Quality and lab staffing set on the hours behind the tests
The quality workload behind a batch is far larger than its tests. Opyflow's model put QA documentation alone at 16 staff-hours per batch at its lower assumptions, and the site set laboratory staffing, shift coverage and testing allocation on the modelled hours.
A biopharma manufacturer preparing to scale needed its quality organisation and laboratories to keep pace with the production plan, including time-sensitive testing and the work to review and release every batch.
Opyflow mapped QA and QC activities, modelled the workload under explicit production assumptions and developed staffing, shift, equipment and organisational recommendations.
16 staff-hours per batch for QA documentation alone (modelled, lower estimate) · Lab staffing and shift coverage set on the modelled hours · External tests reviewed for bringing in-house
The challenge
In the laboratory, investigations, protocols, inspections, training, maintenance and sample handling all consumed hours a sample count never showed. In quality assurance, batch review and release preparation sat alongside deviations, supplier work and manufacturing support.
Timing mattered as much as total hours. Some tests had to follow production promptly, and environmental-monitoring work continued after samples entered incubation. A team that looked adequately staffed over a week could still lack cover at the moment the manufacturing schedule needed it.
Opyflow's work
Opyflow separated testing from routine support and project work, then translated the work into hours. The laboratory model covered biological and microbiological testing, environmental monitoring, raw-material release and the tasks around them, and examined equipment occupancy and redundancy as well as people.
The QA model followed the work from manufacturing records through review, investigation and release preparation, with explicit assumptions for production volume, deviation frequency and severity, task duration and availability. The recommendations included responsibilities and a proposed team structure alongside the headcount.
Both models were tested against the planned manufacturing rhythm of three shifts, five to six days a week. Shift coverage, time-sensitive testing and workload peaks were considered together, and the externally performed tests were reviewed on the same basis.
What changed
At the lower end of the model's assumptions, preparing batch records, reviewing them and assembling data for release added up to 16 staff-hours per manufactured batch. That is staff effort for documentation alone; laboratory testing and deviation investigations come on top.
The site set laboratory staffing, shift coverage and testing allocation on the modelled hours. Staffing and shifts now trace back to the activities that generate them.
The analysis also identified work that could be simplified, including document preparation and release support, and set out requirements by operating scenario, so a change in volume or task duration shows up in the resource plan before it shows up on the floor.
What did the models add beyond batch and sample counts?
The hours and the timing behind the counts. Reviews, investigations, support tasks, equipment occupancy and shift cover all decide how much capacity the quality function can give manufacturing. Here, QA documentation alone came to 16 staff-hours per batch at the model's lower assumptions, before testing and investigations.
See the capability: Throughput, OEE and capacity →