Customer Input Research Articles

Clinical and regulatory perspectives on general/safety pharmacology tests: Results of a pharmaceutical industry survey

AbstractGeneral/safety pharmacology is an emerging discipline within the pharmaceutical industry in which unanticipated effects of new drug candidates on major organ function (i.e., secondary pharmacological effects) are critically assessed in a variety of animal models. A survey was conducted to obtain customer input on the role and strategies of this emerging discipline. Four surveys were distributed to each of 30 U.S. pharmaceutical companies. Two surveys went to individuals within the regulatory department, and two went to individuals within the clinical department of each company. All responses were returned anonymously to the survey authors. Sixty‐six responses from at least 19 different companies were obtained. The responses from the clinical and regulatory departments were essentially the same and led to the following conclusions: (1) Major organ functions are monitored routinely in clinical trials to assess potential adverse drug effects; (2) major organ function studies are considered an essential part of non‐clinical drug safety testing; (3) respiratory, gastrointestinal, autonomic, and endocrine evaluations are considered an important part of major organ function studies, whereas cardiovascular, renal and central nervous evaluations are considered essential; (4) non‐clinical testing of these major organ functions should be conducted early in drug development, preferably before initiation of clinical trials; and (5) organ function investigations involving mechanisms of secondary pharmacological effects or drug interaction are considered an important part of general/safety pharmacology testing. © 1995 Wiley‐Liss, Inc.

QUALITY MANAGEMENT FOR SERVICES: ISSUES IN USING CUSTOMER INPUT

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Lessons learned outfitting the U.S. Coast Guard with oil pollution equipment

Lessons learned procuring U.S.$30 500 000 of oil pollution recovery equipment for the United States Coast Guard (USCG) in response to requirements of the Oil Pollution Act of 1990 (OPA-90) are presented. A generic requirements analysis and a selection process useful for making equipment acquisitions and staging site selections are described. Response mission, oil spill threat, response area peculiarities, available resources, equipment capabilities, training requirements and life cycle costs are all factors which must be carefully considered in outfitting a response organization. A method to ensure you obtain quality equipment which meets your functional requirements is outlined. Long range concerns about logistics support, training and maintenance are also important considerations. Leveraging existing resources such as existing USCG vessels, commercial vessels available on short notice for lease and the original oil response equipment inventory of the two USCG Strike Teams proved to be extremely cost effective. Selection of a vessel of opportunity skimming system (VOSS) and outfitting replacement offshore buoy tenders with an on-board spilled oil recovery system (SORS) eliminated the costly option of procuring dedicated pollution response vessels which are generally underutilized as a single mission platform. A first article field and factory acceptance testing program ensured all equipment functioned as specified, eliminating costly errors. This process also provided valuable customer input and significant equipment improvements before production started. Quality assurance testing and Government oversight ensured production units were fabricated properly with specified materials identical to the approved first articles adding reliability to the entire delivered system. Staging equipment at three Strike Teams and 19 sites near existing Coast Guard buoy tenders best used the available personnel and vessel resources adjacent to primary oil spill threat areas.

Customer focus: obtaining customer input

The overall emphasis of Total Quality Management is on making a product or service match the requirements of its customers. Therefore the service provider must find ways to obtain information regarding both customer needs, and their perception of the current level of performance. Given the limited resources available to information services, it is also important to determine priorities for action by identifying those issues that need improvement and that customers see as being important.This article describes the three main, formal methods used by Telecom Australia's National Information Resource Centre to obtain customer input and to regularly review its products and services.

Performance Based Evaluation Systems Under Total Quality Management

Many firms are moving toward closer relationships with key suppliers to support total quality management (TQM) and just‐in‐time (JIT) systems. Because these systems dictate closer working relationships with suppliers, supplier evaluation systems will also undergo changes. This article focuses on these changes.Evaluation systems under TQM/JIT must be broader in scope and oriented toward proactive problem solving and continuous improvement. They will be characterized by short‐ and long‐term improvements jointly selected by both parties.These propositions are supported by a case study at a large corporation that successfully implemented TQM/JIT. Results indicate that the firm improved its supplier evaluation and selection process. These improvements led to increased customer satisfaction and lower costs. Improvements realized in the evaluation process were accomplished through the increased use of data, customer and supplier input, and feedback from the purchaser. Finally, the case study reviews the broader evaluation measures used in a TQM/JIT system.

Screening new products for potential winners

New product success is predictable. This paper highlights the findings of an extensive study into new product success and failure, and pinpoints what separates winners from losers. The key success factors are: product superiority—delivering unique benefits to customers, upfront homework—before development gets underway, sharp and early product definition, a strong market orientation with constant customer contact and input, and quality of execution of key activities in new product process. Sadly many firms and new product efforts are lacking on these success factors. This points to the need for a more disciplined approach to product development. One solution proposed is the implementation of a stage-gate or formal new product process—a blueprint for the process from idea to launch. A generic stage-gate is outlined in the article. The experiences of managers in firms which have implemented such processes are investigated, and the performance results are positive: improved teamwork, less recycle, higher success rates and shorter cycle times.

