CHA Computer Systems & Software Updates 3 — Questions and Answers
Question 1: A facility's HACCP software update includes a patch that modifies how the system stores CCP temperature readings. What document must be updated FIRST?
- The equipment calibration log
- The software change control record (Correct answer)
- The supplier approved vendor list
- The corrective action log
Correct answer: The software change control record
A formal change control record must be initiated before implementing any software modification that affects CCP data storage or processing.
Question 2: Which qualification protocol verifies that a newly installed HACCP monitoring software performs correctly under actual production conditions?
- Installation Qualification (IQ)
- Design Qualification (DQ)
- Performance Qualification (PQ) (Correct answer)
- Operational Qualification (OQ)
Correct answer: Performance Qualification (PQ)
Performance Qualification (PQ) tests the system under real production conditions to confirm it meets HACCP monitoring requirements in actual use.
Question 3: When a HACCP auditor reviews a computer system change log, what is the MOST critical element to verify?
- That updates were performed on weekends to minimize disruption
- That each change was authorized, tested, and approved before implementation (Correct answer)
- That the IT vendor was certified by a third-party organization
- That the software is the most current version available globally
Correct answer: That each change was authorized, tested, and approved before implementation
Effective change control requires documented authorization, testing results, and approval signatures before any change goes live in a regulated HACCP environment.
Question 4: A facility uses automated software to flag CCP deviations and trigger corrective action notifications. During an audit, the system fails to flag an actual deviation. This represents a failure of:
- Preventive maintenance on the server hardware
- Software performance qualification requirements (Correct answer)
- The master sanitation schedule
- Personnel training records
Correct answer: Software performance qualification requirements
Failure to detect and flag a real CCP deviation is a performance qualification failure, indicating the system does not meet its validated functional requirements.
Question 5: In a HACCP computer system, what is the purpose of maintaining a 'system specification document'?
- To list all employees authorized to use the software
- To define the intended functions, inputs, outputs, and performance requirements of the system (Correct answer)
- To record daily IT maintenance activities
- To satisfy insurance requirements for equipment coverage
Correct answer: To define the intended functions, inputs, outputs, and performance requirements of the system
The system specification document is the baseline reference that defines what the software must do, enabling validation activities to verify those requirements are met.
Question 6: A software update is rolled back after it causes erroneous CCP alerts. What HACCP documentation action is required?
- No documentation is needed since the issue was corrected quickly
- A deviation report and corrective action record documenting the impact on HACCP monitoring (Correct answer)
- Only the IT ticket needs to be closed with a resolution note
- Update the HACCP plan to reflect that software errors are an acceptable risk
Correct answer: A deviation report and corrective action record documenting the impact on HACCP monitoring
Any software failure that affected HACCP monitoring must be documented as a deviation with a formal corrective action record addressing root cause and impact assessment.
Question 7: Which federal regulation specifically governs electronic records and electronic signatures used in FDA-regulated food facility HACCP systems?
- 21 CFR Part 120
- 21 CFR Part 11 (Correct answer)
- 21 CFR Part 110
- 21 CFR Part 117
Correct answer: 21 CFR Part 11
21 CFR Part 11 is the FDA regulation that establishes criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures.
CHA Computer Systems & Software Updates 3
A facility's HACCP software update includes a patch that modifies how the system stores CCP temperature readings.
What document must be updated FIRST?