What are acceptance criteria?

• A. The required number of samples in a batch.
• B. Specified limits that are placed on a measurement, quality control sample or process.
• C. The acceptable range of pH for a reagent.
• D. The minimum recovery percentage for a method.

Answer: (B)

Acceptance criteria are predefined, objective limits that determine whether a measurement, a quality control sample, or a process is acceptable. They establish the pass/fail standard before testing, guiding decisions and ensuring consistency and regulatory compliance. In practice, they specify what a result must meet—for example, a calibration measurement within a stated tolerance, a QC result within control limits, or a method performance such as recovery meeting a minimum percentage. They aren’t simply the total number of samples to test (that’s a sampling plan), nor do they describe just one property of a reagent; they are the overall limits used to judge acceptability. So the concept centers on the defined limits placed on measurements, samples, or processes that determine whether results are acceptable.