Quality Management System(QMS)

Quality Management System (QMS) is a set of procedures and practices that contribute to product quality. It targets individual processes and personnel involved in product manufacturing and prevents them from drifting away from quality standards.

THESE PROCEDURES INCLUDES:
  • Change control
  • Deviation
  • CAPA
  • Market complaints
  • Lab incidents
  • Out of Specification (OOS)
  • Out of Trend (OOT)
  • Internal audits
  • Vendor Qualifications
CHALLENGES:
  • When handled manually, there are high chances of human errors.
  • Getting approvals from various individuals cannot be done on timely basis which leads to delay.
  • As the number of plants is increasing, it is difficult to assemble employees from different plants at one place.
  • All these procedures involve a large amount of data which needs to be stored securely.
  • There are high chances of losing data or documents when handled manually.
BENEFITS:
  • Alerts and reminders for the activities are sent.
  • Helps in compliance to regulatory requirements.
  • Decision making process becomes faster and more efficient.
  • Reduces turn around time in getting approvals.
  • No scope for human errors.
  • Can be accessed 24/7 from anywhere in the world.
  • Users can easily retrieve required information.

CHANGE CONTROL

ABOUT CHANGE CONTROL:

Change control is required to lay down a procedure to control, manage, track and implement the proposed changes to the approved documents / procedures / validated analytical methods, facilities, equipment, software etc.

This standard process ensures that all the changes affecting any aspect of testing are appropriately reviewed, assessed and approved.

PROCESS FLOW:
  • All change controls are initiated and reviewed by various people like HOD, QA Coordinator.
  • Cross functional assessment by the identified departments to come up with action items based on the impact assessment.
  • The proposed change goes through Regulatory authority review, customer review based on the requirement.
  • Risk and impact assessment by the QA Coordinator and finalize all action items in the change control.
  • After HOD and QA Head approves the change control, action items are implemented.
  • Implemented action items are thoroughly verified and effectiveness of the changes is checked before closure by HOD, QA Coordinator, QA Head.
 CHALLENGES:
  • As changes are very frequent in life science industry, it is very difficult to manage them on paper.
  • It is difficult to track all the action items which leads to delayed closures of change controls.
  • It gets complex to handle manually when the change is at multi department stage.
BENEFITS:
  • With the help of Change control management software, the whole process of the change control can be followed step by step without missing any step and helps in improving transparency.
  • Change controls can be tracked at any phase from initiation to closure.
  • It is easier to train the employees whenever changes are made as the software is integrated with Learning management system.
  • As the process is standard, the cycle time is reduced and as most processes are automated, the expenses of change controls are reduced.
  • Employees can easily retrieve information about a change control from electronic records.
  • Timely approvals and closures are ensured with the help of automatic alerts.
  • Department’s efficiency in handling the change control operations can be monitored.
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DEVIATION:

Deviation Management System module is an effective tool to find out the root cause of the deviations in an organization and ensure continual improvement is undertaken in a timely and effective manner.

PROCESS FLOW:
  • All deviations are initiated and reviewed by HOD and remedial actions are taken if required.
  • Then reviewed by QA Coordinator and QA Head.
  • QA Head forms investigation team.
  • The investigation team investigates and the Investigation owner submits the CAPA.
  • Investigation team acknowledges.
  • After receiving approvals from HOD, QA Coordinator and QA Head CAPA is implemented.
  • Implemented CAPA is thoroughly verified before closure by HOD, QA Coordinator, QA Head.
FEATURES:
  • Impact can be mapped for products or batches.
  • Based on company’s workflow, repeated deviations can be linked.
  • Once the CAPAs are assigned to an individual or departments, action items along with the option to attach additional action items are assigned by the system.
BENEFITS:
  • By using different assessment methods like fishbone approach, 5 why’s analysis, etc. root cause analysis processes can be regulated.
  • Depending on the priority of the deviation, action can be taken.
  • Effect of deviation can be quickly detected using critical quality attribute(cqa).
  • Data can be collected based on the deviations that occur which can help in avoiding recurrence.
  • The overall impact of a change can be assessed.

CAPA

CAPA provides a sequence of steps for identification, creation, tracking, implementation and monitoring to ensure the continuous improvement of the system and to prevent the reoccurrence of deviations or any un-expected circumstances notified through QMS elements.

