HGS’ quality assurance program (QAP) is guided by DOE Order 414.1D which sets down the overarching requirements for a government-compliant quality assurance system. HGS’ QAP is also in full compliance with HGS’ principal contractor’s (Holtec International) quality program which is premised on 10CFR50 Appendix B, 10CFR71 Subpart H, ASME Section III NCA-3800, NQA-1 and ISO-9001. Furthermore, additional quality assurance requirements are often imbedded in the project specifications reflecting the unique exigencies of a federal project. To accommodate the QA imperatives of the various supervening authorities, HGS follows a QAP structure that is fungible and customized to meet the need of each project. Meeting the QA requirements of 10 CFR 830, Subpart A, for conducting activities including providing items or services, that affect or may affect, nuclear safety of DOE nuclear facilities is an example of this customization. The QAP will describe how the QA criteria of 10 CFR 830.122 are satisfied integrating the QA criteria with the HGS Safety Management System. The fungibility is achieved by the HGS’ QAP infrastructure which, mirroring Holtec International’s, rests on four foundational pillars that support the Company’s quality edifice. They are:
- The Quality Assurance Manual (HQAM)
- The Quality Procedures Manual (HQPM)
- HGS Project Procedures (HPPs)
- HGS Standard Procedures (HSPs)
The HGS Quality Assurance Manual (HQAM) and ISO 9001:2015 Manual define the requirements and commitments that the Company must follow in any nuclear safety significant project. This manual is organized into eighteen sections, with each section covering a distinct criterion.
Each of the quality commitments in HQAM is granulized into specific requirements via a set of Quality Assurance Procedures that parallel the level of detail in ASME’s NQA-1. The Quality Assurance Procedures thus expand on the commitments in the Quality Manual while also providing the pathway to fulfill them.
Unlike the above two documents, the Project Procedures (HPPs) are the quality documents that are prepared exclusively for a project to incorporate the unique and specific quality requirements conveyed to the Company by the client through the project’s contract documents. It is the HPPs that customize the QAP architecture of the project to meet the client’s differentiating requirements. No HPP is developed if the client does not specify any unique requirements.
Standard procedures (HSPs) comprise the third set of generic quality documents (along with the HGS QAP and the HQP manuals) etc.
The HSPs have been derived from a number of authoritative sources such as:
- MIL-Q-9858 with QRC82 Quality System Specification
- MIL-I-45208 with ISR1 Inspection System Specification
- NAVSEA 250-1500 Welding Specification
- MIL-STD-248 Welding Specification
- ASME Section III Division 1 & 3
- ASME Section VIII Division 1, 2 & 3
- ASME Section III Ferrous & New Ferrous Material Organization
- ASME Section V
- ASME Section IX
- ISO 9001
HSPs also contain the wide range of manufacturing and inspection procedures needed to fabricate safety significant weldments. They pertain to areas such as:
- Visible & Fluorescent Dye Penetrant and Magnetic Particle Test
- Ultrasonic Tests of base material and welds
- Radiography up to thick weldments
- Acoustic Emission Test
- Helium Leak Test
- Hydrostatic Test
- Coordinate Measuring Machine
- Laser & Optical Measuring machine
Implementing a Sustainable QA Program
HGS’ 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 key strategies employed to maintain and sustain the QA Program’s Caliber are:
- Supportive and vigilant Senior Management
- Maintain a culture of complete transparency and accountability
- Internal audits and surveillances
- Audits and surveillances by company’s clients
- Control of suspect/counterfeit items
- Control nuclear safety software
- On-line trending of problems
- Client feedback on ongoing projects
- Lead Company’s internal enhancement drive through Quality Initiatives
- Promptly implement wisdom received from stakeholders
- Recruit only those QA personnel who have a solid track record, an in-depth experience and appropriate certifications in AWS, CWI, ANSI, N45.2.6, ANSI N45.2.23, SNT-TC-1a and other pertinent standards.
- Ensure that the calibration and testing of measurement apparatus complies with the commitments in the governing QA documents
Principal functions of the QA Organization
The principal duties and responsibilities of the Company’s QA organization are summarized below:
- Maintain a state-of-the-art and rigorously documented quality program with a comprehensive graded approach to quality
- Serve as the relentless invigilator of each project team to insure compliance of each contract’s quality provisions in the HGS produced documents such as drawings, procedures, specifications, reports, and purchase orders
- Audits and surveillance of sub-suppliers in the Company’s Approved Vendor List (AVL), ensuring that subcontractors and suppliers satisfy the criteria of 10 CFR 830.122.
