50-ic30-gen-017a mrb

Document NO.: 50-IC30-GEN-017A

Document Title : MRB

Vietnam Work Instruction

Approval List:Authorization Required

Quality Assurance Manager Materials Manager Inventory Control ManagerManufacturing ManagerTest ManagerPlanning ManagerManufacturing Engineering Manager

Revision History

REV UPDATED BY REV DATE REVISION SUMMARYA Frankily Lam Jun 28 2007 New release,

1.0 PURPOSE

The purpose of this work instruction is to define a process for efficient disposition and tracking of the non-conforming material that was rejected/generated during manufacturing process.

2.0 SCOPE

This work instruction shall apply to all direct material / semi products / finished products used in manufacturing process.

3.0 DEFINITION

3.1 IQA - Incoming Quality Assurance3.2 MRB - Material Review Board - a designated group of representatives (ME, TE, QE, IQA/VQE, Material & Business department) to evaluate and disposition the non-conforming materials.3.3 UAI - Use As Is3.4 RTV / RTC - Return To Vendor / Return To Customer

Document NO.:50-IC30-GEN-017A

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3.5 QA - Quality Assurance3.6 QE - Quality Engineering3.7 ME - Manufacturing Engineer3.8 TE - Test Engineer3.9 VQE - Vendor Quality Engineer3.10 EOL - End of Life3.11 SAP - Systems, Applications, Products

4.0 REFERENCE Not applicable.

5.0 RESPONSIBILITY

5.1 It shall be the responsibility of the managers listed in 3.1 to indoctrinate this work instruction and assure understanding in its entirety by all personnel in the Production MRB process.

5.2 It shall be the responsibility of all personnel to follow this work instruction when discrepant or non-conforming material detected in manufacturing process.

5.3 The workcell/line manager & Quality Engineer shall drive and co-ordinate the MRB meeting and provide proper disposition for the non-conforming materials with the support from all personnel in the workcell to eliminate scrap/RTV/RTC.

5.4 It shall be the responsibility of manufacturing/respective section to pre-screen, segregate and identify the non-conforming material with correct quantity specified.

5.5 It shall be the responsibility of ME/TE/QE to verify the non-conforming materials. The nonconforming product of Medical Device is accepted by concession only if regulatory requirements are met.

5.6 Based on the workcell decision, it shall be responsibility of the purchasing/buyer to transact and execute all materials with the vendor for RTV and Failure Analysis.

5.7 All scrap materials will be moved to scrap bay by MRB coordinator for disposal after completing the scrap transactions. Only pending disposition & RTV/RTC materials will be kept in MRB cage.

5.8 The MDR traveler will stay with the suspected material until the SAP transaction has been completed moving the material to an RTV or RTC location.

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5.9 If material is deemed RTV or RTC the yellow copy of the MDR traveler will be distributed to the buyer or BUC.

5.10 If material is deemed scrap only the MBR coordinator will keep the white copy, the yellow copy will not be kept.

6.0 PROCESS FLOW

6.1 Production MRB Process Overview Flow

6.1 Non-conforming Material Identification, Segregation and Verification Flow

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Para Responsibility Flow Interface

Raise MDR

Verification

Disposition

System Transaction

System Transaction

Shipping

6.1.1

Production Reject/Scrap

System Transaction

DispositionSystem

TransactionScrap Bay

System Transaction

Production/Stock

Vendor/Customer ScrapUAI

RTV/RTC/Pending

RTV/RTC

6.1.3 MRB coordinator <=SAP System Transaction

6.1.2 Workcell (Mfg, ME, TE&QE)




6.1.7 Shipping personnel <=SAP System Transaction

6.1.8 Stockroom personnel <=SAP System Transaction







6.1 Production MRB Disposition – Production, Process & Test Reject Flow

6.1 Production MRB Disposition - Salvage (Rework/Sort/UAI) Flow

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Para Responsibility Process Flow Interface

Identify non-conforming material – prescreened,

segregated by manufacturer, labeled, identified and

quantified for verification

6.2.1 Respective section Material Disposition Report Form

50-IC30-GEN-017-01

Verification Process on daily basis

6.2.2 ME/TE/QE

As and when necessary the Workcell / Line Manager to drive daily clearance

Disposition – production and test reject

Material Disposition Report Form

50-IC30-GEN-017-01

6.2.3 ME/TE/QE at the minimum

All production/test rejects not salvageable.

MDR – raised by the respective areas – Prod,

Process, Test

6.3.1 Respective section Material Disposition Report Form50-IC30-GEN-017-01

Update the MDR transaction and send the

physical scraps

6.3.2 MRB Coordinator

Store the scraps in the scrap bay

Material Disposition Report Form35-IC30-GEN-017-01SAP System

6.3.3 Shipping Personnel


Start

Stop

Start

Stop




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All production/test rejects salvageable must be pre-

identified.MDR – raised by the respective

areas – Prod, Process, Test

6.4.1 Respective section Material Disposition Report Form35-IC30-GEN-017-01

Update the MDR transaction and send the physical parts for

rework/Sort/UAI


Reuse the physical parts


6.4.3 Area of use coordinator

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Stop

Start

6.1 Production MRB Disposition - Profile Boards Flow

Document NO.:50-IC30-GEN-017A



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Sample boards used for setup and FA run must be identified.MDR – raised by the respective

areas – Prod, Process, Test

6.5.1 Respective Engineer Material Disposition Report Form35-IC30-GEN-017-01

Update the MDR comments column as “Profile Bds”. Acknowledge by IA and

signed

6.5.2 Workcell IA / Workcell Manager, (PROD / ME / TE/ QE)

Update the MDR Transaction in the system as scrap *


6.5.4 Area of use coordinator

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Start

Stop

6.5.3 MRB Coordinator Material Disposition Report Form35-IC30-GEN-017-01SAP System as “Profile Bds”

* - This scrap will not be treated as normal Production scrap and reclassified to Material NRE cost under BOM Cost By finance.

6.1 Incoming / Vendor Reject Flow

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Material disposition as vendor reject or pending Failure analysisMDR – raised by the respective areas and logged into MRB cage

Material Disposition Report Form35-IC30-GEN-017-01

Update the MDR Transaction in the system

6.6.1 Workcell IA / (PROD / ME /TE/ QE / Buyer

MDR data update and forward a copy to buyer for vendor

notification



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6.6.3 MRB Coordinator & Buyer

Start

Stop

6.1 Vendor Scrap Flow




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Material disposition as vendor scrap to be disposed in house

MDR – raised by the respective areas and

logged into MRB cage


To specify in the “others” column in the

MDR with vendor authorization document to remove material from

MRB

6.7.1 Workcell IA / PROD / ME / TE/ QE / Buyer



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6.7.2 Buyer

6.7.3 MRB Coordinator &

Start





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Stop

6.1 RTV / Pending Failure Analysis Flow

Material disposition as RTV / Pending Failure Analysis

MDR – raised by the respective areas and logged into MRB

cage


To transact with vendor for return and the SQE / IQA shall follow up & coordinate with vendor for Failure analysis

6.8.1 Workcell IA / PROD / ME / TE/ QE / Buyer



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6.8.2 Buyer


Start

Stop


7.0 ATTACHMENT

7.1 Appendix 1 - General Checklist

7.2 50-IC30-GEN-017-01? - Material Disposition Report

8.0 RECORD RETENTION

No Title Retention Distribution1 MDR 1 year(7 years for

Medical Device) by MRB coordinator

Purchasing (RTV)Buyer/Shipping

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50-ic30-gen-017a mrb

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