40+ Assistant Manager Quality Assurance Interview Questions and Answers

Guidelines for a Quality Management System (QMS) and examples of QMS activities

• Guidelines for QMS include establishing processes, monitoring performance, and implementing corrective actions

• Example of a QMS activity like a corrective action could be identifying a root cause of a quality issue and implementing a solution

• Another example could be investigating a deviation from standard procedures and implementing preventive measures

• Market complaint investigation involves analyzin...read more

Knowledge of regulatory affairs in relation to dossiers, licensing, and product permissions.

• Understanding of regulatory requirements for submitting dossiers for product approval

• Knowledge of the licensing process and requirements for different markets

• Familiarity with obtaining product permissions from regulatory authorities

• Experience in preparing and maintaining regulatory documentation

• Ability to ensure compliance with regulatory standards and guidelines

Hold time studies in OSD forms involve determining the time periods at different stages to ensure product quality and stability.

• Hold time studies should be conducted to determine the maximum time a product can be held at different stages without compromising quality.

• Different stages in OSD forms include blending, compression, coating, and packaging.

• Hold time periods can vary depending on the specific formulation and manufacturing process.

• For example, hold time for blending ma...read more

HACCP stands for Hazard Analysis and Critical Control Points. CAP refers to Corrective Action Plan.

• HACCP is a systematic approach to identify, evaluate, and control food safety hazards.

• It involves seven principles: conducting hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping.

• CAP is a plan developed to address and correct any identified non-conformities or d...read more

Different types of process validation include prospective validation, concurrent validation, and retrospective validation.

• Prospective validation: Validation conducted before the process is put into routine production.

• Concurrent validation: Validation conducted during routine production.

• Retrospective validation: Validation conducted on processes that have been in use for some time.

• Examples: Prospective validation would involve testing a new manufacturing process before full-sc...read more

Handling major change control involves several steps to ensure proper implementation and minimal impact on operations.

• Identify the need for change and document it

• Convene a change control board to evaluate the change and its impact

• Develop a plan for implementing the change and communicate it to all stakeholders

• Implement the change and monitor its impact on operations

• Evaluate the success of the change and document the results

• Close out the change control process

Raw materials used in cathode include lithium, cobalt, nickel, and aluminum. Anode materials typically consist of graphite, silicon, and lithium.

• Cathode raw materials: lithium, cobalt, nickel, aluminum

• Anode raw materials: graphite, silicon, lithium

I am proficient in pivot tables and lookup functions in Excel.

• I have experience creating pivot tables to summarize and analyze data.

• I am skilled in using lookup functions such as VLOOKUP and HLOOKUP to search for specific information in a dataset.

• I can use pivot tables to create interactive dashboards and reports for data analysis.

• I am familiar with advanced features of pivot tables like calculated fields and grouping.

• I have used lookup functions to merge data from multiple s...read more

Cp and Cpk are statistical process capability indices used in FMEA to measure the ability of a process to produce products within specifications.

• Cp measures the potential capability of a process to produce products within specifications, assuming the process is centered at the mean.

• Cpk measures the actual capability of a process to produce products within specifications, taking into account the process mean and variation.

• Cpk is a more accurate measure of process capability th...read more

I will listen to the customer, apologize for the inconvenience, investigate the issue, and provide a solution.

• Listen attentively to the customer's complaint

• Apologize for the inconvenience caused

• Investigate the issue to identify the root cause

• Provide a solution to the customer

• Follow up with the customer to ensure satisfaction

Various processes and method statements for construction activities

• Developing a project plan outlining the scope, schedule, and budget

• Conducting risk assessments to identify potential hazards and develop mitigation strategies

• Implementing quality control measures to ensure compliance with specifications and standards

• Documenting all construction activities and maintaining accurate records

• Regularly inspecting work progress to identify any deviations from the plan

• Training and sup...read more

In diagnostics for accuracy check, I perform various tests and analyses to ensure the accuracy of the results.

