Quality control device, quality control method, and quality control program

The quality control device addresses the challenge of managing diverse product quality by using updated statistical values for automatic pass/fail judgments, enhancing quality management and reducing operational burden.

JP7754870B2Active Publication Date: 2025-10-15OBIC CO LTD
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Patent Information

Application Number
JP2023049889
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2023-03-27
Publication Date
2025-10-15
Estimated Expiration
2043-03-27

AI Technical Summary

Technical Problem

Existing quality control systems struggle to detect abnormal values and perform trend analysis as they rely solely on static standard inspection specification values, making it difficult to manage diverse product quality and improve quality standards.

Method used

A quality control device and method that utilizes a memory unit to store inspection statistical value data, including specification and control limit values, which are updated based on accumulated inspection results, enabling automatic pass/fail judgments and flexible determination of inspection specifications.

Benefits of technology

This approach reduces operational burden by automatically recalculating statistical values and determining inspection results, allowing for flexible inspection specification determination and improved quality management, applicable to both manufactured and incoming products.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a quality management apparatus, a quality management method, and a quality management program configured to enable management for improving the quality by executing quality inspection based on a control limit which is updated every time with accumulated inspection results of the quality inspection as well as a standard value.SOLUTION: A quality management apparatus is configured to: acquire inspection result data in which inspection measurement values and pass / fail determination of inspection items for a product are set, on the basis of the inspection measurement values detected in accordance with an inspection instruction set in association with the product and the inspection items and inspection statistic data; and update the inspection statistic data on the basis of the inspection result data.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] The present invention relates to a quality control device, a quality control method, and a quality control program. [Background technology]

[0002] Patent Document 1 discloses a configuration in which, when the inspection standard values ​​for an object to be inspected are updated, they are registered in a storage unit as standards to be applied, and when the application date for the updates arrives, the inspection standard values ​​stored in the storage unit are updated, thereby enabling inspections to be performed using the new updated inspection standard values. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2013-134560 Summary of the Invention [Problem to be solved by the invention]

[0004] However, in the invention described in Patent Document 1, quality control is carried out by defining standard inspection specification values ​​for various inspection items. However, as the required level of quality increases and the products handled become more diverse, there is a problem that it is difficult to detect abnormal values ​​and perform trend analysis by managing only the standard inspection specification values.

[0005] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a quality control device, a quality control method, and a quality control program that can perform management to improve quality by performing quality inspections based not only on inspection specification values ​​but also on control limit values ​​that are updated each time based on the accumulated inspection results of quality inspections. [Means for solving the problem]

[0006] In order to solve the above-mentioned problems and achieve the object, the quality control device of the present invention is a quality control device equipped with a memory unit and a control unit, wherein the memory unit comprises an inspection memory means for storing inspection statistical value data set by linking specification values ​​that define the quality specifications of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and the control unit comprises an inspection results acquisition means for acquiring inspection measurement values ​​detected in accordance with inspection instructions set by linking the product and the inspection items, and inspection results data that sets the inspection measurement values ​​and pass / fail judgments of the inspection items for the product based on the inspection statistical value data, and an update means for updating the inspection statistical value data based on the inspection results data.

[0007] Furthermore, in the quality control device according to the present invention, the inspection result acquisition means acquires the inspection measurement values ​​detected in accordance with the inspection instructions set in association with the product and the inspection items, and the inspection statistical value data, and if the inspection measurement values ​​are between the specification value and the control limit value, acquires the inspection result data in which the pass / fail judgment is set to issue a warning for the inspection items for the product.

[0008] Furthermore, in the quality control device according to the present invention, the inspection result acquisition means acquires the inspection measurement values ​​detected in accordance with the inspection instructions set in association with the product and the inspection items, and the inspection result data in which the pass / fail judgment is set to determine that the inspection items for the product are pass, if the inspection measurement values ​​are between an upper limit specification value and a lower limit specification value, based on the inspection measurement values ​​detected in accordance with the inspection instructions set in association with the product and the inspection items, and the inspection statistical value data.

