Qms Executive Interview Questions and Answers

Investigating stability failure for RS test and performing risk assessment

• Conduct a thorough investigation to identify the root cause of the stability failure

• Perform a risk assessment to determine the potential impact on patient safety and product quality

• Evaluate the dissolution and CU criteria to ensure they are within acceptable limits

• Consider a product recall if necessary to prevent harm to patients

• Document all findings and actions taken for regulatory compliance

Change control procedure ensures systematic handling of changes to prevent negative impact on quality. Deviations are managed through investigation and corrective actions.

• Change control procedure involves documenting and assessing proposed changes, obtaining approval, implementing changes, and reviewing effectiveness

• Deviations are identified through quality control checks and can be caused by equipment malfunction, human error, or other factors

• Deviations are investigated to d...read more

To ensure sterility after autoclave sterilization, proper handling and storage techniques must be followed.

• Ensure proper loading of items in autoclave to allow for adequate steam penetration

• Use appropriate sterilization parameters such as time, temperature, and pressure

• Allow items to cool down completely before handling to prevent contamination

• Store sterilized items in a clean and dry environment to maintain sterility

• Regularly monitor and validate autoclave performance throug...read more

Spurious market complaints can be handled by investigating the root cause, verifying the complaint, and taking corrective actions.

• Investigate the root cause of the complaint

• Verify the authenticity of the complaint

• Take corrective actions to prevent future occurrences

• Communicate with the customer to resolve the issue

• Document the investigation and actions taken

Biological indicators are used to monitor sterilization processes. Types include spore strips, spore suspensions, and self-contained biological indicators.

• Spore strips: paper strips with spores that are placed in the sterilization process and then incubated to check for growth

• Spore suspensions: liquid suspensions containing spores that are used to test sterilization processes

• Self-contained biological indicators: complete units that contain spores and growth medium for monitor...read more

QMS stands for Quality Management System, which is a set of policies, processes, and procedures required for planning and execution in the core business area of an organization.

• QMS ensures that products and services meet customer requirements and quality standards.

• ISO9001 is a standard that sets out the criteria for a quality management system.

• It helps organizations improve customer satisfaction, efficiency, and continual improvement.

• ISO9001 certification demonstrates a compa...read more

Investigated a customer complaint regarding product quality issues

• Conducted interviews with production staff to gather information

• Analyzed production records and quality control data

• Identified root cause of the quality issues as a supplier error

• Implemented corrective actions to prevent future occurrences