- OBJECTIVE:
To lay down a Procedure for Quality Management Review.
- SCOPE:
This SOP is applicable for Quality Management Review at {Company Name} {Company Location}.
- RESPONSIBILITY:
- SENIOR MANAGEMENT: CORPORATE OFFICE
- To design or lay down the quality system and Quality Policy.
- Responsible to review and evaluate the review report generated by Plant management.
- To advice or authorize the corrective actions to be taken, if any.
- PLANT MANAGEMENT: ALL DEPARTMENT HEADS
- To participate in the implementation and monitoring of Quality System and Quality Policy.
- To ensure timely and effective communication to Senior Management.
- To conduct periodic review of process performance, Quality System and submission of the review report to senior management.
- Follow up and implementation of suggestion or corrective actions suggested by senior management.
- ACCOUNTABILITY:
Head QA shall be accountable for implementation of this SOP.
- PROCEDURE:
- {Company Name} shall have a Quality Management Review Team, which shall be lead by Head QA.
- The team shall have members from every department and shall include the Production Head, Warehouse Head and Quality Control Head & Engineering Head.
- Depending on the need, concerned officer/executive other than the members may also participate in the Quality Management Review.
- The quality management review meeting shall be conducted once in a Month ± 7 days or as and when required. The quality management review shall be performed as per Annexure-I
- The management review meetings shall include information on the following:
- Process performance and product conformity.
- External quality audits.
- Review of complaint investigations.
- Review of Deviations, Batch Failures Rejections (RM, PM) and their CAPA.
- Review of suppliers and related issues.
- Review of training and training needs.
- Review of major changes that could affect the Quality.
- Follow- up actions from previous management reviews.
- Review of internal audits/Self Inspection.
- Review of pest control trends.
- Recommendations for improvement, consideration for updating the quality system due to new technologies, market strategy and social and / or environmental conditions.
- All the findings, conclusions, recommendations, and preventive action drawn as a result of the review shall be evaluated and agreed by all the unit quality management representatives.
- Quality assurance head shall approve all the proposed changes in the quality management review.
- The summary of findings and the action plan with the recommendations shall be sent to the senior management for their suggestions, advice and comments as per Annexure-I.
- Suggestions and corrective actions of Senior Management Review team shall be implemented by unit Quality Management team.
- Unit management shall discuss, make action plan, and verify implementation of the recommendations suggested by senior management during subsequent quality review meetings.
- REFERENCES:
Not Applicable.
- ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE | FORMAT No.
|
| Annexure- I | Quality management review report | QA-006/F01-00 |
| Annexure- II | Quality management review Planner | QA-006/F02-00 |
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Quality Control
- Controlled Copy No. 03 : Head Production
- Controlled Copy No. 04 : Head Engineering
- Controlled Copy No. 05 : Head Human Resource
- Controlled Copy No. 06 : Head Warehouse
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| SOP | : | Standard Operating Procedure |
| No. | : | Number |
| cGMP | : | Current good manufacturing practices |
| QA | : | Quality Assurance |
| CAPA | : | Corrective and preventive action |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Introduction of New SOP | To Be enter manual |
ANNEXURE-I
| {COMPANY NAME}
{COMPANY LOCATION} QUALITY ASSURANCE DEPARTMENT |
|
| QUALITY MANAGEMENT REVIEW REPORT | |
Plant Location: Month & Year:
| 1.0 | HIGHLIGHTS (Developments / Achievements / Incidents) |
| Concerns: | |
| 2.0 | AUDIT(S) [Include Regulatory & Customers] | ||||||||
| 2.1 | AUDIT(S) [Regulatory] | ||||||||
| No. of audits: | No. of Audits (YTD): | ||||||||
| Date of Audit | Name of Auditor(s)/Agency | No. of Observations | Compliance status | Action Plan | Response status with TCD | ||||
| Critical | Major | Minor | |||||||
| 2.2 | AUDIT (S) [Customers] | ||||||||
| No. of audits: | No. of Audits (YTD): | ||||||||
| Date of Audit | Name of Auditor(s)/Agency | No. of Observations | Compliance status | Action Plan | Response status with TCD | ||||
| Critical | Major | Minor | |||||||
| 2.3 | SELF INSPECTION OR INTERNAL AUDIT | |||||||
| Date of self-inspection | Name of Department | No. of Observations observed during inspection | Compliance status | Action Plan | Response status with TCD | |||
| Critical | Major | Minor | ||||||
| Quality Assurance | ||||||||
| Quality Control | ||||||||
| Human Resources | ||||||||
| Warehouse | ||||||||
| Engineering | ||||||||
| Production | ||||||||
| 3.0 | QUALITY CONTROL ANALYSIS SUMMARY | ||||||
| No. of Material
Received |
No. of batches Sampled | No. of samples
Analyzed & approved |
No of samples Rejected | No of samples pending analysis | No. of sample carried forward | Remarks | |
| Raw Material: | |||||||
| Packaging Material: | |||||||
| Water Sample (Routine rinse water & Cleaning validation sample): | |||||||
| Intermediate/In- Process Sample: | |||||||
| Finish Product Sample: | |||||||
| Stability Sample: | |||||||
| Any other miscellaneous Sample: | |||||||
Note: The carried forward sample means the pending samples from the previous months.
