Guidance on classification of observations for inspecting cells, tissues and organs establishments (GUI-0101): Guidance

On this page

• Assigning risk to an observation
• Issuing the exit notice
• Compliant and non-compliant ratings

Assigning risk to an observation

Health Canada inspectors may inspect any party that conducts regulated activities under the regulations. Health Canada inspections are part of a national compliance and enforcement program.

Health Canada's authority to inspect establishments that process, import, distribute or handle human cells, tissues and organs (CTO) comes from sections 22(1) and 23 of the Food and Drugs Act (act).

During an inspection, an inspector notes deficiencies from the applicable requirements of the act or Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations). These deficiencies appear as observations on the inspection exit notice provided to the CTO establishment.

The possible risk ratings for observations are:

• Critical observation (Risk 1)
  • describes a situation that directly affects the safety of cells, tissues or organs, and is likely to result in a health risk to the recipient or
  • describes a situation that involves fraud, misrepresentation or falsification of the records or data
• Major observation (Risk 2)
  • describes a situation that may affect the safety of cells, tissues or organs, and may result in a health risk to the recipient
• Minor observation (Risk 3)
  • describes a situation that is neither critical nor major, but is a deficiency from the applicable requirements in the act or regulations

Inspectors consider the following criteria when classifying an observation:

• nature of the deficiency
• potential or immediate health risk to the recipient
• number of times the deficiency has occurred
• deficiencies reported during a previous inspection that were not adequately addressed
  • includes the implementation of corrective actions to prevent the deficiency from occurring again
• other relevant CTO policies and guidance
  • includes this document
• the context

List of sample observations

Note: The risk rating assigned to an observation depends on the nature and extent of the deficiency and if it occurs again. The examples provided in this guidance document are examples only.

Inspectors use their discretion when determining compliance with the act and regulations, and assess each case based on the facts at hand. For example, an inspector may assign a higher risk to observations that are repeated from previous inspections depending on the corrective actions that the establishment took at the time of the inspection.

Issuing the exit notice

After an inspection, Health Canada issues an exit notice to the establishment. The exit notice lists all observations with risk ratings made by the inspector.

The notice also indicates the overall rating:

• compliant (C) or
• non-compliant (NC)

Compliant and non-compliant ratings

There are 2 possible overall ratings given at the time of an inspection:

1. Compliant (C): The establishment has demonstrated that they were in control of its regulated activities and the activities it conducts comply with the act and regulations. A "C" rating does not mean that there were no observations or corrective actions required.

   Generally, a compliant rating will be assigned in the following situations:

   • no observations
   • only minor observations
   • some major observations, but the establishment demonstrated that it is in control of its regulated activities
2. Non-compliant (NC): The establishment has not demonstrated that the activities it conducts comply with the act and regulations and they were not in control of their regulated activities.

   Situations that may result in a non-compliant rating include:

   • a critical observation (Risk 1) identified
   • attempt by the regulated party to deceive, misrepresent or falsify records or data
   • major observations that indicate the regulated party is not in control of its activities
   • corrective and preventive action (CAPA) measures were not implemented for some observations made in previous inspections (repeat observations)

If Health Canada is considering an NC rating, we will let the establishment know this. We will ask for an immediate action plan that outlines the corrective measures the establishment will take and how long it will take to implement them.

Establishments that wish to dispute the results of the inspection or the final rating should follow the dispute process. The process is outlined in the letter that is with the exit notice.

Note: An NC rating is serious. Enforcement actions, which may include cancelling an establishment's registration, are taken to protect people's health and safety.

Learn more about the measures that we may take when a regulated party fails to comply with regulatory requirements:

• Compliance and enforcement policy for health products (POL-0001)

For a copy of the Registration policy for cells, tissues and organs establishments under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (POL-0123), email us: roeb.cto-dgoral@hc-sc.gc.ca.