Qualified to 10CFR50 Appendix B and audited by NUPIC — a safety-grade program backed by decades of nuclear-industry experience.
The Quality Assurance Program established by APANTEC, LLC ensures that the required effort, equipment, procedures, and management are directed toward delivering safe and reliable radiation monitoring systems, equipment, and components. The program is structured for compliance with the 18 criteria of 10CFR50 Appendix B, ANSI/ASME N45.2-1977, ANSI/ASME NQA-1 (1989 Edition through NQA-1C-1992 Addenda), NQA-2 (1989 Edition through NQA-2B Addenda), and Federal Government Specifications and Standards CAN3-Z299.3-85, CAN3-Z286.2-86, CAN/CSA-Q396.1.1-89, and CAN/CSA-Q396.1.2-89. All systems are controlled by the Quality Assurance Program.
APANTEC defines the relationship between the President and the management organization. The Quality Assurance Program is administered by the Quality Assurance Manager (QAM), who is appointed by and reports directly to the President.
The Quality Assurance Program is defined and documented through the policies and procedures set forth in the QA Manual. The program covers all services APANTEC provides under its own QA criteria, with project-specific requirements adapted into individual project activities. Controlled copies of the QA Manual are identified by assigned copy number and maintained through transmittals of revisions, additions, and deletions.
APANTEC's design control mechanism ensures that applicable regulatory requirements, customer specifications, and quality assurance requirements are correctly reflected in corporate specifications, drawings, procedures, and instructions.
The QA Manager reviews all procurement documentation for quality-related items and services to confirm that suppliers maintain QA programs consistent with the relevant sections of 10CFR50 Appendix B, ANSI/ASME N45.2, and NQA-1. Supplier QA programs are evaluated during the vendor qualification and audit process.
Corporate Quality Assurance Procedures are generic procedures that supplement the QA Manual with detailed instructions for performing specific quality-related activities — including procurement, document control, and record storage.
Where applicable, vendor QA pre-award surveys are conducted to verify that the supplier's systems, procedures, and equipment can deliver products and services that meet APANTEC's and the customer's standards of quality.
The Quality Assurance Form is used when material is found acceptable by the Receiving Inspection Department, and the material is then placed in the accepted-material section of the stockroom.
Written procedures are established for the control of welding, painting, and soldering as special processes.
Inspections are performed by personnel assigned to the Quality Control Department who are trained for their specific inspection areas and remain independent of production pressures. Inspectors are always different from the personnel who performed the activity being inspected.
The Quality Control and Test Department Managers review and concur with all QC test procedures and revisions. Test procedures are prepared by the cognizant engineer, who ensures that all applicable specifications and contractual requirements are incorporated.
All mechanical and electrical measuring and test equipment used at APANTEC is controlled by the QA Department through documented procedures to ensure that purchased supplies and manufactured products conform to technical requirements.
Packaging and shipment preparation of applicable products are verified by Quality Control to ensure that all shipping documentation is properly completed.
Quality Assurance records are retained as outlined in the QA Manual. Retention duration is governed by customer contracts or by NQA-1-1983. Both permanent and non-permanent QA records are stored in containers with controlled access.
Internal QA procedures define methods for identifying, segregating, and dispositioning non-conforming materials, and ensure that corrective action is taken for any conditions adverse to quality — including measures to prevent recurrence.
All documentation is submitted in accordance with the requirements stipulated in the inquiry and accompanying specifications. At a minimum, documentation includes the following.
Drawings include dimensional outline and installation drawings as well as electrical interfacing information. Detailed wiring schematics and assembly documentation are provided in the Operation and Maintenance Manual. Reproducible drawings are supplied as specified.
An Operation and Maintenance Manual is supplied with each system. The manual covers installation, operation, maintenance, and calibration, and includes assembly and schematic drawings.
Detailed calibration reports and test data on system components are provided. All required documentation is legible, of microfilm quality, and meets the requirements of the inquiry. Support documentation is retained for the life of the plant; if alternative disposition is desired, the buyer is notified to determine resolution.
The final data package includes, but is not limited to: