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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 14971:2012. 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.

 

 

Tip #1 – Allocate the right resources

 

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.

 


 

Tip #2 – Align procedures and templates

 

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’.

 


 

Tip #3 – Use ISO 14971 terminology

 

Design Control Specialist

We recommend using the same terms as ISO 14971:2012 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

 


 

Tip #4 – Establish a list of Generic Hazards

 

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 14971:2012.

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.

 


 

Tip #5 – Establish a Medical Harm List

 

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 14971:2012 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.

 


 

Tip #6 – Make use of pre-filled text fields

 

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.

 

 


 

Tip #7 – Allow for sorting your risks

 

Design Control Specialist

Designing the organization’s risk template allows the project team to sort the risks by their severity of potential harm or another relevant category.

Project Manager

Sorting your risks by e.g. severity of potential harm allows your project team to focus on the most critical risks and create the most impact early in the development process.

 


 

Tip #8 – Think in modules

 

Design Control Specialist

Assigning a specific module or device component to each risk will allow the project team to ensure that risks related to all modules or device components have been identified.

Project Manager

Define the modules or device components of your device to enable identification of risks related to all modules and device components.

 


 

Tip #9 – Allow for filtering risks

 

Design Control Specialist

Allowing the user of the risk template to filter on risks related to a specific component of the device or another relevant category will enable relevant stakeholders to efficiently identify risks related to their responsibility.

Project Manager

Filtering the use-related risks associated with the risk of serious harm allows your usability engineer or human factors specialist to efficiently identify the critical tasks that must be tested in the summative evaluation / human factors validation test.

 


 

Tip #10 – Manage inputs where applicable

 

Design Control Specialist

By managing generic inputs, you will minimize the risk of misspelling. If for instance, a member of the project team filters on risks related to a ‘biological contamination’ hazard, any risk where ‘biological contamination’ is misspelled will not be listed.

Project Manager

If generic inputs are managed, your project team will be able to gain full overview of relevant lists when sorting and filtering without the risk of certain risks not being listed due to misspellings.

Hazard
Biological contamination
Biologicla contamination
Biological contamination
Biological contamination

 


 

Tip #11 – Consider whether mitigations introduce new risks

 

Design Control Specialist

In your templates, you may consider inserting columns allowing assessment of whether implemented risk control measures introduce new hazards or hazardous situations. If so, these should be managed as new risks with a separate risk ID.

Project Manager 

As a project manager, it is important to focus not only on minimizing risks but also whether the risk control measure itself actually introduces one or more new risks.

 


 

Tip #12 – Identify risks throughout the whole medical device lifecycle

 

Design Control Specialist

In your templates, consider assisting the project in identifying risks in all lifecycle steps by adding a column to your template called ‘lifecycle step’. This column can then be filled out for each risk with one of the following lifecycle steps: Transportation, storage, installation, operation (product use), maintenance, repair, decommissioning and disposal.

Project Manager

As a user-centric development team, we often think about device use as the ‘operation’ step of the lifecycle. However, we must also design for – and minimize risks related to – e.g. storage, repair, and disposal.

 


 

Tip #13 – Automatically calculate risk evaluation

 

Design Control Specialist

To minimize miscalculations of whether a risk is acceptable or unacceptable, consider automatically calculating, using a validated spreadsheet, the combination of severity and probability of each risk and assign a color indicating risk acceptability.

Project Manager

Having the spreadsheet perform automatic calculations reduces the risk of incorrectly considering an unacceptable risk ‘acceptable’.

 


 

Tip #14 – Risk Management is an iterative process

 

Design Control Specialist

Allow for iterations by adding a change log to your template allowing the author to describe the updates made in the different versions.

Project Manager

Risk management is an iterative process and you should review your identified risks and assumptions throughout the development process. Early in the process, your focus may be mostly identification of risks – later the focus may be on the effectiveness of your risk control measures. Remember to update your risk management file throughout the project.

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