Document NO.

: 50-IC30-GEN-017A

Document Title : MRB

Vietnam Work Instruction Approval List: Authorization Required Quality Assurance Manager Materials Manager Inventory Control Manager Manufacturing Manager Test Manager Planning Manager Manufacturing Engineering Manager

Revision History

REV
A 1.0

UPDATED BY
Frankily Lam

REV DATE
Jun 28 2007

REVISION SUMMARY
New release,

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 Assurance 3.2 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 Is 3.4 RTV / RTC Return To Vendor / Return To Customer
Document NO.:50-IC30-GEN-017A

Page 1 of 15

3.5 3.6 3.7 3.8 3.9 3.10 3.11 4.0 5.0

QA QE ME TE VQE EOL SAP

Quality Assurance Quality Engineering Manufacturing Engineer Test Engineer Vendor Quality Engineer End of Life Systems, Applications, Products

REFERENCE Not applicable. 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 5.3 It shall be the responsibility of all personnel to follow this work instruction when discrepant or non-conforming material detected in manufacturing process. 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. It shall be the responsibility of manufacturing/respective section to pre-screen, segregate and identify the non-conforming material with correct quantity specified. 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. 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. 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. 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.
Document NO.: 50-IC30-GEN-017A

5.4 5.5

5.6

5.7

5.8

Document Title : MRB

Vietnam Work Instruction Page 2 of 15

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 6.1
Para
6.1.1

PROCESS FLOW Production MRB Process Overview Flow

Responsibility Flow
Raise MDR Verification Production Reject/Scrap

Interface

6.1.2 Workcell (Mfg, ME, TE&QE)

6.1.3 MRB coordinator 6.1.4 MRB coordinator

RTV/RTC/Pending System Transaction

Disposition System Transaction

<=SAP System Transaction <=SAP System Transaction

6.1.5 MRB coordinator RTV/RTC

Disposition UAI

System Transaction Vendor/Customer Scrap System Transaction

Scrap Bay

<=SAP System Transaction

6.1.6 MRB coordinator

System Transaction

<=SAP System Transaction

6.1.7 Shipping personnel

Shipping

<=SAP System Transaction

6.1.8 Stockroom personnel

Production/Stock

<=SAP System Transaction

6.1

Non-conforming Material Identification, Segregation and Verification Flow

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

Document Title : MRB

Vietnam Work Instruction Page 3 of 15

Para

Responsibility

Process Flow

Interface

Start
6.2.1 Respective section Identify non-conforming material prescreened, segregated by manufacturer, labeled, identified and quantified for verification Material Disposition Report Form

50-IC30-GEN-017-01

6.2.2

ME/TE/QE

As and when necessary the Workcell / Line Manager to drive daily clearance
6.2.3 ME/TE/QE at the minimum

Verification Process on daily basis

Material Disposition Report Form

50-IC30-GEN-017-01

Disposition production and test reject

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

Stop

Document Title : MRB

Vietnam Work Instruction 6.1 Production MRB Disposition Production, Process & Test Reject Flow
Para Responsibility Process Flow Interface

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

Respective section All production/test rejects not salvageable. MDR raised by the respective areas Prod, Process, Test

6.3.1

Material Disposition Report Form 50-IC30-GEN-017-01

6.3.2

MRB Coordinator

Update the MDR transaction and send the physical scraps

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

6.3.3

Shipping Personnel

Store the scraps in the scrap bay

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

Document Title : MRB

Vietnam Work Instruction

Page 5 of 15

Para

Responsibility

Process Flow

Interface

Start
All production/test rejects salvageable must be preidentified. MDR raised by the respective areas Prod, Process, Test 6.4.1 Respective section Material Disposition Report Form 35-IC30-GEN-017-01

Stop
Update the MDR transaction and send the physical parts for rework/Sort/UAI 6.4.2 MRB Coordinator

Reuse the physical parts

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

6.4.3

Area of use coordinator

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6.1

Production MRB Disposition - Profile Boards Flow

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

Document Title : MRB

Vietnam Work Instruction

Para Responsibility Process Flow Interface

Start
Sample boards used for setup 6.5.1 and FA run must be identified. MDR raised by the respective areas Prod, Process, Test Respective Engineer Material Disposition Report Form 35-IC30-GEN-017-01

Stop
Update the MDR comments column as Profile Bds. Acknowledge by IA and signed 6.5.2 Workcell IA / Workcell Manager, (PROD / ME / TE/ QE)

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Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

Update the MDR Transaction in the system as scrap *

6.5.4

Area of use coordinator

6.5.3

MRB Coordinator

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System as Profile Bds

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* - 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

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

Document Title : MRB

Vietnam Work Instruction

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Para

Responsibility

Process Flow

Interface

Start
Material disposition as vendor Material Disposition Report Form reject or pending Failure analysis 35-IC30-GEN-017-01 MDR raised by the respective areas and logged into MRB cage 6.6.2 MRB Coordinator Update the MDR Transaction in the system

6.6.3

MRB Coordinator & Buyer

6.6.1

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

Stop

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

MDR data update and forward a copy to buyer for vendor notification

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

6.1

Vendor Scrap Flow Page 10 of 15

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

Document Title : MRB

Vietnam Work Instruction

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Para

Responsibility

Process Flow

Interface

Start

Material disposition as vendor scrap to be disposed in house MDR raised by the respective areas and logged into MRB cage

Material Disposition Report Form 35-IC30-GEN-017-01

6.7.2

Buyer

To specify in the others column in the MDR with vendor authorization document to remove material from MRB

6.7.3

MRB Coordinator & Buyer

6.7.1

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

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

Update the MDR Transaction in the system

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Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

Stop

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

Document Title : MRB

Vietnam Work Instruction Page 13 of 15

6.1

RTV / Pending Failure Analysis Flow

Para Responsibility Process Flow Interface

Start

Material disposition as RTV / Material Disposition Report Form Pending Failure Analysis MDR raised by the respective 35-IC30-GEN-017-01 areas and logged into MRB cage

6.8.2

Buyer

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

6.8.3

MRB Coordinator

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

Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

Update the MDR Transaction in the system

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Material Disposition Report Form 35-IC30-GEN-017-01 SAP System

7.0

ATTACHMENT 7.1 7.2 Appendix 1 General Checklist Material Disposition Report

50-IC30-GEN-017-01? -

8.0

RECORD RETENTION No 1 Title MDR Retention 1 year(7 years for Medical Device) by MRB coordinator Distribution Purchasing (RTV) Buyer/Shipping

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