Doc EQP-12-G001 QUALITY SYSTEM GUIDELINE 05 1 of 37 Title

QUALITY SYSTEM GUIDELINE

Doc EQP-12-G001 Rev 05 Page 1 of 37

Title Nonconforming Material Report Generation & Completion in SAP

This information is confidential to Abbott Medical Optics. The user is responsible for confirming the appropriate revision prior to use. MIL-05-T001 Rev. 02

TABLE OF CONTENTS

1.0 PURPOSE AND SCOPE .......................................................................................... 1 2.0 RESPONSIBILITY .................................................................................................... 1

2.1 Process Owner ............................................................................................... 1 2.2 Intended Audience ......................................................................................... 1

3.0 TERMINOLOGY ....................................................................................................... 2 4.0 CONTENT ................................................................................................................ 2

4.1 CREATING AN NCMR: .................................................................................. 2 4.2 UPDATING AN NCMR ................................................................................. 13 4.3 VERIFY NON-CONFORMING MATERIAL INVENTORY LOCATION ........ 14 4.4 MOVING NON-CONFORMING MATERIAL TO MRB © ............................. 16 4.5 ADDING AN S-BLOCK ................................................................................ 19 4.6 REMOVING AN S-BLOCK ........................................................................... 21 4.7 PRINTING AN NCMR .................................................................................. 22 4.8 ATTACHING DOCUMENTS TO NCMRS .................................................... 26 4.9 ADDING SCAR/CAPA REFERENCES ........................................................ 27 4.10 SELECT IMPACT LEVEL ............................................................................ 27 4.11 DISPOSITION NCMRS ................................................................................ 28 4.12 CLOSING ANNCMR .................................................................................... 31 4.13 RE-OPENING A CLOSED NCMR ............................................................... 31

5.0 REQUIRED PROCEDURES / FORMS .................................................................. 31 Governing Procedure.............................................................................................. 31 Guidelines/Job Aids/Forms ..................................................................................... 31

1.0 PURPOSE AND SCOPE

This guideline describes the process of initiating, completing and closing the Incoming Non-conforming Material Report (EQP-12-F002) and WIP Non-conforming Material Report (EQP-12-F018) © in SAP.

This guideline applies to all nonconforming material reports generated per EQP-12-S001, Nonconforming Material and Defect Tracking.

2.0 RESPONSIBILITY

2.1 Process Owner

Quality Assurance department is the controlling department responsible for interpreting and maintaining this document.

2.2 Intended Audience

Personnel involved in the Nonconforming Material and Defect Tracking process shall train to this document.





3.0 TERMINOLOGY

Refer to Abbott Quality System Glossary and Site Glossary for definitions of additional words within this document.

Acronym/Abbreviation Definition

NCMR Nonconforming Material Report SCAR Supplier Corrective Action Request CAPA Corrective Action/Preventive Action WIP Work In Progress RTS Return to Supplier MRB Material Review Board

4.0 CONTENT

4.1 CREATING AN NCMR: 4.1.1 To create a NCMR, log on to SAP and type IQS1 and press “Enter” This will get you to

the “Create Notification – Initial Screen”.

4.1.2 Enter IL as the Notification Type and press enter.

http://synaptica.web.abbott.com/pvs/headword_list_new.asp?stype=ab





4.1.2.1 For Incoming NCMR, click on NCR (Prod) tab. Enter PO# in the Reference no. field in the Reference Documents section. Press “ENTER”

4.1.2.2 For WIP NCMR, click on NCR (Prod) tab. Enter the work order# in the Prod. Order field in the Reference Documents section. Press “ENTER”

4.1.2.3 In the Plant for mat field enter 1520 for manufacturing, 1527 for Service Depot, 1540 for VisionKey Milpitas, or 2444 for VisionKey Ireland.

4.1.2.4 In the Material field enter the actual part number of the nonconforming part.

4.1.2.5 Select the actual revision number on the dropdown menu.





4.1.3 To find a supplier # by using a material (part) number:

4.1.3.1 Create a new session by clicking on the SYSTEM at the top of the page and select CREATE SESSION.





4.1.3.2 On the new session type MB51 and press ENTER

4.1.3.3 Enter the material number

4.1.3.4 Enter 1520 for Plant

4.1.3.5 Enter 101 for Movement type

4.1.3.6 Press the clock icon (Execute) on the upper left side of the screen









4.1.3.7 Copy the vendor number

4.1.3.8 Go back to the NCMR session

4.1.4 Enter the vendor number on the Vendor Mat No. field of the NCMR session.





4.1.5 Item details.

4.1.5.1 NCR: click on the icon in the field to select the appropriate status. Note: the status shall be A (Findings of Investigation) upon NCMR initiation





4.1.5.2 Text: describe the nonconformance click on “Create Text” box for non

conformance description. Ensure full description is entered such as non conforming specifications, Should Be specifications, reference documentation procedure steps, serial number of assembly where the material failed.

