1. defining the scope of the task steps that are not covered, per definition.2. the lack of a plan to review the documents and tracking performance, comply with the relevant requirements.
1. The scope of procedures that do not cover the requirements 2. Lack of a plan to review the documentation and monitoring of performance in accordance with the relevant requirements.
1. Determination of the scope of the operation procedure not covered on the requirements 2, . The lack of plan document review and tracking performance in accordance with the regulations related .