Partial release
Break the record into sub-records aligned with the releases that are actually possible, instead of one single block reviewed only at the very end.
Batch record · Flow
From 60 days to a few hours: release faster.
On many sites, batch release time isn't constrained by production, but by batch record review: queues, endless corrections, back-and-forth. Field feedback from an international pharmaceutical CDMO (sterile filling), where batch release time went from ~60 days to a few hours.
10%
flow efficiency: over a ~68-day record cycle, only 7 days created value. The record spent 90% of its time waiting.
The batch record documents manufacturing and gates release. When its review is slow, everything slows down: work-in-progress inventory swells, cash freezes, customers wait. The good news: this delay is almost always waste, and therefore recoverable — without touching production.
The real problem
The batch record isn't waiting to be processed: it's waiting for someone to pick it up.
In the case studied, the record sat 51 days in the queue before its quality review, accumulated 13 corrections per batch and triggered endless back-and-forth. The cause was neither skill nor production: it was a poorly designed flow, an overly fragmented record structure, and review rules that re-checked everything, everywhere.
What we did
Four levers, one tight flow.
We tackle the root cause: the design of the record and its review circuit.
Clear structure
Integrate the appendices into the record (no more concatenating a dozen-plus attachments) and organize it into units / procedures / sections / steps.
Risk-based review
Group controls and sign-offs by activity rather than at every instruction, and focus the review on what really matters.
QA closest to the product
Bring quality assurance onto the floor, in real time, to decide fast and fix at the source — with the same headcount.
The results
The delay collapses.
No hiring, no new equipment: just by rethinking the flow.
- 161 → 64 d
- end-to-end cycle time, within a few months.
- 60 d → hrs
- batch release time, once the target flow was in place.
- same headcount
- no new hires: the speed comes from the design.
The biggest source of waste wasn't the work, but waiting — the first of the 7 Lean mudas. Removing it frees up cash tied up in work-in-progress and makes the delivery times promised to customers reliable.
Go further
See the transformation through.
Digitalization
The electronic batch record
How to digitalize the batch record, without waiting for a multi-million-dollar MES.
Read the article → Quality assuranceQA on the floor
Change the review rules to decide fast, without giving anything up on compliance.
Read the article → ConsultingOperational performance
Assess your flows and free up capacity, from €5k.
See the approach →Frequently asked questions
Batch release time & batch record.
Rarely because of production: most often, it's the batch record review that stalls — queues, fragmented records, endless corrections. In the case studied, the record waited 51 days before review, for a value-added time of only a few days.
It's the ratio of value-added time to total elapsed time. At 10%, the record spends 90% of its time waiting. Aiming for 50 to 70% radically changes batch release time — without working more, by working better.
Yes, by combining partial release, a clear record structure, risk-based review and quality assurance present on the floor. These levers eliminate waiting and endless corrections. In the case studied, this was done with the same headcount.
No: we don't remove the review, we concentrate it where the risk requires it, by grouping controls by activity and clarifying the meaning of each sign-off. Traceability and robustness are strengthened, not weakened.
Release your batches at the speed of your production.
Let's assess the flow of your batch records and the release time you could win back.