Biological E Senior Executive QA Interview Questions, Process, and Tips

Change control is a process that ensures all changes to a system are documented, reviewed, approved, and implemented in a controlled manner.

• Change control is essential for maintaining the stability and integrity of a system.

• It involves documenting and tracking all proposed changes, including their impact and risks.

• Changes are reviewed and approved by a designated change control board or committee.

• Proper testing and val...read more

Risk management is the process of identifying, assessing, and prioritizing potential risks and taking measures to minimize or mitigate their impact.

• Identifying potential risks

• Assessing the likelihood and impact of each risk

• Prioritizing risks based on their severity

• Developing strategies to minimize or mitigate risks

• Implementing risk management plans

• Monitoring and reviewing risks regularly

• Examples: financial risk, cybers

VMP stands for Vendor Master Plan. It is a strategic document that outlines the approach and activities for managing vendors in an organization.

• VMP is a comprehensive plan that includes vendor selection, evaluation, and performance management.

• It defines the criteria for selecting vendors and the process for evaluating their performance.

• The plan also outlines the responsibilities and roles of various stakeholders involv...read more

Incident is an unexpected event that may or may not have an impact on product quality, while deviation is a planned or intentional change that may affect product quality.

• Incident is unplanned, while deviation is planned

• Incident may or may not have an impact on product quality, while deviation may affect product quality

• Incident requires investigation to determine the root cause, while deviation requires investigation to...read more