Risk Management – How to document a Risk Management Plan (RMP)?
The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or device development, according to ISO 14971. However, risks cannot be avoided entirely; they can only be mitigated and anticipated through an established risk management plan. It is recommended that the following components be included when documenting the RMP to ensure that the development and product teams are aligned with the risk management plan and are responsive and agile when dealing with risk impacts.
Define the purpose of identifying the risk
The scope of the medical device RMP is to identify risks by anticipating potential product development and manufacturing activities from design to market release. To market a device, the organization should review and update the RMP to ensure that the device was manufactured with appropriate measures and is compliant with industry standards for collecting post-market feedback to ensure the device’s performance as defined for the intended use.
Furthermore, the team can easily leverage and create an RMP in the early stages of the device development process and include updates as and when enhancements and implementations occur in subsequent phases.
Overview of the device development process to analyze the risk
Describe the device design, functions, intended use, environmental conditions required, end-user and indications while documenting the RMP. Along with this, refine the RMP by excluding common issues from the risk analysis coverage. This section will assist the team when a potential risk is identified from the risk plan; The analysis process begins with documenting the changes, their ramifications, and assessing the consequences and their likelihood to determine the mitigation steps. The risk analysis considers the organization’s financial loss, brand reputation, resources, time, and the severity of the risk impact on end-users.
Prioritize and develop a risk strategy
Determine the risk’s priority based on the sources of occurrences, likelihood, and potential impact. Create a comprehensive Risk Management Strategy to ensure that the medical device is safe for its intended use as specified in compliance regulations. This phase entails estimating the current scope of the product and identifying risk impact on priority resolutions. As a result, the product development and manufacturing processes were not slowed or disrupted in preparation for market release.
Evaluate the risk management activities
After identifying and analyzing the risk impact:
- Create a step-by-step list of risk management activities.
- Implement techniques such as Fault Tree Analysis, Benefit-risk Analysis, and others, including the activities of each phase of the treatment plan.
- Create a strategy for dealing with high-priority risks quickly and effectively without jeopardizing the device/product development timeline.
Assign resources, Validate and Review the RMP
As the device development process moves forward, the risk management activities outlined in the RMP address the potential risks that may arise due to the ongoing processes. Plan the resolutions in response to the anticipated risks, and it is critical to track and document the implemented activities and their outcomes. Identify and plan the resource responsible for updating the risk management framework to keep the review process current.
Create an RMR (risk management report) to document the results of aggregate risk management activities, risk acceptability, and residual risk to ensure compliance. Define and document the risk management requirements based on the risk acceptance criteria. Determine risk acceptability levels by applicable national and international regulations and standards.
Monitor the risk, verify activities and deliverables
Monitor the mitigated activities and validate the implementation plans to ensure that the risk control procedures are followed to meet the product quality standards. As a result, it is preferable to describe risk control implementation and risk control effectiveness. Define the process followed in the production and post-production of device marketing in the risk management process to identify risk sources and assess the effectiveness of risk mitigation methods and the impact of medical devices on end-users.
Organize the RMP
Make a table that lists all of the plans, procedures, and policies that should carry out the mitigation plan in the medical device risk management plan for accessible and adequate documentation. It is preferable to arrange the references in the order of their cite but can use another method.
The Advantages of Creating a Risk Management Plan
The benefits of documenting risk management plans are numerous for the organization. The RMP assists the organization in remaining compliant with the regulations. Still, it can also assist the organization in anticipating potential risks from development and compliance respectively and laying plans to treat them before the impact is severe. Knowing about these risks ahead of time allows medical device companies to plan for and deal with them as they arise without jeopardizing the timeline or device marketing. A risk management strategy also helps:
- Enhances Results – With RMP, the organization can increase the likelihood of a successful project by developing a risk strategy for minimizing and eliminating impactful risks, allowing the device’s manufacturing and marketing to complete on time.
- Assist in being proactive rather than reactive – Instead of constantly fighting fires, having a clear risk management plan allows the device companies to be proactive and anticipate actionable steps that will reduce the likelihood of their occurrence and also define proactive measures to reduce potential risks
- Assist in evaluating the device’s intended use – It can assist the organization in assessing the impact of risk associated with the device, aiding in developing best practices for the future, and allowing the organization to be compliant.
