Audit of engineering department MCQs With Answer

Introduction:

This blog provides a focused set of multiple-choice questions on the audit of the engineering department tailored for M.Pharm students studying Audits and Regulatory Compliance. The questions cover practical and regulatory aspects such as maintenance, calibration, validation of utilities, documentation practices, contractor controls, change control, risk assessment, and compliance with cGMP. Designed to deepen understanding beyond superficial points, these MCQs emphasize real-world audit observations, key performance indicators, and corrective actions that influence product quality and regulatory outcomes. Use this quiz to test knowledge, prepare for viva or examinations, and reinforce the critical role of engineering audits in maintaining compliant pharmaceutical manufacturing environments.

Q1. Which primary objective should an auditor focus on during an engineering department audit in a pharmaceutical facility?

• Assessing the cleanliness of office areas
• Evaluating the effectiveness of maintenance, calibration, and utility systems for product quality
• Measuring employee satisfaction in the engineering team
• Reviewing marketing strategies for equipment suppliers

Correct Answer: Evaluating the effectiveness of maintenance, calibration, and utility systems for product quality

Q2. During an audit, which document best demonstrates that a critical HVAC system is maintained under a controlled program?

• Generic vendor catalogues for HVAC units
• Unscheduled repair receipts without schedule
• Preventive maintenance schedule with completed records and trend analysis
• Emails requesting spare parts

Correct Answer: Preventive maintenance schedule with completed records and trend analysis

Q3. What is the most appropriate evidence for verifying calibration status of laboratory measuring instruments?

• Worker testimony that equipment “seems accurate”
• Calibration certificates traceable to national standards with due dates and results
• Photographs of the instrument on the bench
• Purchase invoices for the instrument

Correct Answer: Calibration certificates traceable to national standards with due dates and results

Q4. Which aspect is critical when auditing change control for engineering systems?

• Whether the change reduced cost
• Existence of a documented risk assessment, qualification, and approval before implementation
• How many people were informed via email
• If the vendor promoted the change on their website

Correct Answer: Existence of a documented risk assessment, qualification, and approval before implementation

Q5. What auditor finding indicates inadequate management of spare parts for critical equipment?

• Inventory list showing fast-moving office supplies
• Stock levels for critical spares below minimum levels and no contingency plan
• Excessive quantities of obsolete non-critical items
• Purchase orders from multiple vendors

Correct Answer: Stock levels for critical spares below minimum levels and no contingency plan

Q6. For utility qualification, which element is essential evidence during an engineering audit?

• Utility vendor brochures
• Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) reports
• Employee job descriptions
• Generic diagrams without test data

Correct Answer: Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) reports

Q7. What is the primary purpose of trending maintenance and calibration data in an engineering audit?

• To create colorful graphs for management presentations
• To identify recurring failures and enable preventive corrective actions
• To justify budget increases annually
• To show that no maintenance was performed

Correct Answer: To identify recurring failures and enable preventive corrective actions

Q8. Which audit observation best represents poor contractor management?

• Contractors wear appropriate PPE and sign in/out
• No documented qualifications, no access control, and no supervision during critical area work
• Contractor work scheduled during planned shutdown
• Contractors submit invoices promptly

Correct Answer: No documented qualifications, no access control, and no supervision during critical area work

Q9. When auditing utility alarms and interlocks, what would be considered a major nonconformity?

• Alarms are configured but have documented owners and response procedures
• Interlocks are bypassed temporarily without formal approval or documentation
• Alarm setpoints are recorded in the building management system
• Alarm logs are reviewed weekly and actions documented

Correct Answer: Interlocks are bypassed temporarily without formal approval or documentation

Q10. Which KPI is most relevant for measuring engineering department effectiveness from a quality perspective?

• Number of team-building events per year
• Mean time to repair (MTTR) for critical process equipment and percentage of preventive vs corrective maintenance
• Number of suppliers contacted
• Length of service contracts with vendors

Correct Answer: Mean time to repair (MTTR) for critical process equipment and percentage of preventive vs corrective maintenance

Q11. During an audit, you find undocumented temporary repairs on a critical piping system. What is the most appropriate auditor action?

