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This document is electronically controlled. Printed copies are considered uncontrolled.

Medtronic Confidential

Procedure and Work Instruction Template MPR_DOC_TMP_008418, Revision 3

Father / Parent Document: MPR_DOC_WI_008987

Document Number MPR_PPC_WI_009075

Revision 7 Change Order #

CO10059679

Work Instructions Nonconforming Components Review Process

Quality System Element

Production and Process Control

Scope Instructions on this procedure apply to all MPROC personnel handling and managing nonconforming or potentially nonconforming components.

Purpose The purpose of these work instructions is to establish a standard process for the handling of nonconforming and/or potentially nonconforming components across MPROC facilities.

This procedure establishes the process to follow for the identification, segregation, containment, evaluation, documentation, disposition and trending of non-conforming components send for review due to a nonconformance or potential nonconformance found at Incoming Inspection, Receiving/Warehouse activities and / or Manufacturing Areas.

Reference Documents MPR_PPC_PP_009074 - Managing Nonconforming Product

MPR_PPC_WI_009535, Quality Hold Procedure

Groups or Functions Impacted

Job Function Sourcing Engineering 013 - Family 286 Engineering, PR

Job Function Supplier Quality Engineering 013 – Family 290 Supplier Quality Engineer

Job Function Supplier Quality Engineering 013 – Family 246 Quality Applications

Job Function Incoming 017 – Family 138 Quality Control

Job Function Quality Engineering 013 – Family 091 Quality Engineer

Job Function Quality Engineering 008 – Family 246 Quality Applications

Job Function Manufacturing Engineering 013 – Family 085 Manufacturing Engineer

Job Function Warehouse 014 – Family 110 Deliver: Distribution

Job Function PRB 016 – Family 117 Technician

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Records and Maintenance

1See

Corporate

Retention Schedule for record code definitions and length of time to retain the record.

Record Description Start of Retention Period Record Code1

MPR_PPC_FRM_009078 Recorded Date PRD8000

http://sitebuilder2/cardiovascular/cvcm-sr/QualityRecords/Corporate%20Records%20Retention%20Schedule_70654-SOP.pdf



Document Number MPR_PPC_WI_009075, Revision 7 of 74 Title Nonconforming Components Review Process





A. Change Information

Reason for Change Process Improvement

Background / Why is Required

To improve the procedure based on opportunities observed as part of PR 160217.

In addition disposition instructions were added in order to clarify the steps for evaluation of Manufacturing or Quality engineer before disposition of manufacturing components to manufacturing areas.

Description of Change Clarify instructions for evaluation of Manufacturing or Quality engineer before disposition of manufacturing components to manufacturing areas. Section 4.1 will now read as follows on No defect, use as is, rework and sort dispositions: Factory works comment is required from Manufacturing engineer or Quality Engineer representative.

On section 3.1.4 and 3.1.20 a clarification was included to evaluate CAPA or sCAPA per event generation procedures.

On section 3.1.30 a note to verify the criteria for de-certification per procedure was added.

On sections 4.1 and 7.0 clarify Use as Is Class I and Class II Definitions.

Justification for Change

The change is needed to address PR 160217. In addition, instructions to clarify disposition of Manufacturing or Quality engineer were needed.

Process Section Affected

Section B, C, D, 1, 2, 3, 4, 5, 6.






B. Definitions and Acronyms

Term Definition / Description

Bounding The process to physically and electronically contain all potential non-conforming product affected by a non-conforming and /or potentially non-conforming event with the potential of non-detection.

CAPA Corrective Action Preventive Action

Combination Product

A product comprised of two or more regulated components, i.e., drug/device such as 3830, 4195, 4196, 4296 and 4396 models that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Component Means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

CRDM Cardiac Rhythm and Disease Management

DHR Device History Record

EDC Engineering Data Collection

FW FACTORYworks

JDE JD Edwards – Software (Inventory System)

Lot ID Lot Identification Number

MPROC

Medtronic Puerto Rico Operations Company is the legal entity representing Medtronic businesses established in Puerto Rico. This includes Villalba, Juncos and Humacao with products from CRDM, NEURO, Spinal, Diabetes and Surgical Technologies Divisions.

MRB (Material Review Board)

A cross functional board consisting of personnel necessary to review, evaluate and determine disposition of nonconforming components. MRB Members, as appropriate, consist of: • Supplier Quality Engineer / Quality Engineering / Quality Technician / Sourcing Continuity Engineer or designee

• Additional members by Technical Function: Engineering, Design, Reliability, Design Assurance, Purchasing, Chemical Services, Microbiology, Safety, or any other Engineering function that provides expertise from a specialized area.






Term Definition / Description

MRB Originated Last 7 Days Report

Report which includes PRR’s for Materials originated last 7 days (e.g., may be one report per business or location). Report will be used to confirm lots were received at Nonconforming Area for PRR’s for materials originated during previous week.

Non-conformance or Nonconformity

The non-fulfillment of a specified requirement.

Non Quantifiable Part Number in Factory works

Part Number that is configured in FW with the non Quantifiable attribute as TRUE. When material of this product is consumed in FW, the quantity in the source lot is not decremented. This is sometimes called ‘bulk issue’ material. In JDE, this material will be bulk-issued when it leaves Stores.

Potential Non-conformance or Potential nonconformity

The possibility of a non-fulfillment of a specified requirement, that is under evaluation in order to be confirmed or non-confirmed. Note: Until confirmed, a potential non-conformance is not considered a non-conforming product.

PRB (Product Review Board)

A cross functional board consisting of personnel necessary to review, evaluate and determine disposition of nonconforming product. PRB Members, as appropriate, consist of:

Manufacturing Engineering/Manufacturing Technician or designee

Quality Engineering/Quality Technician or designee

Additional members by Technical Function: Design, Reliability, Design Assurance, Purchasing, Chemical Services, Microbiology, Safety, or any other Engineering function that provides expertise from a specialized area.

PRR Product Review Request

RMR Returned Material Request

Rework

Action taken on a nonconforming product so that it will fulfill the specified requirements before it is released for distribution. Rework decisions for receiving components or sub-components are limited to activities that do not impact form, fit, or function (repackaging, removal of minor contaminants, correcting label information, etc.).

RTV Return To Vendor

Scrap Product does not meet the specification requirements and other dispositions are not feasible.

Sort Sorting is a process of separating conforming product from non-conforming product.

Use As Is Not conforming to specification or requirements after assessment and deemed acceptable for use by engineering analysis.






C. Process Flowchart

Input:

-Nonconforming

Material

Occurrences

1.0 Identification

and Segregation

5.0 Analysis

(Monitoring and

Trending)

3.0 Evaluation

Output:

-Documented

Material

Nonconformance

4.0 Disposition2.0 Containment

Documentation






Detailed Process

Flowchart

Component Lot/Material is found

with a nonconformance

or potential nonconformance

Manufacturing Representative moved

the impacted material lot to the Designated area

for nonconforming materials

Receiving, Warehouse or Other Area Representative Transfer the Lot (s) to the

MR Location in the JDE System

Start

B

Was

the condition found

by personnel form the

Receiving, Warehouse or

other Areas ?

Yes

Receiving, Warehouse or Other Area Personnel

Identified the lot (s) with Non-conformance Label and Moved the lot to the

Designated Area for Nonconforming Materials.

Incoming Inspection designated personnel

induct the lot(s) in the FW system and systematically send all impacted material

to the MRB Area.

NoWas the condition found

during incoming inspection?

