1、Outline Basic conceptions of quality system Auditing Preparation of auditing On-site auditing Auditing report and follow-up actionsWhat is quality audit?A quality audit is a systematic,independent and documented process for obtaining audit evidence and evaluating it objectively to determine the exte
2、nt to which agreed criteria are fulfilled(ISO 9000:2005 clause 3.9.1)Audit criteria Evidence CompareAudit findingconclusionHow many？Yes/No？Three Key Words Evidence Criteria IndependentDistinction of system audits by parties1st party audits(Internal Audits)Organization audits its own QMS according to
3、 a quality standard2nd party audits(Supplier Audits)Customer audits the suppliers quality system3rd party auditsExternal certification audits by an independent institution in order to certify the QMSInternal Audit An independent,objective assurance and consulting activity designed to add value and a
4、pprove an organizations operations.It helps an organization accomplish its objectives by bringing a systematic,disciplined approach to evaluate and improve the effectiveness of risk management,control,and governance processes.-Institute of Internal AuditorsQuestion:What is the difference between thi
5、rd part audit and first part audit(internal audit)Why Audit?To determine whether the quality system conforms to specified requirements To determine the effectiveness of the implemented system To initiate improvements in the system3 types of audits Process audits Product audits System auditsPROCESS A
6、UDITSEvaluation of the contents and effectiveness of specific processes&work activities:To confirm process parameters and improve capability of the process To ensure the realization the process quality characteristics.To ensure improvement of process control during service provision Product AuditsIn
7、vestigation of product conformance to specified characteristics:To obtain additional neutral assessment of products level of quality To obtain additional assurance that specified quality requirements are metProduct audits To identify opportunities for improvement.To establish the quality level of un
8、its after final inspection and testing To establish the capability of the inspection function To determine the usefulness of inspections&testsSystem auditsEvaluation of all the elements of the quality system in order to:Verify usefulness,suitability and effectiveness Verify adequate documentation Ve
9、rify compliance with requirements.Determine weak pointsWho is an auditor?A person who has the qualification to perform quality auditsCriteria for quality auditors Education Training Experience Personal AttributesAttributes of an auditorA AnalyticalU Unassuming/unbiasedD DiplomaticI Inquisitive/indep
10、endentT ThoroughO ObjectiveR-ReliableThe Audit Process Plan and prepare the audit50%Carry out the audit30%Reporting and follow-up20%OVERVIEW OF AUDIT ACTIVITESPlanning and scheduling auditConducting document reviewConducting auditPrepare audit reportConducting follow-upPreparing for on-site activiti
11、esForming an audit team and assign roles and responsibility and agreed on the scopeConducting document review Preparing for the on-site audit activitiesReview documents(SOPs,audit findings,corrective action/preventive action,etc.),check the integrity of the quality system and various controls are ef
12、fectivePreparing audit plan Assigning work to the audit team Preparing work documents(eg.audit checklists,sampling plans,forms for recording information;questionnaires)AUDIT ACTIVITIESAUDIT DOCUMENTATION Audit report is an official document to report the audit findings Audit plan should be sent to a
13、uditee prior to audit activity findings from the last audit should be also mentioned Audit note should include an audit questionnaire all records and comments during the auditAUDIT PREPARATIONEstablish audit type and scopeEstablish audit basis it is the standard,manual,procedures or combination of t
14、hemEstablish audit personnel size is dependent on the type,purpose and scope of audit.Audit team may include specialists,trainee auditors,observers acceptable to audited and audit teamAUDIT PREPARATIONRead basis documentation as well as previous audit reports and determine what records shall be pull
15、ed in advancePrepare process model identifying the expected results of the process to be auditedPrepare an audit plan(or schedule)AUDIT PREPARATIONNotify the auditee in advance of:time,date,the scope,the basis,timetable of the auditPrepare checklists use open ended questions what?Why?Who?How?Which?T
16、he Consideration of the Auditing Schedule1.Auditing Scope2.Operational performance(KPI)3.Customers feedbacks(e.g complains);4.NCR in last auditing;5.Auditing resourcesAn Example of Auditing Schedule 月代号123456789101112审核内容2004-1H环境因素及方案2004-2HEMS运行2004-3H培 训2004-4H复审前自查Auditing PlanBased on auditing
17、schedule;Consider the specific scope and purposes;Consider the auditing resources;An daily work assignment;Worked out by leading auditorCase StudyChecklist Cover all the requirements of the auditing plan;Worked out by each auditor;Road map of the checkout;Focus on the key pointsAudit Approach&RouteA
18、pproach：Based on dep.Based on processRoute：Forward trace Backward traceBased on Dep.Based on processforwardbackwardFlexible combinationAuditing based on departmentResponsibilitiesResponsibilities5.5.1 6.2.15.5.1 6.2.1ResoursesResourses6.2 6.3 6.46.2 6.3 6.4Quality objectivesQuality objectives5.4.15.
