《ISO13485：2016忠告性通知控制程序-英文版.pdf》由会员分享，可在线阅读，更多相关《ISO13485：2016忠告性通知控制程序-英文版.pdf（2页珍藏版）》请在taowenge.com淘文阁网|工程机械CAD图纸|机械工程制图|CAD装配图下载|SolidWorks_CaTia_CAD_UG_PROE_设计图分享下载上搜索。
1、HMIQP-1000 - Advisory Notice and RecallRevision NEW Page of 2Copyright ? 2016 Honeycutt Manufacturing, IncorporatedHMIQP-1000 - Advisory Notice and Recall - Revision NEW1The information contained in this document is the property of Honeycutt Manufacturing, Inc. and is strictly confidential. This inf
2、ormation is not to be shared with anyone outside of Honeycutt Manufacturing, Inc. without prior written approval from management. Any dissemination, distribution, or copying of any of the information herein, either in part or whole, is strictly prohibited.TitleSignatureDateDocument OwnerProduction M
3、anagerOriginal On File03/01/2016Management RepresentativeSales ManagerOriginal On File03/01/2016AUTHORIZATIONS1.0 PURPOSEThe purpose of this procedure is define the actions taken for an advisory notice & recall. The procedure described herein complies with AS9100 and ISO 13485.2.0 SCOPEThis procedur
4、e starts at the time of nonconforming product discovery. The procedure will continue until all product issues are resolved and/or all product is replaced with product that conforms to customer and regulatory requirements.3.0 GENERALThe Quality Assurance Manager and Sales Manager will oversee and man
5、age the advisory notice and recall procedure. An advisory notice and recall may be issued when a nonconforming product is discovered after shipment. The Quality Assurance Agent will determine the nature and seriousness of the nonconformity. The nonconformance report and corrective action will be sta
6、rted by a Quality Assurance Agent. The Quality Assurance Manager will draft an advisory notice. A Sales Manager will send an advisory notice to all affected customers. All control, review, and approval is controlled per the flow chart at the end of this procedure document.4.0 REFERENCE DOCUMENTS? Ho
7、neycutt Manufacturing, Inc. Quality System Manual (Sec. 8.5.1)? AS9100? ISO 134855.0 RESPONSIBILITY? Quality Assurance Manager? Sales Manager6.0 REVISIONRevisionDateChange(s)NEW03/01/16Initial ReleaseHMIQP-1000 - Advisory Notice and RecallRevision NEW Page of 2Copyright ? 2016 Honeycutt Manufacturin
8、g, IncorporatedHMIQP-1000 - Advisory Notice and Recall - Revision NEW2QAQuality Assurance AgentDecisionStart / EndProcessOOriginating AgentBlack circle icons indicate the process owner or decision owner. They imply continuation of ownership for all proceeding processes and decisions until a process
9、or decision with a different owner is encountered while following the chart flow.SMSales ManagerQMQuality ManagerStartNonconformity of product is discovered and QualityAssurance Agent is notifiedDetermine nature and seriousnessof the hazard or non-conformity and the failure to meet regulatory requir
10、ements (as applicable)Create Nonconformance Report Form (QMSF-0017)Advisory Notice is requiredYesNoEndCorrective action is requiredYesNoFollow procedure Corrective Action (HMIQP-1009)Record applicable information and file relevant paperwork on network (as required)Indicate why corrective action is unnecessary on in-process Nonconformance Report Form (QMSF-0017)Issue Advisory Notice and distribute to Sales AgentSend Advisory Notice to customerQAOSMQM