Yes

Incoming Inspection Representative

Transfer the Lot to the MR Location in

the JDE System

Incoming Inspector Identified the lot with

Non-conformance Label.

Incoming Inspector transfer the lot(s) to the JDE MR location and Induct the lot (s) in the FW system and systematically move all impacted material

to the MRB Area.

NoWas the condition found

at manufacturing?

Yes

Manufacturing Representative Identifies

the material with the nonconformance label,

and inform SQE Representative

Manufacturing Representative

systematically send all impacted material lot (s) to the MRB Area in FW

SQE or SCE Evaluate the material to

confirm the alleged condition

Was the

Nonconformance

confirmed?

A

Incoming Inspector Physically place the

lot in the designated area for

nonconforming material at Incoming

Inspection Area.

Yes

NoContact SQE

Representative

No

Is

material/component

assembled in product or

not consumed

yet?

Not consumed

Refer to MPR_PPC_WI_

009055Assembled

Is

component/material

inducted in FW??

No

Yes

SQE or Incoming Inspection designated personnel will

systematically send all impacted material to MRB in

FW, for event under

evaluation.

Is

component/material

inducted in FW??

No

Generate a Quality Hold(Refer to MPR-PPC-WI-009535)

SQE or Representative will complete PRR evaluation and disposition for the condition that previously required the component/material to be in

MRB in FW.

SQE or Representative will systematically send all impacted

material to MRB in FW, for event under evaluation.

Yes

Is

impacted material

already in MRB

in FW?

No

Yes

Is

impacted material

already in MRB

in FW?

No

Generate a Quality Hold(Refer to MPR-PPC-WI-009535)

Yes

SQE or Representative will complete PRR evaluation and disposition for the condition that previously required the component/material to be in

MRB in FW.






Evaluate Event per “Event

Generation Procedure”

Incoming

Inspection

Escape?

Local controls for

detectability exist?

Continue non conformance

monitoring and disposition/

close PRR

Can additional

controls be

implemented and

documented within

PRR?

No

Implement and

Document the aditional

controls



No

Determine if there is additional product

affected and contain, if necessary (Bounding)

Yes

Determine the need of

additional controls at

incoming inspection.

Consider stop incoming

inspection process of

affected material until

implementation based

on local detectability

controls.

Stop process until

controls are

implementedStop process until

controls are

implemented

No

Is this material

Inspected at

Incoming

Inspection?

Yes

No

Confirmed Component/

Material Related Out of

Specification Condition

Supplier Related

Nonconformity?

Evaluate Event per

event generation

procedures MPR-CPA-

WI-009002 and

10052323DOC.

Document Justification

in the PRR Analysis if

No SCAPA will be

generated

Yes

Yes

Contact supplier for

containment and

evaluate detectability at

supplier.

A

Product can be dispositioned?

Track the progress of the Event until data is available to

close PRR

No

Yes

Non-conformance was due to isolate event (with a known

cause) outside the mfg process

Yes

Determined Product Disposition for PRR

closure

B

Determine if other lots are

potentially affected and

place in PRB (if affected).

Contain affected product (if

necessary) in PRB and/or

per containment procedureYes

No

No

No

Yes

C

C Yes






Enter JustificationProvide Rework

Instructions

The Product will be scrap in the FW

system

UAI - No Defect Retest (Sort) Rework SCRAP

Verify that Sorting was Completed,

Operator Signed and the Lot returned to PRB for Disposition

Review Sorting Results and

Disposition Lot as Rework / Sort in the

PRB Analysis

RTV

Lot will automatically

located in the RTV Inventory in FW

SQE or SCE Transfer the lot from the RTV Inventory in FW to

the JDE System

Review Rework Results and

Dispatch

Rework is Performed and Documented

Lot Return to the Normal Process Flow. Refer to

Section 5.

End

B

Modify Defect Code Based on Evalaution

Complete PRR Analysis (FW)

Select the Root Cause Code

Add Reference Documents

(When Applicable)

Is Retest (Sorting)

Required?

No

YesSend Lot to PRR

Retest in FW

Enter Instructions

in FW

Provide and document Instructions to the required personnel (When Applicable)

Is the Defect Code Correct?

Yes

No

Enter Analysis Information

Enter Actions Taken

(When Applicable)

Select lot(s) to be Disposition

Complete PRR Disposition (FW)

Use As Is

If rejected by Manufacturing

Ensure QE or ME are included as

approvers

Quality Approval

Enter Justification


Section 5.

If rejected by Manufacturing

Ensure QE or ME are included as

approvers

Quality Approval(Ensure Additional

Required Signatures are

included/documented)

Select Scrap Reason

Verify that Instructions for

Sorting were provided

Accepted quantity of the Lot is Return

to the Normal Process Flow. Refer

to Section 5.


Section 5.

Lot will be RTV?

Yes

NoLot will be

disposition as No Defect?

Yes

Select the No Defect Root Cause and Defect Code

MRB Designated Personnel Verify

that the PRR contain the Supplier CAPA

Justification Documentation

Suppler CAPA Justification

Properly Documented in the PRR?

Send Lot to PRB

No

No

Lot is sent to Scrap. Refer to Section 5.

Send to the supplier. Refer to Section 5

Yes

If rejected by Manufacturing Ensure QE or ME are included

as approvers

If rejected by Manufacturing Ensure QE or ME are included

as approvers

If a Quality Hold was generated, or still open, complete documentation for closure/release (per MPR_PPC_WI_009535)






Additional product/lots could be affected by the same nonconformance

and there is a potential of non-detection and/or

escapes

Start

Notify Quality Representative

Yes

QA Rep evaluate and determine the extent of bounding. (use FW and/or JDE to query

potential product/lots/material.)

Evaluate all suspected product/lots for the same non-conformance.

Extent of Bounding Considerations:

Previous product/lots- internal

and external

Product/lots in process-WIP

Supplier raw material

Date/time range of suspect

non-conformance

Is the same non-conformance detected on

any product/lots evaluated?

No

Bounding activity complete.

EndDocument the results of the evaluation in FW-PRB comments, include specific lots evaluated,

part number and dates.

Can the extent of the non-conformance be determined?

Yes

Initially three previous product/lots (pending availability) should be evaluated for the same non-

conformance.

No

No

Can the extend of the non-

conformance be determine?

Yes

C(Bounding)

Yes

Further containment activity must be

escalated immediately to

Quality Management and initiate an event in GCAPA Trackwise.

Generate Quality Hold, to contain affected product

(Add additional system containment

mechanisms if required)

Move product to MRB in FW

Move product to MRB in FW

No






D. Responsibility

Role Responsibility

Management with Executive Responsibility

Establish and maintain the Non-conforming Product Management System within their respective business activities

Perform periodic review of Non-conforming Product Management System

Quality Representative Investigation, evaluation disposition and trending of the nonconforming and/or potential nonconforming components.

Ensure the nonconformance and/or potential nonconformance documentation is completed per the requirements of this procedure.

Evaluate any potential impact to products inside and outside the facility. Perform bounding when required.

Sourcing Continuity Engineer (SCE)

For Components under qualification

Investigation, evaluation disposition and trending of the nonconforming and/or potential nonconforming components.

Ensure the nonconformance documentation is completed per the requirements of this procedure.

Evaluate any potential impact to products inside and outside the facility. Perform bounding when required.

Incoming Inspector Ensure components rejected from Incoming Inspection areas are properly identified and segregated in the designated area for nonconforming components and/or potential nonconforming at the Incoming Inspection Area.

Systematically move the components rejected at Incoming Inspection to the FW system and generate the PRR records for those components.

