Management review meeting | MRM

Rahul Kashyap
1

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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  1. Bhut hi bhdiya Information di hai.This Content help me alot. Simple and Important facts are said.

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