4.1.5.3 The text box should look like the screen shot below. Click on Exit arrow

when completed.





4.1.5.4 Cause code: click on the icon in the field to select the appropriate defect

code.

4.1.5.5 Press Choose (check mark) when selected.





4.1.6 Add Requirement failed in the “Cause text” section for example: Failed 0100-5558-L section 5.2. If additional space is required, click on the Display text icon next to it.

4.1.7 Item details section

4.1.7.1 Click on the TEXT box





4.1.7.2 No. of defects: enter the number of defects found

4.1.7.3 DefQTY (intern): enter the number of defect caused by AMO (internal) if in doubt whether it is an internal (AMO) or External (Supplier) defect enter the number in the internal field.

4.1.7.4 DefQTY(exter): enter the number of defect caused by supplier (external)

4.1.7.5 NoOfUnitToBeins: enter the serial number of the nonconforming material. Type N/A if there are no serial numbers.

4.1.7.6 Click Copy icon to exit Item Details.

4.1.8 For multiple items click on Create Item box and repeat 5.6.1.1 through 5.6.3.5.

4.1.9 To Confirm/Change Who Created the NCMR (Originator Name), Select Goto on the top menu and select Reported by





4.1.10 The screen below confirms the originator’s name. At this point, change the reported by name to the name of the NCMR creator. Click on the green check mark to confirm.

4.1.11 When all information for the NCMR is entered, click on the green flag near the top left of the screen. Then press the save icon. This places the NCMR in process and an NCMR number is assigned.

WARNING: Do not click on the checkered flag. Clicking the checkered flag icon will close the NCMR.

4.2 UPDATING AN NCMR

4.2.1 To update a NCMR type, IQS2 and enter the NCMR number in the Notification field. This will allow for any necessary changes to be made after initial creation of NCMR.





4.3 VERIFY NON-CONFORMING MATERIAL INVENTORY LOCATION 4.3.1 To verify the inventory movement from location to location per product

enter SAP t-code LS24

4.3.1.1 Enter Warehouse number: 159

4.3.1.2 Enter the Material (Part) Number: ###

4.3.1.3 Enter Plant: 1520

4.3.1.4 Enter the Storage location: 1529

4.3.1.5 Press Enter





4.3.1.6 Stock per Material will display.





4.4 MOVING NON-CONFORMING MATERIAL TO MRB © 4.4.1 Before moving material in SAP ensure to review the part number and quantity to be

moved. ©

4.4.2 Enter SAP t-code ZOTS to transact parts to 002 MRB location.

4.4.2.1 Enter Warehouse #: 159

4.4.2.2 Enter Storage Type: 002

4.4.2.3 Enter Plant: 1520

4.4.2.4 Enter Material (Part) Number : ####-####

4.4.2.5 Click to execute.





4.4.2.6 Check box for desired material to acquire quantity from original location.

4.4.2.7 Enter desired quantity to be moved.

4.4.2.8 Click to open “Create Transfer Orders from Stock List” window.

4.4.2.9 Enter the new Storage Type: 002

4.4.2.10 Enter new Storage Bin locations for material: MRB

4.4.2.11 Click to execute.





4.4.2.12 Verify the part number and quantity was transacted correctly in SAP. Enter

SAP T-Code LS24. © The image below shows the results of the transaction.

4.4.3 Repeat section 4.4.1 to move nonconforming part from 002 MRB to 930 MRB.

4.4.4 Before phycially moving material ensure to review the part number and quantity is still accurate. ©





4.4.5 Physically move nonconforming part to the corresponding MRB location per the SAP transaction. For example if part is transacted in SAP to 002 MRB, then physically move nonconforming part to 002 MRB location on the manufacturing floor with a completed EQP-12-F001, Tag, Nonconforming Material Reject. ©

4.5 ADDING AN S-BLOCK 4.5.1 After moving parts from 002 MRB to 930 MRB add an “S-block” on every part moving

to MRB. Use SAP t-code MB11 to add or remove “S-block”. Use movement type 344 to add “S-block” and movement type 343 to remove “S-block”.

