What are quality related activities?
It is essential to allocate sufficient time and resource to quality related activities to provide a service which promotes patient safety and supports continuous improvement.
All activities that assure the quality of your service should be captured within your capacity plan but knowing how to incorporate these can be difficult.
Quality related activities are undertaken by all staff groups, not just quality assurance teams. Any activity directly or indirectly related to the quality of your final product should be included in your capacity plan.
Quantifying quality related activities
Documenting time spent on quality related activities is relatively easy for planned, time-bound tasks, but can be challenging for reactive or ad-hoc work. You should make a good attempt to quantify the time spent on each activity and explain your rationale. For instance, you may undertake a time-in-motion study and apply an average figure to activities based upon that.
Timings should be routinely reviewed, in line with the regular review of the whole capacity plan.
Reactive and proactive elements
Quality related activities can be split into ‘reactive’ and ‘proactive’ components, although there is often crossover.
In many NHS aseptic units, a significant proportion of staff time is spent on reactive (or ad-hoc) work, including:
- responding to urgent requests
- investigating deviations
- responding to shortages
Proactive or planned work is essential to ensure that the unit retains compliance with regulatory standards and can meet growing demand for new products.
A sufficiently resourced Pharmaceutical Quality System (PQS), with effective proactive elements will reduce the requirement for reactive elements, improve efficiency and positively impact patient safety.
What to include in your capacity plan
The core elements of an effective PQS are described below, they have been split into the ‘4Ps’. Individual elements will be managed differently across organisations. The categorisation below is an example only, which can be adapted to suit your own organisation.
The article on assuring quality in NHS aseptic services (SPS page) provides more information about the ‘4Ps’.
Premises and equipment
PQS activities related to premises and equipment are often described in a Validation Master Plan (VMP). Some units choose to classify these as production activities instead, regardless of how they are classified, they should be included.
The article about Validation Master Plans (SPS page) provides more information about VMPs.
Routine monitoring
Monitoring and validation are important tasks which must be considered. Results must be regularly reviewed, trended and reported. Time should be allocated in your capacity plan to undertake reviews and act on the findings, for example, by adjusting alert limits.
Technical agreements
Time should be allocated to maintaining technical agreements, including supplier engagement meetings and reviewing key performance indicators.
Storage and transport
Essential quality related activities should be accounted for in the capacity plan, including, but not limited to:
- mapping and validation of storage areas and distribution methods
- calibration of temperature monitoring probes
- routine maintenance of remote temperature monitoring systems
This article provides more information on mapping the temperature of medicines storage areas (SPS page).
IT systems
Routine qualification and requalification of IT systems should be incorporated into the capacity plan. See this article on computer system validation (SPS page) for more information.
Reactive activities
Reactive activities include responding to incidents like out-of-specification (OOS) results and larger scale incidents such as flood or fire damage. This may include considering time and resource required for further testing and planning repairs. Larger incidents may also result in the need to specify and purchase equipment, develop validation plans, and undertake validation work. This can often be both time-consuming and of extended duration, consideration should be given for building this work into your capacity plan.
People
It can be hard to determine whether some activities are related to PQS or human resources process (e.g. appraisals). All activities which impact staff availability should be considered within your capacity plan.
Training
Staff training covers a variety of activities, from full training programmes for new staff, to refresher training and revalidation activities. Consider the time and resource required to develop and deliver training as well as attendance at training sessions.
Meetings and updates
Time should be allocated for internal and external meetings, including Quality Management Meetings, technical, and service-related forums. Required time for preparation, attendance, and follow-up activities should be included.
Additionally, staying up to date with regulatory requirements should be factored into work plans, whether through formal meetings, webinars, or reviewing new guidance and standards.
Processes
All processes must be standardised, validated, monitored and clearly defined in Standard Operational Procedures (SOPs). Time and resource for review and development of processes should be included in the capacity plan.
Change management
Proactive components of change management include scheduling time to implement changes and formal review of change requests, impact assessments and post-implementation reviews.
Example:
Aseptic Unit E recorded the amount of time they spent working on change controls, and which members of staff were involved across one month. Aseptic Unit E used this data as a guide to allocate time each month to specific members of the team. There is a plan to review the allocation in 6 months.
This article on change management in NHS aseptic units (SPS page) provides more information.
Deviation management
Many aspects of deviation management are reactive, including make-safe actions, risk assessments, investigations and Corrective and Preventative Actions (CAPA). Managing complaints could also be considered in this section. It can be difficult to quantify the time and resource required for this, an example of how one unit achieved this is described below.
Example:
Aseptic Unit F allocated staff time for deviation work each week (one afternoon for the lead operational technician and two mornings for the quality lead). When developing their capacity plan, they were able to include this time directly in the plan.
Proactive components of deviation management include error trending and reporting of incidents (internally and externally). The article deviation management in NHS aseptic units (SPS page) provides more information about deviation management.
Capacity management
Capacity planning itself is an essential element of a PQS, and sufficient resource to manage, update and review the capacity plan should be allocated.
Documentation
Document management and data integrity requirements, including maintaining current documentation and archiving, are essential and should be considered in your capacity plan.
These articles on clinical trial records in hospital pharmacy (SPS page) and retaining and storing pharmacy records in England (SPS page) provide more information about document management.
Risk management
The regular review and update of risk register entries and their associated risk assessments should be considered in the capacity plan. In addition, the pursuit of continuous improvement initiatives should be considered.
Audit and inspection
External and internal audits (self-inspections) are core components of a PQS. These are scheduled in advance. Time and resource should be allocated for preparation for the audit, writing and reviewing the report, and completion of actions.
The article preparing for audits and inspections of aseptic services (SPS page) provides more information about audits in aseptic units.
Development of the PQS
The PQS itself requires ongoing review and development. This will include as a minimum, development and updating core documents, responding to changes in legislation and reviewing systems and processes.
Products
Products must be safe and of a suitable quality and presentation. Both production and quality staff undertake specific quality related tasks regarding specific products. Regardless of the person undertaking each task, the activity should be captured in your capacity plan.
Product files
Ensuring the quality of products relies on having detailed, accurate product specifications, which should be regularly reviewed and updated.
It is essential to develop and regularly review documented stability data on which to base the shelf-life of aseptically prepared medicines. The article deriving and assessing stability data for medicines (SPS page) provides more information about stability assessments.
Product testing
It is important to be assured of the quality of medicines prepared by the aseptic unit. For some units, such as radiopharmacies, routine radiochemical purity testing can take a considerable amount of time and must be accounted for specifically.
The time and resource for managing sterility testing and final product testing schedules should also be considered. The article Quality Control chemical testing of aseptically prepared products (SPS page) provides more information.
Clinical trials and ATMPs
Some products will have additional product-specific requirements and may need additional time and resource dedicated to their safe management. Our articles introduction to advanced therapy medicinal products (ATMPs) (SPS page) and clinical trials provide more information about these medicines.
Recall
Managing a recall can take a considerable amount of time. The recall process must be tested annually where a live recall has not occurred. Activities related to the management of recall should be included within the capacity plan.
The article stock handling, waste and recall records in pharmacy (SPS page) provides more detail about product recall.