NQA Certification Program @ San Diego Oct 2010

ASME Certification of

NQA-1 Suppliers

Joseph PangASME

Project Engineering ManagerConformity Assessment

Background

• Market survey in fall 2009– Mixed feedback– Utilities have effective joint audit program for existing

facilities– Benefits for new suppliers for new construction

• Interest by a wide variety of suppliers– Desire for a system parallel to the existing ASME

Nuclear Certification Program– Interest for international suppliers– Management wants ISO type certification with focus on

the nuclear power sector

Need for Certification Program

• Resurgence of nuclear power • Nuclear supply chain expansion• RG 1.28 (Rev 4, June 2010)

endorses NQA-1-2008 and the 2009 Addenda

• Promote consist application • Assist suppliers in becoming

“qualified” bidders

Benefits for New Construction

• Advantage for new suppliers• Consistency and standardization• Recognition by ASME that program

meets NQA-1 Standard– Independent quality evaluation– Confirms program implementation to

supplier’s management

• Allows new supplier to state they are “ready to be a nuclear supplier”

Status

• At their June 8, 2010 meeting, the ASME Standards and Certification Board of Directors voted:

To approve the establishment of the Nuclear Supplier Certification Program.

• Implement a NQA Certification Program by June 30, 2011

HistoryASME Conformity Assessment

• 1915 Began issuing BPV Certification/Stamps• 1968 Began Nuclear Certification Program• 1972 US Justice Department Issues Consent

Decree, ASME agrees to certify companies outside of the US and Canada

• 1987 Began Accrediting other Conformity Assessment Bodies (At the request of the Elevator Industry)

• 1990 Began Certifying Individuals (At the request of the US EPA)

ASME Conformity Assessment Programs

Board on Conformity Assessment

Personnel Certification

Product Certification

Accreditation

GDTP(847 Certificates)

QHO(85 Certificates)

QFO(39 Certificates)

QRO(1580 Certificates)

C-BPVCA(BPV - 5766 Companies)(PRD – 10 Companies)

CNC(N-type – 220 Companies)

(QSC – 61 Companies)

RTP(10 Companies)

QAI(23 Companies)

QEI(3 Companies)

Data as of Sept. 2010

Definition – NQA Certification

• A certification program that verifies by QA manual evaluation and site audit that a supplier has implemented a quality program that meets the requirements of the ASME NQA-1 Standard.

NQA Certification• ASME NQA Certification will be limited to

only verifying a QA Program to the requirements of latest edition of the NQA-1 Standard

• Starting with the 2008 Edition and 2009 Addenda, an Applicant may request that their QA Program be frozen to a specific Edition of NQA

• Modifications which do not relax or conflict with existing NQA-1 requirements are allowed

Two Exclusions

• BPV Section III Suppliers– Adequately addressed by existing

program– Require interface with Authorized

Nuclear Inspection Agency• Operating Nuclear Facilities

– Subject to control by regulatory authority

– NQA-1 not approved by NRC for operation

Challenges or Issues

• Certification cost

• Certification renewal after becoming an established supplier

• No initial regulatory recognition

• Need to share audit results with purchasers

Challenges or Issues

• Certificate scopes

• Organizations with multiple locations

• Recognition of an Acceptable QA Program Manual w/o Implementation

• Process to achieve certification

Certification Process

Issuance of Certificate

Initial Preparation

QA Program Manual Review

Certification Decision

Site Audit3-year cycle w/ two

surveillances



Initial Preparation




surveillances



Initial Preparation




surveillances



Initial Preparation




surveillances



Initial Preparation




surveillances

Questions and Answers

Q – Who pays for the cost of the NQA Certification?

A – The organization requesting the certification.

Q – What is the cost?A – Dependent upon the complexity of

the QA Program and the scope of activity.


Q – Will the audit report be a confidential document with the certification being the only proof of compliance?

A – No. A complete audit report will be provided to the supplier for their distribution to purchasers for the purpose of supplier qualification.


Q – How will consistency with the NQA Standard be maintained?

A – Through an open line of communication between the Certification Committee and the NQA Standards Committee and through the issuance of interpretations.


Q – What edition of the NQA Standard will be used for certification?

A – The initial Certification program will be to the NQA-1 Standard currently endorsed by the NRC. Certification will not be available to other historical NQA editions.


Q – What is the length or frequency of the certification?

A – Certification will be for a three year period, which is consistent with the supplier audit frequency.


Q – Will there be an annual evaluation of the supplier?

A – Yes. Two surveillances will be conducted within the 3 year term of the certificate.


Q – What if I want to change my QA program? Do I have to re-certify?

A – A process will need to be developed to accommodate and evaluate the changes. Depending on the extent of the changes the applicant would be provided with the options of: a QA Manual Review, a surveillance or an early renewal audit.


Q – What is the NRC’s and DOE’s view of the ASME Certification program?

A – It has been discussed with the NRC and DOE staff informally. When the details of the program are developed a meeting with the NRC and DOE will be held to obtain their input.

What’s Next

• Work with NQA Officers to form a Project Team (5 NQA members)– Operating Procedures– Scope Statements– Audit Checklist– Application Form– Questionnaire to determine Team Size

and length of time– Report Format– Identify Individual(s) to Train ASME

Consultants

For further information, contact:

Joseph [email protected](212) 591-8525

mailto:[email protected]

Business

NQA Certification Program @ San Diego Oct 2010