The organization keeps and documents a list of its process controls, including devices for inspection, measurement, test and error-proofing, showing the primary control and, where any exist, the alternate or back-up methods that have been approved. A documented process governs how alternate control methods are used, including the internal approvals needed, set by risk analysis such as FMEA and by severity, before an alternate is used in production. Where required, the customer approves before product checked by the alternate method is shipped. The list of approved alternate methods cited in the control plan is kept up to date and reviewed from time to time. Standard work instructions exist for every alternate method. Use of alternate controls is reviewed at least every day to confirm standard work is followed, aiming to go back to the standard process set in the control plan as early as possible. Restart verification is documented over a period set by severity, confirming that the error-proofing device or process is once more fully effective. Everything produced while alternate controls are in use is traceable, for example by checking and keeping the first and last piece from each shift. As revised: SI 11 (April 2018): the list shows back-up or alternate methods only where they exist, so not every primary control needs an alternate.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.