SUPPLIER QUALITY ASSURANCE REQUIREMENTS
(CLAUSES APPLICABLE ONLY AS NOTED ON PURCHASE ORDER)
1. Quality System Requirements
The supplier must be on the 3D Instruments approved supplier list. The Supplier Quality System can
be approved by the following:
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•
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Accredited by a third party Audit
Audited and approved by 3D Instruments Purchasing and/or Quality Management
The supplier can be approved after submitting detailed information requested by 3D
Instruments.
2. Employee Qualifications
Personnel performing work affecting conformity to product requirements shall be competent on the
basis of appropriate education, training, skills and experience. If additional required for qualification
of personnel are required, 3D Instruments will notify supplier with written requirements.
3. Inspection System Requirements
The supplier shall provide and maintain a Quality System commensurate with the complexity and
criticality of the product to be supplied. The Quality System shall be documented to the extent that it
defines the policy, procedures and controls in place to assure product quality.
4. Control of Monitoring and Measuring Devices
The supplier and their sub-tier suppliers shall be responsible for providing and ascertaining the
correctness of tools, gages, and test equipment. The calibration system shall comply with
ANSI/NCSLZ540-3-2006 or ISO 10012. Records of calibration shall be available for review upon
request.
5. Right of Access
The supplier is required the right of access by 3D Instruments, 3D Instruments customer, and a
specified third party (customer/regulatory agency), to the applicable areas of all facilities, at any
level of the supply chain, involved in the order and to all applicable records.
3D Instruments reserves the right for 3D Instruments, a 3D Instruments customer, or a specified
third part (customer/regulatory agency) to perform an audit or inspection at the supplier’s facility
and/or any level of the supply chain involved in the order. Such verification shall not be used as
evidence of effective control of quality. This verification does not absolve the supplier of the
responsibility to provide acceptable product, and does not preclude any subsequent rejection by 3D
Instruments or its customer.
6. Records Retention Requirements
Quality records including raw material certifications, Certification of Conformance, inspection,
special process records and test data shall be retained at the suppliers facility for a minimum of 10
(ten) years after shipment. These records shall be maintained and available for review.
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7. Nonconforming Material
The supplier is required to notify 3D Instruments of nonconforming product and obtain 3D
Instruments approval for nonconforming product disposition using a deviation form. The Supplier is
not authorized to disposition nonconforming material as “repair” or “use as is” for product under 3D
Instruments design authority. Nonconforming material shall be segregated and withheld from
shipment unless written concession is negotiated in advance.
When authorized to ship nonconforming material, the supplier shall clearly identify
product (i.e., tag or label) and include a copy of the approved deviation request with the shipment.
8. Changes to Process, Product, and/or Supply Chain
Direct material suppliers are required to obtain documentation of 3D Instruments approval prior to
implementing any change. This requirement includes direct material suppliers, including
distributors.
Applicable “changes” include but not limited to:
• Approved production processes
• Materials
• Manufacture location
• NDT and special processing
• Change of sub-tier suppliers for raw materials, purchased components or services
• Change to test/inspection sequencing or methods
The continuous improvement philosophy encourages process improvements. However, prior to any
modification to a process being implemented, the supplier must complete all verifications and tests
necessary (including preliminary capability studies) to ensure that a new process continues to yield
components that meet specifications. First article requirements per AS/EN9102 always apply.
9. Drawing and Change Control
The supplier’s quality system must ensure that the latest engineering drawings and specifications are
available at the manufacturing, test or inspection location. This includes applicable previous
revisions if 3D Instruments contract/PO language requires other than the most recent revision(s).
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The written procedure(s) should indicate the method utilized for receipt, review or
distribution of all changes and the method of recalling and disposing of an obsolete item.
A review process must be established in the system to confirm that applicable drawings and
specifications are at the latest revision level with the issuing source.