PROCESS FLOW:
  • Once the CAPA is initiated, it is reviewed by HOD, QA Coordinator, Head QA.
  • Head QA forms an investigation team which conducts the investigation and investigation team owner submits the CAPA.
  • It is then acknowledged by the investigation team.
  • It is then reviewed by HOD, QA Coordinator and QA Head.
  • CAPA is implemented and verified before effectiveness check.
  • CAPA is closed by HOD, QA Coordinator, QA Head.
CHALLENGES:
  • Development and maintenance of CAPA requires manual monitoring.
  • Recurring CAPAs.
  • Tracking effectiveness check dates is very difficult.
  • Defining a CAPA and Root Cause analysis is difficult.
  • It is difficulty to carry out processes consistently due to lack of control.
  • Employees are not held accountable for the causes for the delay as a result of limited managerial visibility.

STAGES:

IDENTIFY ROOT CAUSE OF PROBLEM:

The first stage involves discovering the root cause of the problem in order to identify an appropriate solution.

IMPACT ASSESSMENT:

This stage involves analyzing the impact of the deviation on the quality of the product. This helps in determining the magnitude of the problem.

DEFINING CAPA:

The next stage involves defining a CAPA which includes corrective actions to solve the problem and preventive actions to avoid recurrence of the problem.

BENEFITS:
  • CAPA is automatically initiated when a deviation is found.
  • Effectiveness checks are used to check the effectiveness of the CAPA.

MARKET COMPLIANT

Market Complaint module in eQMS Software, intended to file a complaint from the customer and acknowledge and identity the root cause and verify the analysis and getting closure by reporting to the customer.

PROCESS FLOW:
  • Once a market compliant is initiated, it is acknowledged by QA Head who forms preliminary investigation team with an owner.
  • CAPA is submitted by the Preliminary team owner before sending to team acknowledgement.
  • It is reviewed and approved by QA Coordinator and QA Head.
  • QA Head forms final investigation team if required and assigns an owner.
  • CAPA is submitted by the team owner before sending it to acknowledgement by the team members.
  • It is then revied and approved by QA Coordinator, QA Head before implementation.
  • It is verified and then closed by QA Coordinator and QA Head.
CHALLENGES:
  • Departments do not have required information, which makes manual market complaint processing disjointed.
  • As different people are involved in different stages, it is difficult to maintain transparency.
  • With respect to customer’s expectations, the volume and complexity of complaints increased.
  • It is very difficult to have the clients, partners, etc. at one place as they are located all around the world.
  • Organizations needs to resolve issues raised by the customer and implement the changes.
FEATURES:
  • Simplified market complaint reporting.
  • Robust root cause analysis.
  • Regulatory reporting.
  • Based on severity of the complaint actions are taken.
BENEFITS:
  • Current and previously lodged complaints can be compared to arrive at a better solution.

LAB INCIDENTS

Lab Incident module in eQMS Software, intended to guide and track the execution of an activity that needed as a Lab Incident to address a complaint, Deviations, Changes, Quality event or audit findings and ensure that CAPA with GxP impact are properly documented, approved and implemented by the departments within the organization

PROCESS FLOW:
  • Once the lab incidents are ted, it is sent for review by HOD, QA Coordinator.
  • Then the investigation is carried out and CAPA is submitted by the group leader.
  • It is then sent for acknowledge before sending it for review and approval from HOD, QA Coordinator and QA Head.
  • Then the CAPA is implemented and verified before closure by QA Coordinator and QA Head.
FEATURES:
  • Risks can be evaluated and categorized before allocating then to individuals or departments.
  • If the reports warrants, an additional expert can join the conversations.
  • Urgent issues can be addressed immediately.

INTERNAL AUDITS

Internal Audit module in eQMS Software, intended to guide and track the execution of an activity that needed as a corrective and preventive measures to address a complaint, Quality event or audit findings and ensure that CAPA with GxP impact are properly documented, approved and implemented by the departments within the organization.

