| Verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requires a new set-up;
Maintain documented information for set-up personnel;
Use statistical methods of verification, where applicable;
Perform first-off/last-off part validation, as applicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-off parts in subsequent runs;
Retain records of process and product approval following set-up and first-off/last-off part validations.
| Standardized work document requirements:
communicated to and understood by the employees who are responsible for performing the work;
presented in the language(s) understood by the personnel responsible to follow them;
accessible for use at the designated work area(s).
Also include rules for operator safety.
| review control plans, and update as required, for:
The organization determines it has shipped nonconforming product to the customer
When any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A)
After a customer complaint and implementation of the associated corrective action, when applicable
At a set frequency based on a risk analysis
| Items required in the control plan:
controls used for the manufacturing process control, including verification of job set-ups;
first-off/last-off part validation, as applicable;
methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the customer and the organization;
the customer-required information, if any;
specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically unstable or not statistically capable.