Star Aviation QUALITY ASSURANCE MANUAL 质量保证手册
**** Hidden Message ***** Release Date:01-10-03 Document # QM-001Revision: A
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QUALITY ASSURANCE MANUAL
Approved By: John G. Wacker Director of Manufacturing Approved By: Wayne Fink Director of Quality Assurance
Original Release Date: 08-12-01 Release Date: 01-10-03
Release Date:01-10-03 Document # QM-001
Revision: A
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RECORD OF REVISIONS
Rev Date Pages Affected Description of Revision Approvals FAA Approval
IR 08-12-01 All Initial Release Prepared By: Jerry McKnight Approved By: John Wacker Approved By: Erik Vogt Approved By: Jim Reeves Date Approved: 10-31-01
A 01-10-03 All Name change from Star Aviation Services to Star Aviation, Inc. Basis of compliance from ISO 9002 to AS 9003. Numerous changes throughout to comply with the requirements of AS9003. Prepared By: Jerry McKnight Approved By: John Wacker Approved By: Wayne Fink Approved By: Date Approved:
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TABLE OF CONTENTS
1 INTRODUCTION .....................................................................................................................................4
1.2 Scope.............................................................................................................................................4
1.3 Purpose...........................................................................................................................................4
1.4 Quality Policy..................................................................................................................................4
1.5 Authority..........................................................................................................................................4
1.6 About Star Aviation, Inc..................................................................................................................4
2 QUALITY POLICIES ................................................................................................................................5
2.1 Management Responsibilities ........................................................................................................5
2.2 Quality System................................................................................................................................5
2.3 Contract Review .............................................................................................................................7
2.4 Design Control................................................................................................................................7
2.5 Document and Data Control...........................................................................................................7
2.6 Purchasing......................................................................................................................................8
2.7 Control of Customer-Supplied Product..........................................................................................8
2.8 Product Identification and Traceability...........................................................................................9
2.9 Process Control..............................................................................................................................9
2.10 Inspection and Testing................................................................................................................9
2.11 Control of Inspection, Measuring and Test Equipment ............................................................10
2.12 Inspection and Test Status .......................................................................................................11
2.13 Control of Non-Conforming Product.........................................................................................11
2.14 Corrective and Preventive Action ........................................................................................... 122
2.15 Handling, Storage, Packaging, Preservation and Delivery ......................................................12
2.16 Control of Quality Records........................................................................................................12
2.17 Internal Quality Audits ............................................................................................................. 133
2.18 Training......................................................................................................................................13
2.19 Servicing....................................................................................................................................13
2.20 Statistical Techniques ...............................................................................................................13
3 FIGURES ..............................................................................................................................................13
3.1 Facility layout ................................................................................................................................13
FIGURE 1 ...............................................................................................................................................14
3.2 Organization Charts......................................................................................................................15
FIGURE 2.................................................................................................................................................15
FIGURE 3.................................................................................................................................................15
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1 INTRODUCTION
1.1 Title
1.1.1 Quality Assurance Manual
1.2 Scope
1.2.1 The Quality System that is defined by the Star Aviation Inc. Quality Assurance Manual and Quality Procedures complies with the requirements of ISO 9002:1994 AS 9003 and Federal Aviation Regulations (FAR) Part 21 and Part 45.15 (FAA-PMA). The quality system requirements set forth by this ISO 9002 Quality Assurance Policy Manual pertain solely to the production, installation and servicing of the company’s products. Special requirements for procedures or documentation that exceed the requirements stated above, are required by specific contract or by customer requirements, and do not affect the purpose of this manual, shall be issued as supplements to this manual.
1.3 Purpose
1.3.1 The purpose of this manual is to define and describe the quality system that has been established by Star Aviation Inc., and to provide general procedures for all activities comprising the quality system. In addition, this manual is used to inform our customers as to what specific controls are implemented to assure product quality.