MRB Coordinator or Designee Be the custodian of the MRB inventory.

Ensure components rejected from Receiving, Incoming, Warehouse and other applicable areas are properly identified and segregated in the designated area for nonconforming and/or potential nonconforming components at the Incoming Inspection Area.






Role Responsibility

Systematically move the components rejected at Receiving and Warehouse Areas to the FW system and generate the PRR records for those components.

Perform RTV transactions when components are disposition as RTV in the FW system to ensure components are properly returned to the suppliers.

Review the MRB Originated Last 7 days Report and when applicable document actions related to the review on a weekly basis.

PRB Coordinator or Designee Be the custodian of the MRB inventory located at manufacturing areas designated for nonconforming and/or potential nonconforming components.

Verify all lots with completed dispositions, to ensure completeness, before returning them to Manufacturing, or disposing the material (if lot was scrapped).

Review the MRB Originated Last 7 days Report and when applicable document actions related to the review on a weekly basis.

Manufacturing Representative Ensure components sent to MRB Area in FW from manufacturing areas are properly identified and segregated in the designated area for nonconforming and/or potential nonconforming components at the Manufacturing Area.

Systematically move the components segregated for review at Manufacturing into the MRB Area and generate the PRR records for those components.

Manufacturing / Quality Engineering Representative(Manufacturing line representative)

Upon request of the SQE/SCE or designee evaluate any potential impact of the Use as Is, Use as Is –No defect, Rework and Sort Dispositions to ensure there is no impact to the manufacturability of the product. The representative would be responsible for the evaluation and the second reviewer disposition approval signature.

Materials Personnel Representative

Ensure components sent for review to the MRB area are properly identified and segregated.






E. Instructions

1.0 Identification

Input:

-Potential Product

Nonconformance

Output:

-Clearly documented

Nonconformance

-Proper identification on

nonconforming product

Identification

What is the

Nonconformance?

1.1 Identify Material

Note: Consideration shall be given to ensure that all components that are impacted have been identified.

IF Then

Material is suspected of being nonconforming or is known to be non-conforming

1.1.1 Identify the material with the applicable reject or segregated for review status label and/or form and document the PRR number on it.

1.1.2 Ensure label/form is placed in a visible area of the lot and that other labels/forms with other processing status such as acceptable status are removed or covered by the label / form that identify the material segregated for review.

1.1.3 If non conforming or potentially non conforming lot is located at another MPROC facility awaiting inspection results, ensure the portion of the lot located in the other facility is also properly identified as detailed in this section. Identified material must be sent to MRB in FW.

1.1.3.1 If component/material is already in MRB in FW (for a previous condition), generate a Quality Hold per MPR_PPC_WI_009535, to contain affected population. Product will be placed in Hold automatically after rule execution, and must be transferred to MRB in FW for evaluation and disposition of new condition.

1.1.3.1.1 The Quality Hold may be generated by a quality or manufacturing representative.






2.0 Segregation and Containment

Input:

-Documented Nonconformance

-Proper identification on nonconforming

product

Output:

- Properly Segregated/

contained product

Segregation

Separating and

labeling the

nonconformance

occurrence.

2.1 Segregate Material

IF Then

Component lot (s) is (are) sent for review from Receiving, Incoming, Warehouse or any other area where the rejected component is not inducted in FW

Follow instructions on Table 2A below.

Component lot (s) is (are) sent for review from Receiving, Incoming, Warehouse or any other area where the rejected component is not inducted in FW and the rejected component is a Non Quantifiable Part Number in Factory Works or is a lot where a portion of the lot is located in another facility.

Follow instructions on Table 2B below.

Component lot (s) is (are) sent for review from Receiving, Incoming, Warehouse or any other area where the rejected component(s) is (are) inducted in FW.

1. If material is inducted in FW, but is not in MRB in FW, follow instructions on Table 2B below.

2. If material is already in MRB in FW:

a. Generate a Quality Hold to contain affected population, per instructions established in MPR_PPC_WI_009535.

The Quality Hold may be generated by a quality or manufacturing representative.

b. SQE or Quality Representative will complete PRR evaluation and disposition for the condition that previously required the component/material to be sent to MRB in FW.

c. SQE or Incoming Inspection designated personnel will systematically send all impacted material to MRB in FW, for






event under evaluation.

Component Lot (s) is (are) sent for review from the manufacturing areas and will be sent to PRB by the manufacturing operator that found the condition or a manufacturing representative that is not the operator that originally found the condition.

Follow instructions on Table 2C below.

Component Lot (s) is (are) already inducted in FW, and is (are) located at the manufacturing areas

1. If material is inducted in FW, but is not in MRB in FW, follow instructions on Table 2C below.

2. If material is already in MRB in FW:

a. Generate a Quality Hold to contain affected population, per instructions established in MPR_PPC_WI_009535.The Quality Hold may be generated by a quality or manufacturing representative.

b. SQE or Quality Representative will complete PRR evaluation and disposition for the condition that previously required the component/material to be sent to MRB in FW.

c. SQE Representative will systematically send all impacted material to MRB in FW, for event under evaluation.

Component Lot (s) is (are) already assembled in the product

Refer to MPR_PPC_WI_009055.






Table 2A. Component Lot (s) Segregation when NC Origination is at Receiving, Incoming or Warehouse Areas

Action How?

2.1.1 Move the lot to the MR location in the JDE system.

Go to Materials Management

Select Inventory Management

Click on Raw Material Location Transfers (IT)

2.1.2 Click on the Add button on the Raw Material Location Transfers Screen.

2.1.3 Write the applicable branch plant for the lot being transferred on the From Branch Plant and To Branch Plant fields

2.1.4 Write the Part Number in the item Number Column

2.1.5 Write the Qty to be transfer in the Quantity Column

2.1.6 Write the Lot Number on the From Lot Serial column






2.1.7 ick Ok 2 times to complete the transfer to MR Location

2.1.8 Repeat the steps from 2.1.1 to 2.1.7 to transfer the lot from the MR Location to the applicable Induct from JDE Location. Refer below for the applicable location per business.

Juncos CRDM – IMRHCR

Juncos Neuro/Diabetes/ST- IMRND

Humacao – IMRHCR

Villalba – IMRRN

2.1.9 Login into Factory Works system

2.1.10 In the FW menu Go to Activities

2.1.11 Select the Client Rules option

2.1.12 Then select the Induct Lot from JDE option.

Note: If the following message appear in the screen do not proceed and go to Induct Lot option (Table 2A)






2.1.13 Select InvMRB from the Induct to Inventory field on the induct Lot from JDE screen.

2.1.14 Click Apply

2.1.15 On the Start Quantity field enter the Qty to be inducted if not automatically entered by the FW system.

2.1.16 On the Unit of Measure field enter the Unit of Measure.

Note: The JDE FW interface could take approximately 15 min to be completed.

2.1.17 If a SPLIT is created when the lot is inducted annotates the split lot number in the rejected lot label and click Cancel on the print label screen that is shown.

Note: Update the lot number with the child lot number on the lot identification labels.


2.1.19 Select the Lot Query Option






2.1.20 Write the lot number of the rejected lot in the Specify LotId field of the Lots Query screen

Note: If the rejected lot created a child lot when inducted make sure the lot number entered is the child lot number created.

2.1.21 Click the Query option button.

2.1.22 Right click over the lot in the Lot Query Result screen


2.1.24 Select the Move to PRB option

2.1.25 Go to the Material Containment Section (Section 2.0) of this procedure to complete the PRR generation






Table 2B. Component Lot (s) Segregation when NC Origination is at Receiving, Incoming or Warehouse Areas and the Part Number is a Non Quantifiable Part Number in Factory Works.

