The present invention relates to the integration of process and quality elements into product realization and/or qualification methods. More particularly, the present invention relates to a process platform fully integrated with manufacturing and quality control element(s) for ensuring quality control of the manufactured products.
During an assembly line manufacturing process, a product is tested for quality at multiple points. Usually the enforcement of quality control is performed manually and hence, is prone to human errors such as erroneous data transcription, missing steps or performing incorrect steps in a testing process, erroneous routing through a process flow, using tools for testing that are out of calibration, performing processes for which the user is not trained, among other mistakes. These errors may result in inaccurate test results being obtained. Further, conveying a product with inaccurate test results to a next manufacturing stage may lead to the production of products that suffer from overall inferior quality.
In the later stages of the product development cycle, qualification tests are conducted to verify design performance and establish limits of process induced performance variability. Creating and implementing these test protocols requires significant time and resources.
Most of the manufacturing systems employing quality control processes suffer from drawbacks, such, as lack of integration of manufacturing management element(s), lack of enforcement of manufacturing management element(s) restrictions, misinterpretation of written instructions, difficult data analyses of manual records, inexact process or design change implementation, change implementation at a remote location requiring local manual intervention, and ill-defined traceability between out-of-tolerance calibrated tools and manufactured products.
Hence, there is a need for automated systems and methods for executing and tracking test results of product units being manufactured during multiple stages of production.
There is also a need for a process platform that seamlessly integrates production processes with testing processes and allows data exchange between the processes without requiring manual intervention.
Further, there is a need for a process platform that replaces paper-based manual assembly and test protocols and supports additional processes such as data definition, assembly and test execution and report analysis for different types of products spread across different business units.
Yet further, there is a need for a reliable process and testing platform providing a reduction in time invested in managing in-bound, execution processes and out-bound data.
Additionally, there is a need for integrating design verification testing and production process quality controls which re-use test protocols and routines initially developed for verification purposes.
The present specification describes an automated process platform that integrates an automated quality control testing platform with a manufacturing/production platform for ensuring quality control of the manufactured products.
The automated platform of the present specification comprises a plurality of assembly and test sequences that are executed automatically at predefined stages of the product verification or manufacturing process being implemented by the testing or production platform. In an embodiment, the process platform may be manually configured by using a graphical user interface (GUI). The GUI enables data entry as well as amendment of pre-entered data or test sequences. The process platform may be used for performing quality control checks even at remote locations that are geographically separated from a main data station without requiring an operator for the same at the remote location.
In an embodiment, the present specification provides a new electronic work environment (NEWE) technical user interface and process platform which integrates with existing design and execution platforms, which may, in one embodiment, include design verification, validation and/or qualification elements, to automate and assure quality control at a plurality of stages in a manufacturing process. Information such as design specifications, manufacturing site specifications, manufacturing process variability, testing sequences and manufacturing requirements are input into the NEWE. The NEWE electronically processes the input information and produces information such as test data, process induced performance variation, production results and manufacturing reports. The NEWE also enables equipment tracking throughout the manufacturing process and enforces quality control on the equipment used in the production process. In case of a defect in any of the equipment used, information regarding the products manufactured using the defective equipment may be obtained from an electronic database coupled with the NEWE technical user interface and process platform.
A user may interact with the NEWE database by using a comprehensive GUI which displays required information regarding a manufacturing stage and results of quality control checks performed at the stage.
In one embodiment, the present specification describes a process platform for integrating manufacturing and test process platforms, comprising: a) a manufacturing software subsystem; b) a manufacturing database, in data communication with the manufacturing software subsystem; c) a process design subsystem, in data communication with the manufacturing software subsystem; d) a new electronic work environment technical user interface, coupled to the manufacturing software subsystem; e) at least one display; and f) at least one processor to control the operation of the entire system and its components.
In one embodiment, the manufacturing software subsystem comprises a database that contains manufacturing process software and core system software for controlling manufacturing processes and collecting manufacturing data.
