CHA Computer Systems & Software Updates 5

Question 1

Under FSMA's Preventive Controls for Human Food rule, electronic records of preventive control monitoring must be retained for a minimum of:

Accepted Answer

2 years

Answer

FSMA's Preventive Controls rule (21 CFR Part 117) generally requires that records of preventive control monitoring be retained for at least 2 years.

Question 2

A HACCP auditor is evaluating whether a facility's networked CCP sensors are adequately protected from cybersecurity threats. Which control is MOST directly relevant to food safety data integrity?

Accepted Answer

Segmenting the food safety monitoring network from general business IT networks

Answer

Network segmentation isolates CCP monitoring systems from broader business networks, reducing the risk of cyberattacks corrupting or disrupting food safety data.

Question 3

A software vendor releases a critical security patch for the HACCP monitoring application. What must the facility do BEFORE applying the patch in a regulated environment?

Accepted Answer

Assess the patch impact, test in a non-production environment, and follow the change control process

Answer

Even critical security patches must go through impact assessment, non-production testing, and change control documentation before being applied to validated HACCP systems.

Question 4

Which term describes the documented evidence that a computer system was designed to meet HACCP and regulatory requirements before it was built?

Accepted Answer

Design Qualification (DQ)

Answer

Design Qualification (DQ) documents that the system's design specifications meet the user's requirements and applicable regulatory standards before construction or purchase.

Question 5

A facility uses a SCADA system to control and monitor a pasteurization CCP. During an audit, the SCADA software version in use is found to be two major versions behind the validated version. What is the auditor's primary concern?

Accepted Answer

The system may be operating outside its validated state, making CCP data unreliable

Answer

Operating outside the validated software version puts the system outside its qualified state, potentially invalidating the reliability of CCP monitoring data.

(CHA) Certified HACCP Auditor Practice Test

(CHA) Certified HACCP Auditor Practice Test

CHA Computer Systems & Software Updates 5