RDS-SQ-100 SUPPLIER QUALITY SYSTEM REQUIREMENTS

Transcription

1 RDS-SQ-100 SUPPLIER QUALITY SYSTEM REQUIREMENTS Approved by: Parvez Siddiqi Director of Quality Bruce Reynolds Deputy Director of Quality SQ-100 Revision E January 15, 2016 RDS-SQ-100 Supplier Quality System Requirements Page 1 of 12

2 1.0 Quality Management Terms & Conditions 1.01 Intent The intent of this document is to serve as both a requirement and a general guide to the extent that quality control is required for Suppliers and Subcontractors for government orders. For the purposes of this document, Suppliers and Subcontractors will be collectively referred to as Suppliers Applicability When specified in the Purchase Order, the requirements contained in this document must be adhered to by the Supplier, or the Supplier shall submit to the RDS Quality Team, a time phased implementation plan as to when they will meet these requirements. The plan shall be subject to RDS approval. In the event a Supplier desires an exception to the requirements contained herein, a request delineating the exception must be submitted to Purchasing in order to retain RDS Quality Team approval, prior to acceptance of a Purchase Order. If a conflict exists between the provisions of this document and those of the Purchase Order, the Purchase Order shall take precedence Supplier Qualification Qualified Suppliers will be determined by one or more of the following: manufacturing capability surveys; product evaluation; compliance of procured material with purchase order requirements; a Quality System audit; and/or the promptness and effectiveness of corrective action taken by the Supplier. Continued qualification will be contingent upon continued quality of performance and the satisfactory results of periodic reviews. Supplier ratings, based on the aforementioned elements, will provide comparative measures for determination of procurement sources Quality System Requirements The Supplier shall have a Quality Management System or industrial reputation that is acceptable to RDS. Suppliers already certified to ISO 9001, AS9100, AS9110, AS9120, or are FAA Part 145 Repair Station Approved, are preferred. Supplier s quality system shall include a process that ensures products are initially tested and periodically retested to assess the product s ability to meet all requirements. All workmanship and engineering specifications shall be documented. The Supplier s quality system should be documented in a quality manual and traceable to a standard subset of procedures / work instructions. It shall be the responsibility of the Supplier to perform internal audits on a periodic basis and maintain a quality system in compliance with terms agreed upon by RDS. As indicated on the Purchase Order, the Supplier s Quality Control Manual or equivalent for conformance to applicable program specifications shall be submitted to RDS at least thirty (30) days before shipment, unless otherwise specified. All workmanship and engineering specifications shall be documented Quality Improvement Program The Supplier shall establish and maintain a Quality Improvement Program to improve and sustain the quality and reliability of the processes/product. The program shall be active and contain a prioritized list of scheduled quality issues being addressed. RDS-SQ-100 Supplier Quality System Requirements Page 2 of 12

3 1.06 Corrective Action Completed corrective action reports shall be maintained in a recurrence file. Whenever it is suspected that a quality problem may be a recurrence of a similar problem on which a corrective action has been completed, the recurrence file shall be examined Training Qualifications of personnel shall be as specified on the Purchase Order. Personnel performing inspection, testing, assembly, integration and manufacturing shall be trained for the appropriate skill they are performing. When requested, records of such training shall be made available to RDS Purchasing Calibration Control The Supplier s Quality organization shall audit the records/equipment to ensure that no out-of-date equipment is being used during testing and inspections. The Supplier shall control the calibration of all measuring devices against certified standards traceable to the National Institute of Standards and Technology. The Supplier shall notify RDS Purchasing of any items found to be out of calibration that effect any product delivered to RDS. All test equipment shall be validated to assure that they have the accuracy and resolution to measure the parameters being tested. The test equipment shall maintain repeatability within their allowable tolerances. All calibration will be traceable to standards. Tools, gauges, test equipment, etc., that are inactive or do not require calibration, shall be so identified Surveys and Audits Upon notice, Supplier facilities and operations may be surveyed either before or after the placement of any Purchase Order. The capabilities to meet requirements and to supply a product of consistent quality will be evaluated. Upon notice, audits may be conducted to determine compliance with our purchase requirements and the requirements of this document. RDS, and/or the USG Customer, and/or an authorized USG representative(s) have the right to inspect the Supplier s premises and applicable records during manufacturing, assembly, and/or integration processes. The Government reserves the right to inspect at the Supplier s facility any or all of the deliverables associated with any Order (FAR ) Specific Compliance The Supplier shall certify that all parts, materials, processes, and finished items to be supplied under this or any associated Purchase Order were inspected, tested, and found to comply with the requirements of the Purchase Order. Revisions of referenced military specification, military standards or other revision controlled requirement documents, invoked by reference on the Purchase Order, are in effect as of the date of the Purchase Order Traceability The Supplier shall provide objective evidence of the quality of the item supplied; including manufacturing, assembly, inspection, test and special process records to RDS Purchasing, upon request. All records relating to Critical Safety Items (CSIs) shall be clearly identified and traceable to the date and place of production (manufacturer/oem). Records shall provide the degree of traceability required to enable subsequent verification of all aspects of material, manufacture, special processes, personnel certification, variability control charts, assembly and inspection of Critical Characteristics (CCs). RDS-SQ-100 Supplier Quality System Requirements Page 3 of 12

