Supplier Quality Clauses
A-843-01 External Provider Quality Clauses, Revision A
The following clauses apply to all purchase orders: QC01, QC02, QC03, QC04, QC05, QC06, QC07, QC08, QC09, QC10, QC11, QC13, QC20, QC22, QC23, and QC25.
The following clauses also apply to any purchase orders for raw materials and/or hardware: QC14 and QC24.
The following clauses also apply to any purchase orders for outside processing: QC16 and QC17.
Quality Clause QC12, QC15, QC18, QC19, QC21, QC26, and/or QC27 also applies when called out on the PO.
QC01 Quality System
External provider shall establish and maintain a Quality System acceptable to Abbott Technologies, Inc., for the goods and/or services purchased under this purchase order. As a minimum, the external provider’s Quality System must meet the requirements of ISO9001 or better or Quality System approved by Abbott Technologies, Inc.
When Specifying Compliance to AS9100 “The organization shall have a quality program that complies with International Organization for Standardization document SAE, AS9100 – Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.” Third party certification / registration is not required. “If Customer has accepted Organization’s AS9100 registration and Organization subsequently changes registrars, loses its registration status, or is put on notice of losing its registration status, it shall notify Customer’s procuring Component(s) within three days of receiving such notice from its registrar. ”When specifying Compliance to ISO9000 “The organization shall have a quality program that complies with International Organization for Standardization document ISO9000 – Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.” Third party certification / registration is not required. When Awarding a Contract to an ISO 9000 or AS 9100 Registered Organization “If Customer has accepted Organization’s third-party quality registration and Organization subsequently changes registrars, loses its registration status, or is put on notice of losing its registration status, it shall notify Customer’s procuring Component(s) within three days of receiving such notice from its registrar.
QC02 Flow down Requirements
This clause mandates that all applicable requirements that are invoked or applied to the customer’s purchasing document, including this clause, shall be flowed down to the organization’s sub-tier external providers.
QC03 Record Retention and Disposition
As a minimum, the External provider is to retain documented information for at least 10 years from the date of shipment under each applicable order for all products/part numbers unless otherwise specified in the order. In special circumstances, the purchase order will identify the actual required number of years that the documented information should be maintained. After the minimum retention period is achieved, external providers may disposition the documented information as archive or destroy at their discretion.
QC04 Packaging Protection
External provider to package parts in a manner that will protect parts from any kind of damage. No metal-to-metal contact is ever allowed. In special circumstances, the purchase order may specify the manner the parts are to be packaged.
QC05 Right of Access
Work under this purchase order/contract is subject to government or customer surveillance/inspection at organization’s plant or sub-tier external provider’s facility. The organization will be notified if a
surveillance/inspection is to be conducted.
QC06 QMS Awareness
External providers Personnel must be made aware of:
- their contribution to product or service conformity;
- their contribution to product safety;
- the importance of ethical behavior.
QC07 Control & Monitoring Requirements
External providers must maintain a Quality Level ≥95% and On-Time-Delivery Level ≥95%. If levels drop below target, external provider will be notified and may be placed on conditional status or disapproved if not corrected.
External providers shall ensure the Foreign Object Debris/Damage (FOD) if any, is removed before the shipment wherever applicable will flow down this requirement to its sub-tier external providers.
ITAR REQUIREMENTS: The Code of Federal Regulations 22 CFR International Traffic in Arms Parts 120 thru 130 apply to all items on this order that meet the requirements of 22 CFR 120. When the Abbott Technologies, Inc. Contract or Purchase Order defines that the product being purchased is for a military program or is being developed for a military program the external provider shall ensure they are in full compliance with ITAR requirements.
QC10 Nonconformance/Corrective Action
The External provider is to notify Abbott Technologies, Inc. of a Nonconformance prior to shipping parts. In addition, the External provider will maintain a system of handling non-conformances and corrective actions.
The External provider’s equipment shall be calibrated in accordance NIST standard (ISO 17025/ISO 10012-1/ANSI Z540-1) traceable to national or international measurement standards.
QC12 External provider Furnished Material
External provider shall submit Chemical and Physical test reports in accordance with the latest material specifications and revision. Distributors must provide a certification verifying the materials traceability to the Mill test reports when supplied.
QC13 Part Identification
The External provider is to identify parts in accordance with purchase order requirements.
QC14 Part Number Serialization
All parts should have unique serial numbers assigned. External provider is to maintain traceability throughout the production stage.
QC15 Abbott Technologies, Inc. Furnished Property
External provider is to return all furnished property to Abbott Technologies, Inc. at the completion of the purchase order. Furnished property may include but not be limited to the following: drawings, mylars, process specification, tooling, fixtures, and excess raw material.
QC16 Special Processing Approval
Processor (Contractor and/or Sub tier) shall have current required approval(s) in place at the time of hardware processing. Contractor shall verify approval prior to performing processing.
