A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall risk acceptability, risk management review, and production and post-production risks. This is a living document which must be updated for the entirety of the project development and manufacturing process.
Yes, the risk management file is a dynamic and living document. It is also a reminder of the level of detail and diligence that must go into the creation and eventual commercialization of a medical device. Risk management is an enterprise all by itself. It is more than just a company mitigating its legal liability. Risk management is more of a responsibility of product designers and engineers, than the company's attorneys.
The risk management process for medical devices is straight from the Project Management Professional (PMP) guidelines for comprehensive risk management. As we progress through this Medical Device course, the project management framework introduced at the beginning of the course is becoming more and more relevant. Truly, having a solid design development plan (DDP), evidenced by thorough risk management procedures can compensate for limited knowledge.
When I look back on my failed attempt to develop a better dialysis machine six years ago, I realize that our risk management process was woefully inadequate, even embarrassing, in light of what I know now. We had market size and customer potential down pat, but risk controls, beyond some decent but superficial risk analysis, naw! This course in particular has put risk management in a clearer context for me. Risk management has several layers that need to balanced, just as the design control process as a whole.
The risk register is an important document in the product life cycle and it has to be updated continuously with the following information -
- Prioritised list of quantified risks which were resolved
- Trends in quantitative risk analysis which had significant results
- Updated risk categories and their potential responses
This document is updated with the newest information first in historical order to be used in the future project.
A risk Management file is a “set of records and other documents that are produced by risk management”.The risk management file must contain, or have reference to, the following documents:
- Risk Management Plan
- Risk Analysis
- Risk Evaluation
- Risk Controls
- Evaluation of Overall Risk Acceptability
- Risk Management Review
- Production and Post-Production Risks
The purpose of risk management is to identify potential problems before they occur, or, in the case of opportunities, to try to leverage them to cause them to occur. Risk-handling activities may be invoked throughout the life of the project.
A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall risk acceptability, risk management review, and production and post-production risks. This is a living document which must be updated for the entirety of the project development and manufacturing process.
A risk management file (RMF) is the place where you keep your risk management activities, documentation, and records. A risk management file contains evidences.
A risk management file is where you would keep all the documents and files that are in regards to risk management of projects. Everything should be documented on the risk management file. this document is more like a living document that should be updated along the process of a project and as more risks develop with user experiences.
Yes, I agree with you. Like the DDP and many other documents, the Risk management documents must be updated on a regular basis throughout the entire of device development since all risks may not have been proposed of thought of until fabrication, clinical trials, or post market. Although the design team tries to be as diligent as possible when performing risk assessment and evaluation, the device will not show all risks until in is released and continues to perform with time, therefore, it actuality, the risk management file continuous on even after the device has been working in post-market for years or it fails. The moment at which the device fails could itself bring more risk associated with it that may not have been thought off during development.
The fact that the risk management file is a living document is one of the most important aspects of this area. Risk management is a constant cycle of analysis, evaluation, management, and measurement. This process continues far beyond the release of the product. It is important to include previous risks of the device, its mitigation efforts, and the revised risk management procedure. This document can always be referenced in the case of an adverse event.
A risk management file accumulates all the records, files/documents, and activity logs pertaining to risk management. According to greenlight guru, a risk management file can include all of the following:
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Risk Management Plan
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Risk Analysis
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Risk Evaluation
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Risk Controls
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Evaluation of Overall Risk Acceptability
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Risk Management Review
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Production and Post-Production Risks
A risk management file is a living document that notates risk management activities, documentation, and records for the project. This living document provides evidence of the risk management plan, risk analysis, and risk evaluation. All three areas are important to mitigate the risks of a project. ISO 14971.2019 is the current document that defines the risk management file; it's a file of set records and other documents that are produced by the projects risk management. According to softcomply.com's author the following documents at least need to be reference:
n practice, the risk management file must contain, or have reference to, the following documents:
- (4.2, Note 3) The policy for establishing criteria for risk acceptability.
- (4.4) The Risk Management Plan.
- (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.
- (5.1) The Risk analysis.
- (5.2) Intended Use and Reasonably Foreseeable Misuse.
- (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics.
- (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).
- (5.5) Risk Estimation.
- (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
- (6) Risk Evaluation.
- (7.1) Risk Control Measures.
- (7.2) Verification of Implementation of the Risk Control Measures.
- (7.3) Evaluation of Residual Risk.
- (7.4) the results of the Benefit-Risk Analysis.
- (7.5) Risks arising from implemented risk control measures.
- (7.6) Review of completeness of risk controls.
- (8) Evaluation of Overall Residual Risk.
- (9) Risk Management Report, including Risk Management Review.
- (10.3) Results of the review of the post-production information.
- (10.4) Decision arising from the review of post-production information.
Marion. (2020). What is a risk management file? Soft Comply. Compliance made easy. Retrieved on June 16, 2021 from https://softcomply.com/what-is-risk-management-file/
Risk management is the process of identifying, assessing, and eliminating potential hazards that develop while creating a product, in this case, a medical device. While risks are identified, they are documented and kept in a Risk Management Plan. Risks can occur at any time throughout the design control and manufacturing process, so the RMP is a living document that is constantly changing throughout the project. The RMP includes risk analysis, risk evaluation, risk estimation, risk assessment, risk management report, risk management controls, and the Post Market Review of a product.
A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall risk acceptability, risk management review, and production and post-production risks. This is a living document which must be updated for the entirety of the project development and manufacturing process.
I love this definition of the risk management file. And I completely agree, it should be a living document that has room for growth. One of the top five mistakes of risk management is failing to consider certain elements and limited visibility.
A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk Management Plan. Hazard Analysis, Hazard Evaluation. “set of records and other documents that are produced by risk management”. A risk management file is very important because it contains evidence of what to do. The risk management file can include all the steps such as plans, controls, and evaluations just to name a few.