Boeing 777 high lift control system

The Boeing 777 high lift control systems (HLCS), a state-of-the-art microprocessor-based system that provides fly-by-wire control, protection, and built-in-test and maintenance access functions for the leading edge slats and trailing edge flaps drive and actuation systems, is discussed. This system is designed to take advantage of technologically proven concepts as well as judicious application of new concepts in response to market demands, airline customer input, and a thorough review of lessons learned from previous aircraft programs. The purpose of the HLCS, the wing high lift devices it controls, the HLCS components, its three modes of operation, automatic functions, and system failure protections are described. The use of the EASY5 engineering analysis program developed by the Boeing Company to model dynamic systems in both the time and frequency domains for modeling mechanical and hydraulic portions of the high lift system is discussed. >

Applying robotic technology to aid people with severe disabilities.

Researchers at Rice University and the Baylor College of Medicine in Houston have developed a prototype robotic aid for people with severe disabilities, with emphasis on low cost, versatility, and ease of use. Using custom software written for the Macintosh¿ line of personal computers and a custom input device that emulates a mouse, a user can command a modified HERO 2000¿ robot to perform simple fetch and carry tasks in a structured indoor environment. Further interaction with the environment is possible using a household appliance controller that is also interfaced to the computer.

Total Quality Management in American Industry

The definition of total quality management is conformance to customer requirements and specifications, fitness for use, buyer satisfaction, and value at an affordable price. The three individuals who have developed the total quality management concepts in the United States are W.E. Deming, J.M. Juran, and Philip Crosby. The universal principles of total quality management are (a) a customer focus, (b) management commitment, (c) training, (d) process capability and control, and (e) measurement through quality improvement tools. Results from the National Demonstration Project on Quality Improvement in Health Care showed the principles of total quality management could be applied to healthcare.

The 5ESS® Switch U.S. Market Front End Process

The 5ESS® switch U.S. market front end process (FEP) is a new method AT&T uses to work in partnership with its customers during the early stages of new product planning and development. The FEP is a disciplined approach to evaluating new product or service opportunities, and ensures that development and deployment resources are allocated to the best available opportunities for AT&T and the local exchange carriers (LECs). Customer input and feedback is emphasized throughout the FEP. The process gives management the basis to make informed decisions about the products and services AT&T offers its customers, and improves the company's responsiveness to those customers by decreasing time to market, and by improving customer satisfaction with the new features and services offered.

Don't let your customers lead you astray in developing new products

Axel Johne shows that there are risks associated with close working with existing customers. Despite their importance, customer inputs are only one of several factors which contribute towards long-term product development success. Efficient networking with customers can be useful, but requires skilful management within a wider business context, especially when competing internationally.

A Dynamic Model for Continuous Improvement in the Management of Service Quality

Quality is increasingly becoming the key determinant of demand for goods and services. Managerial philosophy and perceptions shape the overall corporate attitude towards quality and define the parameters for its role as a determinant of competitiveness and performance. Quality of services is defined and determined primarily by individual customers through their perceived delivery of service attributes expected. Customer input and feedback is essential for bridging the gap between the perceptions of management and those of the customers, as they view service quality. It is only the mutual synchronization of perceptions that ensures high quality. This article discusses important limitations of contemporary methods in use for the control of quality in services. It models a system and provides a complete and effective quality management framework. The proposed model is dynamic, flexible and utilizes information gathered through an unbroken chain of customer input and feedback in ensuring competitiveness through continuous improvement. Contributions of the model are also listed.

Development and implementation of an agricultural load management project: a case study

A direct-control load management project for agricultural irrigation pumps has been developed at Pacific Gas & Electric Company. Pacific Gas & Electric Company has 540 accounts representing >15 MW of connected load on this management project. Preliminary estimates predict that approximately 20% of this loan is available for interruption during peak demand days. The design of this rate option, which is a form of dispatchable time-of-use, has relied heavily on customer input from the project's pilot phase in 1983-85. In addition, the project has been greatly influenced by political special-interest groups. It is concluded that improved marketing methods increased the sales rate by more than 100% from 1985 to 1987, demonstrating that demand-side management projects must be sold much like other products offered in an open market.< <ETX xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">&gt;</ETX>

