What an Inspector Looks At

Part of Clinical Laboratory (LAB) Training: Inspection Readiness for the Laboratory.

About 2 minutes. Free, in your language, no account needed.

They audit the record, not your technique

Nobody watches you pipette. They read what you wrote and ask whether it supports the results the study relies on.

That reframing is the whole of inspection readiness.

The usual order

Delegation and training. Were you authorized and trained, and were the dates before the work? This is checked first because it is quick and it fails often.

Equipment. Calibration, maintenance and temperature monitoring records, current and complete.

The sample journey. They pick a participant and follow one sample from collection to shipment, through every log.

Deviations. What was found, how fast it was reported, and whether the corrective action matched the cause.

The traceability walk is the real test

If they can follow one sample end to end without a gap, most of the inspection is already answered.

If they cannot, every other record becomes suspect, because the one they checked did not hold.

Do this walk yourself, periodically, on a sample chosen at random. It finds the gaps while they are still fixable.

Gaps are worse than problems

A documented excursion with a sponsor assessment is a controlled event. An undocumented interval is an unknown, and unknowns expand.

Inspectors are not surprised by problems. They are concerned by records that cannot answer a question.

Do not tidy before an inspection

Reorganizing files, printing fresh copies or completing logs from memory is the fastest way to turn a minor finding into a serious one.

Records created after the fact are usually identifiable, and they raise a question about everything else.

Answer only what is asked

Say what you know. Say you do not know when you do not, and offer to find out.

Speculating creates statements that have to be defended later, and they are rarely accurate under pressure.