Deviation Report Form




Deviation Report Form



DR Number:
DRX-YYYY
Priority


Author
(Reported by)

Date
Reported

Area/Team
Responsible

DR Type: (fill in applicable information)
DR5 Customer Complaint Deviation
Customer No.:

Delivery Doc. No.:

Sales Order No.:

Customer Material No.:

Sold to Party No:



DR8 Material Complaint Deviation
Vendor No. or
Vendor Name:

Purchasing Doc.
Number:

Material Doc. No.:

Vendors Material No.:

DR1 Process / Procedural Deviation
Product code:

Equipment No.

MI Sheet No.:

Batch (BPN):

DR4 Audit Deviation
Audit Ref. No.

Audit Type

DR2 EHS Deviation


Deviation Title
Description  (Must be filled in for all deviation types)




File Location:                                                                                            Date Printed:                                           Page 1 of 3


Management Response Tasks
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)
Name:
Sign:
Date:
2. Second Management Response Tasks
(Review area mangers 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)




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)
Name:
Sign:
Date:
Follow up Tasks
Task 1:
Assigned To

Planned finished date

Confirm Task 1 completed:
Sign:
Date:
Task 2:
Assigned To

Planned finished date

Confirm Task 2 completed:
Sign:
Date:
QA manager Approval Task
Confirm follow up tasks completed:
Sign:
Date:
List all follow up tasks in the QA Metrics Sheet. Place the completed report into completed DR file.


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