By: Oscar Shirani, PE and Certified Lead Auditor per ANSI N45.2.23
Explanation of 10CFR50 Appendix B - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.
Italic formatting represents 10CFR50 Appendix B.
Quality Assurance Manual established by the licensees may also address the Criterion 19 that involves the Regulatory Related requirements and non-safety related items and services, but important to safety such as fire protection, chemistry, ALARA, Security, etc.
Some of the criteria are explained in more simple language as following:
Criterion I. Organization:
The Applicant (i.e. Licensee, Cooper Nuclear Station) should have organization and is responsible for establishing and executing a quality assurance program. Licensee may delegate to others (Naderi, Contech, Woody, etc.) the safety related work, but shall retain responsibility therefor.
Criterion 2. Quality Assurance Program
The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety. The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. The applicant shall regularly review the status and adequacy of the quality assurance program.
Criterion III. Design Control
The licensee shall establish measures to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled.
Measures shall be established for the identification and control of design interfaces and for coordination among participating design organizations. These measures shall include the establishment of procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.
The design control measures shall provide for verifying or checking the adequacy of design. Design control measures shall be applied to items such as the following: reactor physics, stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for in-service inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and tests.
Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that performed the original design unless the applicant designates another responsible organization.
ANSI N45.2.11-1974 (Quality Assurance Requirements for the Design of Nuclear Power Plants)
Section 2 (Program Requirements): Provisions shall be made in the program for periodic audits, review and evaluation of the effectiveness of the program in achieving quality objectives. Correction of deficiencies shall be an integral part of the program.
Procedures shall be employed to assure that design activities are carried out in a planned, controlled, orderly and correct manner.
Item 2.2.3: Technical information exchanges across external and internal interfaces.
Item 2.2.8: Identifying appropriate design input.
Item 2.2.10: Specifying quality levels, acceptance standards, and record requirements.
Item 2.2.11: Performance of design verifications.
Item 2.2.12: Conducting audits of design activities, their reporting and followup.
Section 3 (Design Input Requirements).
Applicable design inputs, such as design bases, regulatory requirements, codes and standards, shall be identified, documented and their selection reviewed and approved. The design input shall be specified on a timely basis and to the level of detail necessary to permit the design activity to be carried out in a correct manner and to provide a consistent basis for making design decisions, accomplishing design verification measures, and evaluating design changes.
Item 3.2 (Requirements):
The design input shall include but not limited to the following, where applicable:
3.2.1: Basic functions of each structure, system, and component
3.2.2: Performance requirements such as capacity, rating, system output
3.2.3: Codes, standards, and regulatory requirements including the applicable issues and/ or addenda
3.2.4: Design Conditions such as pressure, temperature, fluid chemistry, and voltage
3.2.6: Environmental conditions anticipated during storage, construction and operation such as pressure, temperature, humidity, corrosiveness, site elevation, wind direction, nuclear radiation, electromagnetic radiation and duration of exposure.
3.2.7: Interface requirements including definition of the functional and physical interfaces involving structures, system, and components.
3.2.13: Electrical requirements such as source of power, voltage, raceway requirements, electrical insulation and motor requirements.
3.2.15: Operational requirements under various conditions, such as plant startup, normal plant operation, plant shutdown, plant emergency operation, special or infrequent operation, and system abnormal or emergency operation.
3.2.16: Instrumentation and control requirements including indicating instruments, controls and alarms required for operation, testing, and maintenance. Other requirements such as the type of instrument, installed spares, range of measurement, and location of indication should also be included.
Section 4 (Design Process)
Design activities shall be prescribed and accomplished in accordance with procedures of a type sufficient to assure that applicable design inputs are correctly translated into specifications, drawings, procedures or instructions. Appropriate quality standards shall be identified, documented and their selection reviewed and approved.
4.2.5: Documenting assumptions, and identifying those assumptions that must be verified as the design proceeds.
Section 6.3.1 (Design Verification):
- Where the design inputs correctly selected and incorporated into design?
- Are assumptions necessary to perform the design activity adequately described and reasonable? Where necessary, are the assumptions identified for subsequent re-verification when the detailed design activities are completed?
Section 11. Audits
A comprehensive system of planned and documented audits shall be carried out to verify compliance with all aspects of the Quality Assurance Program for design including those procedures delineating quality assurance actions required during the design process.
Section 11.2 (Internal Audits)
Design organizations performing work in accordance with the requirements of this standard shall be audited to assure that their design quality assurance programs are being implemented.
Section 11.4 (Audit Control)
Audits shall include an evaluation of design quality assurance policies, practices, procedures and instructions; the effectiveness of implementation; and actions taken to correct deficiencies in the program. The audits should include the examination of design activities, processes, and documents and records.
Contrary to the above auditing requirements and 10CFR50 App. B, Criteria VII and XVIII for frequent audit of important and complex project such as EQ program which has been subjected to many repeated violations and SERs by the NRC for the past three years, CNS Quality Assurance has failed its obligation to meet the above requirements.
Four Surveillance/Audits conducted by the CNSí QA Department has been reviewed and found to be very programmatic in nature and did not cover the 10CFR50 App. B and design control processes/analysis, Software Verification and Validation (V&V) as required by 10CFR50 Appendix B Criterion III, ANSI N45.2.11, ANSI NQA-1, and ASME NQA-2, Part 2.7 (for Software) endorsed by Reg, Guides 1.28, 1.46, and 1.152 by NRC.
