Navigating the Biotech Frontier: Operational Planning & the “Commander's Intent”
Introduction
A strategic plan is a great way to proactively align your team around a shared purpose. By defining long-term goals, you can outline exactly where you want to go but you are going to need additional planning to help you get there. In the dynamic landscape of biotechnology, where innovation unfolds at an unprecedented pace, effective operational planning for projects is crucial for success. You need an Operational Plan.
Operational Planning Benefits
Operational planning aids in achieving strategic goals. As per Asana, only 26% of knowledge workers understand how their work aligns with company goals. A detailed operational plan can outline short-term actions for long-term objectives.
An operational plan:
Specifies team activities on a narrow scope – weekly, daily, hourly.
Offers a complete guide of operations to achieve long-term goals.
Establishes benchmarks for expectations in set periods, preventing deviations.
What is Operational Planning?
Operational planning is the conversion of a strategic plan into a detailed action plan. It outlines the steps, timelines, and resources needed to accomplish a project. It breaks down tasks into actionable items with specific milestones, catering to the speed of your organization. The plan includes the Commander’s Intent, team responsibilities, and required tools or materials.
What is the Commander's Intent?
In biotech planning, the 'Commander's Intent' can serve as the guiding principle, providing direction throughout the project lifecycle:
Alignment: The intent ensures everyone understands the overarching goal, maintaining a cohesive trajectory toward the endpoint.
Decentralized Decision-Making: It allows teams to make autonomous decisions within established parameters, adapting to emerging challenges.
Flexibility: The intent encourages adaptability, allowing the project to pivot during unexpected events while staying true to its ultimate objective.
For example: Revalidation of 2 lyophilizers:
The commander's intent is a statement that is communicated to all stakeholders before Operational Planning begins as follows:
The Validation Team intends to execute revalidation protocols on two lyophilizers for two sterile lines starting on the first shift on Friday and returning the lines to service on Monday’s second shift. The investigation review board will be standing by to support any unplanned events (UPEs) that may occur to conduct investigations if needed – the priority is to determine the root cause(s), provide a course of action, and return the lines to service.
Objective:
To ensure the continued efficacy, safety, and compliance of our sterile parenteral manufacturing processes, the revalidation tasks will be executed with precision and diligence. We intend to systematically review, assess, and revalidate critical manufacturing procedures and equipment to maintain the highest standards of product quality and compliance with our Revalidation Program without protocol execution errors or safety incidents and return the lines to service within the planned time frame.
Key Focus Areas:
Process Integrity: Validate and reconfirm the integrity of critical sterile manufacturing processes, ensuring they adhere to compliance and regulatory requirements and industry best practices.
Equipment Validation: Revalidate the functionality and reliability of the equipment involved in the sterile parenteral manufacturing process to guarantee optimal performance.
Compliance Assurance: Conduct a comprehensive review of existing procedures and previous UPEs to ensure alignment with current regulatory guidelines and make necessary adjustments to enhance compliance.
Risk Mitigation: Identify and address potential risks associated with sterile manufacturing, implementing preventive measures to safeguard product quality, patient safety, and employee safety.
Cross-Functional Collaboration: Foster collaboration among cross-functional teams, including validation, quality assurance, manufacturing, quality control/microbiology, and regulatory affairs, to ensure a holistic and integrated approach to revalidation.
Documentation Excellence: Enhance documentation practices by meticulously updating and maintaining records to reflect the most current information, facilitating traceability and audit readiness.
Continuous Improvement: Leverage revalidation insights to identify opportunities for continuous improvement in processes, procedures, and technologies, fostering a culture of ongoing excellence.
Communication Transparency: Maintain open and transparent communication channels across all levels of the organization, ensuring that stakeholders are informed about progress, challenges, and outcomes.
Execution:
Assemble a dedicated revalidation task force comprising experienced professionals from relevant departments [and mentor first-time executors of these tasks].
Develop a comprehensive timeline and schedule for the revalidation process, ensuring minimal disruption to ongoing operations.
Conduct thorough risk assessments and prioritize validation activities based on criticality.
Implement a robust documentation system to capture and report all revalidation activities and outcomes.
Regularly update key stakeholders on the progress of the revalidation task, addressing any concerns or challenges promptly.
Through the execution of this revalidation task, we aim to fortify the foundation of our sterile parenteral manufacturing processes, reaffirming our commitment to delivering products of the highest quality while maintaining compliance and safety with industry standards and regulations.
5 steps to Operational Planning
During the operational planning process, you're not creating new plans or developing new goals. Rather, to create an operational plan, assess everything your team is currently working on and everything you need to do on a daily or weekly basis to hit your strategic goals. Here’s how:
Start with a strategic plan
If you haven’t already, create a strategic plan first. You need a long-term vision and goals before you can break down the day-to-day details. Determine your position and develop your strategy to meet an objective or milestone from the strategic plan.
Align the resources to a common goal - the objective and key endpoints. Create a commander’s intent statement so these varied interdisciplinary team members know why they are carrying out these tasks, what their role is when they need to perform their role, what tools they need, and what defines a successful endpoint.
Narrow down your scope
To create a detail-oriented operational plan, you need to narrow the scope to a team, department, or focus area. The scope of your operational plan will depend on the size of your company. For example, imagine you’re breaking down your strategic plan into action plans for various company departments.
Identify key stakeholders
Before creating an operational plan, decide who will be involved in the operational planning process. The team members creating the operational plan should be relatively close to the actions the plan describes.
Create the plan
Your operational plan explains your team’s actions to achieve your goals within a set time frame. To create an operational plan, outline:
Your team’s objectives
The deliverables that will be achieved by the operational plan
Any desired outcomes or quality standards
Staffing and resource requirements, including your operating budget
How you will monitor and report on progress
Here are some questions to answer to develop details that should be included in your operational plan:
What milestones do we need to hit? What do we need to accomplish? This information should come from your strategic plan or yearly goals.
What daily tasks do we need to complete to hit our goals? These can be daily tasks you’re currently doing or new work that needs to be kicked off.
Who will work on what? Who are the people responsible for those tasks? Make sure each task has one owner so there’s no confusion about who to go to for questions or updates.
Where might we run into bottlenecks and how can we avoid them? What early indicators will tell us we're on the right track?
How will we define success? What are our metrics for success? If you haven’t already, make sure your goals follow the SMART framework. For the previous example, the metrics of success would be two revalidation protocols executed with zero protocol execution errors, and zero safety incidents. Additional metrics are: all results met the pre-defined acceptance criteria, the lines were returned to service on time, and no deviations.
Share and update your operational plan
Once you’ve created the plan, share it with key stakeholders so they understand your team’s most important goals and the daily tasks it will take to get there. Manage your plan and updates in a shared tool that captures real-time progress. Like any element of project planning, things will inevitably change. Actively monitor your operational plan and report on progress so key stakeholders and team members can stay updated on how you’re tracking against your goals. Report on the progress at predefined intervals.
Conclusion:
In the rapidly evolving field of biotechnology, operational planning serves as the linchpin that holds together the intricate threads of scientific innovation, regulatory compliance, and collaboration. The commander's intent acts as the guiding force, ensuring a unified direction and purpose. As biotech projects continue to push the boundaries of what's possible, a well-crafted operational plan, anchored in the commander's intent, becomes the key to navigating the complexities and achieving success.
