QMS 065 Manufacturing Rework Procedure Sample
QMS 065 Manufacturing Rework Procedure Sample
QMS 065 Manufacturing Rework Procedure Sample
Related Documents
TEM-115 Protocol Rework- Manufactured Finished Goods
TEM-125 Protocol Rework- In Process Manufactured Goods
Form-515 Goods Return for Rework Form
Form-555 Example-Batch Documentation Checklist for Tablet Packing
Form-055 Material Transfer Order Form
Form-510 Product to be reworked
WAR-015 Warehouse Processing Issues, Return and Rejects
QMS-085 Example-Checklist for Batch Documentation
QMS-035 Deviation Report System
MAN-055 Procedures for Line Clearance, Line Opening and Line Cleaning
MAN-060 Reconciliation of Component and Product
QMS-110 Management and Control of Contract Work
EHS Statement
No safety, health or environmental hazards impact on the implementation of this SOP.
Table of Contents
1. Rework Procedure 2
2. Procedure for Reworking Product at Contract Manufacturer 4
3. Rework Protocols 4
4. Exception to Use of Rework Protocol 5
5. Flowchart – Rework Process Flow 6
6. Summery of Changes 7
Procedure
1. Rework Procedure
1.1. If a process deviation or quality concern is noted, a Deviation Report (DR) is to be raised
detailing the problem with the batch production clearly identifying the part of the batch that
has been affected. See SOP QMS-035.
1.2. Deviation Report could be generated for either In-process Manufactured Goods or
Manufactured finished goods kept in the warehouse waiting for distribution.
3. Rework Protocols
All Reworks must be carried out with an approved Protocol. A Rework cannot be started until
approved by QA.
The following templates are to be used:
• TEM-115 / TEM-125.
The Protocol must replicate the usual production process as closely as possible. Checks and tests
performed in the usual production process MUST be included in the Protocol. For example, if
check-weighing of packed cartons is part of the usual production process, then it must be included in
the Rework Protocol.
The Rework Protocol can be prepared by an Operations team member or a QA Staff. Usually the
Protocol generated as a response to DR.
The Protocol is to be checked and approved as follows prior to execution:
TEM-115 is to be used when a Finished Good is being repacked from one BPN to another
RBPN
The following information is to be provided in the request for Rework Protocol for
Manufactured Finished Good:
• Why the Rework is being done.
• The related DR number
• Initial BPN and Expiry
• Quantity (excluding original sample qty)
End of Procedure
No of Shipper No of Shipper
SECTION: 3
PRODUCT NAME: CODE:
MANUFACTURING INSTRUCTION:
All Phases Complete Checked (MI Sheet Time / Date Blistering Finished
Status must be completed and Signed off) Time / Date Packing Started
Expiry Date Checked Time / Date Packing Finished
Incomplete Entries Checked Carton % Yield Checked
PI Sheet Comments Checked Leaflets % Yield Checked
Manufacturing Date (C of A) / / Label % Yield Checked
Time / Date Blistering Started Tablet % Yield Checked
Retention Samples & Printed Materials Checked–
Product Code, Description, BPN, Expiry Date, Pack Size, Temperature
Shipper Label Checked –
Product Code, Description, BPN, Expiry Date, Pack Size, Temperature,