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    电子印制板审核准则(1)三明TPG_AC7119
    发表时间:2021-06-25     阅读次数:     字体:【

    1.0 SCOPE

    This checklist shall apply to Suppliers seeking Transportation and Power Generation accreditation

    who are engaged in fabrication of Rigid Printed Boards (PBs) in accordance with the requirements of IPC-6012 and / or Flexible PBs in accordance with the IPC-6013.

    The purpose of this Audit Criteria is to provide a means to verify and document that systems are in place to control the processes and that the process procedures are being followed.

    Supplier is expected to maintain a customer-approved Quality System as a prerequisite for this

    Accreditation. As such, Auditors may identify and record non-conformances related to the quality

    system, and the Supplier must address these non-conformances in order to obtain Accreditation.

    2.0 GENERAL INSTRUCTIONS

    2.1 Instructions for the Auditor

    In completing this assessment, Auditors are instructed to respond with a “Yes” or “No” to address

    compliance with each statement of requirement. For any negative responses, the Auditor must

    clearly indicate in the Nonconformance Report (NCR) if the “No” reflects noncompliance with respect to existence, adequacy, and / or compliance. Existence relates to evidence of a procedure or policy, adequacy relates to the completeness of the procedure or policy and compliance relates to evidence of effective implementation.

    The Auditor must verify the list of procedures provided by the Supplier at the time of the audit. Any corrections or updates to the list must be identified using notes inserted at the applicable criterion.

    All negative responses require a NCR or explanation. Not Applicable (N/A) responses do not require an explanation unless otherwise noted.

    The audit results (eAuditNet) shall not include any customer proprietary information or technical

    information on parts designated "Export Controlled - License Required" (EC-LR). If Auditors have

    any questions about this, they should contact the PRI Staff Engineer for directions.

    2.2 Instructions for the Supplier to be Audited

    2.2.1 Prior to the Audit

    The Supplier must have completed a self-audit to TPG-AC7119 in preparation for this audit.

    NOTE: The location and identification (name of procedure and paragraph number, where

    needed) of all applicable documentation must be indicated on the self-audit form. This will

    greatly expedite the audit and avoid the expense of additional audit days.

    Performing a thorough, objective self-audit against each question in the checklist is the critical first step in the accreditation process. This can significantly reduce the number of findings issued by the Auditor and the time required to achieve accreditation. All nonconformances should be

    corrected prior to the actual audit. Nonconformances identified as part of the audit with potential product impact may, at the Transportation and Power Generation Electronics Task Group's discretion, require a Verification Corrective Action (VCA) audit at the Supplier's expense.

    Supplier to forward the following to the assigned Auditor, as directed by PRI, 30 days prior to the

    scheduled audit:

    a. Original Self-Audit

    The self-audit is to be completed with the related document name(s)/procedure number(s) marked next to checklist question where applicable.

    b. Quality Control Manual

    Quality control manual (current uncontrolled copy which Auditor will return to Supplier on request).

    c. List of Purchased Services

    List of purchased services, including names(s) of Supplier(s) for calibration, processing, testing, chemical analysis, etc.

    d. List of Specifications

    List of processing specifications (military, government, industry and customer)

    that Supplier is working to.

    e. Master List of Procedures

    f. Moisture Control Plan as required in checklist

    g. Procedure for control of Electrostatic Discharge as required in checklist

    h. Current List of Accreditations and/or Certifications

    2.2.2 During the Audit

    The Supplier shall provide for an in-briefing with the Auditor. Key members of the applicant's staff

    should attend the in-briefing so the audit purpose, methods and assessment processes can be

    discussed. These may include the Quality Manager, internal audit personnel and others as deemed necessary by the Auditor or Supplier.

    Working space for the Auditor with desks or tables, chairs, telephone, etc., shall be made available.

    A final out-briefing will be conducted at the completion of the audit. Each nonconformance and

    observation will be reviewed at least daily and the Supplier will be given the opportunity to discuss proposed corrective action or to provide any additional information. Note: The PRI Staff Engineers or Transportation and Power Generation Electronics Task Group may, upon review, change the Auditor's determination of a finding.

