Quality management is relatively new to cellular therapy programs and cord blood banks, but the principles of quality assurance and quality control have been long incorporated. For the FACT accreditation process, the real turning point for emphasis on quality management activities was with the release of the third editions of the Cellular Therapy Standards and Cord Blood Standards which included greatly expanded Quality Management sections. Since that time, FACT has developed and introduced quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program.
FACT Quick Reference Guide (FQR):
The FQR: Q Series provides professionals a concise source of information on Quality Management Principles. The guides address current needs in Quality and may include examples, templates, and/or common citations.
Walking the Walk – FACT Conducts Audits of its Own Processes
FACT has an inspection audit system used to ensure that our inspection process is uniformly applied to all organizations. Similar to the purpose of audits in accredited organizations, our audit process is one tool we use to identify how we are doing and how we can continually improve the FACT inspection and accreditation process.
Auditors are volunteers from FACT accredited organizations who have experience in quality management. During an audit, the auditor reviews our inspection processes during an actual on-site inspection. Inspections are randomly chosen in advance and organizations agree to participate in the inspection audit.
The auditor does not make decisions about or participate in the actual inspection process of an organization, or make recommendations about outcomes. Auditors simply observe the process to determine if there are any areas for improvement. Results of the inspection audit are reviewed by the Quality Management Committee and process improvement actions are identified and implemented. Such assessments and resulting improvements will ensure our inspection and accreditation process is effective and enjoyable for our applicants and inspectors.