During the design phases of a project, it is expected that changes and evolution of the design will happen. The key is finding the best way to limit the amount of changes related to philosophy or strategy. Instead, changes should be centered on the evolution of the design as more information is learned as the project moves through its phases.
The most practical way to limit the amount of changes in the design phase is to utilize Early Quality Integration (EQI), an approach that AM Technical Solutions (AM) focuses on across all of its integrated divisions.
Our approach takes Quality by Design (QbD) one step further. We ensure that the design is informed by not only quality-minded teams but also teams that fully understand industry guidelines and how the governing bodies interpret those guidelines.
This approach relies heavily on utilizing a risk-based model that uses scientific justification and data to inform the overall design philosophy and strategy. A risk-based model keeps the design approach consistent through all stages and will protect long term cost, quality, and schedule (CQS).
The Importance of First Time Right Supporting CQS
First Time Right needs to be an operating principle in your construction company’s philosophy -- not just an overused term. The question to ask is: is this a proven part of our delivery?
During construction, choices need to be evaluated constantly. Decisions should be made based on their understood impact to the cost, quality, and schedule…
- Has the correct project philosophical and strategic infrastructure been built?
- Are the right people at the table for the discussion?
- Are both short-term and long-term consequences to cost, quality, and schedule being evaluated?
Consider how our approach to quality by design helps ensure that the long-term cost, quality, and schedule are protected through all phases of the design process.
The AM Approach to Quality by Design (QbD)
The AM approach to QbD -- Early Quality Integration (EQI) -- includes these principles:
- Quality must be inherent in project work at the earliest inception of design.
- Quality is fundamental to the acquisition/build and testing of that design.
This is a great place to start, as no one intentionally leaves quality out of daily activities. However, most construction firms do not possess a cross-functional understanding of the needs of downstream groups/activities.
Therefore, the choices made tend to only take into consideration immediate impact to quality, cost, and schedule without fully considering downstream impact to those very same pillars.
What may be a minor change at the pre-construction phase can mean large amounts of time and effort for correction at the commissioning phase and even a greater amount of time and effort by the qualification phase, ultimately leading to higher cost and delay of project delivery.
Our approach, which is possible through our unique company divisions and cross-divisional under-standing/ training, extends the QbD concept through integration of one or more project-dedicated downstream team members in the design and construction phases.
The placement of an integrated team member ensures that longer-term impact is communicated, considered, and addressed with the project team. This sets up the project for success at the critical Commissioning, Qualification, and Process Validation stages.
Project Execution – We Don’t Accept “Pick 2”
The commonly accepted idea of being only able to “Pick 2” of Cheap (Cost), Good (Quality), and Fast (Efficiency/Schedule) leaves room for not taking responsibility when an element of the project objectives are missed -- whether timelines, cost, or functionality. Any one of these issues could result in cost overruns.
At the proposal stage, a lot of planning, designing, and budgeting has already occurred; choices have already been made to achieve the project within acceptable parameters of Cost, Quality, and Schedule. Why, then, does “Pick 2” enter the picture during the project?
When the industry started accepting this idea for complex projects -- where the impact of decisions extended far beyond the build itself -- solutions became more and more near-sighted. Without the correct people in the discussion they are choosing to optimize the local, short-term goals but compromise the global, long-term goals, resulting in a combination of higher costs, reduced functionality, and longer schedules.
Ensure Project Teams Are Supported by Focused Thinking
Project teams can plan as much as possible, but changes and issues will always arise during construction. Assessing options correctly, and determining the best path forward, occurs only when input is provided by knowledgeable representatives of all impacted groups, especially those groups whose primary background is quality.
This thinking also requires the incorporation of agile methodology, with dynamic in-process corrections. In this way, First Time Right becomes more of a reality with each properly evaluated decision.
The expertise within, and the integration of AM divisions make this concept a reality. In addition to construction and construction management, AM company divisions include Architecture and Design, Clean Room Build and Performance, Quality Control and Commissioning, and Life Sciences. These teams have spent decades in R&D, Manufacturing, and Construction to understand the unique requirements and constraints that need to be considered.
With our focus on communication and our common respect for each team’s knowledge and expertise, you can be assured that any decision we make will provide the least impact to cost, quality, and schedule of the delivered project.
The Solution is Clear: Early Quality Integration
Our solution to successful project execution is based on both our company philosophies and our capabilities.
Our project teams integrate the expertise, experience, programs, and capabilities of our team members by:
- Providing personnel who understand and respect interdependencies of Design, Construction, Engineering, and C&Q lifecycle and work together to do the right thing.
- Utilizing risk-based model to align project philosophy and strategic planning to ensure the design approach stays consistent through all stages.
- Leveraging AM Life Science for early C&Q Integration and a Quality lifecycle focus, enabling First Time Right.
- Evaluating deviations using Risk Management to align with ASTM E2500 guidelines at the point of discovery with quality evaluation and approval, not waiting for these deviations to be discovered at time of CQV execution.
- Reviewing TOPs and field inspections in advance for completeness and providing an effective eDoc management system.
Our solution is possible through our unique company divisions and cross-divisional understanding. AM can extend the QbD concept through early integration of project-dedicated downstream team members. We ensure that the downstream needs will be met by the actions of the construction and/or design team.
The Result: seamless handoff, CQV execution, and, ultimately, First Time Right. Find out more about our proven approach to QbD, Early Quality Integration, by contacting us today.