Concluding Thoughts
Risks are unavoidable; however, a medical device company can reduce errors more effectively with a well-defined risk management plan. RMP is a living document that must be tracked, monitored, updated, and improved regularly. This is where medical device companies need the assistance of quality leaders to understand risk management strategies and the efficiency to document in real-time to use it as a guide before starting a project.
So, why are you still waiting? Allow quality experts to assist you in creating your risk management plan documents as soon as possible. Please contact us at sales@complianceg.com.
FAQ's
How do I create a risk management strategy for a medical device?
Make a risk management plan and document the risk management strategy for the developing medical device following ISO 14971.
Maintain an up-to-date record of your risk management strategy for medical devices. Define the scope of your risk management activities.
Assign responsibilities to authorized team members or members for them to manage, review, and update the risk management plan regularly.
Calculate the risk accessibility criterion.
Define the verification activities and keep track of their effectiveness.
Document the results of risk control and mitigation to review effective pre-and post-production processes following compliance.
How can a comprehensive risk management lifecycle for medical devices be implemented?
Follow the below steps for implementing a comprehensive risk management lifecycle for medical devices
Document a Risk Management Framework
Identify and analyze risk factors by determining their sources and forecasting their impact.
Evaluate and estimate the risk based on the likelihood of occurrences and their severity.
Control the risk by implementing risk-mitigation measures.
Record the outcomes of risk control measures that have been implemented.
When do I have to create a risk management strategy for a design project?
Each design project begins with the creation of a risk management plan for a design or device. The risk management plan must cover the period from the start of the project to the product’s release, but not the post-market methods and risk activities.
What are the 5 types of risk assessment?
Below listed are the 5 types of risk assessments wherein they can be used together or some parts in each type can be used in a single risk assessment.
Qualitative Risk Assessment
Quantitative Risk Assessment
Generic Risk Management
Site-Specific Risk Assessment
Dynamic Risk Assessment
How frequently should a risk assessment be reviewed?
Risk assessments must be documented and reviewed regularly. A risk management plan is a living document that must be improved regularly and should be kept up to date with all reviews and results. However, most businesses opt for an annual review. However, there are times when risk assessments must be reviewed sooner rather than later.
Annual risk assessments are conducted.
When there are legislative changes, they are reviewed.
When the task has undergone significant changes, it is reviewed.
When a product or device is improved, risk assessments are reviewed.
The risk assessment is reviewed when unexpected issues or CAPAs are requested.
Risk assessments are reviewed when there are accidents involving the product or device.
What are the four components of risk management?
The process of identifying, assessing, and prioritizing risks, followed by the application of cost-effective resources to minimize, monitor, and control the likelihood and impact of risk, is known as risk management. In a nutshell, the four critical components of risk management are as follows:
Identify the risk
Analyze the risk
Evaluate and Estimate the risk
Managing and Controlling the risk.
What are the 10 principles (P’S) of risk management?
The ten principles of risk management are as follows
Policy
Planning
Product
Process
Premises
People
Protection
Procedures
Purchasing
Performance
How to manage a medical device risk?
The commitment of medical device management is to reduce the risk caused by the medical device. To demonstrate and review the manufacturer’s commitment to risk control throughout the medical device development life cycle, each phase of device development is subjected to a risk management cycle and is comprehensively documented based on the industry regulation ISO 13485 and ISO 14971 risk management system.
What is the medical device risk assessment procedure?
The Risk Analysis process is a step or a phase outlined in the Risk Management Plan. The Risk Analysis is a process that identifies the potential risk associated with the device while also defining the purpose and scope of the risk. The investigation of the likelihood of occurrences and their severity levels is part of the process. The risk analysis is documented in the intended use statement for the device.
How can risks be reduced or controlled?
There are several ways to mitigate or control a risk: It is possible to reduce risk by changing the product’s design or recalling the device, but this is not always possible. Changing the process or procedure to incorporate protective measures after a specific risk is recommended to reduce the occurrence of the risk and its impact.