Recall readiness checklist

A recall notice names a product and a set of lots. Everything that happens next depends on records you either kept or did not keep, months before. This is the list of questions worth answering while nothing is wrong.

Nothing here is specific to CompliMED. If your answers are good, you do not need us.

Knowing what you hold

1. Can you produce a list of every unit of consignment stock in the field, by lot, today?
2. Does that list say who is holding each unit — not who imported it, the person whose
3. trunk it is in?
4. When was it last reconciled against something other than itself?
5. If a rep left tomorrow, could you account for their stock without calling them?

Matching a notice

1. When a manufacturer names lots, can you match them exactly, or do you match on
2. product and then check by hand?
3. Can you match a lot pattern when the notice gives a range rather than a list?
4. Does the answer include units already used on a patient, or only what is still on a
5. shelf?
6. Can you tell which facility each affected unit went to?

Stopping the bleeding

1. Can you quarantine affected stock so it cannot be used, rather than emailing people and
2. hoping?
3. How long between the notice arriving and every holder knowing?
4. Is there a record of who was told, and when?

Proving it afterwards

1. Can you show what your inventory record said on the day the notice arrived, not
2. just what it says now?
3. Could someone with database access have changed that record without leaving a trace?
4. When you export the evidence, is there a record that the export happened — who ran it,
5. what scope, how many rows?

The questions that usually go badly are 4, 7, 12 and 13. They are the ones that cannot be answered by looking harder at a spreadsheet, because the information was never captured in the first place. Retrofitting them is not possible; a record either exists from the beginning or it does not.