    The following information needs to be accessible upon the Auditor’s arrival on-site:

    a. Schedules

    Schedule of calibrations, production, internal audits, compliance audits, system accuracy

    tests, and solution analysis.

    b. List of Personnel

    List of quality personnel by process

    c. List of Trained Personnel

    List of trained processing personnel by process and date planned for requalification

    d. List of Customers

    List of customers for which Supplier is approved

    e. Statistical Techniques Program

    Statistical Techniques Program or Statistical Process Control (SPC) time/line

    implementation plan

    f. Organization Chart with Names

    2.2.3 After the Audit

    In accordance with Transportation and Power Generation procedures, the Supplier has 21 calendar days from the time the Auditor submits the audit to submit a corrective action plan, identify effective dates for each NCR and when applicable, objective evidence. This response shall be entered directly into PRI’s Electronic Database. The response must address the root cause of the nonconformance from a systems management approach, the immediate action taken to resolve the discrepancy and the actions taken or to be taken to preclude recurrence.

    PRI Staff Engineers or the Transportation and Power Generation Electronics Task Group (ETG) may, after review of the audit report, require additional information or may find cause to issue additional findings. Note: Final authority over the audit report, acceptability of corrective actions and accreditation recommendation rests with the Transportation and Power Generation Electronics Task Group (ETG).

    2.3 Definition of Terms

    Terms and definitions shall be in accordance with IPC-T-50, AS/EN/JISQ9100, ISO 9000 and a PRI

    Quality Manual or as specified herein:

    AUTHORIZED: By Customer

    CALIBRATION: As it relates to this checklist it is a validation of the tool / measuring equipment

    against an agreed upon standard, using a “third party” source with appropriate accreditation to

    national or international standards to establish metrological confirmation.

    CHAMFERING: As it relates to this checklist Chamfering is the same as Beveling.

    CHARACTERISTIC: In this checklist it refers to a quality characteristic inherent in a product or

    process related to a requirement.

    COUNTERSINK: A funnel-shaped enlargement at the outer end of a drilled hole. A countersink is a

    tapered hole drilled with a wide outer portion.

    COUNTERBORE: A straight-walled enlargement, measured to a depth, at the outer end of a drilled hole. A counterbore can refer to a cylindrical flat-bottomed hole, which enlarges another hole, or the tool used to create that feature.

    CUSTOMER: Reference to customer may include the direct Customer (internal / external),

    long term contract and / or purchase order issuer.

    ENGINEERING SOURCE FILE: Source Files/Manufacturing Data Files is a term to define a set of

    data files that are received from the Customer or his authorized design partner to facilitate the

    creation of the tool sets used to fabricate/manufacture the specific product quoted. They shall be a read-only format with a CRC code or date stamp so they can only be downloaded to create cad/cam designs or programming formats. The Supplier shall not be allowed or capable of altering files.

    FIFO: First-in first-out, based upon the date or additional methodology

    FIRST ARTICLE INSPECTION: A complete, independent, and documented physical and functional

    inspection process to verify that prescribed production methods have produced and acceptable item as specified by engineering drawings, planning, purchase order, engineering specifications, and / or other applicable design documents.

    INDUCTION: Recommended time from mixing to first use to allow cross-linking of two-part epoxy or paints.

    IN PROCESS: Parts have been accepted for processing and released to manufacturing but not yet

    accepted at final inspection or scrapped. In process inspections are typically "visual" (water break, uniformity, coverage, etc.) "checks" to determine if parts should proceed to the next processing step.

    JOB: All of the hardware processed to a single order control document as a lot or multiple lots with a unique control number.

    KEY CHARACTERISTICS: The features of a material, process, or part whose variation has a

    significant influence on product fit, performance, service life, or manufacturability.

