The management of nonconformities in blood establishments

Abstract

With the introduction of quality management system as either a voluntary activity or based on legal regulation, a transfusion establishment is committed to consistent use of nonconformity management in all its activities. Nonconformities are mostly detected in blood products, in all steps of the manufacturing process. A product in broad sense also refers to the services offered. Nonconformities may be found in input materials, devices and equipment as well. Efficient management of these nonconformities is one of the key elements of the materiovigilance system. A special category are the nonconformities that need not be identified directly in the products, materials or equipment, but their occurrence may have adverse effects on the product and service quality, safety of those involved in the transfusion chain, user confidence, or transfusion establishment economy. Nonconformities may be detected in regular work process, or during internal and external quality assessment, inspections, evaluation of the quality system by the managing board, management of complaints, etc. Each blood establishment should have written procedure describing nonconformity management, while the personnel should undergo continuous education on all aspects of this segment of quality management. Along with making proper decision on the nonconforming product/nonconformity, in the procedure of nonconformity management it is of great importance to assess the potential impact of this nonconformity on other products or processes, and to prevent the possible additional damage on time. As the management of nonconformities has a critical role for the quality and safety of transfusion treatment and is involved in all transfusion service activities, it is no surprise that an array of quality indicators that serve as a basis for corrective measures and continuous quality improvement derive from this segment of quality management.