“We should work on our process, not the outcome of our processes” – W. Edwards Deming In one form or another the majority of FDA and notified body observations can be traced back to deficiencies in a CAPA System. Too often companies take a narrow approach in their response to solving these deficiencies. They may update a specific procedure or launch an extensive, directed set of Root Cause Analysis training. In other words, they fix the outcome of an ineffective CAPA system rather then fixing the system itself. CAPA is not simply a set of documentation to prove an issue has been addressed. One more time, it is a system which must be integrated as a critical component of your entire Quality System. Specifically you will learn: CAPA Regulations/Requirements 820.100 Ready for an audit? What does the FDA look for? CAPA Process/System Feeders Procedures Data Trending/Evaluation/Alerts Risk Management System Management The CAPA Root Cause Analysis Statistical Tools DELCS Discipline, Engineering Logic, and Common Sense Presenter: Paul Robinson, Senior Director of Regional Operations, R&Q Paul Robinson – 25+ years of domestic and international experience – Previous: Covidien, Boston Scientific, BARD – VP Quality – Maintained 20+ manufacturing plants worldwide

1. 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 ”

2. 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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3. 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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4. 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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5. W H Y ?
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6. 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.
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Time for a
Checkup?

7. 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
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We’ll discuss
what to do in a
few slides

8. W H Y ?
 Real world?
 Managed correctly, it’s an opportunity for improvement
 Reporting problems
 Proactively addressing problems
 Closed loop system
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Don’t be
afraid!

9. 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.”
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Even if not required, it is still
smart to do. I should know, I’m
an owl!
We’re wicked smaht!

10. C A P A S Y S T E M
F e e d e r s
D a t a Tr e n d i n g / E v a l u a t i o n /A l e r t s
C A PA P r o c e s s
S y s t e m M a n a g e m e n t
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One more time.
It is not an assignment
or a project.
It is a SYSTEM!