Template No. 30000234 Rev.

C Sheet 1 of 7

SCOTTSDALE DEPARTMENTAL WORK INSTRUCTIONS (DWI)

TITLE: DWI for Maintaining and Monitoring Supplier ITEM: 30002119

Quality Activity Tracking Log

CATEGORY: 4 − Quality REVISION: G

EFFECTIVE: March 17, 2014 ECO NO: PB01358

Notes:
ANY CHANGES TO THIS DOCUMENT SHALL BE APPROVED BY PLANNING
AND BUYING MANAGEMENT PRIOR TO RELEASE.

This document contains Confidential and Proprietary information which is the property of St. Jude Medical, Implantable Electronic
Systems Division (IESD). This document may not, in whole or in part, be duplicated, disclosed, or used for any purposes, whatsoever,
without prior written permission from IESD.

Effective As Of: 08−01−2013

DWI for Maintaining and Monitoring Supplier Quality Activity Tracking Log Sheet 2 of 7

Table of Contents

1.0 PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.0 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.0 ASSOCIATED DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.0 GENERAL REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.0 DETAILED REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1 NEW SUPPLIER – INITIAL SURVEY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.2 SUPPLIER RE−ASSESSMENT OR DOCK TO STOCK (DTS) AUDIT . . . . . . . . . . . . 4
5.3 SUPPLIER AUDIT (FOLLOW−UP FROM A CONDITIONAL RATING) . . . . . . . . . . . . 5
5.4 COMPLETION OF SLA AND SUPPLIER ASSESSMENT FOR ALL REQUESTS . . 5
5.5 SUPPLIER INFORMATION CHANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.6 SSQATL GUIDELINES – USE OF NAVIGATION BUTTONS . . . . . . . . . . . . . . . . . . . . 7
5.6.1 SEND TO PROMIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.6.2 ADD NEW SUPPLIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.6.3 DELETING A SUPPLIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.6.4 HELP SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.6.5 CLEAR ALL FILTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

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DWI for Maintaining and Monitoring Supplier Quality Activity Tracking Log Sheet 3 of 7

1.0 PURPOSE
The purpose of this document is to define the procedure to monitor and maintain the
Scottsdale Supplier Quality Activity Tracking Log (SSQATL) in the St Jude Medical,
Scottsdale hybrid facility.

2.0 SCOPE
This DWI contains instructions and information necessary for the implementation,
maintenance and monitoring of the SSQATL (30002112).
This document was created in accordance with SOP4.0.6AZ.

3.0 ASSOCIATED DOCUMENTS

• QM0009, Supplier Quality Evaluation
• SOP4.0.6AZ, Document Standards
• SOP4.1.3AZ, Corrective/Preventive Action System
• 9191246, Supplier Liaison Activity Form
• 9191277, Supplier Audit Report Form
• 30000811, Contractor and Visitor Safety & Conduct Agreement
• 30002112, Scottsdale Supplier Quality Activity Tracking Log
• 30004734, DWI for Supplier History Lot Report
• 60032765, Global Supplier Risk Based Audit Procedure

4.0 GENERAL REQUIREMENTS

• The Supplier Quality Assurance Coordinator (SQAC) (this role may be supported
through the Purchasing/Materials function) shall be responsible for the SSQATL
(30002112).
• The SSQATL shall be created and used in accordance with QM0009. The log may be
maintained in electronic or hard copy format.
• All suppliers as defined in QM0009 utilized in the Scottsdale facility shall be listed on
the SSQATL.
• Additional tabs identified are for reference only and not a part of the controlled log.
• For all assessments performed by other facilities for Scottsdale suppliers, at a
minimum, the first page of the report will reference which site performed the audit and
where the audit report package hard copy is located.

5.0 DETAILED REQUIREMENTS

5.1 NEW SUPPLIER – INITIAL SURVEY
5.1.1 If any new supplier is required, the Supplier Liaison Activity (SLA) form
9191246 will be generated. Typically, the requester is responsible for
providing the SLA information, but a Materials representative may also fill out
the form.

