Types of Nonconforming Work

During an audit, a failure to comply with any component of the relevant Standard(s) is recorded as nonconforming work or observations. There are a 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

The intermediate category of nonconforming work is allocated when a number of related minor failures are observed, which together are judged to be an unacceptable quality risk, without constituting an overall system failure in the areas concerned. 

The consequences of nonconformities are different for the different categories. Minor nonconformities will be noted and checked at the next assessment but will not normally appear in the written report. Major nonconformities can result in a total suspension of accreditation or suspension of accreditation for particular work. The intentional misuse of the accreditation body logo or mark is considered to be a serious nonconformity. If, after a previous warning, a laboratory continues to issue test reports showing the accreditation logo when the tests are outside the scope of the accreditation it can result in withdrawal of accreditation. Accreditation can be withdrawn for a particular area if it is found that accommodation is inappropriate and it is impossible to avoid cross contamination of samples. 

The nonconforming work that will require evidence of implementation of corrective and preventive action within a given timescale will include matters, such as, no corrective action taken when the results from a round of a Proficiency Testing scheme indicated the laboratory s result was an outlier, or the competency records of staff do not indicate they are competent to do the accredited work. Listings of nonconformities can be found in a publication produced by the International Laboratory Accreditation Cooperation (ILAC) [9]. 

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