如何在审计末日中幸存：来自审计一线的质量故事.pdf

1、SURVIVING THE AUDITOCALYPSE:A QUALITY TALE FROM THE AUDIT TRENCHESPresented by:Meredith Telander,Regulatory Affairs and Training Manager for Catalyst NutraceuticalsA LITTLE ABOUT CATALYST NUTRACEUTICALS WHAT DOES“AUDIT”MEAN TO YOU?A.U.D.I.T.A Always U Under D Direct I Inspection,T Terrifying!A Alway

2、s U Understand D Details I Investigate T Thoroughly A Are U U D Documenting I It T Though?A Ah!U Unexpected D Discoveries I In T There!A Annual U Unleashing of D Dread I In T Teams A Analyze,U Understand,D Document,I Improve,T TrackTHE AUDIT:FRIEND OR FRENEMY?Internal Audit Focuses on Internal Compl

3、iance “Are we doing what our SOPs say we do?”Customer Audit Focuses on Brand Risk “Will your process damage my reputation”?Regulatory Audit Focuses on Compliance”Are you following the law?”Certification/Third-Party Audit Focuses on Standards “Do you meet this certification”?PEELING THE QUALITY AUDIT

4、 ONION Control What you Can Divide and Conquer Standardize Your PreparationCONTROL WHAT YOU CAN EX.FACILITY AUDIT AGREEMENTDIVIDE AND CONQUER 1.Strong internal audit program with correlating corrective actions 2.Evidence,traceability and accountability through documents and records 3.Strong partnership with Quality and OperationsSTANDARDIZE YOUR RESPONSESHAVE A PLAN FOR YOUR AUDIT TEAM IN THE EVENT OF MULTIPLE AUDITS AT THE SAME TIMENON-CONFORMANCES:THE GIFT THAT KEEPS ON GIVINGMAKE QUALITY A CULTURE NOT A DEPARTMENTTHE HUMAN SIDE OF AUDITSYOUVE GOT THIS!