JP2000067113A - Management support system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To efficiently perform the setting of check items in an internal check, the determination of correcting processing for unsuitable items, efficient review in response to an organization structure and the management of quality records. SOLUTION: A check management system is provided with an unsuitable case data base for holding the template of check items and correcting processing, template receiving part for introducing the template from the data base of a center, template presenting part 16 for presenting the template, and template adding part 17 for introducing the check items and correcting processing to the unsuitable case data base 12 as a new template. The setting of check items and the efficient management of correcting processing for unsuitable items in the internal check for the quality of organization can be performed. The check management system, review system for performing the review in response to the organization quality by hierarchies and quality recording system for managing the quality records are combined and a management support system is constituted so that management can be efficiently supported.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

[0001] 1. Field of the Invention [0002] The present invention relates to a management support system for supporting quality control of an organization based on an ISO or the like via an electronic medium. The present invention relates to a hierarchy-based review system for conducting quality reviews and a quality record system for managing organizational quality records.

[0002]

2. Description of the Related Art ISO 90 is a mechanism for improving the operations of an organization such as a company and improving the soundness and efficiency of management.
Acquisition of the 00 series certification is drawing attention. In particular, following the wave of international division of labor in recent years, building a quality management system for quality management of organizations is an urgent issue not only for large companies but also for small and medium-sized enterprises, which has affected the survival of the company. Has become.

However, since the construction of a quality control system involves a major reform of the business depending on the organization, a quality management support system for supporting the quality control of the organization in order to realize the efficient implementation of the quality control is required. The realization of is essential.

[0004] Since quality control of an organization is based on the documentation of business and the recording of quality, a support system using an electronic medium capable of handling documents and records efficiently is suitable as a support system. I have.

In recent years, the use of groupware as a quality management support system for the ISO quality management system has enabled the quality management system document system, mainly the quality manual, to meet the requirements of the ISO9000 series and the like. Management and quality system internal audits have been developed to realize workflows such as the setting of audit items and the management of corrective actions for nonconformities found in response, management of quality management reviews, and management of quality records. ing.

[0006]

However, the above-mentioned conventional quality control support system merely provides a form and a workflow for inputting those items in the internal audit. For example, setting internal audit items and deciding on corrective actions for nonconformities found in response to them requires experience, but conventional quality control support systems require efficient support for quality control. There was a problem that it was difficult to realize.

In a conventional quality management support system,
The review was performed collectively for various document databases. For example, management reviews actually need to be performed at various levels within the organization. Therefore, it is difficult to carry out a review in accordance with the actual organizational structure, and the conventional quality management support system has a problem that an efficient management review cannot be realized.

Further, in the conventional quality management support system, the record can be discarded only by simply deleting the document data. For example, in order to efficiently manage quality records, it is necessary to sequentially discard documents and the like that are no longer needed, but with the conventional quality management support system, the act of discarding itself cannot be managed. Had a point.

An object of the present invention is to provide an audit management system which solves the above-mentioned problems and which can efficiently set an audit item in an internal audit and determine a corrective action for a nonconformity item found corresponding thereto. As a first object.

[0010] It is a second object of the present invention to realize a hierarchical review system capable of performing an efficient review according to an organizational structure.

It is a third object of the present invention to provide a quality recording system capable of efficiently managing quality records including discarding.

[0012]

In order to solve the above-mentioned problems, according to the present invention, a management support system is provided for setting audit items in an internal audit of an organization's quality system and for checking non-conforming items found correspondingly. The system has an audit management system that manages corrective actions, a hierarchical review system that performs quality management reviews, and a quality record system that manages quality records.

[0013] With this configuration, the setting of audit items in the internal audit, the determination of corrective actions for nonconforming items, the efficient review in accordance with the organizational structure, and the management of quality records are performed. We can provide efficient support.

In addition, the audit management system includes a nonconformance case database means for holding an internal audit audit item and a template for a corrective action of a nonconformity found corresponding thereto, and a nonconformity case database means from an external nonconformity case database system. The template receiving means for receiving and introducing any internal audit audit item and the template for the corrective action of the nonconformity found corresponding to it, and the internal nonconformity case database means during the execution of the internal audit process A template presentation means for extracting and presenting a template of the audit items and the corrective actions for nonconformities found corresponding to them, and the audit items set by the internal audit process and the nonconformities found corresponding to them The corrective action decided on is selected as a new template And configured to have a template additional means for introducing the Failure database means.

[0015] With this configuration, it is possible to provide an audit management system capable of efficiently setting audit items in an internal audit and determining corrective actions for nonconforming items found corresponding thereto.

An external nonconformance case database system can be used to selectively select an internal audit item newly registered in the nonconformance case database means from the template addition means and a nonconformity correction template found corresponding thereto. And a template transmitting means for transmitting to the server. With this configuration, the know-how for correcting nonconformities can be shared across industries.

Further, the configuration is such that the template is received or transmitted by e-mail. With this configuration, the accumulated know-how can be referred to without any manual operation.

A hierarchy-based review system for performing a quality management review is provided by: a department-based management review processing means for individually performing a management review on a department-based database group corresponding to a department of an organization; Department-based management review database means that retains the results of management reviews performed by separate management review processing means, and responds to the higher-level departments in response to the results of each department's management review in the department-based management review database means for each department Upper-level department management review processing means that performs a management review to be performed, and higher-level department management review data that holds the results of management reviews performed by the upper-level management review processing means It has a configuration that includes the over scan means.

With this configuration, it is possible to realize a hierarchical review system that performs efficient reviews in accordance with the organizational structure.

Further, a quality record system for managing quality records is provided by a quality record database means for holding the quality records, and a management review processing means for directly executing the contents of each database or for the management review processing means. A quality record registration unit that registers the obtained execution result as a quality record in the quality record database unit, and a discard target extraction unit that extracts a quality record to be discarded from the quality records registered in the quality record database. The management record processing means further performs a management review on the extracted quality records to be disposed of and is registered as a new quality record in the quality record database means by the quality record registration means. did.

With this configuration, it is possible to realize a quality recording system that efficiently manages quality recording including discarding.

[0022]

BEST MODE FOR CARRYING OUT THE INVENTION
An audit management system that sets audit items in the internal audit of the organization's quality and manages corrective actions for nonconformities found in response to it, a hierarchy-based review system that performs quality management reviews, and manages quality records Is a management support system that has a quality record system that sets audit items in internal audits, decides on corrective actions for nonconformities found in response to those items, reviews in accordance with the organizational structure, and reviews quality, including disposal. This has the effect of efficiently managing records.

According to a second aspect of the present invention, there is provided a nonconformity case database means for holding an audit item of an internal audit of the quality of an organization and a template for a corrective action of a nonconformity item found corresponding thereto, and an external nonconformity. Template receiving means for receiving and introducing any internal audit item and a template for a non-conformity corrective action found corresponding thereto from the case database system to the nonconforming case database means, and processing of the internal audit When executing, the template presenting means for extracting and presenting the audit items of the internal audit and the template of the corrective action of the nonconformity items found corresponding thereto from the nonconformity case database means, Audit items and corresponding nonconformities identified An audit management system including template addition means for selectively introducing corrective actions as a new template into the nonconformity case database means, wherein corrective actions for nonconformities are accumulated as know-how and presented with reference thereto. Has the effect of managing corrective actions.

The third aspect of the present invention is the second aspect of the present invention.
In the audit management system described in the above, the audit items of the internal audit newly registered in the nonconformity case database means from the template addition means and the template of the corrective action of the nonconformity found corresponding thereto are selectively selected, and It has a template transmitting means for transmitting to an external nonconformity case database system, and has an effect of transmitting and accumulating knowhow of nonconformity correction to an external common database.

According to a fourth aspect of the present invention, in the system audit management system according to the second or third aspect, the template is received or transmitted by e-mail. It has the effect of transmitting and receiving without receiving.

According to a fifth aspect of the present invention, there is provided a divisional management review processing means for individually executing a management review on a divisional database group corresponding to an organizational division, and the divisional management review processing means. Management review database means for holding the results of management reviews by the department, and management reviews corresponding to the higher-ranking departments in response to the results of management reviews for each department in the departmental management review database means for each department. A hierarchical review system that includes a higher-level department management review processing means to be performed and a higher-level department management review database means that retains the results of management reviews by the management review of the higher-level department management review processing means. Is a beam, it has the effect that feedback Review the review results of the sub-sectors in the upper division.

According to a sixth aspect of the present invention, there is provided a quality record database means for holding a quality record, and an implementation obtained by executing a management review on the contents of each database directly or by a management review processing means. A quality record registration unit for registering the result as a quality record in the quality record database unit; a discard target extraction unit for extracting a quality record to be discarded from the quality records registered in the quality record database; Means for further performing a management review on the extracted quality records to be discarded in the management review processing means, and registering the execution result as a new quality record in the quality record database means by the quality record registration means; Is a quality recording system equipped with Has the effect that the review and updating.

Hereinafter, an embodiment of the present invention will be described with reference to FIG.
This will be described in detail with reference to FIGS.

(First Embodiment) A first embodiment of the present invention is directed to a non-conforming case database of a user, a non-conforming case database of a center, a template communication unit, a template presenting unit, and a template adding unit. It is an audit management system provided with.

FIG. 1 is a conceptual diagram of an audit management system according to the first embodiment of the present invention. In FIG. 1, a nonconformity case database 11 is a database that holds audit items of internal audits and a template for corrective actions for nonconformities. The non-conformance case database 12 of the center is a database that holds a template of a non-conforming item corrective action set in the center.

The template communication unit 13 is a means for communicating templates between the nonconforming case database 11 and the nonconforming case database 12 at the center, and has a template receiving unit 14 and a template transmitting unit 15. The template receiving unit 14 converts the non-conformance case database system of the center to the user non-conformance case database,
This is a means for receiving and introducing templates for internal audit items and corrective actions for nonconformities. The template transmission unit 15 is a means for transmitting the internal audit audit item and the template of the corrective action of the nonconformity item newly registered in the nonconformity case database from the template addition unit to the nonconformity case database of the center. The reception and transmission of templates are performed by e-mail.

The template presenting unit 16 is a means for extracting and presenting an internal audit audit item and a template of a non-conforming item corrective action from the non-conforming case database when the internal audit processing is executed. The template addition unit 17
This is a means to introduce the corrective actions for the audit items and nonconformities set by the internal audit process into the nonconformity case database as a new template.

The operation of the audit management system according to the first embodiment of the present invention configured as described above will be described below.

An audit item of the internal audit of the quality of the organization and a template of the corrective action of the nonconformity item found corresponding thereto are stored in advance in the nonconformity case database 12 of the center. In the initial stage, the audit item of the internal audit and the template of the corrective action of the nonconformity item are received from the nonconformity case database 12 of the center by the template receiving unit 14 by e-mail, and are introduced into the user nonconformity case database 11.

At the time of execution of the internal auditing process, the template presenting unit 16 extracts the internal auditing item and the template of the corrective action of the nonconforming item from the user nonconformity case database 11 and presents them. The audit items set by the internal audit process and the corrective actions for the nonconforming items are introduced into the nonconforming case database 11 by the template adding unit 17 as new templates.

After the completion of the internal audit processing, the audit items of the internal audit newly registered in the nonconformity case database 11 by the template adding unit 17 and the template of the corrective action of the nonconformity found corresponding thereto are electronically copied. The template is transmitted by e-mail in the template transmitting unit 15 and stored in the nonconforming case database 12 of the center.

Next, the flow of the internal quality audit data from the planning stage to the preparation stage will be described with reference to FIG. Determine the distribution schedule and annual schedule, create an internal audit annual plan, and apply to the approver. The approver checks the contents of the plan and selects approval or resubmission. The approved plan is sent to the recipient.

The audit leader creates an individual execution plan for the internal audit and notifies the head of the audited department. The main items to be described in the implementation plan / notification are the name of the person in charge of the audited department, the audit date and time, the purpose of the audit, the name of the audited department, the name of the auditor, and the audit schedule. The auditor creates an audit checklist and applies to the audit leader.

