Vaccine storage and cold chain checklist

Source anchors

How to use this checklist

Use this checklist to audit whether the service can evidence safe vaccine storage and cold-chain governance. It can be used monthly, before a high-volume vaccination clinic, after a cold-chain incident, or before an inspection-readiness review.

For each row, record:

Met: evidence is current and complete.
Part met: evidence exists but has a gap or needs follow-up.
Not met: evidence is absent or the control is not working.
Not applicable: the service does not carry out this activity.

Every Part met or Not met item should create an action with an owner and due date.

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Service details

Field	Local entry
Service name
Location
Date completed
Completed by
Registered Manager
Cold Chain Lead
Fridge asset identifier
Period reviewed

1. Governance and ownership

Check	Evidence to review	Status	Action owner	Due date
Cold Chain Lead is named.	Procedure, role list, governance record.
Cold Chain Deputy is named.	Procedure, rota, absence cover record.
Staff know who to contact if there is a cold-chain concern.	Staff interview, induction record, procedure.
Current cold-chain procedure is available to staff.	Procedure location, staff briefing record.
Procedure has been reviewed against current UKHSA and CQC source material.	Review date, source check, governance minute.

2. Fridge and equipment

Check	Evidence to review	Status	Action owner	Due date
Vaccines are stored in a dedicated vaccine or pharmaceutical fridge.	Physical check, asset record.
Domestic fridge is not used for vaccines.	Physical check, equipment record.
Fridge is secure and access is controlled.	Physical check, key/access process.
Fridge is clean, free of ice build-up and not overfilled.	Physical check, cleaning record.
Vaccines are kept in original packaging and away from fridge walls and door.	Physical check.
Power supply is protected from accidental switch-off where reasonably practicable.	Physical check, socket label or equivalent control.
Servicing, maintenance or calibration evidence is current.	Service record, calibration record, asset log.
A backup plan exists for fridge failure or power failure.	Business continuity plan, cold-chain procedure.

3. Temperature monitoring

Check	Evidence to review	Status	Action owner	Due date
Temperature record covers every required day in the review period.	Temperature log.
Current temperature is recorded.	Temperature log.
Minimum and maximum temperatures are recorded.	Temperature log.
Staff name or initials are recorded.	Temperature log.
Thermometer reset is recorded where required by local procedure.	Temperature log.
Out-of-range readings are clearly escalated.	Temperature log, incident record, advice record.
Data logger use does not replace required routine readings.	Data logger record, temperature log.
Temperature records are reviewed by the Cold Chain Lead.	Review signature, governance note.

4. Stock control

Check	Evidence to review	Status	Action owner	Due date
Current stock list is accurate.	Stock record, physical stock check.
Batch numbers and expiry dates are recorded.	Stock record, delivery record.
Shortest expiry stock is used first.	Physical layout, stock rotation record.
Expired or damaged vaccines are removed from usable stock.	Physical check, disposal record.
Stock levels are proportionate to clinic need and fridge capacity.	Stock record, clinic schedule, ordering record.
Repeated waste or expiry has been reviewed.	Audit record, incident/action log.

5. Ordering, receipt and transport

Check	Evidence to review	Status	Action owner	Due date
Vaccine deliveries are recorded on receipt.	Delivery record, stock record.
Delivery condition concerns are escalated before use.	Delivery note, incident record.
Vaccines are moved into the fridge without avoidable delay.	Receipt process, staff interview.
Transport outside the fridge is approved and recorded.	Transport record, cold-chain procedure.
Transport records identify vaccine, batch, destination and time out of fridge.	Transport record.
Temperature assurance during transport is recorded where required.	Transport record, container validation evidence.

6. Cold-chain excursion response

Check	Evidence to review	Status	Action owner	Due date
Affected vaccines are labelled and kept separate from usable stock.	Physical check, incident record.
Affected stock is not used until advice and decision are recorded.	Quarantine record, advice record.
Excursion duration and temperature range are recorded where known.	Temperature log, incident record.
Affected vaccines, batches, expiry dates and quantities are identified.	Incident record, stock record.
Advice route is documented.	Advice record, email, call note.
Final decision is recorded for each affected vaccine.	Advice record, disposal record, stock release record.
Patient impact has been assessed if affected vaccine was administered.	Clinical review, patient contact record.
Duty of candour and external reporting were considered where relevant.	Incident review, governance note.

7. Incidents, learning and improvement

Check	Evidence to review	Status	Action owner	Due date
Cold-chain excursions are recorded as incidents.	Incident register.
Vaccine errors are recorded and clinically reviewed.	Incident record, clinical review.
Adverse-event reporting route is considered where relevant.	Incident record, Yellow Card decision record.
Root cause is identified for significant or repeated failures.	Investigation record.
Corrective actions have owners and due dates.	Action log.
Actions are closed only when completion evidence exists.	Action record, evidence.
Learning is shared with relevant staff.	Team briefing, supervision, training update.
Repeated issues are added to the risk register or governance agenda.	Risk register, governance minutes.

8. Staff training and competence

Check	Evidence to review	Status	Action owner	Due date
Staff handling vaccines have role-appropriate cold-chain training.	Training matrix.
Staff know the breach procedure.	Staff interview, supervision note.
Staff know not to use quarantined or uncertain stock.	Staff interview, procedure.
Reception or administrative staff know what to do with deliveries.	Induction record, staff interview.
Training is refreshed after incidents or process changes.	Training record, incident action.

9. Summary judgement

Question	Answer
Is the cold-chain system safe today?
Are any vaccines currently quarantined or uncertain?
Are any actions overdue?
Is the risk register up to date?
Does the Registered Manager need to review this immediately?

10. Action log

Action	Source check	Owner	Due date	Completion evidence

11. Completion

Sign-off	Name	Date
Completed by
Reviewed by Registered Manager

This checklist is a working tool. It does not replace clinical judgement, product-specific storage requirements, live regulator guidance or the service's own governance decision.