US20160267421A1 - Quality information management system - Google Patents

Quality information management system Download PDF

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US20160267421A1
US20160267421A1 US15/049,960 US201615049960A US2016267421A1 US 20160267421 A1 US20160267421 A1 US 20160267421A1 US 201615049960 A US201615049960 A US 201615049960A US 2016267421 A1 US2016267421 A1 US 2016267421A1
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Chandran Kymal
Gregory Francis Gruska
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Omnex Systems LLC
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Omnex Systems LLC
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    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/06Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063Operations research, analysis or management
    • G06Q10/0639Performance analysis of employees; Performance analysis of enterprise or organisation operations
    • G06Q10/06395Quality analysis or management
    • GPHYSICS
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    • G06FELECTRIC DIGITAL DATA PROCESSING
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    • G06F40/12Use of codes for handling textual entities
    • G06F40/134Hyperlinking
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/04Forecasting or optimisation specially adapted for administrative or management purposes, e.g. linear programming or "cutting stock problem"
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/06Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/06Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063Operations research, analysis or management
    • G06Q10/0631Resource planning, allocation, distributing or scheduling for enterprises or organisations
    • G06Q10/06315Needs-based resource requirements planning or analysis
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/06Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063Operations research, analysis or management
    • G06Q10/0639Performance analysis of employees; Performance analysis of enterprise or organisation operations
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/10Office automation; Time management

Definitions

  • Embodiments of the present invention relate generally to enterprise and supply chain quality management, and more specifically to computer-implemented methods, computer applications and systems for quality management.
  • Embodiments of the present invention may be implemented as an alternative or supplement to prior art methods and systems for quality management. Notably, the following characterization of the prior art is not intended to set forth or limit that which the applicants regard as their invention.
  • QMS Quality management system
  • linkages often take users to another location within the QMS, without automatically providing the users with a return path.
  • conventional linkages are static and can only be defined by an administrator—not necessarily the “owner” of the relevant information.
  • Conventional QMS packages do not support linkages among product realization information at the design level for the development and maintenance of linked product or process information.
  • Conventional QMS packages also fail to support linkages among product and process realization information at the design level to the process level for the development and maintenance of linked product or process information.
  • Yet another quality management function not support by conventional QMS packages includes linkages among product and process realization information that are used to identify and display quality information for product and process improvement.
  • Embodiments of the present invention will serve as an alternative or supplement to prior art QMS methods and systems to effectively eliminate or reduce some or all of the above drawbacks. Those in the art will recognize, however, that no single embodiment of the present invention can eliminate or reduce all drawbacks associated with all conventional QMS methods or systems.
  • Embodiments of the present invention illustrated and described herein include computer systems and software for quality management.
  • a web-based application hosts quality information managed at one or more distributed sites.
  • Application users at each site can individually manage a subset of the quality information available to them at their respective site such that the subset of the quality information is presented to the users transparent of the source of the quality information.
  • Users may access the quality information according to one or more user-defined quality information levels.
  • the quality information may be sourced and/or maintained at the distributed sites as well.
  • Quality information management supported by this and other embodiments of the present invention may include hosting an approval process for new or revised documents according to a plurality of approval levels. Approvals may be received from one or more individuals at each level. Quality information management supported by this and other embodiments of the present invention may also include displaying most recently approved versions of new or revised documents. Prior versions of revised documents may be displayed as well. Quality information management supported by this and other embodiments of the present invention may also include revising existing quality information.
  • Users may define and submit queries of the quality information and, as a result, receive a more focused subset or status thereof for review. Queries may also be executed based on user or system-defined linkages among the quality information.
  • Sourcing quality information may include defining new quality information, or importing existing quality information from external or legacy locations and/or applications.
  • Site, system and/or module administrators may define functionality and/or the subsets of the quality information available to users at their respective sites.
  • the quality management application may be configured to receive input including quality data from among a plurality of sources, receive input defining one or more business relationship linkages, and generate and output a descriptive or statistical analysis based on the quality data and the business relationship linkages.
  • the application may additionally output a visual representation of the descriptive or statistical analysis.
  • the visual representation may enable a user to “drill” up or down through quality data associated with one or more of the business relationship linkages. These linkages may be defined transparent to the source of the quality data.
  • the quality management application may support business entity-based data analysis. More specifically, the application may be configured to receive input including quality data from among a plurality of sources, receive input defining one or more business entities associated with the enterprise, receive input defining hierarchal linkages among the business entities, and generate and output a descriptive or statistical analysis based on one or more business entities' individual hierarchal linkages to one or more other business entities.
  • the application may be additionally configured to output a visual representation of the descriptive or statistical analysis. The visual representation may enable a user to drill up or down through quality data associated with a business entity based on that business entity's individual hierarchal linkages with one or more other business entities.
  • the quality management application may support continual quality improvement. More specifically, the application may be configured to receive input including a plurality of quality information, receive input defining linkages among products or processes within an enterprise, receive input including an identification of one or more improvement opportunities for one or more of the products or processes, capture content from the plurality of quality information based on the one or more improvement opportunities, and generate a report displaying the captured content linked with a subset of the quality information.
  • the quality information may include real-world product or process data.
  • the report may be linked with a subset of the real world data and may include a descriptive or statistical analysis of the product/process status and/or other quality information. Preferably, the descriptive or statistical analysis is presented in a graphical format. Some or all of the quality information may be sourced from within as well as outside of the enterprise, and captured content may be displayed transparent of its source.
  • the report may also include a comparison of achievement of one or more employees' goals to one or more corresponding goals for one or more business entities within the enterprise.
  • the quality management application may present product or process status information based on linkages among quality information improvement. More specifically, the application may be configured to receive input defining quality information for an enterprise, receive input defining one or more linkages among the quality information, receive input defining a request for a product or process status information, search the quality information for the requested status information based on the one or more linkages, and present search results including at least a portion of the requested product/process status information.
  • the status information may include a current product or process state.
  • the status information may also include one or more product or process improvement opportunities.
  • the improvement opportunities may relate to customers or suppliers of the enterprise.
  • the quality information may include realized product or process information or data.
  • Another embodiment of the present invention may also support product or process status management. More specifically, the application may be configured to receive input defining two or more sets of quality documentation for an enterprise, each set having one or more elements, configured to link two or more of the elements, configured to receive input including an update for at least one of the elements, wherein the update includes realized product or process information, and configured to automatically update any other linked elements.
  • the realized product or process information may include realized product or process data.
  • the linkages may be user-defined.
  • Client-server communication may be facilitated or otherwise supported by corporate intranet (e.g. LAN) and/or the Internet including the World-Wide-Web.
  • corporate intranet e.g. LAN
  • the Internet including the World-Wide-Web.
  • FIG. 1 is a model of a process-based quality management system (e.g. TS 16949:2002 and ISO 9000:2000) including an example of how various aspects of an Enterprise-wide Quality Management System (“EwQMS” may be associated and/or implemented, in accordance with one embodiment or aspect of the present invention
  • EwQMS Enterprise-wide Quality Management System
  • FIG. 2 is an example schematic comparing two hypothetical enterprises that an administrator might define within the EwQMS;
  • FIG. 3 is a block flow diagram illustrating a preferred methodology for setting up certain EwQMS features (sites, entities, users, etc.) within an enterprise, in accordance with one embodiment or aspect of the present invention
  • FIG. 4 is an example GUI for accessing authorized documents from among a plurality of administrator-defined levels or categories, transparent of the source of those documents in accordance with one embodiment or aspect of the present invention
  • FIG. 5 is an example GUI for viewing and maintaining authorized documents in accordance with one embodiment or aspect of the present invention.
  • FIG. 6 is a schematic illustrating an example implementation of EwQMS modules within an enterprise in accordance with one embodiment or aspect of the present invention
  • FIG. 7 is an example data exchanger GUI for creating links between EwQMS data tables and external data in accordance with one embodiment or aspect of the present invention
  • FIG. 8 is an example GUI for specifying a connection between EwQMS data tables and external data in accordance with one embodiment or aspect of the present invention
  • FIG. 9 is an example GUI for executing the data exchange within the EwQMS based upon the defined links (see FIGS. 7 and 8 ) in accordance with one embodiment or aspect of the present invention.
  • FIG. 10 is an example GUI for defining categories of customer expectations and linking those customer expectations with result measurables, key processes, and process measurables in accordance with one embodiment or aspect of the present invention
  • FIG. 11 is an example GUI showing example results when a “key process” of FIG. 10 is selected/changed in accordance with one embodiment or aspect of the present invention
  • FIG. 12 is an example GUI for defining linkages between entity goals and objectives and individual employee goals for realizing the entity goals in accordance with one embodiment or aspect of the present invention
  • FIG. 13 is an example GUI providing a visual analysis according to linkages such as those referred to with respect to FIG. 10 in accordance with one embodiment or aspect of the present invention
  • FIG. 14 is a schematic illustrating an example set of content linkages among a plurality of business documents in accordance with one embodiment or aspect of the present invention.
  • FIG. 15 is an example GUI for establishing linkages such as those referenced in FIG. 14 in accordance with one embodiment or aspect of present invention.
  • FIG. 16 is a block flow diagram illustrating a preferred implementation of process knowledge management in accordance with one embodiment or aspect of present invention.
  • FIG. 1 is a model of a process-based quality management system (e.g. TS 16949:2002 and ISO 9000:2000) including an example of how various aspects of the EwQMS (described in greater detail below) may be associated and/or implemented in accordance with one embodiment or aspect of the present invention.
