Search Trigger Header Search Field English Terms And Conditions Contents Terms and Conditions of Sale – U.S.A. Terms and Conditions of Sale – Europe Terms and Conditions of Purchase Supplier Quality Assurance Requirements Manual Terms and Conditions of Sale – U.S.A. The following Terms and Conditions (this “Agreement”) apply to the sale of all Bal Seal Engineering products, materials and services. The items sold by Bal Seal Engineering, are referred to singularly as “Product” and collectively as “Products”. Bal Seal Engineering, LLC is referred to as the “Seller” and the Customer is referred to as the “Buyer.” 1. Prices The price of the Product is printed on the quotation or on Seller’s acceptance of Buyer’s order. The cost of packing and shipping (and insurance, if required) is an additional charge and will be added to the Invoice. Prices quoted are based on known Buyer requirements and conditions at the time of the quotation. Pricing is subject to change for new requirements or conditions. 2. Delivery Seller will ship Product at the earliest possible date unless otherwise specified in Buyer’s Purchase Order. Delivery will be F.O.B. Seller’s facility in Foothill Ranch, CA. Seller’s shipment of quantities between 95% and 100% of the quantity ordered shall be deemed compliant with the order and Buyer shall be obligated to pay for the quantity actually shipped not to exceed 100%. Seller’s weights taken at shipping point shall govern. Seller reserves the right to route shipments. If Seller cannot fulfill the order due to any cause beyond Seller’s reasonable control, including, but not limited to the following: natural disaster, casualty, labor disputes, accidents, or unavailability of supplies or transportation, the estimated delivery time will be extended accordingly and Seller will not be liable to Buyer for any damages caused by the delay. 3. Payment Subject to prior credit approval, Buyer shall make payment in U. S. currency within thirty (30) days after the date of Seller’s invoice. Payments not received when due will incur a late payment charge that will be computed at the rate of one and one‐half percent (1.5%) of the amount due per month or the highest rate allowed by law. Buyer shall be liable for all attorneys’ fees and costs incurred in connection with collecting any amounts past due, including but not limited to, pre‐litigation and litigation fees and costs. Buyer shall be assessed a base handling fee for any Buyer’s check which is not honored by the bank for any reason. Thereafter, Seller may, at its option, require that all future payments by Buyer be made by COD. If, in Seller’s judgment, reasonable doubt exists as to Buyer’s financial responsibility, or if Buyer is past due in payment of any amount owing to Seller, Seller reserves the right, without liability and without prejudice to any other remedies, to suspend performance, decline to ship, or stop any material or Products in transit, until Seller receives payment of all amounts owing to Seller. 4. Taxes Seller’s price does not include any taxes, brokerage fees, or duties. Buyer is liable for all taxes, brokerage fees, and duties, whether invoiced by Seller or not. 5. Changes Seller will notify Buyer in writing of changes that involve form, fit or function in the manufacture of Product, but reserves the right to make other changes without notice unless mutually agreed upon between Buyer and Seller. 6. Returns No returns can be made without the authorization of Seller. All returns shall be in accordance with Seller’s specific shipping instructions. 7. Warranty Limited Warranty and Remedies: Seller warrants that Product sold here under shall be of merchantable quality and shall conform to the attached specifications, if any, and otherwise to Seller’s standard specifications for such Product, and manufactured to the required specifications for such Product. Upon payment of the purchase price, Buyer will receive good title to such Products free from any lien or encumbrance. SELLER MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AND SELLER EXPRESSLY DISCLAIMS ANY WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, AND ALL OTHER WARRANTIES ARE HEREBY EXPRESSLY EXCLUDED. Buyer’s sole and exclusive remedy for breach of warranty or contract shall be the repair or replacement of defective Product, or, at Seller’s option, to refund the purchase price; provided (1) Product has not been altered, damaged, or modified; (2) Product has been properly stored, installed, maintained, and operated; (3) Product has not been stored more than 6 months; and (4) Buyer promptly notifies Seller of any defect, and returns Product to Seller within 45 days of notice of defect, freight prepaid. Defective Product replaced by Seller shall become the property of Seller. Repaired or replacement Product will be shipped to Buyer F.O.B. Buyer’s facility. Product not found defective shall be shipped back to Buyer F.O.B. Seller’s facility. Seller is not responsible for any charges relating to warranty work that has not been authorized by Seller in writing. If Seller, without separate compensation, furnishes Buyer with advice or other assistance concerning any Product or any system or equipment in which any such Product may be installed, the furnishing of such advice or assistance will not subject Seller to any liability whether in contract, tort (including negligence and strict liability) or otherwise. Buyer will indemnify and hold harmless Seller from and against all damages, losses, claims, and expenses, including attorney fees, incurred by Seller as a result of: 7.1. Incorporation of the Product into another product, 7.2. Any breach by Buyer of any of its obligations under these terms of sale, or 7.3. Any claimed unfair competition or patent, trademark, or copyright infringement or any other claim resulting from Seller’s manufacture of goods to Buyer’s specifications. 8. Cancellation Orders accepted by Seller are not subject to cancellation except with Sellers consent and after arrangement of terms which will indemnify Seller for any losses or damages including lost profit occasioned by such cancellation. Buyer shall be responsible for all costs incurred in executing a Product order, up to the time of cancellation. 9. Applicable Law This Agreement shall be governed by and shall be construed according to the laws of the State of California. All claims relating to this Agreement or to the Products shall be brought exclusively in the Federal or State courts of the County of Orange, State of California. 10. Confidentiality The design and specifications of the Products are proprietary to Seller and may not be disclosed by Buyer to any third parties or used by Buyer other than as provided herein. Buyer is granted a conditional, non‐exclusive, royalty‐free license to sell/use Seller’s Products provided the Products are purchased by Buyer from Seller.” 11. Patent Marking Where a Product (or Product packaging) is marked by Seller with patent or patent application references, Buyer is requested to also mark its products which incorporate Seller’s Product with those same patent references.” 12. Quality Standards Seller’s standard specifications for product and quality assurance protocols are designed to comply with general industry quality standards. Buyer requirements for special quality assurance protocols may necessitate a commercial negotiation to satisfy both parties. 13. Merger The terms set forth herein constitute the sole terms and conditions upon which Seller offers the Products for sale. No other terms, conditions, or understanding, whether oral or written, shall be binding upon Seller, unless hereafter made in writing and signed by an Officer of the Seller. Seller hereby specifically objects to any different or additional terms that may be contained in Buyer’s request or quotation, purchase order, or any other offer or counter‐offer. © Bal Seal Engineering, LLC LE-186-K, 20-Feb-2020 Terms and Conditions of Sale – Europe The following Terms and Conditions apply to all sales of Bal Seal Engineering products and services specifically sold in Europe. The items sold by Bal Seal Engineering are referred to as “Goods” or “Products” (the term Products may include Seller services). Bal Seal Engineering is referred to as the “Seller” and the Customer is referred to as the “Buyer.” 