One of the most important principles for medical device, equipment and supplies manufacturers is risk management. Medical manufacturers are required to keep consumers safe and minimize risk by offering products that are reliable, work as expected and do not cause harm. These expectations are outlined by the FDA and ISO 14971. However, there are many components to exercising proper risk management. These are the major considerations for managing risk for medical manufacturers.
Risk Management Framework
A risk management framework is a guide for minimizing risk. This framework includes the process for developing the device, the roles and duties of the staff involved and the necessary documentation of your plan. When your framework is in place, you can move on to assessing risk analysis.
Risk Analysis
During risk analysis, manufacturers initially focus on defining the intended use of the product. Although this may seem unrelated to risk, defining a product’s use clarifies the potential hazards involved with the device. It is critical to identify these relevant hazards, their causes and how much harm they could cause. If risk analysis is a weak area in your business, then you need to align proper business processes with your software. Datix takes a business-first approach with our clients to ensure that we know every aspect of how a company works so we can increase their competitive advantage and overcome their challenges. Learn how Datix can provide you with a risk analysis solution.
Risk Evaluation
In addition to risk analysis, risk evaluation must also take place. Risk evaluation is the process of comparing the estimated risk against established risk criteria. It is used to determine if a risk is considered acceptable or not. The simplest way to evaluate risk is to use a risk acceptability matrix. There are many variations of risk acceptability matrices, but here is one example:
| Probability | Harm severity | |||
|---|---|---|---|---|
| Minor | Marginal | Critical | Catastrophic | |
| Certain | High | High | Very high | Very high |
| Likely | Medium | High | High | Very high |
| Possible | Low | Medium | High | Very high |
| Unlikely | Low | Medium | Medium | High |
| Rare | Low | Low | Medium | Medium |
| Eliminated | Eliminated | |||
For each risk associated with a product, you can pinpoint where it falls on the matrix based on two factors: the probability it will happen and the amount of harm caused if it does. Based on this information, you can evaluate if action needs to be taken to prevent or minimize the severity of the risk. Your ERP or software system can help you evaluate risk for each of your products using tools like a risk acceptability matrix. If you need help setting up your ERP to support evaluating risk, look to an ERP expert like Datix. As a one-stop shop, we are dedicated to finding our clients the right solution for their specific challenges. With 25 years of project experience, we can offer nonbiased guidance to finding new software or executing best practices for medical manufacturers.
Risk Control
Risk control allows manufacturers to mitigate risk to an acceptable level, but not all options are as effective as others. Consider risk control choices in order of priority:
- Inherent safety by design
- Protective measures in the actual medical device and/or manufacturing process
- Information for safety, such as labeling and instructions for use
These priority levels are based on levels of effectiveness. No matter how many warning labels are added to a device, safe product design will always be a better strategy for minimizing risk. However, it is important to remember that redesigning a product to reduce one risk could result in adding new risks, so you must evaluate risk after every product redesign.
Reporting and Documentation
The last step to risk management is documenting your plan and strategies to demonstrate compliance with the FDA and ISO 14971. Documentation should be happening continuously during the risk management process and include all actions, reports, assessments, and diagrams created for the risk management planning process. These documents should also include data from after development, including how well your control actions mitigated risk. With a poor software setup, keeping up with risk documentation feels tedious and time consuming. However, the right ERP or software solution takes care of much of the reporting for you, so your team can devote their time to developing the best products possible. To streamline the risk documentation process, look to a software consultant like Datix. We focus on offering our clients continuous improvement, meaning that we map out real solutions to your issues, implement them and offer support after you receive your working solution. Learn how you can grow with a partner like Datix.
Wrap Up
Risk management is an essential part of medical manufacturing, but it is only one part of a complex set of business processes to delivering quality products. A software consultant like Datix can help you align your business processes with software to maximize your outcomes.
Read how to Simplify Quality Control for Medical Manufacturers
About Datix
For medical manufacturers, Datix is the software consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.