  • EwQMS described in greater detail below
  • associations between the quality management system and EwQMS modules shown in FIG. 1 may be adapted or modified to best-fit a particular implementation of the present invention.
  • features of the present invention may be implemented to support a wide variety of other business and quality system structures (e.g. QS 9000, ISO 14000, VDA 6.1 etc.).
  • functionality supported by the EwQMS may be generally referenced by or “divided” into different modules including but not limited to those referenced in Table 1.
  • Table 1 additionally provides a non-exclusive summary of functionality that each module provides.
  • Module Summary 70 Document Manages and controls online documents in Manager any data format. Manages and controls online document/revision feedback and approval process, including automatic e-mail notification and escalation. Security can be set at user-defined levels of granularity (e.g., site, group, individual, etc.). Manages and controls user-defined linkages among documents, including content-based linkages. Documents can be aggregated among an unlimited number of user-defined levels - each with their own user-defined security controls. User functionality and menu options are limited based on user rights and privileges. Limitations are transparent to the user. 60 Product/Process Develops and maintains documents relating to Realization the product and process development cycle (e.g., Advanced Product Quality Planning process, etc.).
  • Product/Process Develops and maintains documents relating to Realization the product and process development cycle (e.g., Advanced Product Quality Planning process, etc.).
  • Maintains user and system-defined linkages among related product realization documents Supports multiple user-defined formats for each document type. Flexibly filters and sorts documents according to a user-defined specification based on any document content. Highlights changes (e.g., revisions, additions, deletions, etc.) in documents based upon user-specified dates. Links table entries according to different levels of user-defined scope (e.g., global, family, product, etc.) Supports multiple ways of creating products (i.e.
  • System and attribute measurement systems Analysis Enables a user to conduct bias, linearity, stability, and gage repeatability and reproducibility studies Determines the uncertainty related to a specific measurement system and traceability chain Supports a wide variety of graphical analyses Manages calibration activities including automated e-mail notifications. Compliant with the automotive industry's measurement systems manual. Links specific process document content to document content maintained by other modules (e.g., products which are maintained by the Product/Process Realization module). 66 Productive Manages and controls preventive and reactive Maintenance maintenance activities.
  • Maintains a historical record of maintenance activities Automatically issues preventive maintenance work orders
  • Supports the creation of reactive maintenance work orders Analyzes the reactive maintenance activities and causes of failure (e.g., mean time between failure, mean time to repair, cause of failure, etc.).
  • Links specific process document content to document content maintained by other modules e.g., products which are maintained by the Product/Process Realization module.
  • 56 Business Enables a user to develop and Operating maintain/manage linkages among customer Systems expectations, business strategies, processes, and product and process metrics. Manages the continual improvement process.
  • Meeting scheduling and management including automatic e-mail notification to participants Reporting of meeting minutes to participants through the Document Manager Maintains links to improvement proposals and improvement proposal ratings Maintains links to the problem solving documentation maintained by the Problem Solver module.
  • Audit Manager Manages and enables enterprise-wide audit activities Supports any type of audit (e.g., standard based, financial, safety, environmental, housekeeping, etc.) Audit scheduling and management including automatic e-mail notification to participants
  • Flexible audit handler Provides auditors with forms for documenting audit results Provides auditees with audit results and forms to document non-conformance resolutions Provides auditors with capability to close out an audit (e.g., after submission of an auditee's corrective action reports) Generates wide variety of management reports based on audit results (e.g., filtered by auditor, nonconformance- type, element, etc.) Maintains links to the problem solving documentation maintained by the Problem Solver module.
  • Maintains links to visual analysis e.g., drill- down analysis functionality
  • power tracker functionality e.g., drill- down analysis functionality
  • visual analysis functionality e.g., drill-down analysis, etc.
  • SPC Maintains and analyzes variables and attribute process data: Enables a user to conduct stability, capability and performance studies Determines the statistics related to specific product and process characteristics Supports a wide variety of graphical analyses Manages the control and analysis activities including automated e-mail notifications. Compliant with the automotive industry's statistical process control (SPC) manual. Links specific process document content to document content maintained by other modules (e.g., products which are maintained by the Product/Process Realization module). 62 Process Enables the development, maintenance and Analyzer use of user-defined fault trees including user- defined fault tree depth. Links real-world data (e.g., from the SPC module, the Data Exchange Manager module, etc.) to related document content.
  • SPC statistical process control
  • an administrator characterizes an enterprise within the EwQMS in terms of “sites” and “entities.”
  • a “site” may be defined as those tangible parts of an enterprise having administration of local processes and documentation. Often, sites are defined geographically (e.g., individual plants, campuses, regions, etc.).
  • An “entity” may be defined as the business organization or architecture of an enterprise. Notably, an entity may cross one or more sites within an enterprise as well as include representation outside of the enterprise (e.g. customers, suppliers, distributors, etc.).
  • a business unit responsible for a particular line of automobiles (an “entity”) within the automotive industry might include elements from (i) the corporate “site” (e.g., engineering development), (ii) one or more manufacturing “sites” and (iii) one or more assembly “sites.” These sites could be distributed across multiple geographic regions including countries and continents.
  • FIG. 2 is an example schematic comparing two hypothetical enterprises that an administrator might define within the EwQMS.
  • Enterprise 10 consists of an international corporation 12 having three business units 14 a - 14 c .
  • Business unit 14 a has plants A, B and C in country X.
  • Business unit 14 b has plants D and E in countries Y and Z, respectively, and business unit 14 c has a single plant F in country Z.
  • Enterprise 10 can be defined within the EwQMS as having six enterprise-wide “sites”.
  • enterprise 16 consists of a domestic corporation 18 having a single campus with three business units 22 , 24 and 26 .
  • This enterprise can be defined within the EwQMS as having a single “site.”
  • the EwQMS may be flexibly implemented to support and manage the unique needs and architectures of any number of diverse enterprises.
  • FIG. 3 is a block flow diagram illustrating a preferred methodology for setting up certain EwQMS features (sites, entities, users, etc.) within an enterprise.
  • an administrator After installing and initializing the EwQMS application, as represented in block 28 , an administrator provides input to the EwQMS defining sites within the enterprise, as represented in block 30 . There is no limit to the number of sites that an enterprise may possess.
  • the administrator defines entities within the enterprise. Notably, entities may have sub-entities associated with them creating an entity hierarchy. For example, an entity may be associated with a customer, and sub-entities could be specific product lines for the enterprise, which that customer purchases. Like sites, there is no limit to the number of entities that an administrator may define.
  • the administrator next defines EwQMS users.
  • User definition includes demographic information, contact information, username, password as well as a site and entity association for the user.
  • a user account is properly defined within the EwQMS, that user can then access certain information and functionality supported by the EwQMS.
  • the information and functionality that a user has access to is controlled within the EwQMS by the site and entity that user has been associated with.
  • an administrator may limit or expand user access and functionality rights with respect to any information or functionality supported by the EwQMS.
  • an enterprise typically includes processes that span multiple sites (e.g., corporate, business unit, plant, etc.). Some processes are defined and utilized at multiple sites, while others may be defined and utilized by only a single site. More specifically, a particular site can administer and manage documentation associated with his or her site-specific processes. However, where a particular process covers more than one site, one of those sites is considered to be the “owner” of the documentation relating to that process. If a process only applies to a single site, that site is considered the “owner” of the documentation relating to that process.
  • the “owner” of the process documentation grants the other sites access to that documentation.
  • an individual user is provided access to that documentation in a fashion that is transparent of the owning site. Consequently, a user may have access to documentation comprising process documentation originating from that user's site as well as process documentation originating from other sites (over which a multiple-site process transcends).
  • the actual location or “owner” of the process documentation will be transparent to that user.
  • FIG. 4 illustrates an example of this aspect of EwQMS.
  • FIG. 4 is an example GUI 36 having a menu region 38 and a data input/presentation region 40 .
  • the “Documents” menu item 42 enables a user to select authorized documents from among a plurality of administrator-defined levels or categories 44 (e.g., quality manuals, procedures, work instructions, etc.).
  • An administrator may define an unlimited number of document levels.
  • document level “Procedures” for example, a user is presented with a table of contents 46 including a plurality of procedure documents to which that user has been granted access. Notably, these documents may originate from the user's own site, or from other sites within the enterprise.
  • procedure “SOP011” may be “owned” by or originate from the corporate site, whereas procedure “SOP052” may be “owned” by a manufacturing site.
  • the true origination of the document is transparent to the user enabling a site to efficiently utilize other sites' documentation and thereby reduce redundant documentation and ensure consistent knowledge across the enterprise.
  • a user may be presented with a GUI 48 such as that illustrated in FIG. 5 .
  • Functionality provided to the user includes the ability to view the document, submit a request to the document “owner” to modify or delete the document, solicit a draft revision to selected users for comment, and download the document.
  • a user can view and access documents that are related (i.e., “linked”) to the current document via menu 52 .
  • related documents are displayed according to their document level.
  • functionality such as that shown in FIGS. 4 and 5 is provided to a user without reference to or limitation by the site that “owns” the document.
  • the true origination of the document is transparent to the user enabling a site to efficiently utilize other sites' documentation and thereby reduce redundant documentation and ensure consistent knowledge across the enterprise.
  • an enterprise maintains a wide variety of data across several business functions (e.g. human resources, manufacturing activities, inspection and testing activities, continual improvement activities, etc.).