1. General Agreement If Buyer has not otherwise agreed to these terms and conditions of sale, Buyer’s acceptance of delivery or payment for the Goods will constitute Buyer’s agreement to these terms. No modification of, addition to, or waiver of, any of these terms and conditions will be effective unless agreed to in writing by an authorized representative of Seller. 2. Payment Subject to prior credit approval, Buyer shall make payment in the currency of invoice within the payment terms of Seller’s invoice. Payments not received when due will incur a late payment charge that will be computed at the rate of one and one-half percent (1.5%) of the amount due per month or the highest rate allowed by law. Buyer shall be liable for all attorneys’ fees and costs incurred in connection with collecting any amounts past due, including but not limited to, pre-litigation and litigation fees and costs. Buyer shall be assessed a base handling fee for any Buyer check which is not honored by the bank for any reason. Thereafter, Seller may, at its option, require that all future payments by Buyer be made by wire transfer. If, in Seller’s judgment, reasonable doubt exists as to Buyer’s financial responsibility, or if Buyer is past due in payment of any amount owing to Seller, Seller reserves the right, without liability and without prejudice to any other remedies, to suspend performance, decline to ship, or stop any material or Products in transit, until Seller receives payment of all amounts owing to Seller. 3. Prices The price of the Product is printed on the Seller’s invoice. The cost of packing and shipping (and insurance, if required) is an additional charge and will be added to the Invoice. Prices quoted are based on known Buyer requirements and conditions at the time of the quotation. Pricing is subject to change. 4. Taxes Seller’s price does not include any taxes, brokerage fees, or duties. Buyer is liable for all taxes, brokerage fees, and duties, whether invoiced by Seller or not. 5. Delivery Seller will ship Product at the earliest possible date unless otherwise specified in Buyer’s Purchase Order. Seller’s shipment of quantities between 95% and 105% of the quantity ordered shall be deemed compliant with the order and Buyer shall be obligated to pay for the quantity actually shipped not to exceed 105%. Seller’s weights taken at shipping point shall govern. Seller reserves the right to route shipments. If Seller cannot fulfill the order due to any cause beyond Seller’s reasonable control, including, but not limited to the following: natural disaster, casualty, labor disputes, accidents, or unavailability of supplies or transportation, the estimated delivery time will be extended accordingly and Seller will not be liable to Buyer for any damages caused by the delay. 6. Changes Seller will notify Buyer in writing of changes that involve form, fit or function in the manufacture of Product, but reserves the right to make other changes without notice unless mutually agreed upon between Buyer and Seller. 7. Returns No returns can be made without the authorization of Seller. All returns shall be in accordance with Seller’s specific shipping instructions. 8. Warranty Limited Warranty and Remedies: Seller warrants that Product sold hereunder shall be of merchantable quality and shall conform to the attached specifications, if any, and otherwise to Seller’s standard specifications for such Product and manufactured to the required specifications for such Product. Upon payment of the purchase price, Buyer will receive good title to all such Products free from any lien or encumbrance. SELLER MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AND SELLER EXPRESSLY DISCLAIMS ANY WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, AND ALL OTHER WARRANTIES ARE HEREBY EXPRESSLY EXCLUDED. Buyer’s sole and exclusive remedy for breach of warranty or contract shall be the repair or replacement of defective Product, or, at Seller’s option, to refund the purchase price; provided: 8.1 Product has not been altered, damaged, or modified; 8.2 Product has been properly stored, installed, maintained, and operated; 8.3 Product has not been stored more than 6 months; and 8.4 Buyer promptly notifies Seller of any defect, and returns Product to Seller within 45 days of notice of defect, freight prepaid. Defective Product replaced by Seller shall become the property of Seller. Repaired or replacement Product will be shipped to Buyer Ex-Work-Buyer’s facility. Seller is not responsible for any charges relating to warranty work that has not been authorized by Seller in writing. If Seller, without separate compensation, furnishes Buyer with advice or other assistance concerning any Product or any system or equipment in which any such Product may be installed, the furnishing of such advice or assistance will not subject Seller to any liability whether in contract, tort (including negligence and strict liability) or otherwise. 9. lndemnity Buyer will indemnify and hold harmless Seller from and against all damages, losses, claims, and expenses, including attorney fees, incurred by Seller as a result of: 9.1 incorporation of the Product into another product, 9.2 any breach by Buyer of any of its obligations under these terms of sale, or 9.3 any claimed unfair competition or patent, trademark, or copyright infringement or any other claim resulting from Seller’s manufacture of goods to Buyer’s specifications. 10. Applicable Law This Agreement shall be governed by and shall be construed according to the laws of The Netherlands. All claims relating to this Agreement or to the Products shall be brought exclusively in the courts of The Netherlands. 11. Cancellation Orders accepted by Seller are not subject to cancellation except with Sellers consent and after arrangement of terms which will indemnify Seller for any losses or damages including lost profit occasioned by such cancellation. Customer shall be responsible for all costs incurred in executing a Product Order, up to the time of cancellation. A minimum charge of 500 Euros will be applied for all cancelled orders in addition to cost of products delivered. 12. Confidentiality Products are the subject of issued or pending United States and foreign patents. Products of the Seller are Proprietary and may not be manufactured, reverse engineered or caused to be manufactured, by any other party. The designs and specifications of the Products are Proprietary to Seller and may not be disclosed by Buyer to any third party or used by Buyer other than as provided herein. © Bal Seal Engineering Europe BV LE-187-E, 20-Feb-2020 Terms and Conditions of Purchase 1. ACCEPTANCE: Seller has read and understands this order and agrees that Seller’s written acceptance or commencement of any work or service under this order shall constitute Seller’s acceptance of these terms and conditions only. All terms and conditions proposed by Seller which are different from or in addition to this order are unacceptable to Buyer; are expressly rejected by Buyer, and shall not become part of this order, unless agreed to in writing by an officer of Buyer. 2. SHIPPING AND BILLING: Seller agrees: (a) to properly pack, mark and ship goods in accordance with the requirements of Buyer and involved carriers in a manner to secure lowest transportation cost; and (b) to make no charge for handling, packaging, storage or transportation of goods unless otherwise stated in this order. 3. DELIVERY SCHEDULES: Deliveries shall be made both in quantities and at times specified in Buyer’s schedules. Buyer shall not be required to make any payment for goods delivered to Buyer which are in excess of quantities specified in Buyer’s delivery schedules. Buyer may change the rate of scheduled shipments or direct temporary suspension of scheduled shipments, neither of which shall entitle Seller to a modification of the price for goods or services covered by this order. 4. PREMIUM SHIPMENTS: If Seller’s acts or omissions result in Seller’s failure to meet Buyer’s delivery requirements and Buyer requires a more expeditious method of transportation for the goods than the transportation method originally specified in Buyer’s delivery schedules. Buyer may change the rate of scheduled shipments or direct temporary suspension of scheduled shipments, neither of which shall entitle Seller to a modification of the price for goods or services covered by this order. 