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Supplier Quality Requirements - 7362066 REV H

Harmonic Drive LLC

Supplier Quality Requirements (SQR)

QUALITY REQUIREMENTS

General Requirements applicable to all Purchase Orders. The Supplier requirements below apply to all Suppliers and sub-tier Suppliers to Harmonic Drive LLC providing materials, products and services. Acceptance of a Purchase Order from Harmonic Drive LLC binds the Supplier to the Terms and Conditions listed in the Purchase Order and the requirements listed in this document. The Supplier is not authorized to outsource any portion of the Purchase Order requirements unless specifically authorized by Harmonic Drive LLC and must flow down these requirements to any sub-tier Suppliers. Note that these requirements correspond with the requirements of Harmonic Drive LLC’s customers and with the requirements of AS9100/ ISO 9001 Clause 8.4.3.

A.) The processes, products, and services to be provided including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);

Refer to Harmonic Drive LLC’s Purchase Order for this information.

B.) The approval of: products and services; methods, processes, and equipment; the release of products and services;

HD LLC will not accept items delivered under the Purchase Order if the supplier fails to submit certifications or other documentation specified in the purchase order. Each shipment must be accompanied by one legible copy of a certificate of analysis (C of A) or certificate of Compliance (C of C). Material certifications shall show quantitative analysis of each element and physical testing as required by specifications referenced. Traceability for Raw Material is required and shall be retained and provided to Harmonic Drive LLC with product. Final acceptance of product will be at Harmonic Drive LLC after receiving inspection.

C.) Competence, including any required qualification of persons;

Supplier shall ensure that employees and people working on its behalf possess applicable competency and qualification e.g. skills, training, assessment, evaluation, levels of qualification, periodic re-assessment, maintained competence.

D.) The Supplier’s interactions with the Harmonic Drive LLC;

Suppliers shall secure all information received from Harmonic Drive LLC in confidence and no third party request for information will be authorized unless approved, in writing, by Harmonic Drive LLC.

E.) Control and monitoring of Supplier’s performance to be applied by Harmonic Drive LLC;

Harmonic Drive LLC will score and evaluate Suppliers based on Quality, Delivery, and/or Service. Suppliers will be issued corrective actions as warranted.

F.) Verification or validation activities that Harmonic Drive LLC, or its customer, intends to perform at Supplier’s premises;

Harmonic Drive LLC and its customers reserve the right to perform verification and/or validation activities at the Supplier’s premises.

G.) Design and development control;

If Suppliers performs design and development for HDLLC, the Supplier shall provide all information required by Harmonic Drive LLC to meet the requirements of the product and service specification and requirements. Harmonic Drive LLC Supplier Quality Requirements (SQR)

H.) Special requirements, critical items, or key characteristics;

Supplier shall maintain compliance to Special requirements, critical items, or key characteristics requirements as specified by HDLLC.

I.) Test, inspection, and verification (including production process verification);

All processes and machines used in the production of goods shall be calibrated at appropriate intervals. The Supplier shall maintain a quality / inspection system that shall ensure all goods and services conform to contract requirements whether manufactured or processed by the Supplier or procured from Sub- Tier Suppliers.

For Suppliers providing calibration services, the calibration must be performed using standards whose accuracies are traceable to the National Institute of Standards and Technology. All provided calibration certifications must specifically state this traceability.

Supplier will maintain a quality/inspection system that will ensure all goods and services conform to contract requirements whether manufactured or processed by Supplier or procured from Sub-Tier Suppliers.

J.) The use of statistical techniques for product acceptance and related instructions for acceptance by Harmonic Drive LLC;

The Supplier will use a sampling plan, consistent with applicable industry standards, unless otherwise specified or agreed upon in writing by Harmonic Drive LLC.

K.) The need to:

1) Implement a quality management system;

When specifically requested by Harmonic Drive LLC in writing, Supplier will maintain a quality system in compliance to recognized Quality Management Systems and/or approved by Harmonic Drive LLC.

2) Use customer-designated or approved external providers, including process sources (e.g., special processes);

When required by Harmonic Drive LLC or by Harmonic Drive LLC’s customers, Suppliers will use customer-specified sources.

