Quality System Standard Operating Procedure 2-OF-02142

Transcription

1 Page: 1 of 15 Quality System Standard Operating Procedure TITLE WPQR-9100 Santa Clarita Supplement Purchasing Quality Assurance Stakeholder(s):

2 Page: 2 of 15 TABLE OF CONTENTS PURPOSE... REFERENCES... SITUATIONAL REQUIREMENTS... DEFINITIONS... DOCUMENT REQUIREMENTS... APPENDIX... REVISION RECORD... PURPOSE REFERENCES Reference documents: WPQR OF WPQR P OF WISE Screens: None SITUATIONAL REQUIREMENTS 7.4 Purchasing APPLICABLE SITES Santa Clarita

3 Page: 3 of 15 I. General This document establishes for all suppliers additional quality system requirements when listed on the purchase order (PO) issued by Woodward. These quality system requirements supplement the following documents referenced on the purchase order: a) Quality Systems Requirements for Woodward Suppliers (WPQR-9100), and b) Woodward Terms and Conditions of Purchase ( ). c) US FAR and DFARS Supplemental Terms and Conditions Requirements in Section II apply to all purchase orders and supplement the requirements of WPQR The supplemental requirements may replace or be added to the applicable section of WPQR Other Quality requirements not listed in this document are the Procurement Quality Assurance (PQA) Codes that apply when specified on a Woodward purchase order. PQA codes are in 4-OF Procurement Quality Assurance (PQA) Codes PQA codes may be flowed-down to any given supplier on their purchase order. Those PQA codes are found in document 4-OF A PQA code is an additional quality requirement beyond the requirements found in WPQR-9100, this supplement to WPQR- 9100, or elsewhere. PQA codes provide additional quality requirements unique to the part being procured, as required by the customer, the commodity, or specific regulations applicable to a part. Order of Precedence In the event of any conflict among the requirements of these documents, the following order of precedence shall apply: 1) Any authorized changes to the purchase order, and the text of the purchase order, 2) WPQR-9100 Santa Clarita Supplement 3) WPQR-9100 Quality Systems Requirements for Woodward Suppliers, 4) Woodward Terms and Conditions of Purchase, 5) 4-OF Procurement Quality Assurance Codes Woodward Airframe Systems, and, 6) Other purchase order documents. Communication All written and oral communications with suppliers and specifications, procedures, certifications, and reports provided by suppliers shall be in English unless other specified on the purchase order.

4 Page: 4 of 15 Acceptance by a Woodward auditor, source inspector, receiving inspector, or any other representative of Woodward does not relieve the Supplier of their responsibility to furnish products or services that conform to all purchase order requirements. Supplier Quality Management System Requirements In addition to the supplier quality systems requirements as specified in WPQR-9100, all Woodward suppliers and supplier candidates must demonstrate compliance to the following quality standards, as applicable: Exceptions will be identified in Woodward s Approved Supplier List: AS9100 (current revision) AS9120: Distributors (current revision) NADCAP: Special Processors ANSI/NCSL-Z540.3 or IEC/ISO17025: Calibration Laboratories DO-178: Software Consideration in Airborne Systems and Equipment Certification : Woodward Supplier Process Change Control Procedure The Supplier shall notify Woodward regarding any change of certification status within 48 hours (including failing an audit). Changes in the supplier s management, ownership, location/address, and/or quality system may require Woodward quality re-approval. It is the responsibility of the Supplier to provide to Woodward Supplier Quality Engineering a written statement of any of these changes within (30) days of change. Employee Awareness and Suitable Environment In accordance with AS9100, suppliers shall ensure that their members are aware of; their contribution to product or service conformity; their contribution to product safety; and the importance of ethical behavior. In addition, the supplier shall ensure that a suitable environment is fostered by management which can be a combination of human and physical factors, such as: a. Social (e.g., non-discriminatory, calm, non-confrontational); b. Psychological (e.g., stress-reducing, burnout prevention, emotionally protective); c. Physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise). Material Review Submittals and Supplier Deviations Waiver Suppliers must comply to all purchase order requirements, including any document, specification, drawing, standard, instruction, or quality codes specified in the purchase order. A supplier may request approval, in writing, to waiver from the requirements of the purchase order or deviate from those requirements prior to product realization. Right of Access The supplier shall grant Woodward, its customers, and regulatory authorities the right of access to applicable areas of all facilities at any level of the supply chain involved in the order and to all applicable records. The supplier shall flow down this right of access