5. CHANGES: Buyer reserves the right at any time to direct changes or cause Seller to make changes, to drawing and specifications of the goods or to otherwise change the scope of the work covered by this order, including work with respect to such matters as inspection testing or quality control and Seller agrees to promptly make such changes; any difference in price or time for performance resulting from such changes shall be equitably adjusted by Buyer after receipt of documentation in such form and detail as Buyer may direct. A. Seller agrees to make no change to product and/or process to make such product supplied to Bal Seal without prior written approval from Bal Seal’s VP of Quality Assurance or an Executive Officer of Bal Seal. 6. NONCONFORMING GOODS: To the extent Buyer rejects goods as nonconforming, the quantities under this order will automatically be reduced unless Buyer otherwise notifies Seller. Seller will not replace quantities so reduced without a new order or schedule from Buyer. Nonconforming goods will be held by Buyer for disposition in accordance with Seller’s instructions, at Seller’s risk. Seller’s failure to provide written instructions within ten (10) days, or such shorter period as may be commercially reasonable under the circumstances, after notice of nonconformity shall entitle Buyer, at Buyer’s option, to charge Seller for storage and handling, or to dispose of the goods, without liability to Seller. Payment for nonconforming goods shall not constitute an acceptance, limit or impair Buyer’s right to assert any legal or equitable remedy, or relieve Seller’s responsibility for latent defects. 7. WARRANTY: Seller warrants the goods and services covered by this order unconditionally for a period of not less than one (1) year from receipt by Buyer, unless a different period is agreed in writing between Seller and Buyer. Seller also warrants that all goods or services covered by this order will conform to the specifications, drawings, samples, or descriptions furnished to or by Buyer, and will be merchantable, of good material and workmanship and free from latent defects. In addition Seller acknowledges that Seller knows of Buyer’s intended use and expressly warrants that all goods covered by this order which have been selected, designed, manufactured, or assembled by Seller, based upon Buyer’s stated use, will be fit and sufficient for the particular purpose intended by Buyer. 8. CANCELLATION FOR BREACH: Buyer reserves the right to cancel all or any part of this order, without liability to Seller, if Seller (a) repudiates or breaches any of the terms of this order, including Seller’s warranties; (b) fails to perform services or deliver goods as specified by Buyer; or (c) fails to make progress so as to endanger timely and proper completion of services or delivery of goods, and does not correct such failure or breach within ten (10) days (or such shorter period of time if commercially reasonable under the circumstances) after receipt of written notice from Buyer specifying such failure or breach. 9. TERMINATION: In addition to any other rights of Buyer to cancel or terminate this order, Buyer may at its option immediately terminate all or any part of this order, at any time and for any reason, by giving written notice to Seller. Upon such termination, Buyer shall pay to Seller the following amounts without duplication: (a) the order price for all goods or services which have been completed and delivered in accordance with this order and not previously paid for; and (b) the actual cost of work-in-process and raw materials incurred by Seller in furnishing the goods or services under this order to the extent such costs are reasonable in amount and are properly allocated or apportionable under generally accepted accounting principles to the terminated portion of this order, less, however, the reasonable value or cost (whichever is higher) of any goods or materials used or sold by Seller with Buyer’s written consent, and the cost of any damaged or destroyed goods or material. Buyer will make no payments for finished goods, work-in-process or raw materials fabricated or procured by Seller in amounts in excess of those authorized in delivery releases nor for any undelivered goods which are in Seller’s standard stock or which are readily marketable. Except as provided in this Paragraph, Buyer shall not be liable for and shall not be required to make payments to Seller, directly or on account of claims by Seller’s subcontractors, for loss of anticipated profit, unabsorbed overhead, interest on claims, product development and engineering costs, facilities and equipment rearrangement costs or rental, unauthorized depreciation costs, and general and administrative burden charges from termination of this order. Within sixty (60) days from the effective date of termination, Seller shall submit a comprehensive termination claim to Buyer, with sufficient supporting dates to permit Buyer’s audit, and shall thereafter promptly furnish such supplemental and supporting information as Buyer shall request. Buyer, or its agents, shall have the right to audit and examine all books, records, facilities, work, material, and other items relating to any termination claim of Seller. 10. INTELLECTUAL PROPERTY: Seller agrees: (a) to defend, hold harmless and indemnify Buyer, its successors and customers against all claims, demands, losses, suits, damages, liability and expenses (including reasonable attorney fees) arising out of any suit, claim or any action for actual or alleged direct or contributory infringement of inducement to infringe, any United States or foreign patent, trademark or copyright, or mask work right by reason of the manufacture, use or sale of the goods or services ordered, including infringement arising out of compliance with specifications furnished by Buyer, or for actual or alleged misuse or misappropriation of a trade secret resulting directly or indirectly from Seller’s actions; (b) to waive any claim against Buyer under the Uniform Commercial Code or otherwise, including any hold harmless or similar claim, in any way related to a claim asserted against Seller or Buyer for patent, trademark, copyright or mask work right infringements or the like, including claims arising out of compliance with specifications furnished by Buyer; and (c) to grant to Buyer a worldwide, nonexclusive, royalty-free, irrevocable license to repair and have repaired the goods ordered hereunder. 11. CONFIDENTIAL INFORMATION: During the course of this order, either party may have or may be provided access to the other’s confidential information and materials. Provided such are marked in a manner reasonably intended to make the recipient aware, or the recipient is sent written notice within forty-eight (48) hours of disclosure, that the information or materials are “Confidential”, each party agrees to maintain such information in accordance with the terms of this order or any applicable separate nondisclosure agreement between Buyer and Seller. In the absence of another written agreement, at a minimum each party agrees to maintain such information in confidence and limit disclosure on a need to know basis, to take all reasonable precautions to prevent unauthorized disclosure, and to treat such information as it treats its own information of a similar nature, until the information becomes rightfully available to the public through no fault of the non disclosing party. The parties agree that neither will disclose the existence of this order, nor any of its details or the existence of the relationship created by this order, to any third party without the specific, written consent of the other. 12. INDEMNIFICATION: Seller shall for itself and its assigns, indemnify and hold Buyer and its officers, directors, employees, and agents, harmless from and against any claims of any kind whatsoever, including reasonable attorneys fees and related expenses, which in any manner are caused by, arise from, or are incident to Seller’s performance of this Agreement. This includes, but is not limited to, contractual claims for breach; labor and employment law claims; governmental obligations, such as, but not limited to, obligations under the laws pertaining to social security, unemployment insurance, worker’s compensation, income tax and other reports, deductions, and withholdings required by state and federal law; and injury or death to persons and damage to property, except only claims caused solely by Seller’s negligence or willful misconduct. 