All too often otherwise successful projects in the GMP space encounter scheduling and compliance challenges for a simple reason: A failure to properly integrate Quality Systems and compliance requirements into the project planning effort. Complex build outs, engineering efforts and process changes can all fall flat in the final hour for these simple reasons. There are few things more frustrating than completing months of technically challenging work on budget and on schedule only to see the project slip because a quality record was not in the correct state or a required reviewer was missed.
So what can firms do to avoid this frustration? How can we ensure success in meeting timelines, accounting for the final 2-5% of the project effort? The answer is to integrate the quality systems into the project from the earliest stages. This answer seems simple, but requires a dedicated effort and the right people to be involved at the right time throughout project planning and execution.
Starting with early design and engineering, seek out quality representatives to begin assessing impact, determine system criticality and related documentation requirements. As the project progresses to planning and execution, consult Quality Operations units ensuring the right resources are informed and consulted. Identify clearly the quality system requirements and associated timelines, integrate these as deliverables and milestones into the overall plan and schedule. Keep lines of communication open with Quality as project variances will inevitably occur, adjust not only the technical side of the project plan but the associated quality system and documentation requirements. A consistent integrated approach ensures compliance, timely project completion and eventual turnover.
There always seems to be a segmented approach to project planning in which quality system efforts are considered a final stage, when in reality a proper integrated approach is the best way to ensure compliance. Navigating and understanding quality requirements early and often is critical to project success in the cGMP space.
ICQ Consultants offer a wealth of experience from early design, engineering, construction / execution, and quality system management. Our goal is always to understand the many aspects of a project and integrate all phases to ensure success, avoiding the dreaded delays after months of successful execution. Please reach out to our management team to find out how we can support an integrated project plan for your next effort.
By: Michael Olival, Managing Consultant
ICQ Consultants, Corp.