19、4.1CommunicationsCommunications5.5.35.5.3Process in chargeProcess in chargeClauseClauseData analysisData analysis8.48.4improvementimprovement8.58.5 ProcessEXAMPLE OF AN AUDIT CHECKLISTGeneral format for an audit checklistEXAMPLE OF AN AUDIT CHECKLISTCHECKING LIST FOR GMP ASSESSMENT Date :Location :W
20、arehouse Auditor:Auditee:DESCRIPTION GMP.REF.PARAMETER AUDIT FINDING Personnel 1.2.1 5.1.2 2.1.5-Organization structure-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 G
21、MP-HVAC system-Record of monitoring parameter Sanitation 3.1 5.3-Pest record program-The map of bait-The cleanliness 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 INTERNA
22、:AUDIT QUESTIONAIRESArea audited:_ Date:_Question(QSR-GMP 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
23、is the last breakdown of the machine?Are there any product being affected?MONITORINGPERFORMING THE AUDITBefore the start of audit:Auditees management informs personnel in the involved departments about expected audit Lead auditor and rest of the team must be acceptable to auditee managementFOUR PHAS
24、ES OF AN AUDITOpening meetingExecution of auditAuditors meetingClosing meetingAUDITING ACTIVITIESConducting on-site audit activitiesInterviews with different personnelCarry out both horizontal and vertical audits.Focus on safety and quality of product.Use“Trace-back”method vConduct opening meeting v
25、Good communication during the audit vRoles of escort and observervSteps in conducting on site audit:Typical opening meeting agenda Introduction of members and observers and recording of those present Confirm objectives,scope,basis,reasons and benefits of the audit Review of audit plan Explanation of
26、 the audit method and documentation to be used Explain the tasks of the accompanying auditees representatives(i.e.guide)Execution of auditTHE AUDIT LOZENGEAskRecordCheckObserveEXECUTION OF AUDIT Must be done according to timetable Only ask open,factual questions Verify answer through observation Fol
27、low an audit trail Do more listening than talking,2 ear 1 mouth;therefore listen 2/3 of the timeSome rules for auditors Keep calm and relaxed Look at the other person-eye contact Keep discussion factual Ask one question at a time Do not lecture Let the other person finish talkingSome rules for audit
28、 Keep the right distance from the person Be friendly without being too familiar If your question causes uneasiness or uncertainty,formulate it differently Involve all participants Use the right gestures/expressions Keep personal opinions to yourselfAUDITOR SINSAn auditor should neverCompare the audi
29、tee with othersBe sarcasticSwearCriticizeBe side trackedArgueDiscuss personalitiesDiscuss religion or politicsDiscuss company policyDrink beer before an interviewBe lateObjective evidence Remember-SHOW ME Check for documents,records,reports,data in computers etc Ensure auditees statements are cross
30、checked by supporting evidence e.g.statements by other personnel with specified authority,records,documentary evidence e.g.Critical Points for checking Documents and records;Machinery and equipments;Measuring devices;Workers and their operations;Raw materials and components;Logistics;On-sites cleani
31、ng and environmentsAUDITORS MEETING Compilation of findings/observations Recording of non-conformities Preparation of summary report Formation of opinion to be presented at closing meetingGenerating audit findingsEither conformity or non-conformitySort out isolated or systemic deficiencies Isolated
32、deficiency:Tends to happen randomly;no meaningful pattern;rarely happensSystemic deficiency:Could be connected to a particular process,product,material,person or organisation;shows pattern;happens more than onceAUDITING ACTIVITIESISOLATED VERSUS SYSTEMIC DEFICIENCY NON CONFORMANCE DEFICIENCIES ISOLA
33、TEDSYSTEMICLatex gloves ripSOP contains errorsWrong expiration date written on a reagent bottleBatch record is poorly written so instruction can be confusingOperator or lab technician spills a sample Area management does not reinforce requirement to continually record information properlyPressing ma
34、chine of eye shadow burns outPreventive maintenance program does not include liquid filling machine motorThe audit finding can be classified into 2 groups:Compliance:Satisfactory/AdequateOutstandingNon-compliance:Critical deficiencyMajor deficiency1.Minor deficiencyAUDIT MONITORINGObjectivesAudit sc
35、opeIdentification of audit team leader and membersDate and place where the on-site audit activities were conductedAudit criteria and findingsConclusions AUDIT REPORTTypical closing meeting agenda Introductions and recording of attendance Thank the auditee Mention the principles of sampling followed
36、during the audit Summarize audit observations(positive,general observations and nonconformities)Give non conformities in detailsTypical Closing Meeting Agenda Present overall summary and conclusions Allow for discussion Request corrective actions and corrective action dates Agree on follow-up date C
37、lose meetingNoclauseFindingsGradingLocationAuditeeAuditor1.2.1.1Production and QC departments are headed by the same personCriticalHuman ResourcesAbasBudi2.4.3Monitoring of temperature in a warehouseMajor or MinorWarehouseTutiMay Lin311.1Inadequate control over sub-contractorMajor or MinorProduction
38、HermanIdaAUDIT REPORT:AN EXAMPLEREPORTING OF AUDITS A standard form for the reporting of audit should be used.Using the standard audit report sheets prepare a narrative summary of the audit Ensure the positive as well as the negative findings are summarizedREPORTING OF AUDITSReport should cover the
39、following headings:-TitleScopeBasisAudit teamIntroduction(opening meeting)FindingsDebriefing(closing meeting)SummaryThe audit report including any non-conformity report,Corrective action notices are issued to the all auditees REPORTING OF AUDITS ISO 19011:2008 includes recommendations for report con
40、tents Audit reports should be kept confidential lest Auditors lose respect Auditees are less willing to identify areas for improvementANALYSIS OF AUDITS Management Representative will analyze audit reports to identify areas of common deficiency within QMS This will initiate changes to the audit sche
41、dule A full analysis of audit reports is presented to management review meetingCorrective Action Follow-upIt is important to ensure that the auditee implements:-Effective correction1.Effective corrective actionsCLOSURE Follow-up and closing of loop:Receive 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