4 1.12 Counterfeit Parts The Supplier shall demonstrate in their processes how they control, detect and authenticate counterfeit parts or components, and eliminate the use of counterfeit parts. The processes shall maximize availability of authentic, originally designed and / or qualified parts throughout the product's life cycle. Suppliers with documented operating processes that meet AS5553 and AS6081 requirements for procuring electronic parts are preferred Inspection and Test Each inspection or testing activity shall have documentation that describes detailed requirements such as parameters to be checked, statistical methods, sampling plan, non-conformance criteria, etc. An inspection and test plan for the control of articles furnished in accordance with this Purchase Order shall be prepared and specifically written to outline the product flow from receipt of materials through fabrication, assembly, and test operations. The plan defines the inspection points throughout the manufacturing sequence and describes what, where, and when inspections shall be implemented to control the product. Upon request, this plan will be available for review by RDS Quality. Inspection and testing results shall be recorded and analyzed using control charts or a similar technique as appropriate for the purpose of identifying problem areas and monitoring the effectiveness of the quality system. Each time any change is made in the established operation (for example, a new operator, new machine, new technique); a critical examination shall be made of the first unit(s) processed after the change is implemented. If noted in any associated Purchase Order, the Supplier will contact RDS Purchasing in order to notify the RDS Quality Team of the change. All fasteners require inspection by the Supplier before shipment to RDS Control of Non-Conforming Product All non-conforming material shall be identified, isolated and properly disposed. RDS Purchasing shall be notified in writing of all non-conformances, and no such product will be shipped unless prior authorization is received in writing from RDS Purchasing. The Supplier shall also notify RDS Purchasing in writing of all nonconformance found at any time after delivery Material Test Results The Supplier shall submit a chemical and physical test report along with the materials shipped under this or any associated Purchase Order, including actual test results from samples representative of this material Quality Records Supplier s Quality records for products and deliverables shall be maintained and, as a minimum, include product identification; quantity of product inspected; inspection procedures followed; inspector, tester, quality representative; date of inspection, and number, type, and severity of defects found. The Supplier s Quality records shall be retained by the Supplier for the duration of the contract with RDS, and thereafter for 3 years from the inspection and acceptance of the last delivery. As identified on the PO, when required by an RDS customer, contract, or authority, the Supplier may be required to retain additional records for an additional two (2) years. These records shall be sufficient to RDS-SQ-100 Supplier Quality System Requirements Page 4 of 12

