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