Why does it occur?
Investigate the design, materials, tooling, process conditions and assembly that can create the failure.
The same defect. Another batch.
Get to the cause of defects that keep coming back.
Discuss a quality problemWhy does the defect occur?
Why do existing controls miss it?
What evidence will show the fix works?
You have repeated defects, rejected batches or unstable supplier quality. You need to protect current production and make a change that prevents the problem from recurring.
Distinguish between the cause of the defect and the reason existing controls missed it. Replacing a batch may contain the immediate problem without fixing either.
Investigate the design, materials, tooling, process conditions and assembly that can create the failure.
Investigate the controls and measurement that should detect or prevent the nonconformity.
Protect current production while investigating the cause. Then verify the change in later production. Replacing a batch alone won’t prevent a repeat.
Agree the defect definition, measurement method and affected scope. Establish temporary controls and clear decisions for suspect stock.
Review samples, process settings, revisions and previous actions. Test why the defect occurs and why it gets through the existing controls.
Link the changes to the supported causes. Assign owners and dates, then verify changes to design, tooling, instructions, measurement or process control.
Review results against agreed criteria over an appropriate follow-up period. If the problem returns, revisit the cause rather than repeating the same temporary fix.