We’ve helped Pharmaceutical and Bio-Pharmaceutical Manufacturers deliver value and productivity by proactively managing deviations and targeting effective CAPAs. They see our approach as a novel way to build reliability into their processes, increase capacity in their facility, and develop capability of their workforce.
We’ve helped Pharmaceutical and Bio-Pharmaceutical Manufacturers deliver value and productivity by proactively managing deviations and targeting effective CAPAs. They see our approach as a novel way to build reliability into their processes, increase capacity in their facility, and develop capability of their workforce.
Deviation management remains a burden for Pharmaceutical and Bio-Pharmaceutical Manufacturing. This is reflected in FDA and MHRA data on top reasons for inspection findings and recalls. Deviations cost a lot of money and all GMP organisations work on the basis that CAPAs are required to ensure that it “never happens again”. There are two key challenges we can help with this ambition:
For people working in deviations, it can feel like they are drowning under an overwhelming wave of deviations. As they are required to develop a CAPA to close it out within a specified timeframe e.g. 30 days, the objective becomes closing out the CAPAs rather than developing sustainable solutions. We then have boomerang CAPAs that return to us later because they are ineffective, further burdening our workload, using up finite resource, redirecting finances away from innovation making us feel like we’re fighting a losing battle.
We have proven, reliable tools to identify and develop sustainable solutions for better CAPAs that you can easily integrate into your quality and lean systems.
Deviation management remains a burden for Pharmaceutical and Bio-Pharmaceutical Manufacturing. This is reflected in FDA and MHRA data on top reasons for inspection findings and recalls. Deviations cost a lot of money and all GMP organisations work on the basis that CAPAs are required to ensure that it “never happens again”. There are two key challenges we can help with this ambition:
For people working in deviations, it can feel like they are drowning under an overwhelming wave of deviations. As they are required to develop a CAPA to close it out within a specified timeframe e.g. 30 days, the objective becomes closing out the CAPAs rather than developing sustainable solutions. We then have boomerang CAPAs that return to us later because they are ineffective, further burdening our workload, using up finite resource, redirecting finances away from innovation making us feel like we’re fighting a losing battle.
We have proven, reliable tools to identify and develop sustainable solutions for better CAPAs that you can easily integrate into your quality and lean systems.
Too many people are spending too much of their time looking back at the wake of deviations behind the boat, rather than steering a better course by looking ahead. Proactive deviation management can pay dividends by avoiding minor and major crashes before they happen, which is better for the organisation and makes work more enjoyable, so people want to continue to work with you.
Human and Organisational Performance (HOP) leadership needs to be nurtured no matter where you and your team are on your improvement journey. It might still be quite novel as you try to move away from blame and re-train philosophies. You might be starting out and need new strategies to trial, or you might be experienced and want a sense check and coaching.
We can help wherever you are.
Human Performance has traditionally worked on a blame (human error) and re-train philosophy. However, many non-pharma sectors are waking up to Human Factors and HOP principles for more sustainable and profitable results.
Prevent issues before they occur saving you time and the organisation money. SHERPA (Systematic Human Error Reduction in Process Analysis) can help: identify critical tasks, conduct hierarchical task analysis, identify potential failures, and de-risk them.
Stop boomerang CAPAs, which are designed with good intentions only to return to trip us up again. People feel frustrated with offering training and new procedures as a way of fixing deeper problems they can’t see. We can offer tools and advice to help you ‘see’ more and a better suite of solutions to select from to make these fixes more sustainable.
Stay ahead of the field by learning the latest Human and Organisational Performance (HOP) strategies. An inclusive and engaging approach that supports your team wherever they are on their journey. We can support you, whether it be an introduction, embedding it in practice, or reflecting on innovations in the area.
Traditionally developing capability in the workforce has been behavioural, fitting the person to the job and training them. We take a different approach by fitting the job to the person, making their work easier and less prone to error producing conditions. This enhances the capacity for the process and facility and capability of the workforce by improving the system and not the person.
