In 5.3, there are conditions that require a new or partial FAI when a change occurs “that can potentially affect fit, form or function”. How is this assessed?
B8. Response: The only people able to evaluate these changes for “fit, form or function” are those knowing the product, the processes, the environment and knowing which problems occurred in the past (lessons learned). These people belong to the producer (“the organization” in 9100). You may also be influenced by your customer. Standards provide requirements but cannot provide methods for meeting the requirements. C.
