Purpose
To lay down the procedure for conducting management
review meeting to evaluate effectiveness of Quality management system, and to
identify the area of improvement.
Procedure
- QA Personnel or Designee shall prepare the agenda for management review meetings and share with management review committee.
- Management review committee shall comprise of all HOD’s of different departments like QA Head, QC Head, Production Head, Engineering Head, Warehouse Head, HRD etc.
- QA-Head or designee shall co-ordinate with relevant Heads of other Departments at least one week before date of management review meet.
- Head of Department shall be responsible for preparation of reports along with (Word or Excel format) and submit them to QA Head or Designee.
- The members of management review committee shall provide information /action plan to QA Head w.r.t. improvement in quality management system.
- QA-Person or Designee shall present the current status of quality management system before management review committee to Head-QA.
Following shall be discussed
during management review (But not limited
to):
- Status of previous management review committees meeting points with present state of proposed action plans (executed / ongoing) including target timelines.
- Status of audits (customer / Regulatory agencies) including any overdue CAPAs.
- Annual Product Quality Review (APQR) & recommendations (If any)
- Change Control
- Deviation Management
- Product Complaint
- CAPA
- Out of Specification(OOS)
- Out of Trend (OOT)
- Product Recall / Product Return
- Vendor Qualification / Rejection
- Laboratory Incident
- Raw / Packing Material rejection
- Water Trend
- Stability Study
- Compressed Air Trending
- Batch Re-Processing
- Occupancy Utilization
- Trend of Yield
- Training
- Safety
Other information can also be
included like;
- Need of resources. (E.g. Resources in-terms of manpower, facility, equipment & instrument etc.)
- Realignment of resources. (E.g. Job rotations, transfer of equipment & instrument etc.).
- Graphical representation shall be done for Change Control, Deviations, Product Complaint, OOS, Laboratory Incidence, rejections, CAPAs with timelines, Water Trends, Stability Trends & Yield Trend for better understanding & clarity.
- The members of management review committee may propose action plan to Quality Assurance & Managing Director as a part of continual improvement / Customer or Internal Audit findings and to improve quality system (if any).
- Proposed action plan shall include supporting evidence that will provide a reference as to why the proposed action plan is necessary and why it is considered to be appropriate.
- QA Head shall take follow up for approval / rejection of proposed action plan.
- QA Head shall update the current status of approved action plans (executed / Ongoing) including target timelines and responsible persons to Managing Director.
- After submission of complete reports by all concerned department’s QA shall prepare the final Management Review Report .
Frequency of management review
meeting:
- Management Review meeting shall be conducted on first week of every quarter (third month).
- The status on action plan with target timelines of first quarter shall be reviewed in second quarter of same year.
- The status on action plan with target timelines of all quarter shall be reviewed in first quarter of next succeeding year.
- The Management review meeting shall be conducted as per schedule. Any deviation shall be recorded with suitable justification.
- Management Review Report shall be kept confidential and shall be used as internal tool for quality improvement.
- Personnel QA or Designee shall prepare minutes of meeting in Microsoft word document and shall send to all concerned HODs with 07 working days after management review meeting.
- Concerned HOD may initiate their action immediate after close out of Management Review Meeting.
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