• Conducting quality control tests on diagnostic equipment

• Comparing test results with known standards or reference values

• Performing statistical analysis to identify any discrepancies

• Verifying the accuracy of measurements and calculations

• Troubleshooting and resolving any issues or errors

• Documenting and reporting findings to the relevant stakeholders

I investigate root causes of complaints, implement corrective actions, and monitor effectiveness.

• Investigate the root cause of the complaint to determine the underlying issue

• Implement corrective actions to address the root cause and prevent future occurrences

• Monitor the effectiveness of the corrective actions to ensure the issue is resolved

• Communicate with the customer to provide updates and ensure satisfaction

• Document the entire process for future reference and continuous im...read more

Customer complained about receiving a damaged product. Resolved by offering a replacement and ensuring better packaging in the future.

• Listen to the customer's complaint and empathize with their situation.

• Apologize for the inconvenience caused and assure them that their feedback is valuable.

• Offer a solution such as a replacement product or a refund.

• Take steps to prevent similar issues in the future, such as improving packaging or quality control processes.

Heat treatment processes include normalising, hardening, and annealing.

• Normalising involves heating the material above its critical temperature and then cooling it in still air.

• Hardening involves heating the material to a high temperature and then rapidly cooling it, usually in water or oil.

• Annealing involves heating the material to a specific temperature and then slowly cooling it, often in a controlled environment.

• Other heat treatment processes include tempering, case harde...read more

Water system qualification involves multiple phases to ensure pharmaceutical water meets quality standards.

• Phases include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)

• DQ ensures the water system is designed correctly for its intended use

• IQ verifies that the system is installed correctly according to design specifications

• OQ tests the system under normal operating conditions to ensure it functions ...read more

Lead acid batteries operate on the principle of electrochemistry, where chemical reactions involving lead and sulfuric acid generate electrical energy.

• Lead acid batteries consist of lead dioxide (positive plate), sponge lead (negative plate), and sulfuric acid (electrolyte)

• During discharge, sulfuric acid reacts with lead dioxide to form lead sulfate and water, releasing electrons

• During charging, lead sulfate is converted back to lead dioxide and sponge lead, absorbing electro...read more

The step by step process of constructing a building involves planning, site preparation, foundation laying, structural work, finishing, and final inspection.

• 1. Planning: Determine the design, materials, and timeline for the project.

• 2. Site preparation: Clear the land, level the ground, and set up utilities.

• 3. Foundation laying: Pour concrete footings and build foundation walls.

• 4. Structural work: Construct the framework, floors, walls, and roof.

• 5. Finishing: Install plumbing,...read more

Handling OOS (Out of Specification) involves investigating the root cause, implementing corrective actions, and documenting the process.

• Identify the OOS result and document it

• Investigate the root cause of the OOS

• Evaluate potential factors that may have contributed to the OOS

• Implement corrective actions to prevent recurrence

• Document the entire investigation process and actions taken

Rcm milk stands for Regional Cooperative Milk Producers' Union Limited.

• Rcm milk stands for Regional Cooperative Milk Producers' Union Limited

• It is a popular brand of dairy products in India

• Rcm milk is known for its quality and freshness

CC and SC in FMEA are decided based on severity and occurrence of potential failures.

• CC (Criticality Criteria) is determined based on severity of the potential failure.

• SC (Severity Criteria) is determined based on occurrence of the potential failure.

• CC and SC are usually rated on a scale of 1 to 10, with higher numbers indicating higher severity or occurrence.

• CC and SC are used to prioritize failure modes for further analysis and mitigation.

• For example, a failure mode with a ...read more

Maintaining sampling and quality involves implementing effective quality control measures and regularly monitoring and evaluating the sampling process.

• Establish clear quality standards and guidelines for sampling procedures

• Train and educate staff on proper sampling techniques and quality control measures

• Regularly inspect and calibrate sampling equipment to ensure accuracy

• Implement a robust quality assurance program to monitor and evaluate the sampling process

• Conduct regular a...read more

The main role in construction is to plan, coordinate, and oversee building projects from start to finish.