[0009] Furthermore, in the quality control device according to the present invention, the inspection result acquisition means acquires the inspection result data in which the pass / fail judgment is set to fail the inspection item for the product when the inspection measurement value exceeds an upper control limit value or when the inspection measurement value falls below a lower control limit value, based on the inspection measurement value detected in accordance with the inspection instruction set in association with the product and the inspection item, and the inspection statistical value data.

[0010] In addition, in the quality control device according to the present invention, the memory unit further includes a statistical management master in which the inspection items, the number of objects for statistical value calculation, and control limit constants are set in association with each other, and the inspection memory means stores the inspection statistical value data in which the specification values ​​of each of the inspection items for the product, the average values ​​of the inspection measurement values ​​for the inspection items, the standard deviations of the inspection measurement values, and the control limit values ​​for the inspection items are set in association with each other, as well as inspection performance history data in which the inspection items, inspection dates, the inspection measurement values, and the pass / fail judgments for each of the products are set in association with each other, and the update means calculates new average values ​​and standard deviations of the inspection measurement values ​​based on the inspection performance data, the statistical management master, and the inspection performance history data, and calculates new control limit values ​​based on the average values, standard deviations, and control limit constants, thereby updating the inspection statistical value data.

[0011] Furthermore, in the quality control device according to the present invention, the updating means calculates new average values ​​and standard deviations of the inspection measurement values ​​for the number of objects for which statistical values ​​are to be calculated based on the inspection performance data, the statistical control master, and the inspection performance history data, and calculates a lower control limit value obtained by subtracting the product of the standard deviation and the control limit constant from the average value, and an upper control limit value obtained by adding the product of the standard deviation and the control limit constant to the average value, thereby updating the inspection statistical value data.

[0012] Furthermore, in the quality control device according to the present invention, the update means calculates new average values ​​and standard deviations of the inspection measurement values ​​for the number of statistical value calculation objects for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistical control master, and the inspection performance history data, and calculates new control limit values ​​based on the average values, the standard deviation, and the control limit constants, thereby updating the inspection statistical value data.

[0013] In addition, in the quality control device according to the present invention, the inspection statistical value data is set so as to be further linked to a process capability index of the product, and the updating means is further characterized in that it calculates a new process capability index based on the specification value, the average value, and the standard deviation, and updates the inspection statistical value data.

[0014] In addition, in the quality control device of the present invention, the control unit is characterized by further comprising a screen display means for displaying an inspection statistical value inquiry screen in which the inspection statistical value data and the inspection performance history data are set so that they can be referenced, and in which the specification values ​​are set so that they can be changed.

[0015] Furthermore, the quality control method of the present invention is a quality control method to be executed by a quality control device having a memory unit and a control unit, wherein the memory unit comprises an inspection memory means for storing inspection statistical value data set by linking specification values ​​that define the quality specifications of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and is characterized by including an inspection results acquisition step executed by the control unit, which acquires inspection measurement values ​​detected in accordance with inspection instructions set by linking the product and the inspection items, and inspection results data that sets the inspection measurement values ​​and pass / fail judgments of the inspection items for the product based on the inspection statistical value data, and an update step that updates the inspection statistical value data based on the inspection results data.

[0016] Furthermore, the quality control program of the present invention is a quality control program to be executed by a quality control device having a memory unit and a control unit, wherein the memory unit comprises an inspection memory means for storing inspection statistical value data set by linking specification values ​​that define the quality specifications of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and the control unit executes an inspection results acquisition step of acquiring inspection measurement values ​​detected in accordance with inspection instructions set by linking the product and the inspection items, and inspection results data that sets the inspection measurement values ​​and pass / fail judgments of the inspection items for the product based on the inspection statistical value data, and an update step of updating the inspection statistical value data based on the inspection results data. [Effects of the Invention]

