AS9100纠正和预防措施程序英文版

1、Subject:CORRECTIVE AND PREVENTIVE ACTIONRev. AQP 14001 of 51.0 PURPOSE1.1. The purpose is to provide a procedure for ide ntify ing Noncon forma nces and pote ntial Noncon forma nces, in vestigat ing the cause, determ ining and tak ing actions to elimi nate the cause and follow-up activities to en su

2、re agreed actions were take n and effective.2.0 SCOPE2.1 This procedure applies to all Noncon forma nces and pote ntial Noncon forma nces ide ntified within the Quality Man ageme nt Systems.3.0 RESPONSIBILITY3.1 The Man ageme nt Represe ntative, or delegate, is resp on sible for:* Assig ning CAR nu

3、mbers* Assig ning resp on sibility to inv estigate the cause and recomme nd acti on to be take n* Review ing cause, recomme nded acti on and impleme ntati on schedule for adequacy* Assig ning In ternal Auditors to verify impleme ntati on and effective ness of CARs* Forwardi ng copy of closed CARs to

4、 the Observer* Mai ntai ning CAR database and copies of CARs* An alyz ing appropriate in formati on in order to detect opport un ities for preve ntive acti on3.2 The appropriate personnel are responsible for investigating the cause of noncon forma nce/pote ntial noncon forma nee, record ing the resu

5、lts of the inv estigatio n, recommending appropriate action, implementing agreed action and applying sufficie nt con trols to en sure acti on is effective.3.3 The Observer of a noncon forma nce/pote ntial noncon forma nee is resp on sible for origi nati ng a CAR and forwardi ng to the Man ageme nt R

6、eprese ntative.3.4 The Internal Auditor is responsible for verifying that agreed action has been impleme nted and is effective.4.0 GENERAL4.1 The Man ageme nt Represe ntative forwards a CAR to the supplier whe n it is determ ined that the supplier is resp on sible for the root cause. If the supplier

7、 is intern al, the CAIR process is used.5.0 DEFINITIONS5.1 Pote ntial Noncon forma nee: The predictio n that con diti ons exist which may lead to a noncon forma nee uni ess acti on is take n.5.2 Noncon forma nee: The non fulfillme nt of a requireme nt. Examples in clude:Subject:CORRECTIVE AND PREVEN

8、TIVE ACTIONRev. AQP 14002 of 55.2.1 The abse nee of a procedure required by the Quality Man ageme nt System.522 Failure to effectively impleme nt a procedure required by the Quality Man ageme nt System.5.2.3 A con firmed customer compla int.5.2.4 An out of calibration instrument or measuring device.

9、5.2.5 A rejected product.5.2.6 A quality systems violation.5.3 Corrective Acti on: acti on take n to elimi nate the cause of a detected noncon forma nee or other un desirable situati on. Corrective actions preve nt recurre nee.5.4 Preve ntive Actio n: actio n take n to elimi nate the cause of a pote

10、 ntial noncon forma nee or other un desirable pote ntial situati on. Preve ntive actions preve nt occurre nee.5.5 Observer: anyone observ ing a noneon forma nce/pote ntial noneon forma nee or recei ving a customer compla int.5.6 Immediate Action: corrective or preve ntive as appropriate to elim in a

11、te the cause of a noneon forma nce/pote ntial noneon forma nee in order to preve nt recurre nce/occurre nee.5.7 Root Cause: Underlying reason of why the discrepancy occurred, determined as results of an in vestigati on of the product, process an d/or quality system.5.8 Corrective Action Verification

12、: Activity undertaken immediately after impleme ntati on of root cause correcti on to verify impleme ntati on5.9 Follow-Up: Planned activity to determine if implemented root cause corrective action is effective and being adhered to.5.10 CAR -Corrective Actio n Request gen erated from any noneon form

13、a nee.&0 PROCEDURE6.1 The Observer of a noneon forma nce/pote ntial noneon forma nee orig in ates a QPF1400- 1 CAR form by complet ing the detail secti on of the CAR. The Observer provides sufficie nt details of the noneon forma nce/pote ntial noneon forma nee to permit an effective inv estigati

14、 on of the cause.Subject:CORRECTIVE AND PREVENTIVE ACTIONRev. AQP 14003 of 56.2 The Observer forwards the CAR to the Man ageme nt Represe ntative.6.3 The Man ageme nt Represe ntative reviews the details provided to en sure they are sufficie nt and request additi onal details as appropriate.6.4 The M

15、an ageme nt Represe ntative assig ns a CAR nu mber and other in formatio n such as refere nee, procedure nu mber, requireme nt sect ion nu mber, etc. as appropriate in the database.6.5 The Man ageme nt Represe ntative assig ns resp on sibility for inv estigati ng the cause of the noncon forma nce/po

16、te ntial noncon forma nee and forward a copy of the CAR to that in dividual.6.6 The assig ned in dividual inv estigates the cause of the noncon forma nce/pote ntial noncon forma nee, record the results of the inv estigati on, recomme nd appropriateacti on to be take n and forward the completed CAR t

17、o the Man ageme nt Represe ntative.6.7 The Man ageme nt Represe ntative reviews the completed CAR to determ ine if the cause, recomme nded acti on and schedule for impleme ntati on are appropriate to the effects of the noncon forma nee encoun tered. The Man ageme nt Represe ntative reissues using QP

18、F 1400-2 for additional effort if the cause, recommended actions or schedule for impleme ntati on are con sidered in adequate.6.8 The Man ageme nt Represe ntative assig ns an In ternal Auditor to verify that the agreed acti on was take n and was effective. The Man ageme nt Represe ntative closes the CAR