- Oversight of quality-relevant procurement activities
- Oversight of manufacturers of Company-engineered equipment
- Manage a comprehensive Personnel training program.
- Continue programmatic and procedural enhancements gleaned from ongoing operations
- Manage lessons learned database and insure their incorporation in the Company’s operating procedures
- Review and approval of “permanent” records such as hardware and site services “document packages”
- QA Oversight of site construction activities
- Maintain a vigorous Corrective Action Program
- Oversight of Company’s Safety program
- Oversight of the Quality Control inspection organization
- Host visits by client and governmental inspection teams
- Present periodic “status of QA” report to the executive management; adopt measures to prevent organizational complacency
Project Execution Plan
The Project Execution Plan is the central organizing vehicle for executing a safety significant project in accordance with the HQAM. The HQAM requires that a Project Execution Plan be prepared for all safety significant projects by the Project team and reviewed/approved by the QA department before initiating any work on that project. The Project Execution Plan identifies the scope of work for the project and assigned responsibilities for all project participants. The Project Execution Plan also identifies any additional project-specific procedures that may be required to complete the scope of work. The Project Execution Plan references all documents applicable to the project that govern the technical requirements, QA protocols, and contractual commitments on the project. It defines the makeup of the project team, lists all hardware and software deliverables, names all Quality Procedures that are invoked in the project, and provides all necessary information on communications on the project. Public domain and Company proprietary computer codes that are to be used in the performance of the contract are also required to be identified in the Project Execution Plan. Finally, the Project Execution Plan also lists the quality requirements imposed on the Company and the subcontractors including project surveillance and audit activities, and long-term record retention.
The Project Manager is the custodian of the Project Execution Plan, and is solely responsible to maintain it on the company’s network for ready access to all project team members, and to ensure that the client has the latest revision. The primacy of the Project Execution Plan is a central element of quality implementation at HGS. The overriding objective of the Holtec QA program is to ensure that the systems, structures and components (SSCs) contracted by the Company meet their intended functional requirements in full compliance with applicable federal regulations.
The critical role of QA in the project’s life cycle
Control of the design function for safety significant projects is rigorously controlled under the Company’s QA Program which contains the measures necessary to assure the control of the design process from input data & specification through final design and its verification. A design basis is defined at the start of each project to identify the appropriate codes, standards and other relevant documents to be met by the design. Specifications, drawings, procedures, design analysis and test reports are the main documents produced during the design process. The QA program requires that all design reports include, as applicable, a defined purpose, assumptions, references, inputs, outputs and results. Design reports are subject to a multi-personnel reviews and approval regimen by the Project Manager. Each design report is verified by an individual or group of individuals other than the author of the report as part of the verification (checking) process. Verification may be made either by qualification testing, design review, or alternative calculations. Changes to any Holtec design document (e.g., specifications, drawings, design reports, etc.), must be reviewed and approved in the same manner and to the same standards as the original document.
Personnel Indoctrination, Training, Qualification, and Proficiency Testing
Holtec’s Personnel are required to receive extensive training related to their job assignments. Training requirements are defined within the Company’s QA procedures and standard procedures. Training consist of both QA indoctrination and process/job specific training. Training is conducted through a well-structured combination of classroom training, computer module based training and on the job (OJT) training. Proficiency or qualification testing is performed for QA indoctrination and certain process applications in order to assure individuals have gained the necessary knowledge related to the applicable content. QA refresher training is provided annually.
The program of continuous training is premised on the fact that the best-written QA documents are less than effective unless accompanied by vigorous training and surveillance. To achieve its indoctrination objectives, the Company employs a wide variety of classical and innovative tools to disseminate, implant, and uphold a quality culture in its professional organization. Conventional training means consist of periodic indoctrination sessions wherein members of the company’s QA group make formal presentations to the professional staff. The traditional training regimen is supplemented by frequent short QA written communication by the QA department on the company’s computer network wherein new enhancements, as well as subtle aspects of the company’s QA programs, are explained to the reader. Innovative indoctrination tools using by the company include network-based, password-protected electronic questionnaires that seek to gage a nuclear worker’s knowledge germane to his/her competence in a particular discipline or QA.
