How Health Canada inspects medical device establishments: Corrective action plan template

This template can be used to prepare a corrective action plan.

Establishment information

• Establishment name:
• MDEL number:
• Number of observations identified in the inspection report:
• Date of issuance of the inspection report:

Observation information

• Observation (enter the observation number and a description of the observation as outlined in the inspection report):
• Root cause of the observation (the cause of a detected deficiency):
• Risk (1,2 or 3 as identified in the inspection report):
• Observation status (resolved/unresolved):

Corrective and preventive action(s)

• Corrective action(s) you have taken (actions taken to eliminate the root cause of a deficiency and to prevent recurrence):
• Documents you are providing to support the corrective action(s): evidence of corrective actions you have already taken
• Name of the person or department responsible for the completion of the corrective action(s):
• Timelines/date for the completion of the corrective action(s) (if applicable):
• Preventive action(s) you have taken (actions taken to eliminate the cause of a potential deficiency):
• Documents you are providing to support the preventive action(s): evidence of the preventive actions you have already taken
• Name of the person or department responsible for the completion of the preventive action(s):
• Timelines/date for the completion of the preventive action(s) (if applicable):