Had enough yet? One more instalment. Here is the standard. 7.3.6 Design and development validation; Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation is completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions are maintained. 7.3.7 Control of design and development changes; Design and development changes are identified and records maintained. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions are maintained.
Yep, my head still hurts. These two parts are very prescriptive. Do you really need me to spell it out any further? Validity is by definition is proof design works. Get it tested, seek peer evaluation, trial, etc. Get the results, check the results, compare results to the previous five elements. Is it OK? If not, record what isn’t and fix it. Redo all previous steps. All good? Proceed.
The last is just making sure that if you change anything, record it. Record it on the design documentation, in test results, in meeting minutes, etc. And when you change it, do the previous six steps again, review it again, change it again and record it again. Happy designing.
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