Title: Supplier Quality Requirements
QOP 100-7.4.2 Rev. G
1.1 This document describes the minimum quality requirements acceptable to conduct business with Delta Hi-Tech, Inc.
2.1 This document is applicable to all Delta Hi-Tech / Delta Fabrication / Delta Medical Products suppliers of products and/or services and is independent of any additional requirements contained within the purchase order. Any Revision change to this document requires notification to Delta IT Department to update Delta Website: www.deltahi-tech.com to reflect latest requirements.
2.2 The flow down of this document is in accordance with Delta Hi-Tech. / Delta Fabrication / Delta Medical Products Quality System Manual, and the requirements of ISO 9001 / AS 9100 and ISO 13485.
3.1 Right of Access
3.1.1 The supplier shall allow the right of access by Delta Hi-Tech / Delta Fabrication / Delta Medical Products and/or their customers and regulatory authorities to all facilities during the manufacturing and/or processing of the order, and to all applicable documents.
3.2.1 The supplier shall maintain a Quality / Inspection system in compliance with ISO 9001 / AS 9100 or ISO 13485 requirements to ensure the prevention of shipping nonconforming product.
3.3 First Article Inspection
3.3.1 The supplier shall provide Delta Hi-Tech / Delta Fabrication / Delta Medical Products with a completed FAI of work performed, when specified per Purchase Order requirement on first production run of a new part or following any change that invalidates the previous FAI results. First Article Reports shall be in accordance with AS 9102 format when required by Purchase Order.
3.4.1 The supplier shall control the calibration of all measurement equipment used, accept or reject products or services. Inspection, measuring, and test equipment shall be controlled, calibrated, and maintained in accordance with ISO 17025 and or ANSI/NCSL Z540-1.
Calibration shall be traceable to National or International Standards. It is the responsibility of the supplier to return any customer supplied equipment to Delta Hi-Tech / Delta Fabrication / Delta Medical Products prior to the calibration due date.
3.5 Customer Approved Process Sources
3.5.1 The supplier shall ensure the use of any designated customer-approved special process source as indicated on purchase order or other specific instructions.
3.6 Flow Down Requirements
3.6.1 The supplier shall ensure the flow down of all applicable purchase order requirements to any sub-tier supplier, including any specific or key characteristics where required.
3.7 Control of Documents
3.7.1 The supplier shall control all documents supplied by Delta Hi-Tech. / Delta Fabrication / Delta Medical Products pertaining to the order. It is the responsibility of the supplier to destroy any documents supplied by Delta Hi-Tech. / Delta Fabrication / Delta Medical Products that are obsolete or superseded. The supplier may choose to utilize their internal document control process.
3.8 Control of Records
3.8.1 The supplier shall retain all process, inspection, certifications and test documents/records pertaining to the order for a minimum of ten (10) years. When requested, the supplier shall provide Delta Hi-Tech. / Delta Fabrication / Delta Medical Products with copies of records pertaining to specific orders within 2 working days of request.
3.9 Certifications and Inspection/Test Data
3.9.1 The supplier shall provide certification of conformance, and where applicable, inspection and/or test data with each shipment. Certifications to specifications shall reflect the latest revision level unless otherwise noted on purchase order.
3.10 Nonconformance Notification
3.10.1 The supplier shall notify Delta Hi-Tech / Delta Fabrication / Delta Medical Products of any non-conformances identified prior to and /or after product delivery. Supplier shall submit a deviation/waiver request along with nonconforming product to Delta-Hi Tech / Delta Fabrication / Delta Medical Products for evaluation and subsequent disposition. (See Attached)
3.11 Change Notification
3.11.1 The supplier shall notify Delta Hi-Tech / Delta Fabrication / Delta Medical Products prior to any changes to the product, processes, suppliers, facilities, tooling and or gages relevant to the order.
3.12 FOD (Foreign Object Debris)
3.12.1 Foreign Object Debris is not allowed. All parts must be verified 100% for this condition. Any FOD identified must be removed prior to shipment to Delta Hi-Tech / Delta Fabrication / Delta Medical Products.
3.13.1 The supplier shall package products appropriately to avoid the possibility of damage of product / services ordered during shipment.
3.14 ITAR’s Compliance and DPAS Flow-down
3.14.1 When the Delta Hi-Tech / Delta Fabrication Purchase Order identifies ITAR’s Compliance and that the information contained may be subject to International Traffic Arms Regulations (ITAR) or Export Administration Regulations (EAR) Controls and may not be disclosed to any foreign person(s) or firm, including persons employed by or associated with your firm, without first complying with all requirements of the ITAR, 22 CFR 120-130 and the EAR, 15 CFR 730-774, ITAR’s Regulation’s / compliance / controls shall be required.
By this notification, you as a Delta Hi-Tech / Delta Fabrication supplier have been so advised of its compliance obligations under the ITAR.
3.14.2 DPAS Rating – Government Order certified for National Defense. When a ‘DPAS RATING’ is identified on Delta’s vendor Purchase Order, it is Supplier / Processor’s responsibility to comply and follow all provisions of the Defense Priorities and Allocation System Regulation – (15 CFR 350).
3.14.3 Domestic Specialty Metals – Any specialty metals incorporated in the articles produced and delivered under this contract shall be melted in the United States or qualified country in accordance with DFARs 252.225-7014, Preference for Domestic Specialty Metals.
All printed copies are UNCONTROLLED. Controlled copy resides on the Delta Hi-Tech computer network.