5 prove conformance to all applicable specifications and drawings. These records shall be made available to RDS Purchasing upon request within two (2) business days Purchasing Changes in pricing, delivery specifications, scope of work and other direction shall be communicated to the Supplier in writing by the RDS Purchasing Department. The Supplier is required to assure that their sub-suppliers maintain an adequate inspection and Quality System to assure product conformance. Suppliers must flow down all requirements on any associated Purchase Order, including key characteristics, to all sub-suppliers Deviations and Substitutions The Supplier is required to comply with the requirements of any associated Purchase Order. No deviations, changes and/or substitutions in material, design, specifications, product configuration, or operating performance are permissible unless documented by a Change Order generated by RDS Purchasing or an approved deviation request. In order to request a Change Order or deviation, the Supplier will submit a Supplier Deviation Request RDF which is located at the end of this document, to RDS Purchasing. Purchasing will forward the request for approval, as required Sub- Suppliers The Supplier is required to assure that their sub-suppliers maintain an adequate inspection and Quality System to assure product conformance. Each inspection or testing activity shall have documentation that describes detailed requirements such as parameters to be checked, statistical methods, sampling plan, non-conformance criteria, etc. Suppliers must flow down all requirements on any associated Purchase Order, including key characteristics, to all sub-suppliers Handling, Storage, Packaging and Delivery The Supplier s packing sheet and invoices are to reflect the same MIL-SPEC and Supplier s part numbers listed on the RDS Purchase Order. Part Identification: All items supplied under this order shall be identified with complete nomenclature and part numbers in accordance with MIL-STD Identification Marking of U.S. Military Property, or as specified. All deliveries purchased for use on product and delivery to the Government shall be accompanied with a Certificate of Conformance (CofC), signed by a member of the Supplier s management staff authorized to assure conformity to the Purchase Order requirements. The CofC shall be accompanied by, when required, material certificates, serial numbers, and test records pertinent to the material and or product. COTS Items purchased from large commercial retail organizations, such as Lowe s, Wal-Mart, and Staples, are excluded from this requirement. The Supplier shall contact RDS Purchasing in order to confirm that they are excluded from this requirement. On all Critical and Limited Life Items, the date of manufacture or shelf life must be supplied with each limited life item. Limited life items delivered must have a minimum of 50% of their shelf life remaining. A Safety Data Sheet (MSDS/SDS) should accompany each shipment, as required. RDS-SQ-100 Supplier Quality System Requirements Page 5 of 12

6 All raw material, including plate, bar, extrusion, and sheet of aluminum, steel, or other material, must be identified per the applicable specification. Identification to Purchase Order Number is required. Raw material deliveries shall be accompanied by a Safety Data Sheet (MSDS/SDS), as well as Material Test Reports (physical & chemical), providing evidence that the material used meets the requirements of the drawing. All material requiring an SDS will be in compliance with the Globally Harmonized System for Hazard Communication (GHS): The OSHA Hazard Communication Standard 29 CFR requires a "downstream flow" of information, addressed as "FAX on Demand" described requirements of the regulation as stated in paragraphs (g)(6) and (g)(7) of the standard. Areas used for handling, storage, packaging, inspection, and test of products or services shall be clean, safe, and well organized to ensure that they do not adversely affect quality or personnel performance. Where applicable, the transporting of material shall be such as to avoid damage to the material and/or installed/completed equipment. Each container should have a consistent number of parts except the final container may have a quantity difference. Each container shall be identified with the part number, revision, and quantity. The material supplied on an RDS Purchase Order shall be manufactured in an environment free of foreign objects, and material supplied shall be free of foreign objects. The Supplier shall have provisions for the prevention of Foreign Object Damage (FOD) and have a course of action to implement in the event it does occur. The Supplier will ensure personnel are trained and evaluated on employee knowledge, awareness, and responsibilities associated with FOD control, prevention, and reporting procedures. Where the possibility of spoilage exists, items in storage shall be date stamped/coded, etc., and used on a First-in First-out basis. Static sensitive parts will be packed in a conductive frame or with leads inserted in conductive elastomer or foam to protect them against electrical charges. External labels shall identify the package on at least two sides as containing static sensitive devices. All ESD items shall follow ANSI/ESD S Packaging, and marking, must allow for the administration of FIFO (First In - First Out) inventory control. It is preferred that all Suppliers separate and identify lots containing multiple date codes. Product marking shall be in accordance with drawing requirements and MIL-STD Identification Marking of U.S. Military Property. (Reference paragraphs through of the Standard) Materials are to be shipped in containers in keeping with good commercial practices to preclude any damage, or loss being incurred during shipping and storage. Materials in boxes shall be shipped in boxes rated for the weight contained. Materials received in broken boxes may be repackaged, by RDS personnel, in appropriate containers and consideration shall expected by the Supplier REQUESTS TO USE PROHIBITED HAZMAT: the Supplier must contact the RDS Environmental Engineer prior to purchasing any the following: Prohibited HAZMAT CAS Actinolite (Asbestos variation) RDS-SQ-100 Supplier Quality System Requirements Page 6 of 12