3) Notify Harmonic Drive LLC of nonconforming processes, products, or services and obtain approval for their disposition;

DISCREPANCIES

Any deviations from established drawing or specifications intended for shipment must be reported to the HD LLC Buyer immediately. No deviations will be considered approved without written confirmation from HDLLC. Repairs are not to be undertaken without prior written approval from HDLLC. Unless otherwise specified in this Purchase Order, the Supplier and/or any of their Suppliers/Subcontractors DO NOT have authority to process “USE-AS-IS”, “REPAIR”, “STANDARD REPAIR PROCEDURES (SRPS)” or “NON-SRPS” via their Material Review Board (MRB). These dispositions, as well as deviations and request for waivers, requiring MRB disposition shall be submitted to HD LLC for approval. This does not include REWORK or SCRAP. The Supplier/Subcontractor shall utilize its appropriate nonconforming material Harmonic Drive LLC Supplier Quality Requirements (SQR) disposition form and submit it to the Buyer for HD LLC approval.

CORRECTIVE ACTION

Acceptance of this Purchase Order obligates the supplier to perform, upon request, a Corrective Action investigation when discrepant material is received at HD LLC. A written report shall be submitted to HDLLC, within a stipulated time period, which is specific and conclusive to prevent a recurrence of the discrepancy.

4) Prevent the use of counterfeit parts (see 8.1.4 of AS9100);

Supplier shall prevent the purchase of counterfeit or suspect / unapproved products and ensure product identification and traceability. Material and part substitutions are not allowed without HDLLC approval.

5) Notify Harmonic Drive LLC of changes to processes, products, or services, including changes of their external providers or location of manufacture, and obtain Harmonic Drive LLC’s approval;

Supplier shall not accept verbal changes to the Specifications, Drawings or Purchase Order Requirements without supporting documents from HD LLC.

The Supplier shall make no Changes to Work under this Purchase Order or Contract including any change in design, manufacturing process, materials, or otherwise which may affect form, fit, or function of the Work without prior notification to and approval by HD LLC. Such notification shall consist of detailed drawings clearly defining such Changes and the date such changes are proposed to be effective. Such notification shall not constitute approval of the proposed change nor relieve the Supplier of the obligation to comply with requirements contained in the Purchase Order or Contract. If the proposed Change is approved, the Change Approval shall be documented.

6) Flow down to external providers applicable requirements including customer requirements;

Suppliers shall flow-down to Sub-Tier Suppliers the applicable requirements as required by the general requirement and any additional SQR clauses defined on the Purchase Order specifically or by reference.

7) Provide test specimens for design approval, inspection/verification, investigation, or auditing;

When requested by Harmonic Drive LLC or its customers, Supplier will provide test specimens for inspection/verification, investigation and/or auditing purposes.

8) Retain documented information, including retention periods and disposition requirements;

Unless otherwise specified on the Purchase Order, the latest specification revision in effect at the time the lot of raw material/parts was originally manufactured or processed shall apply. In the event a document has been superseded, the latest revision of the superseding document shall apply. All certifications, test reports, and inspection reports, as well as receiving inspection, in- process inspection, final inspection, calibration records, and all other records shall be retained for fifteen (15) years, unless otherwise specified by Harmonic Drive LLC. These records will be made available to Harmonic Drive LLC, Harmonic Drive LLC’s customers, or regulatory agency upon request. In the event that the supplier cannot comply with the record retention requirement all pertinent documentation shall be forwarded to HDLLC for retention.

For COTS (commercial off the shelf), section K.8 will not apply

L.) The right of access by Harmonic Drive LLC, Harmonic Drive LLC’s customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain; Harmonic Drive LLC Supplier Quality Requirements (SQR)

Harmonic Drive LLC and their customers reserve the right to perform an on-site inspection of the Supplier’s facility or visit the facility. Harmonic Drive LLC will give reasonable notification to the Supplier prior to the on-site inspection. The on-site inspection may include surveillance to conduct periodic audits of Seller’s Quality Assurance inspection system or equivalent Quality System, and to witness and/or conduct inspections and tests to assure materials or supplies satisfactorily meet procurement document requirements; review Corrective Action activities and other records pertinent to the purchased product or service. The Supplier shall provide the necessary data as specified by HDLLC.

M.) Ensuring that persons are aware of:

  • their contribution to product or service conformity;
  • their contribution to product safety;
  • the importance of ethical behavior.

