Batches waiting without anyone knowing why, month-ends in waves, priorities that change every day: your release process is a black box. We make it visible, manage it and remove its bottlenecks one by one, with an approach inspired by the theory of constraints.
46 → 34 daysaverage release lead time, in one month
€6Mof stock released in six months
−49 %overdue anomalies blocking release
2 days → 3 hfor record review by QA technicians
Results measured on several production sites.
Do you recognise your release process?
Teams spending their time chasing batches and replanning.
A month-end phenomenon, with waves of releases.
Release as a black box: nobody knows where batches are, or what is blocking them.
Vague release prerequisites, with a missing one discovered too late.
Priorities that change every day, in favour of the batches that make the most noise.
Management that takes up the issue when inventory is already rising.
Understand your flow to control it
1Robustness before performance
An average release lead time hides what matters. Two sites can show the same average and live opposite realities: one releases predictably, the other alternates between express batches and forgotten ones, with the chaos of priorities and the month-end waves that go with it.
The average
A single figure that hides the spread: impossible to know whether batches go out on time.
The box plot
The box contains half of the batches, the whiskers show the extremes. The taller it is, the more unpredictable the flow.
The goal
First squash the box to make the flow predictable, then bring it down to gain days, for good.
2FIFO leads to OTIF, not the other way round
Pushing late batches or batches a customer is waiting for to the front seems logical. But every queue-jump overtakes others, which become tomorrow’s emergencies. Handling batches in order of arrival, with controlled work in progress, makes lead time predictable instead: commitments are met, and OTIF follows.
Controlled work in progress
FIFO alone isn’t enough: if the queue grows, each batch waits longer, even in order. We limit work in progress and plan at the pace of the bottleneck.
An express lane, strictly limited
Real emergencies exist, such as a risk of stock-out. They go through a dedicated lane, limited to one or two batches and decided in a ritual, not ad hoc.
OTIF, an outcome indicator
OTIF is tracked at management level. Using it to reprioritise batches day to day is what creates chaos.
3The bottleneck moves: every step must be managed
Each day, your site releases no more batches than its slowest step. But a release flow chains steps that are sometimes synchronised, sometimes in parallel, and the bottleneck moves over the weeks. Managing the overall cycle time isn’t enough: you need to see, at each step, what comes in, what waits and what goes out.
What we measure at each step
Inflow, work in progress and how it evolves, actual throughput time against target, available capacity and versatility.
Why centralised management
To see where the bottleneck is today, anticipate tomorrow’s, and avoid local optimums that penalise the overall flow.
What this changes
Resources go where they really unblock batches, instead of speeding up steps that don’t limit release.
Our approach: manage the flow before trying to improve it
Even before speeding up a step, effective flow management already delivers results on the overall time.
1
Put out the fire, if needed
When the situation has deteriorated, the Effective Quality Brigade runs a time-limited task force: batch piles sorted by age, normal flow isolated, target set and workload quantified.
task forceEffective Quality Brigade
2
Map the flow and its prerequisites
With the qualified persons, we describe all the release prerequisites and the steps leading to them, as well as the data available, or not, in your systems.
release prerequisitesmapping
3
Measure accurately
Work in progress, throughput and lead times at each step, analysed statistically rather than as averages: robustness comes before performance.
work in progress and throughputvariability
4
Manage by colours
Centralised, visual management, run through short rituals, which shows where each batch stands and what is blocking it. It delivers results even before the steps are improved.
visual managementrituals
5
Plan around the bottleneck
The counter-intuitive but decisive approach: plan all activity at the pace of the slowest step. The leadership team is on board from the start.
theory of constraintsleadership team
6
Remove bottlenecks one by one
Identify the bottleneck, plan around it, improve it, then start again with the next one: batch record review, deviations, quality control or organisation.
continuous improvementbottlenecks
Three projects, three results
Injectables production unit
Twelve days of release time gained in one month
An average release lead time of around 46 days and finished-goods inventory to reduce. The batch record review flow was identified as the priority lever: review rules, on-line review and management.
Records reviewed on the line, during production
Two review steps maximum before release
Daily management of the review flow
46 → 34 daysaverage release lead time, in one month
CDMO site, sterile dosage forms
Millions of euros of stock released
Finished batches blocked by unhandled anomalies and finished-goods inventory rising sharply. Management of anomalies and high-stakes batches, a targeted task force and investigation coaching.
Open anomalies: 212 → 117
Overdue anomalies: 119 → 61
A product quality support department created afterwards
€6Mof stock released in six months
CDMO site, second entity of the same group
Record review that no longer takes days
The same approach applied to a second entity, focused on the quality assurance record review flow.
Release prerequisites with the qualified persons, detailed steps, matrix of available data. The leadership team is introduced to the theory of constraints.
2Measure and manage
Introduction for managers, data collection tools, visual management rolled out in the departments and observed on the shop floor until it runs on its own.
3Remove bottlenecks
A first improvement loop on the main bottleneck, with our methods for batch records, deviations or organisation.
+Option · Put out the fire first
A time-limited task force from the Effective Quality Brigade, to get back to a calm situation before improving the flow for good.
It’s the time between the end of a batch’s production and its release. It includes all prerequisites: batch records, quality control analyses and data, deviations, OOS, environmental monitoring. It is what weighs on your inventory and service level.
Why not manage cycle time by its average?
Because the average hides variability, which creates the chaos of priorities and month-end waves. We measure cycle time statistically, with work in progress and throughput at each step: that’s what lets you act in the right place.
What is the theory of constraints applied to release?
A release flow chains several steps, and the site releases no more batches per day than its slowest step, the bottleneck. The approach consists of identifying this bottleneck, planning all activity at its pace, then improving it, before starting again with the next one.
What are the most common bottlenecks?
Most often: batch record review, deviations and anomalies, quality control and the organisation around the flow. The bottleneck can also move over time, hence the importance of continuous management.
Should you start with a task force?
Only if the situation has deteriorated. A time-limited task force from the Effective Quality Brigade puts out the fire, by isolating the normal flow and handling the oldest batch piles. But it isn’t sustainable: you then need to manage and improve the flow.
Do you need software to manage release?
Not to get started: we begin with simple tools, fed by your data extracts. Our PERISQOPE tool can then centralise the data from your systems and replace scattered Excel files.
Are your batches waiting to be released?
Tell us about your situation in thirty minutes. We’ll tell you where your bottleneck probably is.