DR Number:
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DRX-YYYY
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Priority
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Author
(Reported by)
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Date
Reported
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Area/Team
Responsible
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DR Type: (fill in applicable information)
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DR5 Customer Complaint Deviation
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Customer No.:
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Delivery Doc. No.:
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Sales Order No.:
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Customer Material No.:
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Sold to Party No:
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DR8 Material
Complaint Deviation
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Vendor No. or
Vendor Name:
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Purchasing Doc.
Number:
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Material Doc. No.:
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Vendors Material No.:
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DR1 Process / Procedural Deviation
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Product code:
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Equipment No.
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MI Sheet No.:
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Batch (BPN):
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DR4 Audit
Deviation
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Audit Ref. No.
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Audit Type
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DR2 EHS Deviation
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Deviation Title
|
|||||
Description (Must be filled
in for all deviation types)
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File Location:
Date Printed: Page 1 of 3
Management Response Tasks
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1. Area Manager Response
Tasks
(Describe the facts, corrective actions taken. If a preventative action is necessary list in the Follow
up tasks. Sent the report
to Second
management response tasks)
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Name:
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Sign:
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Date:
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2. Second Management Response Tasks
(Review area manger¶s response and justify
efficacy of corrective actions taken. If a preventative action is necessary list in the Follow up
tasks. Sent the report to QA management response tasks)
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File Location:
Date Printed: Page 2 of 3
3. QA Management Response Tasks
QA Manager to evaluate the deviation and assess the potential impact to the product quality, validation and regulatory requirement.
Asses efficacy of the actions
taken. Approve the DR)
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Name:
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Sign:
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Date:
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Follow up Tasks
|
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Task 1:
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Assigned To
|
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Planned finished date
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Confirm Task 1 completed:
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Sign:
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Date:
|
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Task 2:
|
||||
Assigned To
|
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Planned finished date
|
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Confirm Task 2 completed:
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Sign:
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Date:
|
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QA manager Approval Task
|
||||
Confirm follow up tasks
completed:
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Sign:
|
Date:
|
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List all follow up tasks in the QA Metrics
Sheet. Place the completed report into completed
DR file.
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