A deviation report records the moment a batch went differently from its batch record: the step, what the record says, what happened instead, and what that means for the product. A mixing temperature missed, an ingredient from a different supplier, a step signed the next morning. The report says whether it was planned or unplanned, how serious it is, what was done with the batch, why it happened, and whether the batch is released, reworked or scrapped, and by whom. In the example below, a lotion maker adds the preservative 7 °C too hot, holds 96 bottles, sends a sample to a lab, and releases them a week later with a fix to the batch record. Below is what goes in a deviation report, how to class one, a filled-in example, a month's log, and a free template.
The short version
- A deviation is any departure from the batch record, found during or after the batch.
- Planned deviations are approved before the batch; unplanned ones are found during it.
- Class each one: minor, major or critical, by what it could do to the product.
- Hold the batch while a major or critical deviation is assessed.
- Record the effect on the product, the cause, the disposition and who approved it.
- If it could happen again, open a corrective action.
- TaroStack holds a batch apart from what's for sale and keeps its readings, limits and notes on the batch record. More below.
What goes in a deviation report
| Part | What it records |
|---|---|
| Number and date | DV-2026-014, the day it was found |
| Product, lot and batch size | Which batch, and how much of it |
| Step | Where in the batch record it happened |
| What the record says | The instruction or limit |
| What happened | What was done instead, with the reading |
| Planned or unplanned | Approved in advance, or found during the batch |
| Class | Minor, major or critical |
| Right away | What was done with the batch |
| Effect on the product | The assessment, and any tests with their results |
| Cause | Why it happened |
| Disposition | Release, rework, downgrade or scrap |
| Corrective action | Whether one is needed, and its number |
| Approved and closed | Who decided, and when |
Minor, major or critical
| Class | Means | Then |
|---|---|---|
| Minor | No possible effect on quality or safety | Recorded, batch released |
| Major | Could affect quality | Batch held, assessed and tested before release |
| Critical | Could affect safety, or the product is out of specification | Batch held; rework or scrap |
The class is set by what could go wrong, not by what did: a preservative added too hot is major even if the lotion looks perfect, because the problem it could cause can't be seen. A product that fails its specification is a nonconforming product as well, handled the way nonconforming product form describes.
Planned and unplanned
A planned deviation is a change approved before the batch starts: a second supplier's beeswax because the usual one is out, a smaller batch for a trial. It's written up first, approved, and the batch record notes it. An unplanned deviation is found during or after the batch, and the report is written then. Both go in the same log, so a planned deviation that happens every month shows it's time to change the master record. How the master record and each batch record relate is in master batch record vs batch record.
A filled-in example: a lotion batch
Salt Marsh Soap Co., a made-up soap and lotion maker in Charleston, South Carolina, I use in these examples, makes a 24 kg batch of body lotion, 96 bottles:
| Part | Salt Marsh Soap Co.'s report |
|---|---|
| Number | DV-2026-014, October 8 |
| Product and lot | Body lotion, 8 oz bottles, lot LO-261008A, 96 bottles |
| Step | Step 7, cool-down: add the preservative |
| What the record says | Add the preservative at 45 °C or below; the preservative's data sheet says below 50 °C |
| What happened | Added at 52 °C; the thermometer was read at the top of the kettle while it was still cooling |
| Planned or unplanned | Unplanned |
| Class | Major: the preservative may work less well, which can't be seen in the lotion |
| Right away | All 96 bottles put on hold and tagged; none had shipped |
| Effect on the product | pH 5.6 (limit 5.0 to 6.0) and viscosity in range at 24 hours; lab microbial count within the lab's limits |
| Cause | No hold point at the cool-down step; the thermometer read at the surface |
| Disposition | Release, approved by the owner on October 15 |
| Corrective action | CA-2026-009: a temperature sign-off before the preservative, read at the center of the kettle |
The batch was saved by a lab test that cost less than the batch; the corrective action is what keeps the next one from needing it. How a hold is placed and released is in hold and release procedure, and the batch record itself in cosmetic batch record template.
A month's log
| Number | Product and lot | Class | What happened | Disposition | Days open |
|---|---|---|---|---|---|
| DV-2026-011 | Bar soap, SB-260909A | Minor | Batch record signed the next morning | Release | 0 |
| DV-2026-012 | Lip balm, LB-260918A | Minor | Beeswax from a second supplier, planned | Release | 0 |
| DV-2026-013 | Bath soak, BS-260930A | Major | Fragrance weighed at 2.4% against 2.0% | Rework | 2 |
| DV-2026-014 | Body lotion, LO-261008A | Major | Preservative added at 52 °C | Release | 7 |
| DV-2026-015 | Body lotion, LO-261013A | Critical | Emulsion separated at the 24-hour check | Scrap | 1 |
Two lotion deviations in one week, one of them a lost batch, say the lotion's batch record needs more attention than the soap's. The bath soak was reworked by blending in unscented soak, a fifth of the batch's weight, which brings 2.4% back down to 2.0%.
Get the template
Download the deviation report template. Three sheets: a blank deviation report to print or fill in; the lotion example, filled in; and a log with days open and status filling in, and counts of minor, major, critical, planned and still-open deviations at the side. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The report is a separate sheet from the batch record, the hold is a paper tag on a shelf, and the lab result is a PDF in an email. When a shop asks about lot LO-261008A six months later, the answer is in three places. And a hold tag doesn't stop someone packing an order from the shelf.
How TaroStack does it
TaroStack holds a batch apart from what's for sale and keeps its readings, limits and notes on the batch record.
Readings with their limits. A printable batch record form carries your own fields, such as the temperature at the cool-down step, the pH and the viscosity, with their limits and a sign-off, and a text field for what went differently, so the deviation is written on the batch it happened to.
A hold that holds. A held batch is kept apart from what's available to sell, so it doesn't reach a picking list until it's released. A scrapped batch leaves stock with its reason, recorded with who, when and why.
Good and rejected. Each batch records how many units came out good and how many were rejected, and the lots it used, so a deviation's cost and the ingredients involved are on the record.
| The job | Paper | In TaroStack |
|---|---|---|
| The reading that went out of range | Written on the sheet | On the batch record, against its limit |
| Keeping the batch from sale | A tag on the shelf | Held, kept from sale |
| What a scrapped batch cost | Worked out later | Rejected units and a reason |
| Lot LO-261008A six months later | Three folders | One batch, with its fields and lots |
Batch records, holds and adjustments are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.