7 Amosite (Asbestos variation) Anthophyllite (Asbestos variation) Asbestos (friable) Chrysolite (Asbestos variation) Crocidolite (Asbestos variation) Hexavalent Chromium Mercury and Mercury Compounds Ozone Depleting Substances Class I * Polychlorinated biphenyls (PCB) Tremolite (Asbestos variation) Restricted HAZMAT (1) CAS 1,3-Butadiene ,4'-Methylenebis(2-chloroaniline) (MBOCA) Aminobiphenyl Acetaldehyde Arsenic and Arsenic Compounds Benzene Beryllium and Beryllium Compounds Cadmium and Cadmium Compounds Ethylene oxide Formaldehyde Nickel Compounds *Note: If a material contains both prohibited and (1) restricted HAZMAT, it shall be categorized as prohibited. No uses of any Class I Ozone Depleting Chemical/Ozone Depleting Substance (ODC/ODS) (identified at in the manufacture or support of items required by RDS prime contract W58RGZ-12-D-0089, unless a waiver is obtained from the Government via RDS Purchasing. All Suppliers support service activities shall be in compliance with applicable federal, state, and local Environmental laws and regulations. RDS acceptance does not absolve the Supplier from providing acceptable product nor shall it preclude subsequent rejection by RDS Quality Government Furnished Equipment and Material Upon notice, Suppliers may be subject to an RDS audit to ensure compliance with the following FAR clauses: Government Property, Government Property (Fixed Price Contracts), Government-Furnished Property (Short Form), and Government Property (Cost Reimbursement, Time and Material, or Labor Hour Contracts), as referenced in any RDS Purchase Order Electronic Components: RDS-SQ-100 Supplier Quality System Requirements Page 7 of 12

8 For electronic components, the CofC shall contain the original component manufacturer (OCM) certification. Workmanship Standards shall comply with IPC J-STD-001 Class 3, IPC/WHMA-A-620 Class 3, IPC-A-610 Class 3, and IPC-A-600, as applicable, unless otherwise specified. Electrostatic Discharge protection shall comply with ANSI/ESD 20.20, as applicable. Electronic Components being procured are exempt from Lead Free directives being pursued by commercial entities, therefore, only components whose part finishes (Leads, Packaging, or Contents) with greater than 95% tin (SN) and greater than 3% lead (PB) shall be accepted. Solder shall include at least 30% lead (PB), unless otherwise approved by RDS Quality through notification of RDS Purchasing. Tin-Lead dipped leads shall conform to all military solder ability requirements. When components can only be procured from Lead Free sources the Supplier shall obtain concurrence from RDS Purchasing, in writing, prior to shipping the product. The packaging must clearly identify the part as being Lead Free Paint, Primer and Coatings RDS will only accept paint, primer and coatings that are manufactured to military specifications from (QPD/QPL) Qualified Product Database approved manufacturers, as determined by the QPD. The QPD database must be accessed to verify that the correct combination of color/type/class, etc. is approved and a manufacturer for this combination must be used for purchasing the material. The QPD approved manufacturer must be identified on all quotes and material certifications. The Supplier is responsible for passing RDS MIL-SPEC purchase requirements to all sub-suppliers, including original equipment manufacturers. The Certificate of Conformance (CofC) for all QPL/QPD managed MIL-SPEC items must include the original manufacturer of the product Design Control For Technical Data Packages (TDPs) such as drawings, the Supplier shall establish a process to monitor and review for quality content, errors, and errors per sheet in accordance with requirements specified in SOP-ENG-01, to be obtained through the Project Engineering contact provided. The Supplier shall be required to supply this data monthly to the Project Engineering contact as provided within the applicable contract or Purchase Order. The Supplier s program shall be established and operational to ensure that all design changes are implemented in a smooth and timely manner and do not adversely affect product quality or project schedule. The Supplier s documented procedure(s) shall exist to inform customers when a design change affects product features and performance Process Control The Supplier shall maintain control and approval of all manufacturing processes (such as welding, soldering, plating, and painting) and inspection processes used in the fulfillment of any associated Purchase Order. The Supplier shall maintain objective evidence of process qualification in accordance with applicable specifications; the approval status of which will be subject to review and may be disapproved by RDS. Any deviation from required materials and/or processes that affect fit, form, or RDS-SQ-100 Supplier Quality System Requirements Page 8 of 12