[0017] According to the present invention, statistical values ​​are recalculated each time based on the results of various inspection measurements, and the statistical values ​​are used to automatically determine whether an inspection result is passed or failed when the inspection result is registered, thereby reducing the operational burden of quality control and improving quality. Furthermore, according to the present invention, by accumulating performance data such as mean values ​​and standard deviations and then parameterizing the acceptance range, inspection specification values ​​can be flexibly determined. Furthermore, according to the present invention, statistical data is calculated when registering inspection performance data, thereby enabling automatic pass / fail determination of inspection items based on the statistical values. Furthermore, according to the present invention, the present invention can be applied to inspection work not only for manufactured products but also for incoming products. Furthermore, according to the present invention, one-sided or two-sided specifications for various values ​​can be calculated for the inspection statistics, which can be used to evaluate process capability. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a block diagram showing an example of the configuration of a quality control device according to this embodiment. [Figure 2] FIG. 2 is a flowchart showing an example of processing performed by the quality control device according to this embodiment. [Figure 3] FIG. 3 is a diagram showing an example of quality control processing in this embodiment. [Figure 4] FIG. 4 is a diagram showing an example of pass / fail determination in this embodiment. [Figure 5] FIG. 5 is a diagram showing an example of quality control processing in this embodiment. [Figure 6] FIG. 6 is a diagram showing an example of quality control processing in this embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0019] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described in detail with reference to the accompanying drawings. However, the present invention is not limited to this embodiment.

[0020] [1. Overview] First, an outline of the present invention will be described.

[0021] Traditionally, quality control has been important in the manufacturing industry, but the high costs of managing quality standards have been an issue. In particular, in the manufacturing industry, where the range of products handled has become more diverse, high-quality requirements are high for high-performance materials and chemicals, and where there are manufacturing processes involving manual labor, stricter quality management for manual labor is required, further strengthening of quality control has been required. For this reason, in the past, quality standards were set for each product, and when operating a system, the quality standards had to be constantly reviewed and managed. Furthermore, in the conventional operation, once standards were set, the occurrence of low-quality passing products that only slightly met the quality standards was tolerated, and management to improve quality was not possible.

[0022] Therefore, in this embodiment, various measurement values ​​are internally stored during inspection to manage statistical values, and pass / fail is automatically determined based on the statistical values ​​during inspection work.When calculating statistical values, the number of records to be calculated and the upper and lower quality range limits are set for each product and inspection item, and inspection statistical values ​​can be queried.This provides a mechanism that reduces the operational burden of quality by automatically updating quality standards by the system and enables quality improvement.

[0023] [2. Configuration] An example of the configuration of a quality control device 100 according to this embodiment will be described with reference to Fig. 1. Fig. 1 is a block diagram showing an example of the configuration of a quality control device 100 according to this embodiment.

[0024] 1, the quality control device 100 is a commercially available desktop personal computer. Note that the quality control device 100 is not limited to a stationary information processing device such as a desktop personal computer, but may also be a portable information processing device such as a commercially available notebook personal computer, PDA (Personal Digital Assistant), smartphone, or tablet personal computer.

[0025] The quality control device 100 comprises a control unit 102, a communication interface unit 104, a storage unit 106, and an input / output interface unit 108. The units included in the quality control device 100 are connected to each other so as to be able to communicate with each other via any communication path.

[0026] The communication interface unit 104 communicatively connects the quality control device 100 to a network 300 via a communication device such as a router and a wired or wireless communication line such as a dedicated line. The communication interface unit 104 has a function of communicating data with other devices via the communication line. Here, the network 300 has a function of connecting the quality control device 100 and the server 200 so that they can communicate with each other, and is, for example, the Internet or a LAN (Local Area Network).

[0027] An input device 112 and an output device 114 are connected to the input / output interface unit 108. The output device 114 may be a monitor (including a touch panel), a speaker, or a printer. The input device 112 may be a keyboard, a mouse, a microphone, or a monitor that cooperates with a mouse to achieve a pointing device function. In the following, the output device 114 may be referred to as the monitor 114 or the printer 114, and the input device 112 may be referred to as the keyboard 112 or the mouse 112.