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Note: On the Contractor, Consultant & Service Quality Assessment

Checklist sheet, form 9191246, in regards to SJM procedure
training for Contractor, Consultant & Service representatives,
this training question does not need to be completed. This
requirement is fulfilled by the Contractor and Visitor Safety and
Conduct Agreement, form 30000811, completed upon entry into
the SJM Scottsdale facility.
5.1.2 The SLA and the purchase requisition will be submitted to the Materials
Department. (The SLA may be submitted prior to the purchase requisition.)
5.1.3 The SQAC will verify that all of the required fields are filled out. If there is
information missing, the SQAC may return the SLA to the requester. When
all required information is on the form, the SQAC will add the initial survey
required date. Typically, the initial survey required date is 90 days from the
SLA initiation date.
5.1.4 A Materials representative will contact the supplier and request a W−9 form.
The SJM credit sheet may also be sent to the supplier upon request.
5.1.5 When the W−9 form is returned from the supplier, a Materials representative
will enter the supplier data into the applicable ERP (Enterprise Resource
Planning) system, which will assign a unique supplier code. The supplier
code will be recorded on the SLA.
5.1.6 The SQAC will add a row with the supplier name and code in the In Process
SLA Log worksheet located in file containing the SSQATL. The In Process
SLA Log worksheet is used to track the approval progress of the SLA and
assessment status for each supplier.
5.1.7 Go to section 5.4 to continue.
5.2 SUPPLIER RE−ASSESSMENT OR DOCK TO STOCK (DTS) AUDIT
5.2.1 The SQAC shall monitor the Audit Re−Assessment and DTS
Re−Assessment Due Dates for existing suppliers periodically on the
SSQATL.
5.2.2 Typically 90 days or more prior to a re-assessment date, the SQAC shall
generate an SLA indicating whether it is an Audit or DTS.
Note: On the Contractor, Consultant & Service Quality Assessment
Checklist sheet, form 9191246, in regards to SJM procedure
training for Contractor, Consultant & Service representatives,
this training question does not need to be completed. This
requirement is fulfilled by the Contractor and Visitor Safety and
Conduct Agreement, form 30000811, completed upon entry into
the SJM Scottsdale facility.

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5.2.3 The SQAC will add a row with the supplier name and code in the In Process
SLA Log worksheet located in file containing the SSQATL. The In Process
SLA Log worksheet is used to track the approval progress of the SLA and
assessment status for each supplier.

5.2.4 Go to section 5.4 to continue.

5.3 SUPPLIER AUDIT (FOLLOW−UP FROM A CONDITIONAL RATING)

5.3.1 The Supplier Engineer (SE) will fill out an SLA form for the Follow−Up
Survey including entering the Date Required based on the supplier’s
corrective action completion dates. The SLA will be provided to the SQAC.

5.4 COMPLETION OF SLA AND SUPPLIER ASSESSMENT FOR ALL REQUESTS

5.4.1 The SQAC will then send the SLA form to Materials and Quality
management or their designee for approval.

5.4.2 When the approvals are complete and the SLA form has been returned, the
SQAC will submit the SLA to the SE for processing.

5.4.3 The SE will proceed with an assessment of the supplier per QM0009. The
Supplier History Lot Reports shall be generated per DWI 30004734. The
assessment should be performed before the required date noted on the SLA.

Note: If the re−assessment cannot be performed by the Audit or

Re−Assessment Due Date due to supplier or SE scheduling, the
Supplier Audit Report may be used to extend the due date up to
90 days by documenting the reason for the extension if the
supplier has previous approval status. The new Audit or
Re−Assessment Due Date noted in the Supplier Audit Report will
be recorded in the applicable column in the SSQATL.
5.4.4 After the SE performs an assessment, and the audit report and associated
documentation has been completed, the SE will submit the audit report
package to the SQAC.

