QMS-065_Manufacturing_Rework_Procedure_sample (1) -...

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Standard Operating Procedure Title: Manufacturing Rework Procedure ______________________________________________________________________________________ Copyright© . All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 2 of 12 DR Deviation Report BPN Batch Production Number RBPN Reworked Batch Production Number WIP Work in Progress Area PS1 Production Staging Area 1 PS2 Production Staging Area 2 IP Interim Production Staging Area 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.
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Standard Operating Procedure
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