1. 097639-QSY-Understanding Corrective and Preventive Action1

2. Background
As part of the Quality Improvement Plan a single CAPA procedure has been implemented at MPROC.
References:
MPR-CPA-PP – MPROC CAPA Policy
MPR-CPA-WI – Corrective and Preventive Action Process
MPR-CPA-WI – Event Generation
As a result policy MPR will be inactivated and a new procedure, QSY has been created to handle events not escalated to a CAPA.

3. What is the purpose of procedure 097639-QSY?
Defines the process for conducting, documenting, and monitoring, corrective and/or preventive actions resulting from quality events not escalated to formal CAPA as well proactive preventive actions. MPROC CAPA procedures supersede the requirements of this work instruction for those events escalated to a CAPA.

4. Task Planning and Closure
Due dates are assigned according to Timeliness Guidelines established in procedure MPR-CPA-WI These guidelines were previously established in procedure QSY.
Note: Procedure QSY is being inactivated.
Actions identified for those events not escalated to a CAPA (i.e internal audit, nonconforming trending reports, sterilization investigations, management review items etc.) will still using the MPRI Form #2519 unless an electronic system used to close task complies with minimum requirement of this form. (example gAudit, GCAPA)

5. Extensions The Extension Request Form, MPR-CPA-FRM-009017 is required.
- Note: MPR Form #2088 is being inactivated.
Approval requirements remains as is. One extension is allowed per task. The approval of the corresponding area Manager/Business Unit Leader and Manufacturing Director are required.
- Note: Extensions requirements of events escalated to CAPA are governed by MPR-CPA-WI

6. Escalation
Investigation owner, task owner or designee may elevate any corrective/preventive action out of MPROC Villalba site scope in the Management Review, CAPA Board and / or may request ad-hoc management meeting. Actions may include, but are not limited to:
Design Changes
Process Changes
Quality System Changes

7. Overdue Tasks
Note: Subsequent Notifications will be sending to the attention of VP MPROC Operations.

8. Overdue Tasks/Monitoring
Notification memos will apply until release from overdue status is accomplished either by an extension request or completion of actions.
Actions will be monitored thru the Issue Tracking and Status Report.