NE14. key quality elements at genzyme

《NE14. key quality elements at genzyme》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、AssessingQualityPerformanceatGenzymeManufacturingSitesToddSnellGenzymeCorporationApril20,20051AgendaAgenda°PastProductRegulatoryComplianceChallenges°WhyIntroduceMetrics?°ApplyingMetricstoCorporatePoliciesandComplianceAudits°5-StarQualityProgram°Questions2PastProductRegulatoryComplianceChallen

2、ges°Seniorunderstandingofcomplianceperformancecompliance°Attentiontoauditreports°Detailedinformationwithoutoverallperspective°Deploymentofcompliancepolicies°Interpretation°Responsibilityforcompliance°Qualityfunctionpushingotherfunctionalgroups°Consistencyofcompliancerequirements°Amongauditors

3、°Betweenauditorsandsites°AuditProcess°‘Hideandseek’°Lackofcomplianceperformancevisibility°Keyriskareas°Bestpractices°Siteperformance3WhyIntroduceComplianceMetrics?WhyIntroduceComplianceMetrics?°Establishcomplianceperformancevisibility°Captureandmaintainseniorattention°Ensuresitefollow-up°Visi

4、bilityofbestpractices°Abilitytoviewcross-corporatecompliancetrends°Increaseaccountability‘transparency’°Encouragethedevelopmentand/orclarifyapplicablerequirements°Site/functionalgroupattentiontorequirements°Establishabaselineandgaugeforfuturecomplianceimprovementactivities4WhyIntroduceComplia

5、nceMetrics?WhyIntroduceComplianceMetrics?“Ifwecanobserveit,wecanmeasureit.”“Ifwecanmeasureit,wecanimproveit.”Juran5MeasuringPoliciesandAudits:ExpectationsMeasuringPoliciesandAudits:Expectations°“Tellmewheremyorganizationiswithquality”°Minimizeregulatoryrisk°Setabaselineacrosscompany°Leverageb

6、est‘quality’practices°Identifykeycrosscorporateimprovementareas°Createamaturitymeasurement6MeasuringPoliciesandAudits:5-StarQualityProgram°AnassessmentprocessforGenzymemanufacturingsitestoassessthemselvesacrosskeyqualityelements;aconsistentapproachforcorporateauditevaluations°Listof15criteria

7、(manufacturing)°Eachcriteriacontain‘factors’atLevel3,4,and5ratings°Level3closelyrepresentsgmpandISO°Level4/5representsperformancebeyond‘compliance’°Level3isthecorporatetargetmaturitylevel;Level4/5attainmentisdeterminedbylocalmanagement°Acommo