ASME NQA-1 Certification - KEPIC : 방문‌„ ™•©ë‹ˆë‹¤. NQA-1 Certification The ASME NQA-1 Certification

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  • ASME NQA-1 Certification

    Matthew Vazquez

    September 4, 2017

  • NQA-1 Certification

    The ASME NQA-1 Certification Program seeks to meet the needs of the nuclear industry by expanding the supply chain with organizations who are committed to understanding quality and providing high quality products and services.

  • Conformity Assessment

    Programs

    Product Certification

    BPV

    Nuclear Component

    RTP

    BPE

    Quality Program

    Certification

    NQA-1

    Nuclear Materials

    Accreditation

    AIA

    PRD

    Personnel Certification

    GDTP

    QRO

    ANDE

    November

  • Conformity Assessment

    Requirements

    Most CA Schemes including ASME have the

    following:

    1. Inspection

    2. Examination

    3. Testing

    4. Evaluation

    5. Auditing

    6. Certification

  • NQA-1 Certification Program

    Applies to organizations supplying items or services which

    provide a safety function for nuclear facilities

    The ASME NQA-1 Certification program provides a means for an

    organization supplying items or services that are safety related to

    have its Quality Assurance Program recognized by ASME.

    The ASME NQA-1 Certification program audits an organizations

    Quality Assurance Program and is verified to be in conformance

    with the requirements of the ASME NQA-1 Standard.

    The ASME Certification program applies to organizations whose

    Quality Assurance Program is based upon the ASME NQA-1-

    2008 Standard and subsequent editions/addenda of the Standard.

  • NQA-1 Certification Program

    Having an NQA-1 QA Program recognized by an independent

    organization that is internationally known and respected.

    Provides confidence to your customers that you have the knowledge

    and resources to implement an NQA-1 QA program.

    Assist new suppliers gaining entry into the supply chain.

    Reduce amount of time, effort and resources to purchasers in

    determining if a potential supplier has an acceptable NQA-1 program.

    Provides confidence to Senior Management that the established QA

    program is being satisfactorily implemented by their employees.

    Creates a level playing field with promoting consistent application

    of NQA-1 standard within the industry and supply chain.

  • ASME Certification Scheme

    Quality Manual Describes how ASME will administer its accreditation and certification programs in a competent, consistent and impartial manner. It meets the essential requirements and principles of:

    ISO 17011 Conformity Assessment General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies

    ISO 17065 Conformity Assessment Requirements for Bodies Certifying Products, Processes and Services

    ASME Certification Scheme

  • NQA-1, The QA Manual and

    meeting the following conditions:

    The Manual cannot be a reiteration of the NQA-1 Standard, but rather, an auditable detailed written document which clearly describes the controls for each quality element.

    The Manual should not be written to address multiple quality programs; it should only address the requirements of the ASME NQA-1 Standard.

    The Manual needs to describe the scope of the items, products and services provided by the organization.

    The Manual must be in written in English. A version of the Manual may be in ones native language; however, the English version will govern.

  • Things to do prior to submitting an

    application

    Review relevant information about the desired certification program on ASME's website

    Decide on scope of work that will be certified by ASME

    Obtain required standards

    Prepare the quality manual, a written description of the quality program

    Indoctrinate and train personnel to implement the quality program

  • Applying for NQA-1

    Certification

    New applicants will need to create an account in CA Connect

    Existing account holders should first ensure that the primary contact for the account is correct. Changes to contact are made through CA Connect

    Complete the NQA-1 application

    Submit the signed accreditation and Certification agreement form

  • CA Connect

  • CA Connect

  • Application

    The application forms for the NQA-1 Certification Program is constructed to obtain a significant amount of information to allow ASME to determine:

    I. the expertise needed

    II. the size of the audit team

    III. the locations to be audited

    IV. the duration of the audit.

  • Application

    Information required by the application includes the following:

    I. Name, address and organization contacts.

    II. Identification and descriptions of locations performing

    activities affecting or controlling quality.

    III.Identification of activities affecting quality performed

    and/or subcontracted by the organization, including the

    applicability of each NQA-1 Part I and II requirement.

    IV.Identification of the type of product/services being

    provided.

  • Complete NQA-1 Package

    A completed application package contains:

    A controlled and approved copy of the Quality Assurance Manual;

    A completed "NQA-1 Quality Assurance Manual Checklist".

    The Checklist can be downloaded from the Nuclear Quality

    Assurance (NQA-1) Certification web page;

    Completed application forms; (Submitted on line)

    The advanced deposit fee.

  • Manual Checklist

  • Certification Timeline

  • Successful QA Manual Implementation

  • 19

  • Quality Manual vs Implementing

    Procedures

    20

    0 20 40 60 80 100

    How

    Where

    When

    Who

    What

    QA Manual

    ImplementingProcedures

  • 2

    1

    Implementation and the NQA-1

    Manual Organization Verify Indoctrination

    Indoctrination

    How are personnel identified

    to receive indoctrination;

    Identify indoctrination topics;

    Codes and standards

    Company procedures,

    QA program requirements

    Records;

    Topic

    Training Logs

    Attendance sheets

    Dates

    Records

    Topic

    Identify

    Personnel Indoctrination

    Quality

    Manual

  • 2

    2

    Organization

    Verify Training

    Training

    Written procedures for the

    qualification of personnel:

    Welders & Operators

    NDE Personnel

    Auditors & Lead Auditors

    Inspection & Test Personnel

    Only personnel who meet the

    requirements are permitted to

    perform these activities;

    Records contain required

    information;

    Records

    of Training &

    Certification

    Personnel

    Permitted to

    Perform

    Activity

    Written

    Procedures

    Training

    Quality

    Manual

    Implementation and the NQA-1

    Manual

  • 2

    3

    Design Control

    Verify

    The Design Outputs has been

    reviewed, and certified by the

    responsible persons

    Software when used has been

    validated

    Drawings show required

    information.

    Calculations are complete

    Document Changes are identified

    Design Output Documents when

    required has been prepared

    Control of Records

    Final

    Records

    Design

    Output

    Revision

    Calculations Drawings

    Software

    Users

    Design

    Spec-

    Quality

    Manual Design

    Control

    Implementation and the NQA-1

    Manual

  • 2

    4

    Procurement Document Control

    Verify

    The transfer of information

    from design documents;

    Purchase documents indicate

    required information;

    Preparation of Approved

    Vendors List (AVL);

    Maintenance of Approved

    Vendors List (AVL);

    Selected of Vendor(s) are from

    AVL;

    Transfer of information for

    receiving inspection.

    Information

    Transmitted

    for Receiving

    Selected

    Vendors

    On AVL

    Maintenance

    of AVL

    Preparation

    of AVL

    Required

    Info Included

    in PO

    Transfer from

    Design Doc.

    Procurement

    Document

    Control

    Quality

    Manual

    Implementation and the NQA-1

    Manual

  • 2

    5

    Final

    Records

    Audit

    Records

    Calibration

    Records

    NCRs

    Insp. &

    Test

    Records

    Purchasing

    Documents

    Design

    Documents

    Procedures

    Instructions

    Document

    Control

    Document Control

    Verify

    Only current documents

    that have been prepared,

    reviewed, and approved or

    certified by the responsible

    persons, distributed to

    where they are used, and

    that obsolete versions are

    removed.

    Quality

    Manual

  • 2

    6

    Identification & Control of Items

    Verify

    Only correct and accepted

    items are used or installed;

    Identification is maintained on

    the items or in documents

    traceable to the items or in a

    manner which assures that

    identification is es