quality assurance
Meaning of quality assurance: The point is to build a process that reliably produces good work, not to inspect finished work afterward and hope it passes.
Definition of quality assurance
Quality assurance is a planned, continuing system of checks designed to confirm that work meets a defined standard and to catch the conditions that produce errors before an error occurs. In healthcare and clinical research it means documented procedures applied at set intervals, rather than review that happens only when someone notices a problem.
How does it differ from quality control?
| Quality assurance | Quality control | |
|---|---|---|
| Aim | Prevent problems by designing and auditing the process | Detect problems in the output |
| Timing | Before and during the work | After a result exists |
| Focus | The system and the people running it | The specific product, sample or result |
| Example | Writing and auditing the procedure for handling specimens | Running a known control sample alongside a batch of tests |
The two are complementary, and neither substitutes for the other. Quality control catches a bad result; quality assurance is what stops the same fault recurring next week.
What does it involve in a clinical trial?
It confirms that a study is being run as written and as required: according to its own protocol, applicable regulations, and the international standard known as Good Clinical Practice. Typical activities include comparing entries in study records against the original medical notes, verifying that consent was obtained and documented before any study procedure took place, checking that the investigational product was stored at the right temperature and fully accounted for, confirming that adverse events were reported within required timeframes, and reviewing staff training and delegation records. An audit is conducted by the sponsor or an independent group; an inspection is conducted by a regulator. Findings are documented and corrective actions tracked until closed.
Where else does it apply?
Laboratories check instruments and reagents on a schedule and take part in external programs where many laboratories test the same unknown sample and compare results. Imaging departments monitor equipment performance and radiation output. Blood banks, pharmacies and operating theaters run their own systems, as do the registries that collect outcome data from a clinical trial network. What unites them is a defining feature: the checks happen on a timetable, whether or not anything appears to be wrong, because the purpose is to notice drift before it becomes damage.
Also known as
Used in a sentence
The clinical trial's quality assurance review confirmed that study procedures were being followed as written.
Good to know
Quality assurance focuses on preventing problems through ongoing checks of a process, which distinguishes it from quality control, the narrower activity of checking whether a specific output meets a standard after it has been produced.