10. Sub-Tier Selection/Control & Contract Requirements Flow-downs to Sub-Tier Suppliers
3D Instruments reserves the right to specify or approve sub-tier suppliers contracted by its suppliers
for work performed on 3D Instruments material. This includes but is not limited to special process,
services, materials testing services, distributors, and other subcontractors.
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Suppliers shall flow down to its sub-tier contractors, all relevant quality requirements
imposed by this manual and other contractual document, including government-regulatory
and Defense requirements.
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11. Certificate of Compliance or Certificate of Conformance
The supplier shall certify that all material and process supplied meet 3D Instruments and other
referenced design, quality and specifications requirements. Certification must include as applicable:
• Supplier Name
• Purchase Order
• 3D Instruments part number and revision
• Quantity
• Special process specifications and revision
• Indication Material lot or heat number when applicable.
• Authorized signature and title
12. Mill Material Certification/Test Report (Raw Material Certification)
The supplier and their sub-tier suppliers shall provide one (1) legible copy of test reports identifiable
with purchase order number, material heat or lot number, and the applicable specification and
revision with each shipment. Report must contain:
• Chemical/Physical analysis
• Typical Test Report
13. Acceptance Data Package
The supplier is required to provide one (1) copy of the following items with product shipment:
a) Packing slip
b) Certificate of Conformance and/or Certificate of Compliance
c) Material Certification and/or Test Report (if applicable)
d) Certificate of Conformance from Sub-Tier Supplier (if applicable)
e) First Article Inspection Report when applicable
14. Handling and Delivery
Handling, storage, packaging, preservation and delivery of product shall be in accordance with best
commercial practice to prevent damage and ensure product integrity, unless otherwise specified on
the drawing or purchase order.
15. Workmanship Quality
General workmanship practices and standard term for the prevention of FOD to products apply:
a.
b.
Foreign Object Debris (FOD): A substance, debris or article alien to the part/item(s), which would
potentially cause damage (Finishes of threads, ports, orifices, intersecting holes shall be free of
loose parts and material such as solder, metal pieces, etc. used in fabrication of a unit. Also
fragments such as dirt, dust, fluid, oil, vapors or like Material. )
Foreign Object Debris (FOD): Any damage attributed to a foreign object that can be expressed in
physical or economic terms that may or may not degrade the product’s required safety and/or
performance characteristics.
Surface finishes shall be free of irregularities beyond limits specified on drawings.
16. Outgoing Product Controls
The supply’s quality plan must have sufficient controls to ensure that the product to be shipped
conforms to 3D Instruments physical, dimensional and visual requirements. These controls may
include final inspection and dock audit (component and packaging) outlines in written procedures.
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17. Age-Sensitive Material Certificates (Age Control)
Supplier and their sub-tier suppliers of material shall mark the products and exterior container in
accordance with the specification, as required, including the identification of manufacturer, cure date
and expiration date.
Supplier and their sub-tier suppliers shall provide certification to actual specification, and revision;
including batch identification, manufacture date, cure date, and expriration date, as required. The
certificate shall bear the signature and title of supplier’s authorized representative, and state that the
evidence of compliance is on file and available upon request. In addition, the certificate shall include
information whether the shelf life is to be controlled at room temperature or at refrigerated
condition, as well as information if shelf life can be extended by refrigeration. Material with less than
90% of useful life shall not be shipped on this order.
For material with a shelf life less than 90% as stated above, supplier or sub-tier supplier shall have
written authority from 3D Instruments in order to ship.
18. Traceability
The supplier shall identify material on this order with traceability to a lot or batch number.
Identification shall be via bag and tag unless otherwise specified on the drawing or purchase order.
19. First Article Inspection Report
The Supplier shall perform a First Article Inspection Report (FAIR) using AS/EN9102 forms on the
initial part or lot (as applicable) at the detail, subassembly and/or assembly level. The results of the
FAIR shall indicate 100% conformance to engineering drawing characteristics, special processes,
functional test, and laboratory requirements. The FAIR requirement is to be applied even after initial
compliance. Partial or complete re-accomplishment of the FAIR for affected characteristics is
required for the following events.
