When postmortem 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 Quality Control (QC)1. This could be due to lack of timely availability of tested raw materials, holdup owing to delays in in-process testing, or dispatch delays due to pending finished batch releases.  Stricter tracking of the performance metrices of each section in QC is the usual strategy arrived at to prevent the situation from arising again. However, this does not only address the root cause of these problems but also triggers a vicious loop of actions that aggravates them. Let us see how. <h5>QC performance metrics and their impact</h5>At the heart of QC's performance evaluation lie two critical metrics: Service Level (Turnaround Time - TAT2) and Productivity. TAT encompasses not only the actual testing time but also the time required for any campaign formation (waiting time) and is managed with SLAs (Service Level Agreements) with user departments for the testing protocols. Failure to meet TAT SLAs involves significant scrutiny from user departments to an extent where manufacturing starts leading the daily QC planning and leaves very little room for QC to decide for an optimum campaign. And when backlog/pendency increases, many times procurement team forces QC to release batches as significant delays are often linked to delays in clearing vendor payments and becoming a challenge for the department to supply 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 lab to absorb external & internal uncertainties without impacting any of the outcome metrics. Moreover, improved productivity often leads to cost savings as it helps running lab with fewer manpower (analyst) required. SLAs or TAT commitments underscore the importance of testing pending samples promptly after they are received. So, on one side, it is strongly held that if QC begins testing early, they will be able to 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 is having 2 batches of product X on day 1 and another batch is going to come in QC on day 5. Ajay has 2 options. <figure class="image"><img style="aspect-ratio:2084/2084;" src="https://new-stage-be.vectorconsulting.in/storage/editor_uploads//m1_1710145946.png" width="2084" height="2084"></figure>As can be seen in this example, a typical test only needs 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 in an effort to optimise the testing process. This creates a significant level of Work-in-Progress (WIP) within the lab. This is planned fori 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 Quality Control (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, increasing Work-in-Progress (WIP) and prolonging lead times. To compound matters, operational inefficiencies like instrument breakdowns, absenteeism, and the need for retesting due to Quality Management System (QMS) issues, priority changes to tests needed to help expedite vendor payments can disrupt workflow. These disruptions result in a growing number of pending samples, leading to increased delays in the release process and a rise in Turnaround Time (TAT).<figure class="image"><img style="aspect-ratio:16669/11615;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//image_1746016012.png" width="16669" height="11615"></figure>While the extent of problems is less pronounced, similar issues persist in both in-process testing and finished goods (FG) testing. In FG testing, Work in Progress (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 & 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 simultaneously improve productivity.<h5> </h5><h5>Core issue</h5>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 and variable lead times, hence the delays. <figure class="image"><img style="aspect-ratio:2083/2083;" src="https://new-stage-be.vectorconsulting.in/storage/editor_uploads//m2_1710149038.jpg" width="2083" height="2083"></figure><h5>The way out!</h5>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 pharmace  uticals, all while maintaining rigorous compliance with regulatory standards and requirements, notably Good Lab Practices (GLP). Consequently, while the productivity is not to be dismissed, the primary focus of quality control (QC) is TAT.  A support department like QC is, in fact, expected to operate with surplus capacity. Efforts to enhance productivity through attempts to maximise capacity utilisation in service departments or non-constraints by 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 then lack the necessary capacity cushion to handle fluctuations in workload, which is a common occurrence in pharmaceutical manufacturing facilities.  The variability in workload within the laboratory is not solely a result of fluctuations in production but is also influenced by various external factors, such as changes in Standard Operating Procedures (SOPs) mandated by regulatory authorities, global Corrective and Preventive Actions (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 of ensuring TAT commitments.  So, what can we monitor at each of the different QC labs to ensure that production/dispatch is never delayed due to the availability of tested material while also achieving good enough 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 laboratory. <h5>RM/PM Lab: </h5>The RM (Raw Material) 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 raw materials, its performance should be assessed based on how many days of production coverage it can consistently provide 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 to 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 plant can give the central procurement visibility for 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 both from manufacturing and from the demands of procurement, in turn, enables the RM QC department to allocate sufficient waiting time for strategic planning and efficient execution of testing campaigns, ultimately leading to a reduction in Turnaround Time (TAT).  <h5>Finish Product and In-Process Lab:</h5>The purpose of the Finished Product (FP) and In-Process (IP) labs is to guarantee the availability of the necessary quantity of Quality Control (QC) approved finished products before the scheduled dispatch date. Days of dispatch coverage is then the primary metric of interest here. To achieve this high coverage, buffers for finished products (on similar lines 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 provided by these buffers for production. 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 making testing campaigns, again ultimately leading to a reduction in Turnaround Time (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 Turnaround Time (TAT) the most suitable metric for assessing the lab's performance.  However, pharmaceutical companies often impose stricter timelines for stability sample testing compared to the guidelines set forth in Good Lab Practice (GLP) 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.  <h5>Conclusion</h5>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 match the precise expectations for the lab. Once established, continuous improvement in processes can focus on delivering better results for these new lab metrics.Remarkably, when this is done, both productivity and Turnaround Time (TAT) emerge harmoniously, without any compromise.

