The records once there is more than one of you

One person making one sauce keeps a batch sheet and that is the whole system. Everything below starts mattering at the point where you are not personally present for every batch.

Five sets, not one

Processing records, one per batch, covering the critical factors your process specifies. The batch sheet, and the subject of its own page.

Process documents. Your scheduled processes, the filings they correspond to, and the process authority letters. One folder, current versions only, with superseded ones dated and kept separately rather than thrown away.

Incoming material. Supplier, lot, date received, and for peppers the condition on arrival. Traceability runs backwards as well as forwards and the backward half is the one nobody builds.

Sanitation and maintenance. What was cleaned, when, by whom, and any equipment work. This is the set that is entirely uninteresting until an investigator asks for it.

Complaints and dispositions. Every complaint, what was found, what was done. Three unrelated complaints look like noise; three complaints against one batch code look like something else, and only a written set shows the difference.

Retention

Records are kept, not just made. How long depends on the shelf life of the product and on which requirements apply to you, and the working rule producers often land on is the shelf life plus a comfortable margin, never less than the period your own requirements set.

Ask the question once, write the answer down, and put the retention period on the folder. A rule nobody can state is a rule that quietly becomes "until we ran out of space".

Who writes them when you are not there

The moment somebody else runs a batch, the record stops being a note to yourself and becomes a document one person writes and another reads. That changes what it has to be.

Entries initialled, so a question has somebody to ask. No blanks, because a blank is unreadable later and "not applicable" is not. Corrections struck through rather than overwritten, with the original still legible.

And the person signing has to have been shown what the numbers mean. Somebody writing down a pH they do not understand will write down a wrong one without noticing.

The retrieval test

Hand yourself a bottle with a code on it. How long to produce the batch record, the lot numbers of everything in it, the pH with its timestamp, and the list of who it went to?

Under an hour is a working system. A day means you have records but not a recall procedure. Run the test on a quiet afternoon rather than discovering the answer on the day it matters.

Where it breaks at scale

It is rarely the batch sheet. It is the second product sharing a form designed for the first, the supplier lot copied from the last sheet because the sack is already open, and the month somebody was covering and nobody had shown them the file.

All three are fixed the same way, by making the correct thing the easy thing: a form per product, the lot written when the sack is opened, and the folder where the work happens rather than in an office.

References