In one embodiment, the manufacturing database is used for housing process parameters for driving manufacturing processes and data collected from the manufacturing processes.
In one embodiment, the process design subsystem is used for storing test sequences and providing a series of instructions to the manufacturing software subsystem to be executed at one or more stages of the manufacturing process.
In another embodiment, the present specification describes a process platform for integrating manufacturing and test process platforms, comprising: a) a manufacturing software subsystem, which comprises a database that contains manufacturing process software and core system software for controlling manufacturing processes and collecting manufacturing data; b) a manufacturing database, in data communication with the manufacturing software subsystem, and used for housing process parameters for driving manufacturing processes and data collected from the manufacturing processes; c) a process design subsystem, in data communication with the manufacturing software subsystem, used for storing test sequences and providing a series of instructions to the manufacturing software subsystem, executed at one or more stages of the manufacturing process; d) an electronic work environment technical user interface, coupled to the manufacturing software subsystem; e) at least one display; and f) at least one processor to control the operation of the entire system and its components.
In one embodiment, the new electronic work environment technical user interface comprises a main interface coupled with the manufacturing software subsystem and is responsible for managing the launching of a manufacturing sequence, synchronizing with the manufacturing sequence, and displaying instructions or results for an operator.
In one embodiment, data is exchanged between the manufacturing software subsystem and the manufacturing database via a database API.
In one embodiment, the process parameters and data collected that are housed within the manufacturing database include at least one of: product lines and definitions, station definitions, user rights definitions, process definitions, or test sequence definitions.
In one embodiment, the process platform further comprises a traceability GUI for handling traceability and tracking definitions and versions of the manufacturing software subsystem, exchanged between the manufacturing database and manufacturing software subsystem.
In one embodiment, the process platform further comprises a publishing GUI for enabling a user to define parameters of the process platform, wherein said parameters include at least one of: assembly details, test details, traceability requirements, or tracking requirements.
In one embodiment, the process platform further comprises an engineering tools GUI for enabling a user to define parameters within the manufacturing software subsystem.
In one embodiment, the process platform further comprises a report viewer for displaying production report results.
In one embodiment, the process platform further comprises a sequence authoring GUI for building and editing test sequences used within the process design subsystem.
In one embodiment, the present specification describes a method for performing automated testing of a product being manufactured at multiple sites of the manufacturing operation, said method being executed by a process platform having at least one computing device executing programmatic instructions stored in non-volatile memory, comprising: a) storing data indicative of a product line in a non-volatile memory; b) storing data indicative of a process for manufacturing said product line in a non-volatile memory; c) storing data indicative of a process for testing said product line in a non-volatile memory, wherein said processes coordinate data flows from a manufacturing software subsystem, a manufacturing database, and a process design subsystem; and d) automatically executing quality control and process flow procedures stored in a non-volatile memory at predefined stages of a manufacturing process being executed by the process platform.
In one embodiment, the manufacturing software subsystem comprises a database that contains manufacturing process software and core system software for controlling manufacturing processes and collecting manufacturing data.
In one embodiment, the manufacturing database houses process parameters for driving manufacturing processes and data collected from the manufacturing processes.
In one embodiment, the process design subsystem stores test sequences and provides a series of instructions to the manufacturing software subsystem that are executed at one or more stages of the manufacturing process.
In one embodiment, the method further includes tracking equipment used in the manufacturing process by automatically monitoring quality parameters of the equipment.
In one embodiment, the method further includes a means for integrating a main production site with a plurality of remote production sites.
In one embodiment, the method further includes a means for implementing quality control procedures at a plurality of remote production sites integrated with a main production site.
In one embodiment, the present specification discloses a system for managing a quality control process, comprising: a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, cause a first graphical user interface to be displayed on a screen; receiving data indicative of a quality level of a component; a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, determine if said quality level meets a threshold level; a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, causes a second graphical user interface to be displayed on a screen, wherein said second graphical user interface comprises a rework option; and a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, causes said component to be disassembled based upon a selection of said rework option.
