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. Holtec also maintains an ISO 9001 acceditation. The Holtec Manufacturing Division (HMD) also maintains various ASME certificates including "N" and "U".

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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) also audit Holtec’s QA program at periodic intervals.

On average, Holtec hosts four to six external audits of the company’s QA program each year. In addition to these audits, Holtec is also audited by ASME, the NRC and NUPIC (Nuclear Procurement Issues Committee). No audits have ever resulted in the uncovering of a fatal flaw in our QA program or its implementation.

Holtec International firmly believes that to reach and maintain an unimpeachable plateau of 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 is held as the fundamental QA doctrine of our company.

The Quality Triad

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 two decades of 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

Mark Soler: Corporate Quality Assurance Manager

• Holtec’s Q.A. program is led by Mark Soler, a degreed Mechanical Engineer (University of PA, 1986). Mark Soler has led Holtec’s Q.A. program for over 20 years.
• Holtec maintains a staff of QA personnel who are responsible for training, internal oversight, external vendor surveillances, etc. The QA department includes a number of degreed personnel as well as individuals with extensive experience in various aspects of quality control and quality assurance.

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 external activities such as site services
• Implementation of root cause evaluation and Corrective Action Request (CAR)
• Managing of quality improvement initiatives initiated by the company

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. Holtec's self-assessment program includes, but is not limited to:

• 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 full compliance with any updated codes and to indentify enhancements.
• 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
• Submittal of report card forms to customers to complete so Holtec may evaluate both positive and negative feedback.

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 (Holtec Manufacturing Division).

HI-STAR Overpack in fabrication

The quality mantras at HMD enforced on the shop floor are:

• 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.

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 operandi that emphasize 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 message 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 $600 million dollars of equipment and services to the “quality triad” illustrated in the foregoing.