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BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA. BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING. THE PROCESS THE PITFALLS. Definition of Audit. INSPECTION TO AN APPLICABLE STANDARD. PREPARATION FOR THE AUDIT PROCESS. PURPOSE OF THE AUDIT
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BEST PRACTICES IN INTERNAL COMPLIANCE AUDITINGWillis Ennis Director QA/RA
BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING • THE PROCESS • THE PITFALLS
Definition of Audit • INSPECTION TO AN APPLICABLE STANDARD
PREPARATION FOR THE AUDIT PROCESS • PURPOSE OF THE AUDIT • DEFINE THE SCOPE OF THE AUDIT • DETERMINE RESOURCES • AUTHORITY FOR THE AUDIT
PREPARATION FOR THE AUDIT PROCESS • IDENTIFY PERFORMANCE STANDARDS • NOTIFY AUDITEE • CHECKLIST • REVIEW PREVIOUS AUDITS
PURPOSE • MEANS OF OBJECTIVE FEEDBACK TO MANAGEMENT • CONTINUOUS IMPROVEMENT • REGULATORY RISK ASSESSMENT
SCOPE • DEFINE THE FOCUS OF THE AUDIT • CBER/CDER/CDRH • EU/EMEA • ISO/SIX SIGMA • INTERNAL SOPs • CUSTOMER’S EXPECTATIONS
RESOURCES • QA • QC - TECHNICAL RESOURCE • AREA SUPERVISOR • OTHER?
NOTIFICATION • SCHEDULE SOME TIME • MINIMIZE DISTRACTIONS • DON’T SURPRISE THEM (WHO DO YOU THINK YOU ARE THE FDA?)
PERFORMANCE STANDARDS • SOPs • POLICIES • PROCEDURES • DOCUMENTS • DRAWINGS
REVIEW • PREVIOUS INTERNAL AUDITS • CAPAs • DEVIATIONS • CHANGE CONTROLS • FDA INSPECTION TRENDS • CUSTOMER OBSERVATIONS
CHECKLIST • PROS • ORGANIZED • FOCUSED • CONSISTENT • CONS • CONSTRAINING • CHECK THE BOX • NOT ALWAYS APPLICABLE
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
AUTHORITY • MEDICAL DEVICE QUALITY SYSTEM REGULATION 820.XXX • PLANNED AND PERIODIC AUDITS • INTERNAL SOPs • ISO • INDUSTRY EXPECTATION
FREQUENCY • ROUTINE • ANNUAL, BI-ANNUAL • AUDIT SCHEDULE BASED ON CRITICALITY AND RESOURCES • PROBLEM / FOR CAUSE… STERILITY ISSUE, NON-CONFORMANCE
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
AGENDA • LABORATORY / TESTING / QC • MANUFACTURING
TYPES OF AUDITS • PROCESS • GAP ANALYSIS • ASSESS INDIVIDUAL SYSTEMS • TOP DOWN • BOTTOM UP
CAPAWHAT IS YOUR INTENTION • 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 $$
WHAT YOU DON’T WANT TO HAVE HAPPEN.. • YOUR CAPA SYTEM IS OVERLOADED… CONGRATULATIONS! YOU HAVE THE RECORD, NOW WHAT? • MANUFACTURING IS OVERBURDENED, SO IS QA • CAPA IS NO LONGER EFFECTIVE • YOUR CAPA IS CRAPA…
BUM$$ • 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 • START THE WHEEL TURNING • IDENTIFY AND RESOLVE • MAKE MINOR CHANGES TO SOPs PROCESS IMPROVEMENTS