Quality Management

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 Quality Handbook

The intent of this Handbook is to provide practical advice and examples from Quality experts in the cellular therapy and cord blood bank communities. The Quality Handbook provides fundamental information about quality systems including chapters on Document Control Elements, Outcome Analysis, and Validation and Verification of Critical Procedures.

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FACT Quality Management Series Webinars:


Quality Management Series Module 1
Administrative Aspects of QM

Quality Management Series Module 2
Quality Assessment Activities

Quality Management Series Module 3
Reporting QM Information

Quality Management Series Module 4
Personnel

Quality Management Series Module 5
Facilities

Quality Management Series Module 6
The Quality Organization

Quality Management Series Module 7
Outcome Analysis

FACT Quick Reference Guide (FQR):
Q Series

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.


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As a Matter of FACT

FACT inspectors have free access to all FACT training and educational opportunities.

Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more