Doc.
Code :
QUALITY SYSTEM PROCEDURE
Rev. No. :
PROCESS NAME REWORK Date :
PROCESS OWNER HEAD-QA & HEAD-MFG Page No. 01 of 04
PURPOSE To achieve the product quality as per the customer requirement after rework of NC product
SCOPE This procedure applicable for Reworkable Non conformance product
CLAUSE REF. ISO 13485:2016 :- 8.3.4
Turtle Diagram
Resources Responsibility
Rework Tools Head Operation
Skilled person Head QA
Quarantine area Head MFG
INPUTS OUTPUTS
Identification Tag, Job order ,Route card, NC register
Applicable regulatory requirements Rework Register
Re inspection report
Scrap note
PROCESS NAME :REWORK
Key Performance Indicators Document & Record Reference
Rework register
Re inspection report
Scrap note
Rework register
Re inspection report
Scrap note
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QUALITY SYSTEM PROCEDURE
Rev. No. :
PROCESS NAME REWORK Date :
PROCESS OWNER HEAD-QA & HEAD-MFG Page No. 02 of 04
# KEY INPUTS RESPONSIBILITY ACTIVITY FLOW OUTPUT
Incoming,Inprocess,final Collecting NC parts from process stage and Update NC
1 Head MFG &Head QA register , move the material to Quarantine Area NC Register / Quarantine Area
Inspection NC parts
NC Register / Quarantine Check the possibility for Rework
2 Head MFG &Head QA
Area
Decision / Action
No
3 Feasibility of Rework Head MFG &Head QA Feasible? Reject the Part
Yes
4 Move the material to rework area & Rework the parts as per
rework instructions
5 Fail
Result ? Reject the Part
Rework Work instruction / Rework Register / Re
Head MFG &Head QA
Skilled person Pass inspection report
100 % Reinspection of the reworked products and put
6 Identification Mark on component as per customer request (or)
Internal Purpose
( Not by the reworked operator )
7 Update the details on Rework Register
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QUALITY SYSTEM PROCEDURE
Rev. No. :
PROCESS NAME REWORK Date :
PROCESS OWNER HEAD-QA & HEAD-MFG Page No. 03 of 04
Key Performance Indicators
Parameters for effectiveness / efficiency UOM Source of input Monitoring frequency Responsibility
Document / Record reference
Category
[Link] Description Code Filing Method / Indexing Location Retention Period
(Document / Record)
1
9
Doc. Code :
QUALITY SYSTEM PROCEDURE
Rev. No. :
PROCESS NAME REWORK Date :
PROCESS OWNER HEAD-QA & HEAD-MFG Page No. 04 of 04
Revision History
Rev. No. Date Brief Description of Change Reason For Change
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Doc. Code :
QUALITY SYSTEM PROCEDURE
Rev. No. :
PROCESS NAME REWORK Date :
PROCESS OWNER HEAD-QA & HEAD-MFG Page No. 04 of 04
Prepared By: Reviewed By: Approved By: