A note in the margin
During a batch of conditioner, the heating overshoots the target temperature for a while. The compounder writes a note in the margin of the batch sheet and carries on. On another batch, a different lot of an ingredient is used because the planned one ran out. On a third, homogenising ran longer because the mixer was struggling. Each note is honest and sensible.
Nobody reviews them together, so nobody notices that the same mixer has struggled on several batches, or that the heating on one vessel overshoots regularly.
Deviations are written, not handled
Compounders generally do record what went differently. The trouble is that a margin note is not a process. It has no reviewer, no decision and no follow-up.
- Deviations are written wherever there is space on the batch sheet.
- Nobody is formally asked to review and decide.
- The decision, if made, is not written down.
- Actions such as servicing a mixer are not tracked.
- Deviations across batches are never looked at together.
What unmanaged deviations cost
Batches with unreviewed deviations may be released without anyone having considered them, or held without anyone knowing why. Repeated equipment problems continue until something fails badly. When a question arises later about a batch, the margin note is hard to find and says little. How you handle deviations, and what they mean for a batch, is for you and your adviser to decide. We make sure each one is recorded, reviewed and followed through.
There is a people side as well. Newer compounders are often unsure whether something is worth writing down at all, so small deviations go unrecorded. Experienced ones fix things on the fly and move on. Either way, the knowledge of what really happens in the vessels stays with individuals rather than with the business.
A deviations log tied to the batch
- From the digital batch record, or from a simple form if records are on paper, the compounder raises a deviation at the step where it happened, choosing a type and describing it.
- Readings that fall outside the limits you set on the batch record can prompt a deviation automatically.
- The deviation is routed to the reviewer you nominate for that type, and the batch shows as having an open deviation until it is decided.
- The reviewer records their decision and any actions: for example, a check to be added, a service booked, or a procedure to be reviewed.
- Actions have owners and due dates, and overdue ones are flagged.
- A report shows deviations by type, product, vessel and month, so repeated issues stand out.
| Part of the process | Margin note | Deviations log |
|---|---|---|
| Recording | Wherever there is space | At the step, with a type |
| Review | Nobody asked | Routed to a named reviewer |
| Decision | Not written down | Recorded against the batch |
| Follow-up | Forgotten | Actions with owners and dates |
| Patterns | Invisible | Report by type, product and vessel |
A production room that learns
Compounders raise deviations easily, knowing someone will look at them. Every batch shows whether it has open deviations. Decisions are recorded where anyone can find them later. And recurring issues, like the vessel whose heating overshoots, are spotted and fixed, rather than written in margins for months.
It also changes the tone. When deviations lead to fixes rather than blame, people record them more readily, which is the point.
Is this how you handle deviations?
- Deviations are written in margins of batch sheets.
- Nobody formally reviews them.
- Decisions about deviations are not recorded.
- Equipment problems recur.
- You cannot list last year's deviations.