Qualification

The qualification process is generally carried out together with the customer. Depending on the respective customer requirements, the qualification depth carried out by Ortner can vary. 
In fact, three categories of qualification depth can be distinguished.


Qualification category 1

  • Ortner delivers documents for the DQ and carries out commissioning. A FAT or SAT will not be done.
  • The customer plans the entire qualification process and carries it out on its own responsibility. The scope and quality of the documents to be provided by Ortner shall be specified in the QPP.

Qualification category 1

Qualification category 2

  • Ortner delivers documents for the DQ, creates a FAT and/or SAT plan and performs the FAT, SAT and commissioning. The FAT is no longer required for simple systems or systems which are delivered in assemblies.
  • The customer plans the entire qualification process and carries it out under its own responsibility. The scope and quality of the documents to be delivered by Ortner are defined in the QPP.
Qualification category 2

Qualification category 3

  • Ortner creates the corresponding specification documents and carries out the qualification process until the end of the OQ on its own responsibility. The FAT and/or SAT can be omitted depending on the scope and delivery status of the system. This determination is made with the customer in the QPP.
  • The customer is responsible for the DQ. It includes the completed qualification directly into its system and if necessary, continues with the PQ. The documents are defined in the QPP.
Qualification category 3

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