  • data associated with one of these activities may not be unique to that activity, and may overlap with others within the enterprise.
  • the EwQMS enables data sharing between sites and entities to reduce redundant data entry and ensure consistent knowledge across the enterprise.
  • FIG. 6 is a schematic illustrating an example implementation of EwQMS modules within an enterprise. Notably, the content or arrangement of FIG. 6 may be adapted, reduced or expanded to best-fit a particular implementation of the present invention. Table 1 lists and generally describes the function of each EwQMS module.
  • Linkages between EwQMS modules 54 through 78 may be generally divided into three categories: core interrelationships (denoted by solid lines 84 ), document flows (denoted by short-dashed lines 80 ) and data exchange (denoted by long-dashed lines 82 ).
  • the data exchanger module 54 enables EwQMS to share data with non-EwQMS applications (e.g. “legacy” systems, enterprise resource planning systems, etc.) in an effort to reduce redundant data entry and ensure consistent knowledge across the enterprise.
  • non-EwQMS applications e.g. “legacy” systems, enterprise resource planning systems, etc.
  • FIG. 7 is an example data exchanger GUI 86 for creating a link between EwQMS data tables and external data.
  • a user selects the “Data Source” button 88 and is presented with pop-up GUI 90 illustrated in FIG. 8 .
  • GUI 90 the user specifies the connection between the EwQMS data tables and external data (e.g. connection type, driver, database, username, password, etc.).
  • the “Source Tables” region 92 is populated.
  • the “Field Names” region 94 is populated. The user performs the same method with respect to the “Suite Tables” 96 and “Field Names” 98 .
  • the user selects respective fields and depresses the “Make Link” button 100 .
  • the EwQMS establishes the data link as shown in region 102 .
  • a user selects the “Save Links” button 104 to finalize the link.
  • FIG. 9 is an example GUI 106 for executing the data exchange within the EwQMS based upon the defined links (see FIGS. 7 and 8 ).
  • a user selects one or more linked tables within region 107 , transferring them to region 108 .
  • the user also inputs a job name 110 and a start time and execution frequency 112 .
  • the EwQMS captures and utilizes these interrelationships in enterprise-wide manner to (i) define and maintain a constancy of purpose in achieving goals of the business strategy, and (ii) reduce error and effort (i.e., redundancy) in developing and administering documents related to achieving those goals within an enterprise.
  • the EwQMS enables a user to define categories of customer expectations 126 and link customer expectations 116 , result measurables 118 , key processes 120 and process measurables 122 to those categories in an online fashion.
  • a user may define and use an “Alignment Chart” by inputting or otherwise selecting an “Entity” 124 .
  • An “Expectation Category” 126 is selected from a pull-down list of user-defined categories of customer expectations.
  • An “Alignment Chart” for the selected “Expectation Category” is then displayed. This chart consists of the “Customer Expectations” 116 , “Result Measurables” 118 , “Key Processes” 120 , and related “Process Measurables” 122 .
  • the user can restrict the display to only those “Customer Expectations” which satisfy logical constraints determined by pull-downs 128 and 130 (e.g. an “Importance Level” greater than a user-defined value).
  • the user can also add elements in the “Result Measurables”, “Key Processes”, and related “Process Measurables” areas by clicking on the respective “New” buttons ( 132 , 134 , 136 ) and either by entering free-text or selecting an element from a table of user-defined result measurables, key processes, or process measurable.
  • a user can input and display strategic goals 114 for achieving the selected expectation category 126 .
  • FIG. 11 shows example results when the key process “Advanced Quality Planning” shown in FIG. 10 is selected via radio button 138 .
  • the process measurables entry “gates missed” is also selected via radio button 140 .
  • This feature of the EwQMS enables a user to initiate online proposals for improving the selected key process (by clicking the “Improvement Proposal” button 142 ).
  • This feature of the present invention facilitates and manages an enterprise's continual improvement activities.
  • this feature of EwQMS supports data analysis through a “drill-down” functionality (discussed in greater detail below).
  • EwQMS business goals and objectives can also be linked to individual employees within an enterprise.
  • This feature of EwQMS ensures constancy of purpose down to a personal or individual level of granularity.
  • employee performance evaluation including recognition (e.g. appraisal and bonus systems), as well as a visual display of an employee's achievement of goals over time (i.e. trends) or at a specific point in time.
  • FIG. 12 is an example GUI illustrating user-defined linkages between entity goals and objectives 144 and individual employee goals 146 for realizing the goals of the entity 144 .
  • the example GUI displays related “Short Term Goals” 148 and “Long Term Goals” 150 for each “Expectation Category” 144 .
  • the user selects an “Employee” 152 and inputs one or more “Short Term Goals” and “Long Term Goals” for any or all of the “Expectation Categories” of the entity.
  • the user can also relate a “Visual Analysis Worksheet” 154 and “Power Tracker Value” 156 to each goal.
  • a visual analysis worksheet collects and displays the results for a particular result or process measurable ( FIG. 10 ) over time (e.g. trend analysis, pareto analysis, etc.).
  • a power tracker evaluates the product or process measurable with respect to the short and/or long term goals for a specific time or time period.
  • a status indicator e.g. stoplight icon 158 ) may visually reflect the extent to which the employee has achieved the corresponding goal(s).
  • FIG. 13 is an example GUI illustrating this feature of EwQMS. More specifically, a “Visual Analysis” is provided for a user-defined and selected measurable (e.g. “downtime” 160 ) over a user-defined period of time and periodicity (e.g. “monthly”) 162 . A path 164 of aggregation levels for the Visual Analysis is provided demonstrating to the user various levels of granularity among the relevant data.
  • a “Visual Analysis” is provided for a user-defined and selected measurable (e.g. “downtime” 160 ) over a user-defined period of time and periodicity (e.g. “monthly”) 162 .
  • a path 164 of aggregation levels for the Visual Analysis is provided demonstrating to the user various levels of granularity among the relevant data.
  • a user “drills down” into the aggregation levels by selecting a data feature (e.g. line, legend item, bar, etc.) on the displayed graphic 166 (e.g. line graph, bar graph, pie chart, pareto chart, etc.).
  • a data feature e.g. line, legend item, bar, etc.
  • the displayed graphic 166 e.g. line graph, bar graph, pie chart, pareto chart, etc.
  • a user may “drill up” by selecting the “Back” button within the user's Web browser.
  • other methods for drilling into or out of aggregation levels may be provided (e.g. zoom-in, zoom out, etc.).
  • logical interrelationships exist or should be defined among business document content (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.).
  • business document content e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.
  • the EwQMS captures and utilizes these interrelationships in enterprise-wide manner in an effort to reduce redundant data entry and ensure up-to-date and consistent knowledge across the enterprise.
  • EwQMS implements linkages between business document content such that information entered into certain portions of one document automatically propagates to appropriate portions within other documents that use or include the same type of information.
  • this propagation of content is dynamic in that the user can enter the information from any of the documents that contain it.
  • the user is not constrained to a specific path of information entry or document development. This approach minimizes redundant data entry and reduces the risk that related documents will have different revision levels of the same data.
  • FIG. 14 is a schematic illustrating an example set of content linkages among a plurality of business documents.
  • the business documents relate to “product realization.”
  • linkages among business document content may be established within EwQMS for a wide variety of other document categories (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.).
  • FIG. 14 displays example content linkages among various documents generated during product realization activities.
  • design verification planning and reporting (“DVP&R”) 168 and design failure mode and effects analysis (“DFMEA”) 170 are documents that are typically generated during the design phase of the product realization process.
  • Linkages 172 and 174 ensure that information (i.e. item number and design control, respectively) that are input by a user into the DFMEA 170 is automatically reflected in appropriate sections of the DVP&R 168 , and visa-versa.
  • This feature of the EwQMS reduces or eliminates the need for redundant data entry in documents having common content. As a result, this feature minimizes user error and ensures that all users of the EwQMS are provided with consistent and up-to-date information.
  • FIG. 14 also displays content linkages among process documentation (e.g. process flow 176 , process FMEA 178 , control plan 180 and check sheet 182 ).
  • Linkages are also provided between the design and process documents.
  • linkage 184 might link a first effect of a process failure mode input into the PFMEA 178 to a design failure mode within the DFMEA 170 .
  • This linkage 184 results in the creation of linkage 186 , which relates product and process characteristics from the process documents ( 176 - 182 ) to the DFMEA 170 .
  • Additional linkages 214 may be established between and among EwQMS documentation (e.g. FIGS. 4-6 ).
  • linkages 216 may be established between any document content item (e.g. cell within a control plan) and any document managed by the EwQMS.
  • a user may link a particular cell within a control plan to the related work instruction document or process inspection checksheet or form.
  • FIG. 15 illustrates an example “pop-up” GUI for establishing such linkages.
  • a user performs a “right-click” operation over a document cell to obtain the GUI shown in FIG. 15 .
  • the user selects a level 218 and then selects one or more available documents for that level through listing 220 .
  • the EwQMS automatically makes available to the user the latest and most up-to-date version of the linked document.
  • the EwQMS enables a user to continually improve products and processes within an enterprise.
  • the EwQMS provides an efficient tool for identifying a concise subset of product and process document content for evaluation by a user (e.g. subject matter expert) in an effort to identify and act upon improvement opportunities.
  • FIG. 16 is a block flow diagram illustrating a preferred implementation of process knowledge management in accordance with a preferred embodiment of the present invention. Notably, the content or arrangement of FIG. 16 may be modified or adapted to best-fit a particular implementation of the present invention. Activities associated with process knowledge management may be divided into categories including: continual document updating 188 , fault tree development 190 , improvement opportunity development 192 , and improvement opportunity evaluation 194 .
