How to Maintain Accuracy, Consistency, and On-Time Delivery in the QC Lab
Joe Christensen, Senior Director QC, Commercial QC Lab, Jay Sapp, Director Operations, and Gregg Nicholson, QC Process Improvement Specialist
You have to rely on QC lab data to guide critical decisions, but flaws in project approaches, techniques, methods, and processes can easily lead to false data with untold ramifications down the road. Furthermore, testing failures that necessitate repetition are costly and threaten timelines. That’s why, at Societal™ CDMO, we have developed a system to minimize the risk of such outcomes.
With our “right-first-time” approach, we proactively uncover issues in established QC laboratory processes and resolve human errors to prevent defects and build in efficiencies throughout our QC lab operations.
While it may sound simple, this task is not. Gathering layers of information and sifting through it for evidence that can drive stepwise improvements is challenging, yet vital. However, we have developed a reliable, systematic, data-gathering approach that helps us build in efficiencies and future-proof processes to ensure reliably accurate results that are delivered on time, as economically as possible.
Identifying Trends: An Ongoing Process of Root Cause Pattern Recognition
How do you look at a complex system and methodically approach improvement? If you only react to discreet issues as they arise, you will always be playing catchup. Instead, for a more proactive approach, we:
- Identify trends in root causes
- Institute mitigating improvements in QC laboratory processes
- Monitor to ensure that past errors do not recur
To recognize patterns in operational setbacks, we developed a customized tool for organizing and sorting all the information pertaining to errors in the lab. This elaborate and flexible tracking tool is both searchable and sortable for maximal utility.
Having analyzed more than a year’s worth of laboratory investigations, deviations, and incidents, we extracted the findings into the new, more trackable format and re-categorized the root causes. New parameters for this large database included identifiers such as material, analytical technique, analytical method, chemist, software, and portion of the testing process where the issue occurred.
Through computer-aided filtering and manual analysis, we pinpointed a few major areas for improvement. While historic data was our starting point, this process of continually updating the program and finding ways to improve is now integral to our QC lab. Our key performance indicator (KPI) for this project is the percent of batches and samples produced without any issue.
Examples of Findings and Proactive Process Improvements
Improving processes to prevent recurrence and the occurrence of other, related errors is an incremental, but worthwhile endeavor. The following are examples of the kinds of process improvements we have made as a result of this program.
|Trend Noted||Process Improvement||Result|
|Staff members newly trained on a certain type of equipment along with its associated software had a greater preponderance of errors when using it to execute tests||Revamp the training program for the equipment and software in question||75% reduction in errors among newly trained employees during the first six months of performance with the test/equipment/software in question
Average training time decreased by over 60%
|Two test types showed issues related to improper setup or missed documentation||Create checklists targeted toward equipment usage and documentation requirements||63% reduction in occurrences|
|Many flagged events were linked to data processing involving one piece of software with a root cause of differences in the software setup for different in-process materials and finished products||Harmonize the differences between materials; standardize nomenclature, reports, and calculations; create job aids on the process steps||90% reduction in occurrences|
Proactive Vigilance Achieves Greater Efficiency and Reliability for Clients
A holistic, data-driven view of systems, processes, and human behavior allows us to solve problems quickly and future-proof our QC operations. This approach enables Societal to operate better and more efficiently. For clients, it means they can meet milestones more quickly and bring much-needed therapies to patients on time through:
- Greater Efficiency With Faster Delivery and Lower Costs
- Reliable Data
- Reliable Turnaround Times
- Societal Expertise
With this methodology, our chemists and management group reduced the total occurrences of issues significantly.
|Laboratory investigations, deviations, incidents||Progress 2019 to 2020|
|Total occurrences||Reduced by over 60%|
|Human error||Reduced by over 70%|
|Right-first-time metric (KPI)||90%⇨96%|
When you are investing in products that can change lives, Societal’s creative solutions, flexibility, and focus on quality deliver excellence in pharmaceutical development and manufacturing.