Christie Digital Systems Canada Inc. Supplier Quality Standard Page 1 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality Description: Quality Management System Requirements for Suppliers Applies to: As indicated in Christie Engineering drawings Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D Approvals Title Name Manager GSQ Ulku Kiziltan Director, Global Supply Chain Management Adele Evans REVISION STATUS Revision Release Date Authorized by Released per ECO Number 04-26-07 Dan Rubicini 02 08-17-07 Dan Rubicini 03 07-13-09 04 01-13-14 Laura Tecsa 13-3868 05 03-13-15 Laura Tecsa 15-2198 IC IA 01 O FF Dieter Lenz Revision History 06-4278 07-3206 09-1325 Update requirements : Updated template to new Christie requirements, updated 2.1 Acronyms *Added Medical requirements under 2.2 References, and added 3.5 e CofC, f and g added to RMA /RMO requirements 3.3 d Updated with Disaster Recovery Plan 3.7 e Packaging updated with Recycling req. 3.13 Updated Supplier Acknowledgment sheet with Christie approval “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 2 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 1 Contents 1 CONTENTS ................................................................................................................................................................................ 2 2 Introduction .................................................................................................................................................................. 3 3 D ACRONYMS ....................................................................................................................................................................................... 3 REFERENCES ...................................................................................................................................................................................... 3 DOCUMENT CONVENTIONS .................................................................................................................................................................. 4 SCOPE .............................................................................................................................................................................................. 4 CHRISTIE’S QUALITY POLICY ................................................................................................................................................................. 4 CHRISTIE’S ENVIRONMENTAL POLICY ...................................................................................................................................................... 4 Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E 2.1 2.2 2.3 2.4 2.5 2.6 Supplier Responsibilities .................................................................................................................................. 5 O FF IC IA 3.1 QUALITY MANAGEMENT SYSTEM REQUIREMENTS .................................................................................................................................... 5 3.2 CHANGE MANAGEMENT REQUIREMENTS ................................................................................................................................................ 5 3.3 RESOURCE MANAGEMENT RESPONSIBILITIES ........................................................................................................................................... 6 3.4 DESIGN AND PRODUCT DEVELOPMENT ................................................................................................................................................... 6 3.4.1 Drawings/ Specification Control and Contract Review .......................................................................................................... 6 3.4.2 Supplier Design and Development ........................................................................................................................................ 7 3.5 PURCHASING OF MATERIAL USED FOR CHRISTIE PRODUCTS ....................................................................................................................... 8 3.6 PRODUCT REALIZATION AND IN‐PROCESS CONTROL .................................................................................................................................. 8 3.6.1 First Article Inspection General Requirements (FAI) ............................................................................................................ 10 3.6.2 FAI Report ............................................................................................................................................................................ 11 3.6.3 Measurement / Inspection Requirements for Optical Parts ................................................................................................ 12 3.6.4 Measurement / Inspection Requirements for Mechanical Parts ......................................................................................... 13 3.6.5 Measurement / Inspection Requirements for Electrical / Electronic Parts .......................................................................... 14 3.7 PACKAGING ..................................................................................................................................................................................... 15 3.8 CHRISTIE’S PROPERTY INCLUDING INTELLECTUAL PROPERTY AT SUPPLIER ...................................................................................................... 15 3.9 CONTROL OF MONITORING AND MEASURING DEVICES .............................................................................................................................. 