C A P A O N C A P A

“ W e s h o u l d w o r k o n o u r p r o c e s s , n o t t h e o u t c o m e o f o u r p r o c e s s e s ”

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A B O U T R & Q

Regulatory and Quality Solutions (R&Q) provides industry-leading regulatory and quality engineering services throughout the entire product lifecycle.

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A B O U T T O D A Y ’ S S P E A K E R

25+ years of domestic and international experience

Previous: Covidien, Boston Scientific, BARD

VP Quality - Maintained 20+ manufacturing plants worldwide

Paul Robinson, Senior Director of Regional Operations, R&Q

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A G E N D A

Why? Real world

Ready for an audit? What does the FDA look for? CAPA regulations/requirements

820.100

CAPA system Feeders Data trending/evaluation/alerts CAPA process

Risk management System management

The CAPA Root cause analysis Statistical tools ELCD – Engineering, Logic, Common Sense, and Discipline!

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W H Y ?

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W H Y ?

Real world FDA audit 80/20 rule – ever heard of that?

Remember: CAPA is not an assignment or project. It is a system. CAPA has been called the ”immune system” of the Quality Management System. It

must work for your organization to repair or improve itself properly.

Time for a Checkup?

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W H Y ?

Indications that your CAPA system may be feeling a little under the weather: CAPA metrics are inadequate for management understanding and control;

too many, too few, too confusing CAPA projects are not progressing There is a very weak “CAPA culture” Your organization seems to have too many CAPA projects or they are languishing

We’ll discuss what to do in a

few slides

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W H Y ?

Real world? Managed correctly, it’s an opportunity for improvement

Reporting problems Proactively addressing problems Closed loop system

Don’t be afraid!

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W H Y E L S E ?

Regulations require it! 21 Code of Federal Regulations (CFR) 820.100

“Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.”

ISO 13485:2003, 8.5.2, 8.5.3“The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.”

Even if not required, it is still smart to do. I should know, I’m

an owl! We’re wicked smaht!

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C A P A S Y S T E M

F e e d e r s

D a t a T r e n d i n g / E v a l u a ti o n / A l e r t s

C A P A P r o c e s s

S y s t e m M a n a g e m e n tOne more time.

It is not an assignment or a project.

It is a SYSTEM!