1、会计学1Quality System Auditing质量体系审核质量体系审核2第1页/共65页3第2页/共65页4Audit criteria Evidence CompareAudit findingconclusionHow many？Yes/No？第3页/共65页5第4页/共65页6第5页/共65页7第6页/共65页8第7页/共65页9第8页/共65页10第9页/共65页11第10页/共65页12第11页/共65页13第12页/共65页14第13页/共65页15第14页/共65页16第15页/共65页17第16页/共65页18OVERVIEW OF AUDIT ACTIVITESPla
2、nning and scheduling auditConducting document reviewConducting auditPrepare audit reportConducting follow-upPreparing for on-site activities第17页/共65页19Review documents(SOPs,audit findings,corrective action/preventive action,etc.),check the integrity of the quality system and various controls are eff
3、ectivePreparing audit plan Assigning work to the audit team Preparing work documents(eg.audit checklists,sampling plans,forms for recording information;questionnaires)AUDIT ACTIVITIES第18页/共65页20AUDIT DOCUMENTATION Audit report is anofficial document to report the audit findings Audit planshould be s
4、ent to auditee prior to audit activityfindings from the last audit should be also mentioned Audit note should includean audit questionnaireall records and comments during the audit第19页/共65页21第20页/共65页22第21页/共65页23第22页/共65页24第23页/共65页25An Example of Auditing Schedule 月代号123456789101112审核内容2004-1H环境因素
5、及方案2004-2HEMS运行2004-3H培 训2004-4H复审前自查第24页/共65页26第25页/共65页27第26页/共65页28第27页/共65页29第28页/共65页30Based on Dep.Based on processforwardbackwardFlexible combination第29页/共65页31ResponsibilitiesResponsibilitiesResoursesResourses6.2 6.3 6.46.2 6.3 6.4Quality objectivesQuality objectivesCommunicationsCommunicati
6、onsProcess in chargeProcess in chargeClauseClauseData analysisData analysis8.48.4improvementimprovement8.58.5 Process第30页/共65页32第31页/共65页33CHECKING LIST FOR GMP ASSESSMENT Date :Location :Warehouse Auditor:Auditee:DESCRIPTION GMP.REF.PARAMETER AUDIT FINDING Personnel 1.2.1 5.1.2 2.1.5-Organization s
7、tructure-Personnel hygiene-Training record Storage area 10.1.1 3.1 3.6 3.9&3.10 3.12.2-Design and layout of defined area-Flow of personnel and goods-Structure of the storage area,based on GMP-HVAC system-Record of monitoring parameter Sanitation 3.1 5.3-Pest record program-The map of bait-The cleanl
8、iness of weighing apparatus Documentation 4.3 10.2.2.3 10.2.2.1-Record of maintenance and calibration of weighing apparatus-The effectiveness of label system-Inventory stock control 第32页/共65页34INTERNA:AUDIT QUESTIONAIRESArea audited:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D a te:_Question(QSR-GMP
9、Reference)Response1.Does the company have a work instruction to operate the machine?2.How is the machine being cleaned and maintained?3.Are personnel trained to use the machine?4.How often is the equipment being calibrated and cleaned?5.When is the last breakdown of the machine?Are there any product
10、 being affected?MONITORING第33页/共65页35第34页/共65页36第35页/共65页37Interviews with different personnelCarry out both horizontal and vertical audits.Focus on safety and quality of product.Use“Trace-back”method vConduct opening meeting vGood communication during the audit vRoles of escort and observervSteps i
11、n conducting on site audit:第36页/共65页38第37页/共65页39第38页/共65页40AskRecordCheckObserve第39页/共65页41第40页/共65页42第41页/共65页43第42页/共65页44第43页/共65页45第44页/共65页46第45页/共65页47第46页/共65页48第47页/共65页49第48页/共65页50第49页/共65页51Isolated deficiency:Tends to happen randomly;no meaningful pattern;rarely happensSystemic deficien
12、cy:Could be connected to a particular process,product,material,person or organisation;shows pattern;happens more than once第50页/共65页52NON CONFORMANCE DEFICIENCIES ISOLATEDSYSTEMICLatex gloves ripSOP contains errorsWrong expiration date written on a reagent bottleBatch record is poorly written so inst
13、ruction can be confusingOperator or lab technician spills a sample Area management does not reinforce requirement to continually record information properlyPressing machine of eye shadow burns outPreventive maintenance program does not include liquid filling machine motor第51页/共65页53AUDIT MONITORING第
14、52页/共65页54AUDIT REPORT第53页/共65页55第54页/共65页56第55页/共65页57第56页/共65页58NoclauseFindingsGradingLocationAuditeeAuditor1.2.1.1Production and QC departments are headed by the same personCriticalHuman ResourcesAbasBudi2.4.3Monitoring of temperature in a warehouseMajor or MinorWarehouseTutiMay Lin311.1Inadequa
15、te control over sub-contractorMajor or MinorProductionHermanIda第57页/共65页59第58页/共65页60第59页/共65页61第60页/共65页62第61页/共65页63第62页/共65页64Receive a satisfactory response from auditee and their commitment to correct for any deficiencyEnsures follow-up actions identify the root cause and they are satisfactory,accomplished and documented Timeframe for follow-up actions is being followedVerify and track effectiveness by scheduling a follow-up audit and/or requesting for an updated SOP第63页/共65页65第64页/共65页
