The defined acceptance limits and rules used to determine whether an instrument meets its required specifications during calibration, resulting in a pass (in tolerance) or fail (out of tolerance) determination.
Pass/fail criteria establish the boundaries for declaring whether an instrument conforms to its specifications. These criteria typically consist of the tolerance limits for each measurement parameter and the decision rule that defines how measurement uncertainty is considered in the determination. The criteria must be clearly defined in the calibration procedure before calibration begins.
The simplest approach uses the manufacturer's specified tolerance as the pass/fail boundary, without accounting for measurement uncertainty (simple acceptance). More rigorous approaches incorporate decision rules that consider measurement uncertainty, such as guard-banding (narrowing acceptance limits to control false accept risk) or the approach specified in ANSI/NCSL Z540.3 (limiting the probability of false accept to 2% per tolerance limit).
For calibration management, pass/fail criteria must be documented, traceable to requirements, and consistently applied. The criteria may come from multiple sources: manufacturer specifications, industry standards, customer requirements, or engineering specifications. When multiple sources exist, the most stringent criteria typically apply. Calibration software should enforce the correct criteria for each instrument type and automatically flag results that fall outside the acceptance limits. Clear documentation of pass/fail criteria on calibration certificates provides transparency to the customer and supports audit compliance.
Pass/fail criteria are derived from manufacturer specifications, industry standards, or customer requirements. They define the tolerance limits and decision rules (including whether measurement uncertainty is accounted for) that determine conformity.
Yes. Modern standards (ISO 17025, ANSI/NCSL Z540.3) require that measurement uncertainty be considered when making conformity statements. This is implemented through decision rules, often using guard-banding to control false accept risk.
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