  • Continual document updating 188 includes collecting real world data 196 and linking that data within EwQMS to related documents or portions thereof, as represented in block 198 .
  • Linkages may be established in a manner similar to that illustrated and described with respect to FIGS. 6 and 14 .
  • product and process characteristics e.g. characteristic performance—stability and variability metrics including occurrence values in the PFMEA, etc.
  • product and process characteristics may be linked and automatically updated within EwQMS with actual performance results or data available directly through EwQMS suite modules (e.g. SPC, Process Pro, Process Analyzer, Audit Pro, Boss) ( FIG. 6 ) or imported by the suite from external programs (e.g. data entry via handheld device links to a hard gage in the customer's, plant's, or supplier's production facility).
  • continual document updating should be implemented in on an ongoing basis within an enterprise.
  • Element definition may include a related product number or other identifier that links the element with related documentation.
  • EwQMS uses (i) these user-defined linkages and (ii) linkages between the user-defined levels and fault tree elements themselves to relate a specific set of product realization and/or other business documentation (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.) to the fault tree 202 .
  • improvement opportunity development 192 includes periodic management review of result and process metrics (e.g. FIGS. 10-13 ) in an effort to identify product or process improvement opportunities, as represented in blocks 206 and 204 .
  • result and process metrics e.g. FIGS. 10-13
  • EwQMS relating to the opportunity
  • the EwQMS executes the user-defined query relating to an improvement opportunity against the fault tree and linked documentation, as represented in block 210 .
  • Query results preferably include a subset of documentation or documentation content.
  • the EwQMS automatically associates the results of the user-defined query with real world data 198 related to those results.
  • process indices such as Cp, Cpk, Pp, Ppk or ppm can be linked to the occurrence rating contained in the PFMEA (see FIG. 14 , item 212 ).
  • This feature of the present invention enables a user (e.g. subject matter expert) to review and identify potential solutions for realizing improvement opportunities both inside and outside of the enterprise (e.g. among suppliers, distributors, customers, etc.).
  • aspects of the present invention are implemented according to a client-server architecture.
  • functionality such as that illustrated and described herein may be implemented or otherwise delivered over a variety of other platforms including but not limited to mainframe and stand-alone computing environments.
  • Functionality such as that illustrated and described herein may also be delivered in a source code or object code format embodied in a wide variety of mediums (e.g. CD-ROM, magnetic disc, DVD, online download, etc.).
  • Table 2 includes recommended technical specifications for a client-server implementation of the present invention.
  • IIS Internet Information Server
  • IIS version 4.0 on Windows NT 4.0 SP 6 or later IIS version 5.0 or later on Windows 2000 (part of NT/2000 server set-up) OS Apps SQL Server 7 SP2 or SQL Server 2000 (preferred)

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Abstract

Embodiments of the present invention illustrated and described herein include computer systems and software for quality management. In one embodiment of the present invention, a web-based application hosts quality information managed at one or more distributed sites. Application users at each site can individually manage a subset of the quality information available to them at their respective site such that the subset of the quality information is presented to the users transparent of the source of the quality information. Users may access the quality information according to one or more user-defined quality information levels. The quality information may be sourced and/or maintained at the distributed sites as well.
Quality information management supported by this and other embodiments of the present invention may include hosting an approval process for new or revised documents according to a plurality of approval levels. Approvals may be received from one or more individuals at each level. Quality information management supported by this and other embodiments of the present invention may also include displaying most recently approved versions of new or revised documents. Prior versions of revised documents may be displayed as well. Quality information management supported by this and other embodiments of the present invention may also include revising existing quality information.
Users may define and submit queries of the quality information and, as a result, receive a more focused subset or status thereof for review. Queries may also be executed based on user or system-defined linkages among the quality information.
Sourcing quality information may include defining new quality information, or importing existing quality information from external or legacy locations and/or applications.
Site, system and/or module administrators may define functionality and/or the subsets of the quality information available to users at their respective sites.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • This application is a continuation of Ser. No. 13/616,0.33, filed Sep. 14, 2012, now abandoned, which was a reissue continuation of RE44,964, filed Jul. 19, 2011, issued on Jun. 24, 2014, which was a reissue of U.S. Pat. No. 7,818,192, issued Oct. 19, 2010, which was filed on Mar. 1, 2004, based on U.S. Provisional No. 60/450,628, filed Feb. 28, 2003.
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention
  • Embodiments of the present invention relate generally to enterprise and supply chain quality management, and more specifically to computer-implemented methods, computer applications and systems for quality management.
  • 2. Background Art
  • Embodiments of the present invention may be implemented as an alternative or supplement to prior art methods and systems for quality management. Notably, the following characterization of the prior art is not intended to set forth or limit that which the applicants regard as their invention.
  • Prior art quality management system (“QMS”) packages are not designed to effectively support and integrate enterprise-wide (i.e. multi-site) quality management. For site level control and management, conventional QMS packages must be loaded on site-specific computing platforms. Users must log into separate programs to view quality documents and information owned and maintained by diverse and/or distributed enterprise locations or sites. In addition, consolidation of information from several locations into an organization report requires duplication of data.
  • If an organization elects to implement a central (single) QMS, the administration of individual sites, and control of quality documents and information access is governed by a central administration. This reduces the value and efficiency of site autonomy in quality management. In addition, a single QMS arrangement requires that all “sites” utilize the same document levels and nomenclature.
  • Functionality for defining linkages among quality information is limited. For example, linkages often take users to another location within the QMS, without automatically providing the users with a return path. In addition, conventional linkages are static and can only be defined by an administrator—not necessarily the “owner” of the relevant information.
  • Another drawback associated with conventional quality management systems is their failure to effectively recognize and support entity and business relationship linkages across quality information. Without such linkages, an inefficient multi-level analysis of quality data is required.
  • Although certain limited functionality supporting quality data analysis and management is available in the market today, its is not integrated. Users are required to enter the same or similar information into several different applications. In addition, having multiple discrete applications to support quality data analysis and management involves porting common information from one application to another. Typically, different applications utilize different or proprietary data formats and thus require inefficient and error-prone data conversion. This inefficiency is compounded each time data is updated.
  • In the generation of product/process realization quality information, documentation and reports are conventionally developed with limited linkages among the various documents based on entity and business relationship linkage references. In addition, tracking of the quality data and information generated is not integrated with process review activities. Packages that do track quality data and information generated and related to transactional and business processes require unique, separately developed programs.
  • Furthermore, the comparison of achievement of one or more employees' goals to one or more corresponding goals for one or more business entities within the enterprise is not part of any continual quality improvement system.
  • Other drawbacks associated with conventional quality management systems include their failure to (i) recognize interrelationships among quality information, (ii) require a specific order and timing of information entry, and/or (iii) support interdependence among quality information within a single QMS function.
  • Conventional QMS packages do not support linkages among product realization information at the design level for the development and maintenance of linked product or process information. Conventional QMS packages also fail to support linkages among product and process realization information at the design level to the process level for the development and maintenance of linked product or process information. Yet another quality management function not support by conventional QMS packages includes linkages among product and process realization information that are used to identify and display quality information for product and process improvement.
  • Embodiments of the present invention will serve as an alternative or supplement to prior art QMS methods and systems to effectively eliminate or reduce some or all of the above drawbacks. Those in the art will recognize, however, that no single embodiment of the present invention can eliminate or reduce all drawbacks associated with all conventional QMS methods or systems.
  • SUMMARY OF THE INVENTION
  • Embodiments of the present invention illustrated and described herein include computer systems and software for quality management. In one embodiment of the present invention, a web-based application hosts quality information managed at one or more distributed sites. Application users at each site can individually manage a subset of the quality information available to them at their respective site such that the subset of the quality information is presented to the users transparent of the source of the quality information. Users may access the quality information according to one or more user-defined quality information levels. The quality information may be sourced and/or maintained at the distributed sites as well.
  • Quality information management supported by this and other embodiments of the present invention may include hosting an approval process for new or revised documents according to a plurality of approval levels. Approvals may be received from one or more individuals at each level. Quality information management supported by this and other embodiments of the present invention may also include displaying most recently approved versions of new or revised documents. Prior versions of revised documents may be displayed as well. Quality information management supported by this and other embodiments of the present invention may also include revising existing quality information.
  • Users may define and submit queries of the quality information and, as a result, receive a more focused subset or status thereof for review. Queries may also be executed based on user or system-defined linkages among the quality information.
  • Sourcing quality information may include defining new quality information, or importing existing quality information from external or legacy locations and/or applications.
  • Site, system and/or module administrators may define functionality and/or the subsets of the quality information available to users at their respective sites.
  • According to another embodiment of the present invention, the quality management application may be configured to receive input including quality data from among a plurality of sources, receive input defining one or more business relationship linkages, and generate and output a descriptive or statistical analysis based on the quality data and the business relationship linkages. The application may additionally output a visual representation of the descriptive or statistical analysis. The visual representation may enable a user to “drill” up or down through quality data associated with one or more of the business relationship linkages. These linkages may be defined transparent to the source of the quality data.