5.4.5 The audit report package will be submitted for approval per QM0009.

5.4.6 After all of the applicable approvals are obtained, the audit report package
will be returned to the SQAC.

5.4.7 The SQAC will add or update the supplier in the Main Log in the SSQATL.
The SQAC will scan the audit report. The log information pertaining to that
supplier will be entered including hyperlinking the audit report to the supplier
code number. All linked files will be saved in the Supplier Tracking folder on
the public directory.

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• The SLA or Re−Assessment Status, see paragraph 5.2.2, shall be

updated in the SSQATL accordingly.
• If a DTS Re−Assessment was performed as noted on the Supplier Audit
Report, also record the DTS Re−Assessment Due Date in the applicable
column. The DTS supplier audit frequency will be determined by
60032765. See Supplier Audit Report for date.
• If the Supplier Audit Results on the Supplier Audit Report Form are
Cond−Approved or Disapproved, the audit result is entered into the
Survey Status column and N/A needs to be entered into the DTS
Re−Assessment Due Date column. The Corrective Action Plan Required
date will be entered into the Audit Re−Assessment Due Date.
Note: If an audit requires Corrective Action, a Supplier Corrective
Action Request is to be generated per SOP4.1.3AZ.
• The Commodity Risk Classification shall be updated in the SSQATL, per
QM0009, as code: A, B, or C.
• The Initial or Routine Supplier Audit Report will be hyperlinked to the
MFGPro Supplier Code in the SSQATL.
• The DTS Supplier Audit Report will be hyperlinked to the Supplier Name
in the SSQATL.

5.4.8 All hard copies will be filed.

5.5 SUPPLIER INFORMATION CHANGES

• Supplier Name Changes – keep the original name in the original row, noting the
new name, and delete all supplier information including the supplier code. Move
all of the assessment information to the row with the new name including the
supplier code. The obsolete name may be removed and recorded in a history
worksheet based on inputs from Quality and Purchasing Materials.
• Address Changes – delete the old address and enter the new address. Record
the date the address changed in a history worksheet.
• Removal of a Supplier – record information in the discontinued worksheet.
Note: The removal of a supplier from the SSQATL shall be documented
using the SLA form or the Supplier Audit Report Form by
indicating Discontinued on either form.
• Supplier Code Change – follow the new supplier process. See section 5.1.
• Any other applicable changes to the supplier information can be noted in a
history worksheet.

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5.6 SSQATL GUIDELINES – USE OF NAVIGATION BUTTONS

5.6.1 Send to PROMIS

After adding a new supplier or updating the “Audit Re−Assessment Due
Date”, PROMIS needs to be notified of these changes. This is done by
clicking on the “Send to PROMIS” button at the top on the spreadsheet. This
will send the data to PROMIS.

5.6.2 Add NEW Supplier

To add a new supplier, click on the “Add NEW Supplier” button at the top of
the spreadsheet. This will open a new line allowing you to enter the
appropriate data. This new line will also add all pre−determined formatting.

5.6.3 Deleting a Supplier

Select supplier to be deleted by clicking on supplier information line (any
cell). Click on the “Delete Supplier” button at the top of the spreadsheet. The
information about that supplier will be displayed at the top of the screen.
Click “Delete” to delete the supplier or “Cancel” to abort. If the “Delete”
button is clicked, the supplier information will be logged on the “Deleted
Supplier Records” sheet before the supplier is deleted. If the “Cancel” button
is clicked, the supplier will remain unchanged.

5.6.4 Help Screen

Clicking on the “Help” button will display filter and sort features in the
spreadsheet. Click on “Return to Program” to return to the “Main” page.

5.6.5 Clear All Filters

To clear all filters on the spreadsheet, click on “Clear All Filters” on the top of
the spreadsheet.

Note: Contact the Computer Integrated Manufacturing (CIM)

department if there are any issues with the spreadsheet.

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