Client Business Situation
See the video of the conference presentation about this case study HERE.
Like many regulated life science manufacturers, 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.
Table of Contents
The outcome of this work consisted of a large set of identified risks, issues, and gaps that necessitated the development of a robust remediation approach. Bayer’s Vice President of Quality sought to develop a “strategic quality plan” to align the remediation objectives with business considerations and ensure compliance and quality gaps and issues were assessed adequately for applicable risk considerations.
With a full plate of activities in front of the Quality Department, Bayer sought expert consulting assistance to develop 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 for prioritizing risk and remediation significance and understanding 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 with business objectives made remediation funding difficult to secure. Another challenge Bayer and many regulated manufacturers face is the 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 comprises a defined method, proprietary risk and complexity algorithms, and a cloud-based software tool to drive 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 assess, aggregate rapidly, and formally prioritize their portfolio of risks, issues, objectives, etc., for both risk and complexity considerations.
By using this approach and creating alignment in how to score, differentiate, and prioritize using individual risk scores, Bayer could consider and determine the most appropriate resource utilizations, focused on the highest relative risk concerns, while considering the complexity of remediation activities.
The CRPN Quality Roadmap® methodology can be deployed and fully implemented in weeks to months, depending on an organization’s 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 assigned a small, dedicated team of Bayer Quality SMEs to work alongside Compliance Architects® expert consultants. Although new, fresh audits and assessments are sometimes needed where data and information are lacking, organizations often possess sufficient information from pre-existing audits and assessments, active CAPAs, inspection outcomes, internal audits, etc.
To maximize the value received, Compliance Architects® recommends starting with pre-existing information, which can constantly be augmented with fresh data and information from audits and assessments.
Within a month of commencing work on-site in Berkeley, preliminary information was gathered, and risk scoring confirmed site quality suppositions about risk and priority. Algorithmic risk determination helped stakeholders 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 could mobilize resources with the assurance that they were on the optimal path for risk reduction with the most effective resource utilization.
Using the CRPN Quality Roadmap® cloud-based software, Bayer could quickly review findings and risk scoring with multiple stakeholder sets and 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 could share and socialize drafts of its strategic Quality Plan in weeks instead of months.
Benefits Realized
The lack of a plan to remediate and improve Bayer Berkeley’s biomanufacturing facility following the identification of quality and compliance gaps, risks, and issues prevented the organization from making positive changes.
The CRPN Quality Roadmap® methodology and Compliance Architects® expert consulting support helped galvanize the Bayer Quality and Operations personnel around a standard set of remediation objectives that would reduce risk and move the organization to a higher state of compliance and more excellent quality capability.
The Bayer Pharmaceuticals Berkeley Site Quality Plan is in place and being executed. It has served as a model for strategic quality and operational planning for the rest of Bayer Corporation.
