Field Book · Chapter 7 of 8 · PFMEA, control plan, instruction, audit

Lock It In

Four records have to change together after a repeat defect: the PFMEA, the control plan, the work instruction and the layered process audit. Then check they all agree.

Update four records so they say the same thing: the PFMEA row (cause, ratings and new controls), the control plan row with a reaction plan written as steps, the work instruction with a new revision, and one yes or no question on the layered process audit. Then check all four agree on the characteristic, the gage, the interval and the limit.

Thursday, week 17, the quality office. The pin gage is on the die and the fixture gage is at the press. Neither is in a controlled record yet. If it stays that way, the fix lives in a few people's memory, which is where the last one lived.

Four records change, and they must end up saying the same thing.

The PFMEA

Find the row for hole spacing. In this case it was there. The failure mode was right, but the cause read "operator misload" and the only control was the first piece check. Change the cause to pilot wear. Raise the occurrence rating, because the die has no wear control until today. Add the pin check as a prevention control and the fixture gage as a detection control. Then rate it again with the new controls. If the failure mode was not on the PFMEA at all, that is the bigger finding: say so in the report. Book 1 covers the step in Fix the Risk.

The control plan

The spacing row currently says first piece, one piece per run, plug gage. Change it to fixture gage, first piece, every 600 pieces and the last piece. The reaction plan matters most. Write it as steps: stop the press, sort back to the last good reading, never more than 600 pieces, and tell the supervisor. "Notify supervisor" alone is not a reaction plan. The free control plan blank has a column for it. See Lock It In in Book 1 for the full method.

The work instruction

The die setup instruction gets a new step before release: pilot pin check, sign the setup sheet. Name the pin gage and write the limit on the step. Issue the new revision and pull the old one from the press the same day. See Change the Work.

The layered process audit

Add one yes or no question: is the pilot pin check signed on the current setup sheet for the die running on this press? That keeps the fix under review after the people who built it move on. See Check the Floor.

Then check all four agree on the characteristic, the gage, the 600 piece interval and the limit. Where one differs, someone will follow the wrong one.

Read more: how to write a PFMEA, how to write a control plan, how to write a work instruction and how to run a layered process audit.

The mistake to avoid

Updating the work instruction and leaving the PFMEA alone. The next person to open it starts from the old cause.

ON THE FLOOR MONDAY
  • Find one closed repeat on your PFMEA.
  • Check the control plan and instruction agree.
  • Add one audit question for it this week.

Open the printable Monday Board

Want every tool on this trail in one purchase? The Repeat Defect Trail Bundle has all 12.

The part, the die, the lots and every number in this book (sensor bracket BK-6139) are a made-up example. The tool sidebars show ShopFloorOps tools, which I make and sell. Every chapter teaches the step itself, so you can use your own forms. New to a term? See the quality glossary.