1.4 Quality Policy
1.4.1 The management of Star Aviation Inc. Inc. is committed to continuous improvement in order to provide our associates with the necessary tools, equipment and working environment to deliver high-quality products that meet the needs and expectations of our customers.
1.4.2 This policy is understood by all employees and is maintained at all levels of the company.
1.5 Authority
1.5.1 This manual is issued under the authority of Director of Quality Assurance and the Director of Manufacturing
1.6 About Star Aviation Inc.
1.6.1 Star Aviation Inc. is located at 2150 Michigan Ave. Mobile, Alabama 36615
1.6.2 The current facility occupies approximately 3700 square feet of space, of which 2500 square feet is used for production, and 1200 square feet is used for support activities. A floor plan of the plant facility is shown in Figure 1.
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2 QUALITY POLICIES
2.1 Management Responsibilities
2.1.1 The Director of Quality Assurance has the responsibility and authority to define the company quality system documentation and policy. These topics are contained in Quality Procedures SAS 01-01, 01-02, 01-03.
2.1.2 The responsibility, authority and interrelation of personnel, who manage, perform and verify work-affecting quality is identified. This interrelationship is shown in the organizational chart (see Figure 2), and is discussed in Quality Procedure SAS 01-01, 01-02, 01-03. Those representatives identified are provided the organizational freedom and authority to:
2.1.2.1 Initiate action to prevent the occurrence of non-conformities relating to product, process, and quality system;
2.1.2.2 Identify and record any problems relating to the product, process, and quality system;
2.1.2.3 Verify the implementation of solutions;
2.1.2.4 Control further process, delivery or installation of non-conforming product until the deficiency or unsatisfactory condition has been corrected.
2.1.3 The Director of Quality ensures adequate and properly trained resources are provided. These requirements are discussed in Quality Procedure SAS-18-01.
2.1.4 The Director of Quality is responsible for establishing, implementing and maintaining the quality system. This responsibility is outlined in Quality Procedure SAS-01-01.
2.1.5 This system shall be maintained in accordance with AS 9003, as provided for in Quality Procedures.
2.1.6 The Director of Quality Assurance shall report the performance of the quality system to the Director of Manufacturing for use as a base for improvement of the quality system. This topic is discussed in Quality Procedure SAS-01-01.
2.1.7 A review of the quality system is held annually. Director of Quality Assurance and the Director of Manufacturing attend at a minimum. The review is held to ensure the continuing suitability and effectiveness of the quality system in meeting the requirements of ISO 9002.
2.1.8 As a minimum, the agenda comprises of the following topics:
2.1.8.1 Management objectives, market response to the quality effort, results of internal audits, effectiveness of corrective actions, internal cost of quality, and assessment of continuing suitability of the quality system.
2.2 Quality System
2.2.1 A quality system has been established, documented and maintained to AS 9003 requirements as a means of ensuring that product conforms to specified requirements. The Director of Quality Assurance is assigned the responsibility and authority for the design, implementation and monitoring of the effectiveness of the quality system.
2.2.2 The scope of the quality system is defined in the following documents:
2.2.2.1 Quality Manual
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2.2.2.2 Operational procedures
2.2.2.3 Work instructions, process procedures and internal standards
2.2.2.4 Applicable national and international standards
2.2.2.5 Product drawings, bills of materials, specifications, etc.
2.2.3 These documents collectively define a quality system that complies with AS 9003, ISO 9002:1994 and FAA-FAR Parts 21 and 45. The Quality Procedures explain the purpose and methods for controlling these documents. This topic is addressed in Quality Procedures SAS-05-01 and SAS-05-
02.
2.2.4 Star Aviation Inc. believes that planning for quality is one of the more proactive steps that a company can take to ensure delivery of a product that meets the needs and expectations of the customer. At Star Aviation Inc., the quality planning process begins during contract review where requirements are defined and understood, continues throughout the manufacturing process, and culminates with the issuance of a Shop Traveler (ST) for products. During development, review and approval of each ST, consideration is given to each of the following, as described in procedure SAS- 09-01 Process Control.
