Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd
Upload
102 views

Rework Procedure

1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

Uploaded by

Tushar Wagh
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
102 views

Rework Procedure

1) The rework process flowchart outlines the steps taken when a process deviation or quality concern is raised, including raising a deviation report, determining if rework is required with QA assessment, and approval from QA or QAM depending on the criticality of the defect. 2) For in-process or finished goods, a rework protocol is raised by QA and approved, then the rework is performed and the completed protocol is documented with the batch. 3) For finished goods, production requests the return of goods from the warehouse using a form, then the rework is done and documented.

Uploaded by

Tushar Wagh
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

QMS-065 Manufacturing Rework Procedure

Flowchart – Rework Process Flow

Process deviation or quality


concern raised

DR raised

Rework required?
QA to assess

QA approve for rework to go Critical product defect? Only QAM approve for
ahead rework to go ahead

Production planner is to
schedule a rework

In-Process Manufactured Manufactured Finished


Goods (IPMG) Goods (MFG)

Planner to create rework


QA to raise a rework
RBPN
protocol, TEM-125

QA to raise a rework
Protocol approved and protocol, TEM-115
signed off

Protocol approved and


signed off
Rework done

Production to request goods


Completed Rework Protocol to transfer from warehouse.
included in the batch Use ‘Goods Return for
documents Rework Form’

Warehouse picks and send


goods/material as requested

Rework done. Retention


sample kept.

Completed Rework Protocol


included in the batch
documents

You might also like