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NASA NTRS2023

Next Steps Following Quality Management System Implementation

While Quality Management Systems (QMS) have become increasingly common in industry over the past twenty-five to thirty years, government has been slow to adopt. There are several reasons, including the fact that government is not as tightly focused on specific groups of products as is private industry, and therefore must adapt from a product realization focus to a mission realization focus. This article will present an approach for translating the production-oriented Quality Management Systems Standards, such as those included in ISO 9001, Quality management systems-Requirements and translating them to a mission realization approach. Once a mission approach is developed and understood, it will provide the needed greater clarity and a framework for an agency to implement a QMS. When the QMS is established and implemented, agencies can then take the next steps toward continual improvement. The graphic in Table 1 illustrates the ISO 9001 provisions and the corresponding mission-related concepts and definitions are included in Table 2.

Quality Management System↗
NASA NTRS2018

Government Quality Management Systems: Case Study from the Hawaii Missile Alert

The unfortunate Hawaii False Ballistic Missile Alert event on January 13, 2018 provides many examples of how a Quality Management System (QMS, e.g. ISO 9001 Quality Management Systems-Requirements) can be applied to government operations, and illustrates the need for existing quality standards to provide more clarity in their applicability to services. The event provides a valuable case study for those who ask the question: how do QMS systems and standards apply to government services? The following information is taken from the Hawaii Emergency Management Agency (EMA) investigation report.

Shepherd, Christena C.↗
NASA NTRS1996

IS0 9000 Implementation and Assessment: A Guide to Developing and Evaluating Quality Management Systems

The agency has developed this reference publication to aid NASA organizations and their suppliers in the transition to IS0 9000. This guide focuses on the standard s intent, clarifies its requirements, offers implementation examples and highlights interrelated areas. It can assist anyone developing or evaluating NASA or supplier quality management systems. The IS0 9000 standards contain the basic elements for managing those processes that affect an organization's ability to consistently meet customer requirements. IS0 9000 was developed through the International Organization for Standardization and has been adopted as the US. national standard. These standards define a flexible foundation for customer focused process measurement, management and improvement that is the hallmark of world class enterprises.

Navarro, Robert J.↗
NASA NTRS2004

Manufacturing Bms/Iso System Review

The Quality Management System (QMS) is one that recognizes the need to continuously change and improve an organization s products and services as determined by system feedback, and corresponding management decisions. The purpose of a Quality Management System is to minimize quality variability of an organization's products and services. The optimal Quality Management System balances the need for an organization to maintain flexibility in the products and services it provides with the need for providing the appropriate level of discipline and control over the processes used to provide them. The goal of a Quality Management System is to ensure the quality of the products and services while consistently (through minimizing quality variability) meeting or exceeding customer expectations. The GRC Business Management System (BMS) is the foundation of the Center's ISO 9001:2000 registered quality system. ISO 9001 is a quality system model developed by the International Organization for Standardization. BMS supports and promote the Glenn Research Center Quality Policy and wants to ensure the customer satisfaction while also meeting quality standards. My assignment during this summer is to examine the manufacturing processes used to develop research hardware, which in most cases are one of a kind hardware, made with non conventional equipment and materials. During this process of observation I will make a determination, based on my observations of the hardware development processes the best way to meet customer requirements and at the same time achieve the GRC quality standards. The purpose of my task is to review the manufacturing processes identifying opportunities in which to optimize the efficiency of the processes and establish a plan for implementation and continuous improvement.

Gomez, Yazmin↗
NASA NTRSDate not supplied

What Is the OPP Approach to the Next Generation of Laboratory Requirements

Planetary Protection Quality Management System NASA’s Office of Planetary Protection uses a quality-based process evaluation approach to verify planetary protection bioburden compliance over a project’s life cycle. The verification strategy shifts from a comparative direct assay approach validating hardware bioburden at a “moment in time,” to one that implements a continual quality assurance demonstration of the analytical process via established data requirements, laboratory operational, and management parameters throughout the mission’s entire assembly process. Laboratory quality-based systems and management strategies are standardized and implemented across government and industry. A standardized laboratory quality system approach increases transparency throughout the project’s life cycle and aligns planetary protection analytical approaches with government and industry practices to support both NASA and commercial endeavors. Strategies include the implementation of a laboratory quality management structure that documents and routinely validates parameters critical to experimental design and data collection, provides data quality assessment parameters, and ultimately validates that the collected data is of sufficient quality and quantity to meet the specified technical goals. Planetary protection can draw on these practices to provide a systematic process-based quality approach to support planetary protection validation and compliance requirements. Quality approaches including data quality objectives, method performance, data acceptance criteria and the associated laboratory quality management system are presented to provide an overview and framework for a planetary protection laboratory quality management system.