[0028] The storage unit 106 stores various databases, tables, files, etc. The storage unit 106 stores computer programs that cooperate with the OS (Operating System) to issue commands to the CPU (Central Processing Unit) to perform various processes. The storage unit 106 may be, for example, a memory device such as a RAM (Random Access Memory) or a ROM (Read Only Memory), a fixed disk device such as a hard disk, a flexible disk, or an optical disk. The storage unit 106 includes an inspection database 106a and a statistics management master 106b.

[0029] The inspection database 106a stores product inspection data. The inspection database 106a may store inspection statistics data, which are set by linking together specification values ​​defining the quality standards for each product inspection item and control limits that define the quality standards for the inspection items and are updated based on the inspection results. The inspection database 106a may also store inspection statistics data, which are set by linking together specification values ​​for each product inspection item, the average inspection measurement values ​​for the inspection item, the standard deviation of the inspection measurement values, and the control limit values ​​for the inspection item, as well as inspection results history data, which are set by linking together the inspection items, inspection dates, inspection measurement values, and pass / fail judgments for each product. The inspection statistics data may also be set by linking together a process capability index for the product. The process capability index may be Cp (Process Capability Index) or Cpk (Process Capability Index based on Katayori).

[0030] The statistics management master 106b is a master in which the test items, the number of statistical value calculation targets, and the control limit constants are linked and set.

[0031] The control unit 102 is a CPU or the like that performs overall control of the quality control device 100. The control unit 102 has an internal memory for storing control programs such as an OS, programs that define various processing procedures, required data, etc., and executes various information processing operations based on these stored programs. Functionally, the control unit 102 includes an inspection record acquisition unit 102a, an update unit 102b, and a screen display unit 102c.

[0032] The inspection result acquisition unit 102a acquires inspection result data that includes the inspection measurement values ​​of a product and pass / fail judgments for the inspection items for the product. Here, the inspection result acquisition unit 102a may acquire inspection result data that includes the inspection measurement values ​​and pass / fail judgments for the inspection items for the product based on the inspection measurement values ​​detected in accordance with the inspection instructions set by linking the product and the inspection items and the inspection statistical value data. Furthermore, the inspection result acquisition unit 102a may acquire inspection result data that includes the inspection measurement values ​​and pass / fail judgments that issue a warning for the inspection items for the product, based on the inspection measurement values ​​detected in accordance with the inspection instructions set by linking the product and the inspection items and the inspection statistical value data, if the inspection measurement values ​​fall between the upper specification limit and the lower specification limit. Furthermore, the inspection result acquisition unit 102a may acquire inspection result data that includes the inspection measurement values ​​and pass / fail judgments that issue a pass / fail judgment for the inspection items for the product, based on the inspection measurement values ​​detected in accordance with the inspection instructions set by linking the product and the inspection items and the inspection statistical value data, if the inspection measurement values ​​fall between the upper specification limit and the lower specification limit. Furthermore, the inspection result acquisition unit 102a may acquire inspection result data that includes a pass / fail judgment that the inspection measurement value and the inspection item for the product are rejected if the inspection measurement value exceeds the upper control limit value or if the inspection measurement value is below the lower control limit value, based on the inspection measurement value detected in accordance with the inspection instructions set in association with the product and the inspection item, and the inspection statistical value data.