Since a standard check list is registered, check items related to requirements to be audited are displayed in a question format. If non-conformity that occurred in the past with the same check item is accumulated as know-how,
Can be referred to as nonconformities.

Next, the flow of the internal quality audit data in the execution stage will be described with reference to FIG. Perform an audit based on the approved checklist. The results of the audit are entered in a checklist. The auditor creates a nonconformity report and obtains the approval of the audit leader. The approved nonconformity report is notified to the head of the audited department.

The head of the audited department checks the content of the nonconformity and selects an agreement or a request for reconsideration. After agreeing to the content of the nonconformity, the audited department manager prepares a corrective action plan that describes the cause of the nonconformity and the corrective action, and applies it to the auditor. The audited department manager implements corrective actions based on the approved corrective plan and reports the results. The report should include the date of completion, details of the implementation, and the effects of corrective actions.

Next, the flow of the internal quality audit data at the reporting stage will be described with reference to FIG. The auditor creates an overall report of the internal audit and obtains the approval of the audit leader. The approved report is notified to the head of the audited department. The internal audit report is registered in the management review database as data for the management review meeting.

Specific examples of the check items and the points to be pointed out will be described. For example, the check item is "Select two types of overseas laws and regulations to be managed and investigate the latest version management procedure", and the pointed out item is "IEC standard is out of control. If it is included in the management list ", the judgment is" x ".

The check item is "confirm the contents of the authentication service and investigate how the records of the results of the authentication service are managed". If the procedure is not documented ", the judgment is" x ".

The check item is "Investigate whether the report of the result of the internal quality audit has been received", and the pointed out item is "I checked the result of the previous internal quality audit but was not the chief auditor. , I am checking the content of the correction. "
The judgment is "x".

The check item is "Investigate whether nonconformity has occurred as a result of the internal quality audit and confirm the implementation status of the corrective action." It is one day and the procedure will be revised by April 20, but the procedure has already been revised on March 24. "

The nonconforming matter registration flow will be described with reference to FIG. In step 1, by applying for the nonconformity and corrective action entered in the nonconformity report of the internal audit, it is registered as know-how. The approver selects one of “approval”, “resubmit”, and “reject”. If approved, it will be registered as know-how. FIG. 6 shows a screen image of the nonconforming item registration form.

When the contents of the registered know-how are to be updated, the contents are updated by applying. The approver selects one of “approval”, “resubmit”, and “reject”. If approved, it will be registered as know-how. In the case of rejection, it returns to the state before the update.

The mechanism for sharing the nonconformity corrective action information between the user and the center will be described. At the time of the audit, access to the nonconformance case database held by the center by e-mail etc. to obtain audit check items and corrective methods for nonconformities found. You may actually visit and access it in a consulting manner.

The found nonconformity information is accumulated as know-how together with the search keyword in the nonconformity case database of the user. At this time, the registration of unnecessary information can be suppressed by filtering the registered data. By calling the registered know-how based on the conditions at the time of performing the internal audit, the internal audit without omission becomes possible. In order to enable a search method for registered non-conformance cases and corrective action methods according to the application, three types of views are provided, by requirement, by industry, and by department.

The nonconformity found on the user side and the correction method are registered by e-mail or the like in the nonconformity case database in the center. At this time, the registration of unnecessary information can be suppressed by filtering the registered data.

In the case of creating a checklist to be used when performing an audit in the internal audit management system, past cases and accumulated information are extracted according to the audit conditions. Audit conditions include audited departments, JISZ9901 requirements,
By inputting three items of keywords created based on the know-how accumulated in the center, a check item matching the condition is searched and displayed from many accumulated data.

For the found nonconformity, an effective corrective action is displayed based on past cases. The conditions to be displayed are the I of the check item quoted when the checklist was created.
D is stored, and when a nonconformity is found, a corrective action example is retrieved from the nonconformity case database based on the ID and displayed.

As described above, in the first embodiment of the present invention, the audit management system includes a nonconforming case database, an external nonconforming case database, a template communication unit, a template presenting unit, and a template adding unit. In this way, the know-how to correct nonconformities is shared across industries, and the accumulated know-how is referred to and presented without human intervention, enabling the setting of audit items in internal audits and corresponding measures. The decision of the corrective action of the nonconformity found by the inspection can be efficiently realized.

(Second Embodiment) In a second embodiment of the present invention, a group of departmental databases, a departmental management review processing unit, a departmental management review database, and a higher departmental management review processing unit And a higher-level department management review database.

FIG. 7 is a conceptual diagram of a hierarchical review system according to the second embodiment of the present invention. In FIG. 7, a database 21 is a database for each department. The section-specific management review processing section 22 is a means for individually executing a management review on a group-specific database group corresponding to a section of the organization. The section-specific management review database 23 is a means for holding the results of the management review performed by the section-specific management review processing unit. The upper section management review processing section 24 is means for executing a management review corresponding to the upper section with respect to the execution result of each section management review in the section management review database for each section. The upper section management review database 25 is a means for retaining the results of the management review by the management review of the upper section management review processing section.

The operation of the hierarchical review system according to the second embodiment of the present invention configured as described above will be described below. The database 21 stores data for each department. The division-specific management review processing unit 22 individually performs a management review on a division-specific database group corresponding to the division of the organization. The implementation results are stored in the departmental management review database 23 and are fed back to the departmental database group.

The upper section management review processing section 24 carries out a management review corresponding to the upper section on the execution result of each section management review in the section management review database for each section. The implementation result is stored in the upper section management review database 25 and is fed back to the section management review processing unit 22.

Next, the flow of the hierarchical review will be described with reference to FIG. At the site, each database of the system is operated and records are accumulated. At the review meeting for each department (primary review), the necessary records accumulated in each department are used to make regular reviews. The section manager checks the accumulated necessary information and checks the status of the system at the site at the section review meeting. Review results of each department are registered in the management review. The management reviews the entire system based on the review results for each department, and issues instructions to each department.