• Planning and designing construction projects

• Coordinating with architects, engineers, and contractors

• Ensuring projects are completed on time and within budget

• Overseeing quality control and safety measures

• Managing resources and personnel

• Obtaining necessary permits and approvals

The quality of raw materials is maintained through a rigorous process of inspection, testing, and supplier evaluation.

• Inspection: Raw materials are visually inspected for any defects or abnormalities.

• Testing: Samples of raw materials are tested for quality, purity, and compliance with specifications.

• Supplier evaluation: Suppliers are assessed based on their track record, certifications, and adherence to quality standards.

• Documentation: All quality-related information, includi...read more

Various codes and standards are essential for ensuring quality in construction work.

• Building codes set minimum requirements for the design and construction of buildings, such as the International Building Code (IBC).

• Quality standards like ISO 9001 provide guidelines for quality management systems in construction projects.

• Material standards like ASTM International specify the properties of construction materials, such as ASTM A36 for structural steel.

• Safety standards like OSHA...read more

Internal audit point for ISO 9001:2015 ensures compliance with quality management system requirements.

• Internal audits are conducted to assess the effectiveness of the quality management system.

• Auditors review processes, procedures, and records to identify non-conformities.

• Findings are documented and corrective actions are implemented to address any issues.

• Audits help in continuous improvement and maintaining ISO 9001 certification.

• Example: Auditors may check if documented pro...read more

The procedure for HVAC system involves the installation, maintenance, and repair of heating, ventilation, and air conditioning systems.

• The first step is to assess the building's heating and cooling needs.

• Next, the appropriate HVAC system is selected based on the building's requirements.

• The system is then installed, including the placement of ductwork, vents, and thermostats.

• Regular maintenance is crucial to ensure the system operates efficiently and effectively.

• This includes ...read more

Legal limits and printing updates are important for quality assurance.

• Stay up-to-date with changes in legal requirements for printing and labeling

• Ensure all products meet legal limits for ingredients and packaging

• Regularly review and update quality assurance procedures to reflect changes in regulations

• Train employees on legal requirements and how to comply with them

• Maintain accurate records to demonstrate compliance with legal requirements

I address customer complaints by listening attentively, empathizing with their concerns, offering solutions, and following up to ensure satisfaction.

• Listen actively to understand the customer's issue

• Empathize with the customer's frustration or disappointment

• Offer solutions or alternatives to resolve the complaint

• Follow up with the customer to ensure their satisfaction

• Document the complaint and analyze trends for continuous improvement

FMEA stands for Failure Mode and Effects Analysis, a systematic method for identifying and preventing potential failures. SPC stands for Statistical Process Control, a method for monitoring and controlling processes.

• FMEA is used to analyze potential failure modes of a product or process, determine their effects, and prioritize actions to address them.

• SPC involves using statistical tools to monitor and control processes, ensuring they are stable and within control limits.

• FMEA ...read more

Axles are shafts that rotate with the wheels and support the weight of the vehicle. They come in various types depending on the vehicle's design and purpose.

• Solid Axle: A single piece of metal that connects the wheels on either side of the vehicle.

• Independent Suspension Axle: Each wheel has its own axle, allowing for more flexibility and better handling.

• Drive Axle: Transfers power from the engine to the wheels, can be front, rear, or all-wheel drive.

• Dead Axle: Does not transm...read more

Quality management is the process of ensuring that products or services meet established standards and customer expectations.

• Setting quality standards and guidelines

• Implementing quality control measures

• Continuous monitoring and improvement

• Involving all employees in quality assurance

• Using tools like Six Sigma or Total Quality Management

• Examples: conducting regular audits, analyzing customer feedback, implementing corrective actions

There are several types of bearings used in various industries, including ball bearings, roller bearings, plain bearings, and fluid bearings.

• Ball bearings are the most common type and consist of balls enclosed between inner and outer races to reduce friction.

• Roller bearings use cylindrical rollers instead of balls for higher load capacity and durability.

