TABLE 1.
Laboratory | Number of nonconformities at exit audit | Number of nonconformities at surveillance audit | Coverage of nonconformities in corrective action plan (%) | Number of recurring* nonconformities at surveillance audit** |
|
---|---|---|---|---|---|
n | % | ||||
Laboratory A | 100 | 31 | 69 | 20 | 65 |
Laboratory B | 23 | 19 | 17 | 12 | 63 |
Laboratory C | 87 | 52 | 40 | 38 | 73 |
Laboratory D | 60 | 53 | 12 | 30 | 56 |
Laboratory E | 88 | 36 | 59 | 24 | 66 |
Any nonconformity identified at both exit and surveillance audits in the same laboratory was classified as a recurring nonconformity.
Common nonconformities (N = 10) included lack of critical procedures, lack of or incomplete management review records, incomplete personnel files, lack of equipment or method validation, lack of equipment calibration records, deficient internal audit, inconsistent internal quality control monitoring, unacceptable proficiency testing results, ineffective corrective action and deficient quality indicator monitoring.