Strain Measurement Devices Quality Terms and Conditions requirements apply to suppliers including sub-tiers used by a supplier providing purchased products or processing services. Supplied products or processes shall conform to the latest revision level of the applicable drawing and specification unless otherwise noted on the Purchase Order (PO).
Suppliers shall flow-down to their sub-tier(s) the applicable requirements in their purchasing documents, including the requirements for certifications and First Article Inspection.
Strain Measurement Devices documentation and information shall be maintained and considered proprietary in nature.
Order of precedence of documentation is based on PO, drawing, specification and authorized Strain Measurement Devices change documents. Should a conflict occur over requirements, questions must be directed to purchasing management at Strain Measurement Devices.
Strain Measurement Devices shall reserve the right to make changes to the PO using written change notification and/or an amended PO. The supplier shall notify Strain Measurement Devices in a timely manner, in writing, confirming the change.
Suppliers shall review the PO and any changes and notify Strain Measurement Devices regarding compliance, such as; quality, price and delivery. The supplier must immediately notify Strain Measurement Devices in writing of changes that could affect product quality, including, but not limited to changes in personnel, location, process, equipment, and/or procedures.
Inspection & Quality System:
Suppliers must provide product and processes that are controlled by a quality system that assures the following:
Gauges and equipment used for processing and acceptance shall be calibrated at documented intervals and traceable to NIST. The calibration shall be based on ANSI Z540-1, or equivalent.
Provide inspection to confirm all product requirements. The inspection system shall include documented results for incoming, in-process and final inspection. Product shall not be released to Strain Measurement Devices until successful completion of inspection checks are completed and documented. Inspection sampling maybe used based on ANSI/ASQ Z1.4, Sampling Procedures and Table for Inspection by Attributes, utilizing C=0 criteria.
Work instruction, routers, travelers, test reports and inspection records shall be maintained. Quality system structure shall be based on ISO9001, AS9001, ISO13485 or similar requirements.
Right of Entry:
Strain Measurement Devices, its customers and applicable regulatory agency shall be assured “right of entry” without prior notice, to all facilities and to applicable records and materials involved in the execution of the PO to perform Quality Audits and Inspection Surveillance at their discretion.
Certification of Conformance:
Suppliers shall submit with each shipment a typed, legible, reproducible statement certifying conformance referred to as a Certification of Conformance (C of C). The C of C specifies the items listed thereon comply fully with all purchase order requirements. The C of C shall include: the supplier name, authorizing signature with title, date, purchase order number, part number, revision, quantity and lot or serial number (when required).
Material & Special Certifications:
Suppliers shall maintain on file, and submit with the first shipment, the Material Certifications associated with the PO. When a specific material or alloy is specified, a Material Certification must accompany each shipment. Suppliers shall maintain on file, and submit with the first shipment any special process certification of test pieces. The Certifications shall include: description of the material, trade name, manufacture’s name; specification number (type, grade etc.) manufactures part number, batch and heat lot number if applicable.
Raw Material Certification:
Specifies chemical and physical analysis shall be provided with each order of Raw Material. Suppliers shall maintain copies of Raw Material Certifications. Raw Material Certifications shall include:
- a) Batch, heat or lot, number.
- b) The material specification and revision.
- c) Certification of the composition to within acceptable limits where MIL reports are not available. (Metals require specific values of composition.)
Functional Test Reports:
The supplier providing product requiring functional or final test reports shall submit the report, with each shipment. The report shall include: actual test results, identifiable to the respective parts or products, part number, revision, quantity, test requirements, and other technical information.
First Piece Inspection:
Performed by the supplier prior to initial production and shipment to Strain Measurement Devices. The supplier shall furnish Strain Measurement Devices the initial pieces separately identified, to be retained as samples for the initial production. The initial piece samples shall be made to the process that will be used for production, with the same material, process and manufacturing cycle as for the production run, including any sub-contracted processing based on production ready work instructions. Whenever practical, variable data is to be recorded and the inspection device documented. One to five initial piece samples shall be utilized.
First Article Inspection (FAI):
Reports shall be provided for a first production run, or when the manufacturing method has changed, or when the print revision has changed. The FAI report shall include: a list all characteristics including notes, tolerance limits, dimensions, inspection devices, pass/fail status, and material requirements. An itemized ballooned drawing shall accompany the FAI report. FAI shall be provided to Strain Measurement Devices and be maintained on file by the supplier.
The supplier shall not make any changes/substitutions to materials, products, or processes required by the engineering documents without written authorization from Strain Measurement Devices. Authorization must be in writing based on approved engineering change documentation and may be contingent upon a facility visit.
Age Control Materials:
Materials or articles having manufacturer’s expiration date or having characteristics subject to degradation with age shall be marked in a manner to indicate the date of manufacture and the expiration date. The supplier shall not deliver articles with less than 80% of shelf life remaining at the time of delivery. Examples of shelf life materials include but are not limited to shrink tubes, RTV compounds, sealants, rubber-molded articles, etc. Material without appropriate shelf life may be rejected by Strain Measurement Devices.
Electrical, electronic, and electro-mechanical parts with conductive silicon based components are treated as electrostatic sensitive devices to ESD. Product sensitive to ESD must be protected from ESD and enclosed in ESD protective materials when delivered. ESD labeling indicating that the contents contain electrostatic sensitive devices shall be used.
Foreign Object Debris (FOD):
Suppliers shall ensure that foreign objects, debris, and loose material are eliminated from parts prior to shipment. Suppliers shall maintain a FOD free environment during machining, manufacturing, assembly, soldering, inspection, storage, packaging and shipment that ensures parts are clean and free of contaminates.