The "P's and Q's" of quality systems

Quality improvement in blood collection centers has been a priority of regu latory and accrediting agencies for the past several years. The Food and Dr ug Administration and the American Association of Blood Banks have develope d guidelines for quality assurance activities. Inspection programs have foc used on evaluation of processes and how they are controlled to assure the s afety and efficacy of blood components. A review of Food and Drug Administr ation enforcement actions shows that all such actions cite similar deficien cies related to management control, personnel training, error, and record m anagement policies. A quality program that includes management commitment t o compliance and continuous improvement defined personnel training, interna l audit, and error management policies provides documented evidence to mana gement and regulatory agencies that operations are in control.