Trans-Tech, Inc Adamstown Road Adamstown, MD Verify Approval Before Use

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1 Trans-Tech, Inc Adamstown Road Adamstown, MD Verify Approval Before Use Work Instruction Title: Supplier Qualification and Monitoring WI Number TT-WI-0137 Revision: 15 Department: Purchasing Quality Assurance Primary Document: Approved & Released Work Instruction Area: Purchasing Quality Assurance Document Type: Work Instruction 1.0 Purpose: This procedure establishes the method used to select,evaluate,qualify, monitor and potentially disqualify suppliers. 2.0 Scope: This procedure applies to level 1, & 4 suppliers (see definitions sec. 4): see procedure Environmental Services Supplier Qualification, TT-WI-0265 for level 3 suppliers. 3.0 Responsibilities: Quality Engineering / Process Engineering Responsible for providing support during qualification processes such as generating test plans or requests, authoring material specifications, and performing testing and material qualification for products as indicated. Also provide performance data where needed. Supplier Quality TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 1 11/30/2015

2 Responsible for supplier qualification and monitoring, and potentially disqualification; supplier audits; supplier database maintenance. Sourcing Responsible for providing contact information and assisting in supplier qualification and monitoring activities. Supplier Evaluation Team Comprised of a minimum of Quality Engineering, Sourcing, and Engineering (typically Process Engineering), responsible for supplier evaluation. 4.0 Definitions: Approved Supplier List (ASL) Database used to track supplier qualification status, monitor supplier performance and retain records related to supplier monitoring activities. Contract Manufacturer: A level 1 supplier that provides a service. Level 1 Supplier: Supplier that provides material used in the manufacture of finished product and directly impacts its form, fit or function. (Ex.: Foundries, Assembly houses, Test houses, parts/components, raw materials) Level 2 Supplier Supplier that provides material or service not used to support / impact the direct manufacture of finished product nor an environmental management service. Examples: Office equipment and supplies Misc. Manufacturing Supplies Consulting Capital or other Equipment Building maintenance Maintenance Parts, Spare Parts, and Materials Level 3 Supplier Supplier that provides environmental management services such as hazardous and non-hazardous waste removal, sludge removal, and / or spill remediation on TTI facilities. Level 4 Supplier: Supplier that provides critical services that directly impacts the form, fit or function of the finished product TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 2 11/30/2015

3 (Ex.: Calibration, Laboratory services used for product qualification or failure analysis) On-Site Quality Systems Audit Audit performed at the suppliers facility to assess the supplier's compliance to the Trans-Tech Quality Manual as well as their manufacturing capability, technical proficiency and overall competency. On-Time Delivery A delivery received three days prior - two days after the actual due date on the Purchase Order. Probation Supplier status whereas supplier monitoring performance is less than 80 for three consecutive months. As a consequence, the supplier is requested to provide an overall improvement plan to address the issues that caused their supplier score to fall below the minimum threshold. Raw Materials Materials that become constituents or components of finished Trans-Tech products. 5.0 Work Instruction Steps: TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 3 11/30/2015

4 TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 4 11/30/2015

5 5.1 Supplier Selection The engineering, manufacturing, or sourcing shall submit a Candidate Supplier Procurement Survey Request, Form TT-F0081, to the Purchasing Department for evaluation of a new product, service or external process The originator completes the top portion of the request Purchasing reviews the request and either accepts or rejects the request Purchasing completes the middle portion of the request If rejected, Purchasing returns Form TT-F0081 to the originator with an explanation of the reason(s) for rejection. The originator may resubmit or seek alternative suppliers For raw materials, purchasing may obtain a screening sample from the potential supplier of <1kg, or economic qty, for a screening review Engineering would review the screening sample and determine whether or not to continue with the supplier qualification and the full material evaluation For new chemicals, the originator needs to complete TT-F0459: New Chemical Request Form and submit it to Facilities-EHS department. The originator will be notified when this chemical is approved Purchasing then forwards the Survey Request, TT-F0081, to the Quality Department. 5.2 Supplier Qualification Upon receipt of the Approved Supplier Procurement Survey Request, Quality will enter the potential new suppliers into the Supplier Management database and submit the following items to the Supplier: TT-SOP Trans-Tech Supplier Quality Manual Form TT-F Candidate Supplier Procurement Survey The supplier is expected to review the specifications, complete and return the survey to the Quality Department for review and approval. In addition, the supplier shall also provide a copy of the table contents of their Quality Manual or suitable document that shows evidence of a Quality System. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 5 11/30/2015

