When post-mortem reviews are made of rampant order supply delays and the consequent customer complaints, at any typical pharmaceutical company, it is common for manufacturing teams to point fingers at QC.(1) This could be due to a lack of timely availability of tested RMs, hold-up owing to delays in IP testing, or dispatch delays due to pending finished batch releases.    Stricter tracking of the performance metrics for each section in QC is the usual strategy adopted to prevent the situation from arising again. However, this not only addresses the root cause of these problems but also triggers a vicious loop of actions that aggravates them. Let us see how.  <h5> </h5><h2>QC performance metrics and their impact</h2>At the heart of QC's performance evaluation lie two critical metrics: Service Level (Turnaround Time and Productivity.) TAT encompasses not only the actual testing time but also the time required for campaign formation (waiting time) and is managed through SLAs (Service Level Agreements) with user departments for testing protocols. Failure to meet TAT SLAs attracts significant scrutiny from user departments to the point where manufacturing starts leading daily QC planning and leaves very little room for QC to decide on an optimal campaign. And when backlog/pendency increases, the procurement team often forces QC to release batches, as significant delays are often linked to delays in clearing vendor payments and becoming a challenge for the department in supplying subsequent lots to manufacturing in a timely manner.   Productivity, on the other hand, quantifies the number of samples released relative to the available resources within a given month. With a growing backlog of samples to be cleared with limited resources, this parameter too is of paramount interest. Higher productivity helps the lab to absorb external & internal uncertainties without impacting any of the outcome metrics. Moreover, improved productivity often leads to cost savings as it helps run the lab with fewer manpower (analysts) required.  SLAs or TAT commitments underscore the importance of promptly testing pending samples upon receipt. On the one hand, it is strongly held that if QC begins testing early, they can release the sample on or before the target date.    However, increasing campaign size is seen as a means to enhance productivity by making the most of existing resources. Let’s take a hypothetical example to understand how this works.  Let’s say planner Ajay has two batches of product X on Day 1, and another batch is going to come into QC on Day 5. Ajay has two options.  <figure class="image"><img style="aspect-ratio:2084/2084;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//m1-1710145946_1767609596.png" alt="Vector Consulting Group | Article | Measurement conflict in pharmaceutical labs | Image 01" width="2084" height="2084"></figure>As shown in this example, a typical test only requires a small amount of extra capacity to release an additional sample. So, the output from the same resources increases dramatically if QC increases batching or forms campaigns.    But waiting to form testing campaigns can sometimes be time-consuming. Further, once these campaigns are planned, lab planners open multiple samples to optimise the testing process. This creates a significant level of WIP within the lab. This is planned for(1) and wouldn’t be an issue if all goes well. However, things don’t go as planned.   For instance, fluctuations in the monthly production plan in response to market changes can force the QC department to redirect its resources towards urgent samples needed for immediate production in RM testing. The new tests required add to the existing WIP, leading to higher WIP and, in turn, longer lead times. To compound matters, operational inefficiencies like instrument breakdowns, absenteeism, and the need to retest due to Quality Management System (QMS) issues, as well as priority changes to tests needed to expedite vendor payments, can disrupt workflow. These disruptions result in a growing number of pending samples, leading to longer delays in the release process and higher TAT. <figure class="image"><img style="aspect-ratio:16669/11615;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//image_1746016012.png" alt="Vector Consulting Group | Article | Measurement conflict in pharmaceutical labs | Image 02" width="16669" height="11615"></figure>While the extent of problems is less pronounced, similar issues persist in both IP testing and finished goods (FG) testing. In FG testing, WIP accumulates due to frequent changes in priorities prompted by the urgency to test samples with imminent airfreight deadlines. Conversely, in in-process testing, this occurrence may be attributed to emergent variability or quality failures. All these lead to the expansion of TAT/poor productivity and a dissatisfied manufacturing department. When faced with these challenges and mounting complaints from the production team, QC loses its control of productivity & optimum campaigning and starts firefighting. Management heightens its expectations of QC. They emphasise the need to improve productivity simultaneously. <h5> </h5><h2>Core issue</h2>Clearly, at the crux of this vicious loop is the dilemma of the section planner who manages the show. While he may want to start testing available samples in small batches in hand to meet the SLA, the need for productivity drives him to wait and form large campaigns. This, along with inherent uncertainties and variability, results in long, variable lead times, which, in turn, cause delays.  <figure class="image"><img style="aspect-ratio:2083/2083;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//m2-1710149038_1767609701.jpg" alt="Vector Consulting Group | Article | Measurement conflict in pharmaceutical labs | Image 03" width="2083" height="2083"></figure><h2>The way out!</h2>A viable solution becomes evident when we can precisely define the primary objective of the quality department within a pharmaceutical manufacturing facility. The quality department primarily serves as a support team, tasked with facilitating the timely production and dispatch of pharmaceuticals, while maintaining rigorous compliance with regulatory standards and requirements, notably Good Laboratory Practices (GLP). Consequently, while the productivity is not to be dismissed, the primary focus of QC is TAT.    