16 3.10 NONCONFORMING PRODUCT CONTROL ................................................................................................................................................ 16 3.11 CORRECTIVE AND PREVENTIVE ACTION .................................................................................................................................................. 16 3.12 CHRISTIE SCORECARDS ...................................................................................................................................................................... 17 3.13 SUPPLIER ACKNOWLEDGEMENT SHEET ...................................................................................................................................... 18 “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 3 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 2 Introduction Acronyms IA IC FF O ATP BOM CB CDS CRD CSA DFM DFT EPR ESD FAI FCT FMEA GD&T GSQ ICT ISO MAC MTBF OTS PCB PO PPR REACH RoHS SPC SQS UL WEEE FDA RMA/RMO COFC 2.2 A Change to a part or process involving or affecting Form, Fit, Function, Man, Machine, Material or Method Acceptance Test Plan Bill of Material Certification Body Christie Digital Systems Comprehensive RoHS Declaration Canadian Standards Association Design For Manufacturability Design For Testability Engineering Pilot Run Electrostatic Discharge First Article Inspection Functional Circuit Test Failure Modes and Effects Analysis Geometric Dimensioning and Tolerancing Global Supplier Quality In-Circuit Test International Organization for Standardization Media Access Control Mean Time Between Failures Off The Shelf Printed Circuit Board Purchase Order Production Pilot Run Registration, Evaluation, Authorization and Restriction of Chemicals Restriction of Hazardous Substances Statistical Process Control Supplier Quality Standard (this document) Underwriters Laboratory Waste Electrical and Electronic Equipment Federal Drug Administration Return Material Acknowledgment /Purchase Order Certificate of Compliance D 3F4M change Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E 2.1 References ASME Y14.5 -1994 Dimensioning and Tolerancing IPC-7711/7721 Rework, Repair and Modification of Electronic Assemblies IPC-A-610 Acceptability of Electronic Assemblies ISO 9001:2008 Quality Management Systems - Requirements “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 4 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 2.3 D ISO 14001:2004 Environmental Management Systems – Requirements With Guidance for Use MIL-C-48497A Coating, Single or Multilayer, Interference: Durability Requirements For *ISO 13485 7.4.1 Purchasing Process *FDA QSR 21 CFR Subpart E Purchasing controls Section 820.50 9 (a) Evaluation of suppliers, contractors, and consultants (b) Purchasing data Document Conventions 2.4 Scope Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E Shall is used to indicated a mandatory requirement. Will is used to indicate a statement of intent or fact. Should is used to indicate a preferred alternative or design goal, but is not mandatory. May is used to indicate an option. The purpose of this document is to define and describe the necessary quality and performance requirements to ensure a successful partnership between Christie Digital and our suppliers. The SQS outlines the minimum activities and quality performance required of the supplier's quality management system and of delivered products or services and is aligned to ISO 9001:2008 and ISO 14001:2004 requirements. IA The requirements contained in this SQS are considered part of the PO issued by Christie Digital Supply Chain. FF IC The supplier’s acceptance of a PO constitutes acceptance of the following requirements: a. Notes and reference items in the PO; b. Notes and specifications on drawings or engineering specifications; c. This SQS document. O In case of a conflict between this SQS document and Christie drawings or specifications, Christie drawing or specification shall take precedence. 2.5 Christie’s Quality Policy Christie Digital is committed to understanding Customer needs through effective communication. We are committed to providing products and services that consistently meet or exceed customer expectations. Christie Digital is committed to continually improving our products, services and, processes to enhance customer satisfaction. 2.6 Christie’s Environmental Policy We recognize our responsibility to control impacts to the environment from our business activities, products and services. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 5 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality We are fully committed to environment friendly solutions for current and future generations and to meet or exceed applicable laws, regulations and organizational objectives. As an industry leader, we are committed to prevention of pollution and continual improvement through implementation of our environmental management system. Quality Management System Requirements Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E 3.1 D 3 Supplier Responsibilities a. The supplier shall establish, document, implement and maintain a quality management system and continually improve its effectiveness (per ISO 9001:2008). b. When supplier chooses to outsource any process that affects product conformity with Christie requirements, the supplier shall ensure control over such processes. These processes shall be identified and communicated to Christie upon contract acceptance. c. Supplier shall have a documented procedure to review and approve documents and forms. 