Quality Management System(QMS)
13
Quality Management System(QMS)
A quality management system QMS is the key procedure to maintain quality, traceability and Integrity of product, facility, equipment etc.
?
Principles of Quality Management
Procedure
- Customer focus
- Relationship Management
- Leadership
- People involvement
- Evidence-based decision making
- Continual improvement
- Process approach
Principle
Explanation
Change Control Management
Change Control Management
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state
Steps of Change Control
Classification
Major change
Critical change
Minor change
Minor change is a change that has minimal potential to have an adverse effect on identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
Major change is a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product
Critical change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as they may relate to the safety or effectiveness of the product.
Motives for change control
Motives
- Experiences from developmental and transfer phases.
- Results of process monitoring and statistical process control.
- Finding from quality control and stability results.
- Continuous improvement processes and processes optimization.
- Strategic consideration (changing suppliers, product transfer).
- CAPA processes.
- Customer requests.
- Regulations (legal change and official requirements)
Implementation of change
Final assessment after Implementation
Deviation Controlling System
A deviation is an activity performed or occurred either planned or unplanned in a different or modified form from specified manner.
Deviation divided into two parts planned Deviation and unplanned Deviation
Deviation Controlling System
Source of Deviation
Other
Inadequate documentation
Operator Error
Source of Deviation
Process Error
Equipment Breakdown
Process flow diagram for deviation management
Corrective Action & Preventive Action
Corrective Action & Preventive Action
Corrective Action: Action to eliminate the reason of a detected non-conformity or undesirable situation.
Preventive Action: Action to eliminate the reason of a potential non-conformity or other undesirable situation. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent reocurrence.
- Problem solving
- Actual root cause determine
- Criticality Classification (Critical/Major/Minor)
- Time scale for resolving the issue & scope.
Objective
RESPONSIBILITIES
1. Concern Department
2. Quality Assurance Department
3. Deputy Manager Quality Assurance
4. Head of Quality Assurance
RESPONSIBILITIES
PROCEDURE
General Instruction
1. The concern Department will submit the source document of CAPA to QA Department.
2. After reviewing, the source documents (Change Control, Deviation etc.) QA Head will give the decision whether CAPA is required or not.
3. If CAPA required, QA Department will record the source document name, source document no., initiating date, initiating department, description of CAPA etc. on the CAPA form (F/NP/QA/062).
PROCEDURE
PROCEDURE
- Follow up of Effectiveness of CAPA:
Follow up of effectiveness of CAPA will be done for specific duration as per the requirement.
- Review of Effectiveness of CAPA:
Effectiveness of CAPA will be reviewed by Manager, QA.
- Documents Update & Training:
Documents upgradation & training (if needed) will be provided by respective department.
- Closing of CAPA:
CAPA will be closed by representative of QA mentioning Closing Date & Remarks. Finally QA Head will approve the CAPA.
Investigation:
- QA Department will compose an investigation team for the respective CAPA. investigation team will investigate the deviation and identify the root cause accordingly.
- Identification of Action Needed:
Identification of action needed will be determined as per the recommendations of investigation team.
- Action Implementation Review:
Action Implementation will be verified by QA and reviewed by the Head of respective Department. If the CAPA not completed on target date, justification must be recorded.
- Distribution of CAPA:
QA Department will distribute the copy of completed CAPA form to respective departments as per requirement.
General Flow to handle OOS event
Out of specifications(OOS) means that the test results for sample do not meet the accepted established criteria. These criteria may be set by either an official compendia, by organization or by the testing laboratory
Out of specification
Market Complaint / Customer Complaint
Error can be caused by human or machinery
Human error in manufacturing
Test analysis error in QC lab
Production equipment malfunctioning
Lab equipment malfunctioning
Evaluation can be done by Investigation Phase I & Phase II (EU & WHO), while UK-MHRA guideline gives its investigation as Phase-I, Phase-II & Phase –III.
General Flow to handle OOS event is as below:
- Requisition to be send to QA for OOS Form Issuance
- QA will allot the respective no.
- QA will Issue the Form with filled details like OOS No., Initiation Date, Form Issued by & received by, Brief description of event.
- QC Senior / head along with QA start Investigation in Phase –I (Re- Measurement & Repeat Analysis of Sample)
- If error identify in Phase-I then CAPA is generated and OOS shall be closed with remarks.
- If error is not identified in Phase-I then go for Phase-II & Phase-III (If applicable).
- Investigation of Phase II & Phase III (if applicable)
- Phase II Investigation includes Re-sampling, Different Analyst, Different System, Out Side Analysis etc. as per SOP.
- Then Evaluation of Investigation
- Initiation of CAPA
- Closing of complaint with remarks.
Any complaint, written or verbal, received directly from the customer, retailer, distributor, field staff or any Government Agencies regarding purity, labeling defects, shortages etc. such complaints shall be considered as a market complaint.
Complaints shall be divide into three categories on the basis of criticality;
- Critical Complaints
- Major Complaints
- Minor Complaints
Product Recall
- Stop the distribution and sale of the affected product.
- Effectively notify management, customer and regulatory authority.
- Efficiently remove the affected product from the market place, warehouse and distribution area.
- Dispose and conduct a root cause analysis and report the effectiveness of the recalls.
- Implement a corrective action plan to prevent another recall.
Product Recall
Class I Recall
Class II Recall
Class III Recall
As per ICH Q9,
A systematic process for assessment control communication and review of risk to the quality of the drug product across the product life cycle.
Risk Management
Conclusion
Risk Management is now a day’s basic requirements for organizations and in fect Risk Management is also part of ISO 9001:2015 quality standard.
Every action has an equal reaction and when you take an attitude full of uncertainties in to a project, process, activity you taking risk.
The role of risk management process is to ensure that these project, process, activity questions don’t cause future harm by maximizing all the good points and opportunities.