| Ensure that the planned arrangements to verify that the product & service requirements have been met, encompass the control plan, and are documented as specified in the control plan
Planned arrangements for initial release of products & services encompass product or service approval.
Ensure that product or service approval is accomplished after changes following initial release
| Work instruction for each alternate process control method
Review operation of alternate controls daily
Return to standard process ASAP
Methods may include daily audits, daily leadership meetings…
Restart verification is documented for a defined period
Traceability is required for all product – alternate process control
| Identify, document, & maintain a list of the process controls, including inspection, measuring, test, & error-proofing devices, that includes the primary process control & the approved back-up or alternate methods.
Document the process that manages the use of alternate control methods – including approvals to be obtained prior to use of alternate control method
Before shipping, obtain approval from customer
Maintain and periodically review the list of approved alternate process control methods (Referenced in control plan)
| Changes (including suppliers), should require a production trial run for verification to validate the impact of any changes on the mfg. process.
When required by the customer
Notify the customer of any planned product realization
Obtain documented approval, prior to the change;
Complete additional verification or identification requirements, such as production trial run and new product validation.