North Penn Business Park, 4500 North Cannon Ave. Lansdale, PA 19446, USA Tel No.: (267) 436-3991 Fax: (215) 362-5343 CRAIG MILLS: Email id: cmills@apantec.com Tel No.:267-436-4034 Monday, March 15, 2010 Apantec Partners with Fuji More Monday, November 24, 2008 Shin-Kori 3 & 4 complete RMS system award! More [-- BACK to About Apantec --] QUALITY ASSURANCE CONTROLS AND PROCEDURES Organization Quality Assurance Program Design Control Procurement Control Instructional Procedures and Drawings Control of Purchased Material, Equipment, and Services Identification and Control of Materials, Parts, and Components Control of Special Processes Inspection Test Control Control of Measuring and Test Equipment Handling, Storage, and Shipping Non-conforming Materials, Parts, or Components Quality Assurance Records DOCUMENTATION DRAWINGS MANUALS REPORTS 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. Organization 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. 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. Design 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. 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. 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.). 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. Identification and Control of Materials, Parts, and Components 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. Control of Special Processes Written procedures are established for the control of welding, painting, and soldering special processes. 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. Test 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. 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. 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. Non-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. 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. 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: DRAWINGS 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. MANUALS 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. REPORTS 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). [-- BACK to About Apantec --]   © 2009; Apantec,LLC. All Rights Reserved.