3.2 Change Management Requirements IA a. Christie requires advanced notification of any major design, materials, organizational or process changes - referred to as 3F4M change, to allow Christie to review the impact on its products and customers. IC b. Supplier shall submit to GSQ the Supplier Deviation Change Request or their own form if considered appropriate by Christie GSQ. FF c. Supplier shall implement the proposed change only after Christie’s approval. O d. Typical areas include changes in critical supply chain, manufacturing facility, final test, final inspection or other critical processes, materials and test methodologies, as well as changes to the part affecting form, fit or function. e. Potential changes which require notification and approval may include but are not limited to the representative examples listed below: i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. Supplier or subcontractor/s change; Specification change; Material or manufacturer change; Safety critical components change; Changes affecting regulatory and agency reports; Change of secondary processes : e.g. plating chemicals or methods; Addition/ change of major processing equipment; Change or addition of manufacturing facility; Change of manufacturing process; Change in test and inspection process and equipment; Change of tooling design; “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 6 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality xii. xiii. xiv. i. ii. iii. iv. v. vi. vii. viii. 3.3 Detailed description of change; Purpose and justification of change; Risk of change; Price impact; Plan for Supplier Qualification; Results of Supplier Qualification; Plans for identifying, marking and segregating parts; Time schedule; D Written change requests shall include as applicable: Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E f. Change of packaging ; Change in performance or pass/fail criteria; Change in location and content of any markings (barcode, license label, MAC address, part#, etc.); Resource Management Responsibilities a. Supplier shall determine and effectively communicate to Christie the contact personnel for each of: Sales, Engineering, Quality Assurance and Compliance. b. Business and technical discussions will be conducted in English and all suppliers shall have staff trained and available for communications. All relevant documentation shall be submitted in English. IC contract/ drawing review; product verification; product and process design; FF i. ii. iii. IA c. When called out in Christie specifications, it is the Supplier’s responsibility to ensure personnel are competent in reading, understanding and applying ASME Y14.5 -1994 GDT where required including personnel involved with: O d. Supplier to provide and maintain: workspace, process equipment and transportation to assure conformity to Christie product requirements. Supplier to maintain a Disaster Recovery Plan available for Christie review. e. The Supplier shall ensure compatibility with Christie design file formats. f. Supplier shall provide normal working hour access to their facilities/working area for logistics purposes. g. Supplier shall assist Christie staff in organizing quality audits at their facilities. Christie will communicate the audit agenda and schedule a minimum 2 weeks prior to agreed audit date. 3.4 Design and Product Development 3.4.1 Drawings/ Specification Control and Contract Review a. Supplier shall conduct internal Contract, Specification and Drawing review related to the product. This review shall be conducted prior to the commitment to supply product to Christie Digital and shall ensure: “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 7 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality i. ii. iii. product requirements are defined; evaluation of changes on contract or purchase orders, differing from previously received; that the supplier is able to meet the defined requirements; D b. Upon review, any changes to the Contract, Specification or Drawing(s) are to be approved by Christie via a drawing specification update or deviation prior to manufacturing. The supplier is bound to the Contract, Specification and Drawing(s) once approved and released. (See watermark below). Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E c. Records of the review and actions taken shall be maintained and their progress shall be effectively communicated to Christie, and through the supplier’s organization. Implementation of the changes shall be assured. d. Supplier shall ensure that Christie specifications and drawings are available, understood and applied. e. The supplier shall ensure the drawing revision corresponding to the Christie issued PO is used for all design and manufacturing purposes. This includes any engineering/ technical specifications called on Christie drawings. If discrepancies are found, Christie Purchasing shall be contacted for clarification. f. All Christie released drawings will carry one of two watermarks; “Officially Released” and “For Quote only”. Drawing watermark for Production parts Drawing watermark for Prototypes and Engineering samples FF IC IA OFFICIALLY RELEASED Document Control FEBRUARY 20 2013 UNAPPROVED PRINT FOR QUOTE ONLY Do Not Use to Manufacture Parts May 30 2013 O g. Documents and records required by Christie shall be controlled. h. Required records by this standard shall be kept on file for 5 years after fulfilling the last received PO. Upon request, records shall be retrieved and sent electronically to Christie within 24 hours. 3.4.2 Supplier Design and Development a. When design and development services are provided, the Supplier shall maintain a detailed project plan including schedule. This is to be reviewed, verified and validated at each design stage by the supplier with Christie. b. Suppliers shall asses and communicate any risks to the design through DFMEA or other risk analysis method. c. Supplier shall assure they meet the Christie specification and drawings through review of design inputs. Records of the design review to be documented and communicated to Christie, including inadequacies in specifications or drawings or deviations from Christie requirements. Suppliers are encouraged to suggest potential alternate solutions to those specified to support improved manufacturability, reliability, optimum cost, etc. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 8 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality d. Design outputs shall be measured against design inputs. E.g. Part verification and qualification at each design phase. Records of the design qualification shall be documented and communicated to Christie, including inadequacies in specifications or drawings or deviations from Christie requirements and drawings. 3.5 Christie design stages are: i. Prototype, ii. Engineering Pilot Run (EPR), iii. Production Pilot Run (PPR), and iv. Mass production Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E f. D e. Drawings and specifications generated by Supplier require approval by Christie Engineering. Records of the approval shall be maintained. Purchasing Of Material Used For Christie Products a. The supplier is required to assure purchased material meets Christie specifications and must ensure that no counterfeit parts or part substitutions are used in Christie product. b. Material traceability shall be maintained by suppliers. Records of purchased material shall be maintained. c. Supplier shall fulfill environmental requirements and prepare CRD/REACH (Comprehensive RoHS/REACH Declaration) upon request by Christie Compliance department. IA d. Suppliers are required to have an adequate supplier control program: e.g. qualified supplier list, supplier audit program, and supplier selection and qualification criteria. Returned nonconforming material to supplier shall be issued based on a RMA number. Disposition of RMA material: rework/ repair, scrap, testing etc. requires GSQ approval. O f. FF IC e. *Suppliers that supply parts for medical device to provide certificate of compliance (CofC) with each shipment. See content for this document under 3.6 h. i. Any deviation from Christie specifications needs to be recorded in the CofC. g. *Formal RMA Return Report signed by supplier is required for medical parts only. Supplier to provide together with shipping documents for RMA parts the RMA Return Report. This is a record for destruction of nonconforming product in case GSQ will decide to scrap the product at the supplier’s facility. Report needs to be sent by e-mail to GSQ. 3.6 Product Realization and In-Process control a. Suppliers are authorized to produce parts for Prototype and Engineering samples to drawings marked “OFFICIALLY RELEASED” and/or “FOR QUOTE OR SAMPLES ONLY”. b. Production parts shall be produced by suppliers only to drawings that are marked “OFFICIALLY RELEASED”. c. Supplier to ensure Part Number markings and Vendor Code markings as per drawing requirements. Vendor code shall be requested from Christie Supply Chain. d. Critical features/characteristics evaluation methods – required for on-going production : “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 9 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 1 Critical features are marked on the drawing with a “squircle” confirm conformance. require demonstrated ability to control processes, and 2 Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D There are 3 possible levels: 1 Designation means: Critical feature requires final acceptance evaluation and data capture per sampling plan in the table below: First pass random Acceptance level Lot Size sample size 9-15 3 0 failures 16-25 5 0 failures 26-50 8 0 failures 51-90 8 0 failures 91-150 13 0 failures 150-300 20 0 failures > 300 32 0 failures Designation means: Critical feature requires a capability study performed to ensure the process is capable with a capability index Cpk>1.33. The sampling plan to be established in agreement with Christie GSQ, this includes the necessary data collection, required to maintain control and improve the process, and specific plans for initial capability studies. 3 Designation means: FF Documentation developed by supplier to fulfil “In process controls” shall include: i. process step; ii. feature/characteristic inspected; iii. method of inspection; iv. sample size and frequency of inspection; v. reaction plan if non-conforming product is detected. O f. IC IA The drawing will call up a specific Acceptance Test Plan (ATP) or method. This may include test methods, fixtures, gauges, processes and sample sizes specific to that feature. Unless otherwise specified, this is a 100% check. e. Supplier’s processes and their in process controls and final inspection, shall be clearly defined through a process control plan or alternate document (e.g. Job traveller). Records of measurements and inspection to be maintained. g. Product traceability and the necessary labeling on product and/or packaging to be reviewed with Christie during design review: i. Serialized parts, when required on the drawing/specifications, require traceability to the supplier’s critical processes, batch builds, manufacturing dates etc. ii. Non-serialized parts require traceability to Christie part number, lot/batch number, date code, and manufacturer name on product and/or packaging. h. Suppliers that supply plastic made parts/components as part of the assembly, in order to meet UL(Underwriters Laboratories)/CSA(Canadian Standard Association) traceability requirements, shall submit a Certificate of Compliance with every shipment, that shall contain: “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 10 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality i. If supplier has set-up its own UL/CSA File#, the Certificate of Compliance shall be replaced with a label applied on transportation boxes, that contains: Supplier name, UL/CSA Code, UL/CSA File No., Customer (Christie Digital Systems), Part Number, Part Name, Purchasing Order#, Lot#, Quantity Shipped, Molding date, Date packed. D i. Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E i. Supplier name, UL/CSA Code(if applicable), Customer (Christie Digital Systems), Part Number, Part Name, Declaration statement, Purchasing Order#, Quantity Shipped, and Material specified, Material Supplier, Material lot#, Serial#(if applicable), Manufacturing/Molding date, Date and Authorized supplier signature, Title. 3.6.1 First Article Inspection General Requirements (FAI) First article inspections are conducted to ensure the production processes are capable of producing component or assemblies which conform to all requirements. a. FAI records in electronic format shall be submitted by Supplier by e-mail or posted in Supplier Portal, prior to parts being received by Christie. b. Prototypes and Engineering sample (EPR)(s) shall include first article inspection reports. IA c. Production representative parts (PPR), and on-going mass production shipments that had Engineering changes, or rework parts -require FAI. IC d. FAI records in electronic format must be kept on file at the Supplier, and available as required. Any discrepancies to be documented and approved prior to mass production. Approval will take the form of: i. Approved temporary deviation; ii. Drawing/specification update; O f. FF e. FAIs to be repeated for product, process changes. The level of FAI required for changes to be determined by Christie GSQ. g. A minimum of three pieces, randomly chosen, from the first production run shall be inspected and/or tested for all drawing/specification requirements including, but not limited to dimensions, functional requirements, and drawing notes. A record of all inspection data and test results indicating pass/fail determination shall be submitted as part of the FAI. h. FAIs of top level assemblies shall include an FAI on the components of the assembly. i. FAIs of assemblies shall include a verification of the assembly against the bill of material (BOM). j. Items identified with 2 shall have a capability study performed to ensure the process is capable (Cpk>1.33). k. Material certifications for raw material shall be provided as part of the FAI, where material is specified by Christie. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 11 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality l. Test/inspection plans for ongoing production shall be submitted to Christie prior to full production. m. If additional testing is specified (environmental, vibration and drop tests, etc.), these test results shall be submitted as part of the FAI. n. A Comprehensive RoHS Declaration shall be provided prior to product approval to production, as per European Union Directive 2011/65/EU. 3.6.2 FAI Report Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D o. Packaging to assure product integrity, and cleanliness during transportation. Where packaging is specified this shall be approved by Christie. The following information is required on a completed FAI report: Date; Name and signature of inspector; Part name and number, including revision measured; CAD file revision shall be included where referenced in the drawing; For measurement values: i. Nominal specification; ii. Specification tolerance range; iii. Measured value for all pieces; iv. Column indicating pass/fail; v. Evaluation of all GD&T features (ie. provide value for position, profile, geometric control measurements, rather than just providing basic dimensions). f. Method and instrument of measurement beside each value; g. Marked-up drawing with numbers corresponding to FAI result (or positional code corresponding to drawing – ie. A-2 p2.). O FF IC IA a. b. c. d. e. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 12 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 3.6.3 Measurement / Inspection Requirements for Optical Parts 3.6.3.1 Optics and Opto-Mechanical Additional FAI Requirements: a. FAI submission for optics shall include reliability test results as specified on the drawing. D b. FAI Transmission and Reflection measurement results shall be provided in both graphical (coating curve) and in tabular (spreadsheet) formats. Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E 3.6.3.2 Witness Samples a. For optical coatings, witness samples shall be produced by for each coating run. b. Witness samples to be placed in coating chamber to represent worst case variation. c. Witness samples shall be retained for a minimum of five years. 3.6.3.3 Optical Coating Reliability Tests a. Coating reliability tests as specified on the drawing/specifications shall be performed for every production coating run. b. When no reliability tests are specified on the drawing/specifications, adhesion and moderate abrasion tests shall be performed as specified in MIL-C-48497A as a minimum requirement. 3.6.3.4 Optical Modules IA c. Records of reliability tests shall be retained as specified by this procedure. FF IC a. Electronic assemblies within optical modules shall be built and repaired according to IPC-7711, IPC-7721, IPC-A-610E class 2 for high performance electronic assemblies (most recent issues) unless otherwise specified in the module specifications. O b. An Acceptance Test Procedure (ATP) shall be provided to and approved by Christie prior to production launch. c. Evidence that the product meets all requirements in the Module Specification shall be provided prior to production approval. Evidence shall be cross referenced to Module Specification requirements numbers. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 13 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 3.6.4 Measurement / Inspection Requirements for Mechanical Parts FAI requirements Supporting documents Dimensional including drawing notes Three (3) parts measured as specified on drawing Marked-up drawing Custom OTS D Production (PPR) Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E Prototyping and Engineering approval (EPR) Dimensional inspection report with tolerances and pass and fail or reject/ accept result 3 parts measured as specified on drawing x Including Notes Material and functional as requested Material data sheet ROHS & REACH Certificate as requested including secondary processes Testing overview and testing records with pass and fail result x Secondary processes to be reported on Paint material data sheet **Process capability study shall be agreed with GSQ prior first production run –where required Process flow chart , or process control plan, or job traveler , and testing plan O FF applies to painted cosmetic parts Four (4) color samples/ chips on the same substrate as the part shall be provided by supplier for appearance / color match approval IC Appearance (where specified) : IA FAI(coatings, painting etc.) as requested Process control: as requested Samples shall be individually labeled with: Supplier name; Paint code & paint manufacturer; Project name; Approved by Christie______________ Process FMEA (Failure Mode and Effect Analysis) as requested x x x **Process capability/SPC record (Squircle #1/ #2/ #3) Safety Critical Part as requested Certificate of compliance /UL file Part/ packaging label Certificate of compliance x x “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 14 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 3.6.5 Measurement / Inspection Requirements for Electrical / Electronic Parts O FF IC IA Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D 1. Designed by Christie- Typically PCB assemblies, harnesses; 2. Supplier Custom Design for Christie- Typically power supplies, ballasts, board assemblies; 3. OTS (Off the Shelf)- Typically PCB assemblies, harnesses, electronic components, power supplies, motors, fans, fluid movers (e.g. compressors, pumps) Table -with typical test/data collection required (as subject to mutual agreement) 2- Supplier 1Designe Custom 3- OTS REQUIREMENT Design for d by Christie Christie All Christie assemblies shall be built and repaired according to IPC-7711, IPC-7721, IPC-A-610E CLASS 2 FOR HIGH IPC Class GENERAL PERFORMANCE ELECTRONIC PRODUCTS (MOST X X 2 min. RECENT ISSUE) guidelines unless otherwise specified in the assembly/module spec. Design review Pre-prototype DFM and DFT Performance and reliability test scope Reviews and planning planning to be done X X between Christie and Safety critical items review Supplier as required Visual inspection X X DFM/DFT review for producibility and testability and X X reporting problems PROTOTYPING MTBF- Calculated and/or Real as agreed X X AND Design validation test results X ENGINEERING CRD (Comprehensive RoHs Declaration), REACH, WEEE X X X APPROVAL – The following data Tested to Harness continuity/short, cross talk, crimp height, Hi-pot, information to be X X assure dimensional measurement, pull test results provided as required compliance Mechanical interface measurements of all samples X X Special handling procedures if required X X X PRODUCTION 1ST Process Flow Chart X X ARTICLE ICT and functional test plan and coverage data X X The following data Harnesses: continuity/short, cross wire, crimp height, Hito be provided as X X pot, dimensional measurement, pull test results required Regulatory Agency Approval Data ( such as UL, CB, etc. X X reports and certificates) as required - Production process yield data Boards, ONGOING X X Ballasts, Power - ATP: Special instructions as agreed PRODUCTIONSupplies The following data 100% ICT & FCT test results X X to be available as Harness 100%:Continuity/short, cross wire,Hi-pot Tested to required. X X Sampling: Pull test; crimp height; strip assure ATP: Special instructions as agreed compliance “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 15 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality Supplier to have repair analysis database of all rejected material and provide feedback upon request RMA X X When Requested 3.7 Packaging a. All samples and product shipments shall reference a valid purchase order (PO number) from Christie. This shall be referenced on the packing slip. Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D b. Packaging to assure product integrity, and cleanliness during transportation. Where packaging is specified this shall be approved by Christie. c. Supplier shall have a documented procedure for finished parts packaging. d. All goods, wrappers, and containers shall be packed, marked and labeled as required by federal, provincial and municipal laws and regulations for the protection and safety of persons and property. e. Supplier shall follow the requirements outlined in spec 010-101136-01, CDS Guideline For Packaging for the responsibility of packaging design/marking and material selection for the parts provided to Christie Digital. As a general rule, material used for packaging shall be chosen from environmental friendly recycling materials and supplier should avoid any excess packaging if not mandated. f. Goods must be boxed, packed or crated so as to qualify for lowest freight or transportation rates, and to prevent damage to the goods during transit. IA g. ESD-sensitive material to be packaged in ESD safe protective material/containers. 