Drawing on more than four decades of unwavering commitment to quality and compliance, Lifecore’s Quality team plays a central role in ensuring every product meets the highest global standards.
In the latest edition of our ‘Quality to the Core’ interview series, Heather Schmidt, Principal Quality Systems Specialist, discusses her team’s responsibilities, the role of audits, and the ways quality is embedded within the organization.
In her almost 30 years working at Lifecore, Heather has held various roles across the quality function, including work in the quality control (QC) laboratory and quality assurance. Over this time, she has managed everything from batch record review and product release to hosting audits and leading major quality system updates.
What does your team handle at a high level?
We manage regulatory and quality compliance-licenses, ISO certifications, EU GMP certificates, and regulatory filings. We oversee audit management, document control, complaint handling, change management, and risk assessments. Essentially, we ensure Lifecore meets global regulatory requirements as well as customer quality agreement requirements.
How does quality touch the entire organization?
Quality is everywhere. From manufacturing to maintenance, every department interacts with and understands quality. Personnel partner with Quality who advises and monitors processes and data, but the competence of Lifecore personnel and Subject Matter Experts (SMEs) is instrumental in achieving compliance across the organization. We routinely receive auditor feedback that Lifecore personnel show a lot of pride in their work, and that our employees are highly competent and demonstrate ownership for their processes.
Employees across the organization are given opportunities to actively participate in quality, whether as a member of a cross-functional team focused on evaluating specific systems or processes, or as a member of the internal audit team, where they gain a deeper understanding of regulatory requirements and the importance of quality. They can then take these learnings back to their departments and use this knowledge in their day-to-day activities.
What role do audits play beyond compliance?
Audits are both a way of demonstrating our compliance, and they are a learning opportunity. Due to the variety of product types that we manufacture, including drug products, medical devices, and an active pharmaceutical ingredient (sodium hyaluronate (NaHy)), and the different auditing bodies we work with, including customers, regulators and notified bodies, we gain valuable industry insight and identify best practices. We use this information to implement improvements within our Quality Management System. This sharing goes both ways, and we’ve had customers take some of Lifecore’s best practices back to their company.
How do you keep the quality system current?
We monitor regulatory changes, perform gap assessments, and update procedures as needed to ensure we meet current requirements. Through a robust process where we monitor upcoming changes to regulations and standards, as well as maintaining memberships in professional quality organizations and participating in industry training, we remain current on industry changes. We are currently working on a quality management system update to align with FDA’s rewrite of the Quality System Regulation 21CFR820, which is their medical device regulation. Our team is actively working on implementation to comply with the changes that are going into effect this year.
Additionally, we look for opportunities for continuous improvement. This is built into our quality system through trending, management reviews, and other feedback loops, including internal audits. Internal audits of the quality management system are performed at regular intervals to ensure it is effective and to evaluate opportunities for improvement.
After nearly three decades, what keeps you engaged?
I have never been bored. Lifecore’s growth and diverse products mean constant learning and evolution. Plus, the people here are dedicated and high-integrity it’s a great environment.