Introduction
A capacity plan should be developed by the accountable person (unlicensed) and/or with input from production and quality departments (licensed). The plan should detail the current resources available. It can be helpful to consider what is needed within the context of the 4Ps. Our article on assuring quality in NHS aseptic services (SPS page) provides more information about the 4Ps.
People
A well-resourced aseptic unit will have the correct skill mix of staff to ensure that tasks can be undertaken by the most appropriate person. The capacity plan should be based on such a model.
You should document the agreed establishment for the department, including planned and unplanned leave. Most NHS Human Resources (HR) departments apply a standard figure to workforce planning which will be determined locally, your local HR department can advise further.
Protected education and training time must be a fundamental part of the aseptic unit’s capacity plan. Consider the number and skill mix of staff available and incorporate work time of each member after planned and unplanned absence. Calculate and document the anticipated time and resource required to train a new operator and make allowances for those in training. You could do this by reducing the production time allocated to trainees in the capacity plan. The time required for staff delivering training should also be included. Additional training requirements for specialist activities such as intrathecal chemotherapy, radiopharmacy and clinical trials should also be considered.
In many aseptic units, activities not directly related to aseptic processing are undertaken, for example, dispensing oral chemotherapy or outsourced medicines and replenishing emergency kits. If these activities impact on the available personnel and premises, they should be acknowledged in the capacity plan. This could be managed by including the activities in the workload, or by reducing the available staff time to account for this. Clearly define the scope of the capacity plan in relation to these activities.
Premises
Review the available facilities and equipment and their realistic capabilities. Consider their age and condition, anticipated lifespan, and planned routine downtime, for example, regular shutdowns for planned maintenance. Facilities for storage of raw materials, consumables and final products should also be considered.
Describe the current use of space and equipment, including whether areas designated for aseptic activity are used for other tasks such as outsourced dispensing. Explain bottle necks, such as only one hatch for “in” and “out” processes or small changing rooms impacting the time required to enter or exit the unit. It is helpful to describe the nature of any shared space with the wider pharmacy team and explain its impact on the service.
Document the frequency of planned maintenance and other downtime, referencing planned maintenance and validation schedules.
It is also important to detail facility life-cycle management and future plans, for example, refurbishment. The facility and equipment, including digital assets, should be on the organisation’s capital replacement list or asset register.
The availability and capacity of quality control (QC) facilities and services should also be described whether these are on-site or off-site.
Products
Consider which products can be prepared by the unit (this could be impacted by the equipment available) and the maximum quantity that can be prepared. Complex products often take longer to prepare than simple products. Therefore, the type and complexity of the products prepared should be considered when determining maximum output.
Discuss whether each item matches your product range and whether space or equipment could be more effectively employed to maximise output.
Processes
Include all activities undertaken in the aseptic unit and/or by aseptic unit staff. This includes routine activities directly related to aseptic processing (ancillary tasks), such as quality management system maintenance, ordering, gowning, cleaning, environmental monitoring and product release.
Activities undertaken periodically such as validation activities and self-inspection should also be built into the capacity plan.
Quality-related activities
You must allocate time within your capacity plan for quality-related activities. This is relatively straightforward for planned, time-bound activities, such as Quality Management Meetings or self-inspections. However, this can be more difficult to establish for reactive or ad-hoc work, such as investigating deviations or responding to complaints.
Where it is more complicated to define specific timeframes, explain the rationale for timings allocated to each activity. You could undertake a time-in-motion study and apply an average monthly figure to activities based upon that. While accurate data is preferable, establishing an informed estimate of time required will provide you with a baseline to highlight changes and trends. Allocated timings should be routinely reviewed, in line with the regular review of the whole capacity plan.
Previously, a specific percentage of time has been arbitrarily allocated to ‘quality related activities’ when capacity planning. However, the actual resource needed to maintain and develop the pharmaceutical quality system (PQS) in line with current Good Manufacturing Practice (GMP) requirements varies considerably between units. Therefore, it is essential that aseptic management teams define and quantify the relevant quality related activities and necessary resources to support these at their site. Accurate local data will allow teams to develop their service to meet current needs and support future planning.
Our article on incorporating quality related activities into your capacity (SPS page) provides more detail on what to include in this section of your capacity plan.
Performance monitoring
It is important to monitor the performance of your unit in line with your capacity plan. This ensures that the plan effectively supports the safe operation of your unit, maximising efficiency and value, while prioritising product quality and patient safety.
Key performance indicators
Key performance indicators (KPIs) allow senior management to maintain oversight of production capability and support early, targeted intervention where necessary.
To achieve a balanced and comprehensive assessment of service safety and resilience, capacity data should be considered alongside supporting performance and quality data, such as:
- number of products prepared, sorted by product type
- actual turnaround times versus agreed targets
- product failure rates
- service and quality complaints
- facility and equipment utilisation
- staff sickness
- staff overtime and backfill
- trends, for example, deviations and corrective and preventative action (CAPA)
- environmental monitoring results
- overdue actions
KPIs should also align to regulatory standards and requirements in addition to internal quality assurance metrics. Your capacity plan should detail the planned frequency and format of reviews, defining clear routes of escalation where KPIs may demonstrate potential increased risks.
Wider departmental quality KPIs are good identifiers of capacity issues within the overall operation and can also be utilised to highlight capacity issues.
Regular review
Monitoring and trending of capacity is an essential and continuous activity. More detail about the benefits of regular review can be found in our article on managing aseptic service capacity effectively (SPS page).
Daily review
Daily review allows workload demand to be safely matched to the available staffing and equipment.
Monthly review
Monthly review is a regulatory requirement and should be incorporated into Quality Management Meetings as a standing agenda item. Monthly review involves the retrospective and prospective review of capacity data and safe working limits. This can provide an early warning of emerging issues, such as capacity approaching limits, staffing or equipment issues, including planned downtime. A monthly review will include a documented assessment of impact of emerging issues and agree and document actions to manage any potential risks. Monthly review should also evaluate whether previously agreed actions and mitigations are effective or require adjustment.
Annual review
The capacity plan should be formally reviewed at least annually, and more frequently if significant changes to any of the above factors occur.