AS9100纠正和预防措施程序英文版

1.0PURPOSE1.1.The purpose is to provide a procedure for identifying Nonconformances and potentialNonconformances, investigating the cause, determining and taking actions to eliminatethe cause and follow-up activities to ensure agreed actions were taken and effective.2.0SCOPE2.1This procedure applies to all Nonconformances and potential Nonconformancesidentified within the Quality Management Systems.3.0RESPONSIBILITY3.1The Management Representative, or delegate, is responsible for:∙Assigning CAR numbers∙Assigning responsibility to investigate the cause and recommend action to be taken∙Reviewing cause, recommended action and implementation schedule for adequacy∙Assigning Internal Auditors to verify implementation and effectiveness of CARs∙Forwarding copy of closed CARs to the Observer∙Maintaining CAR database and copies of CARs∙Analyzing appropriate information in order to detect opportunities for preventive action3.2The appropriate personnel are responsible for investigating the cause ofnonconformance/potential nonconformance, recording the results of the investigation,recommending appropriate action, implementing agreed action and applyingsufficient controls to ensure action is effective.3.3The Observer of a nonconformance/potential nonconformance is responsible fororiginating a CAR and forwarding to the Management Representative.3.4The Internal Auditor is responsible for verifying that agreed action has beenimplemented and is effective.4.0GENERAL4.1The Management Representative forwards a CAR to the supplier when it isdetermined that the supplier is responsible for the root cause. If the supplier isinternal, the CAIR process is used.5.0DEFINITIONS5.1Potential Nonconformance: The prediction that conditions exist which may lead to anonconformance unless action is taken.5.2Nonconformance: The nonfulfillment of a requirement. Examples include:5.2.1The absence of a procedure required by the Quality Management System.5.2.2Failure to effectively implement a procedure required by the QualityManagement System.5.2.3 A confirmed customer complaint.5.2.4An out of calibration instrument or measuring device.5.2.5 A rejected product.5.2.6 A quality systems violation.5.3Corrective Action: action taken to eliminate the cause of a detected nonconformanceor other undesirable situation. Corrective actions prevent recurrence.5.4Preventive Action: action taken to eliminate the cause of a potential nonconformanceor other undesirable potential situation. Preventive actions prevent occurrence.5.5Observer: anyone observing a nonconformance/potential nonconformance orreceiving a customer complaint.5.6Immediate Action: corrective or preventive as appropriate to eliminate the cause of anonconformance/potential nonconformance in order to prevent recurrence/occurrence.5.7Root Cause: Underlying reason of why the discrepancy occurred, determined asresults of an investigation of the product, process and/or quality system.5.8Corrective Action Verification: Activity undertaken immediately afterimplementation of root cause correction to verify implementation5.9Follow-Up: Planned activity to determine if implemented root cause corrective actionis effective and being adhered to.5.10CAR – Corrective Action Request generated from any nonconformance.6.0PROCEDURE6.1The Observer of a nonconformance/potential nonconformance originates a QPF1400-1 CAR form by completing the detail section of the CAR. The Observer providessufficient details of the nonconformance/potential nonconformance to permit aneffective investigation of the cause.6.2The Observer forwards the CAR to the Management Representative.6.3The Management Representative reviews the details provided to ensure they aresufficient and request additional details as appropriate.6.4The Management Representative assigns a CAR number and other information suchas reference, procedure number, requirement section number, etc. as appropriate in the database.6.5The Management Representative assigns responsibility for investigating the cause ofthe nonconformance/potential nonconformance and forward a copy of the CAR to that individual.6.6The assigned individual investigates the cause of the nonconformance/potentialnonconformance, record the results of the investigation, recommend appropriateaction to be taken and forward the completed CAR to the Management Representative.6.7The Management Representative reviews the completed CAR to determine if thecause, recommended action and schedule for implementation are appropriate to the effects of the nonconformance encountered. The Management Representative re-issues using QPF 1400-2 for additional effort if the cause, recommended actions or schedule for implementation are considered inadequate.6.8The Management Representative assigns an Internal Auditor to verify that the agreedaction was taken and was effective. The Management Representative closes the CAR if no action is recommended.6.8.1The Internal Auditor closes the CAR if the agreed action is verified asimplemented and effective and forwards the CAR to the ManagementRepresentative.6.8.2The Internal Auditor returns the CAR to the Management Representativeif the agreed action was not implemented or could not be verified aseffective.6.8.2.1The Management Representative reassigns the ineffective CARrequesting additional information.6.9The Management Representative forwards a copy of each closed CAR to the Observerand update the database to reflect the status of CARs.。