Quality-System-Auditing质量体系审核学习教案课件.pptx

会计学,1,Quality System Auditing质量体系审核,会计学1Quality System Auditing质量体,2,Outline,Basic conceptions of quality system AuditingPreparation of auditingOn-site auditingAuditing report and follow-up actions,第1页/共65页,2OutlineBasic conceptions of q,3,What is quality audit?,A quality audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled,第2页/共65页,3What is quality audit? A qu,4,Audit criteria,Evidence,Compare,Audit finding,conclusion,How many？,Yes/No？,第3页/共65页,4Audit criteria Evidence Compa,5,Three Key Words,EvidenceCriteriaIndependent,第4页/共65页,5Three Key WordsEvidence第4页/共6,6,Distinction of system audits by parties,1st 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页/共65页,6Distinction of system audits,7,Internal 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 of risk management, control, and governance processes. -Institute of Internal Auditors,第6页/共65页,7Internal Audit An independent,8,Question:What is the difference between third part audit and first part audit (internal audit),第7页/共65页,8Question:第7页/共65页,9,Why Audit?,To determine whether the quality system conforms to specified requirementsTo determine the effectiveness of the implemented systemTo initiate improvements in the system,第8页/共65页,9Why Audit?To determine whethe,10,3 types of audits,Process auditsProduct auditsSystem audits,第9页/共65页,103 types of auditsProcess au,11,PROCESS AUDITS,Evaluation of the contents and effectiveness of specific processes & work activities:To confirm process parameters and improve capability of the processTo ensure the realization the process quality characteristics.To ensure improvement of process control during service provision,第10页/共65页,11PROCESS AUDITSEvaluation of,12,Product Audits,Investigation of product conformance to specified characteristics:To obtain additional neutral assessment of products level of qualityTo obtain additional assurance that specified quality requirements are met,第11页/共65页,12Product AuditsInvestigation,13,Product audits,To identify opportunities for improvement.To establish the quality level of units after final inspection and testingTo establish the capability of the inspection functionTo determine the usefulness of inspections & tests,第12页/共65页,13Product auditsTo identify o,14,System audits,Evaluation of all the elements of the quality system in order to:Verify usefulness, suitability and effectivenessVerify adequate documentationVerify compliance with requirements.Determine weak points,第13页/共65页,14System auditsEvaluation of a,15,Who is an auditor?,A person who has the qualification to perform quality auditsCriteria for quality auditorsEducationTrainingExperiencePersonal Attributes,第14页/共65页,15Who is an auditor?A person,16,Attributes of an auditor,A AnalyticalU Unassuming/unbiasedD DiplomaticI Inquisitive/independentT ThoroughO ObjectiveR - Reliable,第15页/共65页,16Attributes of an auditorA,17,The Audit Process,Plan and prepare the audit50%Carry out the audit30%Reporting and follow-up20%,第16页/共65页,17The Audit ProcessPlan and pr,18,OVERVIEW OF AUDIT ACTIVITES,Planning and scheduling audit,Conducting document review,Conducting audit,Prepare audit report,Conducting follow-up,Preparing for on-site activities,第17页/共65页,18OVERVIEW OF AUDIT ACTIVITESP,19,Forming an audit team and assign roles and responsibility and agreed on the scopeConducting document review Preparing for the on-site audit activities,Review documents (SOPs, audit findings, corrective action/preventive action, etc.), check the integrity of the quality system and various controls are effective,Preparing 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,19Forming an audit team and as,20,AUDIT DOCUMENTATION,Audit report is anofficial document to report the audit findings,Audit planshould be sent 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,20AUDIT DOCUMENTATION