2.2.4.1 The preparation of plans;
2.2.4.2 The identification and acquisition of any controls, processes, equipment (including inspection and test equipment) fixtures resources, and skills that may be needed to achieve quality;
2.2.4.3 Ensuring the compatibility of the design, the production process, installation, servicing, inspection, and test procedures, and the applicable documentation;
2.2.4.4 The updating, as necessary, of quality control, inspection, and testing techniques, including the development of new instrumentation;
2.2.4.5 The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;
2.2.4.6 The identification of suitable verification at appropriate stages in the realization of product;
2.2.4.7 The clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;
2.2.4.8 The identification and preparation of quality records.
2.2.5 The Star Aviation Inc. quality system documentation is structured as follows:
2.2.5.1 The Star Aviation Inc. ISO 9000, AS 9003Quality Assurance Policy Manual is the top-level document. It describes the quality system in accordance with the stated quality policy and objectives and the applicable ISO 9000, AS 9003 series standard.
2.2.5.2 The Operational Procedures comprise the next level of documentation. These documents provide a description of the activities at Star Aviation Inc. needed to implement the quality system elements.
2.2.5.3 The next level of documents includes the detailed work documents, including forms, reports and work instructions.
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2.2.6 Star Aviation, Inc. requires that the requirements of this quality system “Flow Down” to its suppliers and subcontractors. Copies of necessary sections of this manual, operational procedures, forms, or other requirements should be available to them on request.
2.3 Contract Review
2.3.1 The processes by which contracts are reviewed and the responsibilities assigned are contained in Quality Procedures SAS-03-01. The Directors of Quality and Manufacturing have the responsibility and authority for the contract review process. Specific responsibilities and requirements include:
2.3.1.1 Establishing and maintaining documented procedures for contract review and coordination of these activities.
2.3.1.2 The review of each accepted tender, contract and order to ensure that requirements are adequately defined and documented, any requirements differing from those in the tender are resolved, and that Star Aviation Inc. has the capability to meet the accepted order requirements.
2.3.1.3 The process by which amendments to contracts are made and how this information is disseminated to the cognizant departments.
2.3.1.4 The final approval of contract reviews, as indicated by their signatures, or by a subordinate’s signature, when directed.
2.3.1.5 The maintenance of records of contract review.
2.4 Design Control
2.4.1 Star Aviation, Inc. is not implementing the element of Design Control in its Quality Assurance program at this time. Until documented otherwise this Quality Assurance program is intended for inspection of manufactured and purchased aviation related products provided by Star Aviation, Inc. to its customers. This element is not applicable.
2.5 Document and Data Control
2.5.1 The Director of Quality Assurance has the responsibility and authority for document and data control at Star Aviation Inc. The processes by which the document and data control activities are maintained are contained in Quality Procedures SAS-05-01.
2.5.2 A document and data control system that controls all documents and data that relate to AS 9003 shall be established and maintained. In addition, all documents of external origin, such as standards and customer drawings, shall be addressed.
2.5.3 Document and data approval and issue:
2.5.4 All documents and data are reviewed and approved for adequacy by authorized personnel within the customer’s organization prior to issue.
2.5.5 A master list or equivalent of the current revision status of documents is maintained, and is readily available to preclude the use of invalid and/or obsolete documents.
2.5.6 Documents are available at all locations where they are needed.
2.5.7 Obsolete documents are promptly removed from all points of use.
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2.5.8 Any obsolete historical/legal documents are suitably identified.
2.5.9 All document and data changes are reviewed and approved by the same functions/organizations that performed the original review, unless specifically designated otherwise. The designated functions have access to pertinent background information upon which to base their reviews and approvals. When practicable, the nature or changes shall be identified in the document or the appropriate attachments.