3.8 Special packaging for custom parts/assemblies specified on drawings is subject to Christie’s approval. Christie’s property including intellectual property at supplier O i. FF IC h. Large PCB’s to be delivered in slotted shipping containers/trays. Smaller boards can be bulk packed provided they are adequately protected. a. Supplier shall have a documented procedure to identify, verify, protect and safeguard Christie property for use or incorporation into the product. b. Christie owned tooling (includes: molds, fixtures, gauges, testing equipment) or other property (including intellectual property) shall be under supplier’s control. A tool bailey (tool loan agreement) will be initiated by Christie Purchasing and signed off by supplier and Christie. c. Any modifications or improvements to Christie owned tooling must be approved by Christie GSQ prior to changes. Supplier shall communicate details via Supplier Change Request Form. d. Any damage or defect on Christie owned tooling or other property shall be communicated to Christie in 24h after preliminary investigation and provide interim action plan associated. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 16 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 3.9 Control of monitoring and measuring devices a. A Calibration Control Program must be in place for control of monitoring on measuring devices/gauges/ testing equipment/fixtures. Measuring equipment calibration shall be traceable to national or international standards. Any Christie designed test equipment shall be on supplier’s Calibration Control Program. 3.10 Nonconforming Product Control D b. Calibration, inspection and maintenance records shall be maintained. Calibration status shall be defined on gauges, fixtures and /or instruments. Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E a. Supplier shall have an established system of non-conformance control to prevent defective product from being shipped to Christie. If suspect or non-conforming parts have been shipped, GSQ shall be notified immediately. b. Any request to use non-conforming material or material deviating from current officially released drawing must be through a completed Supplier Deviation and Change form. Form can be provided by GSQ and shall be submitted to Christie Supply Coordinator. Approval from Christie in writing is required before shipping. c. Returns to supplier of nonconforming product (RMA) will be coordinated by Christie Supply Coordinator. IA d. Rework/sort activities include: i. Local third party will be hired by Christie Supply Coordinator on behalf of supplier for urgent containment action on nonconforming products received from supplier in Christie stock. ii. Supplier will be notified prior to rework /containment action, and material disposition after sort, and costs to be agreed. O FF IC e. First shipment after containment inspection by supplier/third party shall have “Certified tag” on external boxes: CERTIFIED ‐OK PARTS TAG BY: P/N: PCS: Problem: 3.11 Corrective and preventive action a. Non-conformances conveyed by Christie via Corrective Action Request (CAR) require : Acknowledgement and interim action plan within 2 working day of receipt of the CAR is required. i. ii. Interim action plan for containment and effective date (e.g. replacement timing /rework/ sort at supplier); Root cause analysis shall be provided as per CAR form submitted by GSQ; “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 17 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality iii. Final solution Plan shall include preventive action plan to prevent potential causes from recurrence and implementation date (shipment date and PO). Preventive action shall address the actual root cause(s); Verification Plan shall include method of verification that the taken actions were effective (E.g. FAI/ dimensional measurement/inspection record/ capability study etc.). iv. b. Supplier shall provide supporting documents with the CAR response. 3.12 Christie Scorecards Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D c. Records of the CARs and supportive documents shall be archived as specified by this standard. a. Suppliers may be selected to receive a periodic scorecard. Scorecards are used to convey feedback on the supplier’s performance. b. When a scorecard is issued, Christie requires the supplier to: Acknowledge receipt; Provide feedback on contents; Utilize as a tool for continual improvement. O FF IC IA i. ii. iii. “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates Christie Digital Systems Canada Inc. Supplier Quality Standard Page 18 of 18 Doc No: 010-101164-01 Rev: 5 Release Date: March, 2015 Department: Global Supplier Quality 3.13 SUPPLIER ACKNOWLEDGEMENT SHEET (To be returned to Christie Global Supplier Quality) Supplier Name Ju Doc LL ne ume Y R nt 16 Co E , 2 ntrol L E AS 01 5 E D The undersigned certifies on behalf of __________________________________________ (the “Supplier”) that the Supplier acknowledges, understands and will comply with the Quality Requirements set forth on Christie’s Supplier Quality Standards Document 00-101164-01. __________________________________________ Name (Please Print) __________________________________________ __________________________________________ Title __________________________________________ (Quality Manager or Authorized Signing Officer) Date __________________________________________ IA Signed IC -------------------------------------------------------------------------------------------------------------------------- O FF Request for deviation to the above document- to be listed below and please attach details if required: Christie Agreement (Name Print and Signature, Title and Date): __________________________________________________________________________________ “*” Note for medical suppliers only SOP Ref: QA-0431; D0118 Template: QA-0367 Rev. 1 Confidential Christie Digital Systems Canada Inc. Christie Digital Systems USA Inc., and Affiliates
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