04/10/15 The details stipulated in this manual are intended as the minimum mandatory requirements for approved production goods and service supplied to X-L Machine Company. Our focus includes a commitment from suppliers of production parts a nd services, and are chosen to provide timely, valued goods and services. Win/win relationships strengthened by success remain a cornerstone in meeting changing customer expectations. QM-Supplier M:/ISO-TS Procedures/Manuals Rev. Level A Date: 04/10/15 1 P age
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TABLE OF CONTENTS I. POLICY---------------------------------------------------------------------------------------------------------------------------------------- 2 i. REQUIREMENTS FOR SUPPLIER APPROVAL ----------------------------------------------------------------------- 4 SUPPLIER APPROVAL ----------------------------------------------------------------------------------------------- 4 SUPPLIER QUALITY SELF ASSESSMENT -------------------------------------------------------------------5-8 PRE-AWARD SUPPLIER -------------------------------------------------------------------------------------------- 9 SUPPLIER QUALITY SURVEY AND CHECKSHEET -------------------------------------------------------- 10 PLANNING FOR PRODUCTS AND SERVICE QUALITY --------------------------------------------------- 11 SPECIAL CHARACTERISTICS ------------------------------------------------------------------------------------ 11 ENGINEERING AND PROTOTYPE SUBMISSION ----------------------------------------------------------- 11 MANUFACTURING PROCESS REVIEW ------------------------------------------------------------------------ 11 PPAP -------------------------------------------------------------------------------------------------------------------11-12 SUPPLIER PPAP CHECKLIST --------------------------------------------------------------------------------------13 VERIFICATION AND REVIEW OF PURCHASED PRODUCT ----------------------------------------------14 WARRANTY --------------------------------------------------------------------------------------------------------------14 CHANGES TO APPROVED PRODUCT AND PROCESSES ------------------------------------------------14 ii. MANUFACTURING CONTROL REQUIREMENTS -------------------------------------------------------------------- 14 NONCONFORMANCE ------------------------------------------------------------------------------------------------ 14 ADMINISTRATIVE CHARGES -------------------------------------------------------------------------------------- 14 CONTAINMENT ----------------------------------------------------------------------------------------------------------14 NONCONFORMANCE REPORT------------------------------------------------------------------------------------ 15 DEVIATION --------------------------------------------------------------------------------------------------------------- 16 CONFORMANCE / CAPABILITY ------------------------------------------------------------------------------------16 DIES, PATTERNS, SPECIAL TOOLING ----------------------------------------------------------------------16-17 GAGES -------------------------------------------------------------------------------------------------------------------- 17 PRODUCT IDENTIFICATION AND PACKAGING --------------------------------------------------------------17 iii. ACKNOWLEDGEMENT PAGE ---------------------------------------------------------------------------------------------- 18 3 P age
II. REQUIREMENTS FOR SUPPLIER APPROVAL AND MANUFACTURING PLANNING Supplier Responsibility: The supplier shall resolve all questions relating to fulfillment of the contract before accepting purchase order. Suppliers shall provide and maintain a controlled system, which shall assure all materials conform to purchase order requirements whether manufactured or processed by you or a subcontractor. Suppliers shall perform all inspections and tests, required for sustaining product conformance to drawings, specifications, and purchase orders, and any other customer specific requirements. The supplier's quality system to control products shall be documented and be available for review by X-L Machine representatives prior to the initiation of production and throughout the life of the purchase order. The supplier's responsibility extends from their supplier base through all manufacturing and assembly to the ultimate end user. X-L Machine requires that its suppliers acknowledge that achievement of Zero defects is a fundamental objective for quality and delivery performance. Supplier Approval Present and potential suppliers to X-L Machine Company must operate within a specified quality system or a formalized plan must be provided and approved. Suppliers shall provide written confirmation and evidence of Third Party Certification. Noncompliant quality systems must conform to the requirements specified in the following AIAG reference manuals: APQP, PPAP, FMEA, MSA, SPC, and X-L Machine Company s Supplier Quality Manual and any additional requirements communicated by X-L Machine as our needs and customer needs change. X-L Machine Company s representative will provide a Supplier Quality Self- Assessment Survey. This form is intended to provide a general understanding of suppliers facility and quality system. This form is to be completed and will be reviewed by X-L Machine Company s representatives. Suppliers maintaining Third Party Registration must furnish a copy of the certification along with an Organizational Chart and a 24-hour Contact List. This must include mailing address, email, phone, extension, and cell numbers, and 24-hour emergency contact. 4 P age