Next, a description will be given of a flow of executing a review by hierarchy (department / management) with reference to FIG. In step 1, records necessary for the department review meeting are accumulated from another database. In step 2, a holding notice for preparing a review meeting for each section is created.
The date and time, place, participants, and agenda should be stated in the notice.
The agenda to be considered is selected from data registered in another database. A new agenda item can be added.

In step 3, after the meeting, the examination result is input for each agenda item. Division managers can give instructions and comments on the results of each agenda item as necessary. After inputting the results of the review on all the agenda items and giving instructions and comments, the division manager completes the review meeting. In step 4, the results of the divisional review meeting (primary review) are used as management review data. The management performs a management review based on the review results received from each department. The procedure for holding the management review is the same as that for the department review meeting, and the results are submitted to each department.

The function of the hierarchical review system will be described. Basically, the main function is to prepare each format so that information from other databases can be registered in a consolidated format, and automatically registered in the management review database when certain conditions are met in each database. You. The following specifically describes what data is registered from each database and at what timing.

Example of qualification database Document name = List of monthly qualifiers Trigger = At storage Main purpose of review = How much education and training has been practiced compared to the education plan registered in the education and training DB Or conduct a review to assist in future education and training plans and business development. Document name = List of qualification holders Trigger = At storage Main purpose of review = Clarify the scope of business responsibilities and review as materials for future business development.

Example of education and training database Document name = annual plan trigger = input of annual education implementation result Main purpose of review = review how much results were achieved with respect to the planned education and training plan.

Example of internal audit database Document name = Internal audit report Trigger = At the time of approval of internal audit report Main purpose of review = Inappropriate internal audit performed, what department was found to be incompatible with what tendency, Review how to deal with.

Example of Document Management Database Document Name = List of Issued and Revised Documents Trigger = At Save Main purpose of review = What kind of document was issued during the period and why the document was revised Review the way of working, etc. by clarifying and reviewing the differences between the rules and the actual work.

Example of Purchasing Management Database Document name = List of outsourced companies Trigger = On saving Main purpose of review = Review the status of the company currently trading based on the evaluation result.

Example of technical document management database Document name = Usage history list Trigger = At save Main purpose of review = Clarify who used the technical document for what purpose, Understanding the frequency of use

Example of calibration management database Document name = Calibration result list Trigger = Saved Main purpose of review = Calibration result list for each model and manufacturer, so that the status of calibration equipment is always kept up to date. I do.

Example of Correction Prevention Database Document Name = Correction Prevention Status List Trigger = At Storage Main purpose of review = By recognizing which department is causing what kind of nonconformity, other departments Review to ensure that similar nonconformities do not occur and that more effective corrective actions can be taken.

Example of quality record database Document name = List of discarded documents Trigger = At storage Main purpose of review = Prevents necessary documents from being discarded by mistake and also confirms unnecessary documents by reviewing them it can.

As described above, in the second embodiment of the present invention, the hierarchy-based review system includes a department-based database group, a department-based management review processing unit, a department-based management review database, and a higher-level department management. A review processing unit and a higher-level department management review database are provided, so that review results of lower-level departments can be reviewed and fed back to higher-level departments, enabling efficient reviews in line with the organizational structure. .

(Third Embodiment) In a third embodiment of the present invention, a database for each department, a quality record database, a management review processing section, a quality record registration section, a discard target extraction section, Is a quality recording system provided with

FIG. 10 is a conceptual diagram of a quality recording system according to the third embodiment of the present invention. In FIG. 10, a database 31 is a database for each department. The quality record database 32 is means for holding a quality record. The quality record registration unit 33 is means for registering, as a quality record, the contents of each database directly or an execution result obtained by performing a management review on the database in the quality review database. The discard target extraction unit 34 is means for extracting a quality record to be discarded from quality records registered in the quality record database. The management review processing unit 35 is means for performing a management review on the extracted quality records to be discarded, and registering the execution results as new quality records in the quality record database by the quality record registration unit.

The operation of the quality recording system according to the third embodiment of the present invention configured as described above will be described below. The database 31 stores data for each department. In the quality record registration unit 33, each database
The content of 31 is directly registered in the quality record database 32 as a quality record. The discard target extraction unit 34 extracts a quality record to be discarded from the quality records registered in the quality record database 32. Management Review Processing Department
At 35, a management review is performed on the extracted quality records to be discarded, and the results are registered as new quality records in the quality record database 32 by the quality record registration unit 33.

Next, the flow of quality record data will be described with reference to FIG. In step 1, the quality record registered in another database is stored in the quality record database 32. It is also possible to newly register a document other than those in the database as a quality record.
In the quality record, the classification, person in charge, storage date, disposal date, storage location, and storage expiration date are described.

In step 2, when the stored record is one month before the destruction date set at the time of registration, the data is automatically transferred to the "discard target" classification. At the same time, an e-mail is sent to the storage staff informing that one month before the disposal. The storage staff selects the quality record to be discarded from the discard targets, and shifts from the "disposal target" to the "discard" category on the database. Create a disposal report.
The report should state which documents are to be discarded.
In step 3, the disposal report is registered in the management review database as the material for the review meeting. At the review meeting, get permission for disposal from the management and the person in charge. The results of the disposal report considered in the management review are registered in the quality record database as the minutes of the review meeting.

An operation example of the quality record database will be described. Information entered on the system and documents stored in paper or the like are managed in a database as quality records. Upon registration, each database is automatically registered in the quality record database based on a certain trigger. The following are examples of databases, documents, and triggers that are subject to quality records.

Example of Education and Training Database Document Name = Annual Plan Trigger = Input of annual education implementation results Document Name = Individual Plan Trigger = Individual Plan Approval Document Name = Result Report Trigger = Result Report Approval Internal Audit Database example Document name = Annual plan Trigger = At the time of approval of the annual plan Document name = Execution plan Trigger = At the time of notification of execution Document name = Checklist Trigger = At the time of approval of the audit leader Document name = Nonconformity / correction report Trigger = Correction result At approval Document name = Department audit report Trigger = At internal audit report approval

Example of document management database Document name = System document issuance / revision request (attached to revised document) Trigger = When revision is completed Purchasing management database example Document name = Outsourced company list Trigger = When saving Calibration management database example Document Name = Calibration result, Inspection result Trigger = When the result is approved Example of Correction Prevention Database Document name = Nonconformity Report, Correction Instruction Trigger = When correction is completed Example of Management Review Database Document Name = Review minutes Trigger = When review is completed

As described above, in the third embodiment of the present invention, the quality recording system includes a database for each department, a quality record database, a management review processing unit, a quality record registration unit, and a discard target extraction unit. Since the configuration includes the section, the quality record can be re-reviewed and updated, and the quality record including discarding can be efficiently managed.