  • According to another embodiment of the present invention, the quality management application may support business entity-based data analysis. More specifically, the application may be configured to receive input including quality data from among a plurality of sources, receive input defining one or more business entities associated with the enterprise, receive input defining hierarchal linkages among the business entities, and generate and output a descriptive or statistical analysis based on one or more business entities' individual hierarchal linkages to one or more other business entities. The application may be additionally configured to output a visual representation of the descriptive or statistical analysis. The visual representation may enable a user to drill up or down through quality data associated with a business entity based on that business entity's individual hierarchal linkages with one or more other business entities.
  • According to another embodiment of the present invention, the quality management application may support continual quality improvement. More specifically, the application may be configured to receive input including a plurality of quality information, receive input defining linkages among products or processes within an enterprise, receive input including an identification of one or more improvement opportunities for one or more of the products or processes, capture content from the plurality of quality information based on the one or more improvement opportunities, and generate a report displaying the captured content linked with a subset of the quality information.
  • The quality information may include real-world product or process data. The report may be linked with a subset of the real world data and may include a descriptive or statistical analysis of the product/process status and/or other quality information. Preferably, the descriptive or statistical analysis is presented in a graphical format. Some or all of the quality information may be sourced from within as well as outside of the enterprise, and captured content may be displayed transparent of its source. The report may also include a comparison of achievement of one or more employees' goals to one or more corresponding goals for one or more business entities within the enterprise.
  • According to another embodiment of the present invention, the quality management application may present product or process status information based on linkages among quality information improvement. More specifically, the application may be configured to receive input defining quality information for an enterprise, receive input defining one or more linkages among the quality information, receive input defining a request for a product or process status information, search the quality information for the requested status information based on the one or more linkages, and present search results including at least a portion of the requested product/process status information.
  • The status information may include a current product or process state. The status information may also include one or more product or process improvement opportunities.
  • The improvement opportunities may relate to customers or suppliers of the enterprise. The quality information may include realized product or process information or data.
  • Another embodiment of the present invention may also support product or process status management. More specifically, the application may be configured to receive input defining two or more sets of quality documentation for an enterprise, each set having one or more elements, configured to link two or more of the elements, configured to receive input including an update for at least one of the elements, wherein the update includes realized product or process information, and configured to automatically update any other linked elements. The realized product or process information may include realized product or process data. The linkages may be user-defined.
  • Preferably, these and other embodiments and features of the present invention are implemented in an online fashion based on a client-server architecture. Client-server communication may be facilitated or otherwise supported by corporate intranet (e.g. LAN) and/or the Internet including the World-Wide-Web.
  • Still further features, objects and advantages of the present invention will become readily apparent to those in the field of art to which the invention pertains upon reference to the following detailed description, drawings and claims.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a model of a process-based quality management system (e.g. TS 16949:2002 and ISO 9000:2000) including an example of how various aspects of an Enterprise-wide Quality Management System (“EwQMS” may be associated and/or implemented, in accordance with one embodiment or aspect of the present invention;
  • FIG. 2 is an example schematic comparing two hypothetical enterprises that an administrator might define within the EwQMS;
  • FIG. 3 is a block flow diagram illustrating a preferred methodology for setting up certain EwQMS features (sites, entities, users, etc.) within an enterprise, in accordance with one embodiment or aspect of the present invention;
  • FIG. 4 is an example GUI for accessing authorized documents from among a plurality of administrator-defined levels or categories, transparent of the source of those documents in accordance with one embodiment or aspect of the present invention;
  • FIG. 5 is an example GUI for viewing and maintaining authorized documents in accordance with one embodiment or aspect of the present invention;
  • FIG. 6 is a schematic illustrating an example implementation of EwQMS modules within an enterprise in accordance with one embodiment or aspect of the present invention;
  • FIG. 7 is an example data exchanger GUI for creating links between EwQMS data tables and external data in accordance with one embodiment or aspect of the present invention;
  • FIG. 8 is an example GUI for specifying a connection between EwQMS data tables and external data in accordance with one embodiment or aspect of the present invention;
  • FIG. 9 is an example GUI for executing the data exchange within the EwQMS based upon the defined links (see FIGS. 7 and 8) in accordance with one embodiment or aspect of the present invention;
  • FIG. 10 is an example GUI for defining categories of customer expectations and linking those customer expectations with result measurables, key processes, and process measurables in accordance with one embodiment or aspect of the present invention;
  • FIG. 11 is an example GUI showing example results when a “key process” of FIG. 10 is selected/changed in accordance with one embodiment or aspect of the present invention;
  • FIG. 12 is an example GUI for defining linkages between entity goals and objectives and individual employee goals for realizing the entity goals in accordance with one embodiment or aspect of the present invention;
  • FIG. 13 is an example GUI providing a visual analysis according to linkages such as those referred to with respect to FIG. 10 in accordance with one embodiment or aspect of the present invention;
  • FIG. 14 is a schematic illustrating an example set of content linkages among a plurality of business documents in accordance with one embodiment or aspect of the present invention;
  • FIG. 15 is an example GUI for establishing linkages such as those referenced in FIG. 14 in accordance with one embodiment or aspect of present invention; and
  • FIG. 16 is a block flow diagram illustrating a preferred implementation of process knowledge management in accordance with one embodiment or aspect of present invention.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S) Overview of the EwQMS
  • FIG. 1 is a model of a process-based quality management system (e.g. TS 16949:2002 and ISO 9000:2000) including an example of how various aspects of the EwQMS (described in greater detail below) may be associated and/or implemented in accordance with one embodiment or aspect of the present invention. Notably, associations between the quality management system and EwQMS modules shown in FIG. 1 may be adapted or modified to best-fit a particular implementation of the present invention. In addition, those of ordinary skill in the art will recognize that features of the present invention may be implemented to support a wide variety of other business and quality system structures (e.g. QS 9000, ISO 14000, VDA 6.1 etc.).
  • More specifically, functionality supported by the EwQMS may be generally referenced by or “divided” into different modules including but not limited to those referenced in Table 1. Table 1 additionally provides a non-exclusive summary of functionality that each module provides.
  • TABLE 1
    Ref. Module Summary
    70 Document Manages and controls online documents in
    Manager any data format.
    Manages and controls online
    document/revision feedback and approval
    process, including automatic e-mail
    notification and escalation.
    Security can be set at user-defined levels of
    granularity (e.g., site, group, individual, etc.).
    Manages and controls user-defined linkages
    among documents, including content-based
    linkages.
    Documents can be aggregated among an
    unlimited number of user-defined levels -
    each with their own user-defined security
    controls.
    User functionality and menu options are
    limited based on user rights and privileges.
    Limitations are transparent to the user.
    60 Product/Process Develops and maintains documents relating to
    Realization the product and process development cycle
    (e.g., Advanced Product Quality Planning
    process, etc.).
    Maintains user and system-defined linkages
    among related product realization documents.
    Supports multiple user-defined formats for
    each document type.
    Flexibly filters and sorts documents
    according to a user-defined specification
    based on any document content.
    Highlights changes (e.g., revisions,
    additions, deletions, etc.) in documents based
    upon user-specified dates.
    Links table entries according to different
    levels of user-defined scope (e.g., global,
    family, product, etc.)
    Supports multiple ways of creating products
    (i.e. sets of product and process documents):
    Create a new product from scratch
    Create an independent product by
    copying the content of an existing
    product
    Links a new product to an existing
    product as a template such that
    changes in the template may be
    reflected in the new product
    Links the process documentation of a
    new product using subsets of process
    steps from existing products such that
    changes in the existing products used
    may be reflected in the new product
    Links specific process document content to
    document content maintained by other
    modules (e.g., gages which are maintained by
    the Measurement System Analysis module).
    Compliant with the automotive industry's
    FMEA and PPAP manuals.
    68 Measurement Maintains, analyzes and controls variables
    System and attribute measurement systems:
    Analysis Enables a user to conduct bias,
    linearity, stability, and gage
    repeatability and reproducibility
    studies
    Determines the uncertainty related to a
    specific measurement system and
    traceability chain
    Supports a wide variety of graphical
    analyses
    Manages calibration activities including
    automated e-mail notifications.
    Compliant with the automotive industry's
    measurement systems manual.
    Links specific process document content to
    document content maintained by other
    modules (e.g., products which are maintained
    by the Product/Process Realization module).
    66 Productive Manages and controls preventive and reactive
    Maintenance maintenance activities.
    Maintains a historical record of
    maintenance activities
    Automatically issues preventive
    maintenance work orders
    Supports the creation of reactive
    maintenance work orders
    Analyzes the reactive maintenance activities
    and causes of failure (e.g., mean time between
    failure, mean time to repair, cause of failure,
    etc.).
    Links specific process document content to
    document content maintained by other
    modules (e.g., products which are maintained
    by the Product/Process Realization module).
    56 Business Enables a user to develop and
    Operating maintain/manage linkages among customer
    Systems expectations, business strategies, processes,
    and product and process metrics.
    Manages the continual improvement process.
    Meeting scheduling and management
    including automatic e-mail
    notification to participants
    Reporting of meeting minutes to
    participants through the Document
    Manager
    Maintains links to improvement
    proposals and improvement proposal
    ratings
    Maintains links to the problem solving
    documentation maintained by the Problem
    Solver module.
    Maintains links to visual analysis (e.g., drill-
    down analysis functionality) and power
    tracker functionality.
    76 Audit Manager Manages and enables enterprise-wide audit
    activities
    Supports any type of audit (e.g,
    standard based, financial, safety,
    environmental, housekeeping, etc.)