The Company’s QAP requires that all activities that are Safety Significant must be prescribed and accomplished in accordance with defined quality procedures. Methods for complying with the applicable quality criteria are also required to be described within defined procedures and to be recorded on quality records. Quality records are required include qualitative and quantitative acceptance criteria in order to verify that Safety Significant activities have been satisfactorily accomplished.
The QAP defines the methods to be employed in the transmittal and control of project documents and records requiring controlled distribution. All documents and records under the control of the QAP must be maintained to reflect current status. These documents and records include, but are not limited to, design documents, design changes, computer program software, procurement documents, quality program manuals, procedures, nonconformance reports, and drawings. An index of all quality records is maintained in the company’s databases. Current revisions of documents are required to be maintained and controlled so that obsolete or superseded documents are not used.
The Company’s QAP establishes review and approval requirements for all quality documents using a computerized protocol known as the Validation Identifier Record (VIR) method. The Validation Identification Record (VIR) method of documenting the reviews of drawings, reports, calculations, and other QA documents (hereafter referred to as “documents”) is a robust, regulatory-compliant, computerized protocol that eliminates many of the weaknesses in the manual signature-based method. For example, a document cannot receive a VIR number until all of the reviews of the document required by the QAP have been completed. Reviews are aided by an appropriate computerized checklist linked to the document being reviewed to ensure thoroughness of the review. A confidential password assigned to each individual is used to document completion of the review and concurrence that all comments have satisfactorily addressed. This method of documenting the review process assures that no safety-significant document is issued until all required reviews are completed, because the VIR number is not generated until all required electronic approvals are in place. A computerized record of the history of preparation and review of safety significant documents provides readily auditable documentation at the company’s headquarters or from a remote location.
Approved Vendors List
The process for qualification of vendors is defined within Holtec Quality Procedures. The Company maintains an active qualified list of material, parts, and service vendors with appropriate annotations as to their qualifications. To evaluate a candidate vendor, the Company’s QA department performs a source evaluation to determine if the proposed vendor’s QA program is adequate and properly implemented to perform the planned safety-significant activities. The level of evaluation is dependent on the safety significant category of the item or service provided by the vendor. As an example, a vendor who will provide an item or service to the highest safety significant category requires an on-site audit. Vendors who are satisfactorily evaluated are then placed on the Company’s Approved Vendors List (AVL). Evaluations are supplemented with additional surveillance activities and reviews as determined to be warranted for the item or activity. Re-evaluation of vendors is performed at prescribed intervals in order to assure the vendor may remain on the AVL.
Manufacturing activities are controlled through a traveler. The traveler identifies critical manufacturing steps along with all inspection and test steps. The traveler includes identification of the applicable controlling procedures and drawings for each activity and provides the vehicle for identification of third party hold and witness points. The traveler is the primary vehicle for determining the current status of a manufactured item or piece of equipment. Activities associated with the traveler package such as welding, inspection and testing are documented electronically in order to provide a direct link to the specific activity and to assure all applicable records associated with the specific activity are captured and controlled.
Welding and non-destructive examination are considered special processes which require that the procedures and personnel must be qualified. Weld procedures and welders are qualified in accordance with ASME Section IX. Holtec also has experience in qualifying weld procedures and welders to other Codes and standards when required by contract. Non-Destructive Examination personnel are qualified in accordance with ASNT-TC-1A.
Material/item traceability on safety significant materials/items is maintained from receipt of the raw material/item until completion of manufacturing such that the material/item installed in the final equipment can be traced back to applicable test and inspection results (i.e. CMTRS). During the course of manufacturing, traceability is maintained through markings or through data input into the traveler package.
Measuring and Test Equipment (M&TE) is calibrated in accordance with HQP 12.0 (Equipment Calibration and Control of M&TE) and applicable HSPs. M&TE is calibrated against certified equipment having known valid relationships to nationally recognized Standards (NIST). If no national Standard exists, then the basis of Calibration shall be developed by the Company and documented as appropriate.
Code Stamps and Certificates held by Holtec Entities
- Proven Quality Assurance Program (10CFR 50 certified QA Program, ISO 9001).
- Design Offices and Fabrication Facilities operate under the same QA Program.
- Holds all ASME Code stamps actively used in the industry (nuclear and non-nuclear).
- Regular industry and regulatory audits.
- Flexible controls and adaptable to international regulations.
