After receiving the audit report submitted by the auditors, SCAN PMT (Program Management Team) will review it and assign the CAPAs (Corrective and Preventative Actions) in Connect SCREEN Supplier system to facilities within 17 days based on the non-conformances identified during the audit. Facilities will then receive a "CAPA Action" notification from SCAN@SCRiskSolutions.com.
Facilities are expected to complete the assigned CAPAs within 60-day threshold upon the date they receive the "CAPA Action" notification. Additional 6 automatic CAPA reminders would be sent to them on 5, 10, 15, 30, 45, and 60-day mark until CAPAs are all completed. SCAN audit sharing members will be blind copied in the last 2 reminders to make them aware that CAPAs are not completed yet.
After receiving the submitted CAPAs, SCAN PMT would review the responses within 10 calendar days and determine to accept, reopen, or reject the CAPA responses based on the SCAN CAPA requirements.
In the situation that the submitted CAPAs are reopened and re-assigned due to insufficient responses, facilities will always have at least 14-days to complete the new CAPA round.
SCAN PMT will update the audit status to "Audit Reviewed" after all CAPAs are completed (either accepted or rejected) in the system, which means the whole SCAN audit cycle has been closed. A "CAPA Completed" notification will be sent to the facility notifying the audit expiration date and the availability of the final SCAN report.
审核后,SCAN PMT(项目管理团队)将根据审核员提交的审核报告,于17天内在Connect SCREEN供应商系统中审核和分配CAPA(纠正和预防措施)。工厂将收到来自SCAN@SCRiskSolutions.com的“CAPA行动”通知。
工厂应在收到通知之日起60天内对所有CAPA做出回应。额外的6个自动CAPA提醒将在5、10、15、30、45和60天的时间点发送给工厂,直到CAPA全部完成。SCAN审核共享成员也将收到最后两次的通知邮件,告知他们工厂的CAPA没有完成,并请求支持以推动工厂在60天内完成CAPA。
在工厂对CAPA做出回应并在系统中提交后,SCAN团队将10个自然日内,根据SCAN CAPA要求,通过接受、重开或拒绝CAPA来审查这些响应。
在提交的CAPA因响应不足而重新开放和重新分配的情况下,设施将始终至少有14天的时间来完成新一轮CAPA。
当系统中所有CAPA完成(被接受或被拒绝)后,SCAN PMT将审核状态更新为“Audit reviewed 已审核”,这意味着整个SCAN审核周期已经结束。“CAPA已完成”通知将发送到工厂,通知审核有效日期和最终SCAN报告完成。
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