PROCESS FLOW:
  • The audit plan is associated with the auditors and auditees and then sent for acknowledgement by the HOD and the audit team.
  • QA Head approves the plan.
  • Auditor submits the audit details and observations which are observed by the auditee/HOD.
  • Action items are prepared by the owner and sent for CFT Acknowledgement.
  • The review is reviewed and approved by HOD, QA Coordinator and Head QA.
  • Then the CAPA is implemented and verified before closure by the HOD, QA Coordinator and HEAD QA.
CHALLENGES:
  • Audit planning and scheduling gets difficult when an organization has multiple plants located at different locations.
  • Audit execution might get delayed as many other events are also planned throughout the year.
  • Audits involves a lot of data from different departments. Hence, makes it difficult to manage.
FEATURES:
  • Convinient audit planning and scheduling.
  • Auditor information.
  • Hassle less event execution.
BENEFITS:
  • Helps in managing the audit end to end.
  • Audit scheduling is simplified.
  • Centralized access.
  • Informative reports.

OUT OF SPECIFICATIONS

OOS occurs when the limits do not fall within the stipulated metrics. Out Of Specification module in eQMS Software, follows authorized procedures that ensure organizations comply with established regulatory standards of authorities

PROCESS FLOW:
  • Once an OOS is initiated, it is then sent for approval by HOD, QA Coordinator.
  • After receiving approval, Lab investigation and hypothesis analysis are carried out.
  • Phase 1 analysis is conducted, results are evaluated and concluded with CAPA.
  • It is thoroughly reviewed and approved by HOD, QA and QA Head.
  • Phase 2 analysis is conducted, original test results are evaluated.
  • Manufacturing investigation and resampling analysis are carried out before concluding phase 2 with CAPA.
  • It is then reviewed and approved by HOD, QA, QA Head.
  • Phase 3 investigation is conducted and concluded with CAPA.
  • It is then reviewed and approved by HOD, QA, QA Head.
  • CAPA is implemented and verified before closure by HOD, QA, QA Head.
FEATURES:
  • The process of reporting OOS is simplified.
  • Issues can be rectified in real time.
  • The whole process of investigation is carried out in three phases allowing retesting and resampling to make sure that they comply with all policies, standards, and regulations.
ADVANTAGES:
  • It ensures that the final product is in more conformance which results in decreasing complaints from the customer.
  • It helps to manufacture product according to original standards and avoid deviations.
  • Allows data capturing.
  • Next phase investigation is automatically initiated based on previous stage results.
  • Solutions are automatically generated and customized.

OUT OF TRENDS

OOT module in eQMS Software, intended to guide and track the execution of an activity that needed as a corrective and preventive measures to address a complaint, Quality event or audit findings and ensure that CAPA with GxP impact are properly documented, approved and implemented by the departments within the organization.

PROCESS FLOW:
  • Once a new OOT is initiated, it is reviewed by HOD, QA before lab investigation.
  • Hypothesis analysis is carried out, reviewed and evaluated before retesting the results and evaluating them.
  • It is then concluded with a CAPA before review, approval by HOD, QA, QA Head.
  • CAPA is then implemented and verified before closure by HOD, QA,QA Head.
FEATURES:
  • Simplified OOT Reporting.
  • The minor tasks such as review, re analysis involving multiple departments can be carried out automatically.
ADVANTAGES:
  • When OOT is reported manually involves collecting large amount of data. This can be simplified by arranging the fields in a simple-to-define pattern.
  • The second phase of the investigation is initiated automatically after the completion of the first phase.
  • It ensures that the final product is in more conformance which results in decreasing complaints from the customer.
  • It helps to manufacture product according to original standards and avoid deviations.
  • Allows data capturing.

VENDOR QUALIFICATIONS:

PROCESS FLOW:
  • Vendor is registered before preparing a checklist to evaluate.
  • This checklist is reviewed and forwarded to vendor.
  • The vendor fills the checklist and send it back.
  • Filled checklist is verified and decided whether site audit is required or not.
  • If required an audit is planned and dates are informed to the vendor.
  • The audit results are submitted and approved.
CHALLENGES:
  • Most of the times the process of vendor qualifications is carried out manually as it takes a lot of time and many times result in inaccurate vendor risk reports.
  • There is no other software that provides this.
  • When this is done manually, communicating with the vendors and collecting feedback is quite challenging.
FEATURES:
  • The vendors are assessed by various checklists.
  • The activity of the vendor can be monitored.
  • Integrated audit management.
  • Vendor ratings.
  • Vendor reports.
  • Vendor metrics are generated automatically.
BENEFITS:
  • The process of qualifying a customer is simplified and made more effective.
  • Suggested vendors can be evaluated faster.
  • Real time issue tracking.
  • Robust vendor assessment.
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