Critical systems audit – ETP MCQs With Answer

Introduction

This blog presents a focused set of MCQs on “Critical systems audit – ETP” tailored for M.Pharm students studying Audits and Regulatory Compliance. It highlights key concepts such as identification of critical process controls in effluent treatment plants (ETPs), qualification and validation of critical equipment, risk assessment, change control, monitoring and sampling strategies, documentation and regulatory requirements. Each question is designed to test practical understanding needed for conducting audits, preparing for inspections, and ensuring environmental compliance in pharmaceutical manufacturing. Answers are provided to help you assess strengths and identify areas for further study ahead of exams and professional practice.

Q1. Which of the following best defines a “critical system” in the context of an ETP audit?

• A system whose failure would cause a temporary delay in production
• A system that directly affects effluent quality and regulatory compliance
• A system used only for administrative record keeping
• A system that is optional and used for research purposes

Correct Answer: A system that directly affects effluent quality and regulatory compliance

Q2. During qualification of an ETP clarifier, which sequence represents the standard qualification phases?

• OQ, IQ, PQ
• IQ, OQ, PQ
• PQ, IQ, OQ
• IQ, PQ, OQ

Correct Answer: IQ, OQ, PQ

Q3. What is the primary objective of conducting a Failure Mode and Effects Analysis (FMEA) for ETP critical systems?

• To document all maintenance activities
• To prioritize potential failures based on risk and mitigate them
• To train operators on how to use laboratory instruments
• To reduce electricity consumption in the plant

Correct Answer: To prioritize potential failures based on risk and mitigate them

Q4. Which parameter is most critical to monitor continuously for biological treatment performance in an activated sludge ETP?

• pH of chemical storage tanks
• Mixed Liquor Suspended Solids (MLSS)
• Ambient temperature in administrative office
• Color of returned sludge

Correct Answer: Mixed Liquor Suspended Solids (MLSS)

Q5. In an audit, which document demonstrates that analytical methods used for effluent testing are suitable and reliable?

• Training matrix for operators
• Validated analytical method reports
• Purchase orders for reagents
• Daily logbook entries without SOP references

Correct Answer: Validated analytical method reports

Q6. What is a critical element of change control when modifying a PLC logic that controls ETP dosing?

• Informing only the procurement department
• Performing risk assessment, testing in simulation, and updating documentation
• Posting a notice on the canteen board
• Allowing operators to implement changes without documentation

Correct Answer: Performing risk assessment, testing in simulation, and updating documentation

Q7. Which environmental parameter is commonly used by regulators to assess organic pollution in pharmaceutical effluent?

• Total Suspended Solids (TSS)
• BOD5 (Biochemical Oxygen Demand over 5 days)
• pH of treated sludge
• Oil and grease only

Correct Answer: BOD5 (Biochemical Oxygen Demand over 5 days)

Q8. When auditing ETP sampling procedures, which practice indicates good chain-of-custody?

• Samples are labeled with date/time, sampler name, and preserved; custody log maintained
• Samples left unattended at the bench before testing
• Multiple samples pooled without documentation
• Samples documented only in a verbal handover

Correct Answer: Samples are labeled with date/time, sampler name, and preserved; custody log maintained

Q9. Which corrective action is most appropriate when routine audit finds repeated out-of-specification COD results due to instrument drift?

• Ignore results during inspections
• Initiate CAPA: recalibrate/repair instrument, retrain analysts, and revalidate method as required
• Replace all lab personnel
• Reduce frequency of testing to avoid failures

Correct Answer: Initiate CAPA: recalibrate/repair instrument, retrain analysts, and revalidate method as required

Q10. Which of the following is a critical control point for preventing hazardous chemical exposure in ETP operations?

• Availability of ventilation and closed dosing systems during chemical transfer
• Color of safety signboards
• Frequency of tea breaks for staff
• Proximity of canteen to the ETP gate

Correct Answer: Availability of ventilation and closed dosing systems during chemical transfer

Q11. What is the role of SCADA/PLC alarm logs in a regulatory audit of the ETP?

• They are irrelevant since manual logs suffice
• They provide electronic evidence of excursions, operator responses, and system performance
• They only show power consumption statistics
• They replace the need for any SOPs

Correct Answer: They provide electronic evidence of excursions, operator responses, and system performance

Q12. Which documentation is essential to demonstrate disposal compliance of hazardous sludge generated by an ETP?

• Waste manifest and authorized transporter/TSDF receipts
• Internal memo requesting disposal
• Photographs of sludge only
• Operator’s verbal confirmation

Correct Answer: Waste manifest and authorized transporter/TSDF receipts

Q13. During an ETP audit, which indicator suggests inadequate microbial activity in biological treatment?

• Stable low MLSS with increased effluent BOD
• Clear effluent with low turbidity
• Consistent return activated sludge flow
• Steady dissolved oxygen (DO) above setpoint

Correct Answer: Stable low MLSS with increased effluent BOD

Q14. Which regulatory permission is typically required before operating a pharmaceutical ETP in India?

• Consent to Establish (CTE) only
• Consent to Operate (CTO) from the pollution control board
• Food safety license only
• No permits are necessary for effluent treatment

Correct Answer: Consent to Operate (CTO) from the pollution control board

Q15. In risk-based prioritization of ETP components, which factor is least relevant?

• Potential impact on regulatory discharge limits
• Likelihood of failure and detectability
• Color of paint applied to equipment
• Redundancy and ease of maintenance

Correct Answer: Color of paint applied to equipment

Q16. Which practice is critical to demonstrate effective training of ETP operators during an audit?

• Presence of up-to-date training records with dates, content, and assessments
• Only verbal confirmation by supervisor
• Training slides saved on a USB without attendance records
• Random informal discussions with new hires

Correct Answer: Presence of up-to-date training records with dates, content, and assessments

Q17. Which parameter is most directly associated with toxicity testing of effluent in an ETP compliance program?

• pH measurement only
• Acute toxicity bioassay such as Daphnia magna or fish mortality tests
• Volume of treated effluent discharged per day
• Color of the effluent

Correct Answer: Acute toxicity bioassay such as Daphnia magna or fish mortality tests

Q18. What is an auditor’s primary concern when reviewing calibration records for ETP online probes (pH, DO)?

• Whether the probe brand is the most expensive
• Whether calibrations are performed per SOP, traceable standards used, and records retained
• Whether operators like the probe interface
• Whether calibrations occurred once at installation only

Correct Answer: Whether calibrations are performed per SOP, traceable standards used, and records retained

Q19. Which action should be documented when an ETP treatment unit is taken offline for maintenance to ensure compliance?

• Record of planned downtime, mitigation measures, authorization, and impact assessment on discharge
• Only a verbal note between operators
• Shutting down without informing environmental officer
• Posting a sign at the gate without documentation

Correct Answer: Record of planned downtime, mitigation measures, authorization, and impact assessment on discharge

Q20. Which performance metric is most useful for long-term trending of ETP operational effectiveness?

• Daily cafeteria menu
• Monthly average effluent BOD/COD and removal efficiency trends
• Number of visitors to the admin office
• Color of the control room walls

Correct Answer: Monthly average effluent BOD/COD and removal efficiency trends

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