QualitySystemAuditing質(zhì)量體系審核學(xué)習(xí)課程

1、1Outline Basic conceptions of quality system Auditing Preparation of auditing On-site auditing Auditing report and follow-up actions第1頁/共65頁第一頁，編輯于星期六：十八點 二十七分。2What is quality audit? A quality audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it o

2、bjectively to determine the extent to which agreed criteria are fulfilled第2頁/共65頁第二頁，編輯于星期六：十八點 二十七分。3Audit criteria Evidence CompareAudit findingconclusionHow many？Yes/No？第3頁/共65頁第三頁，編輯于星期六：十八點 二十七分。4Three Key Words Evidence Criteria Independent第4頁/共65頁第四頁，編輯于星期六：十八點 二十七分。5Distinction of system aud

3、its by parties1st party audits(Internal Audits) Organization audits its own QMS according to 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 QMS第5頁/共65頁

4、第五頁，編輯于星期六：十八點 二十七分。6Internal Audit An independent, objective assurance and consulting activity designed to add value and approve an organizations operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness o

5、f risk management, control, and governance processes. -Institute of Internal Auditors第6頁/共65頁第六頁，編輯于星期六：十八點 二十七分。7Question:What is the difference between third part audit and first part audit (internal audit)第7頁/共65頁第七頁，編輯于星期六：十八點 二十七分。8Why Audit? To determine whether the quality system conforms to

6、specified requirements To determine the effectiveness of the implemented system To initiate improvements in the system第8頁/共65頁第八頁，編輯于星期六：十八點 二十七分。93 types of audits Process audits Product audits System audits第9頁/共65頁第九頁，編輯于星期六：十八點 二十七分。10PROCESS AUDITSEvaluation of the contents and effectiveness of

7、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 第10頁/共65頁第十頁，編輯于星期六：十八點 二十七分。11Product AuditsInvestigation of

8、 product conformance to specified characteristics: To obtain additional neutral assessment of products level of quality To obtain additional assurance that specified quality requirements are met第11頁/共65頁第十一頁，編輯于星期六：十八點 二十七分。12Product audits To identify opportunities for improvement. To establish the

9、 quality level of units after final inspection and testing To establish the capability of the inspection function To determine the usefulness of inspections & tests第12頁/共65頁第十二頁，編輯于星期六：十八點 二十七分。13System auditsEvaluation of all the elements of the quality system in order to: Verify usefulness, su

10、itability and effectiveness Verify adequate documentation Verify compliance with requirements. Determine weak points第13頁/共65頁第十三頁，編輯于星期六：十八點 二十七分。14Who is an auditor?A person who has the qualification to perform quality auditsCriteria for quality auditors Education Training Experience Personal Attri

11、butes第14頁/共65頁第十四頁，編輯于星期六：十八點 二十七分。15Attributes of an auditorA AnalyticalU Unassuming/unbiasedD DiplomaticI Inquisitive/independentT ThoroughO ObjectiveR - Reliable第15頁/共65頁第十五頁，編輯于星期六：十八點 二十七分。16The Audit Process Plan and prepare the audit50% Carry out the audit30% Reporting and follow-up20%第16頁/共6

12、5頁第十六頁，編輯于星期六：十八點 二十七分。17OVERVIEW OF AUDIT ACTIVITESPlanning and scheduling auditConducting document reviewConducting auditPrepare audit reportConducting follow-upPreparing for on-site activities第17頁/共65頁第十七頁，編輯于星期六：十八點 二十七分。18Forming an audit team and assign roles and responsibility and agreed on t

13、he 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 effectivePreparing audit plan Assigning work to the audit team Preparing

14、 work documents (eg. audit checklists, sampling plans, forms for recording information; questionnaires)AUDIT ACTIVITIES第18頁/共65頁第十八頁，編輯于星期六：十八點 二十七分。19AUDIT DOCUMENTATION Audit report is an official document to report the audit findings Audit plan should be sent to auditee prior to audit activity fi

15、ndings from the last audit should be also mentioned Audit note should include an audit questionnaire all records and comments during the audit第19頁/共65頁第十九頁，編輯于星期六：十八點 二十七分。20AUDIT PREPARATION1. Establish audit type and scope2.Establish audit basis it is the standard, manual, procedures or combinatio

16、n of them3.Establish 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 team第20頁/共65頁第二十頁，編輯于星期六：十八點 二十七分。21AUDIT PREPARATION4.Read basis documentation as well as previous audit re