    Audit scheduling and management
    including automatic e-mail
    notification to participants
    Flexible audit handler:
    Provides auditors with forms
    for documenting audit results
    Provides auditees with audit
    results and forms to document
    non-conformance resolutions
    Provides auditors with
    capability to close out an audit
    (e.g., after submission of an
    auditee's corrective action
    reports)
    Generates wide variety of management
    reports based on audit results (e.g.,
    filtered by auditor, nonconformance-
    type, element, etc.)
    Maintains links to the problem solving
    documentation maintained by the Problem
    Solver module.
    Maintains links to visual analysis (e.g., drill-
    down analysis functionality) and power
    tracker functionality.
    74 Performance Manages and enables enterprise-wide training
    Manager activities:
    Supports any type of training (e.g., in-
    house, contract, web-based, etc.)
    Training scheduling and management
    including automatic e-mail
    notification to participants
    Training evaluation: pre-test, post-test,
    and satisfaction evaluations
    Supports personal development planning and
    competency evaluation.
    Customer and employee satisfaction survey
    development and analysis.
    Enables the development and maintenance of
    an organization chart by site, including
    indirect reporting.
    Maintains links to visual analysis
    functionality (e.g., drill-down analysis, etc.).
    64 SPC Maintains and analyzes variables and attribute
    process data:
    Enables a user to conduct stability,
    capability and performance studies
    Determines the statistics related to
    specific product and process
    characteristics
    Supports a wide variety of graphical
    analyses
    Manages the control and analysis activities
    including automated e-mail notifications.
    Compliant with the automotive industry's
    statistical process control (SPC) manual.
    Links specific process document content to
    document content maintained by other
    modules (e.g., products which are maintained
    by the Product/Process Realization module).
    62 Process Enables the development, maintenance and
    Analyzer use of user-defined fault trees including user-
    defined fault tree depth.
    Links real-world data (e.g., from the SPC
    module, the Data Exchange Manager module,
    etc.) to related document content.
    Enables users to query process documents to
    obtain a subset of document content related to
    an improvement opportunity.
    Displays document content linked with
    corresponding real world data.
    Supports user-defined linkages to problem
    solving forms maintained by the Problem
    Solver module.
    58 Problem Solver Enables the development, maintenance and
    use of system or user-defined problem solving
    forms.
    Maintains linkages to other EwQMS modules
    (e.g., Process Analyzer, Business Operating
    Systems, Audit Manager, etc.)
    Links specific problem solving document
    content to document content maintained by
    other modules (e.g., products which are
    maintained by the Product/Process
    Realization module).
    54 Data Exchange Enables the development, maintenance and
    Manager use of system or user-defined linkages
    between EwQMS document content and data
    maintained by non-EwQMS programs.
    Importing data into EwQMS
    according to user-specified timing
    Exporting EwQMS data to user-
    specified non-EwQMS databases
    according to user-specified timing
  • Site and Entity-Based Enterprise Architecture
  • In accordance with one embodiment or aspect of the present invention, an administrator characterizes an enterprise within the EwQMS in terms of “sites” and “entities.”
  • A “site” may be defined as those tangible parts of an enterprise having administration of local processes and documentation. Often, sites are defined geographically (e.g., individual plants, campuses, regions, etc.).
  • An “entity” may be defined as the business organization or architecture of an enterprise. Notably, an entity may cross one or more sites within an enterprise as well as include representation outside of the enterprise (e.g. customers, suppliers, distributors, etc.). For example, a business unit responsible for a particular line of automobiles (an “entity”) within the automotive industry might include elements from (i) the corporate “site” (e.g., engineering development), (ii) one or more manufacturing “sites” and (iii) one or more assembly “sites.” These sites could be distributed across multiple geographic regions including countries and continents.
  • To characterize an enterprise, an administrator defines the enterprise sites and entities. FIG. 2 is an example schematic comparing two hypothetical enterprises that an administrator might define within the EwQMS. Enterprise 10 consists of an international corporation 12 having three business units 14 a-14 c. Business unit 14 a has plants A, B and C in country X. Business unit 14 b has plants D and E in countries Y and Z, respectively, and business unit 14 c has a single plant F in country Z. Enterprise 10 can be defined within the EwQMS as having six enterprise-wide “sites”.
  • In contrast, enterprise 16 consists of a domestic corporation 18 having a single campus with three business units 22, 24 and 26. This enterprise can be defined within the EwQMS as having a single “site.”
  • In comparing the example enterprises 12 and 16 shown in FIG. 2, it is evident that the EwQMS may be flexibly implemented to support and manage the unique needs and architectures of any number of diverse enterprises.
  • FIG. 3 is a block flow diagram illustrating a preferred methodology for setting up certain EwQMS features (sites, entities, users, etc.) within an enterprise. After installing and initializing the EwQMS application, as represented in block 28, an administrator provides input to the EwQMS defining sites within the enterprise, as represented in block 30. There is no limit to the number of sites that an enterprise may possess. Next, as represented in block 32, the administrator defines entities within the enterprise. Notably, entities may have sub-entities associated with them creating an entity hierarchy. For example, an entity may be associated with a customer, and sub-entities could be specific product lines for the enterprise, which that customer purchases. Like sites, there is no limit to the number of entities that an administrator may define.
  • As represented in block 34, the administrator next defines EwQMS users. User definition includes demographic information, contact information, username, password as well as a site and entity association for the user.
  • Once a user account is properly defined within the EwQMS, that user can then access certain information and functionality supported by the EwQMS. In a preferred embodiment, the information and functionality that a user has access to is controlled within the EwQMS by the site and entity that user has been associated with. However, an administrator may limit or expand user access and functionality rights with respect to any information or functionality supported by the EwQMS.
  • Decentralized Document Management and Administration
  • Typically, an enterprise includes processes that span multiple sites (e.g., corporate, business unit, plant, etc.). Some processes are defined and utilized at multiple sites, while others may be defined and utilized by only a single site. More specifically, a particular site can administer and manage documentation associated with his or her site-specific processes. However, where a particular process covers more than one site, one of those sites is considered to be the “owner” of the documentation relating to that process. If a process only applies to a single site, that site is considered the “owner” of the documentation relating to that process.
  • In the case of a process that transcends multiple sites, the “owner” of the process documentation grants the other sites access to that documentation. Notably, an individual user is provided access to that documentation in a fashion that is transparent of the owning site. Consequently, a user may have access to documentation comprising process documentation originating from that user's site as well as process documentation originating from other sites (over which a multiple-site process transcends). The actual location or “owner” of the process documentation, however, will be transparent to that user.
  • FIG. 4 illustrates an example of this aspect of EwQMS. FIG. 4 is an example GUI 36 having a menu region 38 and a data input/presentation region 40. The “Documents” menu item 42 enables a user to select authorized documents from among a plurality of administrator-defined levels or categories 44 (e.g., quality manuals, procedures, work instructions, etc.). An administrator may define an unlimited number of document levels. By selecting document level “Procedures” for example, a user is presented with a table of contents 46 including a plurality of procedure documents to which that user has been granted access. Notably, these documents may originate from the user's own site, or from other sites within the enterprise. For example, the procedure “SOP011” may be “owned” by or originate from the corporate site, whereas procedure “SOP052” may be “owned” by a manufacturing site. In this regard, the true origination of the document is transparent to the user enabling a site to efficiently utilize other sites' documentation and thereby reduce redundant documentation and ensure consistent knowledge across the enterprise.
  • Upon selecting a particular document (“SOP052”), a user may be presented with a GUI 48 such as that illustrated in FIG. 5. Functionality provided to the user includes the ability to view the document, submit a request to the document “owner” to modify or delete the document, solicit a draft revision to selected users for comment, and download the document. Additionally, a user can view and access documents that are related (i.e., “linked”) to the current document via menu 52. Preferably, related documents are displayed according to their document level.
  • Notably, functionality such as that shown in FIGS. 4 and 5 is provided to a user without reference to or limitation by the site that “owns” the document. In this regard, the true origination of the document is transparent to the user enabling a site to efficiently utilize other sites' documentation and thereby reduce redundant documentation and ensure consistent knowledge across the enterprise.
  • Data Sharing Between Entities and Sites
  • Typically, an enterprise maintains a wide variety of data across several business functions (e.g. human resources, manufacturing activities, inspection and testing activities, continual improvement activities, etc.). However, data associated with one of these activities may not be unique to that activity, and may overlap with others within the enterprise. In this regard, as aspect of the EwQMS enables data sharing between sites and entities to reduce redundant data entry and ensure consistent knowledge across the enterprise.
  • FIG. 6 is a schematic illustrating an example implementation of EwQMS modules within an enterprise. Notably, the content or arrangement of FIG. 6 may be adapted, reduced or expanded to best-fit a particular implementation of the present invention. Table 1 lists and generally describes the function of each EwQMS module.
  • Linkages between EwQMS modules 54 through 78 may be generally divided into three categories: core interrelationships (denoted by solid lines 84), document flows (denoted by short-dashed lines 80) and data exchange (denoted by long-dashed lines 82).
  • The data exchanger module 54 enables EwQMS to share data with non-EwQMS applications (e.g. “legacy” systems, enterprise resource planning systems, etc.) in an effort to reduce redundant data entry and ensure consistent knowledge across the enterprise.
