Writing a Quality Management Plan

Abstract

Quality management systems (QMS) are central to FACT-JACIE accreditation standards for haematopoietic cell therapy (HCT) programmes. The quality management plan (QMP) defines the acceptable level of quality of the activities performed or of the products released by the HCT programme and describes how this level of quality in its deliverables and work processes will be ensured. An integrated HCT programme may have a single or several QMPs that addresses all aspects of the clinical, collection, and processing facilities, whilst separate organizations providing the components of an HCT programme may have distinct QMPs joined via service-level agreements (SLAs) and other arrangements. The QMP or QMPs must detail all key elements that affect the quality of recipient and donor care and cellular therapy products. The specific SOPs to be followed for each of these elements should be referenced within QMPs, and linked to the appropriate document where the details are described. The thoroughness in preparation of a QMP and its implementation reflect how quality is perceived within the HCT programme and by external inspectors in the accreditation process.