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A North American Biopharmaceutical company with sites in the United States and Europe, who manufactured aseptic and solid dosage product for distribution in the United States, Europe, and the Rest of the World required help. One of the company’s manufacturing sites in Europe was challenged by a client for lack of systematic Risk Assessment and Risk Mitigation program. During two subsequent inspections by The United States FDA and the local European regulatory agency the firm received a number of observations in relation to risk management system.
To respond to the observations and resolve the issues, ICS Maven was hired by the firm’s corporate office to perform an assessment of the observations including the site’s historical risk assessment reports and to prepare a remediation plan. Upon a thorough assessment, ICS Maven proposed to implement two parallel approaches which would resolve the issue and implement a sustainable risk management program:
Proactive Risk Management: We prepared a procedure to become an integral element of future project initiation activities. This procedure required identification and in-depth assessment of all elements that may expose the project/program to possible risk. It also provided the tool to evaluate the level of severity, probability, and detectability of anticipated risk. Last, it required implementation of ample mitigation and/or reduction of the potential risk to protect the company from any loss of product prior to the actual loss.
Reactive Risk Management: This approach was proposed for any existing problem or accidental issue that was identified after the event. The subject procedure proposed a comprehensive investigation of the issue and exposed areas in order to identify the root cause of the problem. Moreover, it required additional investigation of the possible side effects, areas of impact along with and the control/mitigation options after the loss occurs.
The physical scope or the risk management program that ICS Maven implanted at the client’s site were:
Facility, equipment, and utilities (FEU) including the respective qualifications
Manufacturing process and process validation
QC laboratory and product testing
Warehousing, storage, and distribution
The tool used for this project was Failure Mode Effects Analysis (FMEA) and Fault Tree Analysis (FTA) for an evaluation of potential failure modes and implemented risk mitigation based on the level of severity, probability, and detectability of the failure. Subsequent to implementation of the site Quality Risk Management Program, our associate trained the QA, QC, and manufacturing personnel throughout the company.