Executive Director, Global Quality BioBridge Global San Antonio, Texas, United States
Background/Case Studies: In the blood and biotherapies industries, organizations are looking to improve processes to reduce waste and improve end results. Auditing is a tool used to measure the effectiveness of an organization’s Quality Systems and processes with relation to procedures and regulations. Clients and Regulatory agencies typically audit organizations on a regularly scheduled basis. Many now utilize a risk-based approach to determine frequency of auditing. Organizations are also required to maintain an internal auditing program. The Quality Systems Management (QSM) team at BBG is responsible for managing these audits, along with managing all quality events. This team was managing approximately 50 audits per year. To effectively manage this task and its resulting outputs (e.g., Observations, Opportunities for Improvement), the team created a standardized audit process with the goal of reducing the number of observations, the response time for the observations and making the audits more efficient.
Study
Design/Methods: In 2024, QSM Management decided to break up the QSM team into two distinct groups with each group managing specific tasks. The auditing task was assigned to a team comprised of 4 specialists. The next step was to standardize the audit process. The standardization of the process included the creation of a pre and post audit checklist, limiting the attendance of audit support team, establishing a budget, taking time studies of tasks, and defining roles for audit coverage.
Results/Findings: As a result of this new process, we saw a decrease in average costs per audit go from $153 to $54. This number is primarily based on the amount spent on meals for auditors. We also saw an 87% decrease in observation response times for external audits (from 2021 to 2025). For internal audit observations, that decrease was 37% for the same period. The average number of external audit critical observations has decreased from 3.5 in 2023 to 1 in 2025 and major observations have decreased from 4.2 in 2023 to 2.5 in 2025. The average number of internal minor observations has decreased from 4.7 in 2023 to 3.3 in 2025.
Conclusions: Having a standardized audit process has led to improvements in our organization. Our external and internal clients have also seen the benefits of this standardization with faster observation response times and a more streamlined process. The average number of external critical and major audit observations along with internal minor audit observations are trending downwards since implementing a standardized audit process.