  • FIG. 7 is an example data exchanger GUI 86 for creating a link between EwQMS data tables and external data. To initiate a new link according to this example, a user selects the “Data Source” button 88 and is presented with pop-up GUI 90 illustrated in FIG. 8. Through GUI 90, the user specifies the connection between the EwQMS data tables and external data (e.g. connection type, driver, database, username, password, etc.). Next, the “Source Tables” region 92 is populated. Upon selecting a source, the “Field Names” region 94 is populated. The user performs the same method with respect to the “Suite Tables” 96 and “Field Names” 98. To link a EwQMS field with an external field, the user selects respective fields and depresses the “Make Link” button 100. In response, the EwQMS establishes the data link as shown in region 102. When a link is successfully defined, a user selects the “Save Links” button 104 to finalize the link.
  • FIG. 9 is an example GUI 106 for executing the data exchange within the EwQMS based upon the defined links (see FIGS. 7 and 8). To execute a data exchange, a user selects one or more linked tables within region 107, transferring them to region 108. The user also inputs a job name 110 and a start time and execution frequency 112.
  • Notably, the data exchange process described with respect to FIGS. 6-9 may be implemented with respect to any of the EwQMS modules (see Table 2).
  • Enterprise-Wide Business Operating System Linkages
  • Within an enterprise, logical interrelationships exist or should be defined among business strategies, actions for realizing those strategies, and related documentation. The EwQMS captures and utilizes these interrelationships in enterprise-wide manner to (i) define and maintain a constancy of purpose in achieving goals of the business strategy, and (ii) reduce error and effort (i.e., redundancy) in developing and administering documents related to achieving those goals within an enterprise.
  • As shown in FIG. 10 for example, the EwQMS enables a user to define categories of customer expectations 126 and link customer expectations 116, result measurables 118, key processes 120 and process measurables 122 to those categories in an online fashion.
  • In one embodiment, a user may define and use an “Alignment Chart” by inputting or otherwise selecting an “Entity” 124. An “Expectation Category” 126 is selected from a pull-down list of user-defined categories of customer expectations. An “Alignment Chart” for the selected “Expectation Category” is then displayed. This chart consists of the “Customer Expectations” 116, “Result Measurables” 118, “Key Processes” 120, and related “Process Measurables” 122.
  • The user can restrict the display to only those “Customer Expectations” which satisfy logical constraints determined by pull-downs 128 and 130 (e.g. an “Importance Level” greater than a user-defined value).
  • The user can also add elements in the “Result Measurables”, “Key Processes”, and related “Process Measurables” areas by clicking on the respective “New” buttons (132, 134, 136) and either by entering free-text or selecting an element from a table of user-defined result measurables, key processes, or process measurable.
  • Additionally, a user can input and display strategic goals 114 for achieving the selected expectation category 126.
  • Entries within the “Process Measurables” area 122 are linked to entries within the “Key Process” area 120. FIG. 11 shows example results when the key process “Advanced Quality Planning” shown in FIG. 10 is selected via radio button 138. The process measurables entry “gates missed” is also selected via radio button 140. This feature of the EwQMS enables a user to initiate online proposals for improving the selected key process (by clicking the “Improvement Proposal” button 142). This feature of the present invention facilitates and manages an enterprise's continual improvement activities. In addition, this feature of EwQMS supports data analysis through a “drill-down” functionality (discussed in greater detail below).
  • Within EwQMS, business goals and objectives can also be linked to individual employees within an enterprise. This feature of EwQMS ensures constancy of purpose down to a personal or individual level of granularity. In addition, this feature supports employee performance evaluation including recognition (e.g. appraisal and bonus systems), as well as a visual display of an employee's achievement of goals over time (i.e. trends) or at a specific point in time.
  • FIG. 12 is an example GUI illustrating user-defined linkages between entity goals and objectives 144 and individual employee goals 146 for realizing the goals of the entity 144. The example GUI displays related “Short Term Goals” 148 and “Long Term Goals” 150 for each “Expectation Category” 144. The user then selects an “Employee” 152 and inputs one or more “Short Term Goals” and “Long Term Goals” for any or all of the “Expectation Categories” of the entity. The user can also relate a “Visual Analysis Worksheet” 154 and “Power Tracker Value” 156 to each goal.
  • A visual analysis worksheet (not shown) collects and displays the results for a particular result or process measurable (FIG. 10) over time (e.g. trend analysis, pareto analysis, etc.). A power tracker evaluates the product or process measurable with respect to the short and/or long term goals for a specific time or time period. A status indicator (e.g. stoplight icon 158) may visually reflect the extent to which the employee has achieved the corresponding goal(s).
  • Another feature that EwQMS supports is linkage-based visual data analysis and reporting. Utilizing this feature of the present invention, a user can quickly and visually “drill down” through graphical data displays according to user-defined linkages such as those referred to with respect to FIG. 10. FIG. 13 is an example GUI illustrating this feature of EwQMS. More specifically, a “Visual Analysis” is provided for a user-defined and selected measurable (e.g. “downtime” 160) over a user-defined period of time and periodicity (e.g. “monthly”) 162. A path 164 of aggregation levels for the Visual Analysis is provided demonstrating to the user various levels of granularity among the relevant data.
  • In accordance with a preferred embodiment of the Visual Analysis feature of EwQMS, a user “drills down” into the aggregation levels by selecting a data feature (e.g. line, legend item, bar, etc.) on the displayed graphic 166 (e.g. line graph, bar graph, pie chart, pareto chart, etc.). In a Web-based implementation of the EwQMS, a user may “drill up” by selecting the “Back” button within the user's Web browser. Notably, other methods for drilling into or out of aggregation levels may be provided (e.g. zoom-in, zoom out, etc.).
  • Enterprise-Wide Document Content Linkages
  • Within an enterprise, logical interrelationships exist or should be defined among business document content (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.). The EwQMS captures and utilizes these interrelationships in enterprise-wide manner in an effort to reduce redundant data entry and ensure up-to-date and consistent knowledge across the enterprise.
  • More specifically, EwQMS implements linkages between business document content such that information entered into certain portions of one document automatically propagates to appropriate portions within other documents that use or include the same type of information. Notably, this propagation of content is dynamic in that the user can enter the information from any of the documents that contain it. The user is not constrained to a specific path of information entry or document development. This approach minimizes redundant data entry and reduces the risk that related documents will have different revision levels of the same data.
  • FIG. 14 is a schematic illustrating an example set of content linkages among a plurality of business documents. In the example shown in FIG. 14, the business documents relate to “product realization.” However, linkages among business document content may be established within EwQMS for a wide variety of other document categories (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.).
  • In particular, FIG. 14 displays example content linkages among various documents generated during product realization activities. For example, design verification planning and reporting (“DVP&R”) 168 and design failure mode and effects analysis (“DFMEA”) 170 are documents that are typically generated during the design phase of the product realization process. Linkages 172 and 174 ensure that information (i.e. item number and design control, respectively) that are input by a user into the DFMEA 170 is automatically reflected in appropriate sections of the DVP&R 168, and visa-versa. This feature of the EwQMS reduces or eliminates the need for redundant data entry in documents having common content. As a result, this feature minimizes user error and ensures that all users of the EwQMS are provided with consistent and up-to-date information.
  • FIG. 14 also displays content linkages among process documentation (e.g. process flow 176, process FMEA 178, control plan 180 and check sheet 182). Linkages are also provided between the design and process documents. For example, linkage 184 might link a first effect of a process failure mode input into the PFMEA 178 to a design failure mode within the DFMEA 170. This linkage 184 results in the creation of linkage 186, which relates product and process characteristics from the process documents (176-182) to the DFMEA 170. Notably, an unlimited number and arrangement of content linkages may be provided in accordance within the scope of the present invention. Additional linkages 214 may be established between and among EwQMS documentation (e.g. FIGS. 4-6).
  • According to another aspect of the present invention, linkages 216 may be established between any document content item (e.g. cell within a control plan) and any document managed by the EwQMS. For example, a user may link a particular cell within a control plan to the related work instruction document or process inspection checksheet or form. FIG. 15 illustrates an example “pop-up” GUI for establishing such linkages. To establish a link in accordance with this example, a user performs a “right-click” operation over a document cell to obtain the GUI shown in FIG. 15. To associate one or more documents with the cell, the user selects a level 218 and then selects one or more available documents for that level through listing 220. Notably, after establishing such a link, the EwQMS automatically makes available to the user the latest and most up-to-date version of the linked document.
  • Process Knowledge Management
  • Based on linkages and interrelationships such as those illustrated and described with respect to FIGS. 6 and 14, the EwQMS enables a user to continually improve products and processes within an enterprise. The EwQMS provides an efficient tool for identifying a concise subset of product and process document content for evaluation by a user (e.g. subject matter expert) in an effort to identify and act upon improvement opportunities.
  • FIG. 16 is a block flow diagram illustrating a preferred implementation of process knowledge management in accordance with a preferred embodiment of the present invention. Notably, the content or arrangement of FIG. 16 may be modified or adapted to best-fit a particular implementation of the present invention. Activities associated with process knowledge management may be divided into categories including: continual document updating 188, fault tree development 190, improvement opportunity development 192, and improvement opportunity evaluation 194.
  • Continual document updating 188 includes collecting real world data 196 and linking that data within EwQMS to related documents or portions thereof, as represented in block 198. Linkages may be established in a manner similar to that illustrated and described with respect to FIGS. 6 and 14. For example, product and process characteristics (e.g. characteristic performance—stability and variability metrics including occurrence values in the PFMEA, etc.) may be linked and automatically updated within EwQMS with actual performance results or data available directly through EwQMS suite modules (e.g. SPC, Process Pro, Process Analyzer, Audit Pro, Boss) (FIG. 6) or imported by the suite from external programs (e.g. data entry via handheld device links to a hard gage in the customer's, plant's, or supplier's production facility). Notably, continual document updating should be implemented in on an ongoing basis within an enterprise.
