Modified Kugel Patch Lot History Record (LHR)

Abstract

Background This Capstone project was conducted at Becton, Dickinson and Company (BD) – Humacao, within the Modified Kugel Patch manufacturing line. The project focused on the Lot History Record (LHR) documentation process, a critical component for ensuring product traceability, regulatory compliance, and audit readiness in a highly regulated medical device manufacturing environment. Problem Statement The current LHR documentation process showed a significant increase in documentation-related issues. Documentation non-conformances increased from 1% to 7%, while auditor holds rose from 32% (71 lots) in 2023 to 75% (50 lots) in 2024. The process required more than 445 manual entries per lot, containing redundant and unclear templates, and relied heavily on manual verification loops. These conditions resulted in excessive documentation time, high process variability, increased risk of GDP errors, and delays in lot release. Project Objective The objective of this project was to optimize the Modified Kugel Patch LHR documentation process by reducing non-value-added and non-value-added-but-required activities, improving documentation accuracy and traceability, and minimizing regulatory risk, while maintaining full compliance with FDA Quality System and OSHA workplace safety requirements. Methodology A structured Lean Six Sigma DMAIC methodology was applied. Key tools included process mapping, SIPOC, CTQ analysis, Voice of the Customer (VOC), time studies, Value Stream Mapping, Pareto analysis, Spaghetti diagrams, process capability analysis, and risk assessment using FMEA. These tools were used to identify root causes of documentation errors, quantify process inefficiencies, and prioritize improvement opportunities. Proposed Solution (Future State) The proposed Future State focuses on documentation standardization, elimination of redundant entries, consolidation of verification steps, and improved reconciliation practices. The improvements reduced documentation complexity, lower process variability, and strengthened data integrity while preserving all critical quality controls and regulatory requirements. Risk evaluation confirmed reduced operational risk, and the changes were classified as administrative and procedural, requiring no process revalidation. Results and Impact The proposed improvements are expected to significantly reduce documentation cycle time, auditor holds, and documentation-related non-conformances. Financial analysis estimates annual savings of approximately $106,346.50, driven by reduced rework, fewer investigations, decreased audit preparation time, lower paper usage, and improved labor efficiency. The Future State maintains full compliance with FDA and OSHA requirements while improving audit readiness and operational robustness.