Master Batch Record vs Batch Record, With Examples

A master batch record is the approved instructions for making one product at one batch size: the ingredients and their amounts, the steps in order, the checks with their limits, the expected yield, and the packaging. A batch record is a copy of that master filled in while one batch is made: the lots actually used, the weights actually weighed, the check results, the yield, and who did it. You write the master once and change it with a new version; you fill in a batch record every time you make the product.

The short version

• Master: one per product per batch size, versioned, approved before use. It says what should happen.
• Batch record: one per batch, filled in as you go. It says what did happen.
• The master sets the limits; the batch record shows each result against them.
• When the result is outside a limit, the batch record says what was done about it.
• In TaroStack, the recipe is the master and recording a batch writes most of the batch record. More below.

Side by side

There's a short version of this in what is a batch record, which has a full filled-in batch record. This page is about the pair.

What the rules call them

The terms come from the drug and dietary supplement rules. Food rules don't use them, but buyers, auditors and co-packers borrow them, so it helps to know where they're from.

For dietary supplements, you need a written master manufacturing record for each unique formulation and each batch size, and it must include, among other things, the components and their weights, the expected yield at each step and at the end, and "the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary" (21 CFR 111.210). Every batch then gets a batch production record that follows the master, with the batch or lot number, each component's identifier and weight, the actual yield and its percentage of theoretical, and the monitoring results (21 CFR 111.260).

Drugs use "master production and control records", which must be signed by one person and independently checked and signed by a second (21 CFR 211.186), and "batch production and control records", which begin with an accurate copy of the master (21 CFR 211.188).

For a food maker the practical meaning is the same: a fixed, approved recipe with its checks, and a filled-in record of each batch. This is general information, not legal advice; your inspector or auditor has the last word.

A master batch record, for kūlolo

Here's the master that Windward Roots, the made-up taro business I use in these examples, works from:

Nothing on it is filled in. It's the standard, and every batch record for kūlolo v3 copies it.

Two batch records from it

The batch made on September 22, lot KUL-260922A, is written out in full in what is a batch record. Its batch weight was 42.1 kg, the bake ended at 194°F, cooling took 1 hour 40 minutes, and 117 good trays came out: 97.5% of expected, inside the range. Nothing more to write.

Now a different week. Lot KUL-261006A:

110 trays is below the range, so the batch record gets a deviation note: what happened (a tray rack tipped while cooling, ten trays damaged), what was done (the damaged trays discarded and recorded as waste), and whether the rest of the batch was affected (no: the others were checked and released). The master doesn't change, because the recipe wasn't the problem. If yields kept falling short for a reason in the recipe, that would be a new master, v4, with a date and an approval.

Keeping masters under control

1. Give every master a version and a date, and keep the old versions.
2. One person writes or changes it; a second checks it before it's used. The drug rule requires that; it's a good habit for anyone.
3. Batch records name the master version they followed, so a batch from March can be read against March's recipe.
4. Take superseded masters off the wall and the clipboard. A batch made from last year's master is the classic mistake.

Lot codes for the batch records themselves are covered in how to create lot numbers, and ready-made forms for other kinds of maker are in the cosmetic batch record template and the herbal products batch record.

Where this stops working

On paper, the master lives in a binder and the batch records are photocopies of it, filled in by hand. The weak spots are predictable: a copy made from an old version, a lot number copied wrong from a case, a yield nobody divides by the expected to see if it's in range, and a deviation that was handled on the floor and never written down. And when a buyer asks for every batch made from one ingredient lot, the answer is a morning with the binder.

How TaroStack does it

In TaroStack the recipe is the master: versioned, with sub-recipes, unit conversion and a scrap percentage, so changing it makes a new version and leaves last month's batches tied to last month's recipe. Printable batch-record forms carry your own checklist fields (batch weight, oven setting, end temperature, cooling time, fill weights) with a sign-off, filled in on a phone as the batch is made or on paper at the line.

The batch record writes most of itself. Recording the batch takes each ingredient from the lot that expires first and notes which lots it used and how much, so nothing is copied from a case. The finished batch gets its lot code, and its actual output and cost sit beside what the recipe expects, so a batch like KUL-261006A stands out without anyone doing the division. From your batch history, TaroStack checks whether a recipe really yields what it claims, which is how you know when a master needs a new version.

Recipes, batches and batch records with your own checklists are on Standard at $99 a month, and the first 30 days are free. Your recipes import from a spreadsheet. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

What is a master batch record?

The approved, versioned instructions for making one product at one batch size: ingredients and amounts, steps, checks and their limits, expected yield and packaging. It's blank, and every batch record is a filled-in copy of it.

What is the difference between a master manufacturing record and a batch production record?

Those are the dietary supplement rule's names for the same pair. The master manufacturing record is written once for each formulation and batch size; a batch production record is made every time a batch is manufactured and must follow the master.

Who signs a master batch record?

For drugs, one person prepares and signs it and a second person independently checks and signs it. For food, no federal rule says, but the same two-person check is a sensible habit, and buyers and auditors may ask who approved it.

Do food businesses need a master batch record?

Food rules don't use the term. But a fixed recipe with its checks and limits, and a filled-in record of each batch, is what an inspector, an auditor or a buyer will want to see under whatever name they use.