Maintenance of personal records in QA and QC departments MCQs With Answer

Maintenance of personal records in QA and QC departments is a critical area for B.Pharm students to master, covering creation, control, retention and disposal of personnel documentation to meet GMP, GLP and regulatory expectations. Effective record maintenance ensures traceability, data integrity (ALCOA principles), audit readiness, and clear separation of QA versus QC responsibilities. Key items include training logs, competency assessments, medical and vaccination records, access rights, version control, correction procedures, retention schedules and secure archiving for both paper and electronic systems. Understanding SOP-driven practices, audit trails, confidentiality and corrective actions prepares students for inspections and quality investigations. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of maintaining personal records in QA and QC departments?

• To ensure traceability and regulatory compliance
• To increase production speed
• To reduce raw material costs
• To manage supplier relationships

Correct Answer: To ensure traceability and regulatory compliance

Q2. Which of the following is typically included in a personnel file for pharmaceutical QA/QC?

• Training records, competency assessments, medical certificates and employment history
• Only payroll and salary slips
• Raw material analysis reports
• Equipment calibration logs

Correct Answer: Training records, competency assessments, medical certificates and employment history

Q3. Which guideline emphasizes data integrity principles like ALCOA for record maintenance?

• Good Manufacturing Practice (GMP)
• Pharmacopoeial monographs
• Marketing authorization guidelines
• Packaging design standards

Correct Answer: Good Manufacturing Practice (GMP)

Q4. ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. Which practice supports the “Attributable” principle?

• Signing and dating entries with printed name and role
• Keeping records in a sealed box
• Using white-out to correct mistakes
• Storing records on personal devices

Correct Answer: Signing and dating entries with printed name and role

Q5. For how long should personnel training records typically be retained as per common regulatory expectations?

• For a period defined by the company SOP or regulatory requirement, often the product retention period plus one year
• Only until the employee leaves the company
• One month after training completion
• Forever, without any retention policy

Correct Answer: For a period defined by the company SOP or regulatory requirement, often the product retention period plus one year

Q6. Who is primarily responsible for ensuring completeness and correctness of personnel records?

• Quality Assurance (QA) with input from HR and departmental supervisors
• Raw material suppliers
• Production operators only
• Packaging vendors

Correct Answer: Quality Assurance (QA) with input from HR and departmental supervisors

Q7. Which action best follows when a training record contains an error?

• Make a single-line strike-through, initial, date and add a reason for change
• Erase the error completely with a pen eraser
• Use correction fluid to hide the error
• Replace the page without documenting the change

Correct Answer: Make a single-line strike-through, initial, date and add a reason for change

Q8. What is an audit trail in electronic personnel records?

• A secure log capturing who accessed or changed a record, when and what was changed
• A printed copy stored in a drawer
• An external hard drive with backup files but no logs
• A note on the employee’s desk

Correct Answer: A secure log capturing who accessed or changed a record, when and what was changed

Q9. Which of the following is a key difference between QA and QC responsibilities regarding personal records?

• QA oversees personnel qualification systems; QC focuses on technical competency for testing
• QC handles employee hiring; QA performs all testing
• QA manages raw material testing; QC approves SOPs only
• There is no difference; both perform identical tasks

Correct Answer: QA oversees personnel qualification systems; QC focuses on technical competency for testing

Q10. When should competency assessments be performed for QA/QC staff?

• During initial hiring, after major changes, and periodically as defined by SOPs
• Only if a regulatory inspector requests them
• Never, competency is assumed
• Only once at the end of employment

Correct Answer: During initial hiring, after major changes, and periodically as defined by SOPs

Q11. What is the correct approach to store medical records of employees in QA/QC?

• Keep them confidential, access-controlled and separate from general personnel files
• Post them on notice boards for transparency
• Store them with production schedules
• Keep them in a shared department folder accessible to all staff

Correct Answer: Keep them confidential, access-controlled and separate from general personnel files

Q12. Which regulatory body provides guidance on good documentation practices in pharmaceuticals?

• World Health Organization (WHO) and national agencies like US FDA/EMA
• International Olympic Committee
• World Trade Organization
• Local municipal authorities only

Correct Answer: World Health Organization (WHO) and national agencies like US FDA/EMA

Q13. What is the best practice for electronic record version control?

• Maintain controlled versions with timestamps, author, change history and access controls
• Overwrite the old file with the new file without logs
• Save versions only on the desktop of the author
• Email updated files to everyone and rely on recipients to save them

Correct Answer: Maintain controlled versions with timestamps, author, change history and access controls

Q14. Which of the following is a required element for personnel training records?

• Date of training, trainer name, topics covered, assessment outcomes
• Only the training title
• Only the cost of the training program
• Only the employee’s signature without date

Correct Answer: Date of training, trainer name, topics covered, assessment outcomes

Q15. Why are access controls important for personnel records?

