Design and development validation in AS9100 standard
Design and development validation in AS9100 standard
Clause 7.3.6
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.
Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
In some cases the product cannot be fully validated. An example is where safety critical software cannot be validated under actual circumstances without risking serious consequences or perhaps the circumstances are rare and difficult to create. Due to the inability to validate some software products exhaustively and conclusively, the organization shall demonstrate alternative methods of validation such as operational simulation, or safety/hazard analysis.
The type and extent of methods used shall be commensurate with the risk and consequences of design and development failures.
NOTES:
- Design and/or development validation follows successful design and/or development verification.
- Validation is normally performed under defined operating conditions.
- Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion.
- Multiple validations may be performed if there are different intended uses.
7.3.6.1 Documentation of Design and/or Development Verification and Validation
At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.
7.3.6.2 Design and/or Development Verification and Validation Testing:
Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following:
a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria;
b) test procedures describe the method of operation, the performance of the test, and the recording of the results;
c) the correct configuration standard of the product is submitted for the test;
d) the requirements of the test plan and the test procedures are observed;
e) the acceptance criteria are met.
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