Action How?

2.1.26 Move the lot to the MR location in the JDE system.

Go to Materials Management

Select Inventory Management

Click on Raw Material Location Transfers (IT)

2.1.27 Click on the Add button on the Raw Material Location Transfers Screen.

2.1.28 Write the applicable branch plant for the lot being transferred on the From Branch Plant and To Branch Plant fields

2.1.29 Write the Part Number in the item Number Column

2.1.30 Write the Qty to be transfer in the Quantity Column

Note: For lots where a portion of the lot is located in another facility transfer the total lot quantity including the portion located in another facility.

2.1.31 Write the Lot Number on the From Lot Serial column






2.1.32 Click Ok 2 times to complete the transfer to MR Location.

2.1.33 Login into Factory Works system



2.1.36 Then select the Induct Lot option.






2.1.37 On the Supplier Lot ID document the Medtronic lot number.

2.1.38 On the Product ID document the Part Number.

2.1.39 On the Qualification level document the qualification level of the lot rejected.

2.1.39.1 Select 90 Production for Production Lots

2.1.39.2 Select 70 Qualification for Qualification Lots

2.1.40 In the Supplier ID Drop Down Menu select the Lot supplier. If the supplier is not available in the drop down options select SYS-003 [JDE].

2.1.41 On the Use Before Date document the Use Before Date of the lot if applicable

2.1.42 On the Start Quantity enter the quantity rejected.

2.1.43 If a SPLIT is created when the lot is inducted annotates the split lot number in the rejected lot label and click Cancel on the screen that is shown.

Note: Update the lot number with the child lot number on the lot identification labels.


2.1.45 Select the Lot Query Option







Note: If the rejected lot created a child lot when inducted make sure the lot number entered is the child lot number created.





2.1.51 Go to the Material Containment Section (Section 2.2) of this procedure to complete the PRR generation






Table 2C. Component Lot (s) is (are) send for review from the manufacturing areas and will be send to PRB by the manufacturing operator that found the condition or a manufacturing representative that is not the operator that originally found the condition.

Note: This applies to components/materials that had not been assembled in product.

Action How?

Material is sent for review from manufacturing areas and will be send to PRB by a manufacturing operator that found the condition or by a manufacturing representative that is not the operator that originally found the condition.

Follow instructions on table below

2.1.52 In the FW menu go to Activities

2.1.53 Select the Lot Query option











2.1.59 Go to the Section 2.2 of this procedure to complete the PRR generation.






2.2 Systematically contain the component lots involve in the nonconformance or potential nonconformance in the PRB area designated for components as follows:

2.2.1 Click on the Generate PRR option button.

Note: If a PRR already exist for the rejected condition and the lot being rejected will be included in that PRR select the applicable PRR number from the drop down menu on the PRR Number field.

2.2.2 Click the Select Reject Codes field

2.2.2.1 Select the Reject Code (s) that applies. Refer to next section for instructions on how to select the Reject code (s).

2.2.3 Click on the Additional Comments field and briefly describe the condition found. Refer

to MPR_PPC_JTS_009079 for guidelines on PRR Generation comments.

2.2.3.1 If rejection is from receiving or incoming inspection, also include the following information (as applicable) as a minimum on the additional Comment field:

Description of condition found

Sample size

Qty found Defective and sample size inspected.

Applicable Inspection Procedure number.

2.2.4 Click Ok to generate the new PRR number






2.2.8 Once the PRR is created proceed to document the PRR Number in the label / form that identifies the material as rejected material.

2.2.5 To select the reject code (s) that apply from the Code Selection screen:

2.2.5.1 Click on the “+” signs to select related codes.

2.2.5.2 To select a code: Highlight the desired reject code and select it by

using the down arrow button.

2.2.5.3 To remove a selected code: Highlight the reject code from the Selected Codes list and select the

up arrow button.

2.2.5.4 Repeat the steps 2.2.5.1 to 2.2.5.3 until all applicable codes are selected. Then click on the “OK” button.

2.2.6 The system will show the generated PRR number in the screen.

2.2.7 Verify that the lot (s) ID in the Lots ID field is (are) the correct one (s).

Note: The following information will be automatically populated in the PRR by the system:

Lot Id, Serial Number, Quantity, UOM, Origination Step, Originated By, Origination Date.






2.2.9 Send the material to the corresponding nonconforming product area (MRB / PRB / Others).

IF Then

The component lot is sent for review from Receiving, Warehouse, Final Pack or Incoming Inspection Areas.

2.2.10 Place the material in the designated area for nonconforming or potentially nonconforming components.

2.2.11 If nonconforming or potentially nonconforming lot is located at another MPROC facility awaiting inspections results, ensure the portion of the lot located in other facility is also properly segregated and place in the designated area for nonconforming or potentially nonconforming components. Identified material must be sent to MRB in FW.

2.2.11.1 If component/material is already in MRB in FW (for a previous condition), generate a Quality Hold per MPR_PPC_WI_009535, to contain affected population. Product will be placed in Hold automatically after rule execution, and must be transferred to MRB in FW for evaluation and disposition of new condition.

2.2.11.1.1 The Quality Hold may be generated by a quality or manufacturing representative.

The material is sent for review from manufacturing

2.2.12 Place the material at the designated nonconforming components area for nonconforming or potentially nonconforming components.

Note: Before placing the lot in the Nonconforming Area the quality designated person to coordinate the MRB and/or PRB activities will verify that there is a PRR associated to the material being contained and that the information on the PRR corresponds to the nonconforming or potentially nonconforming lot.

2.2.13 Perform a product bounding activity to determine if additional product/lots could be affected for the same potential non-conformance and/or if there is a potential of non-detection and/or escapes. Quality Representative must be notified immediately. Refer to Sec 3.1.10 for bounding instructions.






2.2.14 On a weekly basis, the MRB Coordinator or designee, PRB Coordinator or designee for the Nonconforming Area will perform the following:

2.2.14.1 Review the MRB Originated Last 7 days Report (e.g., may be one per business or location) to confirm lots were received at Nonconforming Area for PRR’s for materials originated during previous week.

2.2.14.1.1 The following are examples of the MRB Originated Last 7 days Report:

2.2.14.1.1.1 Humacao MRB Originated Last 7 Days Report

2.2.14.1.1.2 Juncos CRDM MRB Originated Last 7 Days Report

2.2.14.1.1.3 Juncos RTG MRB Originated Last 7 Days Report

2.2.14.1.1.4 Villalba MRB Originated Last 7 days Report

2.2.14.2 If a lot had not been received will coordinate with originator of PRR or with designee (e.g., Inspector, PRB Coordinator for materials) to move lots to the designated area for nonconforming materials.

2.2.14.3 If a lot is not found document accordingly on PRR and notify quality representative (e.g., SQE) for investigation and disposition accordingly.

3.0 Evaluation

Input:

-Segregated

nonconforming product

Output:

-Completed assessment

of the nonconformance

Evaluation

Evaluate available

data and

information

3.1 Follow job tool MSPR_PPC_JTS_009819 - Job Tool for MRB Analysis and Disposition to document the minimum requirements for PRB analysis and disposition in Factory Works. Analysis documentation and disposition of the material shall follow the guidelines provided in that tool.