5 clause to all sub-tier and raw material suppliers through the supplier s purchasing system. Page: 5 of 15 No Change Clause Seller shall make no change in design, materials, manufacturing location, manufacturing processes, or sources of supply, after buyer s acceptance of the first production test item or after acceptance of the first completed end item, without the written approval per procedure of the buyer. For Electrical Components: The approval of the buyer will not be required for the seller to make changes in the source of supply of component parts which are classified as Passive Components so long as such supply source changes do not affect form, fit, function, quality, reliability, or safety of the end item, and comply with the counterfeit risk mitigation requirements found elsewhere in this document. II. Woodward Santa Clarita Supplemental Requirements to WPQR-9100 The following requirements apply to all Woodward purchase orders and supplement the requirements of WPQR The supplemental requirements may replace or be added to the applicable section of WPQR Where there is no reference to a WPQR-9100 section, then those WPQR-9100 sections apply as stated with no change. WPQR-9100 Section # 2. Amplification 3.7 Woodward Santa Clarita Supplemental Requirements These documents shall be added to those already listed in Section 2 of WPQR-9100: ISO 9001: Quality Management Systems- Requirements (available from International Organization for Standardization at AS9100:2016 (D Revision) - Quality Management Systems Requirements for Aviation, Space and Defense Organizations WPQR Quality Systems Requirements for Woodward Suppliers AS9102- Aerospace First Article Inspection Requirements WPQR Supplier PPAP Specification US Terms and Conditions of Purchase US FAR and DFARS Supplemental Terms and Conditions OCM : Original Component Manufacturer OEM : Original Equipment Manufacturer Procurement Quality Assurance (PQA): Woodward s PQA Codes. Key Control Characteristics (KCC): An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility that requires specific actions for the purpose of controlling variation as identified on the Engineering drawing or OPMP. Outside Process Manufacturing Planning (OPMP): Woodward HRT

6 7.5.2 Amplification Page: 6 of 15 OPMP. Vendor Material Review Record (VMRR) is a request from supplier to WHRT for material review disposition. Supplier: The seller to Woodward who provides a product or service in accordance with purchase order agreement. Sub-tier Supplier: A direct supplier to Woodward s supplier. Woodward HRT: Woodward in Santa Clarita, CA Deliverable Software (clarification of the stated paragraph in WPQR-9102) Suppliers shall utilize the current version of Radio Technical Commission for Aeronautics (RTCA) DO-178 Software Consideration in Airborne Systems and Equipment Certification or comparable as a guide during development, production, inspection and service of airborne software. First Piece Verification The supplier shall conduct a First Piece Verification at their facility of the first deliverable programmed device. The First Piece Verification shall confirm that the programmed device s checksum matches the value specified in Woodward s Altered Item Drawing (AID). The results of the supplier s First Piece Verification shall be submitted to Woodward for approval prior to shipment. Once approved, the first deliverable programmed device shall be delivered to Woodward. Woodward s Software Quality Assurance shall perform its own First Piece Verification. Non-deliverable Software The supplier shall provide for records and procedures which control configuration and accuracy of software used to manufacture, test, or inspect product. Software may include, but is not limited to, machine control data, CAD/CAM models, N/C tapes or other computer-aided software to control production, test, or inspection related processes. The supplier shall maintain records of test or inspection data verifying accuracy of software, revision control, and appropriate software security. Software Data and Configuration Management The supplier shall implement a configuration control system and data management program that ensures product identification, change management (tracking, reporting, and implementation accountability), interface management, and the maintenance of contract data. All software packages and documentation shall be placed in the supplier s secure storage system which is write-protected and controlled by Configuration Management. The supplier shall be responsible for ensuring the correct version of software is issued to the manufacturing area and incorporated into manufactured software and firmware products. Specialty Metals and High-Performance Magnets Any specialty metals or high-performance magnets (terms as defined