[0033] The updating unit 102b updates various data. Here, the updating unit 102b may update the inspection statistical value data based on the inspection performance data. Alternatively, the updating unit 102b may calculate a new mean value and standard deviation of the inspection measurement values ​​based on the inspection performance data, the statistics management master 106b, and the inspection performance history data, and calculate a new control limit value based on the mean value, the standard deviation, and the control limit constant, thereby updating the inspection statistical value data. Alternatively, the updating unit 102b may calculate a new mean value and standard deviation of the inspection measurement values ​​for the number of statistical value calculation targets based on the inspection performance data, the statistics management master 106b, and the inspection performance history data, and calculate a lower control limit value obtained by subtracting the product of the standard deviation and the control limit constant from the mean value, and an upper control limit value obtained by adding the product of the standard deviation and the control limit constant to the mean value, thereby updating the inspection statistical value data. Furthermore, the updating unit 102b may calculate a new average value and standard deviation of the inspection measurement values ​​for the number of statistical value calculation targets for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistics management master 106b, and the inspection performance history data, and may calculate a new control limit value based on the average value, the standard deviation, and the control limit constant, thereby updating the inspection statistical value data. Furthermore, the updating unit 102b may calculate a new process capability index based on the specification value, the average value, and the standard deviation, thereby updating the inspection statistical value data.

[0034] The screen display unit 102c displays various screens. Here, the screen display unit 102c may display an inspection statistical value inquiry screen that is set so that inspection statistical value data and inspection performance history data can be referenced and that is set so that standard values ​​can be changed.

[0035] [3. Specific Examples] A specific example of this embodiment will be described with reference to FIGS.

[0036] [Quality control processing] An example of quality control processing in this embodiment will now be described with reference to Fig. 2. Fig. 2 is a flowchart showing an example of processing by the quality control device 100 in this embodiment.

[0037] As shown in FIG. 2, the inspection results acquisition unit 102a acquires inspection measurement values ​​detected in response to inspection instructions set by linking the product, lot number, and inspection items input by the user via the input device 112, and inspection results data that sets the pass / fail judgment of the inspection items for the product, based on the inspection measurement values ​​detected in response to inspection instructions set by linking the product, lot number, and inspection items input by the user via the input device 112, and the inspection statistical value data stored in the inspection database 106a (step SA-1).

[0038] Then, based on the inspection performance data, the statistical management master 106b, and the inspection performance history data stored in the inspection database 106a, the update unit 102b calculates a new average value and standard deviation of the inspection measurement values ​​for the number of statistical value calculation targets for which the pass / fail judgment is not "fail," calculates a lower control limit value by subtracting the product of the standard deviation and the control limit constant from the average value, and calculates an upper control limit value by adding the product of the standard deviation and the control limit constant to the average value, calculates a new process capability index based on the specification value, the average value, and the standard deviation, and updates the inspection statistical value data stored in the inspection database 106a (step SA-2).

[0039] Then, the screen display unit 102c displays on the output device 114 an inspection statistical value inquiry screen in which the inspection statistical value data and inspection performance history data stored in the inspection database 106a are set to be referable, and the standard values ​​stored in the inspection database 106a are set to be changeable (step SA-3), and the processing ends.

[0040] An example of quality control processing in this embodiment will now be described with reference to Fig. 3 to Fig. 6. Fig. 3, Fig. 5 and Fig. 6 are diagrams showing an example of quality control processing in this embodiment.

[0041] As shown in FIG. 3 , this embodiment stores test statistical data, which includes test statistical values ​​calculated for each product and each test item, as well as test statistical values ​​calculated based on past test data. A user inputs a test instruction into the test instruction input screen to request an inspection based on the test statistical data to determine whether the inspection measurement value falls within the specification range. When the user inputs the test instruction number into the inspection results screen upon detection of the inspection measurement value, a determination of whether the target inspection measurement value falls within the specification range based on the test instruction number is displayed: "Pass," "Warning," or "Fail." Here, in this embodiment, the test statistical data may have lower and upper specification limits set based on control limits, or the company's own specification limits may be set manually. Furthermore, the test instruction input screen in this embodiment may display specification values, which are master registration values, and control limits, which are reference values ​​updated by the statistical values.

[0042] An example of pass / fail determination in this embodiment will now be described with reference to Fig. 4. Fig. 4 is a diagram showing an example of pass / fail determination in this embodiment.

[0043] As shown in FIG. 4, in this embodiment, an inspection measurement value outside the control limit range may be judged as "fail," an inspection measurement value within the control limit range but outside the specification range may be judged as "warning," and an inspection measurement value within the specification range may be judged as "pass."