Deviations, Non-Conformances, and Corrective Action
The Company’s Quality Procedures HQP 15.1 (Reporting of Defects and Non-Compliances per 10CFR21) and HQP 15.2 (Non-Conformances) implement the company’s quality commitments in respect of identification, evaluation, processing of deviations and non-conformances. HQP 16.0 (Corrective Action Program) and HQP 16.1 (Root Cause Evaluations) provide the requirements for implementation of the Company’s corrective action program. The Company’s QAP and procedures to identify, evaluate, and learn from non-conformances and conditions adverse to quality are premised on the universal fact that the discovery of an error (technical or procedural) with a potential for a significant adverse impact on quality must be a matter of profound concern to any quality conscious organization. Understanding the cause(s) (root or apparent as appropriate) of the error is a critical step in ensuring that the error will not be repeated.
Nonconforming conditions identified during manufacturing activities are appropriately controlled in order to assure the items are not processed further until appropriate dispositions have occurred and necessary corrective actions are taken. Nonconforming items are tagged to provide a visual status indicator.
The Company’s Corrective Action program contains provisions for addressing nonconforming conditions as well as significant conditions adverse to quality. An incremental approach to disposition quality problems ensures that the appropriate level of cause analysis and corrective action follow-up is implemented. For issues determined to be significant conditions adverse to quality, the appropriate measures to prevent recurrence are developed through root cause analysis. The Company’s Corrective Action program is contained in a searchable electronic database that is available to all Company personnel. This ensures visibility of QA issues and also facilitates easy maintenance, auditability and trending of QA related issues.
In the Company’s QA vernacular, any deviation from a governing document constitutes a reportable non-conformance. Thus, a proposed deviation from a client’s Design Specification is a non-conformance that requires remedial action as is a manufacturing operation that deviates from the specified process, drawing, or shop traveler (an ASME Code term).
The Corrective Action Request process is a prolific source of lessons learned for the company and its personnel. The lessons learned through the Corrective Action program are summarized and disseminated through the company’s network. These lessons also provide the grist for improving the training program and test plans. Every lesson learned is memorialized for future referenced through a network-based database.
The Company’s drive for perfection in performance is focused on improving the four essential ingredients that, in our view, constitute the four equally important pillars of excellence. They are:
- information infrastructure
- corporate culture
- training and human factors improvement
A solid information infrastructure is essential to ensure that the company personnel have access to the latest revisions of all company documents, that inadvertent use of superseded information is not possible and that the access to the needed information is extremely convenient. As described in the project management segment, the array of interconnected databases maintained on the company’s network provide 24/7 catalogued access to all QA, technical, and project material to all personnel through a password-controlled protocol.
The second component, namely, clarity and comprehensiveness of the procedures to which all company personnel must adhere in the conduct of their work is an obviously critical element in achieving literal compliance. The company maintains a sustained effort to improve the clarity and eliminate confusion in the verbiage of its operating procedures.
The corporate culture that promotes open communication, rewards merit, provides a supportive environment to help those who need help to excel and expects unimpeachable integrity from everyone provides a fertile soil for a first-rate quality assurance program to flourish. The Company’s corporate leadership attempts to suffuse the company with such a culture through example and through a clear articulation of the company’s mission and its code-of-conduct.
The last element – training – is equally vital. As we discuss above, the company maintains a varied and vigorous program for personnel training and certification.
Finally, recognizing that a stagnant QAP is not in compliance with the spirit of continuous improvement, Holtec International maintains a standing “Quality Initiatives Committee” whose sole function is to suggest systemic improvements in the company’s QAP and its implementation.
To ensure that both the letter and the spirit of the company’s quality program are faithfully followed in the execution of all safety significant projects, the Company follows a two-tier self-evaluation process.
The upper-tier evaluation is carried out by a qualified auditor (commissioned by the company’s Executive management) to perform a formal “management audit” of Holtec. This audit is performed at approximately one-year intervals, and is aimed to replicate an audit the company may be subjected to by any of its clients or a governmental entity.
In addition to the formal annual audits, the company’s QA organization conducts internal surveillance activities which evaluates implementation of the various Holtec processes such as procurement, design and manufacturing. The surveillances are performed using written checklists. Issues identified during these surveillances are documented within the Company’s corrective action program. These surveillances help inform the QA VP and executive management on the status of ongoing QA compliance in the Company.