By Agnes Shanley, Editor in ChiefWe often hear how corporate mergers lead to slash-and-burn downsizing or culture clash, but mergers can also lead to soul-searching, and change a corporate culture for the better. After the formation of AstraZeneca five years ago — a union between Sweden’s Astra AB and the U.K.’s Zeneca Group — the new company’s leadership took a long, hard look at the way it handled quality and efficiency initiatives.By all indications, the company was doing a good job. Progress had already been made with the corporation’s Site Excellence program. The U.S. Operations’ One Site program had helped eliminate silos and ensure that all plants were on the same wavelength, using the same IT and jargon. On a local level, “continuous improvement” teams were solving specific problems. Still, corporate leaders realized that there was more to do.
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At one facility,
cross-functional teamwork
and a capital investment of
less than $100,000
led to more than $60 million
in revenue gains —
without adding staff.
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“We’d always worked on improvement projects,” says Ron Matthews, vice president of manufacturing and supply chain at the company. “But solutions and improvements weren’t always aligned so that benefits cascaded across the entire organization.”All too frequently, Matthews says, data weren’t measured properly and goals weren’t identified early enough. “Staying power” was another issue. “When we looked at results for some programs,” Matthews says, “we found that, two years later, the benefit and enthusiasm had waned.”Matthews and his team knew that they needed to develop an end-to-end strategy for operational excellence that would address everything from raw material receipt to manufacturing, quality control and distribution. “We didn’t want to end up with a patchwork quilt of efforts, and there had to be a logical sequence or order to what we did,” Matthews says.They opted for a program based on three key, interconnected concepts:
- Pull Manufacturing, a subset of Lean;
- Six Sigma’s DMAIC (for “define, measure, analyze, implement, and control”), which establishes a framework for continuous improvement;
- Overall equipment effectiveness (OEE).
Integrating these concepts and making them part of workaday reality are cross-functional teams whose members come from quality assurance, engineering, operations and technical services. “There are lots of consultants out there selling something. We knew we had to use our own people to make this work,” Matthews says.Rather than dive head first into Lean, the company launched a limited, more-focused Pull Manufacturing initiative at its global facilities in 2002. Pull Manufacturing required that the company’s manufacturing teams shift their focus from output to customer alignment and service. “We used Pull to engage staff, identify opportunities and eliminate waste,” Matthews says. The initiative also helped reduce cycle time. In one case, it allowed lead time for a key $1.5-billion-per year product to be reduced by 25% during a period when demand for the drug was increasing by 30%.
If you teach someone to fish . . . AstraZeneca didn’t move full-scale into Six Sigma, either, or deploy small armies of Six Sigma Green and Black Belts. Instead, operations and quality staff were trained to apply DMAIC principles every day, to measure and improve performance through cross-functional “continuous improvement” (CI) teams.Two years ago, at Westborough, Mass., cross-functional CI teams involving QA, engineering and operations applied DMAIC principles to solve a major capacity crunch for a key product. Even though Pull Manufacturing had not yet been implemented at the site, the teams uncovered wasteful processes, effectively adding 20 million extra units of capacity per year. “A capital investment of less than $100,000 led to $60 million to $70 million in revenue gains — without adding staff,” Matthews says.Workgroups have been restructured so that supervisors are very close to the work itself, and teams focus on specific operations. “We’ve engaged operators so that they become owners of the process,” says Matthews. “They feel empowered, have more energy and confidence.”This approach is now carrying over into hiring and recruitment. For example, a new blister packaging line in Newark, Del., involved a novel, much faster process that demanded a new approach to staffing. “Before, we would have looked at seniority and asked for volunteers,” Matthews says. “This time, we went through a selection process, and interviews, for the operators. We needed to ensure that each person had the skills and competencies required for the team.”
