Document Title - Doc No.
:
Revision No. :
Process for Rework & Repair confirmation Effective Date :
Doc Owner - Production
Starting point: Determine the rework & repair to be done
End point : Make the record of rework & repair included with quantity, disposition, disposition date & applicable traceability information
Scope: Covers rework & repair of any products in the organization ( clause no. 8.7.1.4 & 8.7.1.5 )
Overall Responsibility : Overall responsibility of this procedure lies with production department. Cross functional team is responsible for risk assessment of rework & repair activity. QA department is responsible for confirmation as well as
taking customer appproval of reworked product if required by customer.
A. Input / Output Table:
Reason for Existence / Purpose Trigger Inputs From Outputs To
The purpose of this procedure is to ensure confirmation of the product as per specification after Nonconforming Nonconforming Production Confirmation of QA
rework & repair product product need to Reworked or Repaired
rework or repair product
B. Process Map:
Symbols used: Activity - Decision - Travel - Hold / Delay -
Sr. No Activity Responsibility Mfg QA CFT Control Point Reference
1 Determine the rework & repair to be done Production Supervisor As per plan
2 Conduct risk analysis to assess the risk in the process of Cross Function Team Before Rework DFMEA (UTPL/D&D FR/12)
rework / repair. PFMEA (UTPL/DOC/QA/012)
3 Obtain customer approval if required QA Engineer Before Rework
Work Instruction for rework & repair
4 Carry our rework & repair of the product Production Supervisor As per plan (SOP-09) included with re-inspection &
traceability requirement
Control Plan
5 Confirm the product with respect to specification QA Engineer After rework (UTPL/DOC/QA/012)
Make the record of rework & repair included with Rework & Repair Record
6 quantity, disposition, disposition date & applicable Production Supervisor After rework (UTPL/F/QA/008)
traceability information
ADEQUACY CHECKED BY CFT Hard Copies in PU/Dept. other than Q. System Cell are uncontrolled copies.
Prepared by - Production Manager Prints taken are only for reference and must be confirmed by users for their validity
against the soft copies in common folder.
Released by - Production Manager
Revision History
Rev. Date Summary of change Authorized by