Interconnection Protocols for Interorganization Networks

This paper analyzes the technical implications of interconnecting networks across organization boundaries. Such Interorganizational Networks (ION's) are used increasingly to support exchange of CAD/CAM data between manufacturers and subcontractors, software distribution from vendors to users, customer input to suppliers' orderentry systems, and the shared use of expensive computational resources by research laboratories, as examples. We begin by demonstrating that interorganization connections are not satisfied by traditional network design criteria of connectivity and transparency. A primary high-level requirement is access control, and therefore, participating organizations must be able to limit connectivity and make network boundaries visible. We summarize an approach to access control in ION's, based on nondiscretionary control, that allows interconnecting organizations to combine gateway, network, and system-level mechanisms to enforce cross-boundary control over invocation and information flow while minimizing interference with internal operations [6], [4]. The focus of this paper is on the underlying interconnection protocols that are needed to support these access control mechanisms. We describe in detail a particular protocol, called a visa scheme [7]. The visa scheme uses access control servers to authorize a session request and visas to authenticate that successive packets belong to the authorized connection. Control is distributed among the ION participants and each may make its own design tradeoffs between performance and trust. In order to support interorganization communication two (or more) organizations must be able to communicate with one another's access control servers and their respective packet-level gateways and nodes (source/destination) must implement the visa scheme. The security of the proposed mechanism varies according to the security of an organization's components (access control server, gateway, and select hosts) and the encryption function used. The visa scheme's purpose is to allow an organization to modify and trust only those internal systems that require ION access; all other internal systems are inaccessible from and to the ION gateway. We conclude by comparing and contrasting the visa approach to the use of higher level gateways.

Inter-organization networks: implications of access control: requirements for interconnection protocol

When two or more distinct organizations interconnect their internal computer networks they form an Inter-Organization Network(ION) . IONs support the exchange of cad/cam data between manufacturers and subcontractors, software distribution from vendors to users, customer input to suppliers' order-entry systems, and the shared use of expensive computational resources by research laboratories, as examples. This paper analyzes the technical implications of interconnecting networks across organization boundaries. After analyzing the organization context in which IONs are used, we demonstrate that such interconnections are not satisfied by traditional network design criteria of connectivity and transparency. To the contrary, a primary high-level requirement is access control, and participating organizations must be able to limit connectivity and make network boundaries visible. We describe a scheme based on non-discretionary control which allows interconnecting organizations to combine gateway, network, and system-level mechanisms to enforce cross-boundary control over invocation and information flow, while minimizing interference with internal operations. Access control requirements such as these impose new requirements on the underlying interconnection protocols. We demonstrate such alternative interconnection protocols that support loose coupling across administrative boundaries and that accommodate the necessary control mechanisms. Message-based gateways that support non-real-time invocation of services (e.g., file and print servers, financial transactions, VLSI design tools, etc.) are a promising basis for such loose couplings.

Imaging X-ray spectrometer : Patrick A Grant, John W Jackson, George Alcorn, Francis Marshall assigned to The United States of America as represented by the Administrator of the National Aeronautics and Space Administration

Protein switches are ubiquitous in biological signal transduction systems, enabling cells to sense and respond to a variety of molecular queues in a rapid, specific, and integrated fashion. Analogously, tailor-engineered protein switches with custom input and output functions have become invaluable research tools for reporting on distinct physiological states and actuating molecular functions in real time and in situ. Here, we analyze recent progress in constructing protein-based switches while assessing their potential in the assembly of defined signaling motifs. We anticipate such systems will ultimately pave the way towards a new generation of molecular diagnostics and facilitate the construction of artificial signaling systems that operate in parallel to the signaling machinery of a host cell for applications in synthetic biology.

Demand Bus System for Tsukuba Science City and its Simulation Study

A demand bus system for Tsukuba Science City is considered with simulation. The demand bus system is fully computerized. Customers input demands at bus stops, and buses receive allocating information from bus stops by weak wave, which is computed based on demands in a control center. Between bus stops and the center information is transmitted through telephone lines. Simulation is conducted by tracing events in the system - demand generation, bus allocation to demands and pickup and delivery of passengers - at each discretized time. The heuristic algorithm for bus allocation to demands is applied, and a new type of a performance index for bus allocation is proposed to optimize the system. Relations of parameters (number of demands and number of buses) and system characteristics (customers’ level of service, wait time and so on) under steady state are obtained. The results obtained with bus capacity and upper limits on level of service and wait time give basic data for design of the system. Validity of the demand bus system in Tsukuba Science City is shown by comparison with an optimized fixed-route bus system.

Evolving microprocessors which better meet the needs of automotive electronics

The rather explosive historical progress being made in large-scale integration of semiconductor elements is moving faster than the two or three years lead time needed in the automotive industry to move a new idea into production. By presenting a forecast of what can be done soon at a developmental level, both at the automotive electronic-control level and at the LSI microcomputer single-chip development level, the writer hopes that the next generation of automotive electronics in the early 1980's can be started with a clear picture of the calculated risk-taking involved. Topics discussed are the need for custom microprocessors, input and output information rates, and applications to engine control and instrument panel display control, including the concept of satellite assemblies which exchange information available at remote locations.