The SHERPA Software platform can support digital procedures making it easy to present important information to staff in novel ways, keep track of multiple moving parts in a complex task and record who has done what and when freeing people from the burden of confirming every step they do manually.
We make product and data in GMP Pharma. Without good GMP Documentation and Data Integrity practices whole batches are at risk and production stopped causing risk to supply. We can help streamline your process to design, document and assess tasks using Human Factors reducing opportunity for error and improve ALCOA+ performance.
We were asked to reduce the opportunity for human error. We conducted a Systematic Human Error Reduction in Process Analysis (SHERPA) analysis on a task within the organisation to see what value the methodology could bring. Preparing a trolley for the Autoclave was chosen as it was highly manual and suffered from frequent deviations, some of which could be costly.
Ahead of meeting the team we gathered documentation about the task including relevant procedures and batch record sheets to produce an initial task analysis in the SHERPA Software. We then held a series of workshops with cross functional teams to discuss this task analysis and human performance issues.
We found that staff did not have a clear and coherent view on what the top five issues were. There were obvious error traps in the procedure including photos that were confusing and instructions that were ambiguous. We identified other ways in which the task and procedure could be improved. Given high staff turnover and potential inconsistencies in training the organisation saw value in creating a systematic training aid from the process. The staff involved enjoyed the process. Issues after the workshop were greatly reduced.
We were asked to reduce the opportunity for human error. We conducted a Systematic Human Error Reduction in Process Analysis (SHERPA) analysis on a task within the organisation to see what value the methodology could bring. Preparing a trolley for the Autoclave was chosen as it was highly manual and suffered from frequent deviations, some of which could be costly.
Ahead of meeting the team we gathered documentation about the task including relevant procedures and batch record sheets to produce an initial task analysis in the SHERPA Software. We then held a series of workshops with cross functional teams to discuss this task analysis and human performance issues.
We found that staff did not have a clear and coherent view on what the top five issues were. There were obvious error traps in the procedure including photos that were confusing and instructions that were ambiguous. We identified other ways in which the task and procedure could be improved. Given high staff turnover and potential inconsistencies in training the organisation saw value in creating a systematic training aid from the process. The staff involved enjoyed the process. Issues after the workshop were greatly reduced.
After an incident, we had an opportunity to facilitate a Human and Organisational Performance (HOP) workshop for a pharmaceutical company. The workshop aimed to bridge the gap between work-as-done and work-as-imagined, involving the Site Leadership Team (SLT) and front-line workers.
Through individual discussions with the SLT, we explored their approaches to success, challenges, and human factor tools. The one-day workshop included a simulation game emphasising synergy between SLTs and workers.
It concluded with reflection and identification of opportunities to implement Human Performance strategies, such as quality conversations and effective communication. These strategies boosted employee engagement.
After an incident, we had an opportunity to facilitate a Human and Organisational Performance (HOP) workshop for a pharmaceutical company. The workshop aimed to bridge the gap between work-as-done and work-as-imagined, involving the Site Leadership Team (SLT) and front-line workers.
Through individual discussions with the SLT, we explored their approaches to success, challenges, and human factor tools. The one-day workshop included a simulation game emphasising synergy between SLTs and workers.
It concluded with reflection and identification of opportunities to implement Human Performance strategies, such as quality conversations and effective communication. These strategies boosted employee engagement.
Contact us today to discuss how our services can improve human factors in aviation operations and drive continuous improvement in human performance.
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This free 30 minute mini-course will introduce you to Human Factors, and how critical task reviews are used to improve the quality and safety of tasks and processes across different industries.
It’s free, informative and you’ll even get a certificate of completion.
This short and engaging handbook provides a great overview of Human Factors Systems Critical Task Analysis (SCTA) and how it helps people across sectors reduce error and improve human performance.
SCTA can help keep people safe and delivers value.