4.5.2 Enter SAP t-code: MB11

4.5.3 Move Type: 344

4.5.4 Enter Part Number

4.5.5 Enter Quantity

4.5.6 If required, enter either the batch number, serial number, or lot number.





4.5.7 Click to save.

4.5.8 The image below shows the newly added S-block.





4.6 REMOVING AN S-BLOCK 4.6.1 Use SAP t-code MB11 to remove an S-block using movement type 343.

4.6.2 Enter Part Number and Quantity.

4.6.3 If required, enter either the batch number, serial number, or lot number





4.6.4 Click to save.

4.6.5 Enter LS24 to check if transaction was completed without creating a negative quantity.

4.7 PRINTING AN NCMR

4.7.1 To print a NCMR type IQS3 and enter the NCMR number in the Notification field

4.7.2 Press Enter





4.7.3 Select Notification on the top menu and click Print – Notification

4.7.4 Select Print Preview to view the NCMR





4.7.5 Review the NCMR for completeness. (See Incoming and WIP NCMR examples

below.)





4.7.6 Press ESC when complete

4.7.7 To print the NCMR. Select Notification on the top menu and click Print - Notification.

4.7.8 Type LOCL for Output Device and click the Print/Fax icon. The NCR will print to the default printer.

4.7.9 Click Print/Fax to print NCMR.





4.7.10 EMAILING NCMRS TO BUYERS

4.7.11 Click on magnifying glass icon.

4.7.12 Type “email” on the Recipient field and click on the check icon.

4.8 ATTACHING DOCUMENTS TO NCMRS 4.8.1 Click on the “Services for Objects” Icon

4.8.2 Click on the “Create” Icon





4.8.3 Select Create Attachments

4.8.4 Add Attachment

4.9 ADDING SCAR/CAPA REFERENCES 4.9.1 Select Description Icon

4.9.2 Enter Reference # into Text Field

4.9.3 When complete, go back to main NCR screen and save

4.10 SELECT IMPACT LEVEL 4.10.1 Click the Item Column in the Activities Box

4.10.2 Double click on the first item listed

4.10.3 Click the Code Group Box





4.10.4 Select the appropriate impact level and defect code

4.11 DISPOSITION NCMRS 4.11.1 Select Disposition Icon

4.11.2 Select the appropriate ILSE and then the appropriate Disposition

4.11.3 Click the green check mark.

4.11.4 Select NCR Icon





4.11.5 Select “D Final Disposition”

4.11.6 Click the green checkmark.

4.11.7 TRANSACT TO SCRAP ©

4.11.7.1 Enter SAP t-code MB11 to scrap material:

4.11.7.2 Enter NCMR # in the Doc. Header Text Field

4.11.7.3 Enter Movement Type: 551

4.11.7.4 Enter Plant Number: 1520

4.11.7.5 Enter Storage Location: 1529

4.11.7.6 Enter Reason for Movement: 0006





4.11.7.7 Enter Material Number: ####-####

4.11.7.8 Enter QTY:

4.11.7.9 Enter Batch Number/Serial Number/Lot Number if needed.

4.11.7.10 Click to save and execute.

4.11.7.11 Enter LS24 to check if the transaction is correct and did not create negative quantity.

4.11.8 TRANSACT TO REWORK ©

4.11.8.1 If NCMR disposition is Rework then move nonconforming material to 002 Rework for manufacturing or 917 QC for incoming with completed rework instruction form.

4.11.8.2 After rework is performed attach the rework instruction form to the NCMR in SAP.

4.11.9 TRANSACT TO RTS

Perform a ZOTS transaction and move the nonconforming part from 930 MRB to 930 MRB.OUT by following steps 4.3 to 4.5.1.12.

4.11.10 UAI or Accept Disposition:

4.11.10.1 Need DVP of quality’s approval.

4.11.11 VOID AN NCMR ©





4.11.11.1 If nonconforming material is reviewed and found to be conforming then void the NCMR.

4.11.11.2 If duplicated NCMR is created then void NCMR.

4.11.11.3 To void add “VOID” in the event description section and Comment section. Add the justification for VOID on the comment section.

4.12 CLOSING ANNCMR 4.12.1 Select the checkered flag icon:

4.12.2 NCMR is complete.

4.13 RE-OPENING A CLOSED NCMR 4.13.1 Navigate to IQS2

4.13.2 Enter the NCMR #

4.13.3 Select “Notification Functions In Process Again”

5.0 REQUIRED PROCEDURES / FORMS

Governing Procedure EQP-12-S001, Nonconforming Material and Defect Tracking Guidelines/Job Aids/Forms

EQP-12-F002, Incoming Non-Conforming Material Report, EQP-12-F018, WIP Non-Conforming Material Report

END OF DOCUMENT





ATTACHMENT 1: CATEGORY DEFECT CODES

Category Description Category Description A Damage/Cosmetic F Mechanical

B Debris/Contamination G Dimensional

C Documentation/Labeling H Packaging

D Electrical J Optical

E Functional/Test X Other

Sub-Category = Damage/Cosmetic

Sub-Category = Debris/Contamination

Sub-Category = Doc/Id/Labeling

Sub-Category = Electrical

Defect Description Defect Description Defect Description Defect Description A01 Bent B01 Debris C01 Documentation