OEE and operator ownershipWhile Pull and DMAIC address work processes, equipment-focused OEE (see "The Basics of OEE" below) has been critical in allowing the company to squeeze every drop of capacity out of its operating lines. In 2003, for example, on one Newark bottling line, OEE was improved by 10%, adding one million bottles per year of capacity without spending a penny on new equipment.OEE took a while to gain operations’ full support, admits John Callahan, senior packaging manager on that line. He already had over 20 years of industry experience and had led many teams when Newark’s engineering team introduced him to OEE and DMAIC in 2002. Initially, he recalls, “it looked like it would involve a great deal of effort, and I wasn’t sure of the benefit or how performance would be improved.”In 2003, engineering established a pilot program on a bottling line, which led to successes, including the 10% gain in OEE. However, Callahan says, operators still didn’t feel that they fully “owned” the process, but that it belonged instead to engineering.Callahan realized that this would limit the program’s effectiveness. “You can’t push down programs like this,” he says. “Operators must see the idea as their own, and they need to be trained to use the tools.”Last year, ownership of the OEE program shifted to the operators and Callahan became the team leader. Targets of 65% OEE were set for three new lines coming in. Callahan now realized that leadership would make or break the project. “We needed to walk the talk, or the entire effort would fail,” he says.
Servant leaders, NASCAR changeoversCallahan’s visibility on the plant floor is now a given. Even when he spends more than half a day in meetings, the rest of each day is spent interacting with the operators. This close contact and communication has allowed operators to initiate improvements. For example, when leadership set a goal of 40% OEE improvement on some lines, changeovers became a key obstacle. “We needed to take a pit-stop mentality, but at the same time had to ensure quality and eliminate rejects,” Callahan says.Something as basic as cleaning product carts was a time and resource drain. Operators had to hose off and then blow-dry wheels, but they couldn’t get the dryer between the wheels easily. Then an operator came up with the idea of fitting each cart with a knitting ring, whose gap could accommodate an air hose and easily blow between the wheels. Each ring cost only $2, but saved a substantial amount of time.Through these and other improvements, the packaging team was able to reduce daily startup time from 120 to 30 minutes, and the improvements continue to come. Training and empowerment are key, Callahan says (for best practices, see "Keeping Everyone Excited: Secrets to Team Leadership," below). “Energized people can make improvements that you didn’t think were possible,” he says.
Leveraging technologyAlthough people have been the focus of AstraZeneca’s operational excellence efforts, the company has been taking full advantage of the latest packaging and automation technologies. Laser etching, for example, is being used at Westborough as an easier way to emboss Pulmicort asthma medication respules. Some automated lines are already up and running, embossing labels on the polyethylene containers.The company is already using RFID on some small cases, on AGVs and in storeroom operations, but is planning to increase its application. As part of a global initiative, the company is also beginning to implement process analytical technology (PAT) to monitor and optimize processes (see "PAT Focuses on Development" below).
IT and the road aheadOn the IT side, specific software packages such as DT Analyst, developed by Parsec Automation Corp. (Brea, Calif.), have helped with the OEE work. AstraZeneca is also one of a handful of pharmaceutical companies that have implemented an electronic laboratory process management and compliance system (
Pharmaceutical Manufacturing, July 2005, p. 18).Setting the foundation for future improvements, the company has implemented mySAP at all its facilities; it is now also integrating warehouse management into mySAP. Since its introduction last year, the enterprise resource planning (ERP) software has given the company a more robust, common IT platform. This has aided regulatory and compliance efforts by providing easier access to information via fewer interfaces, and by increasing the visibility of inventory throughout the supply chain, says David Walters, Leader of mySAP Business Benefits & Value Realization. The system has already reduced working capital, he says.
Climbing the learning curve togetherThe greatest challenge of the implementation has been transferring knowledge throughout the ranks, says Dan Grieves, senior manager of operations systems services at the Westborough site. The SAP implementation team disbanded shortly after the system went live. “This forced all user groups to rapidly address problems and overcome a sharp learning curve,” which they did through sharing and cooperation, he says.Locally and globally, AstraZeneca is building out the capabilities of the system and integrating it with other data systems. One is Intellution’s iFix SCADA system, which has new applications coming online annually — most recently, to support WFI distribution and the filling line for the Pulmicort Respules asthma treatment. The site currently uses information boards that are updated daily to monitor OEE, but is evaluating software to automate the process. Westborough is using SAP’s front-end computing system (FECS) module to perform preventative maintenance and calibration scheduling and tracking.These systems, coupled with continued equipment upgrades within critical production areas, have allowed Westborough to achieve uptime of greater than 99%, Grieves says. The site is in the process of assessing manufacturing execution systems (MES), and developing a strategy for a unified system.A secure, centrally managed network infrastructure with the appropriate maintenance applications has already gone a long way towards Westborough’s goal of making the site ready for the manufacturing challenges ahead, such as the implementation of PAT.However important technology and IT prove to be, the key to the company’s success will be a motivated and engaged staff that sees its connection to the product, and to the patient relying on that product. Newark senior packaging manager Callahan recalls a recent visit by a motivational speaker charged with helping his teams manage change. After a dynamic presentation, she suddenly took off her wig, revealing not only the results of chemotherapy, but the fact that AstraZeneca’s products were helping her keep her cancer in check. “It was a powerful moment,” he says.“People need to be engaged, to be involved in the product that they’re making,” says Matthews. “When people feel ownership, their commitment will sustain us.”