Supplier must be committed to the highest standards of ethics and business conduct. Supplier must comply with the law, honor commitments, act in good faith, and be accountable. Supplier must strive to maintain full compliance with all laws and regulations applicable to the operation of the business and customer relationships. Supplier must not offer, promise, authorize, or provide, directly or indirectly, anything of value (including business gifts or courtesies) with the intent or effect of inducing anyone to engage in unfair business practices. Supplier will avoid involvement in activities that may be perceived as a conflict-of-interest. Supplier will respect the legitimate proprietary rights and intellectual property rights of customers and Suppliers and take proper care to protect sensitive information, including confidential, proprietary and personal information. Supplier will support product safety by ensuring robust management of special requirements, critical items and key characteristics. If there are concerns with respect to product safety, Supplier will communicate them to Harmonic Drive LLC. If there is a concern at the Supplier’s premises with respect to safety during the manufacture of the product, Supplier will notify its own employees of the concern and whenever possible, mitigate the concern.

N.) PRESERVATION AND PACKAGING

Unless special packaging requirements are referenced in the Purchase Order, the supplier shall use best commercial practices for preservation and packaging of articles supplied to HD LLC, and shall identify each package with the Purchase Order number, date shipped and packing sheet number. Harmonic Drive LLC Supplier Quality Requirements (SQR)

AEROSPACE SUPPIER QUALITY REQUIREMENTS / CLAUSES

The following requirement / clauses become a part of the purchase order when specified by number or letter code on the Purchase Order.

SQR-1 QUALITY MANAGEMENT SYSTEM Supplier shall provide and maintain a quality system that is approved or recognized to meet the requirements of ISO9001 or AS9100 current revision, unless otherwise directed by HD LLC. Immediate notification is required in case of non-compliance to Quality System Requirements, e.g. loss of third party certification.

SQR-2 GOVERNMENT SOURCE INSPECTION Government Inspection is required prior to shipment from your facility. Upon receipt of this order, promptly notify the Government Representative normally servicing your facility so that the appropriate planning can be accomplished. If a government representative does not service the Suppliers’ facility, notify the nearest Defense Contract Administrative Office for direction, or HD LLC.

SQR-3 SOURCE INSPECTION Source Inspection shall be conducted by HD LLC at the Supplier’s facility or where designated in the Purchase Order prior to shipment. Inspection/test of the items shall be performed by the Seller, and shall be subjected to witness by HD LLC. HD LLC shall elect to do 100% or sample of the units. If sample is elected, the sample will be selected by HD LLC. Seller shall have available and present upon request, documented evidence of in-process and/or final inspection/test data. Required documentation for shipment must be completed and signed by its Quality Assurance Manager, or authorized designee, and available for HD LLC review.

SQR-4 CERTIFICATE OF CONFORMANCE

A certificate of conformance shall accompany each shipment signed by its Quality Assurance Manager, or authorized designee, stating the product supplied is in full conformance with all physical configuration and functional test specifications; that all raw material used conforms to applicable specifications. Inspection and test data, physical and chemical analysis, and in-process inspection data are on file subject to review by HD LLC upon request. The certificate of conformance shall be legible and include

  • HD LLC Purchase Order number, part number, and revision letter (unless otherwise specified on the purchase order), quantity and if applicable, serial numbers.
  • HD LLC Job Order number and the mill heat number when supplier supplied material, at a minimum.
  • When multiple lots of material are used in completing a shipment, parts shall not be mixed and all material lot numbers or mill heat numbers shall be reported.
  • When processing is performed against a HD LLC job order, parts shall not be mixed and traceability shall be maintained to the work order.
  • Material or process specifications
  • Manufacturer’s name, address, Country of Origin, and Date.

SQR-5 CHEMICAL AND PHYSICAL TEST REPORTS For raw material shipments, or where material was supplied by the supplier, physical and chemical test report certifications shall be supplied with each shipment. Test reports shall be

legible and include the material designation, specification and revision letter (material must be certified to the latest revision in effect at the time of shipment), results of all specified testing requirements, the mill heat number, and any other requirements specified on the Purchase Order and must be traceable to the material.

