Preparing Medical Stock for a Health Authority Audit

What auditors look for

• Temperature records — evidence that storage conditions were maintained.
• Traceability — batch and expiry tracking of stock.
• Segregation — quarantined and released stock kept apart.
• Documentation — an audit trail from receipt to dispatch.
• Approval — a facility licensed for medical/pharmaceutical storage.

How to stay audit-ready

Audit readiness is not a scramble before an inspection — it is a by-product of running compliantly every day. When temperature is logged continuously, stock is barcoded to batch and expiry, and movements are documented, the evidence an auditor asks for already exists.

Audit-ready by design at SFIMS

SFIMS operates its DOH & MOH approved warehouse with continuous temperature logging, GS1 traceability, GDP-aligned segregation and documented handling — so audits are a matter of showing what is already captured.

How an audit actually runs

Knowing the shape of the day removes most of the anxiety.

An opening discussion establishes scope and what will be examined.

A facility walk round usually comes early, because housekeeping and segregation are visible immediately.

Record sampling follows, typically by tracing specific batches end to end rather than reading procedures in isolation.

Staff questions, often asking someone to demonstrate a routine task. If the demonstration and the written procedure disagree, the procedure is treated as wrong.

A closing discussion sets out findings.

The pattern is consistent: auditors test whether the documented system describes the real one. Nearly every finding is a gap between the two.

The week before

Genuine readiness is built over months, but a focused week helps:

• Confirm calibration certificates are current, not lapsed by a fortnight.
• Check the temperature record can be produced for any period requested, including last summer.
• Review the deviation log and confirm every entry has an outcome recorded.
• Verify training records cover current staff, including recent joiners.
• Walk the floor and look at quarantine, returns and rejects with fresh eyes.
• Run a trace on a random batch and time it.
• Confirm procedures match current practice, and correct the document where they do not.

Resist the urge to write new procedures in the final week. Documents dated shortly before an audit invite exactly the scrutiny they were meant to avoid.

Responding to findings

How findings are answered matters nearly as much as how many there were.

A good response identifies the actual cause rather than the symptom, states corrective action for the immediate problem and preventive action to stop recurrence, gives realistic owners and dates, and closes with evidence that the action was completed.

The weak response blames an individual and promises retraining. That answers almost nothing, because it explains why one person made an error rather than why the system allowed it. Auditors returning for a follow-up look first at whether previous findings genuinely closed, and a reopened finding is treated far more seriously than a new one.