GOALS

• Improve collaboration between design, engineering, and quality teams throughout the product development lifecycle, reducing design iterations and time-to-market
• Implement a data-driven quality management system to identify and address root causes of defects, leading to a 5% reduction in overall manufacturing costs
• Ensure compliance with IATF 16949 automotive quality standards through automated reporting and analysis, facilitating smooth audits and certifications

Frustrations

• Facing communication silos between departments, resulting in miscommunication, delays, and costly rework
• Difficulty in collecting and analyzing quality data from various sources, making it challenging to identify trends and make data-driven decisions
• Time-consuming and tedious manual reporting processes for compliance audits, increasing workload and the risk of human error

GOALS

• Implement a robust CAPA system to effectively manage and track corrective and preventive actions, reducing the recurrence of deviations and improving product quality
• Ensure compliance with FDA 21 CFR Part 820 regulations for medical devices through comprehensive documentation control and audit readiness
• Streamline the supplier qualification process with automated workflows and risk assessments, ensuring the use of high-quality components and materials in medical devices

Frustrations

• Dealing with inefficient paper-based CAPA processes, leading to delays in investigations and implementation of corrective actions
• Difficulty in maintaining accurate and up-to-date documentation for FDA audits, increasing the risk of non-compliance and potential regulatory actions
• Manually managing supplier documentation and qualification processes, consuming valuable time and resources that could be allocated to other critical tasks