Error D01 Bridge

A02 Broken B02 Embedded Material

C02 Documentation Missing

D02 Excessive Solder

A03 Bubble B03 Film Residue C03 Wrong Quantity

D03 Insufficient Solder

A04 Burrs, Sharp Edges

B04 Powder C04 Wrong Label/Id D04 Cold Solder

A05 Die/Tooling Mark

B05 Flash C05 Wrong Location - Label/ID

D05 Pin/Blow Holes

A06 Warp, Bowed, Twisted,

B06 Flaking C06 Missing Label/Id

D06 Solder Splash/Balls

A07 Finish, Plating

B07 Foreign Material

C07 Illegible Label/Id

D07 Solder-ability

A08 Kink, Dent B08 Discolored C08 Certification Incorrect

D08 Solder on Gold Fingers

A09 Molding Defect

B09 Flux Residue C09 Certification Missing

D09 Overhang/ Shifted

A10 Scratch/Cut/ Nick/Dig

B10 Oil C10 Test Results Incorrect

D10 Lifted

A11 Color Incorrect

B11 Grease C11 Test Results Missing

D11 Etch Cut

A12 Cloudy B12 Corrosion/ C12 Incorrect Rev/ D12 Exposed





Rust Serial #/Part # Copper

A13 Smear B13 Oxidation C13 Missing Rev/ Serial #/Part #

D13 Jumper Defects

A14 Blister B14 Smudge C14 Wrong Material D14 Lead Length

A15 De-lamination

B15 Dust C15 Mixed Material D15 Mis-wired

A16 Peeling B16 Fingerprints C16 Bag and Tag Error

D16 Open

A17 Cracked B17 Dirty C17 Printing Error D17 Short Circuit

A18 Crazed B18 Cleaning Residue

C18 Specification Error

D18 Etching/Trace Width

A19 Non-Filled /Short Shot

B99 Other Debris/ Contamination

C19 Shelf Life Expired

D19 Plating Deficiencies

A20 Voids C20 Shelf Life Close to Exp. Date

D20 Bare PCB Issue

A21 Chip C99 Other Doc/Id/ Labeling

D21 Lead No Contact

A99 Other Damage / Cosmetic

D22 Registration/ Breakout

Sub-Category = Functional /Test

Sub-Category = Mechanical

Sub-Category = Dimensional

Sub-Category = Packaging

Defect Description Defect Description Defect Description Defect Description

E01 Bandwidth F01 Damaged Hardware

G01 Oversized H01 Damaged

E02 Blown Fuse F02 Missing Hardware

G02 Undersized H02 Deteriorated

E03 Defective Component

F03 Material Defect

G03 Perpendicularity

H03 Wet, Mildew

E04 Frequency F04 Mis-Aligned G04 Flatness H04 Insufficient Protection

E05 Ground Fault F05 Fabrication Defect

G05 Straightness H05 No Identification

E06 Ground Resistance

F06 Thread Oversized

G06 Parallelism H99 Other Packaging





E07 HiPot F07 Thread Undersized

G07 Concentricity

E08 Leak F08 Missing Hole

G08 Depth/Deep

E09 Noisy F09 Extra Hole G09 Radius

E10 Over Limit F10 Hole not Threaded

G10 Runout

E11 Pressure F11 Poor Crimp G11 Position

E12 Failed Test F12 Missing Cover

G12 Diameter

E13 Software Error F13 Loose G13 Shallow

E14 Incorrect Assembly

F14 Missing Adhesive

G14 Skewed

E15 Sticking F15 Mis-Routed G15 Length

E16 Extra Component

F16 Missing Threads

G16 Width

E17 Wire Cut/Damaged

F17 Stripped Threads

G17 Thickness

E18 Wrong Component

F18 Hardness G99 Other Dimensional

E19 Missing Component

F99 Other Mechanical

E20 Wrong Orientation

E21 Intermittent

E99 Other Functional/ Test





Sub-Category = Optical Sub-Category = Other Defect Description Defect Description

J01 Distortion X01 Reject per Request

J02 Low Transmission

X99 Other

J03 High Transmission

J04 Excessive Loss

J05 Reflectivity

J06 Hysteresis

J07 Wedge

J08 Rough

J09 Bevel

J10 Shape P-V

J11 WFE P-V

J12 Crystal Axis Orientation

J13 Threshold, Damage

J14 Angle of Incidence

J15 Polarization

J16 Witness Sample

J17 Surface Quality

J99 Other Optical





ATTACHMENT 2: NCMR PROCESS FLOW - WIP





ATTACHMENT 3: NCMR PROCESS FLOW – REWORK

END OF ATTACHMENT(S)