FDA Strategic Quality Planning: A Risk-Based Approach Contributing to Biopharmaceutical Manufacturing Excellence
See video of the conference presentation about this case study HERE.
Client Business Situation
Like many regulated life science manufacturers, in an effort to proactively reduce risk and focus on continual quality improvement, Bayer Pharmaceuticals’ primary biomanufacturing site in Berkeley, California engaged in extensive quality and compliance self-analysis during 2015 and 2016. The outcome of this work consisted of a large set of identified risks, issues and gaps that necessitated development of a robust remediation approach. Bayer’s Vice President of Quality sought to develop a “strategic quality plan” that would place the remediation objectives into proper alignment with business considerations, and assure compliance and quality gaps and issues were properly assessed for applicable risk considerations. With a full plate of activities in front of the Quality Department, Bayer was looking for expert consulting assistance with development of its strategic quality plan.
Client Business Pain
While Bayer’s Quality and Operations teams were strong subject matter experts and executed the self-assessment work to develop their extensive “list” of quality and compliance issues, risks and gaps, they did not possess a structured methodology with which to prioritize risk and remediation significance and understand organizational complexity factors that would impact broader remediation success. Without a proven, structured approach and plan, Bayer’s staff had an overwhelming to-do list of things to fix and lacked proper prioritization and resource direction. Further, an inability to communicate priorities to executive stakeholders and affiliated operational departments to align to business objectives made remediation funding difficult to secure. An additional challenge faced by Bayer, and one faced by many regulated manufacturers, is lack of a calibrated way to assign risk scores to the identified issues, gaps and risks.
“When I joined Bayer…. we were working on all these things and making progress, but we weren’t really fixing anything immediately. And it’s because I might be working on five things, I’m not focusing on that one which I might be able to get completed earlier which is actually a higher priority.” – VP, Quality, Bayer Pharmaceutical
Solutions Provided / Services Delivered
Compliance Architects® introduced Bayer Berkeley’s Vice President of Quality, Tina Self, to its proven, innovative consulting methodology and cloud-based software application, the CRPN Quality Roadmap®. This highly-structured service offering comprised of a defined methodology, proprietary risk and complexity algorithms, and cloud-based software tool together drives intelligent, semi-quantitative, risk-based planning for regulated, life-science manufacturers. Bayer was interested in the capability of the CRPN Quality Roadmap® to enable companies to rapidly assess, aggregate and formally prioritize their portfolio of risks, issues, objectives, etc. for both risk and complexity considerations. By using this approach, and by creating alignment in how to score, differentiate and prioritize using individual risk scores, Bayer was able to consider and determine most appropriate resource utilizations, focused on highest relative risk concerns, while taking into consideration the complexity of remediation activities.
The CRPN Quality Roadmap® methodology can be deployed and fully implemented in weeks to a few short months, depending on an organization’s state of readiness. Much of the work can be done using internal company resources; however, where desired, information gathering, assessments, data collection, key personnel interviews, etc. can be done using Compliance Architects® expert consultants to ensure objective analysis and data collection. To speed implementation and outcomes, Bayer chose to assign a small, dedicated team of Bayer Quality SMEs to workalongside Compliance Architects® expert consultants. Although new, fresh audits and/or assessments are sometimes needed where data and information is lacking, organizations often possess sufficient available information from pre-existing audits and assessments, active CAPAs, inspection outcomes, internal audits, etc. To maximize value received, Compliance Architects® recommends starting with pre-existing information, which can always be augmented with fresh data and information from audits and assessments.
Within a month of commencing work onsite in Berkeley, preliminary information gathered and risk scoring 
confirmed site Quality supposition about risk and priority. Algorithmic risk determination helped stakeholders to understand relative risk scoring and drove increased alignment surrounding areas of remediation focus. With the ability to assess and understand organizational complexity factors impacting remediation, Bayer was able to mobilize resources with assurance that they were on the optimal path for risk reduction with most effective resource utilization.
Using the CRPN Quality Roadmap® cloud-based software, Bayer was able to easily review findings and risk scoring with multiple stakeholder sets, along with being able to collaborate with the Compliance Architects® experts as needed. With the ability to push reports directly from the cloud-based software into Microsoft Word and PowerPoint documents, Bayer was able to share and socialize drafts of its strategic Quality Plan in weeks vs. months.
Benefits Realized
Lack of a plan to remediate and improve Bayer Berkeley’s biomanufacturing facility following identification of quality and compliance gaps, risks and issues was preventing the organization from moving forward to make positive change. The CRPN Quality Roadmap® methodology and Compliance Architects® expert consulting support helped galvanize the Bayer Quality and Operations personnel around a common set of remediation objectives that would reduce risk and move the organization to higher state of compliance and greater quality capability. The Bayer Pharmaceuticals Berkeley Site Quality Plan is in place, being executed on, and has served as a model for the rest of Bayer Corporation for strategic quality and operational planning.