In another embodiment, the present specification discloses a system for managing a quality control process, comprising: a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, cause a first graphical user interface to be displayed on a screen; receiving data indicative of a quality level of a component, wherein said quality level comprises a qualitative quality level and a quantitative quality level; a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, determine if said quality level meets a threshold level; a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, causes a second graphical user interface to be displayed on a screen, wherein said second graphical user interface comprises a retry option, wherein said retry option is only selectable or displayed if said component is not assembled; and a plurality of programmatic instructions stored in non-volatile memory, wherein said programmatic instructions, when executed by a processor, causes said quality level checks to be performed again on said component based upon a selection of said retry option.
The aforementioned and other embodiments of the present shall be described in greater depth in the drawings and detailed description provided below.
These and other features and advantages of the present invention will be further appreciated, as they become better understood by reference to the detailed description when considered in connection with the accompanying drawings:
The present specification provides a novel process platform for replacing paper-based manual test platforms, paper-based work instructions, travellers, and data collection used for manufacturing products. Additionally, the present specification enables the close integration of verification or qualification tests with the application and enforcement of quality control steps in the execution process. In various embodiments, the architecture of the process platform supports data definition, product assembly and test execution and report analysis for different types of products spread across a single or multiple business unit(s). Further, in various embodiments, operators interact with the process platform through a touch-screen based graphical user interface (GUI) and a barcode or RFID scanner. This functionality replaces operator interaction with work instructions and travellers of a paper based system, thereby reducing errors in quality testing and enforcing a strict quality control.
The process platform described in the present specification addresses the drawbacks of a conventional assembly and test process used in conjunction with a manufacturing process by providing integration of quality and manufacturing management element(s), and enforcing quality and manufacturing management element(s) restrictions. The process platform also allows transfer of quality and manufacturing data and test sequences between a data center and one or more remote production sites, providing implementation of a change at a remote location without any local manual intervention.
The process platform of the present specification is coupled to at least one display, which displays information about each component within the system and the functioning of the system, by means of a GUI. The GUI also presents various menus that allow users to configure settings according to their requirements. The platform further comprises at least one processor to control the operation of the entire system and its components. It should further be appreciated that the at least one processor is capable of processing programmatic instructions, has a memory capable of storing programmatic instructions, and employs software comprised of a plurality of programmatic instructions for performing the processes described herein. In one embodiment, the at least one processor is a computing device capable of receiving, executing, and transmitting a plurality of programmatic instructions stored on a volatile or non-volatile computer readable medium.
The present specification is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
In an embodiment, the Manufacturing Database subsystem 102 is a database which contains process parameters used to drive manufacturing processes as well as data collected from manufacturing processes. Thus, the Manufacturing Database 102 is a clearinghouse for storing information related to manufacturing processes. The Manufacturing Software subsystem 104 is a database which contains manufacturing process software; graphics used in a new electronic work environment technical user interface (NEWE GUI); and the core system software allowing the manufacturing processes to be controlled and manufacturing data to be collected. Communication between the two subsystems occurs by means of an abstract software communication layer. The Process Design subsystem 106 is a commercial off-the-shelf (COTS) programming environment, and communicates to the Manufacturing Software subsystem 104 by means of uploading its native format files.
A plurality of interfaces is provided to enable user interaction within the subsystems of the process platform 100 of the present invention. In one embodiment, sequence authoring is employed where data is manually input into a software application, such as a word processing or spreadsheet application. In one embodiment, a graphical user interface is employed which involves the exchange of XML files, driven by events such as commencing a manufacturing process, publishing a new process revision, etc. Specific embodiments of interfaces are described with greater detail below.
