Instructional Intervention to Correct and Prevent Document Deficiencies at Sanofi Genzyme Boston

Lauren Shamitz-Crooks, University of Massachusetts Boston

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Sanofi Genzyme, Allston; a biotechnology manufacturing plant, has experienced quality reduction in the Standard Operating Procedures (SOPs), and Batch Records used to manufacture drug substance. Over the past two years, sub-standard GMP documents have compromised operators’ ability to properly execute manufacturing work. Site Management has prioritized remediation of this gap that continues to threaten operator and patient safety, regulatory compliance, and patient drug supply. Needs analysis has revealed inconsistent performance within the document control system on behalf of Document Owners, Document Change Owners, SME reviewers, and Quality Reviewers despite a current training program. The goal of the Document Control System Owners, Instructional Designers, and Site Quality Management: create a more robust, rigorous training/qualification program for personnel who perform one or more of the aforementioned roles in the document control system to facilitate generation of consistent, accurate, and executable documents on the floor. After comprehensive analysis, stakeholders determined the need for both instructional and non-instructional intervention. The instructional intervention: a program including prerequisite system overview training for all document control system roles followed by role-specific training, a test-out pathway for incumbent end-users, enhanced assessment strategy throughout, and performance monitoring with disqualification option. Non-instructional elements include quality audits, resource allocation review, and just-in-time (JIT) performance tools. Analysis revealed a lack of: emphasis on role ownership and accountability, understanding of role performance impact in the system, and ability to write a technical document transferable to on-the-floor execution by operators; all three elements subsequently added to the program. The initial completion timeline has been pushed out due to document control system technology work; the program is in development phase at the time of this report’s publishing.