Are the MHRA threatening your Aseptic Compounding Unit?
All Aseptic compounding units for chemotherapy (both NHS and Commercial) are coming under increased MHRA scrutiny and there is a major focus on the robustness of the Quality Management systems including environmental monitoring and capacity.
A large number of NHS and commercial sites have found themselves with a partial or complete suspension of their licences until the Quality System is beck under control and the capacity figures back in the green.
A recent client of mine was facing these issues, a backlog
of overdue quality management actions (Change Controls, Deviations, Risk
assessments, and Root Cause Analyses) a large number of these documents were
also being raised as the issues which should have been addressed were still
open (bringing numerous repeat issues). Capacity was a major issue as there
were several posts unfilled and no real investment in QA. Our first task was to
reduce the considerable backlog and where possible find root causes and create
appropriate measurable CAPA actions.
By clearing the backlog and putting appropriate CAPA in
place the occurrence of errors was reduced. By clarifying the deviation process
we have seen a reduction in ‘real’ deviations and are able to trend minor
errors which help us spot opportunities for improvement.
We have put simple systems in place which:-
- Provide a risk-based approach to Production, Quality Assurance, Quality Control, Environmental Monitoring and Regulatory Compliance
- Create simple, accurate and valuable KPI data which;
- Report in real-time
- Is easy for the trust to follow
- Highlights issues clearly
- Track trends
- Manage the capacity and;
- Show production performance against both predicted and actual workload
- Evaluate capacity prospectively to show where the extra resource should be spent
- Show QA resource requirement against both reactive and proactive tasks
- Have well described and documented actions to be carried out if a real or predicted overcapacity situation occurs.
- Create a simple manageable management structure which is easy to follow and easier to show roles and responsibilities
- Elevate the microbiology staff and the environmental monitoring actions to a smoothly run well-understood machine which easily spots any trend data, can quickly react to any environmental threats and has brought previously devolved activities back in house.
- Have increased the capability and cross-functional effectiveness of all staff
- Create an environment where there is sufficient capacity to support long term projects
- Create a culture of interdependent facilities and a multifunctional workforce
- Drive continuous improvement
This client has now had its licence reinstated.
We now have a system which can be replicated in other trusts
and other licenced aseptic units. This blueprint has been inspected by the MHRA
and accepted as appropriate to the regulations.
If you want a system which has been audited by the MHRA and passed if you want a system which your regulator has seen before, if you would like us to come in and evaluate your suitability to run with our system or if you want a bespoke system just for you please mail info@29eye.com and we’ll arrange a preliminary meeting to discuss your requirements. We have the experience to make your trip out of IAG back into licenced manufacture simple.
Driving Down Incidents
29 EYE was asked to assist with the backlog of validation, change control and incident actions for a leading multinational company
We began by auditing their quality systems and found that although systems were in place the systems were neither appropriate for the task or being correctly used. With the buy-in from the board we initiated and facilitated root cause analysis (RCA) workshops, Change control panels and validation training and mentoring. We provided training materials and helped in the re-focusing of the Quality Management Systems to create greater visibility of issues and more meaningful trending. The project to roll out root cause analysis training, incident management and change control forums to the company as a whole will later become the continuous improvement initiative. This project will greatly reduce the number of recorded incidents, improved the corrective and preventative action success rates and provided the staff with a workable mechanism to manage incidents, improvements and change.
Most companies have difficulty managing change and dealing with incidents. Our industry standard approach can be modified to meet the specific requirements of your business. As a company 29 EYE has experience in Quality systems, Change management and Incident management.
Detail
On auditing the incident process within the company it was discovered that incidents were being raised at twice the rate they were being closed, root causes were not being effectively investigated and there was a culture where human error was the go-to cause. Actions to address causes were centred on reflective learning and reiteration of procedure rules (there was little concern paid to corrective and preventative actions (CA/PA)), the processes were rarely challenged and where reflective learnings were not stipulated the resolution was to add complexity to the processes.
Incidents were managed within the department which found the issue and no cross-functional dialogue was taking place, each department worked in isolation and found their own specific remedy for each specific incident. If the incident originated in one department they may not be involved in developing the solution unless the issue was also raised in that department. As such the root cause was rarely uncovered, the actual problem persisted and the affected departments (customers) had to add check steps and complexity to address issues from other departments.
It was found that 49% of all the incidents originated in 1 department however due to the isolation of each discipline this trend was not initially seen and the issues with this department not addressed. This led to repeat incidents not being recognised as the faults were never tracked back to the true root cause.
After sharing this information with the board we commenced a series of initiatives to address the shortfalls.
- We set up cross-functional incident investigation teams and rolled out site-wide root cause analysis training
- We facilitated the running of several RCA workshops
- We trained and mentored several RCA champions across every department in the company
- We developed cross-functional Change Control committees to oversee the correct level of approval for changes
- We initiated a CA/PA review process to evaluate the effectiveness of the agreed CA/PA
- We redefined the risk and impact categorisation of incidents to focus only on processes the company were responsible for and to correctly direct findings to appropriate 3rd parties
- We re-wrote the RCA categories so as to provide meaningful trending
Although initially resisted and objected to on the belief that the process would be time-consuming and fruitless, the initial feedback is all positive as staff are more involved in the analysis process and less personal blame is being felt. Where investigations have been completed the contributors to the investigation have been refreshed by the slowly reducing blame culture and feel listened to. Where CA/PA has been instigated there has been no repeat of the stated problems. After the initiation of this project, there was an increase in incidents raised but also faster resolution.
Some of the backlogs of incidents dated back over several years and a decision was made to close incidents without investigation where the incident was more than 12 months old as there was no possibility to properly investigate or derive a cause where so much time has passed.
As a result the company now raises fewer incidents (as once investigated, issues are fixed and don’t re-occur), can perform meaningful trending (which is now the basis for the continuous improvement initiative), and have a more cohesive cross-functional workforce with livelier interdepartmental discussions and a business which sees itself as 1 team.