Audit,21,AUDIT PREPARATION,Establish audit type and scopeEstablish audit basis it is the standard, manual, procedures or combination of themEstablish 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页/共65页,21AUDIT PREPARATIONEstablish a,22,AUDIT PREPARATION,Read basis documentation as well as previous audit reports and determine what records shall be pulled in advancePrepare process model identifying the expected results of the process to be auditedPrepare an audit plan (or schedule),第21页/共65页,22AUDIT PREPARATIONRead basis,23,AUDIT PREPARATION,Notify 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?,第22页/共65页,23AUDIT PREPARATIONNotify the,24,The Consideration of the Auditing Schedule,1. Auditing Scope2. Operational performance (KPI)3. Customers feedbacks ( e.g complains );4. NCR in last auditing;5. Auditing resources,第23页/共65页,24The Consideration of the Aud,25,An Example of Auditing Schedule,第24页/共65页,25An Example of Auditing Sched,26,Auditing Plan,Based on auditing schedule;Consider the specific scope and purposes;Consider the auditing resources;An daily work assignment;Worked out by leading auditor,第25页/共65页,26Auditing PlanBased on auditi,27,STC/JZ02A 4-1,第26页/共65页,27STC/JZ02A 4-1第26页/共65页,28,Case Study,第27页/共65页,28Case Study第27页/共65页,29,Checklist,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页/共65页,29ChecklistCover all the requi,30,Audit Approach & RouteApproach： Based on dep. Based on processRoute： Forward trace Backward trace,第29页/共65页,30Audit Approach & RouteBased,31,Auditing based on department,Responsibilities,Resourses,6.2 6.3 6.4,Quality objectives,Communications,Process in charge,Clause,Data analysis,8.4,improvement,8.5,Process,第30页/共65页,31Auditing based on department,32,EXAMPLE OF AN AUDIT CHECKLIST,General format for an audit checklist,第31页/共65页,32EXAMPLE OF AN AUDIT CHECKLIS,33,EXAMPLE OF AN AUDIT CHECKLIST,第32页/共65页,33EXAMPLE OF AN AUDIT CHECKLIS,34,MONITORING,第33页/共65页,34INTERNA: AUDIT QUESTIONAIRES,35,PERFORMING THE AUDIT,Before the start of audit:Auditees management informs personnel in the involved departments about expected auditLead auditor and rest of the team must be acceptable to auditee management,第34页/共65页,35PERFORMING THE AUDITBefore t,36,FOUR PHASES OF AN AUDIT,Opening meetingExecution of auditAuditors meetingClosing meeting,第35页/共65页,36FOUR PHASES OF AN AUDITOpeni,37,AUDITING ACTIVITIES,Conducting on-site audit activities,Interviews with different personnelCarry out both horizontal and vertical audits. Focus on safety and quality of product. Use “Trace-back” method,Conduct opening meeting Good communication during the audit Roles of escort and observerSteps in conducting on site audit:,第36页/共65页,37AUDITING ACTIVITIESConductin,38,Typical opening meeting agenda,Introduction of members and observers and recording of those presentConfirm objectives, scope, basis, reasons and benefits of the auditReview of audit planExplanation of the audit method and documentation to be usedExplain the tasks of the accompanying auditees representatives (i.e. guide),第37页/共65页,38Typical opening meeting agen,39,第38页/共65页,39第38页/共65页,40,Execution of audit,THE AUDIT LOZENGE,Ask,Record,Check,Observe,第39页/共65页,40Execution of auditTHE AUDIT,41,EXECUTION OF AUDIT,Must be done according to timetableOnly ask open, factual questionsVerify answer through observationFollow an audit trailDo more listening than talking, 2 ear 1 mouth; therefore listen 2/3 of the time,第40页/共65页,41EXECUTION OF AUDITMust be do,42,Some rules for auditors,Keep calm and relaxedLook at the other person-eye contactKeep discussion factualAsk one question at a timeDo not lectureLet the other person finish talking,第41页/共65页,42Some rules for auditorsKeep,43,Some rules for audit,Keep the right distance from the personBe friendly without being too familiarIf your question causes uneasiness or uncertainty, formulate it differentlyInvolve all participantsUse the right gestures/expressionsKeep personal opinions to yourself,第42页/共65页,43Some rules for auditKeep the,44,AUDITOR SINS,An auditor should neverCompare the auditee with othersBe sarcasticSwearCriticizeBe side trackedArgueDiscuss personalitiesDiscuss religion or politicsDiscuss company policyDrink beer before an interviewBe late,第43页/共65页,44AUDITOR SINSAn auditor shoul,45,Objective evidence,Remember - SHOW MECheck for documents, records, reports, data in computers etcEnsure auditees statements are cross checked by supporting evidence e.g. statements by other personnel with specified authority, records, documentary evidence e.g.,第44页/共65页,45Objective evidenceRemember -,46,Critical Points for checking,Documents and records;Machinery and equipments;Measuring devices;Workers and their operations;Raw materials and components;Logistics;On-sites cleaning and environments,第45页/共65页,46Critical Points for checking,47,第46页/共65页,47第46页/共65页,48,第47页/共65页,48第47页/共65页,49,第48页/共65页,49第48页/共65页,50,AUDITORS MEETING,Compilation of findings/observationsRecording of non-conformitiesPreparation of summary reportFormation of opinion to be presented at closing meeting,第49页/共65页,50AUDITORS MEETINGCompilation,51,Generating audit findingsEither conformity or non-conformitySort out isolated or systemic deficiencies,Isolated 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 once,AUDITING ACTIVITIES,第50页/共65页,51Generating audit findingsIso,52,ISOLATED VERSUS SYSTEMIC DEFICIENCY,第51页/共65页,52ISOLATED VERSUS SYSTEMIC DEF,53,The audit finding can be classified into 2 groups:Compliance :Satisfactory /AdequateOutstandingNon-compliance :Critical deficiencyMajor deficiencyMinor deficiency,AUDIT MONITORING,第52页/共65页,53The audit finding can be cla,54,ObjectivesAudit scopeIdentification of audit team leader and membersDate and place where the on-site audit activities were conductedAudit criteria and findingsConclusions,AUDIT REPORT,第53页/共65页,54ObjectivesAUDIT REPORT第53页/共,55,Typical closing meeting agenda,Introductions and recording of attendanceThank the auditeeMention the principles of sampling followed during the auditSummarize audit observations(positive, general observations and nonconformities)Give non conformities in details,第54页/共65页,55Typical closing meeting agen,56,Typical Closing Meeting Agenda,Present overall summary and conclusionsAllow for discussionRequest corrective actions and corrective action datesAgree on follow-up dateClose meeting,第55页/共65页,56Typical Closing Meeting Agen,57,第56页/共65页,57第56页/共65页,58,AUDIT REPORT: AN EXAMPLE,第57页/共65页,58NoclauseFindingsGradingLocat,59,REPORTING 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 auditEnsure the positive as well as the negative findings are summarized,第58页/共65页,59REPORTING OF AUDITSA standar,60,REPORTING OF AUDITS,Report should cover the 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,第59页/共65页,60REPORTING OF AUDITSReport sh,61,REPORTING OF AUDITS,ISO 19011:2008 includes recommendations for report contentsAudit reports should be kept confidential lest Auditors lose respectAuditees are less willing to identify areas for improvement,第60页/共65页,61REPORTING OF AUDITSISO 19011,62,ANALYSIS OF AUDITS,Management Representative will analyze audit reports to identify areas of common deficiency within QMSThis will initiate changes to the audit scheduleA full analysis of audit reports is presented to management review meeting,第61页/共65页,62ANALYSIS OF AUDITSManagement,63,Corrective Action Follow-up,It is important to ensure that the auditee implements: -Effective correctionEffective corrective actions,第62页/共65页,63Corrective Action Follow-upI,64,CLOSURE,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,第63页/共65页,64CLOSURE Follow-up and closi,65,Q & AThank youFor YourAttention,第64页/共65页,65Q & AThank youFor YourAtt,