3.2 Evaluate the component sent for review due to a nonconformance or potential nonconformance.






IF Then

Reason for rejection is related to a component not meeting or potentially not meeting the component design specifications

3.2.1 Review and reference in the PRR the component design specifications.

3.2.2 Verify the rejected condition against those specifications.

3.2.3 Confirm the alleged condition.

IF Then

The condition is confirmed 3.2.4 Assess if there is other product that could be potentially impacted by the condition found. Refer to Table 3A below for guidelines related other product impacted considerations. Document this on the PRR file.

Assess the need to escalate the event into the corrective and preventive action tracking system. Refer to the section A of the detailed process flowchart at the beginning of this procedure for the escalation criteria flowchart. Refer to Table 3B below. Document this assessment result on the PRR file. Evaluate procedures MPR_PUR_WI_10096371, 10052323DOC

,MPR_CPA_WI_009001, MPR_CPA_WI_009002 to determine if a request for CAPA or sCAPA is required.

IF Then

The condition is NOT confirmed 3.2.5 Clarify the criteria in the applicable procedure and/or with the applicable personnel if applicable. Reference procedure change and or awareness session evidence in the PRR file.

http://wwwpi.corp.medtronic.com/qms/document/getDocument.html?documentId=22217






Table 3A. Other Product Affected Extent Considerations Guidelines

3.2.6 Consider if additional components /lots could be affected for the same non-conformance and there is a potential of non-detection and/or escapes.

3.2.7 Bounding Examples:

Product/material mix – Find other product/component lot that could be the source of the mix up on the lot being evaluated.

Mislabeling- Identify other product/component lot that could be also mislabel due to the same source of error.

Environmental Conditions out of Specification: Identify other product / component lots that could be impacted by the same environmental conditions of the lot being evaluated.

Process/equipment failure: Identify other product/components that could be impacted by the equipment failure detected.

Human error: Identify any product / component lots that were processed by the same operator and could be impacted by the condition found.

Note: Use the MES system (ex. Factory Works) and/or ERP system ( Ex. JDE system) to query potential product/lots/material impacted.

3.2.8 Notify the Quality Representative If the determination is that additional product/lots could be affected.

3.2.9 The Quality Representative or designee will evaluate and determine the extent of bounding (Only when applicable).

3.2.9.1 During the identification and segregation of the non-conforming product/lots, the Quality Representative will identify the compromised population. In case of the use of a query, the representative will assure that the report or query used were previously validated.

3.2.9.2 At the moment of generating the PRR or Quality Hold, Quality representative must use the "Search Selected Activity in Lot History” report from Global FactoryWorks Reporting Portal to assure that the activity was correctly performed under FW.

3.2.10 Examples of Bounding Considerations:

3.2.10.1 Previous product/lots- internal and external

3.2.10.2 Product/lots in process-WIP

3.2.10.3 Supplier raw material lot.

3.2.10.4 Date/time range of suspect non-conformance.






3.2.11 Evaluated all suspected product/lots for the same non-conformance found.

3.2.12 If the same non-conformance is not detected on any product/lots evaluated, the bounding activities will be complete.

3.2.13 Document the results of the evaluation in FW- PRB comments with specific lots evaluated, part number, dates.

3.2.14 If the extent of the non-conformance cannot be determined, proceed to identify three previous product/lots (if applicable) and evaluated them for the same non-conformance.

3.2.15 If the same non-conformance is not detected on any of the product/lots evaluated, the bounding/containment activities will be complete.

Document the results of the evaluation in FW- PRB comments with specific lots evaluated, part number, date.

3.2.16 If the non-conformance is detected on any product/lots evaluated and the extent can be determined, the bounding/containment activities will be complete.

Document the results of the evaluation in the FW – PRB comments with specific lots evaluated, part number and date.

3.2.17 If the non-conformance is detected on any product/lots and extent cannot be determined, further containment activity must be escalated immediately to Quality Management and initiate a CAPA event in the Trackwise system as per the CAPA Event Generation procedure.

Note: Refer to the applicable local site procedures for further containment/bounding activity.






Table 3B. Nonconforming Components Escalation Criteria Process

IF Then And

3.2.18 The condition found is considered an isolated condition with a known cause that is not related to the normal process at the supplier, at incoming and/or manufacturing.

Proceed to the Disposition Section to complete the PRR disposition.

Escalation Process end

3.2.19 The condition found is determined to be caused by the component supplier

Evaluate procedures MPR_PUR_WI_10096371 10052323DOC ,MPR_CPA_WI_009001, MPR_CPA_WI_009002 to determine if a request for NC, CAPA or sCAPA is required

Go to section 3.1.21

3.2.20 This part number is inspected at Incoming Inspection

Verify if the inspection procedure include an inspection that should capture the nonconformance found.

Determined if the nonconformance is an escape from the incoming inspection process.


IF Then And

3.2.21 The nonconformance is considered an escape from incoming inspection.

Determine if other lots could be impacted. Refer to Table 3A above.

Determined the need to add controls at incoming inspection

Consider stop incoming inspection until controls are implemented if no other controls are in place downstream on the process


End of the Escalation Process

Proceed with the disposition process.









3.2.22 If the component is not inspected at incoming inspection

Determined if there are local controls to detect the condition found.


3.2.23 If there are local controls to detect the condition found

End the escalation process. Continue Monitoring for the condition found and Proceed to the disposition process.

3.2.24 There are not local controls to detect the condition found.

Determine if other lots could be impacted. Refer to Table 3A above.

Determined if additional controls could be implemented before closing the PRR

Go to Section 3.1.26

3.2.25 Additional controls can be implemented before closing the PRR

Stop process until additional controls are implemented

Implement additional controls

Proceed to the disposition process

3.2.26Additional controls cannot be implemented before PRR closure

Stop process until controls are implemented

Generate the event in the Trackwise system.

Determined if the product can be disposition

Go to Section 3.1.28

3.2.27 If product can be disposition

End the escalation process

Proceed to the disposition process.






IF Then And

3.2.28 Product cannot be disposition.

Track the progress of the event until data is available to close the PRR.

When product can be disposition proceed to the PRR disposition step.

3.2.29 Product rejected is a certified component.

Verify criteria for de-certification as per 10052320DOC. If decertification is needed complete required activities.

Determine if decertification could be implemented before closing the PRR.

IF Then

3.2.30 The reason for the material rejection is unrelated to the component design specifications.

:

Correct the condition found and document the correction in the PRR file.

3.2.31 Examples of material rejection that are unrelated to the component design specifications are:

Missing and/or incomplete documentation (e.g., Missing COC)

Wrong system setup (e.g. MSL Code Discrepancies)

Inspection Procedure Discrepancies






3.3 Once the evaluation is completed proceed to complete documentation of the PRR Analysis tab as follows:

3.3.1 In the analysis tab click on the defect code to select the applicable defect code after evaluation if it is different from the defect code selected during the PRR origination

Note: If defect code selected by the NC originator is not correct, provide feedback to the NC originator on the correct code for the condition found.

3.3.2 Then click on the Root Cause drop down menu to choose the applicable root cause code.

3.3.2.1 If it is a Use as is No defect disposition select the No defect Root Cause Code

3.3.3 Then click on the ReferenceDocuments to attach a document from Documentum to the PRR if needed. See Note below.

3.3.4 Then click on the Additional Analysis field and document the analysis performed.

3.3.5Then click on the Additional Corrective / Preventive Actions field to document any corrective and/ or preventive actions completed and then click ok to complete the analysis tab.

Note: If the file to be attached does not reside in the Documentum system use another applicable quality documents repository system such as EQDMS and annotate the document reference number in the PRR analysis.






