AUDIT DU BPBR

Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 OBSERVATIONS AND RESPONSES WHOLE BLOOD – Staff – C.02.006 1. The following omissions or shortcomings were observed in staff training programs: The files of two employees working in the IT department did not specify which versions of the SOPs for which training and annual recertification have to be completed. Annual recertification has not been carried out during the past year in the following cases: • One employee of the Material Resources department has not been recertified since 2001. • One employee working in the IT department has not received recertification since April 2002. • Two employees working in Production Information Systems have not been recertified since June 2002; however, a request to begin the recertification process was made on January 21, 2004. Response: In reference to IT department employees: In January 2004, an information system quality control specialist joined the IT division team. This person ensures that IT staff receive the appropriate regulatory training and is also responsible for the updating of training files. As a result of Health Canada’s observation, the employee training files have now been corrected and the SOP versions are duly noted. The information system quality control specialist will also ensure that the employee in question is recertified before the end of March 2004. A new position ...