Identifying the occurrence or situation in which a non-conformity exists or potentially exists is the first step in the management of an NCE. Accurately identifying an NCE may take some practice and guidance from experienced laboratory professionals.
Each laboratory should state in the NCE policy which types of occurrences demand definite action. When identifying an NCE, the reporting should include the source of the information used in the identification process. It is also beneficial to examine the data for any trends that develop.
For example, are there increasing CAPA reports coming from corrected reports? This may indicate that the reporting/resulting process needs improvement. Or, are there multiple client complaints of the same nature? Perhaps this would indicate that there is a previously undetected systematic problem. Knowing the source of the information alone can prompt opportunities for improvement.
Identification of a non-conformity also helps determine what type of action to take (correction, corrective action, or preventive action).