| 4.0 | QUALITY CONTROL REJECTION DETAILS | |||||||||||||||||||||||||||||||||||||||||
| 4.1 | RAW MATERIAL REJECTION | |||||||||||||||||||||||||||||||||||||||||
| Sr. No. | Materials / Vendor | Reason for Rejection | Containers / Qty. (No.) | Tick ( √ ) On Appropriate Action | ||||||||||||||||||||||||||||||||||||||
| Received | Rejected | Vendor Deregistered | Communication Sent | No Action | ||||||||||||||||||||||||||||||||||||||
| 4.2 | PACKAGING MATERIAL REJECTION | |||||||||||||||||||||||||||||||||||||||||
| Sr. No. | Name of Materials & Vendor | Reason for Rejection | Containers / Qty. (No.) | Tick ( √ ) On Appropriate Action | ||||||||||||||||||||||||||||||||||||||
| Received | Rejected | Vendor Deregistered | Communication Sent | No Action | ||||||||||||||||||||||||||||||||||||||
| 4.3 | IN PROCESS REJECTION | |||||||||||||||||||||||||||||||||||||||||
| Product Name | Batch No. | Batch Size | Reason for rejection | Remarks | ||||||||||||||||||||||||||||||||||||||
| 4.4 | FINISHED PRODUCT REJECTION | |||||||||||||||||||||||||||||||||||||||||
| Product Name | Batch No. | Batch Size | Reason for rejection | Remarks | ||||||||||||||||||||||||||||||||||||||
| 5.0 REVIEW OF PEST CONTROL TRENDING | ||||||||||||||||||||||||||||||||||||||||||
| ID No. of Fly killer | Maximum No. of Fly insects observed | No. of Fly insects cross the action limit | No. of Fly insects cross the alert limit | Action Plan | Remarks | |||||||||||||||||||||||||||||||||||||
| 6.0 | QUALITY SYSTEMS | |||||||||||||||||||||||||||||||||||||||||
| 6.1 | DEVIATIONS | |||||||||||||||||||||||||||||||||||||||||
| Number of Deviations | YTD | Avg. | No. of Deviation open YTD | No. of Deviation closed YTD | ||||||||||||||||||||||||||||||||||||||
| Deviation Number | Date of Deviation | Details of Deviation(s) | Corrective / Preventive Action(s) applied (CAPA) | |||||||||||||||||||||||||||||||||||||||
| 6.2 | INCIDENT | |||||||||||||||||||||||||||||||||||||||||
| Number of Incidents | YTD | Avg. | No. of Incidents open YTD | No. of Incidents closed YTD | ||||||||||||||||||||||||||||||||||||||
| Incidents Number | Date of Incidents | Details of Incident (s) | Corrective / Preventive Action(s) applied (CAPA) | |||||||||||||||||||||||||||||||||||||||
| 6.3 | CHANGE CONTROL | |||||||||||||||||||||||||||||||||||||||||
| Number of Change controls | YTD | Avg. | No. of Change controls open YTD | No. of Change controls closed YTD | ||||||||||||||||||||||||||||||||||||||
| Change control Number | Date of Change control | Details of Change control (s) | Activities planned | |||||||||||||||||||||||||||||||||||||||
| 6.4 | CUSTOMER COMPLAINTS | |||||||||||||||||||||||||||||||||||||||||
| Number of Complaints | Avg. | YTD | ||||||||||||||||||||||||||||||||||||||||
| Received | ||||||||||||||||||||||||||||||||||||||||||
| Pending for Closure | ||||||||||||||||||||||||||||||||||||||||||
| Complaint Number | Date, Complaint logged on | Complaint detail | Investigation status | Action planned | Remark | |||||||||||||||||||||||||||||||||||||
| 6.5 | CAPA ACTIVITY | |||||||||||||||||||||||||||||||||||||||||
| No. of CAPA initiated in the month | No. of CAPA Closed | No. of CAPA open | No. of CAPA YTD | |||||||||||||||||||||||||||||||||||||||
| Status of open CAPA | ||||||||||||||||||||||||||||||||||||||||||
| CAPA in brief | Date Initiated | Investigation Status | Activities planned | |||||||||||||||||||||||||||||||||||||||
| 6.6 | SOPs | |||||||||||||||||||||||||||||||||||||||||
| QA: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| QC: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| Human Resource: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| Production: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| Engineering: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| Warehouse: | ||||||||||||||||||||||||||||||||||||||||||
| No. of new SOPs prepared | No. of SOPs revised | No. of SOPs under review | No. of SOPs Implementation | No. of new SOP prepared YTD | No. of SOPs revised YTD | |||||||||||||||||||||||||||||||||||||
| 7.0 | Documentation | ||
| 7.1 | Documents Issued | ||
| Name of Documents | Total No. | Remarks | |
| Issuance of log books , Registers and formats
Validation Protocol BMR BPR Specification SOP |
|||
| 7.2 | Documents Preparation: | |
| Sr. No. | Documents | Details |
| 1.