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Pre-Award Supplier Quality Survey An onsite audit may be conducted by an X-L Machine Company representative to obtain facts and make judgement on the potential supplier s quality system and their ability to meet contractual specifications and delivery schedules. All present and potential suppliers offering new products or services shall be required to have a meeting prior to purchase order release unless deviated by X- L Machine Company. Evidence of the items listed on the check sheet must be made available upon request. Supplier Pre-Award check sheet is located on the following page. 9 P age
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Planning for Product and Service Quality X-L Machine Company s CORE Team utilizes the APQP process to ensure effective quality planning and production part approval processes. Suppliers are expected to document and communicate regular APQP status reports and comply with PPAP requirements and X-L Machine Company s specific requirements. a.) Plan to meet and exceed customer expectations both internal and external. b.) All potential real risks that affect product integrity. c.) d.) e.) All opportunities to incorporate error-proofing techniques, in accordance with zero defect objectives. Early identification of changes in product or manufacturing processes. Adherence to minimum required capabilities for all product significant characteristics. Special Characteristics The Supplier shall apply statistical techniques to all X-L Machine Company s and OEM product that has designated Special Characteristics. Statistical analysis should also be used for supplier designated key product characteristics and process parameters. Process potential studies shall be evaluated to minimum acceptance criteria of Ppk 1.33 or greater. Process capability studies shall evaluate to a minimum acceptance of Cpk 1.67 or greater. Product characteristics for which reasonably anticipated variations could significantly affect safety or compliance standards, codes, and regulations is likely to affect customer satisfaction. For this reason, X-L Machine Company recommends that whenever possible, the measurement test equipment utilized to verify and control product characteristics be variable in nature. KPC s, Critical Characteristics, and Special Characteristics require SPC. Engineering and Prototype Submission The supplier for engineering validation testing to X-L Machine Company shall submit engineering prototype parts with documentation of specific conformance. Each sample or prototype, at a minimum must be accompanied by a complete dimensional report, material test report, and performance test result report as described in the AIAG PPAP Manual. Specific instructions, in addition to the stated requirements, will be agreed upon and documented in the Supplier Check Sheet. The supplier shall provide an engineering drawing that identifies each specification and/or characteristics. The supplier shall notify X-L Machine Company prior to shipping of the samples and results form. Each sample shall be clearly identified. Manufacturing Process Review At the discretion of X-L Machine Company, a systematic review of suppliers manufacturing process may be conducted at the supplier s facility prior to PPAP submission. These reviews are known as Run @ Rates. The process to be utilized 11 P age
for the review may be customer specified process as determined by X-L Machine Company s CORE team. This review, if required, will be completed as part of the APQP for new products. Production Part Approval Process (PPAP) Prior to PPAP submission, supplier qualification and approval, a review and evaluation of the supplier quality management system is conducted and supplier is found to meet minimum qualifications and requirements. X-L Machine Company will submit a PPAP check sheet to the supplier to communicate the PPAP requirements prior to production needs. The supplier shall include a copy of the PPAP check sheet with the submittal of the PPAP package. The supplier shall produce the PPAP parts on production intent machines, tooling, fixtures, and etcetera. All testing and evaluation that is required as indicated on the PPAP check sheet must be completed. If any items are not compliant with requirement, the supplier shall contact X-L Machine Company Quality department before submitting the PPAP package. The supplier is responsible for associated costs of evaluating nonconforming samples resulting in PPAP rejection. The cost of any PPAP rejection may be reported on a Non-Conformance Report and may affect the supplier s quality performance rating. X-L Machine Company s Quality department will evaluate the PPAP submission, based on review of product being submitted and will sign off on the package indicating concurrence with disposition or additional requirements needed. The disposition options are Approved, Interim, and Rejected. a.) If the disposition is Approved, a representative