In an embodiment, at least one user interface of the Process Platform 100 comprises a graphical user interface (GUI) 103, coupled to the Manufacturing Software subsystem 104, and is principally used by an operator 112 of the Process Platform 100. In one embodiment, GUI 103 is a New Electronic Work Environment (NEWE) technical user interface which is responsible for managing the launching of a Manufacturing Sequence, which includes both assembly and test processes; synchronizing with the Manufacturing Sequence; and displaying instructions or results for the operator, and is described in greater detail below with respect to
A Traceability API/GUI 114 is provided for handling traceability (association of part identification and part data with the product data); tracking (association of unique part identification with the product data) definitions; and creating versions of the Manufacturing Software subsystem 102 and is principally used by an engineer 116 for defining the traceability and the tracking of parts and products being manufactured and tested by the Process Platform 100. The Traceability API/GUI 114 enables data communication between Manufacturing Software subsystem 104 and Manufacturing Database 102 and ensures that unique part data is linked with the product data to form a complete product data set representing all quality elements of the product.
A Publishing API/GUI 118 is provided for enabling an engineer to define parameters of the Process Platform 100, such as assembly details, test details, traceability and tracking requirements. It constitutes the action of launching the new process design into operation, accomplished by replacement of the existing parameters with new parameters by defining data exchange between the Manufacturing Software subsystem 104 and Manufacturing Database 102.
A database API 105 forms the abstract software communication layer through which data is exchanged; thus, via database API 105, process parameters are collected from the Manufacturing Database 102 and test results get stored back into the Manufacturing Database 102.
An Engineering Tools GUI 122 is provided for defining parameters within the manufacturing database 102, typically used by an engineer.
A Report Viewer 120 is an application provided for displaying production report results that are generated by the Manufacturing Database 102.
A Sequence Authoring GUI 124 is provided to build and edit process design, for process design subsystem 106, typically used by an engineer. Sequence authoring involves manual data input into a commercial off-the-shelf (COTS) software application. Process Design subsystem 106 provides a series of instructions to the manufacturing software subsystem 104, each containing a different set of data elements such as, but not limited to, TQC type, control limits, and Units of Measure.
Process Design subsystem 106 is in data communication with manufacturing software 104, by means of manual uploading of its native format files.
In various embodiments, the manufacturing database 102 may be obtained as a software package from those that may be well-known to those of skill in the art. In an embodiment the Manufacturing Database 102 comprises definitions such as product lines and definitions, station definitions, user rights definitions, process definitions and test sequences definitions that are required for the functioning of the process platform 100.
In various embodiments, the process platform 100, and more specifically, the Manufacturing Database 102 comprises a list of valid products within an organization that are manufactured and subsequently tested, along with their definitions. In an embodiment, the valid products are divided into various product lines, as may be appropriate to the organization that is implementing the process platform. By way of example only, in one embodiment, the product lines may include product lines such as, but not limited to anesthesia delivery and ventilation (AD&V), patient monitoring and connectivity (PM&C), and diagnostic cardiology (DC), each having their specific products associated with that product line.
In an embodiment, process definitions are provided by using a set of structures and rules. In an embodiment, processes are separated by line, group, and sub-group. A sub-group comprises valid product types that share the same process. In an embodiment, the processes are defined in a Sequence of Execution (SOE) module. The SOE module also comprises operation definitions. By way of example only, operations defined in the SOE may include a “Ready” and a “Rework” operation. Each operation defined in the SOE has various characteristics which provide enforcement of manufacturing process. In an embodiment, each operation has a “Fail-transition to the Rework operation” and “Pass-transition between operations” which further enforces the process flow defined in the SOE.
In an embodiment, a publishing repository, housed within Manufacturing Database 102, manages data to be deployed on any remote station where a product requiring the implementation of process(es) described herein is being manufactured. The Manufacturing Database 102 also contains test results and an analysis module which includes formatted information for producing one or more manufacturing and testing reports. The traceability module defines assembly rules that permit multiple products being manufactured to be linked.
