Quality Assurance

Overview

• The staff will file QMS documentation and norms(applicable; expired; withdrawn versions)
• The staff will maintain the list of QMS documentation and norms to update and make sure QMS is reviewed and approved.
• The staff will distribute and eliminate copies of QMS documentation in a controlled way and organize controlled, obsolete
• and archived records.
• The staff will register DCPR deviation reports, register in excel and database, assign a DCPR number, review the
• deviations, and perform follow up with corrective actions.
• Ensure timely closure and documentation of DCPR.
• The staff will assign a change request number and make changes to documents, and is responsible for registering,
• processing, updating, releasing and closing the documents.
• The staff will send a report of the client documentation summary on a monthly basis.
• The staff will initiate a monthly management review checklist and complete the tasks required as per checklist
• The staff will send daily QA end of the day reports to the lab Director
• The staff will check the tasks in the quality calendar and assign tasks to the responsible department.
• The staff shall design a design goal, design requirement and the design output.
• The staff is responsible for quality checks of the database, reviewing the contents of the checklist and ensure all documents
• (notifications, DCPR,etc.) have been filled accordingly.
• The staff will develop and effectively implement quality and operational policies, processes, and procedures to ensure the
• requirements of the AABB standards are met as per the company objective.
• The staff will ensure all policies, processes and procedures are in writing or captured electronically and shall be followed.
• The staff will review and sign the client certificate before final dispatch.
• The staff will verify the storage agreement and assure that it has been completed and signed on the timely manner
• The staff is responsible for ensuring the proficiency testing has been received and monitoring the due date and making
• sure the results are entered on a timely manner.
• The staff will conduct a quality check on the kit content before distribution.
• The staff is responsible for maintaining the equipment files.
• The staff will review and sign the CBU/TU worksheet and check the database.
• The staff shall implement the systems in place as per the quality manual designed by the company.
• The staff will implement and maintain policies, processes, and procedures for scheduling and conducting internal
• assessments that shall be reviewed by personnel independent of those having direct responsibility for the activity being
• assessed.
• The staff will ensure that the medical director shall review and approve all medical policies, processes, and procedures.
• The staff will ensure that the laboratory director shall review and approve all technical policies, processes, and procedures.
• The staff will ensure all staff is trained on emergency operation plans (including policies, processes, and procedures) to
• respond to the effects of disasters and other emergencies.
• The staff will train the new staff in various policies, processes and procedures in regards to the quality system.
• The staff is responsible of reviewing the staff annual competency, staff documents, trainings and training competencies.
• The staff will look after the internal quality control requirements especially in relation to the supplier evaluations, stock
• verifications and approval of stock for manufacturing use.
• The staff will design and approve all the validations and necessary studies required for the same.
• The staff shall be responsible for all the document approval and tracking for all the policies, processes and procedures.
• The staff shall establish and maintain policies, processes and procedures to control, maintain and monitor critical
• equipment.
• The staff shall assign and maintain a unique identifier for all the records, policies, standard operating procedures, forms,
• annexure, files and documents.
• The staff is delegated to be the back-up laboratory technician when need arises.