Follow
OBJECTIVE To review the Quality Management System implementation status and to plan for resolving any outstanding issue and for closing the gaps.
SCOPE This SOP is applicable for holding Quality Management Review meeting system in (Company Name).
RESPONSIBILITY
1. Team members of concerned departments shall attend the meeting to present their current status, proposals, views, observations and recommendations for improvement of current quality management system.
2. Secretary will coordinate the meeting.
3. Chairman will chair the meeting.
4. QA shall be responsible for effective implementation of the procedure.
ACCOUNTABILITY : Head of Quality
PROCEDURE :
*** A meeting for review of quality management system will be held twice in a year.
*** Representative from QA, QC, Production, Engineering, Warehouse, Training, R&D and HR will attend in the meeting.
*** Secretary of meeting will ask for meeting agenda from the team members and make final agenda.
*** To review current status of Quality Management System the participants should –
*** Review minutes of previous meeting, status and issues of changes, non-conformance, deviations and CAPAs that are under implementation. For any outstanding issues suggested actions to be recorded.
*** Review Quality audit findings and review status by both external agencies (including regulatory authority) and self-inspection team and corrective actions arising out of those.
*** Review of previously scheduled training effectiveness.
*** Review and agree validation action plan.
*** Review vendor audit status.
*** Review the status and trends obtained from record of critical parameter of environment, utility (water, compressed air and nitrogen gas) temperature and humidity, microbial count, particle count (sterile facility) etc.
*** Review the status of previous market complaints and corrective action taken to minimize if any potential risk (if any).
*** Review repeated incidence report(s).
*** Review repeated raw & packaging material discrepancy report(s).
*** Review of OOS/Atypical reports, stability study issues and material & product rejection.
*** Review of maintenance & calibration status.
*** After the meeting, Secretary of meeting will prepare the minutes of meeting and circulate to all participants copying to Managing Director & COO.
*** Secretary will preserve all records related to the meeting.
