Manufacturing based definition of quality

    • Quality: American, Japanese, and Soviet Perspectives - JSTOR

      manufacturing-based, and value-based. These approaches are summarized in Table 1.2 These five perspectives highlight distinctive aspects of the quality issue. The transcendent approach points out that quality is difficult to define, yet flawless and universally identifiable. Pirsig expressed the transcendent definition of quality in

    • [PDF File]Investigating the Impact of Standards-Based Interoperability for ... - NIST

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      Investigating the Impact of Standards-Based Interoperability for Design to Manufacturing and Quality iv Executive Summary To achieve the industry vision of a Model-Based Enterprise (MBE), the MBE strategy must include model-centric data interoperability for design to manufacturing and quality in the supply chain. Even

    • Quality Considerations for Continuous Manufacturing Guidance for Industry

      67 manufacturing is an emerging technology that can enable pharmaceutical modernization and 68 deliver potential benefits to both industry and patients. Continuous manufacturing can improve

    • Microbiological Quality Considerations in Non-sterile Drug Manufacturing

      Silver Sprnig M, D 20993 -0002 Phone: 855-543-3784 or 301 -796-3400; Fax: 301 -431-6353

    • ASME Based Enterprise Standards Development - NIST

      4/13/2021 1 ASME Model‐Based Enterprise Standards Development Rev: 04.13.2021 1 By Fredric Constantino ASME Model‐Based Enterprise (MBE) Charter: Develop standards or related products that provide rules, guidance, and examples for the creation, use and reuse of model‐based datasets, data models, and related topics within a Model‐Based Enterprise.

    • [PDF File]Regulatory and Quality Considerations of Continuous Manufacturing

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      The definition of a batch must be stated. Although each continuous process has unique considerations, one may consider a batch definition based on quantity manufactured or duration of the process. In-process controls (IPCs) and sampling considerations will be different. For example,

    • [PDF File]Digital Product Definition - Boeing Suppliers

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      Rapid change of equipment capabilities requires changing quality control practices. Guide questions/examples are not necessarily applicable to each supplier’s manufacturing process. Definitions Authority Dataset This is the engineering definition provided in a 3D representation of the product, viewable on a Computer Aided Design (CAD) system. In

    • [PDF File]IMPROVE QUALITY, REDUCE COSTS, AND INCREASE EFFICIENCY WITH MODEL-BASED ...

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      Improve Quality, Reduce Costs, and Increase Efficiency with Model-Based Definition 2. First deployed in the aerospace and automotive industries—and by some forward-looking manufacturers like those featured in this paper—MBD is an idea whose time has come for all manufacturing companies seeking a competitive advantage.

    • [PDF File]What Is Manufacturing? Why Does the Definition Matter? - NIST

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      manufacturing activities such as molding, cutting, and assembly. These laws establish a variety of potential benefits, preferences, or penalties based on the country in which physical transformation occurs. By and large, federal supports targeted specifically at manufacturing rest on two implicit premises

    • A Quality Definition Continuum - JSTOR

      Manufacturing-Based Quality Since concern for product quality devel oped in the manufacturing function, early Subjective Internal Manufacturing-based Transcendent User-based Value-based External Objective Figure 1: We plotted each definition of quality on the two dimensions of internal to external and objective to subjective. INTERFACES 26:3 108

    • Defining Quality: Alternatives and Implications - JSTOR

      gued that a conformance-to-specifications definition of quality failed to address the unique characteristics of services. An important catalyst for the widespread movement away from conformance to specifications and toward a consumer-based definition of quality was the increasingly im-portant role played by services in the U.S. and other ...

    • [PDF File]Lean Terms and Definitions - University of Idaho

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      Lean Manufacturing An integrated approach to producing goods and services designed to maximize the efficient use of capital, materials and human resources. A manufacturing method used to achieve higher quality, lower costs and shorter lead times. MRP Material Resource Planning – A tool used to plan production levels, material needs and

    • [PDF File]Chapter 9 Quality Control Biochemistry - Biomanufacturing

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      344 Chapter 9 - Quality Control: Biochemistry and reproducibility (inter-laboratory variability). Chapter 4 Metrology covers precision and the related term accuracy Purity assay: a quantitative analytical procedure used to determine the purity of the active product ingredient Purity method: a qualitative analytical procedure used to determine the purity of the active

    • [PDF File]What is the Meaning of Quality? - LMU

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      (reliable) definition of quality -Garvin (1984) described it as the product based approach- where quality is based on the existence or absence of a particular attribute. If an attribute is desirable, greater amounts of that attribute, according to this definition, would label that product as one of a higher quality. Leffler’s (1982 ...

    • [PDF File]Guidance for Industry - Food and Drug Administration

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      manufacturing process and associated variations may not lead to adequate assurance of quality. After establishing and confirming the process, manufacturers must maintain the process in a state ...

    • [PDF File]Introduction to Quality

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      Transcendent definition: excellence Product-based definition: quantities of product attributes User-based definition: fitness for intended use Value-based definition: quality vs. price Manufacturing-based definition: conformance to specifications

    • [PDF File]Re-defining quality - SAGE Publications Ltd

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      quality of design and manufacturing and more with the quality of the decisions taken by the people in command. Indeed, too much confidence in the Titanic’s technological superiority led the people in command to take the ship through an ice field at top speed instead of slowing down, as was the common practice. The result was disastrous.

    • [PDF File]Examining the Product Quality Attributes That Influences Customer ...

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      universal definition of quality exists, at the same time, there are alternative measures laid from five main approaches, which are transcendent, product-based, user-based, manufacturing-based, and value-based (Sebastianelli and Tamimi, 2002). Product quality is product features matched with 8 dimensions namely, performance, features ...

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