1) A change in the design affecting form, fit or function of the part.
2) A change in manufacturing source(s), processes, inspection method(s), location, tooling or
materials with the potential of affecting fit, form or function.
3) When required as part of corrective action for a part number with repetitive rejection
history (typically, a part with three repeated rejections or as required by customer)
4) A change in numerical control program or translation to another media.
5) A natural or man-made occurrence that may adversely affect the manufacturing process.
6) A lapse in production for two years or as specified by customer.
20. Sampling
The supplier may use reduced-frequency (sampling) inspection plans only when historical records
indicate that a reduction in inspection can be achieved without jeopardizing the level of quality. The
supplier may employ sampling inspection in accordance with nationally accepted or customer
required standards, as-specified by the 3D Instruments purchasing department.
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Sampling may not be used to justify the existence of known defectives or discrepancies in a
lot.
The supplier shall maintain quality records in sufficient detail to establish evidence that any
sampling was representative, the required tests and verifications were properly performed,
and that only material meeting specified requirements have been accepted for production
and delivery to 3d Instruments. These records shall be available for review by 3D
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Instruments or a 3D Instrument authorized representative, as required. Copies of individual
records shall be furnished to 3D Instruments upon request.
21. Source Inspection
21.1 The supplier shall notify 3D Instruments purchasing at least 72 hours prior to
inspection/test of product to facilitate inspection/witnessing by a 3D Quality representative.
21.2 Government Source Inspection is required prior to shipment. Upon receipt of this order
promptly notify the Government representative who normally services your facility so that
appropriate inspection task may be scheduled.
22. 100% Inspection Requirement
The supplier is required to perform 100% inspection of this item to ensure compliance to drawing
and specification requirements. Objective evidence of this inspection must be maintained on file and
available for 3D Instruments review.
23. Statistical Process Control
The supplier shall submit a Statistical Process Control (SPC) Plan, detailing how characteristics
and/or parameters will be controlled for this item. Objective evidence of SPC results shall be
maintained on file and available for 3D Instruments review.
24. Certification of Calibration
The supplier shall certify that the item(s) are calibrated and are traceable to nationally recognized
standards. Certifications must include where applicable:
• The National Institute of Standards & Technology (NIST) test number for standards
used and accuracy of the calibration standard(s) used, including as-found and as-left
data for the equipment calibrated.
• Certificate must show the standard which the component was calibrated to
including the accredited (international) procedures used (e.g. ASME)
25. Certificate of NDT
The supplier shall certify that Nondestructive Testing was performed in accordance with the
applicable specification(s). Where appropriate the supplier is to maintain and have available for
examination, records reflecting certification of personnel, equipment and process. Certificate shall
include as applicable same as #10.
26. Supplier Controlled Products/Processes
Substitution, alternatives or equivalents are not to be made for material, product processes or
sources without written approval of 3D Instruments. This includes tools, fixtures, molds, dies, or
other process controls which affect form, fit or function.
27. Special Process Conformance
When special process specification (e.g. heat treat, soldering, welding, anodizing, chemical film
treatment, brazing, NDT, etc.) are a contract and/or drawing requirement, the supplier is responsible
for maintaining a system to control special processes performed at their facility.
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28. DFAR Specific Requirements
Any specialty metals incorporated in articles delivered to 3D Instruments when this clause is
referenced on the Purchase Order shall be melted in the United States, its possessions, Puerto Rico or
a qualifying country. (Reference DFAR)
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This requirement shall be flowed down to all sub-tier raw material sources.
Prior 3D Instruments approval is required if specialty metals not meeting the
requirements are planned for use in articles delivered under contract or Purchase
order to 3D Instruments.
Any and all exceptions to this requirement shall be noted on the Certification of Conformity.
Revision History
Rev.
E
Date
1-17-2015
Description
Extensively revised
By
Sheila Ivy
Approved
Jose Rodriguez
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