Risks are everywhere!
As part of your QMS, analyse your risks. It’s convenient to analyse the risks per step in the workflow below. Do this with a multidisciplinary team, so you can approach this from various angles.
This workflow reflects the elements of the Ishikawa diagram, or 5M method:
- Man
- Human error is the most important source of risk
- People need to be competent based on training, experience, education
- Machine (3D printing)
- 3D printer poorly maintained/calibrated
- Process parameters vary
- Medium (work environment)
- Room temperature too high/low
- Moisture/humidity too high
- Method (steps from imaging to release)
- Insufficient process documentation
- Inefficient process
- Material
- Poor quality or uncontrolled raw materials
- Incorrect storage conditions
Sometimes you even see another M: Measurement. Your testing procedure for release could be flawed or your measuring device is not properly calibrated.
Now you have identified all your risks (actually “hazards” is the more appropriate word, since a hazard is a potential source of harm and risks are formally defined as ‘the combination of the probability of occurrence of harm and the severity of that harm’). The next step is to populate an FMEA in which you think about the potential effects (harm) of the hazards you identified and score them. The score should give you an objective measure of the acceptability of the risks. Unacceptable risks should be addressed/reduced and then scored again.
This effort will give you a good view of all the risks involved in medical 3D printing and once you have reduced all risks to acceptable levels, you can be reassured that your 3D printed devices are safe.
Need help? I have populated and updated an FMEA over the years which you can purchase. It’s not meant to replace your risk management efforts, rather to make sure you didn’t forget any hazards and it can inspire you with potential methods on how to mitigate/reduce the risks. Contact me.