cleaning validation and verification as an inspection foundation
(Inspection as primary basis for food quality and safety)
Stem: A transporter operates a multi-purpose refrigerated
trailer that hauls fresh produce one day and packaged dry
goods the next. During a routine audit, the trailer shows visible
soil but the operator records a sanitation event in the log. What
is the most appropriate immediate action for the auditor?
Options:
A. Accept the sanitation log entry because documentation
satisfies GDP requirements.
B. Require re-cleaning and verify with visual inspection and
temperature/hygiene checks before release.
C. Permit loading if the trailer surface temperature is within
specification.
D. Ask for a signed declaration from the driver that a sanitation
event occurred.
Correct Answer: B
Rationale (correct): Re-cleaning with verification (visual plus
objective checks) is required when soil remains; visual
inspection alone must be supported by verification measures
(Chapter 1 — Transporter Container Sanitation). This aligns with
,GDP and HACCP verification steps.
Rationale (A): Documentation alone is insufficient; GDP and ISO
22000 require verification, not just records.
Rationale (C): Surface temperature does not indicate
cleanliness; it only indicates thermal status, not microbial or
physical contamination.
Rationale (D): A signed declaration is documentation only and
does not substitute for verification of cleanliness.
Teaching Point: Documentation must be supported by
verification — sight plus objective checks.
2
Chapter & Subtopic: Chapter 1 – Traceability and Temperature
Control — Key Concept: linking traceability events to
temperature excursions (Moving to measurement and causal
analysis)
Stem: During a multi-stop cold chain delivery, a 2°C
temperature excursion occurs for 90 minutes due to a
refrigeration failure. Which traceability action best supports
root-cause analysis and HACCP corrective action?
Options:
A. Record the excursion in shipment log and discard shipment
immediately.
B. Document timestamped temperature data, stop location,
point of origin, and receiver contact for investigation.
C. Only notify the customer and leave investigation to them.
, D. Note the excursion verbally to the next driver at handover.
Correct Answer: B
Rationale (correct): Timestamped, location-linked data plus
supply-chain contacts enable causal analysis and corrective
action per HACCP and ISO 22000 (Chapter 1 — Traceability and
Temperature Control). This supports risk-based disposition
decisions.
Rationale (A): Immediate discard may be unnecessary without
investigating product risk; proper documentation first is
required for disposition.
Rationale (C): Solely notifying the customer delays internal
root-cause actions and violates GDP responsibilities.
Rationale (D): Verbal notes are unreliable and do not provide
the necessary data for analysis or regulatory compliance.
Teaching Point: Capture time–location temperature data to
enable causal analysis and safe disposition.
3
Chapter & Subtopic: Chapter 1 – Inspection as Primary Basis —
Key Concept: inspection vs. measurement (Need for technology
and hard data to enter the certification arena)
Stem: A company seeks certification for its transport
operations. Which combination most directly demonstrates
readiness for a modern certification audit?
Options:
A. Photographic evidence of trucks, a printed sanitation SOP,