17、ports and determine what records shall be pulled in advance5.Prepare process model identifying the expected results of the process to be audited6.Prepare an audit plan (or schedule)第21頁/共65頁第二十一頁，編輯于星期六：十八點 二十七分。22AUDIT PREPARATION7.Notify the auditee in advance of: time, date, the scope, the basis,

18、 timetable of the audit8.Prepare checklists use open ended questions what? Why? Who? How? Which?第22頁/共65頁第二十二頁，編輯于星期六：十八點 二十七分。23The Consideration of the Auditing Schedule1. Auditing Scope2. Operational performance (KPI)3. Customers feedbacks ( e.g complains );4. NCR in last auditing;5. Auditing res

19、ources第23頁/共65頁第二十三頁，編輯于星期六：十八點 二十七分。24An Example of Auditing Schedule 月代號123456789101112審核內(nèi)容2004-1H環(huán)境因素及方案2004-2HEMS運行2004-3H培 訓(xùn)2004-4H復(fù)審前自查第24頁/共65頁第二十四頁，編輯于星期六：十八點 二十七分。25Auditing PlanBased on auditing schedule;Consider the specific scope and purposes;Consider the auditing resources;An daily work

20、 assignment;Worked out by leading auditor第25頁/共65頁第二十五頁，編輯于星期六：十八點 二十七分。26第26頁/共65頁第二十六頁，編輯于星期六：十八點 二十七分。27Case Study第27頁/共65頁第二十七頁，編輯于星期六：十八點 二十七分。28Checklist Cover all the requirements of the auditing plan; Worked out by each auditor; Road map of the checkout; Focus on the key points第28頁/共65頁第二十八頁

21、，編輯于星期六：十八點 二十七分。29Audit Approach & RouteApproach： Based on dep. Based on processRoute： Forward trace Backward traceBased on Dep.Based on processforwardbackwardFlexible combination第29頁/共65頁第二十九頁，編輯于星期六：十八點 二十七分。30Auditing based on departmentResponsibilitiesResponsibilitiesResoursesResourses6.2 6

22、.3 6.46.2 6.3 6.4Quality objectivesQuality objectivesCommunicationsCommunicationsProcess in chargeProcess in chargeClauseClauseData analysisData analysis8.48.4improvementimprovement8.58.5 Process第30頁/共65頁第三十頁，編輯于星期六：十八點 二十七分。31EXAMPLE OF AN AUDIT CHECKLISTGeneral format for an audit checklist第31頁/共6

23、5頁第三十一頁，編輯于星期六：十八點 二十七分。32EXAMPLE OF AN AUDIT CHECKLISTCHECKING 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 structure - Personnel hygiene - Training record Storage area 10.1.1 3.1 3.6

24、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 cleanliness of weighing apparatus Documentation 4.3 10

25、.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頁/共65頁第三十二頁，編輯于星期六：十八點 二十七分。33INTERNA: AUDIT QUESTIONAIRESA re a audi t e d : _ _ _ _ _ _ _ _ _ _ _ D a t e : _Question (QSR-GMP Reference)Response1. Does th

26、e 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 being affected? MO

27、NITORING第33頁/共65頁第三十三頁，編輯于星期六：十八點 二十七分。34PERFORMING 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 management第34頁/共65頁第三十四頁，編輯于星期六：十八點 二十七分。35FOUR PHASES OF AN

28、AUDITOpening meetingExecution of auditAuditors meetingClosing meeting第35頁/共65頁第三十五頁，編輯于星期六：十八點 二十七分。36AUDITING ACTIVITIESConducting on-site audit activitiesInterviews with different personnelCarry out both horizontal and vertical audits. Focus on safety and quality of product. Use “Trace-back” metho

29、d vConduct opening meeting vGood communication during the audit vRoles of escort and observervSteps in conducting on site audit:第36頁/共65頁第三十六頁，編輯于星期六：十八點 二十七分。37Typical opening meeting agenda Introduction of members and observers and recording of those present Confirm objectives, scope, basis, reaso

30、ns and benefits of the audit Review of audit plan Explanation of the audit method and documentation to be used Explain the tasks of the accompanying auditees representatives (i.e. guide)第37頁/共65頁第三十七頁，編輯于星期六：十八點 二十七分。38第38頁/共65頁第三十八頁，編輯于星期六：十八點 二十七分。39Execution of auditTHE AUDIT LOZENGEAskRecordChec

31、kObserve第39頁/共65頁第三十九頁，編輯于星期六：十八點 二十七分。40EXECUTION OF AUDIT Must be done according to timetable Only ask open, factual questions Verify answer through observation Follow an audit trail Do more listening than talking, 2 ear 1 mouth; therefore listen 2/3 of the time第40頁/共65頁第四十頁，編輯于星期六：十八點 二十七分。41Some

