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Structure documents
Non-conformity
Location (internal,
external)
• Identify effected
Step1 area
Lot, batch, group

Documented
information • Containment Segregation
Step • Prevent it from
leak or mix with Return back
2 conformed output
• Inform customer Suspension
When output is
non-conform
Special Accept
Step • Actions
• Decide for
3 disposition Corrected
Who
Use-as-it-is authorized?
Step • Corrective Action
4 (if necessary)

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