100+ Executive Quality Assurance Interview Questions and Answers

There are two types of sterilization techniques: dry heat and moist heat. Dry heat uses high temperatures while moist heat uses steam.

• Dry heat sterilization uses high temperatures ranging from 160-180°C for 2-4 hours.

• Moist heat sterilization uses steam at a temperature of 121°C for 15-20 minutes.

• Dry heat sterilization is suitable for materials that can withstand high temperatures such as glassware, metal instruments, and powders.

• Moist heat sterilization is suitable for materi...read more

Various types of microbiology tests are performed for milk to ensure its safety and quality.

• Total Plate Count (TPC) test

• Coliform count test

• Standard Plate Count (SPC) test

• Somatic Cell Count (SCC) test

• Methylene Blue Reduction (MBR) test

• Lactoperoxidase test

• Alkaline Phosphatase (ALP) test

Process verification is the evaluation of individual processes to ensure they meet quality standards, while system verification is the evaluation of the entire system to ensure it functions correctly.

• Process verification involves assessing each step of a process to ensure it is performed correctly and meets quality standards.

• System verification involves evaluating the overall system to ensure all components work together as intended.

• Process verification focuses on the details...read more

Controlling defects analysis can be achieved through effective quality control measures and data analysis.

• Implementing quality control processes to identify and prevent defects

• Conducting thorough analysis of defect data to identify root causes and trends

• Using statistical tools and techniques to analyze defect data

• Implementing corrective actions based on defect analysis findings

• Monitoring and measuring the effectiveness of defect control measures

HACCP is a food safety management system that identifies, evaluates, and controls hazards throughout the food production process.

• HACCP stands for Hazard Analysis and Critical Control Points

• There are seven principles of HACCP: Conduct a hazard analysis, Determine the critical control points (CCPs), Establish critical limits, Establish monitoring procedures, Establish corrective actions, Establish verification procedures, Establish record-keeping and documentation procedures

• Exa...read more

Bacterial endotoxin test is a test used to detect the presence of endotoxins in pharmaceutical products.

• It is a test used to ensure the safety of pharmaceutical products.

• It detects the presence of endotoxins, which are harmful substances produced by certain bacteria.

• The test is performed using a sample of the product and a reagent that reacts with endotoxins.

• The result is measured using a spectrophotometer or other analytical instrument.

• The test is required by regulatory agen...read more

Shop floor activities in production involve dispensing, manufacturing, packaging, and quality control.

• Dispensing of raw materials

• Manufacturing of products

• Packaging of finished goods

• Quality control checks throughout the process

• Cleaning and maintenance of equipment

• Documentation of all activities

• Training of personnel

• Adherence to safety protocols

Led a cross-functional team to develop a medical device, overcoming regulatory hurdles and technical challenges to ensure quality and compliance.

• Faced strict regulatory requirements; collaborated with compliance experts to ensure all documentation met FDA standards.

• Encountered technical challenges with device integration; organized brainstorming sessions to leverage team expertise and find innovative solutions.

• Implemented a rigorous testing protocol that identified potential ...read more

Equipment used in microbiology lab and their uses

• Microscope - to observe microorganisms

• Incubator - to grow and maintain cultures at a specific temperature

• Autoclave - to sterilize equipment and media

• Bunsen burner - to sterilize inoculating loops and needles

• Laminar flow hood - to maintain a sterile environment for handling samples

• pH meter - to measure the acidity or alkalinity of a solution

• Colony counter - to count and record bacterial colonies on agar plates

• Spectrophotometer -...read more

I systematically analyze mechanical issues, leveraging data and collaboration to identify root causes and implement effective solutions.

• 1. Gather data: Collect all relevant information about the mechanical issue, such as operational parameters and failure history.

• 2. Analyze the problem: Use tools like root cause analysis or fishbone diagrams to identify potential causes.

• 3. Collaborate with experts: Engage with team members or specialists who have experience with similar issue...read more

Compression machine parameters and defects identification

• Compression machine parameters include force, speed, and displacement

• Defects can be identified through visual inspection and testing

• Common defects include cracks, voids, and delamination

• Testing methods include ultrasonic testing and dye penetrant inspection

Target Limit is the maximum acceptable value for a Critical Control Point (CCP) to ensure food safety.

• Target Limit is a key parameter in Hazard Analysis and Critical Control Points (HACCP) system.

• It is the maximum limit of a physical, chemical or biological hazard that can be present in a food product at a CCP.

• If the hazard exceeds the Target Limit, corrective actions must be taken to bring it back under control.

• For example, the Target Limit for the temperature of cooked meat...read more

Fixing impurities limit involves identifying the source of impurities and implementing measures to reduce or eliminate them.

• Conduct a risk assessment to identify potential sources of impurities

• Establish impurity limits based on regulatory requirements and product specifications

• Implement measures to reduce or eliminate impurities, such as process optimization or equipment upgrades

• Monitor impurity levels regularly to ensure compliance with established limits

• Document all impurit...read more

Incidents are events that deviate from normal operations. No harm refers to incidents without negative consequences, while near miss refers to incidents with potential harm. HIRA is a risk assessment tool. Patient safety focuses on preventing harm to patients.

• Incidents are events that deviate from normal operations.

• No harm incidents are those that do not result in negative consequences.