2.6 Purchasing
2.6.1 The Director of Quality Assurance has the responsibility and authority to establish and maintain the procedures for purchasing activities. The processes by which purchasing activities are maintained are contained in Quality Procedures SAS-06-01, SAS-06-02 and SAS-06-03.
2.6.2 Documented procedures have been established and are maintained to ensure purchased product conforms to specified requirements.
2.6.3 Evaluation of subcontractors;
2.6.3.1 Subcontractors are evaluated on the basis of their ability to meet sub-contract requirements including quality system and quality assurance requirements.
2.6.3.2 The type and extent of control over subcontractors are defined.
2.6.3.3 Suitable quality records are maintained for acceptable subcontractors.
2.6.4 Purchasing documents contain data that clearly describes the product ordered, including type, class, grade, specification number, drawing numbers, and applicable quality requirements.
2.6.5 All purchase orders are reviewed and approved for adequacy for the specified requirements prior to release.
2.6.6 Product verification;
2.6.6.1 If product is released from the sub-contractor’s premises, the verification arrangements and method of product release shall be contained in the purchasing documents.
2.6.6.2 Where specified in the contract, a customer or their representative shall be permitted to inspect the product at the sub-contractor’s facilities; their inspection results shall not be used as evidence of effective control of quality. Verification by the Star Aviation Inc. shall not absolve the supplier of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.
2.7 Control of Customer-Supplied Product
2.7.1 The Director of Quality Assurance and the Director of Manufacturing have the responsibility and authority to establish procedures by which customer-supplied product is controlled. The processes by which this is performed are contained in Quality Procedure SAS-07-01.
2.7.2 Documented procedures identify product from receipt and during all stages of production, delivery and installation.
2.7.3 Unique identification and traceability is required for most products and is documented in our procedures and the identification is recorded.
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2.8 Product Identification and Traceability
2.8.1 The Director of Quality Assurance has the responsibility and authority to establish procedures that address the identification and traceability of product. The processes by which this is performed are contained in Quality Procedure SAS-08-01.
2.8.2 Documented procedures identify product from receipt and during all stages of production, delivery and installation.
2.8.3 Unique identification and traceability is required for most products and is documented in our procedures and the identification is recorded.
2.9 Process Control
2.9.1 The Director of Manufacturing has the responsibility and authority to establish procedures that address the control of processes that are used in the production of product. The processes by which this is performed are contained in Quality Procedure SAS-09-01.
2.9.2 Documented procedures identify product from receipt and during all stages of production, delivery and installation.
2.9.3 All processes are carried out under controlled conditions. These process include:
2.9.3.1 Documented procedures defining the manner of production, installation and servicing, when the absence of such procedures could adversely affect quality.
2.9.3.2 Use of suitable installation, servicing equipment, and a suitable working environment.
2.9.3.3 Compliance with reference standards/codes, quality plans, and/or documented procedures.
2.9.3.4 Monitoring and control of suitable process parameters and product characteristics.
2.9.3.5 The approval of processes and equipment, as appropriate.
2.9.3.6 Criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g. written standards, representative samples, or illustrations).
2.9.3.7 Suitable maintenance of equipment to ensure continuing process capability.
2.9.4 Special processes shall require pre-qualification of operators, materials and processes, and/or continuous monitoring. Records are maintained for qualified processes, equipment and personnel, as appropriate.
2.10 Inspection and Testing
2.10.1 The Director of Quality Assurance has the responsibility and authority to establish procedures that address the control of inspection and testing at Star Aviation Inc. The processes by which these activities are planned and accomplished are contained in Quality Procedures SAS-10-01, SAS-10-02 and SAS-10-03.
2.10.2 Documented procedures have been created for inspection and testing in order to verify that the specified requirements for the product are met.
2.10.3 Procedures for receiving inspection and testing ensure that incoming product is not used until it has been verified as conforming to specified requirements.
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2.10.4 Evidence of conformance is recorded and maintained.