CNS Procedure 3.4.7
Please refer to the CNS Procedure 3.4.7 for the exact definitions of Status 1 (Active or Design Bases) and Status 3 (on hold or pending) calculations.
Contrary to the requirements of the above 10CFR50 Appendix B Criterion III, ANSI N45.2.11, and ASME NQA-1-1989 Edition and CNS Procedure 3.4.7:
There are at least 89 Equipment Qualification Data Packages remaining (EQDPs) that support the design and operations of thousands (1000ís) of safety related electrical components under harsh environmental conditions subjected to loading under Post Loss of Coolant Accident Heat Up (PLHU), High Energy Line Break (HELB), and Radiation.
These remaining 89 EQDPs and other EQDPs have used the design input from 100ís (500-600 or more) of the design input from Design Engineering Department (DED) Civil, Mechanical, Electrical , and I&C Calculations that are in Status 3 (on hold or pending) and not the required Status 1 (Design Bases or Active) calculations. In order to meet the requirements of 10CFR50.49 (EQ Criteria) and 10CFR50 Appendix B Criterion III (Design Control), all the design input used in the EQDP analyses shall be based on the design bases of the plant (i.e. Status 1) which are not. CNS cannot have a separate definition for the design bases of the plant for EQDPs to ensure that EQDPs meeting the requirements of 10CFR50.49 and be in violation of the design requirements of 10CFR50 App. B and CNSí Procedure 3.4.7 at the same time.
The EQ Components should be subjected to the worse loading /bounding conditions either calculated in the DED analysis or the EQDPs and this is unknown. Existing EQ Design analysis are not in compliance with the requirements of CNS 3.4.7, 10CFR50 Appendix B, and hence not meeting the intent of 10CFR50.49. CNS covered up my concern in this regard from September 5, 2003, and two of my e-mails dated September 8 and 9, 2003 and misled the NRC to obtain the NRCís approval based on 10CFR50.49.
You could not be in violation of 10CFR50 Appendix B, Criterion III (Design Control); ANSI N45.2.11; ASME NQA-1; and CNS Procedure 3.4.7 and meeting the design requirements of EQ Criteria of 10CFR50.49. NRC never discussed these issues during their audit/inspection in October 6-10, 2003 and did a superficial audit as usual.
This is the sad story of my life that I have identified major design flaws with the GE Nuclear Energy, san Jose, CA Quality Assurance Program in August 1997 and issued them a Stop Work Order for 100% failure in the design control processes while NRC had fully inspected the GEís Design Record Files three months prior to my audit and blessed their design control processes.
The same occurred with my audits of US Tool & Die and Holtec in 2000 in which, I forced Holtec to issue a Stop Work Order on its program in May 2000 and when I insisted the same for US Tool & Die in July 2000, I was subjected to many "F" words by Exelon VP Ted Jennings. Exelon falsified my NUPIC Audit of US Tool & Die Report dated August 4, 2000.
My DOL Hearing Exhibit RX-38 clearly shows my 9 findings against US Tool & Die whereas Exelon Exhibit RX-46 dated the same August 4, 2000 that claimed: "all findings were satisfactorily resolved during the audit by the audit team not to have any impact on the dry cask loading at Dresden Station". Exelon intended to load its casks at Dresden and could not do that with pending issues. NRCís Jim Heller has accepted the Exelonís falsification of records as acceptable supervisory discretion. I will expose all the NRCís responses to my 10 technical allegations against Exelon via a congressional hearing and let the public see the 10CFR50 App. B requirements and compare the NRCís responses that are in deliberate violation of its own specification/codes. My kids in high school are laughing at the NRCís responses when they compare it with the codes and they donít know nothing about engineering or Quality Assurance. Code is not very hard to understand, but it is amazing why NRC is covering up for utilities.
My US Tool & Die Audit Report, Page 118 of 198 clearly showed the NUPIC Checklist front page that more than 90% of the 18 Criteria of 10CFR50 App. B was UNSATISFACTORY and Exelon falsified the results of the audit. NRC even ignored their own Guru of Spent Nuclear Fuel Dry Cask, Dr. Ross Landsman who fully supported my issues and still believes that NRC looked the other way.
NRC again covered up this issue. I am pursuing a congressional hearing against Exelon employees and the NRC agents who covered up these black and white documents. NRC is putting 10CFR50 App. B on the shelf to look good, but it does not intend to implement it.
Criterion IV. Procurement Document Control
Measures shall be established to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors. To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.
Criterion V. Instructions, Procedures, and Drawings
Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings. Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
Criterion VII. Control of Purchased Material, Equipment, and Services
Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.
XVI. Corrective Action
Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformance are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.
Contrary to the above requirements and potential 10CFR part 21 reportability of significant issues/concern, CNS hid my concerns raised by my two e-mails sent to Engineering Department and Quality Assurance Department Managers and threatened me for raising the EQ technical and quality concerns a month prior to the NRCís EQ Inspection at CNS.
In addition, three days prior to my termination, I had again documented my concerns in a report to the Chief Nuclear Officer Randy Edington as I also documented in my October 24, 2003 weekly status reporting to my boss, Kevin Jones, but Kevin called me urgently to a private room of Russ Wenzle and instructed not to report my issues to Mr. Edington and he censored my report. Mr. Wenzl was attempting to come to his office, but Kevin told him to hold off until he completely orders me what to do.
Criterion XVIII. Audits
A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Follow-up action, including re-audit of deficient areas, shall be taken where indicated.
This document was posted online December, 2003 by Russell D. Hoffman. For a complete guide to Oscar Shirani's allegations please visit: