Using capacity to inform decisions and manage risks
Effective capacity management requires the use of both retrospective and real-time capacity data to anticipate and respond to risks.
Prospective capacity data can be used to plan workload and support capacity modelling when considering changes to your service.
Capacity data is a measure, alongside performance and quality indicators, which can highlight periods of strain within the service. Trends in capacity data can support judgements about whether resources can safely meet demand and help to identify any emerging risks to patient services.
It is essential that capacity data is accurate and provides a comprehensive overview of the service, to ensure decisions are based on reliable data. Relying on incomplete capacity data could mask underlying issues. For example, capacity data may suggest workload is manageable. However, when reviewed alongside other indicators (such as incomplete audit actions), a different picture may emerge. Rising error rates, increasing product failures or reduced training activities are all signs that resource capability or system resilience is becoming strained.
Risk reduction through capacity management
Understanding and adhering to agreed capacity limits will reduce risks associated with the aseptic preparation process.
Errors
Working within agreed capacity limits will allow sufficient time to undertake all necessary production tasks, for example, generating worksheets and labels and assembly of materials. This allows staff to undertake Good Manufacturing Practice (GMP)-critical tasks in a methodical and controlled manner, without rushing, reducing the likelihood of error.
A good capacity plan will also include adequate time for staff training and revalidation, in addition to appropriate levels of supervision of trainees. This ensures that all staff are adequately supported to carry out their allocated tasks and that essential tasks are not undertaken by untrained staff.
Product failures
Product failures result in increased capacity pressures as items need to be re-made. This can also result in delays to patient treatment. In addition, product failures can have significant financial impact due to drug wastage costs.
Allowing sufficient time for detailed investigation ensures appropriate Corrective and Preventative Actions (CAPA) are identified by thorough root cause analysis. This includes ensuring sufficient resources for implementation of effective, targeted CAPA. Appropriate CAPA reduces the likelihood of recurrence and minimises the number of product failures.
Microbiological contamination
Sufficient time must be included in capacity plans to enable staff to perform cleanroom activities effectively and comply with cleanroom comportment requirements. This reduces microbiological contamination risks to products and patients.
The capacity plan should ensure that there is sufficient time to respond to out-of-specification (OOS) results. Detailed investigation and appropriate CAPA are needed to ensure adverse trends are rapidly addressed, preventing serious and/or repeated breaches.
Financial
A good capacity plan will provide sufficient time to support continuous review and improvement of your systems and processes. This can lead to significant financial benefits as processes are streamlined and optimised, including reducing wastage. Opportunities include maintaining and reviewing storage areas to reduce the likelihood of loss of stock due to inappropriate storage or extreme weather.
Example:
Aseptic Unit A undertook a review of their waste and were able to streamline practices to save £70,000 per year by reviewing their processes.
Monitoring and review of capacity
Monitoring and trending of capacity is an essential and continuous activity. Regular review with sufficient time allocated is required to ensure capacity management remains meaningful and effective.
Daily monitoring and real-time review
Real-time capacity management involves assessing capacity at least daily to ensure continued compliance with safe working and capacity limits. This supports timely decisions to adjust, redistribute, defer or decline work where necessary to maintain safety and service continuity. This can facilitate a rapid response to operational pressures such as urgent inpatient requests, equipment failures or unexpected staff absences.
Example:
Aseptic unit B has integrated its capacity management tool with its electronic prescribing systems. Staffing levels are entered each morning, and capacity updates automatically as products are authorised for preparation. Live capacity status screens give real-time visibility of workload enabling safe adjustments such as bringing tasks forward or shifting to just-in-time preparation.
Monthly review
Monthly review of capacity data, alongside other performance and quality indicators, should assess the aseptic unit’s adherence to capacity limits and the capacity plan. Further detail is given in our article on developing an aseptic capacity plan (SPS page).
Reporting and escalation
Capacity data and review outcomes should be included in regular reports to senior management as part of the aseptic unit’s governance framework. This ensures that emerging trends, capacity constraints, and potential risks are identified early and escalated promptly and transparently, supported by clear and robust evidence.
Annual review
In addition to the review of capacity data, the entire capacity plan should be reviewed annually, or sooner if significant changes occur.
Retrospective and prospective review
A balanced approach to capacity management combines retrospective analysis and prospective demand forecasting. Each provides a different perspective on whether demand is being safely managed, helping to identify emerging risks and support informed decision-making.
Retrospective review
Retrospective review involves analysing past data and events to understand what occurred and why. This supports identification of anomalies and trends, examples may include, COVID surge, service changes, staffing constraints, shutdown, outsourcing. Understanding previous responses to these types of incidents can help to predict future impact of similar events. In turn, these insights can then be used to strengthen future capacity management and drive improvements. This may include:
- reviewing individual capacity breaches or incidents to determine root causes
- assessing the effectiveness of mitigations such as staff backfilling
- identifying reoccurring patterns such as process bottle necks, high-pressure clinic days, seasonal leave challenges or repeated equipment failures
- analysing historical demand trends to inform future staffing or equipment planning
Prospective review
Prospective review involves forecasting future demand and resource capacity to identify risks before they impact the service, enabling proactive planning and communication. This could be used to:
- identify when the aseptic unit is approaching safe working limits
- forecast capacity during periods of planned staff leave or expected staff absence
- assess the impact of proposed service developments such as new or more complex treatments or additional clinics
- model different staffing, skill-mix and workload scenarios to understand thresholds for breaching safe working and capacity limits
Highlighting risks through capacity review
Capacity review is essential for identifying and communicating risks that may impact quality, safety, patient flow or service resilience.
Quantifying risks though analysis of the available data provides objective evidence to support planning and targeted mitigations. This enables proactive escalation of emerging risks and gives senior management confidence that decisions and mitigations are informed, robust and evidence based.
Example:
Following staff resignations, Aseptic Unit C used capacity data to forecast the impact of reduced staffing across specific roles, tasks and days of the week. Scenario modelling identified there would be repeated breaches of safe working limits on Fridays due to high pressure clinics and unplanned inpatient chemotherapy. This analysis enabled:
- early escalation to senior management with clear evidence
- development of a phased contingency plan for peak periods and high-risk days
- agreement with clinical teams to temporarily bring forward prescription cut-off times
- targeted recruitment to the roles which would have the most positive impact on risk reduction
Supporting a case for change
Capacity data is a powerful tool when developing a robust case for change. It provides objective evidence of where investment or process modifications would deliver meaningful improvements.
Scenario modelling can be used to quantify the impact of changes across key areas, including:
- staffing – additional staffing, skill-mix changes, extended working hours
- equipment – new isolators, automation, optimised maintenance schedules
- processes – workflow redesign, scheduling changes, digital tools
- workload – impact of new clinics, product types or treatment pathways
Using capacity data in this way has tangible benefits, such as:
- patient safety – reduced deviations and fewer microbiological out-of-specifications
- service continuity and resilience – fewer capacity breaches, reduced impact of annual leave and sickness
- operational efficiency – faster turnaround times, increased activity and reduced rework
- financial outcomes – cost avoidance, productivity gains and reduced waste
- strategic alignment – clear alignment with organisational priorities and objectives
Example:
Aseptic Unit D used capacity data to identify recurring bottlenecks linked to isolator downtime and limited equipment availability during peak periods. Scenario modelling showed that replacing an ageing isolator and optimising maintenance schedules would significantly reduce capacity breaches and delays. This evidence supported an equipment investment that improved service resilience, reduced deviations, and increased available capacity without additional staffing.