SQR-6A RECORD RETENTION AND RIGHT OF ACCESS– NON-AEROSPACE Supplier shall retain all records pertaining to material, manufacturing processes, special processes, testing, and inspection for a minimum of three (3) years as applicable. Supplier shall notify HD LLC prior to destruction. Supplier shall provide HD LLC, our Customers, and regulatory authority access to all applicable records.

SQR-6B RECORD RETENTION AND RIGHT OF ACCESS - AEROSPACE Supplier shall retain all records pertaining to material, manufacturing processes, special processes, testing, and inspection for a minimum of fifteen (15) years as applicable. Supplier shall notify HD LLC prior to destruction. Supplier shall provide HD LLC, our customers, and regulatory authority access to all applicable records.

SQR-7 FIRST ARTICLE INSPECTION Supplier shall perform and document a comprehensive inspection and test of the article to assure the items conform to all specification requirements. First Article Inspections shall be performed in accordance with Aerospace Harmonic Drive LLC Supplier Quality Requirements (SQR)

Standard AS9102. First Article Inspection is required on a part representative of the production process used in the manufacture of the parts. The First Article Inspection Report (FAIR) must accompany the first shipment of parts.

If two years have elapsed since the last shipment of this part number, a new First Article Inspection is required. If an AS9102-compliant FAIR is not required, an equivalent supplier form may be used and shall include the following:

  • HD LLC part number, revision level,
  • All print requirements including, Notes, Feature, Tolerance,
  • Actual measured value, Method of Gauging, Accept/Reject indication

Where physical testing is required, the results of the test must be recorded. Where special processes are required, verification of each special process must be recorded, applicable certifications retained, and available for review (or submitted with the FAIR if requested by HD LLC). The signature and title of the person performing the inspection and date of inspection must also be included.

SQR-8 SURVEY/AUDIT RIGHTS HD LLC customers and/or regulatory agencies shall have the right to conduct surveys and perform surveillance and have access of supplier facilities to evaluate their capability to comply with contractual requirements.

SQR-9 SPECIAL PROCESS APPROVAL Heat treating, welding, electroplating, laser cutting, EDM, ECM, Non-Destructive Testing, etc. are considered special processes and require approval by HD LLC prior to use. The Certificate of Conformance shall include the specification number and revision of all special processing performed. Special processes, once approved, may not be changed without HD LLC approval of the changes.

SQR-10 APPROVED INSPECTION PLAN When requested; suppliers shall submit a detailed inspection plan to HD LLC Facility for approval before manufacturing begins. Supplier inspection shall be in accordance with the HD LLC approved inspection plan for the part number ordered.

SQR-11 APPROVED SOURCE OF MATERIALS All material used in fulfilling this order must be supplied by a supplier approved by HD LLC unless specifically authorized in writing to the contrary.

SQR-12 SHELF LIFE DATA The Supplier shall furnish the date of manufacturer, useable shelf life, expiration date of useable shelf life, any special storage conditions, and any safety warnings for each item shipped. Material Safety Data Sheet must be included with each shipment. Items will not be accepted by HD LLC where shelf life remaining is less than 75% of total shelf life.

SQR-13 IDENTIFICATION AND CONTROL BY LOT Traceability of items shall be by lot number rather than individual serial number. Seller shall assign a common lot number to all items in a specific manufactured lot.

SQR-14 IDENTIFICATION AND CONTROL BY SERIAL NUMBER Seller shall identify individual serial numbers, to all items shipped to HD LLC and shall appear on the certification. Serial numbers shall be assigned by HD LLC. The method of marking will be specified in the Purchase Order or on a furnished manufacturing drawing. The Seller shall maintain traceability of each serialized item to raw materials used in its manufacturing processes.

SQR-15 TEST AND INSPECTION REPORTS Test and inspection reports, with measured data as required by the applicable procurement specification, must accompany each shipment.

SQR-16 SPECIALTY METALS DFARS 252.225-7009 Alt1 Restriction on Acquisition of Certain Articles Containing Specialty Metals applies to this order if specialty metals are being furnished. Contact HD LLC’s Purchasing for clarification or applicability if necessary.

SQR-17 BUYER FURNISHED MATERIAL When HD LLC furnishes material, the Seller’s System shall provide for the following:

  • Examination upon receipt for transit damage,
  • Verification of quantity,
  • Storage against damage,
  • Improper use or disposition.

