ASME NQA-1 Certification. Matthew Vazquez September 4, 2017

Transcription

1 ASME NQA-1 Certification Matthew Vazquez September 4, 2017

2 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.

3 Conformity Assessment Programs Product Certification Quality Program Certification Accreditation Personnel Certification BPV NQA-1 AIA GDTP Nuclear Component Nuclear Materials PRD QRO RTP ANDE November BPE

4 Conformity Assessment Requirements Most CA Schemes including ASME have the following: 1. Inspection 2. Examination 3. Testing 4. Evaluation 5. Auditing 6. Certification

5 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 Standard and subsequent editions/addenda of the Standard.

6 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.

7 ASME Certification Scheme Quality 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 Conformity Assessment General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies ISO Conformity Assessment Requirements for Bodies Certifying Products, Processes and Services ASME Certification Scheme

8 NQA-1, The QA and meeting the following conditions: The 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 should not be written to address multiple quality programs; it should only address the requirements of the ASME NQA-1 Standard. The needs to describe the scope of the items, products and services provided by the organization. The must be in written in English. A version of the may be in one s native language; however, the English version will govern.

9 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

10 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

11 CA Connect

12 CA Connect

13 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.

14 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.

15 Complete NQA-1 Package A completed application package contains: A controlled and approved copy of the Quality Assurance ; A completed "NQA-1 Quality Assurance 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.

16 Checklist

17 Certification Timeline

18 Successful QA Implementation

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20 Quality vs Implementing Procedures What Who When Where QA Implementing Procedures How

21 Implementation and the NQA-1 Organization Verify Indoctrination Indoctrination How are personnel identified to receive indoctrination; Identify indoctrination topics; Codes and standards Company procedures, Records Indoctrination Quality Identify Personnel QA program requirements Records; Topic Training Logs Topic Attendance sheets 2 Dates

22 Organization Verify Training Training Implementation and the NQA-1 Written procedures for the qualification of personnel: Welders & Operators NDE Personnel Auditors & Lead Auditors Inspection & Test Personnel Records of Training & Certification Training Quality Only personnel who meet the requirements are permitted to perform these activities; Records contain required information; Personnel Permitted to Perform Activity Written Procedures 2

23 Design Control Verify Implementation and the NQA-1 The Design Outputs has been reviewed, and certified by the responsible persons Final Records Software when used has been validated Drawings show required information. Design Output Design Control Quality User s Design Spec- Calculations are complete Document Changes are identified Revision Software Design Output Documents when required has been prepared Control of Records Calculations Drawings 2

24 2 Procurement Document Control Verify Implementation and the NQA-1 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. Selected Vendors On AVL Information Transmitted for Receiving Maintenance of AVL Procurement Document Control Preparation of AVL Transfer from Design Doc. Required Info Included in PO Quality

25 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. Audit Records Calibration Records Final Records Document Control Procedures Instructions Design Quality Documents Purchasing Documents NCR s Insp. & Test Records 2

26 Implementation and the NQA-1 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 established and maintained. Receiving Inspection Records Review of Objective Evidence Information Transmitted for Receiving Identification & Control of Items Traceability To Original Required Marking Quality How are accepted Transfer of Material Marking System Items are Identified 2

27 Identification & Control of Items Verify Implementation and the NQA-1 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 established and maintained. Traceability To Original Required Marking Transfer of Material Marking System Identification & Control of Items How accepted Items are Identified Quality 2

28 Implementation Control of M & T Equipment Verify Calibration schedule established with prescribed times or intervals; traceable to certified equipment or Standards Procedures Reference Standards four times greater than that of the measuring and test equipment being calibrated Control overdue for calibration or found to be out-of-calibration identified Application traceable to its application and use Status Indication Records Status Application Records Control Control of M & T Equipment Reference Standards Calibration Procedures Calibration Schedule Quality Calibration Traceable to Standards 2

29 Nonconforming Items Verify Implementation and the NQA-1 How items are identified; Nonconformity Report Form contains required information; Were revision to documents required; Proposed resolution approved; Approval of Resolution Document Revisions Nonconformity Nonconformity Report Form Quality Identification of Items 2

30 QA Records Verify Implementation and the NQA-1 List of Records to be maintained; How records are protected; How is access to records controlled; How are records revised when required; Who is responsible for maintaining records. Maintaining Records Revision to Records Access to Records QA Records Protection of Records Quality Lists of Records 3

31 Implementation and the NQA-1 Audits Verify Auditor Qualifications Management Review Training Records Audit Scheduling; Audit Records Internal Audits Audit Records Audits Quality Auditor Qualifications External Audits Management Review of Internal Audits Audit Scheduling Training Records 3

32 Closing Questions? Matthew Vazquez