13. INSURANCE: Seller shall maintain insurance coverage in amounts not less than the following: (a) Workers’ Compensation-Statutory Limits for the state or states in which this order is to be performed (or evidence of authority to self-insure); (b) Employer’s Liability – $250,000; (c) Comprehensive General Liability (including Products/Completed Operations and Blanket Contractual Liability) – $1,000,000 per person, $1,000,000 per occurrence Personal Injury, and $1,000,000 per occurrence Property Damage, or $1,000,000 per occurrence Personal Injury and Property Damage combined single limit, and (d) Automobile Liability (including owned, non-owned and hired vehicles)-$1,000,000 per person, $1,000,000 per occurrence Personal Injury and $1,000,000 per occurrence Property Damage, or $1,000,000 per occurrence Personal Injury and Property Damage combined single limit. At Buyer’s request Seller shall furnish to Buyer certificates of insurance naming Buyer as insured, setting forth the amount(s) of coverage, policy number(s) and date(s) of expiration for insurance maintained by Seller and, if further requested by Buyer, such certificates will provide that Buyer shall receive thirty (30) days prior written notification from the insurer of any termination or reduction in the amount or scope of coverage’s. 14. BAILED PROPERTY: All supplies, materials, tools, jigs, dies, gauges, fixtures, molds, patterns, equipment and other items furnished by Buyer, either directly or indirectly, to Seller to perform this order, or for which Seller has been reimbursed by Buyer, shall be and remain the property of Buyer. Seller shall bear the risk of loss of and damage to Buyer’s property. Buyer’s property shall at all times be properly housed and maintained by Seller; shall not be used by Seller for any purpose other than the performance of this order; shall be deemed to be personality; shall be conspicuously marked “Bal Seal Engineering, LLC” by Seller; shall not be commingled with the property of Seller or with that of a third person; and shall not be moved from Seller’s premises without Buyer’s prior written approval. Upon the request of Buyer, such property shall be immediately released to Buyer or delivered to Buyer by Seller, either: (i) F.O.B. transport equipment at Seller’s plant, properly packed and marked in accordance with the requirements of the carrier selected by Buyer to transport such property; or (ii) to any location designated by Buyer, in which event Buyer shall pay to Seller the reasonable cost of delivering such property to such location. Buyer shall have the right to enter onto Seller’s premises at all reasonable times to inspect such property and Seller’s records with respect thereto. 15. ATTORNEY FEES: The prevailing party in any action to enforce the obligations of either party hereunder shall be entitled to receive, in addition to any other recovery, attorney’s fees related to such enforcement. 16. OBSOLESCENCE AND SUPPORT: Seller shall ensure that any items sold hereunder shall be available, whether in their original form or as a replacement acceptable to Buyer, for a period of no less than seven (7) years after the sale of the first such item. Seller shall support all Items sold hereunder with adequate spare parts and service for the life of the items. 17. NON-ASSIGNMENT: Seller may not assign or delegate its obligations under this order without Buyer’s prior written consent. 18. GOVERNING LAW: This order is to be construed according to the laws of the state from which this order issues as shown by the address of Buyer on the face side of this order. 19. ENTIRE AGREEMENT: This order, together with the attachments, exhibits, or supplements specifically referenced in this order, constitutes the entire agreement between Seller and Buyer with respect to the matter contained herein and supersedes all prior oral or written representations and agreements. This order may only be modified by a purchase order amendment alteration issued by Buyer. If this order is for services, including non-recurring engineering, the following terms and conditions also apply: 20. NEW DEVELOPMENTS: A. Seller agrees that all inventions, improvements, developments, and discoveries conceived, made, or discovered by Seller solely or in collaboration with others, in the course of its development of deliverables for Buyer hereunder as well as all patents, copyrights, trade secrets, trademarks, and other intellectual property rights therein and thereto (collectively, “Developments”), are the sole property of Buyer. Seller agrees to assign (or cause to be assigned) and does hereby assign fully to Buyer all such Developments. B. Seller agrees to assist Buyer, or its designee, at Buyer’s expense, in every proper way to secure Buyer’s right in the Developments, including the disclosure to Buyer of all pertinent information and data with respect thereto and the execution of all applications, specifications, oaths, assignments, and all other instruments which Buyer may deem necessary in order to apply for and obtain such rights and in order to assign and convey to Buyer, its successors, assigns, and nominees the sole and exclusive rights, title, and interest in and to such Developments. Seller further agrees that Seller’s obligation to execute or cause to be executed, when it is in Seller’s power to do so, any such application, specification, oath assignment, or other instrument shall continue after the termination of this purchase order. Seller further agrees to assist Buyer in enforcing all patents, trademarks, copyrights, trade secrets, or other ownership rights to protect Buyer’s exclusive interest in Developments. C. Buyer acknowledges and agrees that Seller shall retain sole and exclusive ownership of, and/or unrestricted right to license, any invention, improvement, development, discovery, or other proprietary information owned by Seller or in which Seller has an interest (“Seller IP”). Notwithstanding the foregoing, Seller agrees that if in the course of performing hereunder, Seller incorporates any Seller IP into any Development developed hereunder, Buyer is hereby granted and shall have a nonexclusive, royalty free perpetual, irrevocable, worldwide license, including the right to sublicense, under any such Seller IP to make, have made, use, reproduce, sell, or otherwise distribute such Seller IP as part of or in connection with such Development. ©Copyright, Bal Seal Engineering, LLC LE-188, Rev. C, 20-Feb-2020 Supplier Quality Assurance Requirements Manual Section 1 – Overview 1. BAL SEAL ENGINEERING: Bal Seal provides its customers with innovative, custom-engineered sealing, connecting, conducting and EMI shielding and grounding solutions. Bal Seal Engineering’s quality policy is to provide its customers with products and services that meet or exceed their expectations. This is demonstrated by a commitment of continuous improvement and a strong emphasis on customer satisfaction and to provide on-time delivery with first-time quality. 2. PURPOSE: Bal Seal serves diverse market sectors, such as industrial, automotive, aerospace, defense, analytical, energy management, medical devices, and medical electronics. The purpose of this manual is to inform Bal Seal Suppliers of the core requirements we have regarding the Suppliers’ quality management systems, processes, and manufacturing process controls required for doing business with Bal Seal. This manual describes the requirements Bal Seal has of its Suppliers and to ensure that all Bal Seal requirements are communicated to its Suppliers. 