• Ignore as long as system is running
• Raise a finding citing lack of documentation, evaluate impact on product quality, and request corrective action
• Ask the maintenance person to fix it later
• Approve repair verbally

Correct Answer: Raise a finding citing lack of documentation, evaluate impact on product quality, and request corrective action

Q12. Which piece of evidence demonstrates that engineering training is effective for personnel performing GMP-related maintenance?

• Generic online safety course completion unrelated to GMP systems
• Training records showing role-specific competency checks, SOP assessments, and periodic refreshers
• Attendance list for a company picnic
• Employment contracts with job titles only

Correct Answer: Training records showing role-specific competency checks, SOP assessments, and periodic refreshers

Q13. What is the key consideration when auditing cleaning and cleanliness controls for engineering workshops that service sterile areas?

• Workshop proximity to cafeteria
• Segregation of dirty and clean tools, documented cleaning procedures, and validated cleaning methods
• Workshop color scheme
• Number of toolboxes available

Correct Answer: Segregation of dirty and clean tools, documented cleaning procedures, and validated cleaning methods

Q14. Which audit evidence indicates effective management of change (MOC) for equipment modifications?

• MOC forms completed after implementation with no validation
• Completed MOC with risk assessment, updated drawings, revised SOPs, and requalification where applicable before implementation
• Oral approvals from a supervisor
• Supplier recommendations without internal review

Correct Answer: Completed MOC with risk assessment, updated drawings, revised SOPs, and requalification where applicable before implementation

Q15. In relation to energy and utility audits, which control is important to ensure consistent process performance?

• Random power outages to test resilience
• Uninterruptible power supply (UPS), backup generators, and documented restoration procedures for critical utilities
• Dependence on a single utility vendor contract
• Monthly invoices for energy consumption

Correct Answer: Uninterruptible power supply (UPS), backup generators, and documented restoration procedures for critical utilities

Q16. Which risk-based approach should auditors expect to see in engineering department programs?

• Equal effort applied to all systems regardless of criticality
• Prioritization of maintenance, calibration, and validation activities based on system criticality and impact on product quality
• Delegation of all risk assessments to the vendor
• Only cosmetic risks are documented

Correct Answer: Prioritization of maintenance, calibration, and validation activities based on system criticality and impact on product quality

Q17. What is the correct auditor response when finding expired calibration labels on a cascade control device used in aseptic processing?

• Assume device is still accurate and document nothing
• Record a critical finding, quarantine affected batches if applicable, and require immediate calibration and investigation
• Replace the label only
• Ask production to adjust setpoints manually

Correct Answer: Record a critical finding, quarantine affected batches if applicable, and require immediate calibration and investigation

Q18. Which documentation should be reviewed to verify that shutdown and start-up activities are controlled to prevent contamination risks?

• Social media posts about the shutdown
• Approved shutdown/start-up procedures, checklists, records of execution, and deviation handling documentation
• Generic maintenance calendar without procedures
• Vendor marketing materials

Correct Answer: Approved shutdown/start-up procedures, checklists, records of execution, and deviation handling documentation

Q19. What is an appropriate audit metric to assess contractor performance in the engineering department?

• Number of contractor name badges issued
• Percentage of contractor tasks completed on schedule, quality of work, adherence to safety and GMP controls, and number of post-work deviations
• Contractor office seating preferences
• Amount paid to each contractor regardless of outcome

Correct Answer: Percentage of contractor tasks completed on schedule, quality of work, adherence to safety and GMP controls, and number of post-work deviations

Q20. Which audit observation best indicates that preventive maintenance strategies are aligned with regulatory expectations?

• Maintenance frequency chosen randomly each year
• Maintenance frequencies based on manufacturer data, historical failure trends, risk assessment, and documented justification
• No record of any preventive maintenance for several years
• Only reactive maintenance performed to reduce costs

Correct Answer: Maintenance frequencies based on manufacturer data, historical failure trends, risk assessment, and documented justification

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