Self-Assessment
How ready is your traceability, honestly?
Five questions about your own record keeping. No email required to see the result, and nothing here tells you whether you are compliant - only your own programme and your regulator can do that.
0 of 5 answered
1. When material arrives, is the supplier lot code captured somewhere searchable?
Receiving is where most traces go cold. A lot code on a paper log is not retrievable under time pressure.
2. When inputs become a finished batch, is the link between input lots and the output lot recorded?
This is the step that turns a pile of records into a genealogy. Quantities alone are not enough.
3. Can you say which customers received a specific finished lot?
Forward tracing decides how wide a withdrawal has to be. Vague records mean pulling more than you need.
4. If you were asked today to trace one lot in both directions, how long would it take?
Not how long it should take. How long it would actually take, this week, with the people available.
5. When did you last run a mock recall on a lot you did not pick in advance?
Choosing the lot beforehand tests the paperwork. Not choosing it tests the system.