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FDA Warning Letter
Result
Background
A global health care company received an FDA Warning Letter for quality issues with its manufacturing facility. As the organization began working through the issues identified in the Warning Letter, it became clear, even with good quality systems, improved operational execution was needed to sustain successful results.
Operations Improvement (OI)
The operational improvements were focused in areas such as shop floor discipline / execution, facility housekeeping and maintenance, managerial focus on all levels and, most of all, assessing and attacking specific operational shortfalls within all the operational groups.
Solution
The manufacturing facility engaged Regulatory Compliance Associates® life science consultants to develop and implement a plan for data quality improvements to support the evolving quality management system.
Quality Management System (QMS)
This assessment and subsequent improvements involved needed support from the somewhat skeptical quality management system (QMS) group. RCA and the local operations management team worked jointly to assess the plant and identify gap areas needing improvement to support the quality initiatives.
RCA helped the organization recognize data quality gaps, develop action plans, and create tracking mechanisms to monitor operational progress of the Quality initiatives. RCA raised the bar on operational discipline and feedback.
Data Integrity (DI)
RCA assisted the facility to develop and implement a tracking system to monitor operational tasks, ongoing process improvements and ways to enforce accountability of key personnel. This tracking included key performance metrics for the following areas: training compliance, floor audit performance, batch record error improvement, document timeliness and line clearance performance.
Operational Excellence (OE)
Recognizing that the operations management team was inexperienced, RCA engaged and mentored the key operations floor managers as they began implementing improvements and tracking progress. Besides crafting and implementing the operations improvement plan, RCA assisted the company to instill a culture of operational excellence and individual accountability with an inexperienced team. RCA helped the organization recognize gaps, develop action plans and create a tracking mechanism to monitor operational progress.
Quality Assured
Not only did these actions clearly improve quality assurance (QA) and compliance, but they provided financial returns such as a deviation and inspection cost reductions as well as increased available line time which more than covered the cost of RCA’s third party support.
Quality Circle
Most importantly, the quality circle team learned the importance of communication across all departments and at all levels to achieve success. Ultimately, the facility’s commitment will contribute to an environment of sustainability long after the RCA consultants have left.
About RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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