Pharmaceutical Processing - July 2008 - cResults - (Page 2) 2 p h a r m p r o. c o m Operational Excellence proved communication with manufacturing to enhance finished good samples visibility to allow both stability and finish good labs to improve their campaigning and overall execution. The two labs are working as one cohesive and efficient unit while maintaining 100% compliant performance - meeting the scheduling needs of supply chain and the stability program. * Centralized media to reduce set-up and to focus our analysts more on the science: Establish a new role as a QC technician that focuses on preparing media and mobile phase for the analysts. This does not just improve the efficiency of the analyst and reduce the number of set-ups, but also increases consistency and eliminates waste regarding media disposal. The new system includes a request form submitted by the QC analysts that generates the demands for a specific type of media to be prepared. A QC technician than prepares the required media and mobile phase based on the requested forms, hence allowing the analyst to focus on the science, the test methods, and other value added activities. * Improve our layout to reduce walking distance: The team used Value Stream Mapping7 and other work flow analysis techniques to determine that the walking distance within the lab was excessive and caused inefficiencies created by lab supply location, workstations, instruments, and business processes. The project team came up with a new layout that includes instrument relocation, new Kanban1, 2 system for the labs supply, relocation of offices and other working areas. The Kanban system helps maintain inventory levels of lab supply, and is used as a signal sent to deliver a new shipment of lab supply as material is consumed. The Kanban system was used for the common media. Once the level of media was reduced to 20% of the total volume indicated by a mark, the QC technician would replenish this specific media by preparing an additional 50L. The implementation of the new layout resulted in 25% reduction in overall walking distance. The total walking distance per year was about 5,000 miles prior to the layout changes. * Establish tools/computerized systems: The additional MS Excel communication spreadsheets help improve the lab’s visibility in terms of API needs based on the production plan, sample due date, sample availability, and expected arrival dates. This information also helps to improve the lab prioritization and reduces set-ups by improving samples campaigning. It minimizes expediting samples, which reduces the Raw Material Lab’s backlog and improves its service level. Furthermore, the labs performance is tracked and reported, and sample cycle time and efficiency information is recorded to provide the needed visibility. The new measurement system helped drive accountability and ownership of the lab personnel. * Create additional Key Performance Indicators (KPI) and a dashboard to help measure our progress: The new dashboard measures the efficiency by lab, the expected weekly workload ,and other KPIs such as cycle time and compliance-related metrics. This allows the lab, during its weekly management meeting, to discuss staffing allocation, expected bottleneck and to be proac- savings compared to the previous year. • Raw materials backorder was greatly reduced due to reengineered business processes and improved visibility. • Walking distance was reduced by 25% (~1,250 miles per yr.) • Improved on-time delivery and delivery consistency (i.e., NO Backlog due to lab performance). • Planning standards, scheduling strategy and Dashboard became the core of the continuous improvement infrastructure. Figure 2 outlines the major increase in lab efficiency in terms of throughput to reduce backlog. Once the backlog was substantially reduced, the efficiency improvement was leveraged to reduce overtime, reduce temps and overall cost. The ROI for these outstanding improvements was less than 6 months including internal and external cost. This tremendous success story has made Par Figure 2: Efficiency Improvement and Backlog Reduction tive and more effective. Key to the success of this initiative was a strong project team consisting of bench chemists and lab management. Buy-in at all levels was imperative to drive change. The project team created a continuous improvement communication board which provides each lab with improvement program key activities and the ability to track progress via chart. Some of the key achievements of the 6 months of implementation were: • More than 20% efficiency gain in the QC labs, which translates into major cost reduction/ avoidance (i.e., reduced temp; over time). More than 1 million dollars per year in total QC the role model for the entire site and the journey toward operational excellence continues. Today, the Par QC operational excellence team meets weekly to review the dashboard and make decisions to best meet its customer service expectations. QA Operational Excellence Journey Once the QC laboratory journey commenced, the other quality operation organization, QA, was chartered to improve its performance as well. QA is often inaccurately viewed as inefficient by other departments and as a strictly cGMP function that adds no significant value to the business. Indeed, when it comes to pharmpro.com
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