Standard Interpretation
Standard: 2003 NELAC
Section: 5.4.9.1, 5.4.10.6 (b), 5.5.5.2.2.1 (d), 5.5.10.3.1 (a)
REQUEST:
ICVs have historically been treated as CCVs, in that high-biased failures and samples with no target compounds did not require reanalysis. It has been noted in a previous audit that this is not acceptable even though there would be qualifications on the final client report. Why would this practice not be acceptable?
TNI FINAL RESPONSE:
(Quality Systems Expert Committee and NELAP AC, 4-7-14)
If the Initial Calibration Verification (ICV) does not pass the established acceptance criteria for the calibration technique used, the calibration curve is not valid and corrective actions must be documented and samples reanalyzed. An ICV is not is not the same as a Continued Calibration Verification (CCV), and should not be evaluated against the CCV acceptance criteria.