Inspection Readiness Training
Warehouse (WH) — QA Governance & Execution Boundaries
Training Type: Inspection Readiness / Mock FDA Interview
Applies To: Warehouse Operators, Supervisors, BPOs, QA Liaisons
Regulatory Focus: FDA 21 CFR 111, NSF/ANSI 455-2
Objective: Prepare personnel to respond accurately, consistently,
and confidently during regulatory inspections.
Training Intent
This training simulates real FDA and NSF auditor questioning.
The goal is not memorization, but conceptual mastery of:
- Warehouse execution vs Quality governance
- Where limits, acceptance criteria, and authority reside
- What WINs do — and do not do
- When to STOP and escalate
- How compliance is evidenced
Mock Auditor Interview — Core Questions
Question 1 — “What is the purpose of the Warehouse Family Pack?”
The Warehouse Family Pack defines the authoritative SOP requirements,
minimum WIN control framework, and required Auditable Artifacts
needed to control material receipt, storage, handling, movement,
and shipping.
Auditor reaction: ✅ Clear governance understanding.
Question 2 — “Are WINs SOPs?”
No. SOP requirements are governed by the Family Pack.
WINs enforce execution of those requirements and generate evidence,
but they do not define acceptance criteria or authority.
Auditor reaction: ✅ Correct distinction between WHAT and HOW.
Question 3 — “Who owns material disposition decisions?”
Quality Assurance owns all disposition, release, salvage,
reprocessing, and destruction decisions.
Warehouse performs custody, segregation, and traceability only.
Auditor reaction: ✅ Expected QA authority statement.
Question 4 — “What evidence shows Warehouse is controlling material status?”
Status control is evidenced through Auditable Artifacts such as
material status records, location control, inventory records,
and movement documentation defined in the Family Pack.
Auditor reaction: ✅ Evidence-based response.
Question 5 — “WIN-WH-STORAGE-ENV-MONITOR does not define temperature or humidity limits.
Where are those defined?”
Environmental limits and acceptance criteria are defined in
QA-owned procedures. Warehouse executes monitoring under QA governance.
Auditor reaction: ✅ Correct QA ownership of limits.
Question 6 — “What happens if Warehouse detects an environmental excursion?”
Warehouse documents the condition, places affected materials under
appropriate status control, and escalates the issue through the
Quality system for investigation and disposition.
Auditor reaction: ✅ Correct escalation pathway.
Question 7 — “Is environmental monitoring an IPC?”
No. Environmental monitoring is a storage control.
IPCs apply to in-process material controls during manufacturing.
Auditor reaction: ✅ Terminology used correctly.
Question 8 — “Can Warehouse personnel perform QC or QA activities?”
Warehouse personnel may execute certain QC-owned checks
under documented delegation and training.
Acceptance criteria and oversight remain governed by Quality.
Auditor reaction: ✅ Delegation properly explained.
Question 9 — “How do you know personnel are trained to perform these activities?”
Training requirements are defined in the Family Pack.
Personnel are trained prior to task execution and receive
periodic refresher training, with records maintained per QMS.
Auditor reaction: ✅ Training linkage established.
Question 10 — “What records would you show me to prove control?”
I would present the applicable Auditable Artifacts defined in
the Family Pack, such as receiving records, status records,
environmental logs, inventory records, and escalation references.
Auditor reaction: ✅ Evidence-first mindset.
Trainer Guidance
- Ask trainees to answer without reading.
- Correct phrasing matters — reinforce consistent language.
- Practice “wrong answer” scenarios to reinforce boundaries.
- Do not allow improvisation on ownership or authority.
Successful completion of this training indicates readiness to participate
in regulatory inspections and accurately represent Warehouse controls
within the Quality Management System.