Batch record checklist

When to use it

The batch record reviewer uses this list each time this job or event occurs. Allow about 5 minutes for the checks, plus time for any problem found. Work from the job card and the records kept at the machine. Look at the actual item before ticking it. Mark No when evidence is missing and explain why.

Its scope is specific: food and pharma: every entry in the batch record filled at the time. First confirm batch number is written at start, then examine the relevant work before approval or handover. The person named at the top should complete the checks as the work happens. Do not sign a page from memory later.

If an item is a "No"

For a failed (must) check, hold the affected work at its current stage. The batch record reviewer records the item, current job or lot, time and a clear note. Tell the person authorised to release that work. Do not tick Yes after simply sending a message. Recheck the item and record who accepted it before proceeding.

For this checklist, pay particular attention when critical process readings are entered cannot be confirmed. Check the supporting record or the actual material. A photo alone may not prove a measurement or approval. Note missing evidence.

For other failures, name an owner and due date. Escalate safety, compliance or customer risks before release.

Common mistakes

• Ticking material lots are recorded as used without looking at the actual item or source record.
• Writing "done" when corrections keep original readable has not been checked.
• Closing the sheet even though yield is reconciled with input is still unknown.
• Filing the page with no name, no date or no owner for failed items.

Make it your own

Print this on A4 or keep it in a shared sheet. Add a column for the person clearing each failed item. In a plastics business, adapt the references to the part, lot, machine or delivery document your team actually uses. In fabrication, name the local register and sign-off owner. Remove a check only if it truly cannot apply, and write down why. Do not remove critical safety or statutory checks without qualified review.

Try the list on a real job, then ask the batch record reviewer which records were hard to find. Keep one approved version with a revision date so the team uses the same checks.

Review required: This is a practical starting list, not a legal or safety certificate. Check the current rules and get a qualified person to review it for your site. Items marked [VERIFY] need a site-specific or official-source check before use.

A checklist only works if someone ticks it, every time, and someone reads it.

Questions people ask

Who should sign the batch record checklist?

The batch record reviewer who performed the check signs it. If a different person approves release, capture that name too. Do not use another person’s signature.

What if batch number is written at start cannot be confirmed?

Mark No, describe what you looked at and hold the affected work if it is a critical item. Ask the authorised owner to decide the next action. Keep the result in the same record.

Can we use the short version instead of the full checklist?

Use the short version for a quick reminder. The full list has the remaining checks, failed-item notes and signature. Keep it for the actual decision and review.

Read next

• Related process
• Related problem
• Related checklist