Risk classification guide for medical device establishment inspections (GUI-0079): Determining the risk level of observations
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Criteria used to rate observations
Inspectors use the following criteria to rate observations noted during inspections:
- nature of the deviation, deficiency or failure
- likelihood of a hazardous situation occurring
- likelihood of a hazardous situation leading to harm
- severity of the harm or potential harm
- number and classification of the medical devices involved
- number of times the deviation, deficiency or failure has been noted
The inspector will immediately bring any observation rated as Risk 1, along with any other observations requiring immediate corrective action, to the company's attention.
Repeat observations
An observation may be designated as a "repeat observation" if an observation made during a previous inspection has either:
- not been corrected or
- been observed to reoccur because the root cause of the deficiency has not been addressed
If only part of an observation is repeated, it may be designated as a "partial repeat observation."
The inspector may rate a repeated deviation, deficiency or failure at a higher risk level than it was originally rated.
Rating the risk level of repeat observations
The inspector will consider the following questions when rating a repeat or partial repeat observation:
- Was there a failure to address the deviation, deficiency or failure?
- Did corrective actions fall short of addressing the deviation, deficiency or failure?
- Did the corrective actions taken produce new risks?
- Was the company willing and able to correct the deviation, deficiency or failure?
- Did the company consider the risk of all identified hazardous situations?
- Have new hazards or hazardous situations shown up since the last inspection?
- Did actions taken prevent deviations, deficiencies or failures from recurring?