operators!who!are!deviating!

from!good!documentation!practices.!!!!This!can!be!done!by!identifying!area!where!quality!

records! are! reviewed! and! documentation! errors! are! measured.! You! can! measure! by!

operator,!type!of!documentation,!i.e.!lab!record,!batch!record,!cleaning!log,!by!month,!etc.!!

To!help!with!this!process,!you!may!want!to!answer!some!of!these!questions:!

1.! Who!will!measure!it?!

2.! What!will!be!measured?!

3.! Where!will!it!be!measured?!

4.! When!will!it!be!measured?!

5.! How!will!it!be!measured?!

6.! How!will!measurements!be!analyzed?!

7.! Who!will!data!analysis!be!communicated!to?!

Once!these!questions!have!been!answered,!you!can!move!on!to!developing!ways!to!verify!

CAPA!effectiveness.!

Some! basic! tools! and! principles! can! be! used! to! help! make! these! effectiveness! checks!

successful.!

Compliant, Effective, Efficient.

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• Trend! Analysis! –! In! the! cases! of! human! error,! training,! environmental!

monitoring!excursions,!cleaning!deviations,!testing!errors,!etc.!trend!analysis!

can! help! the! auditor! determine! if! the! corrective! action! has! remediated! the!

issue.! ! The! auditor! can! review! data! over! a! pre-determined! timeframe! and!

determine!if!the!problem!or!deviation!has!occurred!again!after!the!corrective!

action! was! implemented.! ! In! most! cases,! the! data! will ! show! if! another!

corrective!action!should!be!established!or!if!the!fix!was!successful.!

• Periodic! Checks! –! This! method! involves! reviewing! the! process! that! was!

remediated!in!real-time.!!For!example,!if!there!was!a!CAPA!implemented!to!

improve! gowning! practices,! the! auditor! can! observe! the! newly! improved!

gowning!practices!prior!to!the!operator!entering!the!clean!room.!

• Surprise! Audits! –! Audits! a re! intended! to! ensure! that! compliance! is! being!

maintained! in! a! certain! area.! ! When! audits! are! used! to! verify! effectiveness!

checks,! they! can! be! done! in! a! manner! to! make! sure! that! the! operators,!

process! or! equipment! is! following! the! prescribed! corrective! action!

documented!in!the!CAPA.!

• Sampling! –! Sampling! is! a! successful! method! to! verify! corrective! actions!

pertaining!to!environmental!monitoring!or!lab!testing.!!For!example,!if!there!

was!a!deviation!for!an!area!exceeding!environmental!action!limits!and!more!

robust!cleaning!practices!were!in!place,!additional!samples!could!be!taken!to!

verify!that!the!additional!cleaning!was!effective.!

Another! vital! piece! to! ensuring! a! robust! and! properly! managed! CAPA! effectiveness!

verification! is! establishing! the! appropriate! timeframes! to! perform! the! checks.! ! When!

settling!on!a!due!date,!it!is!important!to!give!enough!time!for!the!corrective!action!to!work!

while!maintaining!a!sense!of!urgency!to!ensure! the!problem!is!fixed.!!Some!deviations!or!

problems!may!require!a!simple!procedure!update,!re-training!or!tweaking!to!a!piece!of!!

Compliant, Effective, Efficient.

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equipment.! ! However,! in! most! cases,! CAPAs! are! opened! to! address! more! difficult! issues!

such!as!changing!the!facility!l ayout,!changing! gow ning!practices,!increasing!sample!sizes,!or!

implementing!a!new!piece!of!equipment.!!In!these!cases,!it!is!best!practice!to!set!up!several!

effectiveness!checks!over!a!period!of!time.!!Perhaps!the!first!check!can!be!done!within!a!few!

weeks,!but!others!will!be!spread!out!over!the!next!few!months.!!!

Overall,!CAPA!effectiveness!checks!need!to!be!robust!and!fix!the!issue!at!hand.!!They!are!a!

proven! method! to! track,! trend! and! remediate! some! of! the! more! critical! deviations! that!

occur!during!manufacturing!and!laboratory!testing.!!When!done!well,!effectiveness!checks!

demonstrate!your!firm’s!commitment!to!Quality!and!Compliance.!!!

About%the%Author:%:!Danielle!DeLucy,!MS,!is!owner!of!ASA!Training!and!Consulting,!LLC!which!provides!

Pharmaceutical!and!Biologics!based!companies!with!training!and!quality!systems!!assistance!in!order!to!meet!

Regulatory!compliance.!Prior!to!this!role,!Danielle!has!been!in!the!industry !fo r !1 5 !y e a r s!s e r v in g !in !n u merous !

Quality!Management!Roles,!such!as!the!Director!of!Product!Quality,!the!oversight!of!Sterility!Assurance!practices!

and!provided!QA!oversight!of!numerous!filling!and!packaging!operations.!!Danielle!began!her!QA!career!as!a!

Quality!Control!Pharmaceutical!Microbiologist!at!a!contract!laboratory!where!she!performed!various!tests!for!

their!clients.!!In!the!years!after,!she!ha s!he ld!position s!in!the!Q u ality!m ana ge m en t!aren a!w hile!incr eas ing!he r!

responsibility.!!She!has!helped!to !le a d !many!Re g u la t o ry !Health!In sp e c t io n s !an d!was!ins t ru mental!in !t h e !c o a c h in g !

process!of!her!peers!prior!to!any!inspection.!Currently,!Danielle!assists!companies!who!are!faced!with!warning!

letters,!consent!decrees!and!those!wishing!to!improve!compliance!establish!more!robust!quality!systems!so!that!

the!company !can !succe ed .!