ASME NQA.TR pdf download Evolution of Quality Assurance Principles and Requirements in the U.S. Nuclear Industry
Whereas previous DOE quality assurance directives were applied onlyto contractors, DOE O 5700.6C required both the DOE and contractor organizational elements to develop and implement quality assurance programs that complied with the ten criteria. Attachment 1 to DOE O 5700.6C provided guidance for developing and implementing quality assurance programs to satisfy the ten quality assurance criteria. DOE national laboratories and contractors were required to prepare and submit for DOE evaluation and approval a quality assurance program to describe how each organization would comply with the applicable criteria of DOE O 5700.6C. Where an organization was notin compli- ance,animplementationplanwasrequiredtodescribethe actions and schedules for achieving compliance.
1.5.3 DOE O 414.1 and DOE O 414.1A 7 In November 1998, DOE issued a new draft quality assurance directive, DOE O 414.1, for review and comment. The new Order superseded DOE O 5700.6C. It redefined the scope in conjunction with the new DOE Nuclear Safety Management Rule 10 C.F.R. 830 and § 830.120 and § 830.122. The Order applied to both DOE and contractor organizations.
DOE O 414.1 andDOE O 414.1Aweredevelopedincoor- dination with the DOE-chartered Quality Assurance Topical Standards Committee (QA TOPCOM) and the Quality and Safety Management Special Interest Group (QSMSIG). These committees provided an avenue for DOE to gatherbroadinputfromnationalandinternational standards bodies, standards users, and users of the DOE Order and Guides; DOE charted these committees, which were composed of representatives of DOE, national laboratories, and contractors with expertise in quality assurance, assessments, and management. The QMSIG has since been disbanded. Attachment1 ofDOEO414.1Awasacontractorrequire- ments document (CRD) that included all of the general qualityassurance requirements and the ten qualityassur- ancecriteria. Forexample, theCRD requiredsubmittalofa contractor’s quality assurance program document to a designated DOE official for approval. The CRD was devel- oped by DOE for attachment to all of its Orders and is intended to be a stand-alone document suitable for use directly in a contract. As such, it does notinclude sections from the Order that apply only to federal organizations (e.g., DOE headquarters and field office responsibilities).
Attachment2 ofDOE O 414.1Acontained supplemental quality improvement requirements for corrective action plans for significant safety issues resulting from DOE Office of Oversight reports and other issues as specified by the Secretary of Energy. This new Corrective Action Management Program was developed in response to the Defense Nuclear Facilities Safety Board (DNFSB) Recommendation 98-1. General guidance on implementation of DOE O 414.1A was published in DOE G 414.1-2. This superseded the original guidance in Attachment 1 to DOE O 5700.6C.
1.5.4 DOE O 414.1B DOE O 414.1B superseded DOE O 414.1A. Its purpose was to ensure thatDOE NNSA products and services meet orexceed customerexpectations. This objective was to be achieved based on the following principles:
(a) Quality is assured and maintained by a single, integrated,effectivequalityassuranceprogram,i.e.,amanage- ment system.
(b) Management support for planning, organization, resources, direction, and control are essential to quality assurance.
(c) Performance and quality improvement require thorough, rigorous assessment and corrective action.
(d) Workers are responsible for achieving and main- taining quality.
(e) Environmental safety and health risks and impacts associated with work processes can be minimized while maintaining reliability and performance ofwork product. DOE O 414.1B requirements applied to NNSA and contractor organizations, except for NNSA Naval Reactor Programs. The Order referenced ASME NQA-1– 2000 for nuclear-related activities and ANSI/ASQ Q 9001:2000 for non-nuclear activities. Thus, a DOE contractor’s quality assurance program was (and is still) expected to use the appropriate American national or international consensus standard, where practicable and consistent with contractual and regulatory require- ments. Attachments 1 and 2 contained essentially the same ten basic quality assurance criteria taken from the superseded DOE O 5700.6C and DOE O 414.1A for DOE and contractor organizations, respectively;
Attach- ment 3 described the DOE-wide process for controlling suspect/counterfeit items (S/CI).
The Order updated S/CI requirements based on field experience and was supported by a new guide, DOE G 414.1-3, for controlling S/CI.
1.5.5 DOE Rule 10 C.F.R. 830 The Price Anderson Amendment Act (PAAA) of 1988 amended the Atomic Energy Act of 1954 by providing broad, mandatory indemnification coverage to all persons, including DOE contractors, subcontractors, and suppliers, whose activities as related to DOE nuclear facilities might result in public liability claims under the PAAA.