QC Lab Can Reduce Product Lead Times By Tom DeWit

Pfizer’s quality control (QC) laboratory in Puurs, Belgium, has been applying lean techniques to reduce the total throughput lead time for products across the entire supply chain for several years. In 2010, the QC laboratory met an ambitious target to cut standard lead times. Following that, the lab moved on to the new Pfizer global manufacturing initiative called lean laboratory, which involves adopting new ways of working and a deeper internal customer engagement to achieve real-world results. The lab began its lean journey in 2007, engaging in several agile manufacturing projects and end-to-end value stream assessments. In 2009, the lab set its sights on reducing lead times by 25% for eight major products. In 2010, having met that target, it looked to the next level of quality improvement, the Pfizer lean laboratory initiative. A global model, lean lab is currently being rolled out across Pfizer’s entire manufacturing organization; the Puurs lab was included in implementation at the first 12 sites. New Ways of Working What has allowed the lab to set, meet, and reach new improvement targets is a lean approach that emphasizes broader colleague involvement and engagement to establish a highly effective and collaborative approach to problem solving. At one time, for example, a project lead might have said, “I will determine how to improve results, and I will have it all worked out for you to implement tomorrow.” FIGURE 1. A spaghetti diagram done to measure movements in a lab during the execution of a test. Optimization of time needed for a test is also done by bringing materials and equipment needed for the test into one area. Using this method, movements can be minimized. This method may have worked in that it generated some degree of improvement, but it did not always produce the optimum solution. Because the decision was made without seeking the insight of the colleagues charged with improving results, it didn’t have buy-in from the very individuals who would ultimately carry out the process. In 2009, the lab initiated a more collaborative, lean-centered process that focused on engaging colleagues in the reduction of lead times from the start. Through brainstorming sessions and kaizen bursts, which focus activity on a particular process in the value stream, the lab used define, measure, analyze, improve, and control methodology to analyze its value stream and identify ways to improve existing processes. Other activities included: conducting an inventory of eight high-volume products, realizing that throughput improvements for this group would apply to the remaining products; determining where tests involving these high-volume products were performed within its 13 chemical and microbiological laboratories; establishing baseline lead times using historical data and identifying focus areas, representative tests, products, and laboratory impact; and engaging QC supervisors and analysts from the various laboratories to map out the current value stream and to identify areas of opportunity for developing the future state value stream map. The lean concept invites colleagues to give input and bring forward ideas for consideration that may challenge the “usual” way of working. Just because a process has always been done a certain way does not necessarily mean that is the best way. As expected, the colleagues who perform the work involved in carrying out a specific process, in this case test analysis, have the greatest insight into where, why, and how frequently they were able to identify non-value added activities and their resulting impact on process robustness. For example, colleagues pointed out that test results might wait up to two days before being double-checked, as required by an independent analyst. Their suggestion: Optimize the process to enable double-checking within 24 hours; this waiting period was soon whittled down to between 12 and 24 hours. They created a spaghetti diagram that mapped the movement path within a laboratory during the execution of a test. This visual evidence clarified the amount of non-value added activity that existed, while making it easy to see how co-locating materials and equipment needed for a particular test into one area would minimize wasted movement and time (see Figure 1, p. 35). In order to stick to this tighter time frame, colleagues took on the responsibility of planning, scheduling, and organizing their individual workflows. In this way they operated as self-directed teams, fulfilling the promise of a previously launched initiative. Analyst teams now operate as if they’re running their own business; by scheduling their work, colleagues know what’s coming in and are able to organize workflow without the involvement of a supervisor. Daily huddles enable them to discuss, review, and iron out any issues. FIGURE 2. Follow up of lead time after implementation of actions from a value stream analysis. Achieving a 25% reduction in lead times involved many changes to the value stream map (see Figure 2, right). One area targeted for improvement was the creation of a continuous workflow to execute post-analysis tasks, such as calculations, data input into the laboratory information management system, and double-checking and approval activities. There were also many opportunities to eliminate extra approval steps and wait times. The collective efforts of the laboratory teams not only helped achieve the target, but also maintained an on-time delivery rate to customers of greater than 90% for the eight products, which represent 60% of all manufactured semi-finished lots. This notable success could be considered the harvesting of low-hanging fruit. Now the lab teams are stepping up efforts as part of the Pfizer global manufacturing lean laboratory initiative. Through a multi-phase approach, the teams expect to improve quality, productivity, and effectiveness by looking at not only the value stream but also the volume of products coming into the lab in order to level the workflow and use standard work teams. In cases with high predictability in the incoming volume of work, the company applies a lean technique called rhythm wheels, which allows it to set a fixed schedule for executing certain tests such as weekly pH testing. The train testing method is better suited to less predictable incoming workloads, especially in cases in which testing is dependent upon maximum capacity being reached or approaching deadlines. Because leveling the workflow enables the company to work with standard teams, it can plan ahead more accurately for the time and equipment needed to perform and analyze the required tests. Embracing lean has also yielded another significant benefit: increased customer engagement and transparency. The process is not yet entirely transparent, but the company has made substantial progress toward that goal. Achieving Stretch Targets Throughout 2010, the Puurs lab continued to stretch its targets for reducing total throughput lead times. The lab’s overall goal for 2010, in addition to reducing lead times for its initial group of eight high-volume products, is to achieve a similar reduction across 80% of all the products and volume handled by Puurs QC. Establishing a reduced time schedule for all products is among its targets for 2011-2012. Toward that end, the lab has established a benchmark: to match or beat its sterility testing lead time; 13 or 18 working days within a climate-controlled environment is typical, depending on the particular sterile product. Once this goal is accomplished, the lab can assure its customers of results for any product within two weeks. Another quality initiative focuses on those troublesome testing processes that result in atypical outcomes and lead to additional analyses and follow-up QA investigations. Atypical outcomes may be caused by a number of factors, including broken equipment, test methodology, or flawed sample preparation. Regardless of their cause, the result of such occurrences is always rework and the potential for detailed and sometimes lengthy laboratory investigations. The subsequent impact of such delays affects customer service levels. Getting it right the first time, which optimizes processes, achieves a smoother workflow, and minimizes outcomes that require QA investigations, is the focus of this initiative. The quality improvements accomplished to date, like those the lab is working toward, require a new and different mindset and collaborative approach to problem solving. The most important element is the early engagement of key colleagues involved in the process, giving them both responsibility and accountability for making improvements that support overall lab objectives. These lean efforts incorporate best practices that are in place throughout Pfizer’s global manufacturing network. Reducing lead times means nurturing a culture of continuous improvement that focuses on the customer and advances the company’s collective efforts in quality, productivity, and effectiveness.