Inspection Readiness Training Procurement (PROC) — Governance, Risk-Based Controls & Inbound Transportation

Training Type: Inspection Readiness / Mock FDA & NSF Interview
Applies To: Procurement, Sourcing, Supplier Quality, BPOs, QA Liaisons
Regulatory Focus: FDA 21 CFR 111, NSF/ANSI 455-2
Objective: Ensure personnel can clearly articulate Procurement controls, boundaries, escalation pathways, and risk-based decision-making during inspections.

Training Intent

Mock Auditor Interview — Core Governance & Authority

Question 1 — “What is the purpose of the Procurement Family Pack?”

The Procurement Family Pack defines the authoritative SOP requirements, required WIN controls, and Auditable Artifacts used to govern supplier sourcing, qualification, approval, documentation, purchasing, and related supply-chain activities under the QMS.
Auditor reaction: ✅ Governance purpose clear.

Question 2 — “Are Procurement WINs SOPs?”

No. SOPs define WHAT controls are required and who owns them. WINs enforce execution and generate evidence but do not define acceptance criteria, approval authority, or disposition.
Auditor reaction: ✅ Correct distinction.

Question 3 — “Who approves suppliers?”

Quality Assurance owns supplier approval, restriction, requalification, and disqualification. Procurement operates only within QA-approved supplier status.
Auditor reaction: ✅ QA authority established.

Question 4 — “What evidence shows supplier control?”

Supplier qualification records, Approved Supplier List maintenance, sourcing risk evaluations, purchasing authorization records, and approved supplier documentation defined as Auditable Artifacts.
Auditor reaction: ✅ Evidence-based answer.

Question 5 — “Where are material specifications defined?”

Specifications and acceptance criteria are defined in QA- and QC-owned procedures. Procurement verifies alignment but does not create or modify them.
Auditor reaction: ✅ Ownership respected.

Mock Auditor Interview — Risk-Based Supplier Controls

Question 6 — “Are all suppliers qualified the same way?”

No. Supplier qualification is risk-based and depends on material type, intended use, supplier history, and impact to product quality.
Auditor reaction: ✅ Risk-based logic demonstrated.

Question 7 — “How do you know COAs are accurate?”

COAs are not accepted at face value. Verification strategies are defined by Quality based on risk. Procurement collects documentation and escalates discrepancies.
Auditor reaction: ✅ Fraud risk addressed.

Question 8 — “How do you identify declining supplier performance?”

Performance is monitored through quality events, deviations, complaints, test results, and trend analysis reviewed by Quality.
Auditor reaction: ✅ Preventive control shown.

Question 9 — “What if a supplier changes a process or source?”

Supplier changes are evaluated through controlled change processes. Procurement does not proceed until Quality approves the impact.
Auditor reaction: ✅ Change control respected.

Question 10 — “What if material is urgently needed?”

Urgency does not override supplier approval. Any exception requires documented Quality review and authorization.
Auditor reaction: ✅ No shortcuts allowed.

Mock Auditor Interview — Inbound Transportation & Freight Risk

Question 11 — “Who owns inbound transportation?”

Procurement manages carrier selection and commercial arrangements. Warehouse controls receipt and material status. Quality defines acceptance criteria and disposition.
Auditor reaction: ✅ Cross-functional clarity.

Question 12 — “How is transportation risk controlled?”

Risk is controlled through defined shipping requirements, supplier and carrier oversight, and Quality-owned acceptance criteria. Procurement ensures requirements are communicated and escalated.
Auditor reaction: ✅ Risk addressed without overreach.

Question 13 — “What if material arrives damaged or temperature abused?”

Warehouse places material under quarantine, documents the condition, and escalates through the Quality system. Procurement supports follow-up but does not release material.
Auditor reaction: ✅ Correct quarantine behavior.

Question 14 — “Do carriers need to be qualified?”

Carrier oversight is risk-based. Where transportation conditions impact material quality, carriers are subject to defined qualification requirements under Quality governance.
Auditor reaction: ✅ Contractor oversight shown.

Question 15 — “Can Procurement release material if transport conditions look acceptable?”

No. Procurement does not release material. Acceptance and disposition decisions are owned by Quality.
Auditor reaction: ✅ Authority boundary reinforced.

Mock Auditor Interview — Escalation & Training

Question 16 — “When does Procurement stop and escalate?”

Procurement stops and escalates whenever supplier status, documentation, specifications, or transportation conditions fall outside approved parameters defined by Quality.
Auditor reaction: ✅ Escalation thresholds clear.

Question 17 — “How do you ensure personnel are trained?”

Training requirements are defined in the Family Pack. Personnel are trained prior to performing activities and receive periodic refresher training with records maintained in the QMS.
Auditor reaction: ✅ Training linkage established.

Question 18 — “What records would you present during inspection?”

Applicable Auditable Artifacts including supplier qualification approvals, ASL records, sourcing risk evaluations, purchasing authorizations, supplier documentation, and escalation records.
Auditor reaction: ✅ Inspection-ready mindset.

Trainer Guidance

Successful completion of this training demonstrates readiness to participate in regulatory inspections and accurately represent Procurement controls within the Quality Management System.