[0044] 5, in this embodiment, the inspection statistical value data is updated from the most recent 50 lots, including the current inspection results, based on the number of statistical value calculation lots set in the statistical management master 106b. Here, in the inspection statistical value detailed data (inspection performance history data) in this embodiment, an exclusion flag may be set to exclude the result from statistical value calculation. Also, in the inspection statistical value detailed data in this embodiment, if the pass / fail judgment is "fail," the exclusion flag may be set to "exclude." Also, in the inspection statistical value detailed data in this embodiment, for an inspection result with a pass / fail judgment of "pass," the exclusion flag may be manually set to "exclude" to exclude the result from statistical value calculation. Furthermore, the inspection statistical value data in this embodiment may be "lower control limit = mean value - lower control limit constant x standard deviation," "upper control limit = mean value + upper control limit constant x standard deviation," "specification value (Cp) = (upper specification value - lower specification value) / (6 x standard deviation)," "specification value (Cpk) = (upper specification value - lower specification value) / (3 x standard deviation)," "upper specification value = registered value in inspection database 106a," and "lower specification value = registered value in inspection database 106a." Furthermore, in this embodiment, "Cp ≧ 1.67" may be evaluated as more than sufficient process capability (cost reduction can be considered), "1.67 > cp ≧ 1.33" as sufficient process capability, "1.33 > cp ≧ 1.00" as almost good process capability, "1.00 > cp ≧ 0.67" as insufficient process capability, and "0.67 > cp" as very insufficient process capability.

[0045] As shown in FIG. 6, in this embodiment, an inspection statistics inquiry screen is displayed in which statistical value data and statistical value detail data are set, and specification values ​​can be set with reference to control limit values, and the data can be output and analyzed outside the system in Excel (registered trademark) format.

[0046] [4. Contribution to the United Nations-led Sustainable Development Goals (SDGs)] This embodiment can contribute to improving business efficiency and promoting appropriate management decisions by companies, thereby contributing to the achievement of SDGs Goals 8 and 9.

[0047] Furthermore, this embodiment can contribute to reducing waste and promoting paperless and electronic systems, thereby contributing to the achievement of SDGs Goals 12, 13, and 15.

[0048] Furthermore, this embodiment can contribute to strengthening control and governance, which can contribute to the achievement of Goal 16 of the SDGs.

[0049] 5. Other Embodiments The present invention may be implemented in various different embodiments other than those described above within the scope of the technical concept set forth in the claims.

[0050] For example, among the processes described in the embodiments, all or part of the processes described as being performed automatically can be performed manually, or all or part of the processes described as being performed manually can be performed automatically using known methods.

[0051] Furthermore, the processing procedures, control procedures, specific names, information including parameters such as registered data and search conditions for each process, screen examples, and database configurations shown in this specification and drawings can be changed as desired unless otherwise specified.

[0052] Furthermore, with regard to the quality control device 100, the components shown in the drawings are functional concepts, and do not necessarily have to be physically configured as shown in the drawings.

[0053] For example, all or any part of the processing functions of the quality control device 100, particularly the processing functions performed by the control unit 102, may be implemented by a CPU and a program interpreted and executed by the CPU, or may be implemented as hardware using wired logic. The program is recorded on a non-transitory, computer-readable recording medium containing programmed instructions for causing the information processing device to execute the processes described in this embodiment, and is mechanically read by the quality control device 100 as needed. That is, a computer program for issuing instructions to the CPU in cooperation with the OS and performing various processes is recorded in a storage unit such as a ROM or HDD (Hard Disk Drive). This computer program is executed by being loaded into RAM, and cooperates with the CPU to form the control unit.

[0054] This computer program may also be stored in an application program server connected to the quality control device 100 via any network, and all or part of it may be downloaded as needed.

