Q is for Quality – QA, QC and Flow Cytometry

How do clinical flow cytometry labs ensure that the data they generate is accurate, reproducible, and conforms to regulatory requirements? They use quality management systems, including quality assurance (QA) and quality control (QC). Some scientists seem to use these terms interchangeably, but what do they really mean and why are they important to flow cytometry?

QA vs QC

Quality Control scientistQA refers to aspects of quality management that focus on ensuring that quality requirements are being satisfied. QA includes looking at quality aspects at an organizational level and within a specific protocol, although regulatory requirements may not necessarily include QA for specific aspects of a project. QA is carried out both within an organization and through external audits. These multiple layers of QA are not only critical for satisfying regulatory requirements, but they are also critical to developing effective quality management systems.

Audits can occur at different points of a study, such as critical phase audits that are carried out during a study to certify that protocols are being carried out correctly and standard operating procedures are being used. In contrast, final audits are carried out when studies are completed and these audits evaluate the methods used and if they are reflected correctly in data.

QC involves specific inspection of a research product, like flow cytometry data, such that different parameters are measured and are shown to fit within predetermined QC criteria.

Other quality management elements

Preclinical and clinical research often must be carried out under good laboratory practice (GLP) or good clinical practice (GCP) conditions as this is critical to fulfilling regulatory requirements and producing reliable data for research that may be ultimately used in patients. QA is also critical during the development and implementation of GLP and GCP programs.

Flow cytometry is being used more and more in preclinical and clinical studies. It is critical to work with QA experts to be confident that your quality management practices are satisfactory and that any work done with collaborators and contract research organizations also satisfies QA requirements.