6 5.2.2 If an on-site quality system survey is required, Supplier Quality will assign the audit team, schedule the audit and specify any additionally approval requirements on TT-F0081 (Quality Section) The on-site survey should be conducted in accordance with the Supplier Quality System Survey/Audit, Form TT-F0082 and SQ Supplier Audit Protocol The originator shall determine if additional qualification or First Article Inspection is required If First Article is required, perform per TT-WI-0132, First Article Inspection If the procured item is a raw material, then a raw material evaluation is required. The responsible engineer must submit a Raw Material Evaluation Plan, Form TT-F0053. After completion of the material evaluation (including material cost analysis and identification of usage limitations), the evaluation results must be approved by designated staff, Form TT-F If the procured item is a non-raw material, then determine whether a Non-Raw material evaluation is required. The originator must submit a Raw Material Evaluation Plan, Form TT-F0622. The plan must be approved by the designated staff, Form TT-F0622, prior to the performance of the evaluation. After completion of the material evaluation (including material cost analysis and identification of usage limitations), the evaluation results must be approved by designated staff, Form TT-F If the procured item is packaging, then a packaging qualification is required per Packaging Qualification Report, Form TT-F0626. Note: Consider discussing with the supplier the end-use to help determine the characteristics to evaluate during the qualification Upon receipt of the completed Candidate Supplier Procurement Survey, the Supplier Evaluation Team, led by Supplier Quality, will evaluate the information provided to determine the suppliers compliance to the requirements and if an on-site supplier quality system survey is deemed necessary A survey score of >= 70% indicates the supplier may be approved. A score of 50% - 69% indicates the supplier may be conditionally approved. A score of <50%indicates the supplier is considered unacceptable When a candidate supplier is not approved as a result of a deficient survey, the Quality Department may recommend a re-survey providing the supplier takes action to correct the deficiencies If insufficient information was obtained, the candidate supplier is notified and additional information is requested. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 6 11/30/2015

7 If additional information, or any survey response, can not be obtained from the candidate supplier, Quality management may decide to accept the information already provided or any available information obtained from the suppliers website or other sources in lieu of the completed survey Creating a Supplier Profile Record The information obtained in the supplier survey will facilitate the creation of the supplier profile record in the supplier database. To create a new supplier profile, click on Create Supplier Profile button (see below): Complete the fields as follows: TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 7 11/30/2015

8 Actions / Fields Entry Description Comments Basic Description of the Supplier Parent Corporation Name Name of supplier's parent corporation Leave blank if not Supplier Name Street Address, City, State, Zip Country Skyworks Purchasing Agent Enter supplier name Enter supplier address Select name from pull down menu Supplier ID (DUNS) Number Enter supplier Syteline Vendor # Remit To Address Supplier Quality Contact Phone Number Address Supplier Sales Contact Address Enter name of supplier quality manager Enter supplier quality manager telephone number Enter supplier quality manager address Enter name of supplier sales representative Enter supplier sales representative address Auto completed TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 8 11/30/2015

9 Actions / Fields Entry Description Comments Supplier Qualification Status and Certification Information Specially Designated Supplier (SDS) Select "Yes" if the supplier is a contract manufacturer. Otherwise, select "No" Supplier Standard Certifications Expiration Date Registrar Select the certification(s) for which the supplier has been accredited by a third party registrar. Enter the expiration date of the most "significant" quality certification. For example: o If the supplier is ISO 9001 and ISO certified, enter the expiration date for the ISO 9001 certificate (i.e. the ISO certificate is an environmental certification). o If the supplier is ISO 9001, ISO and ISO/TS certified, enter the expiration date for the ISO/TS certificate (i.e. the ISO/TS certificate is more advanced than the ISO 9001 certification) Enter the name of the third party certification body that was used on the most significant certification TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 9 11/30/2015