[0082]

As is apparent from the above description, according to the present invention, the audit management system includes a nonconforming case database, an external nonconforming case database, a template communication unit, a template presenting unit, and a template adding unit. With this configuration, know-how to correct nonconformities is shared across industries, and the accumulated know-how is referred to and presented without human intervention, thereby setting audit items in internal audits and responding accordingly. The effect is obtained that the determination of the corrective action for the found nonconformity can be efficiently realized without requiring any experience.

The hierarchy-based review system includes a database group for each department, a department-based management review processing section, a department-based management review database, an upper department management review processing section, and an upper department management review database. With this structure, reviewing the results of lower-level departments and reviewing the results in the higher-level department provides feedback, which can be used at various levels within the organization to ensure efficient reviews that match the actual organizational structure. Can be

Further, since the quality recording system is configured to include a database for each department, a quality recording database, a management review processing section, a quality record registration section, and a discard target extraction section, documents which are no longer required By managing the act of sequentially discarding the quality records and the like, the quality record can be re-reviewed and updated, and the quality record including the disposal can be efficiently managed.

[Brief description of the drawings]

FIG. 1 is a conceptual diagram of a configuration of an audit management system according to a first embodiment of the present invention;

FIG. 2 is a flowchart of internal quality audit data from a planning stage to a preparation stage in the audit management system according to the first embodiment;

FIG. 3 is a flowchart of internal quality audit data in an execution stage in the audit management system according to the first embodiment;

FIG. 4 is a flowchart of internal quality audit data at a reporting stage in the audit management system according to the first embodiment;

FIG. 5 is a non-conforming matter registration flow chart in the audit management system according to the first embodiment;

FIG. 6 is an exemplary screen image of a nonconforming matter registration form in the audit management system according to the first embodiment;

FIG. 7 is a conceptual diagram showing a configuration of a hierarchical review system according to a second embodiment of the present invention;

FIG. 8 is a flowchart of a hierarchical review in the hierarchical review system of the second embodiment;

FIG. 9 is a flow chart of a hierarchical (department / management) review in the hierarchical review system according to the second embodiment;

FIG. 10 is a conceptual diagram illustrating a configuration of a quality recording system according to a third embodiment of the present invention;

FIG. 11 is a flowchart of quality record data in the quality record system according to the third embodiment.

[Explanation of symbols]

 11 Non-conformance case database 12 External non-conformance case database 13 Template communication unit 14 Template reception unit 15 Template transmission unit 16 Template presentation unit 17 Template addition unit 21 Database 22 Department-based management review processing unit 23 Department-based management review database 24 Top-level department management review process Department 25 Higher department management review database 31 Database 32 Quality record database 33 Quality record registration unit 34 Disposal target extraction unit 35 Management review processing unit

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[Procedure amendment]

[Submission date] October 26, 1998 (1998.10.
26)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0005

[Correction method] Change

[Correction contents]

In recent years, a group system has been used as a quality management support system for the ISO quality management system, and a quality management system document system centered on a quality management manual has been prepared for requirements such as the ISO9000 series. To develop workflows for the management of audits, the setting of audit items in the internal audit of the quality system, the recording of corrective actions for nonconformities found in response to the audits, the management of management reviews for quality, and the management of quality records Have been.

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0014

[Correction method] Change

[Correction contents]

In addition, the audit management system includes a nonconformance case database means for holding an internal audit audit item and a template for a corrective action of a nonconformity item found corresponding thereto, and a nonconformity case database means from the nonconformity case database system of the center. The template receiving means for receiving and introducing any internal audit audit item and the template for the corrective action of the nonconformity found corresponding to it, and the internal nonconformity case database means during the execution of the internal audit process A template presentation means for extracting and presenting a template of the audit items and the corrective actions for nonconformities found corresponding to them, and the audit items set by the internal audit process and the nonconformities found corresponding to them The corrective action determined for this is used as a new template And configured to have a template additional means for introducing the Failure database means 択的.

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] 0016

[Correction method] Change

[Correction contents]

Also, the internal audit item newly registered in the nonconformance case database means from the template addition means and the template of the corrective action of the nonconformity item found corresponding thereto are selectively selected from the nonconformity case database system of the center. And a template transmitting means for transmitting to the server. With this configuration, the know-how for correcting nonconformities can be shared across industries.

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] 0023

[Correction method] Change

[Correction contents]

According to a second aspect of the present invention, there is provided a nonconformity case database means for holding an audit item of an internal audit of the quality of an organization and a template for a corrective action of a nonconformity found corresponding thereto, and a nonconformity of the center . From the case database system to the nonconforming case database means,
A template receiving means for receiving and introducing a template for any internal audit audit item and a non-conformity corrective action found corresponding thereto, and, during execution of the internal audit process, from the nonconformity case database means, A template presenting means for taking out and presenting the audit item of the internal audit and the template of the corrective action of the nonconformity found corresponding to the audit item, the audit item set by the internal audit process and the audit item found corresponding thereto An audit management system including a template addition means for selectively introducing a corrective action determined for a nonconformity item as a new template to the nonconformity case database means, and accumulating corrective action for the nonconformity item as know-how,
An effective remediation plan and an effective remediation plan
And take corrective action .

[Procedure amendment 5]

[Document name to be amended] Statement

[Correction target item name] 0024

[Correction method] Change

[Correction contents]

The third aspect of the present invention is the second aspect of the present invention.
In the audit management system according to the above, the audit items of the internal audit newly registered in the nonconformity case database means from the template addition means and a template of the corrective action of the nonconformity found corresponding thereto are selectively selected. It has a template transmitting means for transmitting to the external non-conforming case database system,
It has the effect of transmitting know-how to correct nonconformities to the center database and storing it.