[0055] Furthermore, the program for executing the processes described in this embodiment may be stored in a non-transitory computer-readable recording medium or configured as a program product. Here, the term "recording medium" includes any "portable physical medium" such as a memory card, a Universal Serial Bus (USB) memory, a Secure Digital (SD) card, a flexible disk, a magneto-optical disk, a ROM, an Erasable Programmable Read Only Memory (EPROM), an Electrically Erasable and Programmable Read Only Memory (EEPROM (registered trademark)), a Compact Disk Read Only Memory (CD-ROM), a Magneto-Optical disk (MO), a Digital Versatile Disk (DVD), and a Blu-ray (registered trademark) disc.

[0056] Furthermore, a "program" is a data processing method written in any language or description method, and does not matter whether it is in the form of source code or binary code. Note that a "program" is not necessarily limited to a single structure, but also includes a structure that is distributed as multiple modules or libraries, or a structure that achieves its function by cooperating with a separate program, such as an OS. Note that the specific configuration and reading procedure for reading a recording medium in each device shown in this embodiment, as well as the installation procedure after reading, can use well-known configurations and procedures.

[0057] The various databases stored in the memory unit 106 are storage means such as memory devices such as RAM and ROM, fixed disk devices such as hard disks, flexible disks, and optical disks, and store various programs, tables, databases, and web page files used for various processes and providing websites.

[0058] The quality control device 100 may be configured as an information processing device such as a known personal computer or workstation, or may be configured as the information processing device to which any peripheral device is connected. The quality control device 100 may also be realized by installing software (including programs, data, etc.) that causes the device to perform the processing described in this embodiment.

[0059] Furthermore, the specific form of distribution and integration of the devices is not limited to that shown in the drawings, and all or part of them can be configured by functionally or physically distributing and integrating them in any unit depending on various additions or functional loads. In other words, the above-described embodiments can be implemented in any combination, or embodiments can be implemented selectively. [Industrial Applicability]

[0060] The present invention is useful in industries such as the pharmaceutical industry and chemical industry, where strict standards for quality control of high-performance materials are required. [Explanation of symbols]

[0061] 100 Quality Control Equipment 102 Control section 102a Inspection Record Acquisition Department 102b Update section 102c Screen display section 104 Communication interface unit 106 Storage section 106a Inspection Database 106b Statistics Management Master 108 Input / Output Interface Section 112 Input Device 114 Output Device 200 servers 300 Network

Claims

1. A quality control device comprising a memory unit and a control unit, The storage unit an inspection storage means for storing inspection statistical value data that is set by linking together specification values ​​that define the quality standards of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and inspection results history data that is set by linking together the inspection items, inspection measurement values, and pass / fail judgments of the inspection items of each product; a statistical management master that associates the inspection items, the number of statistical value calculation targets, and the control limit constants; Equipped with The control unit an inspection result acquisition means for acquiring inspection measurement values ​​detected in accordance with inspection instructions set in association with the product and the inspection items, and inspection result data that sets pass / fail judgments for the inspection items for the product, based on the inspection measurement values ​​detected in accordance with inspection instructions set in association with the product and the inspection items, and the inspection statistical value data; an updating means for calculating a new average value and a standard deviation of the inspection measurement values ​​of the number of statistical value calculation objects for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistical management master, and the inspection performance history data, and for calculating a new control limit value based on the average value, the standard deviation, and the control limit constant, thereby updating the inspection statistical value data; A quality control device comprising:

2. The inspection result acquisition means The quality control device according to claim 1, characterized in that, if the inspection measurement value is between the specification value and the control limit value based on the inspection measurement value detected in accordance with the inspection instruction set in association with the product and the inspection item, and the inspection statistical value data, the inspection measurement value and the inspection performance data in which the pass / fail judgment is set to cause a warning to be issued for the inspection item for the product are acquired.

3. The inspection result acquisition means 2. The quality control device according to claim 1, wherein, if the inspection measurement value is between an upper limit specification value and a lower limit specification value based on the inspection measurement value detected in accordance with the inspection instruction set in association with the product and the inspection item, and the inspection statistical value data, the quality control device acquires the inspection measurement value and the inspection performance data in which the pass / fail judgment is set to pass the inspection item for the product.

