Customer Service is Crucial
Customer service is not only about having a pleasant relationship with your CMO partner, it also is about timely communication,
effective resolution of issues, response to changes you need, and product delivery when requested. We all know good and poor
customer service when we experience it, so what you really need when evaluating a CMO partner is a way to peer into the organization
and get a good idea of what your service experience will be like after you sign the contract. There are some recent trends
in customer service in the CMO industry that offer you a predictive tool. These include customer service agreements, dedicated
project teams, and mutual alignment on objectives and consequences. Service agreements explicitly spell out "how" the client
and CMO will work together, while dedicated cross-functional teams consisting of representatives from key functions (manufacturing,
technical services, and quality) offer focused and responsive communication for your project.
Leaning on Lean
Lean is a win-win strategy that is customer-focused, while providing cost saving benefits to the organization. As biopharmaceutical
companies continue to struggle with increasing cost pressures, regulatory burden, and more challenging drug development timelines,
the value of Lean operations and efficient execution has become more important.2–6 Sayer and Williams best summarize Lean as ". . . a philosophy and a proven long-term approach that aligns the business
to deliver increasing customer value. It's about focusing people and systems that continuously deliver value to the customer
by eliminating waste and deficiencies in the process. Lean is an everyday practice at all levels to perform consistently,
as well as to consistently improve performance."6 The logic of Lean methodology echoes what has been stated earlier regarding project management best practices and a focus
on customer service. It concentrates on identifying and exploiting shifts in competitive advantage. It encourages individual
initiative and the flow of information highlighting defects, operator errors, equipment abnormalities, and organizational
deficiencies. Operationally, it standardizes workflow and focuses on problem identification, hypothesis generation, and experimentation
in a relentless pursuit for process improvement.
Implementing Best Practices
Table 1 provides an integration matrix of best practices from project management, customer service, and Lean methodology in
terms of process, tools, training and development, and sustainability. Below are two examples of how blending these best practices
provide optimal results for clients adding value to their organizations.
Table 1. Lean, customer service, and project management integration matrix
A client metric scorecard (Figure 1)—a customer service tool—is part of the daily accountability process (Lean) tracking performance
of the client's project and is presented at quarterly client business meetings. The scorecard contains key project metrics
important to the CMO and the client, such as on-time delivery, incident rate (exceptions in the manufacturing process), and
yield. It is a visual control (Lean) that also satisfies the monitor and control stage of the project, and provides an effective
communication tool for customer service. As the client, you can feel confident about how your project is being managed, and
you and your CMO have a common understanding of the status.
Figure 1. An example of a client metric scorecard
A risk assessment (Table 2)—a project management process—is done as part of the technology transfer phase of your project.
The risk assessment document contains the list of risks, the probability of occurrence, the impact should the risks occur,
and the project team response to each risk to mitigate it and build contingency plans. This project management practice identifies
potential waste that can diminish value creation (Lean), while it helps manage mutually agreed expectations (customer service).
The result is that risks are better managed, so there are fewer issues and costly mistakes in the process.
Table 2. An example of a risk-assesment document (red: risk plan is needed; yellow: consider a risk plan; grey: risk plan
Project managers should leverage best practices from project management principles, customer service, and Lean. This helps
integrate the needs of the client, project, and the CMO, focusing on timely delivery of your project to yield the best possible
value to your organization.
Raul Soikes is a senior director of program management and Colleen K. Dixon is a manager of project management office, both at Baxter BioPharma Solutions, Bloomington, IN 812.355.5247, email@example.com
1. Reuters. Biopharmaceutical contract manufacturing study finds industry growth over the past two years and expects to continue
its growth trajectory. 2009 Jun 10. Available from: http://www.reuters.com/article/pressRelease/idUS104649+10-Jun-2009+BW20090610
2. Mann D. Creating a Lean culture: tools to sustain Lean conversions. New York, NY: Productivity Press; 2005.
3. Liker JK, Meier D. The Toyota way fieldbook. New York, NY: The McGraw-Hill Companies; 2006.
4. Graupp P, Wrona RJ. The TWI workbook: essential skills for supervisors. New York, NY: Productivity Press; 2006.
5. Shook J. Managing to learn: Using the A3 management process to solve problems, gain agreement, mentor, and lead. Cambridge,
MA: The Lean enterprise Institute; 2008.
6. Sayer NJ, Williams B. Lean for dummies. Hoboken, NJ: Wiley Publishing, Inc; 2007.
7. Project Management Institute. A guide to the project: the project management body of knowledge. 4th ed. Newton Square,
PA: Project Management Institute, Inc.; 2008.
8. Baxter International. Baxter BioPharma Solutions Process 360. Customer service. Available from: http://www.baxterbiopharmasolutions.com/content/about_bbps/process_360.html.