As pharmaceutical companies work to improve efficiency and product quality, teams are becoming more important than ever, and they are handling most of the work that goes on in manufacturing facilities. Its not easy to build an effective team, or to get members to work together for a common goal, but it can be done.
This article examines what makes manufacturing teams effective, and discusses ways to improve and evaluate performance and build team spirit. It also explores some of the challenges inherent in building, or improving, a pharmaceutical manufacturing team, and how to address them.
Effective teams yield concrete bottom-line results, but equally important intangible benefits for their members, creating ongoing opportunities for empowerment and an atmosphere of continuous learning and improvement. An effective team is rewarding to work on, and the best teams create and foster an atmosphere of trust among members that enhances their ability to work and learn together.
Design the Team
Clear communications, proper team composition and structure, a focused agenda, and the coordination of team activities are prerequisites to an effective team. At the earliest stages of team formation, would-be members must understand why the team is being set up, so they can embrace a common goal.
In understanding what makes for a good team, it is essential to understand the differences between teams and work groups, which exist side by side  in most pharmaceutical manufacturing environments. Each has some of the characteristics of the other, but they are quite distinct. A work group is a set of individuals who work under the direction of a common manager or supervisor. The manager assigns tasks to the members of the group, and integrates the various pieces of work to ensure that the group reaches its goals. Individual members of the group do not necessarily have to collaborate with each other to complete their tasks.
By contrast, a team is a group of individuals with complementary skills connected by their commitment to a common goal and who depend on each other to complete their mission. Although team members look to their leader to provide resources and connect them to the rest of the organization, they are empowered to make decisions independently. For this reason, it is important to articulate how team members will work together and how they will be held accountable.
Its also important to distinguish between the two most common types of teams in use today: self-managed work teams and project teams. Self-managed work teams handle particular ongoing tasks and are responsible for essentially the same work each day. They have some choice regarding how best to do the work and incentives to establish effective procedures and strive for continuous improvement. Project teams, on the other hand, are organized around specific, non-routine tasks and are often disbanded once the project is completed.
Forming a team is a good approach when the following conditions are present:
- No single individual has the right combination of knowledge, experience and perspective to do the job
- Individuals must work together with a high degree of interdependence
- The goal represents a challenge (recurring or unique)
A project team would be needed, for example, to handle manufacturing scale-up and/or validation runs for a new product formulation. A long lead time is required to charter this group, because once the decision is made to create the team, proper team composition is important to ensure that all necessary disciplines are represented.
Find the Right Mix
In a manufacturing environment, cross-functional teams should include members from a variety of disciplines including Production, Quality Assurance, Package Engineering and Finance. If a project involves the introduction of a new product or process, the mix may change and disciplines such as R&D, process development, regulatory affairs, distribution, and global graphics may be more active in the discussions.
Different backgrounds bring different perspectives, help ensure early buy-in, and ensure that key facets of the project are not overlooked. Cross-functional teams are typically led by a designated project manager who is responsible for coordinating the action of the team and, in many cases, is held accountable for the team's accomplishments. It is important to build flexibility into team design since the manufacturing process is extremely data-driven and can require disciplines to come in and go outto join and leave the teamover time.
Great individuals can
Companies with a shortage of experienced staff must instead rely on rigorous training programs, increased management oversight, outside consultants, and extensive quality support systems to optimize performance. These resources often result in higher costs.
Given the demands of working in a highly regulated environment, an effective pharmaceutical manufacturing teams members must demonstrate high levels of technical competence. They should be able to interpret internal SOPs, batch records, technical reports, and numerous FDA guidances and GMP regulations, and then simplify technical information so that it can be passed on to, and understood by, their non-technical colleagues.
The biggest challenge for any team is the heterogeneity of its members, who come from different departments or functional groups within any facility. Reflecting their different origins, team members can often interpret the same event very differently, and they may have very different opinions on strategy development.
An effective team leader will help members learn how to integrate their efforts and work productively. Team members must have, or develop, the patience required to help each other understand how their individual activities fit into the big picture and the business reality for the organization.
Skills that are often perceived as soft, such as emotional intelligence and flexibility in dealing with others, are critical to effective problem-solving and decision-making. In fact, these skills are often more important than the technical skills for which team members were hired because the emphasis is now on the success of the Team.
Set an Agenda, Focus on Process
After forming the team, a clear agenda is needed so each team member understands what will be expected of him or her. Both the project manager and the team members can work together to shape the agenda, assuming that team members have the necessary training and expertise to do so.
Strategic planning is critical to the success of any project since it helps optimize the time the team spends working on the project and eliminates "non-value added" activities. Once the team is operational, a commitment to follow-up on team activities will ensure that roadblocks are removed and scheduled milestones are reached on time. Team members need to know that their team is accountable, and understand how their efforts contribute to the teams success or failure. 
The coordination of team activities is crucial to the end-game and team members need to understand how they will perform their work. Individual roles and responsibilities need to be divided, and members need to understand how information and resources will be shared. Work procedures and other operating guidelines should encourage efficiency and motivate team members to share responsibility and accountability.
Also, once the team has been formed, it is important to put procedures in place to facilitate the process of getting the work done. Communication, company culture and coaching procedures all have an impact, and can either help or hinder success.
Communication is the key to a successful team process. Effective communication means more than simply having regularly scheduled meetings. Active listening, validation, acknowledgment, clarification, and the use of open-ended questions are very useful for understanding and sharing information.
Oral communication is also preferred, since written messages, and particularly e-mails, can often be misinterpreted or misunderstood when read out of context. Although e-mail is valuable for communicating quickly across multiple locations of a large organization, it can become a liability if used excessively or carelessly.
Frequent discussions about team progress are important for keeping the team on track. When a given course of action is not working, the team must be able to assemble quickly and make required changes to redirect the work.