from the X-L Machine Company s Quality team will indicate the approval by checking the Approved box and signing the Part Submission Warrant. b.) If the disposition is Interim, a representative from the X-L Machine Company s Quality team will indicate the approval by checking the Other box and writing Interim and signing the Part Submission Warrant. The Interim will allow a limited authorization for shipments to X-L Machine Company. The supplier may be required to submit a deviation request if required for PPAP deviation. All Interim dispositions require a corrective action plan. The corrective action plan is submitted to the X-L Machine Company s Quality representative. The Quality representative will review the corrective action and reissue the PPAP Submission check sheet for resubmission. c.) If the disposition is Rejected, a representative from the X-L Machine Company s Quality team will indicate the rejection by checking the Rejected box and documenting the a details of the rejection, as well as, signing the bottom of the Part Submission Warrant. All Rejected dispositions require a corrective action plan. The corrective action plan is submitted to the X-L Machine Company s Quality representative. The Quality representative will review the corrective action and reissue the PPAP Submission check sheet for resubmission. The supplier shall resubmit all PPAP submissions, for all products supplied to X-L Machine Company on an annual basis from the last PPAP approval. 12 P age
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Verification and Review of Purchased Product The supplier shall allow both X-L Machine Company and customers the right to verify the supplier s premises where the product and subcontracted product conform to specific requirements. Prior to conducting such reviews, the responsible X-L Machine Company s contact shall supply an agenda prior to the visits. Warranty Requirements for warranty are identified in X-L Machine Company s purchase orders. X-L Machine Company may review/identify additional specific warranty requirements on the supplier check sheet. Changes to Approved Product and Processes X-L Machine Company must give written approval prior to product or process changes. All changes must follow AIAG PPAP requirements. II. Manufacturing Control Requirements Nonconformance A Non-Conformance Report is issued when X-L Machine Company receives material or service that fails to meet applicable quality or delivery specification. The Supplier is expected to maintain Zero Defects and 100% On-Time Delivery. Within 24 hours of receipt of the nonconforming report, the supplier is required to submit a formal, interim corrective action plan to X-L Machine Company s Quality department. At a minimum, this should include the problem description, immediate containment actions, and certification identification. A completed corrective action plan must be submitted 14 days after receipt of the nonconformance report. All cost associated with shipping, handling, processing, warranty, reworking, inspecting, and replacing defective material including the cost of value added operations prior to discovery shall be charged and paid by the supplier. Each notice will include an administrative fee of $300.00 USD and a cost recovery rate for hourly labor rate is $60.00 USD per hour. X-L Machine Company s suppliers are responsible for the control, nonconformance, and continuous improvement efforts of its sub-suppliers. Annually, the supplier must review the sub-supplier controls, quality management systems, and improvement plans. X-L Machine Company suppliers shall require their suppliers to conform to this manual and customer specific requirements. X-L Machine reserves the right to visit sub suppliers as required. Containment Suppliers who are notified that they have been placed on containment status, due to continued poor performance and/or failure to achieve goals and objectives, will be required: a.) To establish and communicate to X-L Machine a plan to containment. b.) To communicate the manner in which product shall be identified as quality assured/inspected by container and individual product. c.) To provide on-site support, as required, as part of the containment action. d.) To accept alternate costs associated with shipping, handling, processing, reworking, inspecting, warranty, and replacing value added operations prior to the discovery of the non-conformance. 14 P age
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Deviation Occasionally suppliers question whether non-conforming product at their location can be used, reworked, scrapped, or sorted. The supplier shall isolate nonconforming product at their location and requests a Temporary Deviation Request, along with pictures and product samples to X-L Machine Company s Quality department. If X-L Machine Company approves the deviation, the deviation is valid for a specific time period and or quantity. If the disposition is rejected, the supplier is not authorized to ship non-conforming product. Conformance / Capability A signed certificate of conformance, certificate of analysis, and or capability data summary may be required to accompany each shipment of specified components or material. The certificate must contain the actual result of physical testing and or measurement specified