  • In one embodiment of the present invention, a fault tree 202 is developed/defined 200 in an online fashion and displayed in an org chart graphical format with one or more user-defined levels (e.g., system fault=>subsystem fault=>component fault=>part fault=>part characteristic, etc.). Element definition may include a related product number or other identifier that links the element with related documentation. EwQMS uses (i) these user-defined linkages and (ii) linkages between the user-defined levels and fault tree elements themselves to relate a specific set of product realization and/or other business documentation (e.g. quality documents, engineering documents, process documents, maintenance procedures, work instructions, etc.) to the fault tree 202.
  • In one embodiment, improvement opportunity development 192 includes periodic management review of result and process metrics (e.g. FIGS. 10-13) in an effort to identify product or process improvement opportunities, as represented in blocks 206 and 204. If an improvement opportunity is identified a user may submit a query to EwQMS relating to the opportunity (e.g. text-based query, fuzzy search, relational query, etc.). In a preferred embodiment, the EwQMS executes the user-defined query relating to an improvement opportunity against the fault tree and linked documentation, as represented in block 210. Query results preferably include a subset of documentation or documentation content.
  • As represented in block 194, the EwQMS automatically associates the results of the user-defined query with real world data 198 related to those results. For example, process indices such as Cp, Cpk, Pp, Ppk or ppm can be linked to the occurrence rating contained in the PFMEA (see FIG. 14, item 212). This feature of the present invention enables a user (e.g. subject matter expert) to review and identify potential solutions for realizing improvement opportunities both inside and outside of the enterprise (e.g. among suppliers, distributors, customers, etc.).
  • System Specifications
  • Preferably, aspects of the present invention are implemented according to a client-server architecture. Those of ordinary skill in the art will recognize, however, that functionality such as that illustrated and described herein may be implemented or otherwise delivered over a variety of other platforms including but not limited to mainframe and stand-alone computing environments. Functionality such as that illustrated and described herein may also be delivered in a source code or object code format embodied in a wide variety of mediums (e.g. CD-ROM, magnetic disc, DVD, online download, etc.).
  • Table 2 includes recommended technical specifications for a client-server implementation of the present invention.
  • TABLE 2
    Component Recommended Specifications
    Server Processor Intel Pentium-class 500 MHZ or higher
    RAM 256 MB
    OS Apps Microsoft Internet Information Server (IIS)
    SMTP component installed.
    IIS version 4.0 on Windows NT 4.0
    SP 6 or later
    IIS version 5.0 or later on Windows
    2000 (part of NT/2000 server set-up)
    OS Apps SQL Server 7 SP2 or SQL Server 2000
    (preferred)
    ORACLE version possible
    OS/Apps Microsoft Data Access Components
    version 2.6 or higher (compatible with
    selected SQL server)
    http://www.microsoft.com/Data/download
    .htm
    OS/Apps Microsoft Transaction Server
    MTS version 2.0 - (NT only)
    http://www.microsoft.com/ntserver/nts/do
    wnloads/recommended/NT4OptPk/default
    .asp
    Hard Disk
    40 MB (min)
    Client OS Win95/98/NT/2000/XP or later
    Processor Pentium-class PC 300 MHZ or higher
    Browser Internet Explorer 6.0 or later
    W3C standards compatible with support
    for client side active X controls (for
    graphical/hierarchical data display, etc.)
    SVG viewer
    http://www.adobe.com/svg/viewer
    /install/
    Monitor 800 × 600 (or better)
  • While embodiments of the invention have been illustrated and described, it is not intended that these embodiments illustrate and describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention.

Claims (20)

1.-36. canceled
37. A system comprising:
a processor configured to:
establish linkages between content elements of a plurality of parent documents, such that changes to a first content element in a first parent document automatically populate to a second linked content element in a second parent document;
determine if a new child product shares a production process with a parent product to which the parent documents apply;
assign parent documents associated with the production process as new child documents, wherein the child documents inherit the content element linkages between assigned child documents, defined with respect to the parent documents based on which the new child documents are assigned, wherein the processor is configured to populate a change to a parent content element to:
linked parent content elements in other parent documents,
any assigned new child document content elements derived from a changed parent document containing the parent content element, and
any linked child content elements linked to the new child document content element;
wherein the parent documents comprise at least a design verification plan and report document (DVP&R), a design failure mode and effects analysis (FMEA) document, a process flow document, a process FMEA document and a control plan document; and
wherein the DVP&R document is linked to at least the design FMEA document, the design FMEA is linked to at least the DVP&R document, the process flow document and the process FMEA document, the process flow document is linked to at least the design FMEA document and the process FMEA document, the process FMEA document is linked to at least the process flow document and the control plan document.
38. The system of claim 37, wherein the DVP&R document is linked to the design FMEA document with respect to a design control content element.
39. The system of claim 37, wherein the design FMEA document is linked to the process FMEA document with respect to a potential failure mode content element of the design FMEA document being linked to a process failure mode content element of the process FMEA document.
40. The system of claim 37, wherein a linkage between a product or process characteristics content element of the design FMEA document relates product or process characteristics from the process flow document to the design FMEA document.
41. The system of claim 37, wherein the products or process characteristics linked between the process flow document and the design FMEA document are also linked to the process FMEA document and the control plan document, such that changes to a PCID element of any one of the process FMEA document, control plan document or process flow document will populate to other linked PCID content elements.
42. The system of claim 37, wherein the process flow document is linked to the process FMEA document with respect to a product characteristics description content element in each of the process flow and process FMEA documents.
43. The system of claim 37, wherein the process FMEA document is linked to the control plan document with respect to a preventative controls and detective controls content element in the process FMEA document being linked to a control methods content element in the control plan document.
44. The system of claim 37, wherein a process function content element is linked between at least the process flow document, the process FMEA document and the control plan document.
45. The system of claim 37, wherein a description content element is linked between at least the process flow document, the process FMEA document and the control plan document.
46. A computer-implemented method comprising:
establishing linkages between content elements of a plurality of parent documents, such that changes to a first content element in a first parent document automatically populate to a second linked content element in a second parent document;
determining if a new child product shares a production process with a parent product to which the parent documents apply;
assigning parent documents associated with the production process as new child documents, wherein the child documents inherit the content element linkages between assigned child documents, defined with respect to the parent documents based on which the new child documents are assigned, wherein a change to a parent content element is populated to:
linked parent content elements in other parent documents,
any assigned new child document content elements derived from a changed parent document containing the parent content element, and
any linked child content elements linked to the new child document content element;
wherein the parent documents comprise at least a design verification plan and report document (DVP&R), a design failure mode and effects analysis (FMEA) document, a process flow document, a process FMEA document and a control plan document; and
wherein the DVP&R document is linked to at least the design FMEA document, the design FMEA is linked to at least the DVP&R document, the process flow document and the process FMEA document, the process flow document is linked to at least the design FMEA document and the process FMEA document, the process FMEA document is linked to at least the process flow document and the control plan document.
47. The method of claim 46, wherein the DVP&R document is linked to the design FMEA document with respect to a design control content element.
48. The method of claim 46, wherein the design FMEA document is linked to the process FMEA document with respect to a potential failure mode content element of the design FMEA document being linked to a process failure mode content element of the process FMEA document.
49. The method of claim 46, wherein a linkage between a product or process characteristics content element of the design FMEA document relates product or process characteristics from the process flow document to the design FMEA document.
50. The method of claim 49, wherein the products or process characteristics linked between the process flow document and the design FMEA document are also linked to the process FMEA document and the control plan document, such that changes to a PCID element of any one of the process FMEA document, control plan document or process flow document will populate to other linked PCID content elements.
51. The method of claim 46, wherein the process flow document is linked to the process FMEA document with respect to a product characteristics description content element in each of the process flow and process FMEA documents.
52. The method of claim 46, wherein the process FMEA document is linked to the control plan document with respect to a preventative controls and detective controls content element in the process FMEA document being linked to a control methods content element in the control plan document.
53. The method of claim 46, wherein a process function content element is linked between at least the process flow document, the process FMEA document and the control plan document.
54. The method of claim 46, wherein a description content element is linked between at least the process flow document, the process FMEA document and the control plan document.
55. A computer readable storage medium, storing instructions that, when executed, cause a processor to perform a method comprising:
establishing linkages between content elements of a plurality of parent documents, such that changes to a first content element in a first parent document automatically populate to a second linked content element in a second parent document;
determining if a new child product shares a production process with a parent product to which the parent documents apply;
assigning parent documents associated with the production process as new child documents, wherein the child documents inherit the content element linkages between assigned child documents, defined with respect to the parent documents based on which the new child documents are assigned, wherein a change to a parent content element is populated to:
linked parent content elements in other parent documents,
any assigned new child document content elements derived from a changed parent document containing the parent content element, and
any linked child content elements linked to the new child document content element;
wherein the parent documents comprise at least a design verification plan and report document (DVP&R), a design failure mode and effects analysis (FMEA) document, a process flow document, a process FMEA document and a control plan document; and
wherein the DVP&R document is linked to at least the design FMEA document, the design FMEA is linked to at least the DVP&R document, the process flow document and the process FMEA document, the process flow document is linked to at least the design FMEA document and the process FMEA document, the process FMEA document is linked to at least the process flow document and the control plan document.
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