• Near miss incidents are those that have the potential to cause harm but are prevented.

• HIRA ...read more

My approach to developing a test strategy involves thorough planning, risk assessment, and alignment with business goals.

• Understand project requirements: Collaborate with stakeholders to gather detailed requirements and expectations.

• Risk assessment: Identify potential risks and prioritize testing efforts based on impact and likelihood.

• Define testing scope: Determine what will be tested, including functional, non-functional, and regression testing.

• Select testing methodologies:...read more

Allergy is a hypersensitivity reaction of the immune system to a foreign substance called allergen.

• Allergens are substances that trigger an allergic reaction.

• Common allergens include pollen, dust mites, animal dander, certain foods, and insect venom.

• Symptoms of allergy include sneezing, runny nose, itchy eyes, skin rash, and difficulty breathing.

• Allergy can be diagnosed through skin tests, blood tests, and elimination diets.

• Treatment options include antihistamines, decongesta...read more

Culture media preparation involves sterilization, mixing of ingredients, and pH adjustment.

• Sterilize all equipment and ingredients before use

• Mix ingredients according to recipe or manufacturer instructions

• Adjust pH as necessary using acid or base solutions

• Autoclave or sterilize the final product before use

• Examples of culture media include nutrient agar, blood agar, and MacConkey agar

OOS stands for Out of Specification. Cleaning Validation is the process of ensuring that equipment and facilities are properly cleaned.

• OOS refers to a result that falls outside the specifications or acceptance criteria for a product or process.

• Cleaning Validation is a documented process that ensures equipment and facilities are cleaned to prevent contamination.

• It involves establishing cleaning procedures, selecting appropriate cleaning agents, and testing for residual contami...read more

QA encompasses four key segments: Planning, Assurance, Control, and Improvement, ensuring product quality and compliance.

• Planning: Establishing quality objectives and defining processes, e.g., creating a quality management plan.

• Assurance: Systematic activities to ensure quality standards are met, e.g., conducting audits and reviews.

• Control: Monitoring and measuring processes to maintain quality, e.g., using statistical process control.

• Improvement: Continuous enhancement of pr...read more

I have conducted internal, external, and supplier audits. Accuracy depends on the scope and objectives of the audit.

• I have conducted internal audits to assess the effectiveness of the company's quality management system.

• I have conducted external audits to evaluate the compliance of suppliers with the company's quality standards.

• I have conducted supplier audits to ensure that the company's suppliers meet the required quality standards.

• The accuracy of the audit depends on the s...read more

Smoke testing is a preliminary test to check the basic functionality of a software build before further testing.

• Smoke testing is often referred to as 'build verification testing'.

• It checks critical functionalities to ensure the build is stable.

• Example: After a new build, testers verify if the application launches and basic features work.

• It is usually automated to save time and resources.

• Smoke tests are not exhaustive; they cover only the most important aspects.

A flag system is a method of indicating a status or condition using a visual symbol or color code.

• Flags can be used in various industries such as aviation, maritime, and construction.

• In aviation, a red flag on the runway indicates that it is closed and cannot be used for takeoff or landing.

• In construction, a yellow flag may indicate caution or a potential hazard in the area.

• Flag systems can also be used in quality assurance to indicate the status of a product or process.

• The f...read more

Pickle making involves soaking vegetables in a mixture of vinegar, salt, and spices.

• Vegetables are sliced or chopped and placed in a jar or container.

• A mixture of vinegar, salt, and spices is boiled and poured over the vegetables.

• The jar is sealed and left to sit for several days to allow the flavors to develop.

• Different vegetables and spices can be used to create a variety of pickles.

• The acidity of the vinegar and salt content help to preserve the vegetables.

Gram staining is a laboratory technique used to differentiate bacterial species into two groups based on their cell wall composition.

• Developed by Danish bacteriologist Hans Christian Gram in 1884

• Involves staining bacterial cells with crystal violet and iodine, then washing with alcohol and counterstaining with safranin

• Gram-positive bacteria retain the crystal violet stain and appear purple under a microscope, while gram-negative bacteria lose the stain and appear pink or red

• U...read more

SOP stands for Standard Operating Procedure. It is a documented procedure that outlines the steps to be followed in a particular process.

• SOP is a set of instructions that describe how to perform a task or activity.

• It is used to ensure consistency and quality in processes.

• SOPs are commonly used in industries such as manufacturing, healthcare, and food service.

• Examples of SOPs include procedures for cleaning equipment, handling hazardous materials, and conducting audits.

• SOPs sh...read more

A cave is a natural underground chamber or series of chambers, typically accessible only by a narrow opening.

• A cave is formed by natural processes such as erosion, weathering, and chemical reactions.

• Caves can be found all over the world and are often used for recreational activities such as spelunking or cave diving.

• Some caves contain unique geological formations such as stalactites and stalagmites.

• Caves can also be used as shelter by animals and humans.

• Caves can be dangerous...read more

The dairy industry's SWOT analysis highlights its strengths, weaknesses, opportunities, and threats.

• Strengths: high demand for dairy products, established distribution channels, diverse product range

• Weaknesses: high production costs, dependence on weather and climate, animal welfare concerns

• Opportunities: increasing demand for organic and plant-based dairy alternatives, expanding global market

• Threats: competition from alternative milk products, government regulations and poli...read more