by contract. At a minimum, SPC data must be documented on special/critical/control characteristics. Specific guidance will be given by X-L Machine Company during the supplier review check sheet meeting. Dies, Patterns, Special Tooling The supplier shall establish preventive/predictive maintenance procedures on all tooling. Records and maintenance schedules and tool history shall be documented and available on request. Evidence of procedure execution shall be made available upon request. All tooling shall be permanently marked so that ownership of item is visually apparent. The supplier shall establish a production lot of the completed units from new tooling that will be supplied to X-L Machine Company for thorough analysis and inspection after PPAP samples are approved and before start of continuous production. Where and when all suppliers furnishing parts or components which have a stipulation of Material Certification Required, must finish proper documentation when submitting PPAP samples, special prototype runs, pilot lot quantities, and production lot quantities. X-L Machine Company is the legal owner of any specified tooling and reserves the right to remove the specific tools at any time following completion of the original order or in the event the supplier is unable to product due to labor difficulties, or any other valid reason without charge. It is understood that individual parts will be checked for compliance to X-L Machine Company s specifications, and if delivered parts differ from approved samples, they are the responsibility of the supplier. The supplier agrees to maintain, preserve in good working condition the molds, dies, patterns, gages, and fixtures at the suppliers expense, thereby producing acceptable parts to X-L Machine specifications and assumes the responsibility for the custody of said terms. The supplier s liability is for routine tooling maintenance and includes normal wear, which may require replacement of major components. A reproducible copy of all tool drawings for molds, dies, or patterns should be sent to X-L Machine Company prior to submission of PPAP Samples. Approval will not be given until drawings are received. 16 P age
When current molds, dies, patterns, or fixtures are revised in any way, an updated copy of the tool drawing must be received with first article inspection samples for the given change. Prior to any change to the drawing, the supplier must submit a written request to X-L Machine Company s Quality department for approval. The appropriate X-L Machine Company representative must approve tool design for new or replacement tool construction. Gauges The supplier will provide two hard copies of detailed gauge drawings for concept approval by an X-L Machine Company representative. The X-L Machine Company representative will sign both prints and return one to supplier with approval or marked with needed changes. A gage number will be assigned, at the appropriate time, to be added to the format and gage label of the gage print as appropriate by the supplier. If the gage print needs changes, resubmission to X-L Machine Company is needed for final approval and is required. The supplier will provide the final accepted gage design via approved CAD file to X-L Machine Company. The supplier will procure gages that provide the final acceptable gage quality standards (AIAG Gage R&R Capability Methods, Industrial Gage Maker Tolerance). It is the responsibility of the supplier to assure gages meet all design requirements. The supplier is solely responsible for correcting all gage discrepancies. Gage must be accepted and readily available before PPAP parts are submitted, all gages will be used as an integral part addition to the normal dimensional layout of the PPAP inspection for all new parts. The supplier is responsible to perform gage calibration at specified intervals and will keep records of all calibration. All records shall be available to X-L Machine Company upon request. Replacement of damaged or worn out gages is the responsibility of the supplier. Product Identification and Packaging Each container shall be identified as instructed or approved by X-L Machine Company. Any unique requirements will be communicated on the Supplier PPAP Submission check sheet. Identification shall permit traceability back to a specific supplier manufacturing site and inspection record. Safety regulated identification criteria shall conform, at a minimum, to all legal, and or X-L Machine Company or customer s specific requirements. No exceptions to this requirement shall be permitted unless acknowledgement, in writing, by an X-L Machine Company representative. In order to ensure the suppliers products are transported in a manner that prevents damage, deterioration, etcetera, suppliers are responsible for maintaining written instructions, detailing proper, packaging, storage, and shipping of its products that confirm to X-L Machine Company requirements. 17 P age
We acknowledge the receipt and requirements of X-L Machine Company s Supplier Quality Manual (SQM), revision A, 04/10/15. Supplier Company Name: Supplier Representative: Representative Position: Date: Received By: X-L Machine Company Representative: Representative Position: Date: 20481 Highway M-60, Three Rivers, MI 49093 ph. 269-279-5128 www.xlmachine.net 18 P age