Quality Assurance Controls and Procedures

The Quality Assurance Program established by APANTEC, LLC assures that the required effort, equipment, procedures, and management are directed toward activities necessary to satisfy the quality objectives of furnishing safe and reliable radiation monitoring systems, equipment, and components. The Quality Assurance Program is structured for compliance in accordance 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, Federal Government Specifications and Standards CAN3-Z299.3-85, CAN3-Z286.2-86, CAN/CSA-Q396.1.1-89 and CAN/CSAQ396.1.2- 89. All systems will be controlled by the Quality Assurance Program.

• keyboard_arrow_downOrganization
  APANTEC, LLC delineates 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 to the President.
• keyboard_arrow_down Quality Assurance Program
  The Quality Assurance Program is defined and documented by the policies and procedures set forth in the Q. A. Manual. This program covers those services APANTEC, LLC is prepared to provide a client under the auspices of its own Quality Assurance Program criteria and specific requirements associated with these criteria have been adapted to APANTEC, LLC's individual project activities through the Q. A. Program. Controlled copies of the Q. A. Manual are identified with an assigned copy number and maintained by transmittals of revisions, additions, and deletions.
• keyboard_arrow_downDesign Control
  APANTEC, LLC design control defines the mechanism ensuring that applicable regulatory requirements, customer specifications, and quality assurance requirements are correctly reflected in corporate specifications, drawings, procedures, and instructions.
• keyboard_arrow_down Procurement Control
  APANTEC, LLC's Quality Assurance Manager reviews all procurement documentation applicable to quality related items and services to assure inclusion of suppliers to have Q. A. programs consistent with pertinent sections of 10CFR50, Appendix "B", ANSI/ASME N45.2, and NQA-1. The suppliers of Q. A. program will be reviewed during the vendor qualification/audit process.
• keyboard_arrow_down Instructional Procedures and Drawings
  Corporate Quality Assurance Procedures are generic procedures delineating instructions, supplementing the Q. A. Manual sections to accomplish specific quality-related activities (e.g., procurement, document control, record storage, etc.).
• keyboard_arrow_down Control of Purchased Material, Equipment, and Services
  Vendor QA pre-award surveys, where applicable, are conducted to verify the existence of systems, procedures, and equipment which are adequate to assure products and services in accordance with APANTEC, LLC and APANTEC, LLC's customer's standards of quality.
• keyboard_arrow_down Identification and Control of Materials, Parts, and Components
  keyboard_arrow_down The Quality Assurance Form is used when material is found to be acceptable to the receiving Inspection Department and the material is placed in the accepted material of the stockroom.
• keyboard_arrow_down Control of Special Processes
  Written procedures are established for the control of welding, painting, and soldering special processes.
• keyboard_arrow_down Inspection
  Inspections are performed by personnel assigned to the Quality Control Department, who have been trained in the areas of assigned inspection and are independent of production pressures. The inspector is a person other than the person who performed the activity being inspected.
• keyboard_arrow_downTest Control
  The Quality Control and Test Department Managers review and concur with all Q. C. test procedures and their revisions. The preparation of test procedures is the responsibility of the cognizant engineer, who ensures that all applicable specification and contractual requirements are incorporated.
• keyboard_arrow_down Control of Measuring and Test Equipment
  Applicable procedures for all mechanical and electrical measuring and testing equipment used at APANTEC, LLC are controlled by the Q. A. Department to assure that purchased supplies and manufactured products conform to technical requirements.
• keyboard_arrow_down Handling, Storage, and Shipping
  Packaging and preparation for shipment of applicable products are verified by Quality Control to assure that shipping documents are properly completed.
• keyboard_arrow_down Quality Assurance Records
  Quality Assurance records are retained as outlined in the Q. A. manual. The retention duration of Quality Assurance records is as stated in the customer's contracts or as defined in NQA-1-1983. Permanent and non-permanent Q. A. records are stored in containers having controlled access.
• keyboard_arrow_downNon-conforming Materials, Parts, or Components
  Corporate internal QA procedures define methods for controlling the identification, segregation and disposition of the non-conforming material and assures corrective action is taken for conditions adverse to quality as identified, which include action taken to prevent recurrence.

Documentation

All documentation will be submitted in accordance with requirements stipulated in the inquiry and accompanying specifications. As a minimum, documentation will include the following.

• keyboard_arrow_downDrawings
  Drawings will 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 will be supplied as specified.
• keyboard_arrow_downManuals
  Copies of the Operation and Maintenance Manual will be provided with the system. The manual will include information on installation, operation, maintenance, and calibration of the system, as well as drawings detailing assemblies and schematics.
• keyboard_arrow_downReports
  Detailed calibration reports as well as test data on system components will be provided. All required documentation will be legible and of microfilm quality and meet the requirements of the inquiry. Support documentation will be retained for the life of the plant or if disposition of said documentation is desired, the Buyer will be notified to determine resolution.

The final data package will include, but not be limited to:

• Certificate of Conformance to the Purchase Order
• Factory Test Reports
• Mechanical and electrical equipment installation drawings and manuals including: dimensional outline drawings, recommended mounting techniques, wiring, powering and grounding instructions and drawings, etc.
• Major manufacturing drawings for the monitor, including assembly drawings, electrical schematics, wiring diagrams and detailed Bills of Material.
• Drawings and technical data sheets of subassemblies, components, devices, appurtenances, and fittings that are part of the final assembly of the monitor.
• Complete calibration procedures and results for detectors with results traceable to the National Bureau of Standards and Technology (NIST).