BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA

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BEST PRACTICES IN INTERNAL COMPLIANCE
AUDITINGWillis Ennis Director QA/RA
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BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING

• THE PROCESS
• THE PITFALLS

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Definition of Audit

• INSPECTION TO AN APPLICABLE STANDARD

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PREPARATION FOR THE AUDIT PROCESS

• PURPOSE OF THE AUDIT
• DEFINE THE SCOPE OF THE AUDIT
• DETERMINE RESOURCES
• AUTHORITY FOR THE AUDIT

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PREPARATION FOR THE AUDIT PROCESS

• IDENTIFY PERFORMANCE STANDARDS
• NOTIFY AUDITEE
• CHECKLIST
• REVIEW PREVIOUS AUDITS

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PURPOSE

• MEANS OF OBJECTIVE FEEDBACK TO MANAGEMENT
• CONTINUOUS IMPROVEMENT
• REGULATORY RISK ASSESSMENT

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SCOPE

• DEFINE THE FOCUS OF THE AUDIT
• CBER/CDER/CDRH
• EU/EMEA
• ISO/SIX SIGMA
• INTERNAL SOPs
• CUSTOMERS EXPECTATIONS

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RESOURCES

• QA
• QC - TECHNICAL RESOURCE
• AREA SUPERVISOR
• OTHER?

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NOTIFICATION

• SCHEDULE SOME TIME
• MINIMIZE DISTRACTIONS
• DONT SURPRISE THEM (WHO DO YOU THINK YOU ARE THE
  FDA?)

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PERFORMANCE STANDARDS

• SOPs
• POLICIES
• PROCEDURES
• DOCUMENTS
• DRAWINGS

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REVIEW

• PREVIOUS INTERNAL AUDITS
• CAPAs
• DEVIATIONS
• CHANGE CONTROLS
• FDA INSPECTION TRENDS
• CUSTOMER OBSERVATIONS

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CHECKLIST

• PROS
• ORGANIZED
• FOCUSED
• CONSISTENT
• CONS
• CONSTRAINING
• CHECK THE BOX
• NOT ALWAYS APPLICABLE

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NOTIFICATION OF AUDITEE

• MAKE SURE THEY ARE READY
• RESOURCES ARE IN PLACE
• DELAY IF REASONABLE BUT IF THE DOG ATE THE
  HOMEWORK
• INCLUDE AGENDA WITH NOTIFICATION

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AUTHORITY

• MEDICAL DEVICE QUALITY SYSTEM REGULATION 820.XXX
• PLANNED AND PERIODIC AUDITS
• INTERNAL SOPs
• ISO
• INDUSTRY EXPECTATION

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FREQUENCY

• ROUTINE
• ANNUAL, BI-ANNUAL
• AUDIT SCHEDULE BASED ON CRITICALITY AND RESOURCES
• PROBLEM / FOR CAUSE STERILITY ISSUE,
  NON-CONFORMANCE

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AGENDA

• MEET WITH LAB HEAD OR AREA SUPERVISOR
• DEFINE SCOPE
• DEFINE LENGTH OF AUDIT
• DEFINE CRITICAL LAB OR MANUFACTURING PERSONNEL
  NEEDED TO PARTICIPATE DURING AUDIT

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AGENDA

• LABORATORY / TESTING / QC
• MANUFACTURING

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TYPES OF AUDITS

• PROCESS
• GAP ANALYSIS
• ASSESS INDIVIDUAL SYSTEMS
• TOP DOWN
• BOTTOM UP

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CAPAWHAT IS YOUR INTENTION

• WHATS THE RECORD FOR THE MOST CAPAs... TOO MANY
• PUMMEL MANUFACTURING INTO COMPLIANCE WAY TOO
  MANY
• BUILD A ROADMAP FOR IMPROVEMENT THATS BETTER
• FIND LOW HANGING FRUIT TELL SENIOR MANAGEMENT
  YOULL SAVE THEM SOME MONEY

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WHAT YOU DONT WANT TO HAVE HAPPEN..

• YOUR CAPA SYTEM IS OVERLOADED CONGRATULATIONS!
  YOU HAVE THE RECORD, NOW WHAT?
• MANUFACTURING IS OVERBURDENED, SO IS QA
• CAPA IS NO LONGER EFFECTIVE
• YOUR CAPA IS CRAPA

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BUM

• BIG UGLY MULTI-FACETED EXPENSIVE
• LONG RESOLUTION TIME, NEED CAPITOL APPROVAL
• LONG TERM PROJECTS ARE WORTHWHILE, NECESSARY AND
  IMPORTANT
• BUT DONT LET THEM DISCOURAGE, DILUTE THE FOCUS

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TAKE SMALL STEPS

• START THE WHEEL TURNING
• IDENTIFY AND RESOLVE
• MAKE MINOR CHANGES TO SOPs PROCESS IMPROVEMENTS