RMP-Risk Management Plan | ISO 14971 Risk Management Plans for Medical Device Industry
Article Context:
Risk Management Plan
A Risk Management Plan is a written document with details of the Risk Management Process for a medical device. Risk Management helps to check on any product-related issues. In addition, risk management is a tool that allows us to design, develop, and manufacture safer medical devices.
Important facts about ISO 14971
ISO 14971 is the standard for medical devices and is used worldwide. ISO 14971helps to identify, evaluate, and resolve any dangers or untoward occurrences associated with the use of medical devices. It is used across the industry to ensure product safety requirements are met. This article is a gist and is an overview of the standard, but not the standard by itself, and may be used for reference purposes.
A quality management system is a risk management system that helps the manufacturers to understand the risks involved in the lifecycle of a medical device.
ISO 14971 does not require implementing a separate quality management system as risk management is integral to an effective quality management system.
Complying with ISO 14971 would mean establishing and maintaining a risk management system all through the product lifecycle, from the planning, implementation, and usage of the products is recorded and stored in a risk management file.
The most important stages like risk analysis, evaluation, and control are undertaken in the overall Risk Management System. It is left at the manufacturer’s discretion to ascertain the standard levels for the products he manufactures. However, a standard guideline is designed for developing a risk management system, ISO 14971compliant.
Risk Analysis in Risk Management System
In Risk Management System, the manufacturer is expected to document or have a record of risk analysis activities in a risk management file, and the file should include the following:
- Guidelines for usage of the device and indicated results of the misuse of the device
- Known and unforeseeable Challenges or Hazards
- Calculate the level of Risk when it occurred and the duration and frequency of the hazard occurrence.
Risk Evaluation in Risk Management System
Risk Evaluation is the process of evaluating the occurrence of any hazard. Therefore, the manufacturers must analyze both the hazard’s probability and impact.
A risk evaluation matrix, such as the following example, is often used to visualize risk acceptability. The basic steps for Risk Evaluation are as under:
- Identification
- Probability of occurrence and the Impact
- Moment of Risk
- Treatment
- Monitoring and Review
Risk Control in Risk Management System
In Risk Management, the manufacturer must have standard operating procedures in place in case of any hazard of an unacceptable risk level. In such cases, it becomes even more important that this structure incorporates the best use of technology, information, and knowledge. Risk control options can be laid down as follows:
- Safety for both designing and manufacturing
- Protective steps undertake during the design and also during manufacturing
- Providing appropriate safety information to the end users.
FAQ's
What is the ISO 14971 standard?
ISO 14971 is a standard incorporating a framework for risk analysis, evaluation, control, and review for monitoring during production and post-production.
Is ISO 14971 required?
The use of ISO 14971 is not mandatory. However, it is observed that most medical device manufacturers use it to ensure product safety from planning to production, followed by medical device usage. ISO 14971 is required to create the much-needed risk analysis, evaluation, control, and review framework. It further helps to create a process for review and monitoring during production and post-production.
What is ISO 14971 and its risk analysis process?
ISO 14971 can be explained as a standard that is the combination of the occurrence of a hazard and the severity of the hazard.
The process of Risk Analysis is:
-To identify and quantify the probable occurrence of the hazard
-To evaluate the overall impact of the
-To complete the Risk Analysis Structure
-To try to execute the Risk Analysis Structure with replication
-Analyse the results of the Risk Analysis Structure
-` Make Decisions to Manage Risk effectively.
How do you structure a risk management plan?
The Risk Management Plan should include
-Risk identification
-Risk measurement and assessment
-Risk mitigation
-Risk reporting and monitoring
-Risk governance.
How do you create a risk management framework?
It is a template with guidelines laid down by companies to identify, eliminate and minimize risks. There are a few steps to follow to create a Risk Management Framework are:
-To Identify the Risk.
-To Analyse the Risk.
-To Prioritize the Risk.
-To Treat the Risk.
-To Monitor the Risk.
What are the four components of a risk management plan?
An effective Risk Management Plan should consider the following without any deviation
-To understand and frame the occurrence of Risk
-To assess the Risk
-To respond to the Risk
-To monitor the Risk.
Which ISO standard applies to the risk management of medical devices?
ISO 14971 applies to Risk Management of Medical Devices. The main objective of ISO 14971 is to reduce and manage risks related to medical devices as per industry standards. The process through which a medical device manufacturer can identify hazards associated with the medical device is specified in this document.
What is ISO 14971 and its risk analysis process?
ISO 14971 is a risk analysis, evaluation, control, and review framework for monitoring during production and post-production. Risk analysis is an essential tool that allows you to optimize the design, considering the possible risks associated with a new product.
What is the difference between ISO 13485 and ISO 14971 for medical devices?
ISO 13485 is a standard focusing on regulatory and customer requirements and medical devices. ISO 13485 is derived from risk analysis and record keeping pertaining to any risk and takes guidance from ISO 14971.
What does the ISO 14971 risk management plan include?
A risk management plan documents the process of producing medical equipment, including identification, evaluation, and risk mitigation. It also includes risk control monitoring, cost analysis, and financial impacts
Important information contained in the ISO 14971 Risk Management Plan are:
-Product definition
-Product Usage
-Core team details which will be taking care of the Risk Management
-Product Risk Acceptability
-Risk Control Measures
-Post- Production activities to be incorporated into the Risk Management Plan