The first step is identifying the occurrence or situation in which a non-conformity exists or potentially exists. Accurately identifying an NCE may take some practice and guidance from experienced laboratory professionals. However, laboratories should state in their policy exactly which types of occurrences demand definite action. When identifying an NCE, the reporting should include the source of the information. It is beneficial to examine this data for any trends that develop. For instance, 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 mean there is a systematic problem that was previously undetected. 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).
