Understanding capacity planning
Capacity planning is a regulatory requirement for both licensed and unlicensed aseptic units. It is a core component of an effective Pharmaceutical Quality System (PQS) and an essential requirement of Good Manufacturing Practice (GMP).
An effective capacity plan helps you provide the best possible service to patients, ensuring that safe products are delivered on time.
Chief Pharmacist responsibilities
Capacity planning is a structured proactive approach to understanding and managing your resources. It helps you understand what can realistically and safely be achieved with the staff, facilities and equipment available.
Chief Pharmacists hold ultimate responsibility for ensuring their aseptic unit is adequately resourced, and should ensure that:
- there is a current and effectively implemented capacity plan which meets clinical demand without compromising quality or patient safety
- the capacity plan is approved by senior hospital management external to pharmacy
This enables pharmacy aseptic unit workload to be visible and be managed as necessary at an organisational level. Any breaches of capacity must be recorded, risk assessed, investigated and appropriate action taken, for example invoking contingency arrangements.
For more information about Chief Pharmacist Responsibilities for aseptic services see our article series about understanding aseptic services in the NHS (SPS page).
Capacity planning
Capacity planning brings together different information about the unit to provide an overview of its current and future capacity potential, as well as any constraints. Capacity is dynamic and the specific aspects will vary day to day, however there is usually one critical factor that determines and limits available capacity. It is helpful to understand and document what the constraints on your system are.
Capacity planning is more than a calculation of workload versus staffing. A capacity plan should include all essential tasks in the unit including allocating sufficient time, resources and skilled staff to quality and regulatory requirements.
The capacity plan should consider people, premises, products, and processes, encompassing the entire scope of work across the unit. Developing an effective capacity plan which will support your service takes time, but it is worth the effort, as it can bring significant benefits.
When working in an aseptic unit, many situations occur which require an immediate response to assure service resilience, product quality and patient safety. This could include events such as equipment failures, product shortages and drug recalls. A robust capacity plan will allow enough “buffer” time to respond to unplanned events in a timely and controlled manner.
The impact of poorly managed capacity
Exceeding agreed capacity limits on a regular basis can lead to increased risks to product quality and ultimately patient safety. Focusing on delivering the required number of products can detract resources away from underpinning quality management activities which keep the unit running safely and effectively.
Errors
Regularly working above agreed capacity limits reduces the time available for essential tasks, which can result in staff rushing. Rushing can lead to cutting corners and not undertaking GMP-critical tasks in a methodical and controlled manner, increasing the likelihood of error.
A good capacity plan includes sufficient time for staff training and revalidation, in addition to appropriate levels of supervision of trainees. This ensures all staff are adequately supported to carry out their allocated tasks and that essential tasks are not undertaken by untrained staff.
Microbiological contamination
Manual transfer decontamination requires diligence in following approved procedures, including ensuring that contact time for decontamination agents is maintained in practice. Where workload exceeds agreed limits, this process may be rushed, increasing the risk of microbial ingress to the critical work zone.
Inefficient decontamination increases the likelihood of product contamination, which is a significant patient safety risk. This risk is amplified as evidence of contamination is not usually available at the time of product release.
Microbiological contamination also leads to increased cleaning activities, which are time consuming and costly. In addition, contamination generates deviation reports, investigations, and corrective actions, which further increase demand on the aseptic workforce.
Certain incidences of microbiological contamination may require restrictions being placed on production capacity to safely mitigate further risks. This has implications for service delivery and resilience.
Benefits of an effective capacity plan
A capacity plan supports a proactive approach to managing capacity and helps build quality and safety into your service. It allows you to monitor workload, adapt to changes in demand and plan for longer term service changes. This enables you to ensure you have the appropriate skill mix and number of trained and competent staff, in addition to appropriate equipment and resources. With all of this in place, you are then able to supply safe, high-quality aseptic products to patients.
An effective capacity plan allows the identification, quantification and escalation of short term and long-term risks. This supports real-time responses to changes in demand, ensuring that resources are directed appropriately in periods of acute stress. It also provides a mechanism to support communication of risks and priorities across the organisation.
A good capacity plan delivers the right balance of staffing and skill mix needed to meet demand and support the safe operation of the unit. This can have a positive impact on staff wellbeing, reducing stress and ensuring staff are able to undertake their allocated tasks safely. This is especially important as staff are often using products with safe handling requirements. Allowing time for staff to undertake tasks without rushing ensures they can utilise all measures available to support them to handle these substances safely.
Furthermore, a robust capacity plan can generate proactive examples of what can be achieved by the service, informing the case for change across the organisation.
Monitoring and review of the capacity plan
Demand fluctuates and should be reviewed regularly. In addition to this, your capacity plan should be formally reviewed at least annually, and more frequently if significant changes to any of the above factors occur.
Internal monitoring
Workload trends should be reviewed monthly, and capacity figures must be reported and reviewed during Quality Management Meetings. A review of capacity should also form part of the self-inspection process.
External monitoring
Unlicensed aseptic units are required to submit capacity data as part of their monthly Quality indicator (QI) submissions. These submissions are regularly reviewed by commissioners and regional quality assurance specialists to ensure robust oversight of NHS aseptic preparation activities. Our article about submitting iQAAPS Quality Indicators (QIs) (SPS page) provides more information about this.
Change management
Retrospective data can be used to help when planning future service changes, for example the impact of a new oncology clinic. This ensures that the unit can respond to requests for new services by confidently calculating the number of staff and/or equipment which may be needed.
Your change control procedure should include assessing the impact of the change on capacity. Similarly, significant changes to your capacity plan should be managed through your change control process.
Our article about change management in NHS aseptic units (SPS page) provides more information about the change management process.