2.10.5 In determining the amount and nature of receiving inspection that is to be performed on material, consideration shall be given to the amount of control exercised at the subcontractor's premises and the historical evidence of conformance.
2.10.6 A positive recall procedure is established for the release and identification of parts and materials for production prior to receiving inspection having been completed. This is done in order to permit immediate recall and replacement of these parts or materials in the event that non-conformity to specified requirements is encountered.
2.10.7 Procedures have been established for in-process inspection and testing to ensure product is not released until all required tests and inspections have been satisfactorily completed.
2.10.8 No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and associated data and documentation are available and authorized.
2.10.9 Inspection and Test Records;
2.10.9.1 Records are maintained to prove the product has been inspected and/or tested and show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria.
2.10.9.2 Records shall identify the authority responsible for the release of product.
2.10.9.3 If product fails to pass any inspection and/or test, the Procedure for Control of Non-Conforming Product, SAS-13-01, shall apply.
2.11 Control of Inspection, Measuring and Test Equipment
2.11.1 The Director of Quality Assurance has the responsibility and authority to establish procedures for the control of inspection, measuring and test equipment (IM&TE). The processes by which this is accomplished are contained in Quality Procedure SAS-11-01.
2.11.2 General requirements;
2.11.2.1 Procedures shall be created that address the control, calibration and maintenance of IM&TE used by Star Aviation Inc. to demonstrate the conformance of product to the specified requirements.
2.11.2.2 Procedures shall include direction in the proper use of the equipment, which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
2.11.3 Control Procedure- Star Aviation Inc. shall;
2.11.3.1 Determine the measurements to be made and the accuracy required and select the appropriate inspection, measuring, and test equipment that are capable of the necessary accuracy and precision.
2.11.3.2 Identify all inspection, measuring and test equipment that can affect product quality, and calibrate and adjust them at prescribed intervals, in accordance with internationally or nationally recognized standards. Where no such standards exist, the basis for calibration shall be documented.
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2.11.3.3 Define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type unique identification, location, frequency of checks, check method. Acceptance criteria, and the action to be taken when results are unsatisfactory.
2.11.3.4 Identify inspection measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status.
2.11.3.5 Maintain calibration records for inspection, measuring, and test equipment.
2.11.3.6 Assess and document the validity of previous inspection and test results when inspection, measuring and test equipment is found to be out of calibration.
2.11.3.7 Ensure that the environmental conditions are suitable for the calibration, inspection, measurement, and test being carried out.
2.11.3.8 Ensures that the handling, preservation, and storage of inspections, measuring, and test equipment is such that the accuracy and fitness for use are maintained.
2.11.3.9 Safeguards inspection, measuring, and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting.
2.12 Inspection and Test Status
2.12.1 The Director of Quality Assurance has the responsibility and authority to establish procedures concerning the identification of product to show its inspection and test status. The process by which this is accomplished is contained in Quality Procedures SAS-12-01 and SAS-12-02.
2.12.2 The inspection and test status of product shall be identified by suitable means that indicates conformance or non-conformance of product with regard to inspection and test performed. The process for using inspection stamps to communicate the inspection status of product is contained in Operational Procedure SAS-12-02.
2.12.3 Only accepted product passing required inspections and/or test, or released under an authorized concession will be dispatched, used or installed.
2.13 Control of Non-Conforming Product
2.13.1 The Director of Quality Assurance has the responsibility and authority to establish procedures concerning the control of non-conforming product and to ensure that it is not used. The processes by which this is accomplished is contained in Quality Procedure SAS-13-01.
2.13.2 The responsibility for review and authority for disposition of non-conforming product shall be defined to meet the requirements of AS 9003.
2.13.3 The process by which the product is reworked, accepted as-is, regraded/downgraded, rejected or scrapped shall be specified.