Complex team projects can involve multiple production facilities located in different countries, posing the threat of culture clashparticularly when team members have different native languages. In such cases, the importance of frequent communication cannot be overemphasized. Regularly scheduled teleconferences and videoconferences can make the process much smoother.
Team leaders should be responsible for disseminating minutes from each meeting, which should include key issues that were discussed as well as action items and target dates. This process provides an effective method for quickly correcting any miscommunications or misunderstandings.
Teamwork is most successful in an organizational culture that encourages employees to work together to get things done and rewards them appropriately. Edgar Schein, a leader in organizational culture, defines culture as a "pattern of basic assumptionsinvented, discovered, or developed by a given group as it learns to cope with its problems of external adaptation and internal integrationsthat has worked well enough to be considered valid, and therefore to be taught to new members as the correct way to perceive, think, and feel in relation to those problems." 
Organizational culture can have a huge impact on employees' willingness to share information and work toward a common goal. Since culture operates at the subconscious level, it is very difficult to identify and therefore hard to change. Teams whose members are struggling to work together effectively would be wise to examine their corporate culture and how it might be affecting the team process.
Solve People Issues
Conflicts do arise and should be expected, even in the most effective teams, but procedures must be in place to manage these episodes so that they do not interfere with team process and progress.
Providing coaching and facilitation services can help, but its largely up to the team leader to keep the team focused. A skilled facilitator should be astute at spotting potential personality conflicts and disagreements between team members and should have proactive discussions with these members outside of the team setting to address any issues.
Many of the process challenges that occur in a manufacturing environment are related to communication skills and style differences. As mentioned previously, cross-functional teams are comprised of many different disciplines that have their own technical skill sets and perspectives. Team members need to learn to appreciate their differences and work together to present a unified front for their project responsibilities. For instance, external communications to contract manufacturing suppliers, vendors and FDA inspectors can also be challenging if team members do not share a common goal.
Self-awareness, flexibility and the appreciation of other team members perspectives and behavioral styles are important for an effective team process. Sharing information constructively, in the form of behavior-based feedback, creates a non-emotional and supportive environment in which every team member can learn and succeed.
Evaluate Team Effectiveness
In determining team effectiveness, one should consider the following fundamental questions:
- Does the team's output meet the needs of its customers?
- Does the teams experience contribute to the well-being of team members and meet their needs?
- Does the team experience create trust and enhance the ability of the team members to work together in the future?
Many organizations simply focus on the first question and evaluate team effectiveness in terms of team output. Although this is an important measure, team effectiveness should also be evaluated based on the way in which the team achieves its results. Process factors such as commitment to team work, level of participation, strength of communication and interpersonal relationships, effectiveness of decision-making and problem-solving, and individual/team learning are indicators of how the team works together and are likely predictors of the team's ultimate success or failure. 
Effective teams provide a positive experience for and meet the needs of individual members. Team members whose personal needs are met are more likely to identify with and support team goals. They also trust their colleagues, not only for the duration of the current project but for future initiatives as well. They can anticipate their colleagues actions and respond to them appropriately. Trust also allows team members to engage in active learning and take risks while operating in a supportive environment. At Alcon Labs, team work has helped employees understand how important it is to remain open-minded, to share ideas, to be open to change, and to work together to meet future challenges.
Team evaluation methods can include project debriefing sessions to review lessons learned and take steps for improving future performance. Feedback, both to team members and stakeholders in the organization, is extremely important. In addition to debriefing sessions, team member self-appraisals, satisfaction surveys from internal and external customers, and assessments by outside consultants can be used to evaluate performance. Each of these methods will garner additional information about the team's performance and overall contribution to the organization.
The pharmaceutical industry has some unique challenges that affect the ability of manufacturing teams to be effective. In this highly regulated industry, many process changes require documented submissions to regulatory agencies and subsequent approvals before they can be implemented. Certain changes may require extensive validation testing. Both of these issues increase the complexity of the process, drain company resources, and delay project milestones. With an increased focus on continuous improvement and greater demands for more efficient operations, industry resources are at a premium and careful planning is required to ensure that projects can be completed in a timely manner.
Effective teams do not evolve naturally but rather have to be nurtured. Organizations and their managers must build their teams proactively and engage in a dedicated effort to support their success. Teams that not only meet customer goals, but also create trust and learning opportunities for their members, are the key to organizational success.
- Harvard Business Essentials, Creating Teams with an Edge: The Complete Skill Set to Build Powerful and Influential Teams, Harvard Business School Publishing, 2004.
- Best Practices, LLC., Pharmaceutical Manufacturing White Paper: The Quality Function, 2004. Retrieved on 7/25/04 from http://www3.best-in-class.com/cr99.htm.
- Hill, Linda A., Managing Your Team, Harvard Business School Publishing, Reprint #9-494-081, 1995, p. 98.
- Schein, Edgar H., Organizational Culture and Leadership, San Francisco: John Wiley & Sons, 1992.
- Harvard Business Essentials, op cit, pp. 103-104.
About the Authors
John Wilmoth is production project manager with Alcon Laboratories, Inc., where he oversees the continuous improvement programs for two Alcon manufacturing plants. Wilmoth holds a BS in Medical Technology, is a certified Six Sigma black belt, and has worked at Alcon for 20 years. He can be reached by e-mail at John.Wilmoth@AlconLabs.com.
Cynthia L. Palka is president of Future Map, Inc., a professional coaching and consulting firm that helps organizations and their executives master change and create success from the inside out. Palka holds an M.S. degree in Biochemistry and is a Certified Empowerment Coach (CEC) by the Institute of Professional Empowerment Coaching (IPEC). She can be reached by e-mail at firstname.lastname@example.org.