    LEGEND: A format of letters, numbers, symbols and patterns that are used primarily to identify

    component locations and orientations for convenience of assembly and maintenance operations.

    Additionally, to identify Supplier vendor code, Supplier vendor logo, lot traceability identification, date code of manufacture and serialization, when required by the Customer.

    MEASURING EQUIPMENT: It is a measuring instrument, a calibrated source, a measurement

    standard, reference material or auxiliary apparatus or combination thereof necessary to realize a

    measurement process.

    METROLOGICAL CONFIRMATION: It is a set of operations required to ensure that the measuring

    equipment conforms to the requirements for its intended use. Metrological confirmation generally includes calibration or verification, any necessary adjustment or repair, and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as well as any required sealing and labeling. Fitness of the measuring equipment for the intended use shall have been demonstrated and documented.

    OBJECTIVE EVIDENCE: As used in this checklist, it is data supporting the existence or verity of

    something. It may be obtained through observation, measurement, test or other means.

    OUTSOURCED PROCESS: "Outsourcing" involves transferring or sharing management control

    and/or decision-making of a business function to an outside Supplier, which involves a degree of two-way information exchange, coordination and trust between the outsourcer and its client."

    PLAN: A scheme or method of acting, proceeding, etc., developed in advance with tasks, time

    bound, and assignments.

    POLICY: A written company philosophy on how something should be done in very broad generic

    terms. The existence of a procedure shall satisfy the requirements for a policy.

    POT-LIFE: The length of time that a catalyzed resin system retains a viscosity low enough to be

    used in processing. Also known as “working life” or “usable life”.

    PREPREG SCALED FLOW TESTING: A test procedure intended to measure multilayer lamination

    prepreg flow characteristics.

    PROCEDURE: As used in this Checklist, a procedure is a specified way to carry out an activity or

    process. A procedure shall be given the same accord as a documented procedure is given in

    International Standards. This means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a procedure may be covered by more than one document. Documentation for the procedure can be in any form or type of medium, including work instructions and drawings.

    RECORD DOCUMENT: As it relates to this checklist, it could be a quality record; a completed

    process notation on a traveler or process sheet; or other documents stating results achieved or

    providing evidence of activities performed. Records can be used to document traceability and to

    provide evidence of verification.

    REQUIREMENT: It is a need or expectation that is stated, generally implied or obligatory. In effect it is an expression in the content of a procedure or process conveying criteria to be fulfilled if

    compliance with the procedure or process is to be claimed and from which no deviation is permitted.

    SPURIOUS FOIL: Random and/or unwanted foil

    TEST: It is a determination of one or more characteristics according to a procedure.

    VALIDATION: As it pertains to this checklist it is confirmation, through the provision of objective

    evidence, that the requirements for a specific intended use or application have been fulfilled.

    VERIFICATION: As it relates to this checklist, it is the same as validation and is used for an in

    process check of the tool /measuring equipment. The production department using the tool could perform the verification, or it could be performed by an inspector or manufacturing engineer who is familiar with the process.

    PRI Publications: Available from the Performance Review Institute TPG-eAuditNet (eAuditNet.com) website.

    IPC Publications: Available from IPC, 3000 Lakeside Drive, Suite 309S, Bannockburn, IL 60015-1219

    IPC-T-50 Terms and Definitions for Interconnecting and Packaging Electronic Circuits

    IPC-A-600 Acceptability of Printed Boards Training and Certification Program

    IPC-6012 Qualification and Performance Specification for Rigid Printed Boards

    IPC-6013 Qualification and Performance Specification for Flexible Printed Boards

    IPC-TM-650 IPC Test Methods Manual PRI

    SAE Publications: Available from SAE, 400 Commonwealth Drive, Warrendale, PA 15086-001

    AS/EN/JISQ9100 Quality Management System- requirements for Aviation, Space and Defense

    Organizations

    ISO Publications: Available from the American National Standards Institute, 11 West 42nd Street, New York, NY 10036

    ISO 9000 Quality management Systems- Fundamentals and Vocabulary


     
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