[Procedure amendment 6]

[Document name to be amended] Statement

[Correction target item name] 0031

[Correction method] Change

[Correction contents]

The template communication unit 13 is a means for communicating templates between the nonconforming case database 11 and the nonconforming case database 12 at the center, and has a template receiving unit 14 and a template transmitting unit 15. The template receiving unit 14 converts the non-conformance case database system of the center to the user non-conformance case database,
This is a means for receiving and introducing templates for internal audit items and corrective actions for nonconformities. The template transmitting unit 15 is a means for selectively transmitting the internal audit item and the template for the corrective action of the nonconformity item newly registered in the nonconforming case database from the template adding unit to the nonconforming case database of the center. The reception and transmission of templates are performed by e-mail.

[Procedure amendment 7]

[Document name to be amended] Statement

[Correction target item name] 0032

[Correction method] Change

[Correction contents]

The template presenting unit 16 is a means for extracting and presenting an internal audit audit item and a template of a non-conforming item corrective action from the non-conforming case database when the internal audit processing is executed. The template addition unit 17
This is a means to selectively introduce, as a new template, the audit items and corrective actions for nonconformities set by the internal audit process into the nonconformity case database.

[Procedure amendment 8]

[Document name to be amended] Statement

[Correction target item name] 0035

[Correction method] Change

[Correction contents]

At the time of execution of the internal auditing process, the template presenting unit 16 extracts the internal auditing item and the template of the corrective action of the nonconforming item from the user nonconformity case database 11 and presents them. The template addition unit 17 selectively introduces the audit items set by the internal audit processing and the corrective actions for the nonconforming items into the nonconforming case database 11 as new templates.

[Procedure amendment 9]

[Document name to be amended] Statement

[Correction target item name] 0036

[Correction method] Change

[Correction contents]

After the completion of the internal audit processing, the audit items of the internal audit newly registered in the nonconformity case database 11 by the template adding unit 17 and the template of the corrective action of the nonconformity found corresponding thereto are electronically copied. The template is transmitted by e-mail in the template transmitting unit 15 and is selectively stored in the nonconforming case database 12 of the center.

[Procedure amendment 10]

[Document name to be amended] Statement

[Correction target item name] 0037

[Correction method] Change

[Correction contents]

Next, the flow of the internal quality audit data from the planning stage to the preparation stage will be described with reference to FIG. Decide distribution with destination and the annual schedule, to create the annual plan of internal audit, to apply to the approver. The approver checks the contents of the plan and selects approval or resubmission. The approved plan is sent to the recipient.

[Procedure amendment 11]

[Document name to be amended] Statement

[Correction target item name] 0038

[Correction method] Change

[Correction contents]

The audit leader creates an individual execution plan and notice of the internal audit, and notifies the head of the audited department.
The main items to be described in the implementation plan and notice are the name of the person in charge of the audited department, the date and time of the audit, the purpose of the audit, the name of the audited department, the name of the auditor,
This is an audit schedule. The auditor creates an audit checklist and applies to the audit leader.

[Procedure amendment 12]

[Document name to be amended] Statement

[Correction target item name] 0040

[Correction method] Change

[Correction contents]

Next, the flow of internal audit data in the implementation stage will be described with reference to FIG. Perform an audit based on the approved checklist. The results of the audit are entered in a checklist. The auditor creates a nonconformity report and obtains the approval of the audit leader. The approved nonconformity report is notified to the head of the audited department.

[Procedure amendment 13]

[Document name to be amended] Statement

[Correction target item name] 0042

[Correction method] Change

[Correction contents]

Next, the flow of internal audit data at the reporting stage will be described with reference to FIG. The auditor creates an overall report of the internal audit and obtains the approval of the audit leader. The approved report is notified to the head of the audited department. The internal audit report is registered in the management review database as data for the management review meeting.

[Procedure amendment 14]

[Document name to be amended] Statement

[Correction target item name] 0043

[Correction method] Change

[Correction contents]

Specific examples of the check items and the points to be pointed out will be described. For example, if the check item is " Document management software
Backup of server data is performed properly
Surveys , and the points pointed out are " soft document management ."
Software, but the document data in the server
Backup procedures are not documented and no personnel are available
If it can't be backed up properly at times, "it will be irrelevant .

[Procedure amendment 15]

[Document name to be amended] Statement

[Correction target item name] 0044

[Correction method] Change

[Correction contents]

Also, the check item is " Influence on the quality.
Inspection and maintenance procedures for machinery and tools are documented
Or a survey to ", pointed out that matters is the connection of the" optical cable
Vessel (arc discharge method) has a great effect on construction quality
However, inspection and maintenance procedures for such equipment and machine tools
Not documented in the quality system "is non-conforming .

[Procedure amendment 16]

[Document name to be amended] Statement

[Correction target item name] 0045

[Correction method] Change

[Correction contents]

When the check item is " Appropriate process parameters "
Investigate whether the monitoring and management of the meter is being performed reliably. "
The pointed out point was, " Temperature, time,
The processing pattern for each material related to the gas ratio has been established.
However, these control values are not specified in any document.
Bought was "if, a non-conforming.

[Procedure amendment 17]

[Document name to be amended] Statement

[Correction target item name] 0046

[Correction method] Change

[Correction contents]

When the check item is “The calibration target device
If you find any deviation from the calibration standard,
Is to investigate whether carried out the evaluation of the validity ", pointed out that matters," the instrument management regulations, the calibration outside of the calibration target device
It is stipulated that if this is found, it will be evaluated for validity.
But the specific evaluation procedure is not clear
Was "if, a non-conforming.

[Procedure amendment 18]

[Document name to be amended] Statement

[Correction target item name] 0049

[Correction method] Change

[Correction contents]

The mechanism for sharing the nonconformity corrective action information between the user and the center will be described. Periodically access the center's database of nonconformities using e-mail or other means to obtain audit check items and corrective measures for any nonconformities found.

[Procedure amendment 19]

[Document name to be amended] Statement

[Correction target item name] 0051

[Correction method] Change

[Correction contents]

Non-conformities and corrections found on the user side
The treatment is registered in the nonconforming case database in the center by e-mail or the like. At this time, the registration of unnecessary information can be suppressed by filtering the registered data.

[Procedure amendment 20]

[Document name to be amended] Statement

[Correction target item name] 0052

[Correction method] Change

[Correction contents]

In the case of creating a checklist to be used when performing an audit in the internal audit management system, past cases and accumulated information are extracted according to the audit conditions. By inputting three items as audit conditions, the audited department, the requirements of the applicable standards, and the keywords created based on the know-how accumulated in the center, much data accumulated From the search items that match the conditions are searched and displayed.

[Procedure amendment 21]

[Document name to be amended] Statement

[Correction target item name] 0059

[Correction method] Change

[Correction contents]

Next, the flow of the hierarchical review will be described with reference to FIG. At the site, each database of the system is operated and records are accumulated. Sectoral review meeting at the (primary review), to take advantage of the necessary records accumulated in each department, perform periodic review. The section manager checks the accumulated necessary information and checks the status of the system at the site at the section review meeting. Review results of each department are registered in the management review. The management reviews the entire system based on the review results for each department, and issues instructions to each department.

[Procedure amendment 22]

[Document name to be amended] Statement

[Correction target item name]

[Correction method] Change

[Correction contents]

FIG. 10 is a conceptual diagram of a quality recording system according to the third embodiment of the present invention. In FIG. 10, a database 31 is a database for each department. The quality record database 32 is means for holding a quality record. The quality record registration unit 33 directly or directly writes the contents of each database to the management review processing unit 35.
Is a means for registering, as a quality record, an execution result obtained by performing a management review in a quality record database. The discard target extraction unit 34 is means for extracting a quality record to be discarded from quality records registered in the quality record database. The management review processing unit 35 is a means for performing a management review on the extracted quality records to be discarded, and registering the execution result as a new quality record in the quality record database by the quality record registration unit.

[Procedure amendment 23]

[Document name to be amended] Statement

[Correction target item name] 0075

[Correction method] Change

[Correction contents]

The operation of the quality recording system according to the third embodiment of the present invention configured as described above will be described below. The database 31 stores data for each department. In the quality record registration unit 33, each database
The content of 31 is directly registered in the quality record database 32 as a quality record. The discard target extraction unit 34 extracts a quality record to be discarded from the quality records registered in the quality record database 32. Management Review Processing Department
In 35, a management review is performed on the contents of each database 31 and the extracted quality records to be discarded, and the results are registered as new quality records in the quality record database 32 by the quality record registration unit 33. .

[Procedure amendment 24]

[Document name to be amended] Statement

[Correction target item name] 0076

[Correction method] Change

[Correction contents]

Next, the flow of quality record data will be described with reference to FIG. In step 1, the quality record registered in another database is stored in the quality record database 32. It is also possible to newly register a document other than those in the database as a quality record.
In the quality record, the classification, person in charge, storage date, scheduled disposal date, storage location, and storage expiration date are described.

[Procedure amendment 25]

[Document name to be amended] Statement

[Correction target item name] 0077

[Correction method] Change

[Correction contents]

In step 2, when the stored record is one month before the scheduled destruction date set at the time of registration, the data is automatically transferred to the "discard target" classification. at the same time,
An email is sent to the custodian informing that one month before disposal. The custodian selects the quality records to be discarded from the discard targets, and displays the
To "discard" category. Create a disposal report. The report should state which documents are to be discarded. In step 3, the disposal report is registered in the management review database as the material for the review meeting. At the review meeting, get permission for disposal from the management and the person in charge. The results of the disposal report considered in the management review are registered in the quality record database as the minutes of the review meeting.

[Procedure amendment 26]

[Document name to be amended] Statement

[Correction target item name] 0079

[Correction method] Change

[Correction contents]

Example of Education and Training Database Document Name = Annual Plan Trigger = Input of annual education implementation results Document Name = Individual Plan Trigger = Individual Plan Approval Document Name = Result Report Trigger = Result Report Approval Internal Audit Database example Document name = Annual plan Trigger = At the time of approval of the annual plan Document name = Execution plan Trigger = At the time of notification of execution Document name = Checklist Trigger = At the time of approval of the audit leader Document name = Nonconformity / correction report Trigger = Correction result approval at the time the document name = internal audit report trigger = internal audit report the time of approval

[Procedure amendment 27]

[Document name to be amended] Statement

[Correction target item name]

[Correction method] Change

[Correction contents]

[0082]

As is apparent from the above description, according to the present invention, the audit management system includes a nonconforming case database, an external nonconforming case database, a template communication unit, a template presenting unit, and a template adding unit. Corrective action for nonconformities
Know-how location and shared across the industry, by the accumulated know-how presented with reference without human intervention, configuration and audit items in internal audits, corrective actions nonconformity to be found correspondingly Can be efficiently realized without requiring experience.

[Procedure amendment 28]

[Document name to be amended] Statement

[Correction target item name] Figure 2

[Correction method] Change

[Correction contents]

FIG. 2 is a flowchart of internal audit data from a planning stage to a preparation stage in the audit management system according to the first embodiment;

[Procedure amendment 29]

[Document name to be amended] Statement

[Correction target item name] Figure 3

[Correction method] Change

[Correction contents]

FIG. 3 is a flowchart of internal audit data in an execution stage in the audit management system according to the first embodiment;

[Procedure amendment 30]

[Document name to be amended] Statement

[Correction target item name] Fig. 4

[Correction method] Change

[Correction contents]

FIG. 4 is a flowchart of internal audit data at a reporting stage in the audit management system according to the first embodiment;

[Procedure amendment 31]

[Document name to be amended] Drawing

[Correction target item name] Figure 2

[Correction method] Change

[Correction contents]

FIG. 2

[Procedure amendment]

[Submission Date] October 6, 1999 (1999.10.
6)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

