Quality Assurance – The activity of providing the evidence needed to establish confidence among all concerned that the quality function is being effectively performed. Dynamic planned quality systems designed with emphasis on prevention. Quality Assurance depends on tangible evidence of adequacy of such characteristics as capability, availability, reliability, operability, maintainability, durability, safety and cost.
Quality assurance demands a degree of detail in order to be fully implemented at every step. Planning, for example, could include investigation into the quality of the raw materials used in manufacturing, the actual assembly, or the inspection processes used. The Checking step could include customer feedback, surveys, or other marketing vehicles to determine if customer needs are being exceeded and why they are or are not. Acting could mean a total revision in the manufacturing process in order to correct a technical or cosmetic flaw.
Competition to provide specialized products and services results in breakthroughs as well as long-term growth and change. Quality assurance verifies that any customer offering, regardless if it is new or evolved, is produced and offered with the best possible materials, in the most comprehensive way, with the highest standards. The goal to exceed customer expectations in a measurable and accountable process is provided by Quality Assurance.
A QA/QC plan is a fundamental element of a QA/QC system, and it is good practice to develop one. The plan should, in general, outline QA/QC activities that will be implemented, and include a scheduled time frame that follows inventory preparation from its initial development through to final reporting in any year. It should contain an outline of the processes and schedule to review all source categories.
The QA/QC plan is an internal document to organize, plan, and implement QA/QC activities. Once developed, it can be referenced and used in subsequent inventory preparation, or modified as appropriate (i.e. when changes in processes occur or on advice of independent reviewers). This plan should be available for external review.
In developing and implementing the QA/QC plan, it may be useful to refer to the standards and guidelines published by the International Organization for Standardization (ISO), including the ISO 9000 series. If working in a Nuclear Facility you should reference ASME NQA-1, EPA QAMS-005/80 guidelines.
This Quality Assurance Program shall provide regulatory requirements for the successful completion of all projects. This Quality Assurance Program ensures compliance to technical and Quality requirements specified in Title 10 Code of Federal Regulations Part 50, (10CFR50) Appendix B, 10CFR830.122 and ASME NQA-1, EPA QAMS-005/80.
The following Quality Assurance Program is written to the requirements of the American Society of Mechanical Engineers (ASME) NQA-1c-1992, “ASME NQA-1989 EDITION-QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR NUCLEAR FACILITIES”, Code of Federal Regulations 10CFR830.122. In addition to the requirements of NQA-1, the requirements of Title 10 Code of Federal Regulations, Part 50, Appendix B. Additional requirements for this Quality Assurance Program can be found in the U.S. Environmental Protection Agency’s (EPA) QAMS-005/80, “interim Guidelines and Specifications for Preparing QA Project Plans”, which provides guidance for all data required to be provided to the EPA.
ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), that define, establish, and maintain an effective quality assurance system for manufacturing and service industries. The ISO 9000 standard is the most widely known and has perhaps had the most impact of the 13,000 standards published by the ISO. It serves many different industries and organizations as a guide to quality products, service, and management.
An organization can be ISO 9000-certified if it successfully follows the ISO 9000 standards for its industry. In order to be certified, the organization must submit to an examination by an outside assessor. The assessor interviews staff members to ensure that they understand their part in complying with the ISO 9000 standard, and the assessor examines the organization’s paperwork to ensure ISO 9000 compliance. The assessor then prepares a detailed report that describes the parts of the standard the organization missed. The organization then agrees to correct any problems within a specific time frame. When all problems are corrected, the organization can then be certified. Today, there are approximately 350,000 ISO 9000-certified organizations in over 150 countries.
Nuclear Quality Assurance Guidelines
The ASME NQA-1c was developed under procedures accredited as meeting the criteria of the American National Standards. In 1975, the American National Standards Institute (ANSI) assigned overall responsibility for coordination among technical societies, development and maintenance of nuclear power quality assurance standards to the American Society of Mechanical Engineers (ASME). The ASME Committee on Nuclear Quality Assurance was constituted on October 3, 1975, and began operating under the ASME Procedures for Nuclear Projects. Parallel with the development of ANSI/ASME NQA-1, American National Standards N46-2 Subcommittee, under the sponsorship of the American Institute of Chemical Engineers prepared Revision 1 to ANSI 46.2, “Quality Assurance Program Requirements for Post Reactor Nuclear Fuel Cycle Facilities”, which was issued as an American National Standard in 1978.
The Standard used for the development of this Quality Assurance Program is an integration of ANSI/ASME NQA-1 and ANSI N46.2, Revision 1.The requirements of the AMSE NQA-1 apply to activities, which could affect the quality of structures, systems, and components of nuclear facilities. Nuclear facilities include facilities for power generation, spent fuel storage, waste storage, fuel reprocessing and plutonium processing and fuel fabrication.