In the design control requirements, the FDA refers to Risk Analysis. This is such a critical aspect of manufacturing medical devices, ISO created a standard for just this subject – ISO 14971 ‘Application of Risk Management to Medical Devices’. ISO 14971 identifies Risk Management as “The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.” This standard provides the framework to manage all aspects of risk to people, property and the environment.
Some key definitions related to risk analysis are:
- Risk – the probability of the occurrence of harm and the severity of that harm
- Hazard – the potential source of harm
- Hazardous Situation – circumstance in which people, property, or the environment are exposed to one or more hazard
- Harm – physical injury or damage to the health of people, or damage to property or the environment
- Severity – measure of the possible consequences of a hazard
- Residual Risk – risk remaining after risk control measures have been taken
There are three tools recommended for the evaluation of risk: Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Failure Mode Effects Criticality Analysis (FMECA). I will discuss these methods in a future “Fact of the Week”.
You may be wondering, when is the right time to perform risk management? The answer is to start at the beginning (design phase) and never stop, even after the product has been in the market for a number of years. During the design phase, you will need to recognize potential hazards. With each modification to your design, you’ll want to make sure the changes do not cause harm (to the design or the user). For each production process change, use risk analysis to ensure the intended improvements are completely thought through prior to initiating the change(s). You’ll also want to perform a risk analysis after any recall – the goal here is to evaluate if the cause of the recall could have been avoided with a more rigorous and objective risk management effort.
It is recommended that a risk management file be created for each medical device. This file can be used to facilitate traceability by recording risk analysis, risk evaluation, risk control measures and residual risk evaluation results for each hazard.
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