3. SCOPE: This manual applies to all Suppliers providing Bal Seal with materials, products, processing, and related services, and when applicable, to Supplier sub-tier sources. The general requirements outlined herein do not supersede conflicting requirements in the Bal Seal contract, purchase order, or drawing, including applicable engineering specifications and process specifications, or applicable long term agreement(s). Questions concerning this manual should be directed to the Bal Seal purchasing or quality assurance team. 4. RESPONSIBILITIES: 4.1. Bal Seal suppliers are responsible for compliance to applicable sections of this document. 4.2. The Bal Seal Quality Assurance department is responsible for the maintenance and upkeep of this document. 4.3. The Bal Seal Purchasing Department is responsible for communicating the requirements of this document to applicable Bal Seal Suppliers. 4.4. The Bal Seal Purchasing and Quality Assurance departments share responsibility for Supplier qualification, monitoring, rating, and dis-qualification of Suppliers. 5. DEFINITIONS: Term Definition DCMA Defense Contract Management Agency IQ / OQ / PQ Installation Qualification / Operational Qualification, Process Qualification. Referenced in ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes May Means that the described action is permissible or discretionary PPAP Production Part Approval Process. Referenced in IATF 16949, Automotive Quality Management System Standard. Shall Means that the described action is mandatory Should Means that the described action is necessary and expected with some flexibility allowed in the method of compliance AQL Acceptable Quality Level DMR Discrepant Material Report CAR Corrective Action Request RFQ Request for Quote POA Purchase Order Amendment 6. REFERENCES: Document Document Title Available From ANSI/NCSL Z540.3 Requirements for the Calibration of Metrology and Test Equipment www.ansi.org AS 6174 Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel www.sae.org, www.asd-stan.org AS 9100 Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations www.sae.org, www.asd-stan.org FMEA Potential Failure Mode & Effects Analysis Manual www.ansi.org, www.aiag.org ISO 13485 Quality Management System Requirements (Medical) www.ansi.org, www.iso.ch ISO 9001 Quality Management System Requirements (General) www.ansi.org, www.iso.ch ISO 9004 Quality Management Systems – Guidelines for Performance Improvements, www.ansi.org, www.iso.ch ISO/IEC 17205 General Requirements for the Competence of Testing and Calibration Laboratories www.ansi.org, www.iso.ch IATF 16949 Automotive Quality Management System Standard www.ansi.org, www.aiag.org LE-170 Bal Seal Mutual Non-Disclosure Agreement Bal Seal Purchasing LE-188 Bal Seal Terms and Conditions of Purchase Bal Seal Purchasing MSA Measurement System Analysis Manual www.ansi.org, www.aiag.org PPAP Production Part Approval Process Manual www.ansi.org, www.aiag.org SPC Statistical Process Control Manual www.ansi.org, www.aiag.org Section 2 – General Requirements 1. Supplier Conduct · Suppliers shall ensure operations are being performed in a manner that is appropriate, as it applies to their ethical, legal, environmental, and social responsibilities. · Suppliers must adhere to the laws and regulations in the locality in which they reside. This includes all local, state, and federal laws/regulations in the country of origin. · The Supplier must maintain and operate its manufacturing/production facilities and processes in relation to environmental, health and safety in accordance with local, state, and federal laws/regulations in the country of origin. · The supplier shall ensure their employees are aware of these requirements and their contribution to product/service conformity. 2. Confidentiality – See LE-188 3. Source Inspection – Supplier’s products or services may be subject to source inspection by Bal Seal, representatives of Bal Seal, or applicable government or regulatory agencies. Source inspection requirements will be included on the contract/purchase order and may apply to any and all operations performed by the Supplier or the Supplier’s sub-tier sources, including prior to delivery of products to Bal Seal. The Supplier shall provide the necessary access, equipment and resources required to effectively accomplish the source inspection. Trade Secret information may limit this requirement. 4. Compliance to Contractual Requirements 4.1. Upon accepting a Bal Seal contract/purchase order, the Supplier is responsible for compliance to all contract (e.g., engineering drawing, specification, purchase order, etc.) requirements. All changes will be documented on a POA, Purchase Order Amendment. 4.2. All documents, drawings and specifications, regardless of origin, are applicable to the Supplier when specified in the contract or documents referenced in the contract, and are required to be used at all levels of the supply chain. 4.3. Unless otherwise specified in the contract, the document revision in effect on the date of issue of the contract applies to the contract. 4.4. Neither audit, surveillance, inspection nor tests made by Bal Seal, representatives of Bal Seal or its customer(s), at Supplier’s facilities, at any sub-tier facilities, or upon receipt at Bal Seal, relieves the Supplier of the responsibility to furnish acceptable products or services that conform to all contract requirements; nor does it preclude subsequent rejection by Bal Seal. 5. Supplier Approval 5.1. Bal Seal requires all products and services Suppliers to be approved prior to the issuance of contracts / purchase orders. All Suppliers shall be approved by Bal Seal, regardless of approvals by its customers or other entities. 5.2. QMS systems certified to ISO 9001, ISO/IATF 16949, AS9100, and/or ISO 13485 are preferred, and in some instances, may be required by Bal Seal. 5.3. The Supplier Approval Process may include the following, as determined by Bal Seal quality assurance: · Supplier Initial Assessment – Bal Seal may request the Supplier to provide a copy of its quality management system certificate and/or complete a self-assessment of its business and quality management system and capabilities (i.e., quality, delivery, technology, cost, and continuous improvement objectives). · Documentation Audit – In those cases where a Supplier’s quality management system has not been certified by an accredited certification body, Bal Seal may request a copy of the Supplier’s Quality Manual and supporting procedures (and perhaps internal audit reports) to determine if the Supplier’s quality management system meets Bal Seal requirements. · On-Site Assessment Audit – When a Supplier is certified to a QMS standard (ISO 9001, IATF 16949, AS9100, and/or ISO 13485) by an accredited certification body, Bal Seal may not conduct an on-site assessment of the Supplier’s quality management system against the same criteria. However, Bal Seal and/or its customers, due to product/process complexity or criticality, or nonconformance history, may elect to conduct on-site assessments of a Supplier’s product or process capabilities and effectiveness. As a result, findings may be issued. These assessments could include: a) Quality Management System (QMS) and/or Process Audit – if necessary, as a result of (or in conjunction with) product or process capability assessments, to determine whether the Supplier’s quality management system meets one or more of the applicable standards, and is functioning effectively. b) Business and Manufacturing Operations – to determine whether the Supplier has the financial resources, production capacity, and other business resources needed to fulfill Bal Seal volume production needs and continuity of supply. c) Continuous Improvement Initiative – to determine if the Supplier’s culture, methods and skills are present to actively pursue continuous improvement. d) Technology Assessment – to determine whether the Supplier has the needed technical resources, including production and inspection equipment, facilities, engineering resources, Bal Seal-specified computer-aided design language/format, electronic commerce capability, etc. e) Business Continuity Planning – to evaluate disaster recovery planning. f) Sub-tiers Supplier Control – to evaluate the effectiveness of the Suppliers sub-tier management processes and ensure that products or services procured from sub-tier sources and delivered to Bal Seal conform to all applicable Bal Seal requirements. g) EHS&S – to evaluate the effectiveness of the supplier’s Environmental, Health, Safety, and Security processes and how they may positively or negatively affect continuity of supply to Bal Seal. h) Counterfeit Parts Control – evaluate the processes for prevention of counterfeit prevention. 