Examined periodically, at least once a year. Records shall be maintained thereof. 6.2.2 Competence, awareness and training: The manufacturer shall— (a) determine the necessary competence for personnel performing work affecting product quality, (b) provide training or take other actions to satisfy these needs, (c) evaluate the effectiveness of the actions taken, (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, (e) maintain appropriate records of education, training, skills and experience, and (f) establish documented procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.