9 function shall be reported to RDS Purchasing in order to obtain RDS Quality approval prior to use or application. All areas to be welded shall meet the welding requirements defined in ANSI / AWS D1.1 and/or D14.3, D1.2, D1.3 and ANSI / AWS B1.11, as applicable. Where Supplier generated Workmanship Standards are to be used, the Supplier shall submit a copy to RDS Purchasing for RDS Quality to review Quality Control Plan When specified by the contract or Purchase Order, the Supplier s Quality Control Manual, or equivalent, shall be submitted to RDS Purchasing for RDS Quality approval, no later than (30) calendar days before shipment Statistical Process Control (SPC) When specified by the contract Purchase Order, Statistical Process Control (SPC) data, in Supplier format, are required with this shipment and should be submitted to RDS Purchasing for RDS Quality acceptance Statistical Techniques When specified by the Purchase Order or contract, the Supplier shall include, as required, training in statistical techniques, process capability studies, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective action. When applicable, the Supplier s Quality organization shall follow-up to assure the effectiveness of the training First Part Inspection When specified by the Purchase Order, the Supplier shall submit a sample first item for dimensional and functional approval prior to making production item(s). The Supplier shall notify RDS Purchasing when the item is ready for approval examination. Such examination may be conducted at the Supplier s facilities or at the RDS receiving inspection area First Article Inspection A First Article Inspection shall be performed for Build-to-Print items that are being produced for RDS for the first time, have not been produced within the previous 24 months, or when specified by the Purchase Order. It is recommended that the Supplier use AS9102 form for the First Article Inspection or another format approved by RDS Quality. Changes to the location of manufacturing, including sub-tier suppliers and outsourced processes, may require a First Article Inspection. The Supplier should contact RDS Purchasing in order to confirm that they are excluded from this requirement. Upon completion of First Articles, and no later than three (3) business days prior to shipment, the Supplier shall notify RDS Quality at YAISOURCEINSPECTIONREQUEST@YMS-HSV.COM, to allow RDS the opportunity to perform First Article inspection at the Supplier s facility. First Article inspection reports shall be accompany deliveries to RDS along with material test reports. This requirement shall be flowed down to sub-suppliers Source Inspection: A Source Inspection is an inspection conducted by an RDS Quality Assurance representative at the Supplier s location. The purpose of Source Inspection is to assist the Supplier in determining conformance with the contract and the specification requirements. Source Inspection neither RDS-SQ-100 Supplier Quality System Requirements Page 9 of 12

10 guarantees final acceptance nor does it relieve the Supplier of the responsibility to furnish an acceptable deliverable. When Source Inspection is specified by the Purchase Order, the Supplier shall notify the RDS Quality at no later than three (3) business days prior to final inspection or testing of the Purchase Order deliverables, to ensure the availability of a RDS Quality Assurance representative who will be present to witness the inspection/test. RDS-SQ-100 Supplier Quality System Requirements Page 10 of 12

11 REVISIONS TO Supplier Quality System Requirements RELEASE DATE DESCRIPTION REVISION Initial Release IR Change required shelf life from 75% to 50% in section 2.8 paragraph 6. Specified FAI requirements for Build-to-Print and other items in section 2.4 paragraph 7. A Added requirement for CARC items to be approved by QPL/QPD. B /6/2015 1/15/2016 Renamed to RDS-SQ-100 RDS Quality System Requirements. Added to 2.14 Retention of Records: Upon request, Quality records must be provided for review. Added exclusions for CofCs from large retail stores, added FOD requirements, added requirements for prohibited HAZMAT, added requirements for GFM/GFE, added requirements for outsourced TDP, edited FAI requirements, added contact for FAI and Source Inspection. Added RDF Supplier Deviation Request All material requiring an SDS will be in compliance with the Globally Harmonized System for Hazard Communication (GHS) C D E RDS-SQ-100 Supplier Quality System Requirements Page 11 of 12

12 Deviation # Deviation Start Date Purchase Order # RDS Supplier Deviation Request Date Submitted Deviation End Date Buyer Part # Revision Supplier Requirement (enter the requirement that cannot be met referencing drawings and/or specifications) Reason for deviation Description (describe how deviation will be performed referencing procedures/guidelines) Purchasing Approvals Department Name Approval Date Print Sign Approve Reject Supplier Quality Project Management Print Sign Print Sign Approve Reject Approve Reject RDF September 2015 RDS-SQ-100 Supplier Quality System Requirements Page 12 of 12