8d Analysis Report

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Customer Complaint Report C & C No. :

Production / Lab / Losistics / Others

Product :

Open date :

1. Complaints Company Sales Application Complaints Lot #

Last updated :

4. Problem statement - D2 What’s the defect on?( pellet, description of part, etc.) Where is the defect ?( on the part and/or in the process ) When was it observed? How serious? ( size of defect, # defective part, % scrap cost impact, etc. ) How many? (bags/bins/lots)

. Emergency Response Actions - D0 ex) Material send back. Emergency material exchange to avoid shut down.

. Team ( Name, Dept, Phone# ) - D1

6. Possible causes - D4

5. Interim containment action - D3 * Short term plan to minimize immediate impact of issue on the customer with clearly defined actions and timings until permanent corrective action has been implemented. Ex) extra sampling, special process conditions, tighten specification.

7. Corrective actions - D5

How did the problem occur ? Summary of analytical tests/statistical experiments done. Why didn’t we defect the issue before we sent material to the customer ?

Verification How was the root causes verified?( Specific detail )

8, Implement and Validation - D6 Proactive communication and training plans formally presented to functional owner of change. Quality manuals & ISO documents must be modified.

10. Team & Individual recognition - D8

9. Prevent recurrence - D7 Re-evaluate inventory status of lot ( on hold ? ) Identify action plan to ensure that corrective action will be permanent ( quality audits ) Quality manual/ISO documents/FMEA/Control plan modified with any procedural changes.

Complaint Close

When was the resolution first communicated to the field? Was any further information sent at a later date? When was the resolution accepted by the customer?

Reported by QACL -F-019 )

Plant Manager

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