6. Conflict Minerals 6.1. Bal Seal is committed to ensuring that products sold do not incorporate “conflict minerals” (minerals that are smelted into tin, tantalum, tungsten, and/or gold) sourced from entities that directly or indirectly finance conflict in the Democratic Republic of Congo or adjoining countries. Bal Seal intends to fully comply with the requirements of Section 1502 of the Dodd-Frank Act in order to support its customers’ requirements. 6.2. Bal Seal requires its suppliers to perform sufficient due diligence into their respective supply chains to determine whether products sold to Bal Seal contain tin, tungsten, or gold, and if, whether and to what extent those metals are sourced from conflict-free smelters. 6.3. Bal Seal required its suppliers to report to Bal Seal the results of such due diligence on the Conflict Minerals Reporting Template or other agreed format, to enable Bal Seal to comply with its customers’ requirements. 6.4. Bal Seal requires its suppliers to commit to being or becoming “conflict-free”, so any such metals are sourced only from conflict-free smelters. 7. Counterfeit Parts 7.1. The supplier shall have a documented process for the avoidance, detection, mitigation, and disposition processes to prevent counterfeit materials, and/or parts from being delivered to Bal Seal. The supplier, as applicable, shall pass down these requirements to their lower tier subcontracts for the delivery of items that will be included in or furnished as materials/parts to Bal Seal. 7.2. Supplier shall ensure their Counterfeit Parts/Material Prevention process/procedure includes training of applicable personnel to the requirements within the procedure. 7.3. The procedure should support the requirements of AS9100 and AS6174 (Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel). 7.4. Supplier shall only purchase products to be delivered or incorporated as goods to Bal Seal directly from the Original Component Manufacturer (OCM)/Original Equipment Manufacturer (OEM), OCM/OEM authorized distributor chain, aftermarket manufacturer, or authorized reseller. These materials/parts shall have verification documentation that are traceable to OCM/OEM; OCM/OEM authorized distributor chain, aftermarket manufacturer, or authorized reseller that identifies the name and location of all the supply chain intermediaries from the part manufacturer to the direct source of the product. If materials/parts can only be acquired from independent distributors or brokers in cases of diminishing material supply (DMS) or obsolescence, written notice shall be provided to the Bal Seal Quality Engineer and Buyer prior to procurement of these goods. After supplier receives written approval by Bal Seal, goods may be subjected to testing and screening process, appropriate to the commodity, using a Bal Seal approved method or third party laboratory. Records of evidentiary tests and inspections performed that ensure verification of the goods shall be provided to Bal Seal for review and approval by Bal Seal at delivery. Written notice is not required for raw material and standard hardware purchased from independent distributors or brokers, but products must be able to provide commodity level traceability to the OCM/OEM. 7.5. Supplier shall provide notification to Bal Seal Quality Engineer and/or Buyer if supplier becomes aware or suspects that it has furnished Counterfeit Goods within 24 hours. Supplier shall provide to Bal Seal Quality Engineer and/or Buyer, upon request, the supply chain traceability to an Original Manufacturer or authorized distributor chain that identifies the name and location of all the supply chain intermediaries from the part manufacturer to the direct source of the product. Supplier shall have a documented process in place to ensure counterfeit goods are contained and do not reenter the supplier chain. 7.6. The supplier shall consider obsolescence when planning product and processes with the goal of minimizing counterfeit part risk. 8. Supplier Performance 8.1. Bal Seal’s supplier evaluation system uses a number of factors to develop an overall Supplier performance rating. This rating serves as an objective measure to determine whether Bal Seal expectations are being met. 8.2. At Bal Seal’s discretion, the Bal Seal Buyer may determine, that to address the Suppliers performance deficiencies, a meeting with Supplier’s management is necessary and a Supplier documented corrective action and improvement plan is required. 8.3. Suppliers are rated on the following criteria. Any category with a rating of equal of less than 80% may require corrective action from the supplier. 8.4. Supplier Rating Factors: · Number of late shipments · Number of Discrepant Material Reports issued · Number of CAPAs issued Section 3 – Quality System Requirements 1. Quality Management System 1.1. Suppliers shall maintain a compliant Quality Management System (QMS) suitable to the products and services provided to Bal Seal per ISO 9001, Quality Management System Requirements. 1.2. QMS systems certified to ISO 9001, IATF 16949, AS9100, and/or ISO 13485 are preferred and in some instances may be required by Bal Seal. 1.3. In some instances, QMS systems compliant to Mil-I-45208, Inspection System, may be contractually required. 1.4. In the absence of third-party certification, depending on the product, its application, value, and criticality, the Bal Seal purchasing and quality assurance representatives may authorize the acceptance of other evidence of compliance. This may include second-party (Bal Seal) audit or first-party (self) assessment to the applicable criteria above, or to a set of alternative basic quality requirements (such as those described in the ‘Bal Seal Supplier Quality Assessment’ checklist). 2. Quality Manual 2.1. Upon request, the Supplier shall furnish Bal Seal with a copy of the Supplier’s Quality Management System Manual, which is to be current and approved by the Supplier’s management, including or making reference to related documents. The quality management system documentation shall include Supplier’s statements of a quality policy. The Supplier shall promptly notify Bal Seal purchasing of any significant changes to the Supplier’s quality management system, personnel, and/or company ownership 3. Product Inspection 3.1. Product inspection requirements, including magnification, may be detailed on the purchase order and engineering documentation. 3.2. Suppliers may delegate inspection authority and product/process inspection and acceptance to production operators. In such cases, the Supplier’s operator self-verification program shall be documented and the criteria used for certification training shall be validated with a statistically based capability study. Both variable and attribute methods shall be validated. For example, workmanship samples and photos can be validated with an attribute Gage R&R study. 4. Product and Material Quality – Sampling Inspection 4.1. The Supplier is responsible for 100% verified quality for all items delivered to Bal Seal. When the Supplier elects to use statistical methods for the acceptance of products or processes, such methods shall be in compliance with the requirements established by DCMA, and in all cases the sample sizes shall be AQL 0.4 or higher (i.e., AQL 0.25, 0.15, etc.) for critical characteristics and 1.0 or higher for non-critical characteristics and the criteria for lot acceptance as zero (i.e., C=0). A copy of Suppliers statistical process control plan shall be furnished to Bal Seal upon request. See Appendix A for zero based acceptance table. 5. Calibration System 5.1. Suppliers shall establish and maintain a measurement management system which meets the requirements of either ANSI/NCSL Z540.3 or ISO/IEC 17025. 5.2. Develop or obtain gages and standards to control their processes and to determine product conformance to specifications. Variable gages and measurements are preferred. 5.3. Measuring equipment shall be calibrated or verified at specified intervals, or prior to use, against measurement standards that are traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded. 5.4. Measuring equipment shall be identified to enable the calibration status to be determined. 