Getting started on risk management is sometimes the hardest part. A series of well-thought-out risk management workshops can give you a flying start in your work and allow you to avoid problems at a later stage. And the cost of changes increases the further you have progressed through the product’s lifecycle. I have put together an article with six common pitfalls and how to avoid them.

1. Have a shared view of the product

Thinking of the same product in risk management workshops
If you’re going to figure out what hazards the product may have, it really helps if you are thinking of the same product. If one person is thinking of a design which is disposable, and another is thinking about a re-usable product, then they will be confused and unable to communicate clearly with each other. Often in the early stages of a project people aren’t always on the same page in terms of the product.

2. Determine the intended use before starting

The intended use answers questions like who the product will be used on, for what and by whom. Simply put, it provides a broad and high-level description of what the product is intended for. Not knowing the intended use when starting the risk management process is a problem. Let’s say you’re working with a product that could be used by professionals.

Now take the same product but where the users are ordinary laymen with no medical training whatsoever, the requirements for the product will be very different. Even the risks will be very different. Therefore, you should determine at least a preliminary intended use before you start so that you have a common baseline for the risk analysis. You can always change the intended use later, but remember to update the risk management work you have done so far.

3. Ensure that your people are trained

Having team members that don’t understand why you are working with risk management or how you should go about it can make the process frustrating and time-consuming.

It is not too uncommon for inexperienced risk management teams, that there are one or two people who attempt to prove that what you are doing in terms of risk management is not meaningful by bringing up more or less absurd examples and risks to prove that risk management is a waste of time. Obstructive behaviour can take on many different forms, for example, people may be:

  • going off track by immediately getting caught up in detailed technical discussions with little or no bearing on risk management.
  • saying things like “…but what if a fireball hit the person using the device?”
  • denying that anything could go wrong with the product, thus implying that the whole process is a waste of time.

Risk management workshops challenges

Those people should be trained in risk management. Ensuring that your staff have training in risk management may increase motivation and self-confidence, and thereby the performance of the individual and ultimately the group. Besides, you are required to have the necessary skill and training and have records of the training for what you do, both according to ISO 13485 and 21 CFR 820.

SEE ALSO: Free online ISO 14971 training course

If training doesn’t work, consider omitting those people from the workshops; instead let them review risk management outputs. Or if you want to deal with this during the meeting, say “I understand that this is the way you feel; let’s move on with identifying more hazards.” Or “I understand that the fireball is of great concern to you. I’ll make a note of it, shall we continue?”

4. Different group sizes work for different things

It is common to brainstorm risks, but if you do, don’t allocate too much time to it. And more importantly, don’t carry out the detailed editing of the results while everyone is participating.

Let’s say there are four or five people in a risk management workshop. Brainstorm together, go through lists or use other methods you usually employ. You can write the results on a whiteboard, use notes or a word processor and projector – or even mind mapping software.

Don’t aim to get the text 100% correct during the meeting. Just make quick notes as you go along, then let one or two people do the editing and present it to the group again at another meeting (if need be). Having five people watching while someone tries to spell “phthalates” can kill the patience of the most inspired souls. And a side note: brainstorming sessions should normally not be any longer than 10 to 15 minutes.

5. Avoid bucket brainstorming

The risk analysis is the easiest part to brainstorm. It will contain things like hazards, reasonably foreseeable sequences or combinations of events, hazardous situations, and harms. Even if it could be considered too early to come up with risk controls in your first risk management workshops, they may very well pop up during your meeting and that is OK. The ISO 14971 standard is a process standard, but that doesn’t mean that you can’t work iteratively.

More importantly, don’t tell people to only come up with hazards, then move on to reasonably foreseeable sequences or combinations of events, then hazardous situations, and finally harms. This would be to brainstorm into “buckets” and will result in a very constipated brainstorming session. Just write everything down, and then file and filter it under the right headings in a smaller group, as suggested above.

6. The agenda

Having an agenda is a very good idea, not only for risk management workshops but for all meetings. Here are proposed agendas for what may be your first workshops:

Workshop 1

1. Purpose of the workshop (expected outcome).
2. Presentation of the product including intended use.
3. Quick walk-through of questions in Annexes C and E of ISO 14971.

Between this and the second workshop, a smaller group may make a preliminary hazard analysis and compile the results from the first meeting.

Workshop 2

1. Purpose of the workshop (expected outcome).
2. Brainstorming hazards and harms and everything in between (first session).

In between workshops, compile the results.

Workshop 3

1. Purpose of the workshop (expected outcome).
2. Discussion about issues that were identified after Workshop 2 (things that smaller groups or individuals weren’t able to resolve on their own).
3. Filling out gaps in the matrix that could not be done by smaller groups.
4. Identifying failures in production processes or any other lifecycle stage that may be relevant (service, design, scrapping, shipping, installation, etc.)

The above is a starting point. It should, of course, be adapted to your situation and product. If you are creating a new model of an existing product, you may focus significantly more on differences than on identifying new things. If you are creating a product with essential performance features (where the product must operate to ensure safety; for example, a ventilator), you may focus more on the reliability of key components and modules in your product.

Do you have your own experience of the above? Please share your best risk management successes or failures in the comment field or by using the contact form.

Good luck with your risk management.

Would you like to learn more about Risk Management?

Get instant access to our online Risk Management for Medical Devices and ISO 14971:2019 course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.

Peter Sebelius

Peter Sebelius - Author image

Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience too, having developed, amongst other things, a mechanical chest compression and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

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