QMS-065 Manufacturing Rework Procedure

Document Owner

Quality Assurance Manager

Affected Parties

All Quality Assurance Staffs and Operation’s Colleagues

Purpose

This SOP contains the steps to be followed when the Rework of an in-process or completed Finished Good is required.

This SOP covers the following Reworks:

a. In-Process Manufactured Goods Rework.  (Reworking of a complete or partial BPN)

b. Manufactured Finished Good Rework

c. Specific in-process procedures

Scope

Responsibility for the procedures set out in this SOP is as follows:

Scope of Rework

Definition

Related Documents

EHS Statement

No safety, health or environmental hazards impact on the implementation of this SOP.

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.

1.3.         Quality Assurance team must assess the Deviation Report and justify the defect category of manufactured goods. QA Manager will review the product defect type and either reject the batch or decide to rework of the full or part of the batch.

1.4.         In the case of a critical product defect only the QA Manager can give approval for the Rework.  Critical product defects include defects that could potentially affect product safety, purity and efficacy

1.5.         For rework of Manufactured Finished Goods (MFG) where batch number will be changed – Once approval for the Rework has been given the relevant Production team is to inform the Production Planner to raise a Reworked Batch Production Number (RBPN), which will segregate the reworked part of the batch from the original batch. For a complete rework there will be nothing left from the original batch. The numbering format of BPN and RBPN will be same but the number must be kept different. The original BPN and reworked RBPN should be released separately by QA for sale after a successful rework has done. The original Batch Production Number (BPN) and Reworked Batch Production Number (RBPN) must be documented in the protocol. Both the original BPN and reworked RBPN batch documents must be kept after rework, as both are GMP document.

1.6.         New Rework Batch Production Number (RBPN) does not need to be assigned for In-Process Manufactured Goods (IPMG).

1.7.         After a decision of the rework has been made, QA has to raise a rework protocol according to section 3 of this SOP before any activity can commence.

1.8.         When the protocol is ready and approved, hand it over to Area Manager where the rework will be carried out. QA Staff should ensure that protocol is agreed and understood, as it will be a part of batch document.

1.9.         Production operator receives the protocol along with all other relevant forms, Visual Displays and documents.

1.10.      Production operator contacts the Warehouse to determine the location of the manufactured product, which is already kept in the Finished Goods storage location in the warehouse. The storage type and the storage bin type of the manufactured goods can be found in the Goods Booking Slip for the BPN.

1.11.      Production operators print out a ‘Goods Returns For Rework Form’ (Form-515) and fill up the “Production To Fill Up” section of the form leaving the “Warehouse To Fill Up” section blank. The form should have the information as follows:

– Person requesting the goods return, name, sign and date.

– WIP or designated area of the process line where the rework will be carried out

– Product Code

– Product Description

– Batch Production Number (BPN)

– Expiry Date

– Quantity to be returned

– Number of shippers

– Number of pallets

– Destination Storage type

– Destination Storage bin

– Shipper labels involved

Production operator has to sign the form and send to warehouse to arrange transfer of goods.

1.12.      Warehouse operator receives the form and pick up the requested stock from the source storage bin. Warehouse operator has to fill up the warehouse section of the form before sending the goods to be reworked, including source storage type and storage bins, number of full shippers and partial shipper, Number of pallets.

1.13.      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.

1.14.      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).

1.15.      If additional components are required a request will be sent from production by issuing ‘Material Transfer Order Form’ (Form-055). See SOP WAR-015 for issuing of components.

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

1.17.      On completion of the Rework the Rework Protocol and samples are forwarded to the QA. The form ‘Batch Documentation Checklist Form-555 must be included with the Rework documents.  Page 1 of this form must be completed by Production.  See SOP QMS-085.

1.18.      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

1.19.      After rework and before the pallets are sent to the Warehouse, remove the signs and clean them using IPA.

2.            Procedure for Reworking Product at Contract Manufacturer

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

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:

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)

– Final RBPN and Expiry

– Initial quantity of BPN received.

– Final quantity of RBPN required.

– Additional materials (components) required for the Rework.

– The location in which the Rework is to be done.

– Procedure to be followed during the Rework.

– Criteria for inspection/rejection of goods.

3.2.         Protocol for In-Process Manufactured Goods – TEM-125

The following information is to be provided in the request for Rework Protocol for an In-Process Manufactured Finished Good:

– Why the Rework is being done.

– The related DR number

– Batch Production Number (BPN) and Expiry date

– Additional materials (components) required for the Rework.

– Initial quantity received (excluding original sample qty)

– Final quantity produced.

– The location in which the Rework is to be done.

– Procedure to be followed during the Rework.

– Criteria for inspection/rejection of goods.

3.3.         The Protocol must include:

– Normal Line Clearance procedures.

– Exact processing details including where Rework was conducted, when work was done and a record of all staff involved.

– All component Code numbers and quantities required.

– Reconciliation of product and all printed components.

3.4.         The Protocol follows the path of any batch document in Production.  It is kept with all other batch documents pertaining to the Rework Process Order.  Protocol is to be forwarded including the retention samples to QA for assessment.

4.            Exception to Use of Rework Protocol

4.1.         Where a controlled form has been created for a specific repeated procedure, this form may be used in place of a signed-off Protocol Rework form (TEM-115 or TEM-125).

4.2.         The procedure defined in this form is not to be changed without appropriate authorization.

4.3.         This form is to be signed-off at the completion of the Protocol.  All documentation relating to the Protocol MUST be included with the Batch Documents.

5.            Figure 1: Flowchart  – Rework Process Flow

Summary of Changes