7 8.2.6 Page: 7 of 15 by DFARS ), incorporated in articles delivered under a Woodward HRT purchase order, shall be subject to DFARS Restriction on Acquisition of Certain Articles Containing Specialty Metals. This clause does not apply to Specialty Metals melted in a qualifying country (as defined in DFARS ) or incorporated in an article manufactured in a qualifying country. The supplier shall insert the substance of this clause in all their purchase orders to their sub-tier sources where specialty metals applies. The following Specialty Metals (DFARS) certifications are required: Assembly Suppliers: The supplier s certification of conformance must state: EITHER No specialty metals or high-performance magnets are used in this product. OR Specialty metals and/or high-performance magnets are used in this product and conform to the requirements of DFARS These specialty metals were smelted or produced in (show country(s) of smelting origin here). AND All specialty metals contained in the product being shipped conform to the DFARS requirements. Supplier must maintain the actual mill certifications at their facility. Detail Parts and Standard Hardware Suppliers: The supplier s certification of conformance must state: EITHER No Specialty metals are used in this product. OR Specialty metals used in this product conform to the DFARS requirements. A copy of the mill material certification must state the melt source and be sent in with each shipment of the product containing Specialty Metals. The supplier shall insert the substance of this clause in all their purchase orders to their sub-tier sources where specialty metals may be used, and shall require all their sub-tiers to further flow down the substance of this clause to all their sub-tier sources through each level of the upstream supply chain. Change Request (CR) To request a change to a Woodward drawing or specification requirement, the supplier may submit an Engineering Change Request (CR) that can be submitted to Woodward Engineering through the Purchasing Agent. Only when the CR is approved by Engineering, and with a corresponding purchase order change notice reflecting the change, the supplier may ship the product to Woodward. The CR form and instructions may be obtained through Woodward s website Approval of CR s will be contractually binding through a Purchase Order

8 Exemption section Page: 8 of 15 Change Notice (POCN), which reflects the requested change (e.g., PQA Codes, Engineering drawing revision). When a supplier s performance fails to comply with specified requirements, Woodward may impose source inspection at the supplier s facility at the supplier s expense. Woodward reserves the right to debit the supplier s account to compensate for Woodward inspection or related activities that take place as a result of a supplier s lack of performance, or capability to supply conforming product or services. Special processes are exempted from the requirement for independent lab testing by a lab other than the source or primary lab. Woodward HRT s Special Processor Definition Any of the processes listed below that are performed in accordance with an applicable specification (Military, AMS, ESS, etc.) are defined as special processes and requires NADCAP accreditation except where noted: Welding (fusion welding, electron beam welding, laser welding, resistance welding, torch and induction brazing, and furnace brazing) Soldering (NADCAP accreditation is not required by Woodward HRT, but Woodward HRT approval is required) Chemical Processing (etching, chemical milling, chemical film, passivation, plating, and anodizing) Heat Treating (normalizing, solution heat treating, nitriding, annealing, stress relieving, hardening, tempering, and carburizing) Non-Destructive Testing (i.e., penetrant, magnetic particle, ultrasonic, or radiographic) Testing (metallurgical, chemical) Surface Enhancement (shot peen) Electrical Discharge Machining (NADCAP accreditation is not required by Woodward HRT, but Woodward HRT approval is required) First Article Inspection The supplier shall perform a First Article (FAI) and submit the First Article Inspection (FAIR) with delivery of product in accordance with the requirements of AS9102, current revision and the Woodward HRT document, 4-OF-01585, First Article Inspection Process. First Articles for castings, forgings, and molded products also shall be in conformance with Woodward HRT P A copy of the current applicable FAIR is not required with each shipment. FAIs shall not be performed against an engineering model of any kind; instead, only the drawing shall be used as the basis of an FAI. The supplier shall flow this requirement to their sub-tier sources. Age Sensitive, Life-limited Parts Parts shall be segregated by manufacturing lot/cure date when shipped to Woodward HRT. Suppliers must provide product to Woodward HRT with 25% remaining shelf life.

