Accelerating ramp-up and meeting business objectives for pharmaceutical projects involve unique challenges that can drive substantial delays and blow-outs. But it doesn’t have to be this way. In fact, the challenges can even be turned into unique opportunities for achieving high levels of operational excellence.
Many pharmaceutical engineering projects face substantial delays in expected ramp-up of production and lower than expected productivity resulting in missed business opportunities in a more and more competitive market. In our experience, one central reason that projects struggle with meeting operational targets is lack of focus in the very early project phases on initiating the development of the future operating model.
What we see is that incentives for the engineering team and operations are misaligned. There is a bias towards meeting targets for construction, process design, equipment selection, purchase and installation while the effort to build an effective and future-proof operating model is ignored or down-prioritized with a notion that “we are too busy to look at that right now”. In addition, resources for addressing operational issues may be very limited during the project phase and they seldom have any experience in designing future operations in a structured way. Their competences lay within running existing operations – not designing new ones.
In the late stage, project managers and operations managers end up struggling to fill the gaps in the operating model, resulting in less than optimal solutions and a stressful working environment in teams already struggling with fatigue. But there are several initiatives that can mitigate this. Leaders need to apply efforts across both the investment project and how to run future operations, by creating plans in the very early phases for both engineering activities and for preparation for operations and ensuring that these plans are continuously aligned.
It needs to be very clear what “execution-ready” means and what the steps are to achieve this readiness. This means defining precisely what “ready” means and which stakeholders have assigned accountability for which criteria or tasks. Leaders must embed a mindset change to ensure that named members of the operations team take ownership of operational readiness by defining their role as “accelerating readiness for operation” rather than “waiting for everything to be ready so they can sign off”.
Our experience shows us that the operations team throughout the project phases may give the impression that they have a plan and an overview of activities remaining to prepare for operations, but the plans are often initiated too late, outdated and very seldom aligned with other stakeholders.
How to prepare for operational readiness to ensure fast ramp-up and sustainable operational excellence?
To ensure fast ramp-up and operational excellence during the project phase, focus should be on technological and operational readiness.
Technological readiness requires the operations team and the engineering provider to ensure a strong link between process and facility design. To achieve operational readiness, you need to build a robust operating model during the project phase.
The operating model describes how the future facility operates across process, organization and technology to deliver value. Importantly, it is very likely that new products will be introduced frequently once the facility is in operations. This calls for a robust operating model that allows for efficient change-over and fast ramp-up of new products.
Creating a new organization and defining how it will operate is a major opportunity for implementing new and better ways of working, such as:
- New more efficient procedures, methods and systems
- New and easier-to-understand procedures and job instructions
- Well prepared on-boarding of operators and supporters
- Early clarification of what impact different design options have on operations
- Integration of plans and visions for improving future operations into the technical requirements and solutions
However, it is a considerable challenge to develop the organizational and operational set-up and simultaneously guiding the engineering project, for example:
- You need to clarify what impact different design options have on operations, e.g. manning, competences, flexibility, room for expansion, compliance with cGMP trends, maintenance
- Your plans and visions for improving future operations must be designed into the requirements and solutions, e.g. batch release/review by exception, paperless documentation and augmented reality
- The availability of competent and motivated user resources is typically a bottleneck
Preparing for operational excellence requires process design, facility design and operating model design to be continuously aligned from conceptual design to handover and ramp-up. This is key to ensuring optimum and cost-effective design.
Deliverables while preparing the operating model
Throughout the development of the operating model all elements must be be addressed and continuously aligned from a conceptual to a specific level. Examples of deliverables include:
- Operating principles
- Manufacturing/business processes
- Organizational, roles and responsibilities
- SOP development plan/program
- Competence/capacity requirements
- On-boarding/training program
- Quality system setup
- It system alignment
- Communication strategy and plan
A structured approach to preparing for operations
The development of an operating model must initially be driven by management in the customer organization. Then, when the more specific elements are developed, it can be gradually taken over by employees. The approach can be adapted for use for any size of project from huge greenfield projects to smaller re-building projects. Below are two best practice examples to demonstrate.
In connection with a major expansion of existing capacity by building a large greenfield API plant at new location, the preparation of the operating model was initiated during the initial phases of the basic design. A site aspiration regarding operational readiness was defined and aligned across the full senior management team including both engineering and operations. Basic operating principles and new ways of working were agreed in the leadership team and the specific implications for the new site were described. A roadmap was created to clarify the activities required to build a future-proof operating model and the coherence between the elements in the model was defined. For each element (business processes, SOPs, training, recruitment, etc.) unique responsibilities were defined and detailed plans were prepared. The plans ensured continuous alignment of preparation of operations with the engineering plans. Overall business processes and manufacturing processes were described and communicated in a clear manner to the organization to ensure process understanding and which operating principles that should guide future operations. New ways of thinking process oriented SOPs and training principles were introduced and developed in the project phase. The result is an organization that is fully aligned and where all elements of the operating model are prepared in due time to ensure seamless ramp-up.
This was a mid-size fill-finish project close to ramp-up at existing site with known processes. An assessment was made to clarify current readiness for operations. Findings and gaps were condensed and aligned in the management team. An overall road map of activities required to close the gaps was created and milestones were aligned with the engineering and product transfer milestones. Detailed plans were created for each element in the operating model (SOPs, training, recruitment, etc.) and unique responsibilities were assigned. The result was full transparency and coherence of plans creating confidence in ability to meet overall business objectives.