2.13.4 Where defined by contract, repaired product must be reported to the customer.
2.13.5 Repaired/reworked product must be re-inspected by documented procedures.
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2.14 Corrective and Preventive Action
2.14.1 The Director of Quality Assurance has the responsibility and authority to establish procedures for implementing corrective action(s) to fix immediate problems, prevent recurrence, and ensure implementation and effectiveness of actions to be taken. In addition, procedures shall be established for implementing preventive action to eliminate causes and potential causes of nonconformities. The processes by which these actions are accomplished are contained in Quality Procedure SAS-14-01.
2.14.2 Corrective Action procedures shall address: customer complaints, internal and external failures, root cause analysis, recording results, determining the corrective action needed to eliminate the cause of nonconformance and the process that is to be taken to ensure that corrective action is taken and is effective.
2.14.3 Preventive Action procedures shall address: the use of appropriate sources of information to eliminate potential causes of nonconformities, how to determine the steps needed to deal with any problem, how to initiate preventive action and that relevant information on actions taken is submitted for management review.
2.15 Handling, Storage, Packaging, Preservation and Delivery
2.15.1 The Director of Manufacturing has the responsibility and authority to establish procedures that address the control of processes that are used for the packaging, preservation and handling of product. The processes by which these functions are accomplished are contained in Quality Procedure SAS-15-01, SAS 15-02 and SAS 15-03.
2.15.2 Procedures shall address the handling of product to prevent damage or deterioration.
2.15.3 Product shall be stored in designated storage areas to prevent damage, and its condition will be assessed at defined intervals.
2.15.4 Procedures shall address the packaging and marking of product.
2.15.5 Methods of preservation that are appropriate for the type of product shall be used, and segregation of product shall be applied.
2.15.6 Procedures shall address the delivered product quality after final inspection and test.
2.16 Control of Quality Records
2.16.1 The Director of Quality Assurance has the responsibility and authority to establish procedures that addresses quality records. The process by which this function is accomplished is contained in Quality Procedure SAS-16-01.
2.16.2 The procedure shall address the following subjects as they apply to quality
2.16.2.1 Records: identification; collection; indexing; access; filing; storage; maintenance; and disposition.
2.16.2.2 Records shall be legible, and must be readily retrievable.
2.16.2.3 Record retention times shall be specified; provisions shall be made for designating and specifying record retention times that are contractually specified and differ from those that are normally specified for the type of record.
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2.17 Internal Quality Audits
2.17.1 The Director of Quality Assurance has the responsibility and authority to establish procedures that address internal quality audits. The process by which this function is accomplished is contained in Quality Procedure SAS-17-01.
2.17.2 A documented procedure shall be used for planning and implementing internal quality audits.
2.17.3 The schedule for these audits shall be based upon the status and importance of the activity.
2.17.4 Personnel who are independent of the area being audited will perform audits.
2.17.5 The audit results shall be recorded.
2.17.6 Follow-up activities shall verify and record the implementation and effectiveness of the corrective action taken.
2.18 Training
2.18.1 The Director of Quality Assurance and the Director of Manufacturing have the responsibility and authority to establish procedures that address employee training. The process by which this function is accomplished is contained in Quality Procedure SAS-18-01.
2.18.2 Documented procedures shall address identifying training needs and providing training for all personnel performing activities affecting quality.
2.18.3 Appropriate records of training shall be maintained.
2.19 Servicing
This section of the as 9003 does not apply to the operations performed by Star Aviation Inc.
2.20 Statistical Techniques The Director of Quality Assurance has the responsibility and authority to
identify the need to establish procedures that address statistical techniques that are to be used. The process by which this function is performed is described in Quality Procedures SAS-20-01.
2.20.1 The need for statistical techniques required for establishing controls and verifying process capabilities and product characteristics shall be identified.
2.20.2 Procedures shall be established to implement the application of those statistical techniques for which needs have been identified.
3 FIGURES
3.1 Facility layout
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FIGURE 1
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3.2 Organization Charts
Director Of Manufacturing Human Relations
Sales/Marketing
FIGURE 2
Shipping/Receiving Materials Management
FIGURE 3
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