2. 3. 4. 5. 6. 7. 8. |
Batch Manufacturing Record
Batch Packing Record Process Validation Protocols Process Validation Report Master Formula Record
Hold time study Protocol Hold time study Report Standard Operating Procedure |
|
| 8.0 | Status of Validation/Qualification | |||||||||||||||
| 8.1 | Process Validation | |||||||||||||||
| Sr. No. | Name of Product | Status of Protocol | No. of Batches manufactured | Report compilation status | Report Approval | Remark | ||||||||||
| 8.2 | Equipment Qualification | |||||||||||||||
| Sr. No. | Name of Equipment | Qualification Status | Status of Protocol | Report compilation status | Report Approval | Remark | ||||||||||
| 9.0 | STATUS OF PRODUCT TRANSFER/METHOD TRANSFER | |||||||||||||||
| 9.1 | Product Transfer | |||||||||||||||
| Sr. No. | Name of product | TT initiation date | Trial/Process validation/ Commercial batch | TT Status | Any failure/
Concern |
Remark | ||||||||||
| 9.2 | Analytical method Transfer | |||||||||||||||
| Sr. No. | Detail of Method | Name of applicable product | Status | Any failure/
Concern |
Remark | |||||||||||
| 10.0 | PRODUCT/ MATERIAL RECALLED / RETURNED / REPROCESSED | |||||
| Product / Material Name | Batch No. | Quantity | Reason(s) | Number of batches YTD | ||
| Recalled | ||||||
| Returned | ||||||
| Reprocessed | ||||||
| 11.0 | YIELD (Loss of productivity on account of low yield | |||||||||||
| Product | Batch No. | Final yield in % | Loss % | #Cost in Rs. | ||||||||
| 12.0 | REQUIREMENT OF EQUIPMENT | |||||||||||
| Department | Name of new equipment required | Nos. | Justification | Budgeted (Yes/ No) | Indent raised on | Approval Status | ||||||
| 13.0 | MAN POWER STRENGTH | ||||||||||||||
| 13.1 | Approved Manpower: | Existing Manpower: | |||||||||||||
| Quality Assurance | Quality Assurance | ||||||||||||||
| Quality Control | Quality Control | ||||||||||||||
| Engineering | Engineering | ||||||||||||||
| Production | Production | ||||||||||||||
| Warehouse | Warehouse | ||||||||||||||
| Human Resource | Human Resource | ||||||||||||||
| 13.2 | Resignation during the month | Joining this month | |||||||||||||
| Sr. No. | Name | Position | Date | Reason | Sr. No. | Name | Band | Date | Replacement (details) / New vacancy | ||||||
| 14.0 | PROGRESS ON SPECIFIC PROJECTS / ISSUES (IF ANY) | ||||||||||||||
| Sr. No. | Project/Issue in brief | Action planned | Status/Progress | Remark | |||||||||||
| 15.0 | NEW INITIATIVE PLANNED (IF ANY) | ||||||||||||||
| Sr. No. | Project/Issue in brief | Action planned | Status/Progress | Remark | |||||||||||
| 16.0 | SPECIFIC PLAN FOR NEXT THREE MONTHS: |
Note : If necessary supporting data can be annexed or hyperlinked
| 17.0 | ABBREVIATION: | |
| YTD : Year to date
TCD : Target completion date CAPA : Corrective and preventive action Avg. : Average TT : Technology transfer |
||
- QUALITY MANAGEMENT REVIEW REPORT
- Review comments, suggestions, advice, and recommendations (if any) by quality management representative:
Signature:
Date:
- Senior management team:
Signature:
Date:
- Quality Management team:
Comments:
Signature:
Date:
FORMAT NO.: QA-006/F01-00 Page No. X of Y
ANNEXURE-II
| {COMPANY NAME}
{COMPANY LOCATION} QUALITY ASSURANCE DEPARTMENT |
|
| QUALITY MANAGEMENT REVIEW PLANNER | |
| Year | ||||||||||||
| Month | Jan | Feb | March | Apr. | May | June | July | Aug. | Sep. | Oct. | Nov. | Dec. |
| QMR Planning date | ||||||||||||
| QMR Execution Date | ||||||||||||
Prepared By Checked By Approved By
Sign/Date Sign/Date Sign/Date
FORMAT NO.: QA-006/F02-00 Page No. X of Y
