Paving the Road for Sustainable Solutions

Design and implementation of a compliance process with global governance: a case study

By Arne Buthmann, Pharma Practice Area Lead, Valeocon Management Consulting

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When PharmaCo (fictitious name) launched its Asset Change Control (ACC) project, the company faced a highly fragmented situation where physical asset changes were managed non-homogeneously across the manufacturing sites of one of its divisions. For instance, some sites would only include GMP equipment in the scope of change control but not utilities and facilities. At other sites the ACC’s scope covered all equipment, but would only evaluate the GMP impact and not the HSE impact. Some sites were operating fully paper-based systems; others used partially automated or self-developed IT applications.

The objectives of the project were therefore to establish a global harmonized asset change control process and to implement a global tool to support the electronic execution and management of asset changes.

Previous efforts to design and roll-out global processes had followed a strict top-down approach, which had led to a lot of resistance and, ultimately, inconsistent local implementation. The project team, therefore, decided to apply concepts and methods from the PharmaCo Operational Excellence and Change Management methodology, something guided by three questions:

  • How to design a standardized global compliance process that fulfills business needs and leverages manufacturing site best practices?
  • How to implement the process consistently while establishing global governance and maintaining local engagement? 
  • How to develop and deploy a global IT system that fully supports this process and is well perceived by its users?

Phase 1: Collaborative Process Design Leveraging Site Best Practices
A collaborative approach (See Figure 1) taps into the potential of all impacted associates while building the right capabilities to make the new process work. A truly participative approach with focus on knowledge sharing and mutual learning is more sustainable over time as employees engage into the proposed change and work together to achieve success. There is a big difference between mandating compliance to end-users versus engaging them in problem analysis and solution development. By providing employees with a stake in the outcome and developing ownership of their local site’s accomplishments, a company as a whole will benefit immensely.

 The emphasis on collaboration needs to be consistently applied from project beginning. The first step on this journey was to design a global business process that would work in reality and not just in theory. Taking the collaborative approach, subject matter experts from the sites were invited to the 1st project workshop in 2011, which aimed at developing the new change control process together. The team aligned on typical process outcome problems such as incorrectly or not completed or lost change requests and long process lead times. Subsequently, they collected Voice of the Customer requirements and analyzed causes of poor change control process performance. The latter impressively demonstrated that the majority of root causes was related to knowledge and skills as well as process issues but not, as initially believed, to the lack of an electronic workflow tool.

The team also tried to establish a baseline for process capability. However, the team had to recognize that due to the fragmented situation actual process data was merely accessible. What came from the workshop and the following design phase was a basic four-step ACC process that ensured good engineering practices while being efficient and compliant at the same time (see Figure 2). The individual process elements were largely based on identified good practices from different sites; the new global process and responsibilities were established in the form of a global standard operating procedure.

Phase 2: Process Implementation with Global Governance and Local Engagement

 Many companies have the tendency to focus on the technology aspect of the people/process/technology equation and try to develop a state-of-the-art platform that addresses all of the problems, presuming the new system will be quickly adopted and implemented. However, most technology-focused efforts fail to deliver the expected results: Developing the system often takes twice as long as planned, important business requirements are sacrificed when in a rush, and users reject the new system outright or fail to use it properly. The need for "employee engagement" is often considered too late in the process. By implementing on a robust business process first, the gaps in the organization can further be identified and closed before any system is developed, thus, the risk of creating an IT system that does not solve the real business problem is significantly reduced. Achieving compliance does not rely on a tool to be rolled out, but requires the stabilization of the current system.

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