[Application of a hazard analysis method to blood manufacturing activities].
French regulations for blood transfusion and the aims of quality insurance policy of the French National Blood Service (EFS), impose the analysis and the control of the whole blood manufacturing process. The methods of hazard analysis are tools used to evaluate the reliability of processes and to mention their critical points. These techniques take part in a broader concept of hazard control. This control imply that hazards have been analysed and evaluated in the aim to set up the best procedures for improving the reliability of blood manufacturing process. The hazards which are analysed can be << real >> hazards leading to a reactive approach, or << potential >> hazards, leading to a preventive approach. This paper presents the main steps of the methods which are used for hazard analysis, and some situations in blood manufacturing where these methods can be applied.
Becel
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Etablissement français du sang Bretagne, Rennes, France. christine.becel@efs.sante.fr
D001688:Biological Products / Q000302:isolation & purification*; D001803:Blood Transfusion / Q000592:standards; D005602:France; D006801:Humans; D017053:Infection Control / Q000379:methods / Q000592:standards; D008962:Models, Theoretical; D012306:Risk; D018570:Risk Assessment / Q000379:methods*; D017751:Safety Management / Q000379:methods* / Q000592:standards; D065227:Transfusion Reaction
D001688:Biological Products