Amy Baker↗
NASA NTRS2016

Systems Engineering and Management Applications of ISO 9001:2015 for Government

The manufacturing segment of the business world is busy assessing the impact of ISO 9001:2015, and updating their management systems to meet the required compliance date. What does the new revision mean for government agencies that deliver large engineering projects rather than mass production? In fact, the standard, especially the new revision, can be used quite readily for government agencies, or applied to specific projects, once it is understood in terms of the similarities with systems engineering and project management. From there it can be extrapolated to "mission realization" systems, and a Quality Management System (QMS) is a logical result that can bring order to processes and systems that likely already exist in some fashion. ISO 9001:2015 is less product-oriented than previous versions. It can be more broadly applied to public organizations as well as private; and to services (missions) as well as products. The emphasis on risk management in the revised standard provides the needed balance for weighing decisions with respect to cost, schedule, technical, safety, and regulatory compliance; so if this is not part of agency governance already, this is a good place to start, especially for large engineering projects. The Systems Engineering standard used for this analysis is from NASA's NPR 7123.1 NASA Systems Engineering Processes and Requirements; however, those who are more familiar with ISO/IEC 26702 Systems Engineering-application and management of the systems engineering process, or SAE/EIA 632 Processes for Engineering a System will also recognize the similarities. In reality, the QMS outlined by ISO 9001 reinforces the systems engineering processes, and serves to ensure that they are adequately implemented, although most of the ISO 9001 literature emphasizes the production and process aspects of the standard. Rather than beginning with ISO 9001and getting lost in the vocabulary, it is useful to begin with the systems engineering lifecycle. Identification of stakeholder expectations, identifying solutions, creating specific product or service designs, production of the product or service, delivery to the public, and the associated management, planning, and control processes, are a familiar place to begin thinking of the overall system of identifying, designing, and competing a project or mission. Lining up this lifecycle with the ISO requirements (see Figure 1) illustrates how a quality management system is concerned with the same processes, and provides a governance and assurance function. If implemented properly, there are cost savings resulting from less rework, repair, reprocessing, failures, misplaced documents, and similar types of deficiencies1. Starting with an organization's systems engineering processes allows the organization to use their own terminology for a QMS plan, and tailor the plan to their own project or organization, so that it is more easily developed, understood, and implemented.

Shepherd, Christena C.↗
DOE OSTI2025

Package Testing Program Process for Validation and Verification of Software

The purpose of this document is to define the process for validation and verification (V&V) of software used to test the thermal data acquisition equipment in the Oak Ridge National Laboratory (ORNL) Package Testing Program (PTP) as part of the testing configuration(s). This process adheres to all applicable ORNL Standards Based Management System requirements and correlates with the PTP Quality Management System and the Software Quality Assurance Plan.

97 MATHEMATICS AND COMPUTING↗
NASA NTRS2015

Systems Engineering, Quality and Testing

AS9100 has little to say about how to apply a Quality Management System (QMS) to aerospace test programs. There is little in the quality engineering Body of Knowledge that applies to testing, unless it is nondestructive examination or some type of lab or bench testing. If one examines how the systems engineering processes are implemented throughout a test program; and how these processes can be mapped to AS9100, a number of areas for involvement of the quality professional are revealed.

Shepherd, Christena C.↗
NASA NTRS1992

Measuring quality progress

The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

Lambert, Larry D.↗
NASA NTRS2014

A Systems Engineering Approach to Quality Assurance for Aerospace Testing

On the surface, it appears that AS9100 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK) that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness. The Systems Engineering (SE) discipline is widely used in aerospace to ensure the progress from Stakeholder Expectations (the President, Congress, the taxpayers) to a successful, delivered product or service. Although this is well known, what is not well known is that these same SE processes are implemented in varying complexity, to prepare for and implement test projects that support research, development, verification and validation, qualification, and acceptance test projects. Although the test organization's terminology may vary from the SE terminology, and from one test service provider to another, the basic process is followed by successful, reliable testing organizations. For this analysis, NASA Procedural Requirements (NPR) 7123.1, NASA Systems Engineering Processes and Requirements is used to illustrate the SE processes that are used for major aerospace testing. Many of these processes are also implemented for smaller test projects, and this set of processes will also look familiar to those who have participated in launch site activation and flight demonstrations.

Shepherd, Christena C.↗
NASA NTRS2015

A Systems Engineering Approach to Quality Assurance for Aerospace Testing

On the surface, it appears that AS91001 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK)2 that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness.

