nqa certification program @ san diego oct 2010
DESCRIPTION
ASME recently presented an update on their new QA Program certification system.TRANSCRIPT
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ASME Certification of
NQA-1 Suppliers
Joseph PangASME
Project Engineering ManagerConformity Assessment
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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
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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
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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”
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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
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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)
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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
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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.
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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
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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
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Challenges or Issues
• Certification cost
• Certification renewal after becoming an established supplier
• No initial regulatory recognition
• Need to share audit results with purchasers
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Challenges or Issues
• Certificate scopes
• Organizations with multiple locations
• Recognition of an Acceptable QA Program Manual w/o Implementation
• Process to achieve certification
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Certification Process
Issuance of Certificate
Initial Preparation
QA Program Manual Review
Certification Decision
Site Audit3-year cycle w/ two
surveillances
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Certification Process
Issuance of Certificate
Initial Preparation
QA Program Manual Review
Certification Decision
Site Audit3-year cycle w/ two
surveillances
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Certification Process
Issuance of Certificate
Initial Preparation
QA Program Manual Review
Certification Decision
Site Audit3-year cycle w/ two
surveillances
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Certification Process
Issuance of Certificate
Initial Preparation
QA Program Manual Review
Certification Decision
Site Audit3-year cycle w/ two
surveillances
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Certification Process
Issuance of Certificate
Initial Preparation
QA Program Manual Review
Certification Decision
Site Audit3-year cycle w/ two
surveillances
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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.
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Questions and Answers
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.
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Questions and Answers
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.
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Questions and Answers
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.
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Questions and Answers
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.
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Questions and Answers
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.
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Questions and Answers
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.
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Questions and Answers
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.
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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