10 Certificate Attachment Supplier Classification Attach a copy of the most significant certificate Select the corresponding classification from the dialog box (reference section 4 for definitions) Actions / Fields Entry Description Comments Plants that Use this Supplier Plant Name / Division Select the appropriate plant location (or type) from the pull down menu Site Supplier Survey Attachment Additional Information o Select the appropriate site check box Attach the completed supplier survey Attach other documents that may be needed to support the approval of the supplier Once the required documentation is received and evaluations complete, Supplier Quality will send the supplier record out for approval and addition to the Approved Supplier List (ASL). Supplier Quality and Purchasing are the minimum required approvers Once approved, the supplier profile status will change to Qualified and will be visible in the Approved Suppliers views If Raw-Material or Non-Raw Material evaluation was performed, the records shall be attached in the supplier database as a miscellaneous activity The ASL includes information related to the qualification activities or the qualification data is otherwise retained on file Additional materials/services submitted by the same supplier may be qualified by association or submitted to full qualification, depending on the application and the Supplier Evaluation Team's decision. This field is not in be a repository of minutes, supplier development revie other data. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 10 11/30/2015

11 5.2.7 A resurvey is required at the discretion of Supplier Quality. Note: All suppliers that were in use prior to January 2009 are considered grandfathered into the ASL. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 11 11/30/2015

12 5.3 Supplier Monitoring Supplier performance shall be scored monthly by the 15th of the subsequent month and shall be maintained in the Supplier Quality database. Supplier performance is measured as a minimum using the following methods: Quality (Number of Supplier Corrective Action Request (SCARs) initiated, number of SCARS remaining open from previous months, and the number of SCARs closed with no response) Delivery (Number of deliveries not on time) Customer complaints as a result of supplier products and/or services. The supplier score is calculated based on a demerit system as noted in the database record. If a supplier has no activity for a particular month, the score is left blank. If there is an open SCAR and no activity for that month, then a note is added to the supplier to reference the SCAR remains open but no score is given for that month. Note: Supplier monitoring for original equipment manufacturers is optional The supplier performance record shall be sent to contract manufacturer every month The supplier performance shall be reviewed by Quality, Purchasing and key manufacturing personnel at least once a quarter. Minutes of the review shall be maintained in the Management Review database Suppliers with expired certifications such as ISO 9001 and ISO shall be required to provided current certifications Complete the supplier as follows: TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 12 11/30/2015

13 TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 13 11/30/2015

14 Actions / Fields For Year Date Created Last Date Modified Last Author OTD Scoring Year To Date Scores Overall Rating Quality Delivery Monthly Data Overall Quality Delivery Supplier Corrective Action Requests Number of SCARs Open Number of SCARs Closed with No Response Delivery Performance Premium Freight Customer Returns Entry Description Enter the year for which the data is being captured Autopopulated Autopopulated Autopopulated Select Events if OTD is tracked by the number of late deliveries or select Percentage if OTD is tracked by the percent deliveries that were made on time Autocalculated Autocalculated Autocalculated Autocalculated Auto calculated Auto calculated Enter the number of SCARs that were opened, or still open during a given month. Note: SCARs dispositioned as No Fault Found can be discounted. Enter the number of SCARs that were closed without a supplier response Enter the number of late deliveries or the percent on time Enter the number of shipments that were made with a delivery method that required expediting above and beyond the normal delivery method Enter the total number of customer returns attributed to the supplier TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 14 11/30/2015

15 5.3.5 Managing / Creating Supplier Activities A variety of records can be associated to the main supplier profile. To create an activity, highlight the supplier profile and click on the Create Activity button. The following options will be available. Supplier CAR Reference TT-WI-0167 External Corrective Action Request Action Item This will create an action item record that can be assigned to an individual for follow up Supplier PCN This will create a product/process change notice. Incoming Correspondence This will create an Incoming Correspondence record that can be used to capture and store significant s or letters from the supplier Meeting Report This will create a meeting record. This can apply to meetings at Skyworks or at the supplier's site. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 15 11/30/2015

