increase the quality and safety
Implementing an effective Risk Management process
Identifying, estimating, and evaluating your device risks at the right time will increase the quality and safety of the device and can motivate the project members. Furthermore, it adds value by decreasing the project risks and avoiding costly late-stage changes. An effective Risk Management process is mandated by regulatory authorities (21 CFR 820 and 93/42/EEC on Medical Devices) and is essential to develop medical devices that are safe and effective.
This article will provide you with some tips on implementing – or improving – your effective Risk Management process.
There are several aspects of implementing an effective Risk Management process. One thing is to establish a Risk Management process including usable and operational templates so that the process complies with ISO 14971:2019. Another thing is to support the organization when working with the Risk Management process. But the foundation for implementing an effective Risk Management process is to have written procedures and operational templates.
For the tips in this article, we have assumed that establishing and maintaining procedures and templates is the responsibility of the Design Control Specialist and using the templates and understanding and applying the procedures is the responsibility of the Project Manager. This article gives you ideas to help you succeed with your Risk Management process by providing some tips for both your procedure and your templates from the perspectives of a Design Control Specialist and a Project Manager.
Design Control Specialist
If your development procedure is aligned with Design Control, you can tailor your procedure to ensure that Design planning is the first activity to be carried out. This ensures that resources, responsibilities, and interfaces to other groups or activities are described and allocated.
Project Manager
The essential part of a successful and value-adding Risk Management process is due diligence and the involvement of the right competencies. This ensures that Risk Management is used as design input and not rationalizing after the device has been designed and developed. Resources should be allocated to Risk Management as successful Risk Management is a team effort and should not be the responsibility of the Risk Manager alone.
Risk assessments are appropriately carried out in workshops where relevant competences participate. This enables a common understanding and insight in the identified risks and the device. Remember that Risk Management is an iterative process and the Risk Management file shall be updated throughout the project.
Design Control Specialist
By aligning the steps of your Risk Management procedure and the columns in your templates you will ensure that your procedure and templates are operational. You can also consider having your procedure illustrate exactly where in the template each step is to be filled out.
Project Manager
If you have questions to a specific column in the template, e.g. ‘hazardous situation’ you will be able to refer to the procedure and read the description of ‘hazardous situation’.
Design Control Specialist
We recommend using the same terms as ISO 14971:2019 throughout your procedures and templates. This will enable efficient review and inspection of procedures and records as well as ensure that correct and consistent terminology is used within the organization. Explaining key terms such as ‘Hazard’, ‘Hazardous situation’, and ‘Harm’ could be done using familiar product risks in the organization.
Project Manager
Using the correct and consistent terminology minimizes the risk of miscommunication within the project. For instance, the term ‘misuse’ should not be used instead of ‘abnormal use’ as these are different terms.
Hazard | Hazardous Situation | Harm | |
Description | Potential source of harm | Circumstance in which people, property, or the environment are exposed to one or more hazard(s) | Physical injury or damage to the health of people, or damage to property or the environment |
Example | Biological contamination | User drops inhaler on the floor. Inhaler is contaminated. The user inhales from contaminated inhaler. | Bacterial infection |
Design Control Specialist
By allowing each team to establish a list of generic hazards, you will facilitate the identification of potential risks and enable the team to consider these in the design of the medical device. You may be inspired by the hazard examples of Annex in ISO 14971:2019.
Project Manager
By establishing a generic list of hazards associated with your team’s device, you will enable your team to start thinking about risks before the final device has been designed. Depending on the device in question, you may rule out Thermal Energy, Chemical Hazards, Software Function or Biological Contamination at this stage. Keep in mind that this is not a thorough analysis to identify all sequences of events but ensures high-level hazards are considered at an early development stage.
Design Control Specialist
To avoid late-stage changes and ongoing discussions on how to evaluate harm, we recommend establishing a Medical Harm List including severity classifications. This constitutes a baseline for the Risk Management of the device. The Medical Harm List can be based on annex C and E of ISO 14971:2019 and can be written by a clinical specialist or medical doctor.
Project Manager
By establishing a project-specific Medical Harm List, you will ensure that the project team members use the correct harm defined by – and agreed on – by a clinical specialist.
Design Control Specialist
Even though not all text fields in a Product Risk Analysis are applicable to predefined text input some are. By defining these, you will ease the use of the templates and the documentation of the project’s risk management process.
Project Manager
Pre-filled text helps to guide you and your team in documenting your risk analysis.
Hazard | Hazardous situation | Harm | Risk Control |
Biologocal contamination | User drops inhaler on the floor. Inhaler is contaminated. The user inhales from contaminated inhaler. | Bacterial infection | |
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