Senior Manager QA

Senior Manager QA Interview Questions and Answers

Updated 11 Feb 2024

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Q1. What is sensitisation, what is fatigue, what is hardness, which material shall be used in manufacturing of ULTRASONIC PROBE, which material is used for manufacturing of ball in ball valve

Ans.

Sensitisation, fatigue, and hardness are material properties. Ultrasonic probes are made of titanium or stainless steel. Ball valves use materials like brass, stainless steel, or plastic.

Sensitisation is the process of making a material more susceptible to corrosion due to heat exposure.
Fatigue is the weakening of a material due to repeated stress or strain.
Hardness is the resistance of a material to indentation or scratching.
Ultrasonic probes are typically made of titanium o...read more

Q2. How you handle certain issues faced in Quality Assurance?

Ans.

I handle issues in QA by identifying root causes, implementing corrective actions, and ensuring continuous improvement.

Identify the root cause of the issue
Implement corrective actions to address the issue
Ensure continuous improvement by analyzing trends and implementing preventive measures
Communicate effectively with stakeholders to address concerns and provide updates
Utilize quality tools and methodologies such as Six Sigma or Lean to improve processes

Q3. how to perform process validation as per FDA approach

Ans.

Process validation as per FDA approach involves establishing documented evidence that a process consistently produces a result meeting predetermined specifications.

Understand the process and its critical parameters
Develop a validation plan
Perform process qualification
Conduct process performance qualification
Document and analyze the validation data
Implement ongoing process monitoring and control

Q4. How to resolve chronically issue

Ans.

Address root cause, implement corrective actions, monitor effectiveness

Identify the root cause of the chronically issue
Implement corrective actions to address the root cause
Monitor the effectiveness of the corrective actions over time

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Q5. Lean tools for standard settings for new product

Ans.

Lean tools such as 5S, Standard Work, and Visual Management can be used for standard settings for new product.

Implement 5S methodology to organize the workspace and standardize processes
Develop Standard Work instructions to ensure consistency and quality
Utilize Visual Management tools like Kanban boards to track progress and identify issues
Continuous improvement through Kaizen events to refine standards over time

Q6. How to perform cleaning validation

Ans.

Cleaning validation is the process of ensuring that equipment used in manufacturing is properly cleaned to prevent cross-contamination.

Identify critical equipment and surfaces that require cleaning validation
Establish acceptance criteria for cleanliness
Develop a cleaning validation protocol
Perform cleaning verification tests
Analyze test results and compare against acceptance criteria
Document the cleaning validation process and results

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Q7. What is 8D method

Ans.

8D method is a problem-solving approach used in quality control and process improvement.

8D stands for 8 Disciplines
It is used to identify, correct, and prevent recurring problems
It involves a team-based approach to problem-solving
The 8 disciplines include: Team Formation, Problem Description, Containment Actions, Root Cause Analysis, Corrective Actions, Preventive Actions, Implementation, and Closure
It is commonly used in the automotive industry and other manufacturing indust...read more