6.5 Definition of approval basis
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6.5 Definition of approval basis

Parent topic: 6 Documentation Requirements

6.5.1 Procedural intent

  6.5.1.1 As a consequence of reviewing the documentation supplied and based on the results from the preview of the documentation, the Administration is in a position to define the approval basis:

  • .1 if regulation challenges are negligible or their impact minor (subject to exemption by the Administration), the design can be approved by means of a conventional process; and

  • .2 if regulation challenges or the impact of challenge is significant, an approval process in accordance with this Guideline should be followed.

  6.5.1.2 The sequence takes place based on the outcome from the preview. First, it consists of an evaluation by the Administration of which elements or operational circumstances (if not all) of the project may be covered by the risk analysis to be compiled. Also, if any elements exist which may be approvable by means of simpler methods, this information is rendered to the Submitter. In principle, this step in the process requires the owner to have selected an Administration, as the design should be subject to the requirements given internationally, regionally and nationally.

  6.5.1.3 The Administration may detail appropriate or equivalent requirements and standards to serve as means of compliance, along with the requirements for the risk analysis. This evaluation eventually leads to a detailed description of the imposed requirements, the necessary process, and the selected means of compliance, which is submitted to the customer responsible for the documentation of compliance with the requirements imposed and implementing improvement measures where necessary or requested by the supervising body.

6.5.2 Documentation to be delivered

  6.5.2.1 The Administration supplies the following to the Submitter:

  • .1 Statement from the Administration on those operations which should be evaluated in depth through the risk assessment;

  • .2 Concise statement from the Administration on intended sets of regulations/standards and processes applicable to the project;

  • .3 The segments (if any) which may be subject to simple compliance with existing regulations; and

  • .4 Summary conditions of compliance and approval from the Administration.

  6.5.2.2 Queries by the Administration preceding preliminary approval:

  • .1 Are all operational phases considered, either by standard compliance verification or by evaluation through risk analysis?

  • .2 Are alternative industry standards, which may have been chosen, relevant and applicable?

  • .3 Have evaluation criteria been assigned?

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