Every nonconforming product must be separated from conforming products at point of recognition during the manufacturing process. Nonconforming is understand to not meet specified properties and requirements. The procedure to deal with nonconforming products must be in writing and implemented.
The procedure for nonconforming products should include at least the identification, the necessary documentation of such products, the evaluation, separation from conforming products and disposition.
In addition, the evaluation of nonconforming products must include a written determination of the need of an investigation and notification of the responsibles.