There is a renewed focus on Risk Management by both the FDA and the European Union for data-driven decisions. This is most evident in the requirement for risk-based decision making and a risk-based approach to quality management as required by ISO 13485:2016. Essential to a data-driven risk-based approach is the Risk Management File, which is frequently created after much of the design and development work is completed, and then after archived or closed thereafter. Instead, risk documents should be initiated at the very early stages of research and development and utilized throughout the design and development process and the product life cycle to create a risk-based approach throughout all processes.
A risk-based approach can streamline processes and be a competitive advantage for your business. Risk management methods such as Failure Modes and Effects Analysis (FMEA) can provide valuable information regarding needed labeling, design, process and purchasing controls. In addition, Risk Management Files provide linkage between Clinical Evaluation Reports, Technical Files, Post-Market Surveillance and Trend Reporting as required by the upcoming European Union Medical Device Regulations and Invitro-Diagnostic Regulations. When initiated as a part of the product definition, design inputs and the development process, risk management can improve the efficiency of product realization and post-market activities.
Application FMEAs identify potential hazards in the use as well as intentional or unintentional misuse of the product. The Application FMEA helps to recognize contraindications and assists in the development of warnings and hazard labeling. The Application FMEA also provides input to Human Factors/Usability engineering and specific needs in Design Validation and/or Clinical Investigation. Design FMEAs identify the critical components and materials as well as key features within the product’s design. This helps to determine the need for Design Verification testing and can translate to inspection criteria for purchased materials/components and production processes. Process FMEAs assist in the determination of required test/inspection points as well as inspection levels (frequency of inspection and the number of units to be evaluated). Thus, use of Application, Design and Process FMEAs provides a risk-based approach to product realization.
Risk Management Files are intended to be living documents used throughout the product lifecycle. Customer feedback, complaint/incident rates, production process metrics, literature research for clinical evaluation and CAPAs serve as continuous data to determine if all appropriate hazards/harms have been identified for the product. These data will also determine if the risk (severity of harm and occurrence rates) estimated at product introduction are still valid. When post-market surveillance data are used to maintain the Risk Management File, this can be used to detect any change in the benefit-risk analysis for the product. Subsequently, changes to the benefit-risk analysis should be linked to the Clinical Evaluation Report, Post-Market Clinical Follow-up (PMCF) activities and the product’s technical documentation.
When used as a tool during product realization and throughout the product lifecycle, the Risk Management File will help an organization identify and prioritize activities related to the product and associated processes. This risk-based approach can improve efficiency and effectiveness of the quality management system by identifying important/high risk activities, as well as by identifying those activities that are less important/low risk and could therefore be reduced. Risk management can help to provide the appropriate priority and focus for the organization, and thus, be used as a competitive advantage for your business.
Contact Validant to help you create and implement an effective Risk Management strategy to increase your competitive edge.
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John M. | Validant Managing Partner since 2016
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Janet W. | Validant Consultant since 2013
In the spring of 2015, my firm had a significant FDA audit with serious findings concerning sterility assurance and data integrity. We had utilized Validant for a previous engagement successfully. Before the audit concluded, I was already in contact with the Validant team for assistance. I was very impressed by how quickly they orchestrated data integrity audits at all of our 20+ other sites. We then turned to them for assistance with our third-party oversight of our manufacturing operation and quality control laboratories.