• To protect confidentiality, prevent unauthorized changes and maintain data integrity
• To make records available to everyone at all times
• To ensure records can be edited by vendors
• To prevent backups from being made

Correct Answer: To protect confidentiality, prevent unauthorized changes and maintain data integrity

Q16. Which is correct when transferring personal records to archive?

• Follow retention schedule, verify completeness, label with retention period and ensure secure storage
• Discard records immediately after transfer without verification
• Mix archived records with active production records
• Archive only digital records and burn paper files

Correct Answer: Follow retention schedule, verify completeness, label with retention period and ensure secure storage

Q17. How should corrections in paper personnel records be handled?

• Draw a single line through the error, initial, date and state the reason for change
• Use correction fluid to hide the mistake
• Tear the page out and replace it without trace
• Rewrite the entire file without noting changes

Correct Answer: Draw a single line through the error, initial, date and state the reason for change

Q18. Which action is part of ensuring data integrity for electronic personnel records?

• Implementing privileged user management, backups, secure audit trails and validation
• Allowing everyone to use the same login
• Keeping electronic files on personal USB drives only
• Disabling system logs to save space

Correct Answer: Implementing privileged user management, backups, secure audit trails and validation

Q19. What should be included in an SOP for personal record maintenance?

• Scope, responsibilities, record types, retention periods, correction and access procedures
• Only the company mission statement
• Only a list of employee names
• Only contact numbers for suppliers

Correct Answer: Scope, responsibilities, record types, retention periods, correction and access procedures

Q20. During an inspection, an auditor requests training evidence for a specific analyst. What is the ideal document to produce?

• Completed training record showing dates, trainer, assessment and results
• The analyst’s CV only
• A verbal assurance without records
• Raw lab data unrelated to training

Correct Answer: Completed training record showing dates, trainer, assessment and results

Q21. Which of the following is NOT appropriate in maintaining personnel records?

• Using personal email accounts for official record submission
• Controlled access and secure storage
• Documented retention and destruction procedures
• Regular audits of record completeness

Correct Answer: Using personal email accounts for official record submission

Q22. If an employee moves roles, what should be done with their competency records?

• Update records with new role-specific training and a competency re-assessment
• Delete all previous records
• Ignore and continue using old role records
• Hand records to the employee for personal safekeeping

Correct Answer: Update records with new role-specific training and a competency re-assessment

Q23. What is the role of HR in QA/QC personnel records?

• Managing employment contracts, personal data and coordination with QA for training documentation
• Calibrating lab instruments
• Approving test results
• Performing routine QC analyses

Correct Answer: Managing employment contracts, personal data and coordination with QA for training documentation

Q24. Which record controls help during an investigation of a laboratory error?

• Complete training history, access logs, change records and documented deviations
• Only the employee’s photo ID
• Only cafeteria attendance logs
• Vendor delivery receipts

Correct Answer: Complete training history, access logs, change records and documented deviations

Q25. How should confidential personal information be handled in shared audits?

• Redact sensitive details and provide only information necessary for audit scope
• Share full personal data with all attendees
• Provide no documentation even when requested
• Publish records on the company website

Correct Answer: Redact sensitive details and provide only information necessary for audit scope

Q26. Which is a key indicator of insufficient record maintenance?

• Missing signatures, undated entries and inconsistent training logs
• Well-archived, dated and initialed records
• Clearly labeled archive boxes with retention dates
• Validated electronic audit trails

Correct Answer: Missing signatures, undated entries and inconsistent training logs

Q27. When destroying personal records after retention period, what must be ensured?

• Destruction is authorized, documented and irreversible (secure shredding or approved electronic deletion)
• Records are burned without documentation
• Records are thrown in regular trash
• Records are sold to third parties

Correct Answer: Destruction is authorized, documented and irreversible (secure shredding or approved electronic deletion)

Q28. What is a CAPA and why is it relevant to personnel records?

• Corrective and Preventive Action; used to address record-keeping deficiencies and prevent recurrence
• Customer Approval Process; used for marketing
• Capital Asset Plan; used for buying equipment
• Clinical Assessment Protocol; used for trials only

Correct Answer: Corrective and Preventive Action; used to address record-keeping deficiencies and prevent recurrence

Q29. Which practice improves reliability of electronic signatures on personnel records?

• Using unique credentials, multi-factor authentication and secure signature capture with audit trails
• Sharing passwords among team members
• Allowing handwritten signatures to be scanned and reused by anyone
• Printing signatures and attaching them to all documents

Correct Answer: Using unique credentials, multi-factor authentication and secure signature capture with audit trails

Q30. During a change of vendor for training services, what record control step is important?

• Document vendor qualification, training materials, attendance records and evaluate equivalency of training outcomes
• Stop all training indefinitely
• Ignore vendor qualification and accept informal training
• Delete past training records to avoid comparison

Correct Answer: Document vendor qualification, training materials, attendance records and evaluate equivalency of training outcomes

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com