4.0 Disposition

Input:

-Evaluated Nonconformance

-Approved impact assessment (UAI)

Output:

-Disposition status

-Sorted Nonconforming

Product

Disposition

of

Nonconformance

4.1 Materials within a PRR can be release with one or more of the following dispositions:

4.1.1 Use As Is - No defect found

4.1.2 Rework

4.1.3 RTV

4.1.4 Scrap

4.1.5 Sort

4.1.6 Use As Is

Category Requirement

Use As Is - No Defect Found (Cat I)

Verify through inspection or re-test (where applicable), to show product meets the specification. Document supporting justification.

If the nonconformance is found to be conforming to product design specification and/ or design requirements after assessment, a Use as Is No Defect disposition can be used along with rationale.

Examples of conditions not related to design specification are:

Missing and/or incomplete documentation (e.g., Missing COC)

Wrong system setup (e.g. MSL Code Discrepancies)

Inspection Procedure Discrepancies not related to design specifications.

-

When the investigation has led to changing the specification/requirement and the product/process/part status are now acceptable and an ECO exist that allows the use of previous revision level, the engineer/designee that will complete the product/material disposition will make sure that the Engineering Change Order (ECO) activity is completed and will document the change control reference number (ECO) and revision level with accompanying description of the change in the PRR Disposition Justification.For non-conforming material rejected by manufacturing where the disposition is Use As Is - No Defect Found (Cat I) the SQE must contact Manufacturing Engineer or Quality Engineer before







disposition. A material assessment shall be conducted by the SQE and the Manufacturing Engineer or Quality Engineer to evaluate the corresponding material disposition. The purpose of the evaluation is to determine if the manufacturing process is not affected by the use of the component. Factory works comment is required from Manufacturing engineer or Quality Engineer representative.

Repair or Rework (Rework/Replace)

Document rework activities. Rework decisions for receiving components or sub-components are limited to activities that do not impact form, fit, or function (repackaging, removal of minor contaminants, correcting label information, etc.). Re-inspection (Sort) does not constitute re-work.

For non-conforming material rejected by manufacturing where the disposition is Repair or Rework the SQE must contact Manufacturing Engineer or Quality Engineer before disposition. A material assessment shall be conducted by the SQE and the Manufacturing Engineer or Quality Engineer to evaluate the corresponding material disposition. The purpose of the evaluation is to determine if the manufacturing process is not affected by the use of the component. Factory works comment is required from Manufacturing engineer or Quality Engineer representative.

Return-to-Vendor (RTV)

To return product to an external supplier or another Medtronic business unit/facility, is a business decision. Coordinate between the Purchasing function and Sourcing Continuity Engineer or their designee as appropriate.

Scrap Document the applicable scrap reason code.

Sort

(Rework/Replace)

Document sort activities. Only product that meets the sort criteria may continue to be processed.

For non-conforming material rejected by manufacturing where the disposition is Sort the SQE must contact Manufacturing Engineer or Quality Engineer before disposition. A material assessment shall be conducted by the SQE and the Manufacturing Engineer or Quality Engineer to evaluate the corresponding material disposition. The purpose of the evaluation is to determine if the manufacturing process is not affected by the use of the component. Factory works comment is required from Manufacturing engineer or Quality Engineer representative.

Use As Is (Cat II)

Evaluation performed confirm that component does not meet design specification and/or design requirement. Perform an Impact Assessment(s) for product nonconformance per applicable procedures. Document justification based on technical or scientific evidence. For non-conforming material rejected by manufacturing where the disposition is Use as is the SQE must contact Manufacturing Engineer or







Quality Engineer before disposition. A material assessment shall be conducted by the SQE and the Manufacturing Engineer or Quality Engineer to evaluate the corresponding material disposition. The purpose of the evaluation is to determine if the manufacturing process is not affected by the use of the component. Factory works comment is required from Manufacturing Engineer or Quality Engineer representative.

Note: Refer to the Procedure for Managing Nonconforming Product MPR_PPC_PP_009074 for a description of the different Disposition Categories and the Minimum Nonconformance Approval Matrix.

4.2 PPProcedure for Use As Is dispositions

IF Then

Components will be disposition as Use As Is

Follow instructions below

4.2.1 Go to the MRB_PRB Dispatch Area in FW.

4.2.2 Select the lot to be disposition, right click over it and select the dispatch lot option.






4.2.3 Go to the PRR disposition tab. Refer to Figure below

4.2.4 In the disposition tab click over the lot to be disposition

4.2.5 Click on the right arrow to move the lot to the selected lots area.

4.2.6 Click the Use As Is option button.

4.2.7 Write the Use As Is Justification.

4.2.8 Click Ok.

4.2.9 Enter your password to confirm the Use As Is disposition

4.2.10 Click Ok






4.2.11 Click ok again in the PRB analysis window.

4.2.12 On the FW Dispatch Area click over the lot and select the Dispatch Lot option.

4.2.13 Click on the Track out button to go to the Track In / Out screen.






4.2.14 On the Track In Track Out Screen click over the Step ID field and then click OK

4.2.15 On the window that appears confirm the use as is step completion by entering your password.

Note: Your signature on this step means that you are in agreement with any rationale used to justify the Use As Is disposition and that the appropriate approval level has been completed.

4.3 PProcedure for Sort Disposition

IF Then

Components will be disposition as Sort and/ or rework









4.3.3 From the PRB Analysis window go to the Disposition tab.

4.3.4 From the Disposition tab click over the lot to be disposition and using the right arrow button move the lot to the selected lots area.

4.3.5 Click the Retest Option

4.3.6 Document the Sorting and/or rework instructions

4.3.7 Click ok.






4.3.8 Click yes on the window that appears to confirm that the sorting and/or rework instructions are complete

4.3.9 Click Ok on the PRB Analysis window

4.3.10 Train the operator that will perform the sorting activity and document the training in the corresponding training record form.






IF Then

The operator that will perform the sorting activity is trained and ready to perform the sorting


4.3.11 Go to the MRB/PRB dispatch lots area and right click over the lot to be sorted and select the dispatch lot option.

4.3.12 Follow the sorting and/or rework instructions On the Lot Track In/Out Screen

4.3.13 Perform the sorting and/or rework activity.

4.3.14 Segregate and identified the sorted and/or reworked material.

4.3.15 Click on the Comment option button.

4.3.16 Select Additional Data from the drop down menu on the Comment Code field.

4.3.17 On the Brief Description field document Sorting and / or rework results

4.3.18 Document the sorting and/or rework results on the Full Description.






Include the quantity sorted and/or reworked and the quantity accepted as a minimum.

4.3.19 Click Ok on the Track In/Out window.

4.3.20 Document your password to acknowledge that the sorting and/or rework activities were completed.






IF Then

Material from the lot was rejected or destroyed as part of the retest during the Sorting and/or rework activity

Segregate the accepted material form the rejected material by following the instructions below

4.3.21 Go to the MRB Dispatch Lots area click over the lot that was sorted and/or reworked

4.3.22 Right click and select Client Rules

4.3.23 Select Split Lot

4.3.24 On the Split Lot Window document the qty rejected in the Split Qty field and a brief explanation of the split reason on the comments field.

4.3.25 Click OK

4.3.26 Annotate the new child lot number on the label of the already segregated rejected portion of the lot.

4.3.27 Inform the SQE or designee when the sorting activity is completed.






IF Then

Sorting and/or rework activity was completed


4.3.28 Once the sorting and/or rework activities are completed the SQE or designee will go to the MRB/PRB Dispatch Lots Area, click over the lot that was sorted and/or reworked and select the dispatch lot option.

