D1: Team Members:
Establish a team of people with product/process knowledge.
D2: Problem Definition:
Specify the problem by identifying the who, what, where, when, why, how, and how many (5W,2H) for the problem.
D3: Interim Containment Plan:
Define and implement containment actions to isolate the problem, and prevent defective parts from escaping to customers. Document the total lot quantity produced, quantity scrapped, quantity reworked, quantity used-as-is, and quantity shipped with deviations.
D4: Root Cause Analysis:
Use the 5 Whys to identify why the problem occurred, and why the problem was not detected at the time it occurred. Classify the source of defects in two ways:
1. According to the 5Ms and an E (Man, Machine, Measurement, Materials, Methods, Environmental Conditions).
2. Mistake or Variation
D5: Permanent Corrective Action:
Answer the question: how can the root cause be eliminated or controlled? Describe the corrective action. Verify that the correction will actually solve the problem.
D6: Implement & Validate:
Implement the corrective actions, and validate that the fix works.
D7: Prevent Recurrence:
Modify the management systems, operation systems, practices, and procedures to prevent recurrence of this and all similar problems.
Here are some suggested checks:1. Have the Design and Manufacturing FMEAs been reviewed and updated?
2. Has the Quality Control Plan been reviewed and updated?
3. Has the impact to similar products and processes been reviewed? Have FMEAs and Quality Control Plans for similar products been updated?
4. Have work instructions and procedures been reviewed and updated?
5. Have gages, fixtures, and machinery settings been reviewed and updated?
D8: Congratulate Your Team:
Thank you for your effort!