Quality information management system

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.

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.