In one embodiment, the process platform of the present specification comprises a New Electronic Work Environment (NEWE) technical user interface. In various embodiments, the NEWE Graphical User Interface (GUI) is responsible for managing the launching of a Manufacturing Sequence, synchronizing with the Manufacturing Sequence, and displaying instructions or results for the operator. Design specifications may be input into the NEWE interface whereby work instructions and work orders may be electronically produced thereby eliminating a plurality of manual errors.
In an embodiment, exemplary features of the NEWE GUI 200 include network accessibility between the Manufacturing Software subsystem 224 and the Main Station Interface 201 on the station where it runs, which are easily usable with a touch screen display and a size of 1920×1080 pixels.
In an embodiment, a Main Station Interface 201 of the NEWE GUI 200 is coupled with a module for controlling execution of manufacturing sequences 202 and at least one module 204 for message display 204, which allows for process platform messaging to the user. Also included are image display 206, video display 208, and display of .pdf files 210 which allow graphic images to be retrieved from the test package and displayed to the operator. In one embodiment, the NEWE also includes a module 212 for displaying a menu; a login/logout module 214 which verifies operator identification and ensures that the system is accessed with permission only; an assembly module 216, which provides assembly instructions for a particular part; a rework routing module 218 which routes specific parts or assemblies to a rework function if the quality step or functional test does not meet specification; a rework assembly/disassembly module 220 allowing tracking of sub-assemblies or parts during a disassembly or repair process; and an auto test display module 222 which initiates or displays execution results from an automated testing sub-routine. In one particular embodiment, all of the above-mentioned modules are created through Manufacturing Software control 224.
In an embodiment, when a new product unit is scanned by using the process platform of the present invention, the NEWE GUI creates the unit record in the Manufacturing Database, and commences the execution of a predefined sequence corresponding to the unit. As illustrated the NEWE GUI may display an image (.jpg file), a video (.avi file) or a .pdf file in section 312. Section 314 of the NEWE GUI displays information such as work station identification, operator identification, a serial number and a product number of the unit being tested, an operation identification code, a published package identification and a page number. In an embodiment, a Sales Order number and Sales Order options value are obtained from an operator and are also displayed in section 314. In an embodiment, the NEWE GUI also provides a display to allow assembly and disassembly of already assembled subcomponents during a ‘Rework’ operation.
In an embodiment of the present invention, five types of TQCs are predefined. A Qualitative TQC is displayed in section 316 with a description and two buttons depicting a pass and a fail result. A Quantitative TQC is displayed in section 318 with a description and a text box to enter a value of Numeric Limit Test result. A Tracked Component Assembly TQC is displayed in section 320 with a description as well a text box to scan a unit (the bar code containing the serial number and the part number). In an embodiment, the result is ‘Pass’ if the unit exists in the Manufacturing Database, is in a ‘Ready’ operation, is not already assembled, and if both a Top (parent) product/component and a child product/component of the unit have the same Sales Order number. A Non-Tracked Component Assembly TQC is displayed in section 322 for entering a serial number and the part number of the unit being tested. A Remote Instrument Calibration TQC is displayed in section 324 with a description and a text box to enter an Asset number of the unit being tested.
In various embodiments, a test sequences module can be launched from the NEWE GUI using an Execution Control component (202 in
The present specification describes a novel process platform that replaces paper-based work instructions, travellers, and data collection used for manufacturing products. The present specification provides a method and platform for performing automated testing of a product being manufactured at multiple sites of the manufacturing operation. The process platform of the present invention may be deployed at multiple locations and be integrated with existing quality control systems. The process platform comprises a plurality of pre-defined instructions and is programmed to execute these instructions automatically at different stages for performing desired quality checks on the product being manufactured at multiple manufacturing stages.
The above examples are merely illustrative of the many applications of the system of present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention. Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.
The present specification relies on U.S. Provisional Patent Application No. 61/647,349, filed on May 15, 2012, for priority.
Number | Date | Country | |
---|---|---|---|
61647349 | May 2012 | US |