Objective Evidence Record (OER) - SAE
Objective Evidence Record (OER) - SAE
Objective Evidence Record (OER) - SAE
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11<br />
8 9 10 <strong>Objective</strong> <strong>Evidence</strong>/Comments<br />
Item # Quality Management System Requirements C NCR<br />
(e.g., observations, OFIs)<br />
7.3.5 Design and development verification (not applicable to 9120)<br />
204 Verifications performed in accordance with planned<br />
arrangements<br />
205 <strong>Record</strong>s of verifications and actions are maintained Verification record(s) ref.<br />
7.3.6 Design and development validation (not applicable to 9120)<br />
206 Validations performed in accordance with planned<br />
arrangements<br />
207 <strong>Record</strong>s of validations and actions are maintained Validation record(s) ref.:<br />
7.3.6.1 Design and development verification and validation testing (not applicable to 9120)<br />
208 Verification and validation tests are planned, controlled,<br />
reviewed, and documented to ensure and/or prove the<br />
following:<br />
209 a. test plans identify the tested product, resources<br />
used, define test objectives and conditions,<br />
parameters recorded, and acceptance criteria<br />
210 b. test procedures describe the method of operation,<br />
test performance, and record of the results<br />
211 c. correct configuration of the product for test<br />
212 d. requirements of the test plan/procedures followed<br />
213 e. acceptance criteria are met<br />
7.3.6.2 Design and development verification and validation documentation (not applicable to 9120)<br />
214 Reports, calculations, test results, etc. demonstrate<br />
product definition meets the specified requirements for<br />
all operational conditions<br />
7.3.7 Control of design and development changes (not applicable to 9120)<br />
215 D&D changes are identified and records maintained D&D change record(s) ref.:<br />
216 Changes are reviewed, verified, validated, and approved<br />
before implementation<br />
217 <strong>Record</strong>s of the change reviews and any actions are<br />
Change review record(s) ref.:<br />
maintained<br />
218 D&D changes are controlled in accordance with the<br />
configuration management process