5.5. Alternative methods, gages or standards may be used at Bal Seal to verify the Supplier’s inspection results. Bal Seal may request the Supplier to participate in a correlation study to compare Supplier measurement results against results obtained by Bal Seal gages and methods. 6. Raw Material Lot Control 6.1. Unless otherwise specified in the contract/purchase order, or specifically approved in writing by Bal Seal Quality Assurance, only one raw material lot can be used per production lot/batch. 6.2. The Supplier shall ensure, document and furnish positive traceability of product to the raw material certification/test report that represents the raw material from which the products were manufactured. Traceability shall be provided by identifying the raw material heat, lot, batch or melt number from the certification/test report on the product and/or on packaging (when used), or the products segregated and identified. 7. Certification and Test Reports 7.1. The supplier is required to provide a Certificate of Conformance indicating that the material(s) or service(s) provided against the contract/purchase order meet all applicable requirements. All certifications, reports and documents shall be legible and reproducible, and shall contain the following, as a minimum: · Purchase order number · Part name, number, revision and quantity · Lot Number(s) · Applicable specification number(s), with revision level(s) · Signature and date of an authorized representative · Cure date (for elastomeric items) Use format “quarter, year” Example: “3Q98” 7.2. Raw Material Certifications – A physical and chemical report from the mill source indicating quantitative values of ingredients and referencing applicable specifications is required. 7.3. Special Process Certifications – A Certificate of Conformance is required for all special processes (i.e. plating, passivation, sintering, heat treating, etc.). 7.4. Mercury-free Certification – By providing material under this purchase order requirement, the supplier certifies that all material supplied has not come into contact with, been exposed to, or contains any form of mercury. 7.5. Ozone Depleting Substances-free Certifications – By providing material under this purchase order requirement, the supplier certifies that the materials supplied to Bal Seal are in compliance with the European Parliament Directive (EU) 2015/863 amendment of Directive 2011/65/EU on the restrictions of use of certain hazardous substances. 7.6. RoHS Certifications – By providing material under this purchase order requirement, the supplier certifies that the materials supplied to Bal Seal complies with the restrictions for Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent chromium (Cr6+), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE) as defined by the European Union. 8. Shelf-Life Control 8.1. Materials – With each delivery of materials or products that have a limited or specified shelf life, the Supplier shall furnish data that shows (a) the cure or manufacture date, (b) expiration date or shelf life, (c) lot or batch number, and when applicable any special handling or storage requirements. 8.2. Unless otherwise specified by contract, for all shelf life limited materials (e.g. Elastomeric materials) and products delivered to Bal Seal, the remaining shelf life shall be a minimum of 80% of the total shelf life for the material. 9. Control and Disposition of Nonconforming Material 9.1. The supplier shall establish and implement a documented process to control nonconforming material and product. 9.2. A Supplier shall not knowingly ship product that deviates from the drawing, specification limits, or design intent without prior written authorization from the Bal Seal Buyer. If such a condition exists, the Supplier may petition the Bal Seal Buyer, in writing, to allow shipment of the product under a written nonconformance deviation. If requested by the Bal Seal Buyer, the Supplier shall send samples of such nonconforming items to Bal Seal for evaluation. 9.3. The cost of shipping, inspection, and testing to determine the potential acceptability of such product will be the Supplier’s responsibility. 9.4. Any parts shipped to Bal Seal that have been approved with deviation shall be clearly identified as such externally on the box, container, or other packaging and on shipping documentation. Inside of each box shall contain a copy of the Bal Seal-approved deviation document. 9.5. Bal Seal approval of a deviation is specific to the products for which it has been submitted and approved and shall not to be construed as a permanent engineering change. 9.6. The Supplier shall begin work immediately on root cause corrective action identification and process improvement to eliminate future occurrence of nonconforming product. 9.7. Nonconforming product identified by Bal Seal at its location may be returned to the supplier and dispositioned as mutually agreed to by Bal Seal and the supplier. 10. Corrective Action Report 10.1. Bal Seal may issue a request for a Corrective Action Preventive Action report (CAPA) to the Supplier when nonconforming material, components, or assemblies are found. When a formal reply is requested (whether hard copy or electronic media), the Supplier shall use the CAPA form supplied by Bal Seal or equivalent format. 10.2. When documenting the root cause, the Supplier shall include the underlying reasons: a) why the specific nonconforming condition or incident occurred, b) why it was not detected by the Suppliers quality controls, and c) why the related process, from a systemic viewpoint, allowed the nonconformance (and potentially others like it) to occur. 10.3. The Supplier shall respond to the CAPA request as follows: · Within 48 hours, acknowledge receipt of CAPA and communicate to Bal Seal initial containment actions to be taken. · Within 72 hours, Confirmation that the Supplier has identified all suspect product in process, in stock, in transit, and potentially at Bal Seal by lot number, and quantity. Any additional specific containment actions needed to be taken by the Supplier and/or Bal Seal. · Within 10 business days, the Supplier shall submit the completed Corrective Action Report indicating the permanent actions taken, or to be taken, to prevent recurrence of the same problem, to prevent the occurrence of similar problems and the applicable effectivity dates. If a longer time period is needed, the supplier may request an extension from Bal Seal. 11. Control, Use, and Release of Bal Seal Furnished Documents – Reference LE-188. 12. Change Control of Approved Processes 12.1. The supplier shall not change any of their drawings, processes, material sources or procedures that were originally subjected to Bal Seal approval without the written authorization from the Bal Seal Purchasing Department. This includes substantial changes to facilities and equipment. 12.2. The Supplier shall notify Bal Seal in writing (a minimum of 90 days when practical), in advance of a change. 12.3. Bal Seal may require a new First Article Inspection (FAI) or PPAP process (IATF 16949) to approved change. Bal Seal quality engineering will provide detailed requirements when applicable. (See Section 3, Paragraph 16, Production and Process Approval Process) 13. Change in Supplier Location 13.1. The Supplier shall notify Bal Seal in writing (a minimum of 90 days when practical), in advance of any sale, relocation, or transfer of Suppliers production or service operations. The Supplier shall include the following, as a minimum, in the written notification: · Purpose of the relocation, · Address of the new location(s), · Assessment of actual or potential impact to current POs, · Risk mitigation plan to ensure compliance to existing requirements, · Plan defining the identification, storage, protection, retrieval and retention of records, · Master schedule and timeline of relocation activities 14. Bal Seal Designated Source 14.1. Where specified by contract, the Supplier shall purchase products, materials or services from Bal Seal designated sources. However, the Supplier is responsible to ensure that items procured from such sources meet all applicable technical and quality requirements. 