4.3.29 On the PRB Analysis window go to the Disposition tab and select the Rework Replace option button






4.3.30 Go to the rework instructions field and document that the sorting and/or rework activities were completed as per re test instructions

4.3.31 Select Sort and/or PRB Rework as applicable from the options provided in the drop down menu of the Available Paths field.

4.3.32 Click Ok and document your password to confirm that the activity was performed.

4.3.33 Go to the Lots in the Dispatch area

4.3.34 Right click over the lot being disposition

4.3.35 Select the dispatch lot option.

4.3.36 On the Track in/Out window click Ok and provide your password to confirm that the sorting and/or rework disposition were completed.






IF Then

The lot was rejected from the receiving, incoming inspection or warehouse areas

Proceed to transfer the lot back to the JDE control to continue its flow following instructions below.

4.3.37 From the Lots in the Dispatch Area right click over the lot that was disposition

4.3.38 Select the Client rules

4.3.39 Select the Transfer to JDE control option.






4.4 UProcedure to follow for RTV dispositions

IF Then

Components will be disposition as RTV



4.4.2 Select the lot to be disposition and right click over it.

4.4.3 Select the Dispatch Lot Option






4.4.4 On the PRB Disposition Tab Select the lot to be RTV

4.4.5 From the PRB Analysis window go to the Disposition tab.

4.4.6 From the Disposition tab click over the lot to be disposition and using the right arrow button move the lot to the selected lots area.

4.4.7 Click the RTV Option button

4.4.8 Select the RTV/RMR area from the drop down menu.

4.4.9 Make sure that the Scrap Lot check box is not selected to avoid the lot to be scrap if the lot will be return to the supplier.






4.4.10 Go to Activities in the FW Client Menu

4.4.11 Select the Lot Query option.

4.4.12 In the Lots Query window Specify LotId Field write the lot number of the lot to be return to vendor and click the Query option button

4.4.13 On the Lot Query Result window right click over the lot to be return.






4.4.14 Select the Client Rule Option

4.4.15 Select the Transfer to JDE Control option.

4.4.16 Go to the Transfer to JDE Location Field and select MR and

4.4.17 Click Ok. This will complete the RTV process in FW






4.5 PPProcedure for Scrap Dispositions

IF Then

Components will be disposition as Scrap




4.5.3 On the PRB Analysis window document a brief explanation of why the material will be scrapped.






4.5.4 From the PRB Analysis window, go to the Disposition tab.

4.5.5 From the Disposition tab click over the lot to be disposition and using the right arrow button move the lot to the selected lots area

4.5.6 Click the Scrap Option button

4.5.7 On the PRB Scrap window select the scrap reason code that apply, click Ok and provide your password to confirm the scrap disposition.

4.5.8 Click Ok in the PRB Analysis Window / Disposition Tab. This will complete the scrap disposition.






4.6 Procedure for Partial Release Dispositions

IF Then

Partial disposition will be perform to a component lot.

Note: This will only apply to components that a sorting activity will be perform to a portion of the lot.


4.6.1 Go to the Dispatch Area

4.6.2 Right click on the lot to be partially disposition.

4.6.3 Select Client Rule

4.6.4 Select Split Lot

4.6.5 Enter the Qty to Split

4.6.6 Click Ok






4.6.7 Go to the PRB Analysis

4.6.8 Click over the Split lot to be disposition.

4.6.9 Click the right arrow to move the lot to the Selected Lots Area.

4.6.10 Complete the disposition of the Split lot following the applicable disposition instructions in section 4.0






4.7 Procedure for Other dispositions

IF Then

Components will be disposition as Other

Note: This will only apply to sites who have configured the Other disposition instead of the Use As Is




4.7.3 Go to the PRR disposition tab. Refer to Figure below

4.7.4 In the disposition tab click over the lot to be disposition

4.7.5 Click on the right arrow to move the lot to the selected lots area.

4.7.6 Click the Other option button.






4.7.7 From the Reason Code drop down menu, select the appropriate Disposition code.

4.7.8 Click Ok.

4.7.9 Enter your password to confirm the Use As Is disposition

4.7.10 Click Ok

4.7.11 Click ok again in the PRB analysis window.






4.7.12 On the FW Dispatch Area click over the lot and select the Dispatch Lot option.

4.7.13 On the data collection window document the Supplier CAPA number if applicable. If no supplier CAPA will be opened then write N/A.

4.7.14 Select a reason for not opening a supplier CAPA from the options available in the drop down menu.






4.7.15 Complete the checklist and click Ok.

4.7.16 Wait until the data is stored.

4.7.17 Click on the Track out button to go to the Track In / Out screen.






4.7.18 On the Track In Track Out Screen click over the Step ID field and then click OK

4.7.19 On the window that appears confirm the use as is step completion by entering your password.

Note: Your signature on this step means that you are in agreement with any rationale used to justify the No Defect disposition and that the appropriate approval level has been completed.

4.8 Remove the reject label before returning the lot to the normal production process flow, when applicable.






5.0 Instructions for the Management of the Lots After Disposition

5.1 After disposition of the material MRB coordinator or designated personnel will perform the applicable verifications and transactions in the JDE system to move the lot that was disposition to the correspondent location based on the documented disposition.

Table 5A. After a Use As Is Disposition

Action How?

5.1.1 Go to the FW system

5.1.2 Select Activities

5.1.3 Select Lot Query

5.1.4 Write the lot number, of the lot that was disposition, in the Specify lot ID field.

5.1.5 Click Query

IF Then

Lot was disposition as Use As Is Follow instructions on table 5A below

Lot was disposition as RTV Follow instructions on table 5B below

Lot was disposition as SCRAP Follow instructions on table 5C below

Lot was disposition as Rework or Sort (Rework Replace)

Follow instructions on table 5D below






5.1.6 Left Click over the lot number one time.

5.1.7 Right Click

5.1.8 Select Client Rules

5.1.9 Select View Lot History

5.1.10 Scroll to the right and click on the PRR button.

5.1.11 Click on the PRR.

5.1.12 Verify the Disposition documented was Use As Is.

5.1.13 Verify that the Use As Is Second Signature was documented.

5.1.14 Verify that the quantity disposition is aligned with the physical quantity

5.1.15 If lot will be release from Incoming Inspection area, verify that the lot was terminated in FW.

5.1.16 Verify if the lot requires incoming inspection






5.1.17 If Incoming inspection is not required move the material to the JDE location for accepted material applicable to the corresponding business.

5.1.18 If the lot requires incoming inspection verify that the incoming inspection was performed.

5.1.19 If the incoming inspection was performed move the material to the JDE location for accepted material applicable to the corresponding business.

5.1.20 If the Incoming inspection has not being performed then move the material to the JDE location for material pending to be inspected applicable to the corresponding business.

Table 5B. After a RTV Disposition

Action How?



5.1.23 Select Lot Query

5.1.24 Write the lot number, of the lot that was disposition, in the Specify lot ID field.

5.1.25 Click Query






5.1.26 Left Click over the lot number one time.

5.1.27 Right Click





5.1.32 Verify the Disposition documented was RTV.


5.1.34 Verify that the lot was terminated in FW.

5.1.35 Send PRR information to the planner buyer for return authorization.






5.1.36 Perform the RTV transactions in the JDE system and send the lot to the supplier upon return authorization (debit memo and shipping memo) is received from buyer.

5.1.37 After the RTV transaction is completed in JDE, the MRB Coordinator or designee will move the material to shipping with the following copies: the transaction in JDE, copy of the debit memo and a copy of the shipping memo attached to the material.