16 Note: Meeting Reports should not be used to capture supplier site audits: these should be managed in accordance with SQ Supplier Audit Protocol Supplier Performance Record Reference section 5.3 Supplier Monitoring Contact This will create a supplier contact record. Generating contact records for meeting attendees is a convenient way to manage information related to supplier functions. Supplier Development Project This will create a record that can be used to track supplier projects related to product or process development or improvement Miscellaneous Use this record for all other types of activities not otherwise listed 5.4 Supplier Disqualification Suppliers that fall below an 80% rating for three consecutive months are placed on probation and an improvement plan is formally requested Suppliers may be removed from probation status if: - The supplier quality representative has accepted the plan - The plan has been completed - Supplier performance is 80% or higher for three consecutive months. Note: Months without any activity are not taken into account when considering "consecutive" months Placing a supplier on probation Select the supplier profile in the Supplier Management database and click edit. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 16 11/30/2015

17 Select the "Place on Probation" button. The supplier will now no longer be listed in the ASL and will be listed under "Probation" status in the All Suppliers list Suppliers that fail to implement positive corrective action as determined by the Supplier Evaluation Team are deemed disqualified Additional factors may be considered such as business strategy, availability of qualified alternate sources, cost impacts, technology strategy, etc Disqualification may be temporary, specific to a part or service, or complete depending on the severity of the TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 17 11/30/2015

18 nonconformance and the response by the supplier. Any disqualification is denoted in the ASL Disqualifying a supplier Select the supplier profile in the Supplier Management database and click edit. Select the Disqualify Supplier button. NOTE: You must be one of the approvers in order to disqualify the supplier in the system If specific products are disqualified via performance issues or lapses in usage, the products are re-qualified by performing testing equivalent to initial qualification as defined by the Supplier Evaluation Team. TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 18 11/30/2015

19 Note: The Supplier Management database will be used to control the ASL, SCARs, Supplier Monitoring and Supplier Disqualification effective January Records: The following records may be generated as a result of following the steps in this document: Identification Form Number Owner Indexing Storage Retention Time Disposition Candidate Supplier Procurement TT-F0081 Quality Supplier Electronic or 7 years Destroy Survey Request Hard copy Candidate Supplier Procurement Survey Supplier Quality System Survey/Audit TT-F0100 Quality Supplier Electronic or Hard copy TT-F0082 Quality Supplier Electronic or Hard copy 7 years Destroy 7 years Destroy Raw Material Evaluation Plan TT-F0053 Quality Supplier Electronic or 7 years Destroy Hard copy Supplier Record - Supplier Quality Supplier Electronic 7 Years Destroy Supplier Development Review SQ Quality Supplier Electronic or Hard copy 7 years Destroy Note: the author is responsible for ensuring that the paper distribution of this work instruction is at the correct revision. 7.0 Associated Documents: TT-F Q RAW MATERIAL EVALUATION PLAN TT-F Candidate Supplier Procurement Survey Request TT-F Q Supplier Quality System Survey / Audit TT-F Q Candidate Supplier Procurement Survey TT-F New Chemical Request Form TT-F Non-Raw Material Evaluation Plan TT-F Packaging Qualification Report TT-SOP TRANS-TECH SUPPLIER QUALITY MANUAL TT-WI First Article Inspection TT-WI Environmental Services Supplier Qualification SQ Supplier Development Review SQ Supplier Development Review SQ Supplier Audit Protocol TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 19 11/30/2015

