BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis
BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA
BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING n n THE PROCESS THE PITFALLS
Definition of Audit n INSPECTION TO AN APPLICABLE STANDARD
PREPARATION FOR THE AUDIT PROCESS n n PURPOSE OF THE AUDIT DEFINE THE SCOPE OF THE AUDIT DETERMINE RESOURCES AUTHORITY FOR THE AUDIT
PREPARATION FOR THE AUDIT PROCESS n n IDENTIFY PERFORMANCE STANDARDS NOTIFY AUDITEE CHECKLIST REVIEW PREVIOUS AUDITS
PURPOSE n n n MEANS OF OBJECTIVE FEEDBACK TO MANAGEMENT CONTINUOUS IMPROVEMENT REGULATORY RISK ASSESSMENT
SCOPE n n n DEFINE THE FOCUS OF THE AUDIT CBER/CDRH EU/EMEA ISO/SIX SIGMA INTERNAL SOPs CUSTOMER’S EXPECTATIONS
RESOURCES n n QA QC - TECHNICAL RESOURCE AREA SUPERVISOR OTHER?
NOTIFICATION n n n SCHEDULE SOME TIME MINIMIZE DISTRACTIONS DON’T SURPRISE THEM (WHO DO YOU THINK YOU ARE THE FDA? )
PERFORMANCE STANDARDS n n n SOPs POLICIES PROCEDURES DOCUMENTS DRAWINGS
REVIEW n n n PREVIOUS INTERNAL AUDITS CAPAs DEVIATIONS CHANGE CONTROLS FDA INSPECTION TRENDS CUSTOMER OBSERVATIONS
CHECKLIST n PROS Ø Ø Ø n ORGANIZED FOCUSED CONSISTENT CONS Ø Ø Ø CONSTRAINING CHECK THE BOX NOT ALWAYS APPLICABLE
NOTIFICATION OF AUDITEE n n MAKE SURE THEY ARE READY… RESOURCES ARE IN PLACE DELAY IF REASONABLE BUT IF THE DOG ATE THE HOMEWORK… INCLUDE AGENDA WITH NOTIFICATION
AUTHORITY n n n MEDICAL DEVICE QUALITY SYSTEM REGULATION 820. XXX PLANNED AND PERIODIC AUDITS INTERNAL SOPs ISO INDUSTRY EXPECTATION
FREQUENCY n n ROUTINE ANNUAL, BI-ANNUAL AUDIT SCHEDULE BASED ON CRITICALITY AND RESOURCES PROBLEM / FOR CAUSE… STERILITY ISSUE, NON-CONFORMANCE
AGENDA n n MEET WITH LAB HEAD OR AREA SUPERVISOR DEFINE SCOPE DEFINE LENGTH OF AUDIT DEFINE CRITICAL LAB OR MANUFACTURING PERSONNEL NEEDED TO PARTICIPATE DURING AUDIT
AGENDA n n LABORATORY / TESTING / QC MANUFACTURING
TYPES OF AUDITS n n n PROCESS GAP ANALYSIS ASSESS INDIVIDUAL SYSTEMS TOP DOWN BOTTOM UP
CAPA WHAT IS YOUR INTENTION n n WHAT’S THE RECORD FOR THE MOST CAPAs. . . TOO MANY PUMMEL MANUFACTURING INTO COMPLIANCE… WAY TOO MANY BUILD A ROADMAP FOR IMPROVEMENT… THAT’S BETTER FIND LOW HANGING FRUIT… TELL SENIOR MANAGEMENT YOU’LL SAVE THEM SOME MONEY $$
WHAT YOU DON’T WANT TO HAVE HAPPEN. . n n YOUR CAPA SYTEM IS OVERLOADED… CONGRATULATIONS! YOU HAVE THE RECORD, NOW WHAT? MANUFACTURING IS OVERBURDENED, SO IS QA CAPA IS NO LONGER EFFECTIVE YOUR CAPA IS CRAPA…
BUM$$ n n BIG UGLY MULTI-FACETED EXPENSIVE $$$ LONG RESOLUTION TIME, NEED CAPITOL APPROVAL LONG TERM PROJECTS ARE WORTHWHILE, NECESSARY AND IMPORTANT BUT DON’T LET THEM DISCOURAGE, DILUTE THE FOCUS
TAKE SMALL STEPS n n n START THE WHEEL TURNING IDENTIFY AND RESOLVE MAKE MINOR CHANGES TO SOPs PROCESS IMPROVEMENTS
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