Follow
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.
