Quality Assurance

As one of America's prominent suppliers of equipment and services to the nuclear power industry, Holtec International places utmost importance on maintaining a strong and effective quality assurance (QA) program. Holtec's QA program complies with the provisions of 10CFR 50 Appendix B, 10CFR72 Subpart G, and 10CFR71 Subpart H.

The company's QA program is documented through a set of hierarchical documents, with the Holtec Quality Assurance Manual (HQAM) situated at the apex of the hierarchy. The HQAM sets the broad criteria and organizational requirements for quality. The commitments of the HQAM are executed through the Holtec Quality Assurance Procedures Manual that is a compendium of some fifty Holtec quality procedures (HQPs). A series of Holtec Standard Procedures (HSPs) serve to provide lower tier implementation details.

The company’s QA program has been assessed by the USNRC and audited by numerous nuclear utilities. The Nuclear Utilities Procurement Issues Committee (NUPIC) and the Dry Storage Quality group also audit Holtec’s QA program at periodic intervals.

Holtec International firmly believes that to reach and maintain unimpeachable quality, a state-of-the-art quality assurance program must be supported by the triad of (i) comprehensive quality procedures, (ii) a vigorous program of implementation, and (iii) a shared sense of ownership and accountability among the company’s associates. The QA triad illustrated in the following is held as the fundamental QA doctrine of our company.

On average, Holtec hosts four to six external audits of the company’s QA program each year. None has ever resulted in the uncovering of a fatal flaw in our QA program or its implementation. The most recent NRC inspection of Holtec occurred in August 2004, resulted in no citation of any violations.

Imperatives of Holtec’s QA Program

• Provide a high level of commitment to NRC and clients via the HQAM
• Provide middle tiered control of services and hardware through HQPs
• Establish working level requirements through Holtec Standard Procedure (HSPs) and Holtec Project Procedures (HPPs).

Means to Maintain and Sustain QA Program’s Caliber

• Intrusive Senior Management oversight
• Internal audits and surveillances
• Audits and surveillances by company’s clients
• On-line trending of problems
• Client feedback on ongoing projects
• Company’s internal enhancement drive through the Quality Initiatives Committee

Industry Inputs to Strengthen the Holtec Quality Program

• Feedback from over a decade of Part 50 work has been filtered into our program from most of the nuclear utilities in the USA
• Both top performing plants as well as plants on the watch list have provided valuable input to our program

Quality Assurance Personnel

• Holtec’s Q.A. program is led by Mark Soler, a degreed Mechanical Engineer (University of PA, 1984). Mark Soler has led Holtec’s Q.A. program for over 15 years.
• Holtec QA personnel are experienced in virtually all aspects of nuclear plant operations
• All QA personnel are degreed personnel with in-depth experience and certifications in AWS, CWI, ANSI N45.2.6, ANSI N45.2.23, and SNT-TC-1a

Overview of Key QA Activities

• Drawings, procedures, specifications, reports, purchase orders, etc., receive reviews and surveillances depending on safety significance and design requirements
• Audits and surveillance of subsuppliers (AVL)
• Procurement reviews and oversight
• Oversight of manufacturers of Holtec engineered equipment
• Training sessions to indoctrinate company personnel
• Ongoing QAM and procedural enhancements
• Incorporation of lessons learned
• Preparation/Review of document packages
• Oversight of site construction activities
• Implementation of root cause evaluation and Corrective Action Request (CAR)

Self-Assessment and Self-Improvement

Holtec International is committed to enhancing all elements of its QA program through a sustained push for self-improvement. The improvements in the quality program are an ongoing process at the company with the Quality Initiatives Committee (QIC) serving as the conceptualizer and catalyst for the enhancements. Some recently implemented measures that typify the QIC’s activities are:

• A periodic complete stem-to-stern review of the HQAM (Holtec Quality Assurance Manual) and HQAPM (Holtec Quality Assurance Procedures Manual) to bring the company Quality Plan and implementation procedures into complete accord with the Quality Assurance Program
• Establishment of an electronic database for tracking and retrieval of QA documentation
• Establishment of a certification program for all engineering personnel
• Establishment of a self-assessment program for use by the Corporate Engineering Organization
• Conduct of roving (unannounced) QA surveillances to supplement existing annual planned internal audits
• Development of a state-of-the-art program for internal nonconformance assessment by the Project Teams and for root cause evaluations
• Extension of the QA processes governing materials acquisition to Safety Related as well as Important-to-Safety category A, B, and C
• Development of a “Lessons Learned” database

Preserving Engineered Quality in Component Fabrication

As a turnkey supplier of safety significant equipment, Holtec’s QA program must be capable of ensuring that the company’s QA commitments are embedded in the fabricated hardware. Fabrication Quality Assurance is the sum total of all undertakings of a company to translate the attributes, reliability, and performance envisioned in the design documents into the manufactured equipment. The road to quality realization is a treacherously complex one; the potential for a quality hiccup during the myriad of activities needed to complete the hardware fabrication is ever present on the shop floor. To thwart such hazards to quality, Holtec has centralized all HI-STAR, HI-STORM and MPC fabrication at a facility of worldwide renown for flawless quality.

HI-STAR Overpack in fabrication (Courtesy UST&D, Inc.)

In 1997, Holtec and U.S. Tool & Die, Inc. established a quality coalition to create proven fixtures and operating procedures to build HI-STAR and HI-STORM components. By taking a long-term perspective and by centralizing all cask hardware manufacture at one facility, Holtec and UST&D, Inc., have eliminated a major source of "quality leaks" through their completely "flanged up" quality programs and project management protocols. Both companies have resolved to reinforce the institutional alliance by faithfully practicing the three central quality maxims:

• An unyielding adherence to written quality procedures on the shop floor.
• Continuous vigilance of shop practices by the top management of the company.
• An unending campaign for weakness detection and self-improvement.

In January 2004, Holtec International acquired 100% of UST&D’s stock. While UST&D continues to function as a stand alone “profit & loss” entity, the Q.A. program of UST&D is in complete control of Holtec’s corporate Q.A. led by Holtec Quality Assurance Manger.

Achieving Quality in Site Construction and Site Services

Holtec International has amassed a long and distinguished record of error-free site construction involving civil/structural work for dry storage, plant “mods” for wet storage and for installation of a variety of capital equipment (heat exchangers, tanks, flow control devices, etc.). The continuing string of success of the company’s site construction projects is rooted in our modus operand: that emphasizes three key elements in all construction projects; namely

• Intensive personnel training and Q.A. indoctrination
• Well articulated procedures that enable and facilitate literal compliance
• A relentlessly delivered mantra that schedule adherence is a distant third to safety and quality

We attribute the QA success in site construction work dating to 1987 involving over $400 million dollars of equipment and services to the “quality triad” illustrated in the foregoing.