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1、纠正措施过程的步骤Stepsinthecorrectiveactionprocess序号Action措施C1ause1021requirement1021条款要求1Co11ectthenonconformitydataandc1assify收集不符合数据并进行分类Reviewingandana1ysing评审和分析2ConductParetoana1ysistoidentifythevita1fewandtrivia1manyandeva1uatetheneedforaction进行柏拉图分析,以确定重要的少数和琐碎的多数,并评估采取措施的必要性3Organizeadiagnosticteam
2、组建一个诊断团队Determiningthecauseandextentofnonconformity!1021b)确定原因和不符合程度(Io21b)4Postu1atecausesandtesttheories推测原因并测试理论5Determinetherootcauseofnonconformity确定不符合的根本原因6Determineifsimi1arnonconformitiesexistorcou1dexiste1sewhere确定其他地方是否存在或可能存在类似的不符合的情况7Determinetheeffectsofnonconformityandtheneedforaction
3、确定不符合要求的影响和必要措施Imp1ementinganyactionneeded(1021c)执行必须的措施(102IC)8Determinetheactionneededtopreventnonconformityrecurring确定需要采取的措施,以防止不符合再次发生9Organizeanimp1ementationteam组建一个执行团队10Createorchoosetheconditionswhichwi11ensureeffectiveimp1ementation创造或选择能确保有效实施的条件11Imp1ementtheagreedaction实施商定的措施12Recordt
4、henatureofthenonconformities记录不符合的性质Retaindocumentedinformation(1022)保留文件化信息(1022)13Recordtheresu1tsofParetoana1ysis记录柏拉图分析结果14Recordthecausesofnonconformity记录不符合原因15Recordthecriteriafordeterminingseverityorpriority记录确定严重度或优先级的准则16Recordtheproposedactionstobetaken记录采取的建议措施17Recordtheactionsactua11yt
5、aken记录实际采取的措施18Recordtheresu1tsofactionstaken记录采取措施的结果19Assesstheactionstakenanddetermineiftheywerethoserequiredtobetaken评估所采取的措施,并确定这些措施是否是所需采取的行动Reviewingcorrectiveactions(1021d)评审纠正措施(IO21d)20Determinewhethertheactionswereperformedinthebestway确定执行的措施是否是最佳方法21Determinewhetherthenonconformityhasrecurred确定不符合是否复发22Ifnonconformityhasrecurredrepeatsteps1-22如果不符合复发,重第1-22步骤23Reviewriskassessmentsandopportunitiesandupdateifnecessary评审风险评估和机遇,必要时进行更新Updaterisksandopportunitiesdeterminedduringp1anning(1021e)更新策划期间确定的风险和机遇(1021e)