4. The inspection result acquisition means 2. The quality control device according to claim 1, wherein, based on the inspection measurement values ​​detected in accordance with the inspection instructions set in association with the product and the inspection items, and the inspection statistical value data, if the inspection measurement values ​​exceed an upper control limit value or if the inspection measurement values ​​fall below a lower control limit value, the inspection measurement values ​​and the inspection performance data are acquired, in which the pass / fail judgment is set to fail the inspection item for the product.

5. The inspection storage means 4. The quality control device according to claim 1, wherein the inspection statistical value data is set by linking together the specification value for each of the inspection items of the product, the average value of the inspection measurement values ​​for the inspection items, the standard deviation of the inspection measurement values, and the control limit value for the inspection items, and the inspection performance history data is set by linking together the inspection item, inspection date, the inspection measurement values, and the pass / fail judgment for each of the products.

6. The update means 2. The quality control device according to claim 1, wherein the device calculates new average values ​​and standard deviations of the inspection measurement values ​​for the number of statistical value calculation targets for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistical control master, and the inspection performance history data, calculates a lower control limit value by subtracting the product of the standard deviation and the control limit constant from the average value, and calculates an upper control limit value by adding the product of the standard deviation and the control limit constant to the average value, and updates the inspection statistical value data.

7. The test statistics data is Furthermore, the process capability index of the product is linked and set, The update means 6. The quality control device according to claim 5, further comprising: a step of calculating a new process capability index based on the specification value, the average value, and the standard deviation; and updating the inspection statistical value data.

8. The control unit a screen display means for displaying an inspection statistical value inquiry screen on which the inspection statistical value data and the inspection performance history data are set so as to be referable and the specification values ​​are set so as to be changeable; 6. The quality control device according to claim 5, further comprising:

9. A quality control method to be executed by a quality control device having a storage unit and a control unit, The storage unit an inspection storage means for storing inspection statistical value data that is set by linking together specification values ​​that define the quality standards of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and inspection results history data that is set by linking together the inspection items, inspection measurement values, and pass / fail judgments of the inspection items of each product; a statistical management master that associates the inspection items, the number of statistical value calculation targets, and the control limit constants; Equipped with Executed in the control unit: an inspection result acquisition step of acquiring inspection result data that sets the inspection measurement values ​​and pass / fail judgments of the inspection items for the product based on the inspection measurement values ​​detected in accordance with the inspection instructions that are set by linking the product and the inspection items and the inspection statistical value data; an updating step of calculating a new average value and a standard deviation of the inspection measurement values ​​for the number of statistical value calculation objects for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistical management master, and the inspection performance history data, and calculating a new control limit value based on the average value, the standard deviation, and the control limit constant, thereby updating the inspection statistical value data; A quality control method comprising:

10. A quality control program to be executed by a quality control device having a storage unit and a control unit, The storage unit an inspection storage means for storing inspection statistical value data that is set by linking together specification values ​​that define the quality standards of each inspection item of a product and control limit values ​​that define the quality standards of the inspection items and are updated based on the inspection results, and inspection results history data that is set by linking together the inspection items, inspection measurement values, and pass / fail judgments of the inspection items of each product; a statistical management master that associates the inspection items, the number of statistical value calculation targets, and the control limit constants; Equipped with In the control unit, an inspection result acquisition step of acquiring inspection result data that sets the inspection measurement values ​​and pass / fail judgments of the inspection items for the product based on the inspection measurement values ​​detected in accordance with the inspection instructions that are set by linking the product and the inspection items and the inspection statistical value data; an updating step of calculating a new average value and a standard deviation of the inspection measurement values ​​for the number of statistical value calculation objects for which the pass / fail judgment is not "fail" based on the inspection performance data, the statistical management master, and the inspection performance history data, and calculating a new control limit value based on the average value, the standard deviation, and the control limit constant, thereby updating the inspection statistical value data; A quality control program to ensure that

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