32、 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 talking第41頁/共65頁第四十一頁，編輯于星期六：十八點 二十七分。42Some rules for audit Keep the right distance from the person Be friendly without being

33、too familiar If your question causes uneasiness or uncertainty, formulate it differently Involve all participants Use the right gestures/expressions Keep personal opinions to yourself第42頁/共65頁第四十二頁，編輯于星期六：十八點 二十七分。43AUDITOR SINSAn auditor should never Compare the auditee with others Be sarcastic Swe

34、ar Criticize Be side tracked Argue Discuss personalities Discuss religion or politics Discuss company policy Drink beer before an interview Be late第43頁/共65頁第四十三頁，編輯于星期六：十八點 二十七分。44Objective evidence Remember - SHOW ME Check for documents, records, reports, data in computers etc Ensure auditees state

35、ments are cross checked by supporting evidence e.g. statements by other personnel with specified authority, records, documentary evidence e.g.第44頁/共65頁第四十四頁，編輯于星期六：十八點 二十七分。45Critical Points for checking Documents and records; Machinery and equipments; Measuring devices; Workers and their operations

36、; Raw materials and components; Logistics; On-sites cleaning and environments第45頁/共65頁第四十五頁，編輯于星期六：十八點 二十七分。46第46頁/共65頁第四十六頁，編輯于星期六：十八點 二十七分。47第47頁/共65頁第四十七頁，編輯于星期六：十八點 二十七分。48第48頁/共65頁第四十八頁，編輯于星期六：十八點 二十七分。49AUDITORS MEETING Compilation of findings/observations Recording of non-conformities Prepara

37、tion of summary report Formation of opinion to be presented at closing meeting第49頁/共65頁第四十九頁，編輯于星期六：十八點 二十七分。50Generating audit findingsEither conformity or non-conformitySort out isolated or systemic deficiencies Isolated deficiency: Tends to happen randomly; no meaningful pattern; rarely happensSy

38、stemic deficiency:Could be connected to a particular process, product, material, person or organisation; shows pattern; happens more than onceAUDITING ACTIVITIES第50頁/共65頁第五十頁，編輯于星期六：十八點 二十七分。51ISOLATED VERSUS SYSTEMIC DEFICIENCY NON CONFORMANCE DEFICIENCIES ISOLATEDSYSTEMICLatex gloves ripSOP contai

39、ns 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 machine of eye shadow burns outPreventi

40、ve maintenance program does not include liquid filling machine motor第51頁/共65頁第五十一頁，編輯于星期六：十八點 二十七分。52The audit finding can be classified into 2 groups:1. Compliance :a. Satisfactory /Adequateb. Outstanding2. Non-compliance :a. Critical deficiencyb. Major deficiencyc. Minor deficiencyAUDIT MONITORING

41、第52頁/共65頁第五十二頁，編輯于星期六：十八點 二十七分。53ObjectivesAudit scopeIdentification of audit team leader and membersDate and place where the on-site audit activities were conductedAudit criteria and findingsConclusions AUDIT REPORT第53頁/共65頁第五十三頁，編輯于星期六：十八點 二十七分。54Typical closing meeting agenda Introductions and re

42、cording of attendance Thank the auditee Mention the principles of sampling followed during the audit Summarize audit observations(positive, general observations and nonconformities) Give non conformities in details第54頁/共65頁第五十四頁，編輯于星期六：十八點 二十七分。55Typical Closing Meeting Agenda Present overall summar

43、y and conclusions Allow for discussion Request corrective actions and corrective action dates Agree on follow-up date Close meeting第55頁/共65頁第五十五頁，編輯于星期六：十八點 二十七分。56第56頁/共65頁第五十六頁，編輯于星期六：十八點 二十七分。57NoclauseFindingsGradingLocationAuditeeAuditor1.2.1.1Production and QC departments are headed by the sam

44、e personCriticalHuman ResourcesAbasBudi2.4.3Monitoring of temperature in a warehouseMajor or MinorWarehouseTutiMay Lin311.1Inadequate control over sub-contractorMajor or MinorProductionHermanIdaAUDIT REPORT: AN EXAMPLE第57頁/共65頁第五十七頁，編輯于星期六：十八點 二十七分。58REPORTING 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 summarized第58頁/共65頁第五十八頁，編輯于星期六：十八點 二十七分。59REPORTING OF AUDITSReport should cover