• Plain bearings have a simple design with a sliding surface to support rotating or sliding components.

• Fluid bearings use a th...read more

IATF stands for International Automotive Task Force.

• It is a group of automotive manufacturers and their respective trade associations.

• It was formed to provide improved quality products to automotive customers worldwide.

• IATF 16949 is a standard that outlines the requirements for a quality management system in the automotive industry.

• It is based on ISO 9001 and includes additional requirements specific to the automotive industry.

• Certification to IATF 16949 is often a requiremen...read more

Code reinforcement is a technique used to increase the likelihood of a desired behavior being repeated.

• Code reinforcement involves providing a reward or positive consequence after a specific behavior is exhibited.

• Examples of code reinforcement include giving praise, bonuses, promotions, or other incentives for meeting quality standards.

• It helps in shaping employee behavior and improving overall quality assurance processes.

SPC stands for Statistical Process Control, a method used to monitor and control a process to ensure it operates within its limits.

• SPC involves collecting and analyzing data to identify and reduce variation in a process

• It helps in identifying when a process is out of control and needs corrective action

• SPC charts are used to visualize the data and identify trends and patterns

• Examples of SPC charts include control charts, histograms, and scatter plots

Transfer from off roll to on roll refers to moving an employee from a temporary or contract position to a permanent position within the company.

• Off roll employees are typically hired for temporary or project-based work

• On roll employees are permanent staff members with benefits and job security

• The transfer process may involve evaluating the employee's performance, skills, and fit for a permanent role

• Examples of criteria for transfer could include meeting performance targets, c...read more

Cubes result acceptance criteria are based on predetermined specifications for dimensions, weight, appearance, and performance.

• Acceptance criteria may include specific dimensions for the cube (e.g. 2 inches on each side)

• Weight tolerance (e.g. must weigh between 50-60 grams)

• Appearance criteria (e.g. no visible defects or scratches)

• Performance standards (e.g. must be able to withstand a certain amount of pressure)

Yes, employee safety is a top priority for us.

• We have implemented safety protocols and procedures to ensure the well-being of our employees.

• Regular safety training sessions are conducted to educate employees on potential hazards and how to prevent them.

• We have safety equipment and gear available for employees to use when necessary.

• We encourage employees to report any safety concerns or incidents immediately.

• We conduct regular safety audits to identify and address any potentia...read more

Milk pH is typically around 6.5 to 6.7, making it slightly acidic.

• Milk pH is important for determining its freshness and quality

• The pH of milk can vary depending on factors such as temperature and processing methods

• A pH of around 6.5 to 6.7 is considered normal for fresh milk

Workability of concrete refers to its ease of mixing, placing, and compacting.

• Workability is influenced by water content, aggregate size, and admixtures.

• Concrete with high workability is easier to place and compact.

• Low workability can lead to difficulties in construction and poor quality of the final product.

Records are a collection of related data while data is individual pieces of information.

• Data is a single piece of information while records are a collection of related data.

• Data can be stored in a database or spreadsheet while records are usually stored in a table.

• Examples of data include a person's name, age, or address while a record could be a customer's order history.

• Records can be made up of multiple data points.

• Data can be manipulated and analyzed while records are used...read more

IATF-16949 audit procedure is a quality management system standard for the automotive industry.

• IATF-16949 audit procedure is a set of guidelines and requirements for quality management in the automotive industry.

• It is based on ISO 9001 and includes additional requirements specific to the automotive industry.

• The audit procedure involves a thorough review of the organization's quality management system to ensure compliance with the standard.

• The audit is conducted by a third-par...read more

Quality tools are techniques used to monitor and improve the quality of products or processes.

• Statistical Process Control (SPC) - used to monitor and control processes

• Root Cause Analysis - used to identify and address the underlying cause of quality issues

• Failure Mode and Effects Analysis (FMEA) - used to identify potential failure modes and their effects

• Pareto Analysis - used to prioritize quality improvement efforts based on the most significant issues

• Control Charts - used ...read more