20 8.0 Document Revision History: Revision: 15 Date Created: 06/26/2008 Date of Last Revision: 11/30/2015 Last Approval Date: 11/30/2015 Document Author: Mokeli Pelamoko Document Manager: Tom E Arnold 9.0 Reason for Change: Revision: Initiator Change Made: Date 1 L. Bartlett Initial Issue of Document. Originally TT-SOP-0005, Rev. 3. Changed to Level III per ISO gap action. Submitted same as SOP 2 S. Clayton Revamped document to include items from SQ Added sections 5.3 and 5.4. Changed title from "Vendor Evaluation and Selection". Updated associated docs. 06/28/08 3 S. Clayton Premium freight removed from supplier monitoring section /22/08 4 S. Clayton Updated/replaced flowchart. A screening sample for raw materials was added to section 5.1. The wording in section 5.1 and 5.2 was revamped for clarification. Record retention times changed to 7 years from 5 years. 5 S. Clayton Modified note under to clarify the cutoff for grandfathering into the ASL. Added note under regarding the adoption of the Supplier Management database. 6 S. Clayton Updated section to remove the need for resurvey in the event of mergers, acquisitions or affiliations. Updated for monitoring regarding SCARs closed with no reponse. Also updated note about a score when there has not been any activity. Changed disqualification, section 5.4, from qtr. to 3 consecutive months and added note. 7 S. Clayton Updated wording of Updated and due to use of database for approvals. Updated flowchart accordingly. Removed rejected shipments as a Quality factor in Updated approver list. 8 B. Muniz Changed second approver to Tom Arnold. Moved definitions of supplier levels to section 4 Added definition for Probation Added for new chemical purchases Added reference to SQ to section Added TT-F0459, SQ to associated documents Added section for creating a supplier profile record Added section for creating a supplier Added section for creating supplier activities Added section for removal of probation status. (PAR-190) Added section for placing a supplier on probation. (PAR-190) Added section for disqualifying a vendor. (PAR-190) Changed minimum supplier score from 70% to 80% in section (PAR-186) Added # SCARs remaining open to section Quality score. 9/15/08 1/20/08 1/21/09 2/23/09 5/20/09 9/11/09 12/10/12 TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 20 11/30/2015

21 9 M. Pelamoko Added section for Non-Raw Material Evaluation Added section for Packaging Qualification Added a note after for consulting with suppliers about the qualification Updated the flowchart to reflect changes to the process 10 M. Pelamoko In 4.0, added definitions for Level 2 and Level 3 suppliers In 5.0, added graphic displaying a summary of supplier requirements Changed from "Supplier quality representative may elect to perform additional supplier monitoring" to "supplier performance shall be reviewed by Quality, Purchasing, and key manufacturing personnel at least once a quarter" Added requiring up-to-date certifications from suppliers Removed which required that plan approval be approved for Raw Material Evaluation Added which requires that records of raw material and non-raw evaluations be archived in the supplier database as miscellaneous activity 11 M. Pelamoko As result of PAR-323, added verbiage requiring a copy of Table Contents of Supplier's Quality Manual or suitable document in M. Pelamoko Changed the definition of level 2 supplier to include suppliers not supplying environmental services nor support of raw or direct materials Changed definition of level 3 supplier from non-manufacturing support suppliers to environmental supplier Updated key in the beginning of section 5.0 to reflect the changes to the supplier definitions Added a link for Environmental Services Supplier Qualification TT-WI M. Pelamoko Changed the supplier performance from monthly to quarterly in section in due to CAR-726 Add a note to section 6 requiring the author to ensure that paper distribution of the work instruction is at correct revision due to CAR M. Pelamoko Added a definition of contract manufacturer in section 4.0 Changed the Specially Designated Supplier from N/A to selecting yes for contract manufacturer and no otherwise in Changed the scoring in from quarterly to monthly due to inclusion of contract manufacturer Added section indicating that scorecard shall be sent to contract manufacturer every month 12/29/13 4/18/14 11/4/14 5/27/15 6/29/15 11/16/15 Last Review Date : 09/20/ Electronic Notification List: TT DOCCNTL, Kim Hope, Kelly A Wauls 11.0 Approvals: Note: You may click on an approvers name to see the entire list of allowed approvers for that signature. First Approver's Signature Name: Sabrina L Winpigler 11/26/ Final Approval by: Anonymous TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 21 11/30/2015

22 Title: Director of Quality Assurance Second Approver's Signature Name: Tom E Arnold Title: Strategic Sourcing Manager 11/19/ Final Approval by: Tom E Arnold Third Approver's Signature Name: Gary G Moore Title: Controller 11/19/ Final Approval by: Gary G Moore Fourth Approver's Signature Name: Myra T Cope Title: In-Process Control Monitor 11/30/ Final Approval by: Myra T Cope Fifth Approver's Signature Name: Gary A Gillette Title: Powder Process Engineer 11/19/ Final Approval by: Gary A Gillette TT-WI-0137; Rev: 15 - Supplier Qualification and Monitoring Page 22 11/30/2015