Traduction de «failure effect analysis » (Anglais → Français) :

With reference to the antimalarial drug mefloquine administered to Canadian Forces bound for Somalia in 1992-93 and the legal framework under which it was available for use and administered: (a) was mefloquine a licensed drug when it was administered to Canadian Forces, if not what was its status, and how was it legally available; (b) were the Canadian Forces participating in the Lariam (mefloquine) Safety Monitoring Study during this period; (c) was the mefloquine administered in accordance with the Lariam Safety Monitoring Study and the Food and Drug Act; (d) who was the “principal investigator” responsible for the Lariam Safety Monitoring Study in the Canadian Forces; (e) who was the Canadian Forces physician responsible to the “prin ...[+++]cipal investigator” of the Lariam Safety Monitoring Study; (f) what was the role of Canadian Forces physician, Dr. Martin Tepper, in the Lariam Safety Monitoring Study; (g) who was responsible for the Lariam Safety Monitoring Study at the Department of Health's Health Protection Branch during this period; (h) what was the role and responsibility of the Health Protection Branch under the Lariam Safety Monitoring Study and the Food and Drug Act and its regulations in regard to the use of mefloquine by Canadian Forces personnel; (i) when did the Health Protection Branch become aware that mefloquine was being administered to Canadian Forces personnel bound for Somalia; (j) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine to inform the manufacturer of its use; (k) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act to the soldiers who were administered the drug; (l) did the Canadian Forces fulfil their responsibility to the manufacturer under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine and if so how did they do ...

This may be based on a Failure Mode and Effect Analysis (FMEA), a Fault Tree Analysis (FTA) or any similar process appropriate to system safety considerations.

This may be based on a failure mode and effect analysis (FMEA), a fault tree analysis (FTA) or any similar process appropriate to system safety considerations.

3.1.3. The verification results shall correspond with the documented summary of the failure analysis, to a level of overall effect such that the safety concept and execution are confirmed as being adequate.

Q-91 Mr. Cummins (Delta South Richmond) With reference to the antimalarial drug mefloquine administered to Canadian Forces bound for Somalia in 1992-93 and the legal framework under which it was available for use and administered: (a) was mefloquine a licensed drug when it was administered to Canadian Forces, if not what was its status, and how was it legally available; (b) were the Canadian Forces participating in the Lariam (mefloquine) Safety Monitoring Study during this period; (c) was the mefloquine administered in accordance with the Lariam Safety Monitoring Study and the Food and Drugs Act; (d) who was the " principal investigator" responsible for the Lariam Safety Monitoring Study in the Canadian Forces; (e) who was the Canadia ...[+++]n Forces physician responsible to the " principal investigator" of the Lariam Safety Monitoring Study; (f) what was the role of Canadian Forces physician, Dr. Martin Tepper, in the Lariam Safety Monitoring Study; (g) who was responsible for the Lariam Safety Monitoring Study at the Department of Health's Health Protection Branch during this period; (h) what was the role and responsibility of the Health Protection Branch under the Lariam Safety Monitoring Study and the Food and Drugs Act and its regulations in regard to the use of mefloquine by Canadian Forces personnel; (i) when did the Health Protection Branch become aware that mefloquine was being administered to Canadian Forces personnel bound for Somalia; (j) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drugs Act prior to the licensing of mefloquine to inform the manufacturer of its use; (k) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drugs Act to the soldiers who were administered the drug; (l) did the Canadian Forces fulfil their responsibility to the manufacturer under the Lariam Safety Monitoring Study and the Food and Dru ...

- failure to use available data, which, combined with a lack of complete and reliable information on the real economic and administrative impact of transit and on the operations themselves, makes it almost impossible to manage the system really effectively and appropriately or to prevent fraud with the help of risk analysis and targeted controls.