and Safety
Key Concept: Role of inspection vs. measurement-based
verification in transportation
Stem: A transporter routinely inspects incoming refrigerated
containers visually and by paperwork but rarely records
objective temperature logs or sensor data. According to modern
best practice, what is the most important deficiency in this
approach?
A. Visual inspection is sufficient if staff are well trained.
B. Lack of objective, time-stamped measurement data prevents
verification of cold-chain control.
C. Paperwork is always more reliable than sensors because it’s
signed.
D. Frequent visual checks obviate the need for traceability
systems.
Correct Answer: B
Rationale — correct: The primary deficiency is the absence of
objective, time-stamped measurement data necessary to verify
continuous temperature control, as described in Chapter 1 —
Inspection as Primary Basis. Measurement-based verification is
required under HACCP and GDP to demonstrate control of
critical limits.
,Rationale — A (wrong): Visual inspection alone cannot detect
transient temperature excursions that affect product safety; it’s
insufficient for HACCP verification.
Rationale — C (wrong): Paper signatures are prone to error or
falsification and lack continuous time-series data needed for
causal analysis.
Rationale — D (wrong): Visual checks are useful but do not
replace traceable sensor data necessary for effective
traceability and risk management.
Teaching Point: Objective, time-stamped measurement is
essential to verify cold-chain control.
2
Chapter & Subtopic: Chapter 1 — The Need for Technology and
Hard Data to Enter the Certification Arena
Key Concept: Data integrity & its role in certification and audits
Stem: During a third-party audit for GDP certification, an
auditor requests temperature sensor raw files. The transport
operator provides manually transcribed daily max/min values
instead. Which issue most directly jeopardizes certification?
A. The operator used a different format for the files.
B. Absence of raw sensor records undermines data integrity and
traceability.
C. Daily max/min summaries are cleaner and preferred for
, audits.
D. Auditors prefer paper records to electronic.
Correct Answer: B
Rationale — correct: Certification and audits require original
electronic records to verify data integrity and allow forensic
review; Chapter 1 emphasizes entering the certification arena
requires reliable hard data. This links to ISO 22000
requirements for documented evidence of control.
Rationale — A (wrong): File format differences are resolvable;
the core issue is the lack of raw data.
Rationale — C (wrong): Summaries remove detail needed to
detect excursions and do not substitute for raw records.
Rationale — D (wrong): Auditors accept electronic records;
authenticity and traceability of original files matter most.
Teaching Point: Maintain and present original electronic sensor
data for auditability and certification.
3
Chapter & Subtopic: Chapter 1 — Moving to Measurement and
Causal Analysis
Key Concept: Using data to identify root causes of temperature
excursions
Stem: A refrigerated load shows a 4-hour temperature rise
during transit. Which immediate action best supports causal
analysis and HACCP corrective action?