Shepherd, Christena C.↗
NASA NTRS1993

Total Quality Management and the System Safety Secretary

The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

Quality Management System Safety Secretary↗
NASA NTRSDate not supplied

Contracting Quality Early in the Lifecycle Using AS9145 Data Deliverables

Development schedules and a highly dynamic supply chain are a challenge to developers of complex systems produced at low volume. Flaws in designs, parts and materials availability problems, poor manufacturability, and a lack of knowledge about critical items and key process attributes can be realized well before traditional second-party quality assurance activities begin. Supplier audits and product inspections may have little mitigating effect once these foundational problems have been realized. Their impacts can be significant lifecycle disruption, cost overruns, inability to deliver to plan, and even project cancellation. AS9145, Requirements for Advanced Product Quality Planning and Production Part Approval Process, can be used to drive quality engineering practices into early development lifecycles to significantly reduce this late-cycle risk and to reduce the cost of quality overall. Since its initial publication in 2016, it has had very limited adoption by the DoD, no adoption by NASA, and sparse adoption in the aerospace and defense supply chain. A task group within the Aerospace Industries Association's (AIA) Joint Strategic Quality Council (JSQC) identified that both acquirers and suppliers see as AS9145 as a cost-adder and are hesitant to use it as an alternative to late-stage-heavy quality assurance approaches. A lack of prior use creates large capability gaps in request-for-proposal (RFP) teams, proposal teams, suppliers’ quality management systems (QMS), and in experienced personnel executing the early lifecycle approach. To create a more realizable on-ramp for using AS9145 in the space and defense sectors, the AIA JSQC task team created five deliverable requirements descriptions (DRDs) that can be used in a contract to begin to engage both parties in early lifecycle quality engineering and quality assurance activities, that reduce exposure to late-stage cost and schedule collapse due to unidentified risks in design, supply chain, and manufacturability. These DRDs drive the parties to engage in planning and analysis discussions early on to understand what production risks can be known and how they will focus resources based on safety criticality and the key elements of design and construction. The suppliers and acquirers who will produce the data and information required by the DRD will be able to incrementally evolve their QMS and the acquirer will incrementally be able to track and understand the benefits of cost shifting from late to early development phases. A white paper describing this approach and the five recommended DRDs will be published by the AIA in late 2024 or early 2025.

Jeannette Plante↗
NASA NTRS2010

Conformance Testing: Measurement Decision Rules

The goal of a Quality Management System (QMS) as specified in ISO 9001 and AS9100 is to provide assurance to the customer that end products meet specifications. Measuring devices, often called measuring and test equipment (MTE), are used to provide the evidence of product conformity to specified requirements. Unfortunately, processes that employ MTE can become a weak link to the overall QMS if proper attention is not given to the measurement process design, capability, and implementation. Documented "decision rules" establish the requirements to ensure measurement processes provide the measurement data that supports the needs of the QMS. Measurement data are used to make the decisions that impact all areas of technology. Whether measurements support research, design, production, or maintenance, ensuring the data supports the decision is crucial. Measurement data quality can be critical to the resulting consequences of measurement-based decisions. Historically, most industries required simplistic, one-size-fits-all decision rules for measurements. One-size-fits-all rules in some cases are not rigorous enough to provide adequate measurement results, while in other cases are overly conservative and too costly to implement. Ideally, decision rules should be rigorous enough to match the criticality of the parameter being measured, while being flexible enough to be cost effective. The goal of a decision rule is to ensure that measurement processes provide data with a sufficient level of quality to support the decisions being made - no more, no less. This paper discusses the basic concepts of providing measurement-based evidence that end products meet specifications. Although relevant to all measurement-based conformance tests, the target audience is the MTE end-user, which is anyone using MTE other than calibration service providers. Topics include measurement fundamentals, the associated decision risks, verifying conformance to specifications, and basic measurement decisions rules.

Mimbs, Scott M.↗
NASA NTRS2008

Measurement Assurance for End-Item Users

The goal of a Quality Management System (QMS) as specified in ISO 9001 and AS9100 is to assure the end product meets specifications and customer requirements. Measuring devices, often called measuring and test equipments (MTE), provide the evidence of product conformity to the prescribed requirements. Therefore the processes which employ MTE can become a weak link to the overall QMS if proper attention is not given to development and execution of these processes. Traditionally, calibration of MTE is given more focus in industry standards and process control efforts than the equally important proper usage of the same equipment. It is a common complaint of calibration laboratory personnel that MTE users are only interested in "a sticker." If the QMS requires the MTE "to demonstrate conformity of the product," then the quality of the measurement process must be adequate for the task. This leads to an ad hoc definition; measurement assurance is a discipline that assures that all processes, activities, environments, standards, and procedures involved in making a measurement produce a result that can be rigorously evaluated for validity and accuracy. To evaluate that the existing measurement processes are providing an adequate level of quality to support the decisions based upon this measurement data, an understanding of measurement assurance basics is essential. This topic is complimentary to the calibration standard, ANSI/NCSL Z540.3-2006, which targets the calibration of MTE at the organizational level. This paper will discuss general measurement assurance when MTE is used to provide evidence of product conformity, therefore the target audience of this paper is end item users of MTE. A central focus of the paper will be the verification of tolerances and the associated risks, so calibration professionals may find the paper useful in communication with their customers, MTE users.

Mimbs, Scott M.↗
DOE OSTI2026

A Framework for Building Security into the Design Process

This report presents guidance to support the implementation of security objectives during the design process for nuclear facilities using an organization’s quality management system. The guidance in this document is intended for design vendors and operators of nuclear power facilities. Additionally, this guidance document can be beneficial to regulatory bodies, industry partners, customers, and other stakeholders within the nuclear power market. This report aims to ensure security consequences are identified before designs are completed, which may lead to reduced costs and higher security effectiveness and efficiency.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