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Manufacturing Rework Procedure: Form-510)

The document outlines the procedures for reworking goods at a manufacturing facility or contract manufacturer. It details the steps of transferring goods to the rework area, checking product codes and labeling pallets, requesting additional components if needed, following the approved rework protocol, forwarding documentation to QA, and cleaning and removing labels before returning pallets to the warehouse. It specifies that all rework must be approved by QA and done according to approved templates and SOPs.

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5K views2 pages

Manufacturing Rework Procedure: Form-510)

The document outlines the procedures for reworking goods at a manufacturing facility or contract manufacturer. It details the steps of transferring goods to the rework area, checking product codes and labeling pallets, requesting additional components if needed, following the approved rework protocol, forwarding documentation to QA, and cleaning and removing labels before returning pallets to the warehouse. It specifies that all rework must be approved by QA and done according to approved templates and SOPs.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • Manufacturing Rework Procedure
  • Procedure for Reworking Product at Contract Manufacturer

Manufacturing Rework Procedure

1. Goods will be transferred to process area (WIP/PS1/PS2/IP) as requested in the form. One

copy of ‘Goods Return For Rework form’ will be kept in the warehouse. The original will be

sent with the goods. Finished goods are to be transferred in the way separated from the

other Raw materials and Components.

2. When the goods are transferred production operator should check the pallet for correct

product code and batch number. Label the pallets with ‘Product to be Reworked Form’

(Form-510).

3. If additional components are required a request will be sent from production by issuing

‘Material Transfer Order Form’ (Form-1). See SOP WAR-015 for issuing of components.

4. The Rework proceeds. The Rework Protocol must be followed and signed off.

5. On completion of the Rework the Rework Protocol and samples are forwarded to the QA.

The form ‘Batch Documentation Checklist Form-2 must be included with the Rework

documents. Page 1 of this form must be completed by Production. See SOP QMS-085.

6. All activities, relating to the Rework MUST be documented. All documentation, relating to

the Rework MUST be included with the batch documents. Information can be included in the

DR or in the specific Rework Protocol

7. After rework and before the pallets are sent to the Warehouse, remove the signs and clean

them using IPA.


Procedure for Reworking Product at Contract Manufacturer

The procedure for Reworking product at a contract manufacturer is covered in SOP QMS-110.

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:

Prepared by: QA Team member or Operations Team member

Checked by: Production Manager (or delegate)

Approved by: Quality Assurance Manager (or delegate)

3.1. Protocol for Manufactured Finished Goods Rework, TEM- 115.

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)

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