Harmonic Drive LLC Supplier Quality Requirements (SQR)

The Seller must furnish certification that the parts used were those furnished by the Buyer and no un-authorized substitution was made.

SQR-18 APPROVED SUPPLIERS As required, HD LLC “Approved Suppliers” are responsible for maintaining a list of their approved suppliers, and shall have it available upon request for review by HD LLC. Information shall include name, address, nomenclature of parts or services provided, part numbers and other pertinent information requested by HD LLC. Suppliers shall only purchase aircraft related parts from their suppliers which are controlled by HD LLC by approval or inspection.

SQR-19 RESERVED

SQR-20 MOVEMENT OF WORK The Supplier agrees that the manufacturing and/or fabrication of Work being delivered under this Purchase Order will not be moved to another production facility without the express written approval of HD LLC.

SQR-21 CALIBRATION SYSTEM COMPLIANCE OF INSPECTION, MEASURING AND TEST EQUIPMENT A system for the maintenance and calibration of inspection, measuring, and test equipment shall be maintained. ANSI/NCSL Z540-1 applicable to calibration activities. Acceptable alternative: MIL-STD-45662A “Calibration System Requirements” All calibration standards must be traceable back to NIST (National Institute of Standards and Technology) and the NIST test number shall be included on the certificate of confrmance. If any measuring equipment is found to be out of tolerance, “As Found, As Left” data shall be included.

SQR-22 FOREIGN OBJECT DEBRIS (FOD)

Supplier shall comply with NAS412 to prevent Foreign Object Damage (FOD) to manufactured products. Supplier shall establish and maintain an effective FOD prevention program through a Continual Improvement approach that proactively addresses and controls the events (conditions and actions) leading to FOD.

SQR-23 EXPORT/IMPORT CONTROLS (ITAR) Supplier shall control the disclosure of, and access to, technical data, information, and other items including hardware received under this purchase order in accordance with U.S. export control laws and regulations, including but not limited to the International Traffic in Arms (ITAR) and the U.S. Department of Commerce, Bureau of Industry and Security (BIS), and Export Administration Regulations. Contact HD LLC Purchasing for clarification or applicability if necessary.

SQR-24 COUNTERFEIT PARTS AVOIDANCE Supplier shall ensure that controls are in place to reduce and mitigate the risk of counterfeit components and/or assemblies from HD LLC in compliance of AS5553 and their Quality Management System. This Procedure outlines the process of procuring parts from reliable sources, assure authenticity and conformance of procured parts, to control parts identified as counterfeit and report counterfeit parts to HD LLC and Government Investigative authorities. Any questionable items should be referred to HD LLC.

SQR-25 INSPECTION SHEETS AND TEST REPORTS With each shipment the supplier shall submit inspection reports, data sheets, test reports, etc… as applicable. Reports shall be identified with the applicable drawing / specification number, revision, HD LLC Purchase Order number, and the Supplier’s lot identification number.

a. Inspection Reports shall cover all physical and dimensional characteristics for the item as called out on the drawing, or in the applicable specification. The Supplier shall report the actual dimensions of each part inspected. The inspection results shall be traceable by serial number or other identification method to the actual part inspected.

b. Inspection Reports shall cover all physical and dimensional characteristics for the item as called out on the drawing, or in the applicable specification. The Supplier shall report the dimensional range and average of parts inspected. The inspection results shall be traceable to the lot of parts inspected.

c. Inspection reports shall list the physical and dimensional characteristics of the items. Sample inspection shall be performed to verify critical dimensional characteristics of the lot of parts are within drawing specification limits. Actual dimensions do not have to be reported except where specific dimensions are requested. Harmonic Drive LLC Supplier Quality Requirements (SQR)

d. Test reports for special tests such as vibration, shock, rain, sand and dust, pressure, environmental, EMI, ATP and others shall be supplied by the Seller.

e. Destructive Testing Analysis (DTA) report is required. The Supplier is to permanently identify the parts that have gone through DTA and are no longer suitable for intended use. The tested parts shall be delivered to HD LLC.

NOTE: Out of tolerance dimensions shall be identified on an inspection report. The Supplier shall not deliver parts that are out of tolerance to HD LLC without approval from HD LLC.


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