6.11 Analysis and testing reports/additional documentation

  6.11.1.1 The Submitter has to consider: The submitted documentation has the scope of covering any remaining open questions of principal significance, such as previously untested methods, materials or applied processes.

  6.11.1.2 Reports of tests (as agreed in the preliminary approval phase) may be delivered at this stage, along with any other relevant documentation stated as necessary to gain full comprehension of the project.

  6.11.2.1 The Submitter delivers the following to the Administration:

• .1 test reports;

• .2 results of further analyses conducted as a consequence of the detailing of the design and the increased understanding of the design;

• .3 detailed drawings of the design, equally as a consequence of detailing;

• .4 tabulated values, achieved figures, measurements;

• .5 possible errors and uncertainties in the applied methods; and

• .6 additional drawings.

  6.11.2.2 Queries by the Administration preceding approval:

• .1 Has the criticality of any errors or uncertainties (with sensitivity analysis) been considered?

• .2 Have any novel processes, materials or methods been documented to an extent granting adequate reliability?

• .3 Does all documentation submitted live up to formal requirements (such as readability, comprehensiveness, language, documented audit trail)?

• .4 Are test methods of a nature which is trusted or sufficiently documented elsewhere to be relied upon?