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

Measurement conflict in pharma labs

When postmortem 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 Quality Control (QC)1. This could be due to lack of timely availability of tested raw materials, holdup owing to delays in in-process testing, or dispatch delays due to pending finished batch releases.  Stricter tracking of the performance metrices of each section in QC is the usual strategy arrived at to prevent the situation from arising again. However, this does not only address the root cause of these problems but also triggers a vicious loop of actions that aggravates them. Let us see how. <h5> </h5><h5>QC performance metrics and their impact</h5>At the heart of QC's performance evaluation lie two critical metrics: Service Level (Turnaround Time - TAT2) and Productivity. TAT encompasses not only the actual testing time but also the time required for any campaign formation (waiting time) and is managed with SLAs (Service Level Agreements) with user departments for the testing protocols. Failure to meet TAT SLAs involves significant scrutiny from user departments to an extent where manufacturing starts leading the daily QC planning and leaves very little room for QC to decide for an optimum campaign. And when backlog/pendency increases, many times procurement team forces QC to release batches as significant delays are often linked to delays in clearing vendor payments and becoming a challenge for the department to supply 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 lab to absorb external & internal uncertainties without impacting any of the outcome metrics. Moreover, improved productivity often leads to cost savings as it helps running lab with fewer manpower (analyst) required. SLAs or TAT commitments underscore the importance of testing pending samples promptly after they are received. So, on one side, it is strongly held that if QC begins testing early, they will be able to 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 is having 2 batches of product X on day 1 and another batch is going to come in QC on day 5. Ajay has 2 options. <figure class="image"><img style="aspect-ratio:2084/2084;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//m1-1710145946_1767609596.png" width="2084" height="2084"></figure>As can be seen in this example, a typical test only needs 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 in an effort to optimise the testing process. This creates a significant level of Work-in-Progress (WIP) within the lab. This is planned fori 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 Quality Control (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, increasing Work-in-Progress (WIP) and prolonging lead times. To compound matters, operational inefficiencies like instrument breakdowns, absenteeism, and the need for retesting due to Quality Management System (QMS) issues, priority changes to tests needed to help expedite vendor payments can disrupt workflow. These disruptions result in a growing number of pending samples, leading to increased delays in the release process and a rise in Turnaround Time (TAT).<figure class="image"><img style="aspect-ratio:16669/11615;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//image_1746016012.png" width="16669" height="11615"></figure>While the extent of problems is less pronounced, similar issues persist in both in-process testing and finished goods (FG) testing. In FG testing, Work in Progress (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 & 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 simultaneously improve productivity.<h5> </h5><h5>Core issue</h5>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 and variable lead times, hence the delays. <figure class="image"><img style="aspect-ratio:2083/2083;" src="https://web-assets.vectorconsulting.in/storage/editor_uploads//m2-1710149038_1767609701.jpg" width="2083" height="2083"></figure><h5>The way out!</h5>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 pharmace  uticals, all while maintaining rigorous compliance with regulatory standards and requirements, notably Good Lab Practices (GLP). Consequently, while the productivity is not to be dismissed, the primary focus of quality control (QC) is TAT.  A support department like QC is, in fact, expected to operate with surplus capacity. Efforts to enhance productivity through attempts to maximise capacity utilisation in service departments or non-constraints by 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 then lack the necessary capacity cushion to handle fluctuations in workload, which is a common occurrence in pharmaceutical manufacturing facilities.  The variability in workload within the laboratory is not solely a result of fluctuations in production but is also influenced by various external factors, such as changes in Standard Operating Procedures (SOPs) mandated by regulatory authorities, global Corrective and Preventive Actions (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 of ensuring TAT commitments.  So, what can we monitor at each of the different QC labs to ensure that production/dispatch is never delayed due to the availability of tested material while also achieving good enough 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 laboratory. <h5>RM/PM Lab: </h5>The RM (Raw Material) 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 raw materials, its performance should be assessed based on how many days of production coverage it can consistently provide 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 to 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 plant can give the central procurement visibility for 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 both from manufacturing and from the demands of procurement, in turn, enables the RM QC department to allocate sufficient waiting time for strategic planning and efficient execution of testing campaigns, ultimately leading to a reduction in Turnaround Time (TAT).  <h5>Finish Product and In-Process Lab:</h5>The purpose of the Finished Product (FP) and In-Process (IP) labs is to guarantee the availability of the necessary quantity of Quality Control (QC) approved finished products before the scheduled dispatch date. Days of dispatch coverage is then the primary metric of interest here. To achieve this high coverage, buffers for finished products (on similar lines 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 provided by these buffers for production. 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 making testing campaigns, again ultimately leading to a reduction in Turnaround Time (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 Turnaround Time (TAT) the most suitable metric for assessing the lab's performance.  However, pharmaceutical companies often impose stricter timelines for stability sample testing compared to the guidelines set forth in Good Lab Practice (GLP) 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.  <h5>Conclusion</h5>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 match the precise expectations for the lab. Once established, continuous improvement in processes can focus on delivering better results for these new lab metrics.Remarkably, when this is done, both productivity and Turnaround Time (TAT) emerge harmoniously, without any compromise.

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

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Explore the challenges faced by pharmaceutical Quality Control (QC) departments in balancing efficiency and turnaround time (TAT), and discover strategies to optimize lab performance effectively.