9 8.5.4-e exemption Page: 9 of 15 Each container shall be labeled with part-number, revision, part name, quantity, manufacturer name, manufacture date code, lot or batch number, cure/mix date and expiration date. Preservation Woodward Santa Clarita exempts its suppliers from clause e, which states, The organization shall segregate products by manufacturing lot / cure date for shipment to Woodward. Delivery Documentation The supplier shall provide all certifications and test data as required by the PQA codes listed on the purchase order or OPMP. All certifications and test data shall be in the English language stating the acceptance for each item delivered in accordance with the purchase order/contract. The documentation shall be submitted electronically into Woodward s documentation portal prior to shipment unless alternate method approved by Woodward. A certification of conformance must be submitted with every shipment and be signed by the supplier s quality representative who can attest to the conformance of the articles and shall include the signatory s title and date. This does not preclude the use of electronic stamps or signatures, which includes electronic printed names and, therefore, Woodward will allow electronic stamps and signatures from its suppliers on certifications and test data. It is the supplier s responsibility to assure that special processes are performed by Woodward approved sources, or customer approved sources when PQA Code 13 is called out in the purchase order. The Certificate of Conformance shall include the following information: Woodward purchase order. Part number and revision as listed on the PO. Woodward part number and revision. Quantity shipped. Supplier s name. Supplier s address. Statement of conformance attesting to the conformance of the article(s). DFAR statement per paragraph 4.20 (when specialty metals apply). Serial numbers (when required by drawing, may be on test data). Manufacturer s name and lot date code (when electronic MIL-SPEC or DESC-components apply). Raw Material Certification The supplier shall comply with the requirements of AS6174 (Counterfeit Materials). Each shipment shall be accompanied by one (1) legible and reproducible copy of the following: a. Mill certification (including chemical & physical test results). b. Distributor certification of conformance documenting chain of

10 custody/traceability from the Mill to Woodward. The mill and distributor certifications shall indicate the name and address of applicable specifications and revisions. Page: 10 of 15 Non-Domestic Raw Metallic Material (This clause is over and above the requirements of Specialty Metals. It is applicable to all raw metallic material purchased from a non-domestic source.) Raw metallic material produced in foreign countries must be tested for compliance to the material specification. Supplier must have an established periodic raw material independent testing process (i.e., annual oversite program) that validates raw material and the accompanying certifications. (The material validation process must be documented and evidence of compliance must be made available to Woodward upon request within 10 working days or sooner from date of request.) Procurement of Castings and Forgings Suppliers who procure castings or forgings shall comply with Woodward HRT document, P10-06, and ensure the casting/forging supplier is listed on Woodward HRT s Approved Supplier List (ASL) which may be obtained through Woodward s website Counterfeit Risk Mitigation The supplier shall provide certification to Woodward, and maintain in the supplier's records and available for audit, the traceability records of all components showing supply chain traceability to the approved source as shown on Woodward s drawing or purchase order (for electronic parts, that would be an OCM or authorized distributor) which identifies the name and location of all of the supply chain intermediaries from the part manufacturer to the direct source of the product for the seller. Note that brokers of electronic parts are not franchised or authorized distributors of OEM components. Specifics for Electronic Parts Under certain circumstances, electronic parts from component brokers may occasionally be used, but only if the traceability described above is provided and authorization is received in advance from Woodward and/or Woodward s customer. In these circumstances, the broker shall provide: 1. Original Certification of Conformance of the parts origin including manufacturing dates or lot codes, and traceability as stated above, OR

11 Page: 11 of Certification of Conformance from an authorized distributor of the original component manufacturer that produced the component and traceability as stated above If neither of the above is available, the supplier shall notify and receive advance agreement from Woodward and, when required, Woodward s customer, for the verification tests to be per-formed by the supplier or a third party on the electronic component to establish that the component(s) are authentic, new, and previously unused. Any tests to confirm performance and electrical characteristics shall be based upon the original OEM datasheet or specific attributes as indicated by Woodward Engineering. The supplier shall provide certifications indicating the inspection or testing performed. Reference the latest version of SAE document AS 5553 (Fraudulent/Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition) for the types of verification processes, inspections, or testing that are recommended or required to mitigate the risks of receiving counterfeit electronic components. Specifics for Non-electronic Parts The supplier shall comply with the requirements of AS6174 (Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel). Further, unless PQA Code 7 is invoked, which requires certifications to accompany shipments, the supplier shall retain indefinitely and upon request make available for audit the following documents related to each shipment: a. Mill certification (including chemical and physical test results). b. Distributor certification of conformance documenting chain of custody/traceability from the Mill to Woodward. The mill and distributor certifications shall indicate the name and address of applicable specifications and revisions. Country of Origin Commercially available off-the-shelf items, domestic end product, qualifying country end product, and foreign end product, as referenced in this paragraph, are defined as per DFARS Buy American Act and Balance of Payments Program. If the item supplied does not qualify as a commercially available off-theshelf item (COTS), the supplier must include one of the following two statements in their quote and on their Certificates of Conformance: a. Use the following statement if the item qualifies as a domestic end product or qualifying country end product, even if PQA code 38 is applied to the item: "The offeror certifies that the following end products are domestic end products or qualifying country end products. The country of origin is."

12 Page: 12 of 15 b. PQA code 38 must be applied to an item to use the below statement on the Certificate of Conformance. PQA code 38 will be added to an item as a result of the inclusion of the statement below in the offeror's quote and acceptance by the buyer. Use the following statement if the item does NOT qualify as a domestic end product or qualifying country end product (enter "unknown" if the country of origin is not known): "The following end products are other foreign end products, including end products manufactured in the United States that do not qualify as domestic end products. The country of origin is." Woodward HRT s Special Processor Definition Any of the processes listed below that are performed in accordance with an applicable specification (Military, AMS, ESS, etc.) are defined as special processes and requires NADCAP accreditation except where noted: Welding (fusion welding, electron beam welding, laser welding, resistance welding, torch and induction brazing, and furnace brazing) Soldering (NADCAP accreditation is not required by Woodward HRT, but Woodward HRT approval is required) Chemical Processing (etching, chemical milling, chemical film, passivation, plating, and anodizing) Heat Treating (normalizing, solution heat treating, nitriding, annealing, stress relieving, hardening, tempering, and carburizing) Non-Destructive Testing (i.e., penetrant, magnetic particle, ultrasonic, or radiographic) Testing (metallurgical, chemical) Surface Enhancement (shot peen) Electrical Discharge Machining (NADCAP accreditation is not required by Woodward HRT, but Woodward HRT approval is required) Submission of Electrical Discharge Machining (EDM) or Other Metallurgical Test Specimens EDM is prohibited on Woodward HRT design detail parts unless specified on the drawing and/or approved by Woodward HRT in accordance with ESS008. Unless otherwise specified on the purchase order, all metallurgical lab samples required to be submitted to Woodward HRT for approval prior to processing must be submitted to the Purchasing Agent identified on the purchase order. The Purchasing Agent will forward the samples to the metallurgical lab and return the results to the supplier. Control of Woodward Supplied Product and Tools Product Control: The supplier shall establish and maintain a documented procedure to identify, store, control, account for inventory balance, and maintain Woodward supplied material or articles that are provided for the

13 8.5.4 Amplification Amplification Page: 13 of 15 supplier to incorporate into Woodward procured articles. Any such product that is lost, damaged, or is otherwise unsuitable for use shall be recorded per the supplier s internal procedure and submitted to Woodward. Excess Woodward Furnished Material: The supplier shall contact the Purchasing Agent to obtain disposition instructions for excess Woodward furnished material. Certification of Woodward Furnished Material: Strict accountability of the material furnished for this order must be maintained. A certification stating that the parts were manufactured from the material furnished by Woodward is required. Tool Control: The supplier is responsible for proper storage, control, monitoring for life, and handling of Woodward tools as well as protection against damage or affects from the environment. The supplier also is responsible to maintain the identification and whereabouts of the tools, as appropriate, to assure its intended use and recall when needed. Notification of Tooling Condition: The supplier shall advise Woodward Purchasing and Procurement Quality Assurance in writing when the condition of the tool is worn or damaged such that it may affect the ability to produce conforming product. The supplier must advise Woodward purchasing with sufficient time in advance to allow Woodward to disposition the tool by repair or replacement and assure continuity of part supply without the need for deviation from specifications. Batch Management and First-in-First-out (FIFO): Supplier will maintain positive control, segregation, and identification of furnished material to be incorporated into procured articles that include Woodward assigned batch numbers. The supplier will use product in a FIFO sequence and report to Woodward in their shipping paperwork the Woodward assigned batch numbers that were used in the manufacture of the procured articles. Preservation, Packaging, and Shipment Identification on packages shall include the PO number and line item to which they apply. Use of staples, paper clips, or other potential foreign object debris (FOD) is prohibited in packaging. Foreign Object Damage and Debris Prevention Unless otherwise specified on the purchase order, the supplier shall establish and maintain a Foreign Object Damage (FOD) program that meets the requirements of NAS412 Foreign Object Damage/ Foreign Object Debris (FOD) Prevention. Nonconforming Product Nonconforming product shall be reviewed in accordance with documented procedures. It may be: a) Reworked to meet the specified requirements.

14 b) Scrapped. c) Accepted with or without repair - formal Woodward approval is required. d) Repaired - formal Woodward approval is required. e) Regraded this disposition is not used at Woodward. Page: 14 of For Woodward HRT, the organization shall, unless otherwise instructed by Woodward HRT, obtain formal approval by submitting a Vendor Material Review Record (VMRR). Any request for material review action for nonconforming product on a Woodward HRT order must be submitted on a VMRR to Woodward HRT through the Supplier portal at Only when a supplier has obtained a response from Woodward HRT with a disposition that allows the supplier to ship, the product may be shipped to Woodward HRT. The supplier shall reference the Nonconforming form number on the Certificate of Conformance document. The VMRR form and instructions may be obtained through Woodward HRT s website The VMRR must be accompanied with a corrective action. For nonconformities where product quality may be impacted, containment must be completed within 48 hours. Corrective actions, when requested by Woodward, shall be responded to in a manner that complies with AS9100 standards and shall be documented on Woodward corrective action forms. For nonconformities where product quality may be impacted, containment must be completed within 48 hours. Latent Defect Reporting and Seller s Notification of Escape (NOE) Communication When seller determines or suspects a nonconformance on goods and/or services provided, Seller shall provide a written Notification of Escapement (NOE) to Buyer s Procurement Representative. Seller shall provide the NOE within three (3) business days of when the nonconformance or suspected nonconformance was determined. If the nonconformance affects flight safety or mission critical hardware, Seller shall provide the NOE and all available information immediately. Seller shall include the following information in the NOE (as minimum criteria): Shipment Date(s) of affected and/or possibly affected goods and/or services. Buyer s Purchase Order contract number and line item. The affected Part number(s) and associated serial number(s) and/or lot

15 Page: 15 of 15 number(s) and/or batch number(s) as applicable. Quantity affected. Date of manufacture including any other pertinent information. Description of the nonconformance including the should be and is condition referencing applicable engineering documentation and/or specification numbers and paragraphs. Information regarding whether the nonconformance is determined to exist or suspected to exist or both with relevant details. Containment, and a preliminary root cause and root cause corrective action plan. NOTE: For nonconformities where product quality may be impacted, containment must be completed within 48 hours. Details regarding immediate containment and potential crossover into other parts and/or processes. Name(s) and contact information of Seller s Quality personnel involved in collecting and reporting the NOE information. Date of NOE submittal. REVISION RECORD Revision Date 25-Apr Revision Level Approval Description 1 ON FILE Initial release of Santa Clarita s supplement for WPQR Woodward Santa Clarita Approval(s): Steve McNeal, Chris Murray, Suzanne Saulus, Steve Szekely 8-May ON FILE Aligned with the new WPQR-9100 (Rev 30) which corporate just updated to reflect AS9100D. The alignment to the new WPQR entailed renumbering all of our added s, exemptions, and amplifications see blue font. Took exemption to clause e Woodward Santa Clarita Approval(s): Steve McNeal, Chris Murray, Suzanne Saulus, Steve Szekely