Ennis ISD - Ennis Junior High School - 2008 Texas School Survey of Drug and Alcohol Use
BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA
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Transcript of BEST PRACTICES IN INTERNAL COMPLIANCE AUDITING Willis Ennis Director QA/RA
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