Special Process – A method controlled by a contractually required specification where:
- A product undergoes a physical, chemical, or metallurgical transformation or inspection. Conformance to the specification cannot be readily verified by normal inspection methods and,
- The quality of the product depends on use of specific equipment operated in a specific manner, under controlled conditions, by trained personnel with instructions, procedures, or standards.
Contractually required specifications include Lockheed Martin, Industry or Government specifications identified in the Lockheed Martin Purchase Agreement, subordinate drawings, statements of work, or other contractual documents. Certain special processes are required to comply with this contract. Special processes shall be performed only by sources that have been surveyed and approved by Lockheed Martin to perform
those processes. A special process certification shall be provided with each shipment of item(s) delivered on this
contract. Special Process Certifications may be in external provider format and shall include the following:
Customer’s Order number;
- Part number(s);
- Serial and/or lot numbers, of the hardware processed (if applicable,);
- Material process specification & revision;
- A certification stating the special process was performed per the applicable drawing/specification requirements;
- Processing Organization ’s name and address;
- Each certification must be signed and dated by a company official of the Organization and/or Processor attesting to the acceptance of the processes performed to the required specification(s). The Organization shall insert the substance of this clause, including this sentence, in all lower tier subcontracts for work performed under this contract.
QC17 NADCAP Approval
Special processing NADCAP approval is required. The special process requirements will be listed on the actual purchase order.
QC18 First Article Inspection
The External provider to submit a First Article per AS9102 with this purchase order. It should identify all the process specifications and dimensional data.
QC19 BUY AMERICA ACT
Items procured under this purchase order must be compliant with DFAR 252.225-7000.
External provider must provide notice at least 180 days prior of any products approaching obsolescence and allow final purchase before obsoleting any product.
QC21 Shelf-Life Materials
The external provider provides the manufacturing date, shelf life, and expiration date for all limited shelf-life items under this order. All items will have 85% or more of their shelf life remaining at the time of shipment to Abbott Technologies, Inc. All items are packaged, labeled, and transported per their applicable regulatory requirements.
QC22 Acceptance Authority Media
Media such as inspection stamps and electronic signatures used for product acceptance/inspection must be controlled and traceable to the personnel they are issued to.
QC23 Counterfeit Prevention
Vendor must have a process in place to detect and prevent the use of counterfeit parts/materials.
QC24 Test Reports
Organization will include with each shipment the raw material manufacturer’s test report (e.g., mill test report) that states that the lot of material furnished has been tested, inspected, and found to be in compliance with the applicable material specifications. The test report will list the specifications, including revision numbers or letters, to which the material has been tested and/or inspected and the identification of the material lot to which it applies. When the material specification requires quantitative limits for chemical, mechanical, or physical properties, the test report will contain the actual test and/or inspection values obtained. For aluminum mill products (except castings), certifications for chemistry may indicate compliance within the allowed range. Certifications for physical properties will show actual values.
QC25 Certificates of Conformance
Organization shall provide a certification with each shipment to attest that the parts, assemblies, subassemblies, or detail parts conform to the Order requirements. When applicable, the true manufacturers, lot, heat, batch, date code, and/or serial number must appear on the certification.
Certification must contain the following:
* Customer’s Order number;
* Part number;
* Name and address of manufacturing or processing location;
* Manufacturer’s lot, heat, batch, date code, and/or serial number (if applicable);
* Quantity and unit of measurement (each, box, case, gallons, etc.);
* Be signed and dated by an official of the company.
The applicable material test results, process certifications and inspection records shall be presented upon Customer’s request. Organization shall perform inspection, as necessary, to determine the acceptability of all articles under this Order. All articles submitted by Organization under this Order are subject to final inspection at Customer’s plant.
QC26 Certificate of Calibration
The organization shall submit for each item calibrated, one reproducible record of actual calibration results, including applicable graphic and tabular data. Records shall be traceable to the individual item tested, by part number, serial number and customer’s order number for the item shipped. The organization’s calibration certificate shall include a unique calibration tracking number, tolerance range, and when applicable, environmental conditions for each parameter calibrated. The certificate shall also state the operating error per specification, the degree of correction of out of tolerance condition, and remaining uncorrected out of tolerance condition, if applicable.
QC27 Critical Processes
The following shall apply to customer designated “critical processes” performed by the organization:
The organization will notify the customer of proposed changes in process definition and, will obtain approval from the customer prior to implementing the change. Changes affecting processes, production
equipment, tools, and programs shall be documented. Procedures shall be available to control their implementation.
The following shall apply to organization designated “critical processes” that have been sub contracted:
“The external provider will notify the organization of proposed changes in process definition and, will obtain approval from the customer prior to implementing the change. Changes affecting processes, production
equipment, tools, and programs shall be documented. Procedures shall be available to control their implementation.