The Basics of OEE
Overall Equipment Effectiveness is the product of a production line’s availability, performance and quality percentages. The methodology, key to more pharma operational excellence programs, allows equipment downtime to be readily viewed as a function of total available time. World class OEE is estimated to be around 85%. The pharmaceutical industry has reached close to that figure for some of its packaging lines, but for batch processing, the benchmark is quite a bit lower. For a good primer on OEE, see www.pharmamanufacturing.com.
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Keeping Everyone Excited: Secrets to Team Leadership
AstraZeneca typically establishes cross-functional teams with representatives from each “stakeholder” department. Each team has a project leader and sponsor, and begins the process by creating a charter, which outlines the scope, objectives, deliverables, and timeline, explains Westborough team leader Steve Grenier.
A formal Employee Suggestion Program keeps operators involved in continuous improvement, says fellow Westborough team leader Rob Reinfurt. During the program’s first two and one-half years, almost 900 ideas were submitted, $400,000 saved, and over $40,000 awarded. Rewards are made in public and those involving significant savings are publicized. In addition, where appropriate, operators are utilized on project teams.
Communication is ensured by holding regular meetings involving all levels of management. For operators, this includes meetings with Supervisors, Directors, and Senior Directors. Education and training are regularly discussed at these meetings. Product quality is often built in as a measured objective within each employee’s annual performance management plan and cGMP Notebooks are issued as required reading by the Compliance Group. Bulletin boards are utilized throughout the site, posting information on key performance indicators (KPI), both performance and targets.
In addition, Town Halls are held with the Site General Manager. The site newsletter is sometimes used to communicate key information, while posters and displays are used for site events, such as a Site Fair that explained OEE.
At Newark, team meetings are held monthly. These one-hour reviews involve operators, maintenance, engineering, technical services and packaging management, distilling the essence of what they need to know and outlining how each will be accountable.
Since they received training in troubleshooting and rapid changeover, Newark packaging teams demonstrated a real sense of self-direction, says John Callahan, senior packaging manager. In one case, when one packaging team’s two supervisors were out on leave, the team operated independently, achieving 75% OEE without any supervision, and sustaining that level for the three weeks that the supervisors were out.
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PAT Focuses on Development
In Sweden, AstraZeneca’s development group uses PAT whenever possible to support formulation and process development. “The earlier PAT can be used in drug development, the better,” says Ulrika Henningsson, manager of the Process Analytical Chemistry team for Drug Product Supply in Gartuna, Sweden. Operations gets involved from Phase 3 onwards, and the company uses risk-management tools such as FMEA (Failure Mode and Effects Analysis) to identify raw materials and unit operations that might benefit from PAT and lead to greater product quality. Financial gains from improved yields and Right First Time rate, and reduced cycle times, are also figured into the equation.
Manufacturing is doing some pilot-level PAT work in Newark for antipsychotic therapies. The PAT team at the site is using near-infrared (NIR) spectroscopy to determine the content uniformity of one of the solid oral dosage forms manufactured at the site, says PAT project leader Ziggy Waraszkiewicz. NIR is being used, first, in the QA analytical lab to reduce lab test cycle time, but may later be moved to the manufacturing area to obtain content uniformity data while the product is being made.
AstraZeneca’s strategic use of PAT should also improve technology transfer and “handoffs” in the future. For example, the company’s R&D group in Wilmington, Del., is using PAT to gain information to identify critical process parameters and product attributes for solid oral dosage forms in development, Waraskiewicz explains. With this information, the group will be able to optimize the manufacturing process, and ease the move from development to full-scale production.
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