Table 5C. After a SCRAP Disposition

Action How?










5.1.42 Enter the lot number of the lot that was disposition.



5.1.45 Verify the Disposition documented was SCRAP.

5.1.46 Verify that the disposition quantity is aligned with the physical quantity

5.1.47 Perform the JDE system transactions required to change the lot status to scrap. Generate electronic movement in JDE from the location where the lot is to the applicable scrap account, and perform scrap transaction in JDE.

5.1.48 Move the scrapped lot to the designated area for material to be scrap.

5.1.49 The scrap material can be provided to a person or department designated by engineer for nonproduction use. The designated person or department is responsible to identify the material as “scrap” and/or “NOT FOR HUMAN USE”.

5.1.50 Scrap material should be disposed in a manner that it could not inadvertently get into the Production line. Contact the EHS Specialist to dispose chemicals






Table 5D. After a SORT or Rework Disposition (Rework Replace)

Action How?










5.1.55 Enter the lot number of the lot that was disposition



5.1.58 Verify that the Sorting and/or rework activity was completed

5.1.59 Verify the Disposition documented was Rework./Replace

5.1.60 Verify that the Lot Exit MRB.


Note: Make sure the quantities accepted and rejected after sort or rework are physically segregated and identified.

5.1.62 Verify that the lot was terminated in FW.

5.1.63 Verify if the lot requires incoming inspection.

5.1.64 If Incoming inspection is not required move the accepted portion of the lot to the JDE location for accepted material applicable to the corresponding business.

5.1.65 If the lot requires incoming inspection verify that the incoming inspection was performed.

5.1.66 If the incoming inspection was performed move the accepted portion of the lot to the JDE location for accepted material applicable to the corresponding business.






5.1.67 If the Incoming inspection has not being performed then move the accepted portion of the lot to the JDE location for material pending to be inspected applicable to the corresponding business.

5.1.68 Perform the JDE system transactions required to ensure that the non acceptable portion (if applicable) of the lot is scrap or RTV as applicable.

Note: The Pentaho or FW Reporting Tool Reports can also be used to verify the lots and PRRs disposition status

5.1.69 MRB Coordinator or designee- Labeled the segregated material with the corresponding reject and accepts labels. Reject label for the material disposition as “RTV” and “Scrap”. Accept label for the material disposition as “Use As Is”, Sort (Acceptable Portion) and Rework (Acceptable Portion)

Note: Place the new label over the label used for the identification of the lot as per identification section of this procedure. (Section 1.0)

5.1.70 MRB Coordinator or designee- Make sure that prior to perform any transaction in JDE system that the material that was disposition is properly labeled and identified with part number, quantity, Medtronic Lot Number, Vendor Lot Number on supplier shipper box and trays (If applicable). Any discrepancy shall be notified to Incoming Supervisor and/or SQE for clarification

6.0 Monitoring and Trending

Input:

-Nonconformance Data

Output:

-Determine whether a

CAPA or Engineering

Change Request (ECR)

is needed.

Analysis

of

Nonconformance

6.1 Gathered and analyze nonconforming product data in a monthly basis. Refer to MPR_PPC_FRM_009078 – MRB Evaluation Meeting for the minimum required data.

6.1.1 Refer to MPR_PPC_JTS_009996 for guides on how to gather the data.

6.2 The following representatives (PRB) shall be present as a minimum:

6.2.1.1 Supplier Quality Engineer, Quality Manager or designee for these functions

6.3 Determine if further investigation of nonconformance occurrences or an engineering change request is required based on the data analysis. If further investigation is required, it will be managed through the Corrective Action and Preventive Action System. Refer to MPR_CPA_PP_009001 – Corrective Action Preventive Action Process for further details.

6.4 Document in MPR_PPC_FRM_009078 - MRB Evaluation Meeting.






6.5 The MRB Evaluation Meeting Filled Form along with the signed attendance sheet will be stored in EQDMS. Refer to MPR_PPC_PP_009074 -Managing Nonconforming Product.

6.6 The approval of the minutes shall be performed by the Quality Manager or designee and SQE representative(s) as minimum.

7.0 Guideline: Minimum Disposition Requirements

F. Change History

Revision Description of Change Effective Date

3.X -Update table on section 4.1 to clarify use as is disposition requirement. SQE will contact Manufacturing Engineer or Quality Engineer before use as is dispositions for Manufacturing non-conforming material.

-On section 4.7, add procedure for Other dispositions.

-On section 6.4 correct typo errors on document name.

03 – FEB- 2012

4.X Delete Work Instructions and forms numbers from the reference document section.

14 – FEB - 2012

General

Document the confirmation of the defect code. Change defect code if necessary.

Include the references of the procedures, specifications, documents used as part of the evaluation of the condition found.

Document disposition justification and rational (UAI, Rework, etc.)

Document Corrective Action/Preventive Action in the respective field, if applicable.

Reference Supplier CAPA and/or GCAPA event (PR #), if applicable. Document rationale for not open an SCAPA.

UAI – No Defect(Cat I)

Document the rationale for acceptance. Guideline for the UAI Justification Window: What was the suspected defect? How was it determined that there was no defect? Reference any supporting document for justification, if applicable

UAI (Cat II)

Rationale for Acceptance and impact assessment. Justification Window Guideline: What is the defect? Why is it being accepted with the defect? Reference the supporting document for justification.

Sort Perform Sorting at the retest step. Document Sorting Instructions. Document the sorting results and quantity sorted. Disposition as Rework Replace under the Sort path.

Rework Rework Instructions and Re-evaluation Results.

Scrap Document Scrap rationale on the PRB Analysis Tab. Select the applicable reject code.

RTV Select the applicable code (RTV reason).






Revision Description of Change Effective Date

5.X To implement a job tool MPR_PPC_JTS_009819 to be used as an aid in the documentation of the PRR.

To eliminate the EDC steps from the process as part of the implementation of a new Job Tool MPR_PPC_JTS_009819 for the documentation of the PRR.

To enhance and clarify instructions provided in the procedure related to sort, rework and the documentation related to those activities.

To modify instructions related to generation of PRR for lots which have a portion of the lot located in another facility. To clarify Scrap dispositions documentation.

To clarify instructions on the Minimum Disposition Requirements section to include additional guidelines for the release of lots once disposition is completed. Add Manufacturing Quality Engineering/Manufacturing Engineer Representative role and include instructions for the SQE/SCE or designee to confirm with manufacturing Engineering/Quality Representative that the disposition of the material does not impact product manufacturability. This as part of CAPA 129711.

14 - SEP - 2012

6.X Change template MPR_DOC_TEMP_008418 used to create this document (Work Instruction MPR_PPC_WI_009075) from revision 1 to most current revision, revision 3.

Changes related to CAPA PR129273, TASK PR 136711:

Included instructions to review lots of PRR’s are physically received at MRB Area on a weekly basis. Report to be used for the review is the MRB Originated Last 7 days Report. Also, included instructions to be taken if lots had not been received at MRB Area. Changes related to CAPA PR 128556, TASK PR 134778:

Clarify instructions to identify, segregate and contain non-conforming and/or potentially non-conforming component/material, in Sec 1 and 2, and update Process Flowcharts in Sec C. Clarify instructions to conduct product bounding exercise in Sec 3. Remove EDC use instructions in Flowchart in Sec C. Add MPR_PPC_WI_009535 (Quality Hold Procedure) in Reference Documents section.

Changed (simplified) title of section 3 thru 6.

14 - DEC - 2012