A support department like QC is, in fact, expected to operate with surplus capacity. Efforts to enhance productivity by maximising capacity utilisation in service departments or non-constraints, such as reducing resources or streamlining operations, often risk transforming them into bottlenecks, ultimately hindering the overall performance of the system (in this case, the plant as a whole). This is because these departments may lack the necessary capacity cushion to handle fluctuations in workload, which is common in pharmaceutical manufacturing facilities.    The variability in workload within the lab is not solely due to fluctuations in production but is also influenced by external factors, such as changes in Standard Operating Procedures (SOPs) mandated by regulatory authorities, global Corrective and Preventive Action (CAPA) initiatives, and testing errors, among others. Therefore, the lab requires sufficient capacity to effectively accommodate these workload fluctuations. Clearly, QC has to balance the need for efficiency with the primary need to ensure TAT commitments.    So, what can we monitor across the different QC labs to ensure that production/dispatch is never delayed by the availability of tested material while also achieving sufficient productivity? What parameters should be observed to detect early signals of delays, and what can we track to drive continuous improvement in lab processes?    As mentioned earlier, the solution lies in further defining the purpose of each type of QC lab.  <h5> </h5><h5>Raw Materials/Packaging Materials lab: </h5>The RM lab has a clear purpose: to prevent production lines from experiencing shortages and to avoid delaying vendor payments. If the primary goal of the RM lab is to maintain a continuous supply of tested RM, its performance should be assessed by the number of days of production coverage it consistently provides to each production line.  <h5> </h5><h5>Ensuring adequate dispensing days cover for each line:</h5>Gaps in the availability of approved materials required for scheduled production should be derived. The sequence of the production schedule should guide the prioritisation of testing activities in the RM QC department. Planners should be permitted to campaign as many lots as possible, provided that the testing sequence aligns with production requirements. RM QC should strive to maintain dispensing coverage for each production line equivalent to 2-3 weeks of operations. This buffer will provide the flexibility needed to accommodate urgent release requirements arising from changes in the production schedule driven by market dynamics.   Secondly, monitoring a separate buffer of tested and yet-to-be-tested material in the plant can give the central procurement team visibility into replenishing them as consumption occurs. This ensures that procurement orders only what is necessary for the plant's operations, reducing the likelihood of SKUs being delivered but remaining unused. As a result, timely vendor payments can be made, and the RM lab can maintain focus without the constant switching between materials required for production and those needed for vendor payments.   This decoupling, from manufacturing and from procurement demands, in turn, enables the RM QC department to allocate sufficient waiting time for strategic planning and the efficient execution of testing campaigns, ultimately leading to a reduction in TAT.   <h5>Finish Product and In-Process lab:</h5>The purpose of the FP and In-Process (IP) labs is to ensure the availability of the necessary quantity of QC-approved FPs before the scheduled dispatch date. Days of dispatch coverage are then the primary metric of interest here.   To achieve this high coverage, buffers for FPs (similar to what was discussed for RM) can be established based on market demand. Both production and the FP/IP lab can align to these defined buffers to coordinate production and testing efforts. For this, plant production can use replenishment signals from these buffers. Simultaneously, the FP/IP lab can view the demand and align with ‘right’ campaigning to ensure timely releases for both production & dispatches.   This decoupling, both from manufacturing for IP and from the demands of dispatch for FG, allows the QC department to allocate sufficient waiting time for testing campaigns, ultimately reducing TAT while ensuring maximum productivity.  <h5>Stability lab:</h5>The Stability lab functions uniquely compared to other labs as it operates independently of plant operations and maintains a predictable flow of samples. Its primary objective is to ensure that samples are tested within the specified time frames, as detailed in the Standard Operating Procedures (SOP) for stability testing. This approach reduces the need to report exceptions, making TAT the most suitable metric for assessing the lab's performance.   However, pharmaceutical companies often impose stricter timelines for stability sample testing than those set forth in Good Lab Practice (GLP) guidelines issued by regulatory authorities. These tighter Service Level Agreements (SLAs) can hinder the stability lab's ability to plan testing campaigns effectively. As a result, the lab may be compelled to conduct tests under suboptimal campaign conditions, leading to significant inefficiencies without delivering substantial value within aggressive timelines. Therefore, enabling the stability lab to formulate campaigns while still adhering to regulatory requirements would enhance its overall effectiveness.   <h2>Conclusion</h2>Mindlessly adhering to industry-standard metrics for evaluating lab performance is a recipe for disaster. The wisest course of action is to tailor lab metrics to meet the lab’s precise expectations. Once established, continuous process improvement can focus on delivering better results for these new lab metrics. Remarkably, when this is done, both productivity and TAT are achieved harmoniously, without compromise.

Key Takeaways

Discover innovative solutions to resolve inherent conflicts in pharmaceutical quality control, streamline processes, overcome operational bottlenecks, and enhance efficiency.

Measurement conflict in pharmaceutical labs

Pharma QC labs face a constant conflict between efficiency and turnaround time. Discover how balancing metrics with strategic buffers can eliminate bottlenecks and speed up batch releases.

<h4>Measurement conflict in Pharma labs</h4>

Download PDF

Explore how conflicting QC metrics drive bottlenecks and order delays in pharma labs, and learn how strategic buffers can align productivity with turnaround time.