Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061) - Summary

The Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061) is an administrative tool and is intended to:

  • Assist in the classification of observations noted during inspection of establishments regulated under the Blood Regulations;
  • Promote uniformity in the assignment of the rating to individual observations and to overall inspection ratings of the blood establishments; and
  • Provide examples of situations of non-compliance with the Blood Regulations.

This guidance document applies to inspections of all establishments regulated under the Blood Regulations and provides some examples of situations or observations and their assigned risk classification. During an inspection, inspectors assess compliance of a blood establishment with the Food and Drugs Act, the Blood Regulations and the referenced sections of the Canadian Standards Association (CSA), CAN/CSA-Z902 Blood and blood components, as applicable. Furthermore, Health Canada has developed a guidance document entitled Guidance Document: Blood Regulations, which interprets the requirements of the Blood Regulations.

For a complete copy of the GUI-0061, please contact the Blood, Tissues, Organs and Xenografts Compliance Unit.

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