15. Control of Sub-Tier Suppliers 15.1. The Supplier, as the recipient of the contract, is responsible for meeting all requirements, including work performed by the Supplier’s sub-tier Suppliers (also known as Sub-Suppliers or subcontract Suppliers). When the Supplier uses sub-tier sources to perform work on products and/or services scheduled for delivery to Bal Seal, the Supplier shall include (flow-down) on contracts, to its sub-tier sources, all of the applicable technical and quality requirements contained in the Bal Seal contract, including quality system requirements, regulatory requirements, the use of Bal Seal designated sources, and the requirement to document and control ‘key characteristics’ and/or ‘key processes, and to furnish certifications and test reports as required. Bal Seal and its customers reserve the right of entry to sub-tier facilities, subject to proprietary considerations. 15.2. Approval per LE-188 is required before any information regulated by the Bal Seal/Supplier nondisclosure agreement can be communicated to a Sub-tier Supplier. 16. Production and Process Approval Process 16.1. A First Article Inspection (FAI), PPAP process (IATF 16949), or IQ / OQ / PQ (ISO 13485) process may be required to initially qualify a part and/or process for Supplier approval. 16.2. When required, FAI, PPAP, or IQ/OQ/PQ instructions and format will be supplied by Bal Seal quality engineering. 16.3. When a PPAP or IQ/OQ/PQ is required, the Supplier shall: · Develop a Control Plan by identifying special product and process characteristics that are key to achieving quality. The Supplier shall also include those special characteristics designated by Bal Seal in the drawing, specification, or contract. Where specified in the Control Plan, the Supplier is required to apply effective statistical process controls. Instructions and format for control plans will be supplied by Bal Seal quality engineering. · Develop a visual diagram (flow chart) of the proposed or current process. This diagram shall clearly describe the production process steps and sequence, and meet the specified Bal Seal needs, requirements and expectations. · Develop a Process FMEA in accordance with, and compliant to, Bal Seal-specified requirements. A single Process FMEA may be applied to a process manufacturing a family of similar parts or materials if reviewed for commonality by the Supplier. · (If the Supplier has product design responsibility) Develop a Design FMEA in accordance with, and compliant to Bal Seal-specified requirements. A single Design FMEA may be applied to a family of similar parts or materials. · Perform Measurement Systems Analysis (MSA) studies, e.g., gage repeatability & reproducibility, bias, linearity, stability, for all new or modified gages, measurement, and test equipment. See AIAG MSA Manual and contact Bal Seal quality engineering. 17. Process Capability 17.1. Process Capability studies may be requested for special circumstances or by contractual requirement. The Process Capability Index (Cpk) is a comparison of the inherent variability of a process output to specification limits under statistically stable conditions. Most methods for estimating capability require that the characteristic being evaluated is approximately normally distributed, and in statistical control. The distribution should be determined prior to estimating capability. If the process is not in statistical control, all assignable causes shall first be identified and removed. Special techniques are available for calculating capability when inherent assignable causes, such as tool wear, are present. 17.2. Definitions and calculations for Cpk and Ppk indices are found in AIAG PPAP and SPC Manuals. Unless otherwise approved by Bal Seal, the Supplier shall use the following as acceptance criteria for evaluating initial process study results of special characteristics for processes that appear stable. Results Interpretation: · Index > 1.67 – The process currently meets acceptance criteria. · 1.33 ≤ Index ≤ 1.67 – The process is marginally acceptable. · Index < 1.33 – The process is not acceptable. 18. Preventive Maintenance – The supplier shall identify key process equipment, utilities, environment controls and provide for periodic maintenance. Records of such activities shall be maintained. 19. Packaging 19.1. The Supplier shall adequately plan for packaging designed to prevent product contamination, deterioration or loss and to eliminate shipping damage. 19.2. Packaging, packaging materials, handling and shipping of items shall be in accordance with the contract/purchase order, or when not specified, in accordance with best commercial practices to prevent damage, deterioration, and to maintain the quality of the product and/or material while in transit and storage. 19.3. To prevent product damage, packaging shall secure the product from moving and rubbing against itself during shipment. 20. Records 20.1. Records of materials, processes and tests shall be maintained on file for a minimum of 15 years after the last delivery of products and/or services on the contract. Contractual/purchase order requirements may increase this retention period. 20.2. Prior to discarding, transferring to another organization, or destruction of such records, the Supplier shall notify the Bal Seal Buyer in writing and give Bal Seal the opportunity to gain possession of the records. These requirements are also applicable to records generated by Supplier’s sub-tier sources. 20.3. Upon request, the Supplier shall be capable of retrieving and delivering required records to Bal Seal within forty-eight hours from time of request by Bal Seal. Section 4 – Specific Requirements for Processes, Products, or Supplier Category 1. Automotive Products and Services 1.1. Suppliers of product or services designated for automotive use shall be certified to ISO-9001. 1.2. These suppliers shall have the ultimate objective of becoming certified to IATF 16949. 2. Calibration Suppliers 2.1. Calibration Suppliers shall establish, maintain, and document by evidence or certification a measurement management system that is in compliance with either: a) ANSI/NCSL Z540.3 – Requirements for the Calibration of Metrology and Test Equipment, or b) ISO /IEC 17205 – General Requirements for the Competence of Testing and Calibration Laboratories 2.2. OEMs (Original Equipment Manufacturer) providing calibration service to Bal Seal are not required to be certified to the ANSI/NCSL Z540.1 or ISO 10012 requirement listed above in Section 4 Paragraph 2.1.a and 2.1.b. They shall perform calibration against measurement standards that are traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded. 3. Passivation Suppliers 3.1. Passivation shall be performed as specified in the contract/purchase order or engineering drawings: 3.2. Passivated parts shall only be handled with Nitrile (non-Latex) gloves. 3.3. Passivated parts shall be packaged per the contract/purchase order or engineering drawing. If no requirement is noted on the contract/purchase order or engineering drawing, passivated parts shall be placed in clean poly bags or other appropriate packaging that will prevent corrosion or damage during transportation and storage. 4. Plating Suppliers 4.1. Plating will be completed per the requirements of the contract/purchase order or engineering drawings. 4.2. Verification of plating will be performed per the testing specified on the contract/purchase order or engineering drawings. 4.3. Plated parts shall only be handled with Nitrile (non-Latex) gloves. 4.4. Plated parts shall be inspected for staining, contamination, nodules, and other plating defects. Contamination and staining is not acceptable. 4.5. Plated parts shall be packaged per the contract/purchase order or engineering drawing. If no requirement is noted on the contract/purchase order or engineering drawing, plated parts shall be placed in clean poly bags or other appropriate packaging that will prevent corrosion or damage during transportation and storage. Appendix A: ZERO-BASED ACCEPTANCE SAMPLING PLAN QC-209, Rev. C, 20170925 Start The Conversation REQUEST A DESIGN Custom components that drive tomorrow’s technologies. 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