1. A nonconformity case database means for holding an audit item of an internal audit of a quality system of an organization and a template for a corrective action of a nonconformity item found corresponding thereto, and a nonconformity case database from an external nonconformance case database system. Means, a template receiving means for receiving and introducing any of the audit items of the internal audit and a template of the corrective action of the nonconformity found corresponding thereto, and the nonconformity case database upon execution of the internal audit process Template presenting means for taking out and presenting a template of the corrective action of the audit item of the internal audit and the nonconformity found corresponding thereto from the means,
Template addition means for selectively introducing, as a new template, the nonconformity case database means, the audit item set by the internal audit process and the corrective action determined for the nonconformity found corresponding thereto, An audit management system comprising:

2. An external audit item newly registered in the nonconformance case database means from the template addition means and a nonconformity correction template found corresponding thereto are selectively selected from the external 3. The audit management system according to claim 2, further comprising a template transmitting unit that transmits the template to the nonconforming case database system.

3. A process according to claim 1, characterized in that the reception or transmission of the template performed by e-mail or
2. The audit management system according to 2 .

4. A management review is individually performed on a database group for each department corresponding to a department of an organization.
Departmental management review processing support means having a function of supporting
And departmental management review database means for holding the execution result of the management review obtained Ri by the support means, for the implementation results of each sector management review of the departmental management review database means for each sector, higher An upper section management review processing support unit having a function of supporting the execution of a management review corresponding to a section, and an execution result of the management review obtained by the upper section management review processing support unit is held. A hierarchy-based review system comprising a higher-level department management review database means.

5. A quality record database means for holding a quality record, and an execution result obtained by executing a management review on the contents of each database directly or with the support of a management review processing support means. ,
A quality record registration means for registering the quality record in the quality record database means as a quality record; a discard target extraction means for extracting a quality record to be discarded from the quality records registered in the quality record database; It said against the target of discarding quality records management review process payments
Quality recording system characterized by comprising a means for registering the result of further conducted <br/> management reviews the aid of assistance means as a new quality recorded in the quality record database means by said quality records registration means .

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0018

[Correction method] Change

[Correction contents]

A section having a function of supporting the implementation of a management review individually for a group of departmental databases corresponding to departments of an organization is provided by a hierarchical review system for performing a quality management review. br /> and management review processing support means Monbetsu, and departmental management review database means for holding the execution result of Manejime <br/> cement review obtained Ri by the departmental management review processing support means, division of each sector A function to support the execution of management reviews corresponding to higher-level departments based on the results of management reviews for each department in the separate management review database
The upper division management review processing support means,
Obtained by upper-level department management review processing support means
And a higher-level department management review database means for holding the results of the implemented management reviews.

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] 0020

[Correction method] Change

[Correction contents]

A quality record system for managing the quality record is managed by a quality record database means for holding the quality record and the contents of each database directly or in response to the support of the management review processing support means. The quality record registration means for registering the results of the management review as a quality record in the quality record database means, and the quality records to be discarded from the quality records registered in the quality record database. Means for extracting the discard target to be extracted, and a management review processing support means for the extracted quality records to be discarded.
It was configured to register as a new quality records Quality records database means via imaging <br/> result quality recording registration means further conducted management reviews the aid of.

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] 0022

[Correction method] Deleted

[Procedure amendment 5]

[Document name to be amended] Statement

[Correction target item name] 0023

[Correction method] Change

[Correction contents]

[0023]

DETAILED DESCRIPTION OF THE INVENTION The invention of claim 1, wherein the present invention,
A non-conformance case database means for holding an audit item of an internal audit of an organization's quality and a template for a corrective action of a non-conformity item correspondingly detected, and an external non-conformance case database system to the non-conformance case database means, A template receiving means for receiving and introducing a template of an internal audit audit item and a corrective action of a nonconformity found corresponding thereto, and, when executing the internal audit process, from the nonconformity case database means,
A template presenting means for taking out and presenting the audit item of the internal audit and the template of the corrective action of the nonconformity found corresponding to the audit item, the audit item set by the internal audit process and the audit item found corresponding thereto An audit management system including a template addition means for selectively introducing a corrective action determined for a nonconformity item as a new template to the nonconformity case database means, and accumulating corrective action for the nonconformity item as know-how, It has the effect of managing corrective actions by presenting with reference to it.

[Procedure amendment 6]

[Document name to be amended] Statement

[Correction target item name] 0024

[Correction method] Change

[Correction contents]

According to the second aspect of the present invention, the first aspect is provided.
In the audit management system described in the above, the audit items of the internal audit newly registered in the nonconformity case database means from the template addition means and the template of the corrective action of the nonconformity found corresponding thereto are selectively selected, and It has a template transmitting means for transmitting to an external nonconformity case database system, and has an effect of transmitting and accumulating knowhow of nonconformity correction to an external common database.

[Procedure amendment 7]

[Document name to be amended] Statement

[Correction target item name] 0025

[Correction method] Change

[Correction contents]

The invention according to claim 3 of the present invention, according to claim 1
Or In 2 audit management system according, the reception or transmission of the template are those carried out by e-mail, an effect that send and receive expertise incompatible remedied without human intervention.

[Procedure amendment 8]

[Document name to be amended] Statement

[Correction target item name] 0026

[Correction method] Change

[Correction contents]

The invention according to claim 4 of the present invention has a function of supporting the execution of a management review individually for a department-specific database group corresponding to a department of an organization.
And sector management review processing support means for a departmental management review database means for holding the execution result of <br/> management review obtained Ri by to the site Monbetsu management review processing support means, the division of each sector for the implementation results of each sector management review another management review database means, supported to implement management reviews corresponding to the upper sector
High-level department management review process with support function
A hierarchy-based review system including support means and an upper-level department management review database means for holding the results of the management review obtained by the upper-level department management review processing support means ; It has the effect that feedback to support the review of the upper division.

[Procedure amendment 9]

[Document name to be amended] Statement

[Correction target item name] 0027

[Correction method] Change

[Correction contents]

According to a fifth aspect of the present invention, a quality record database means for holding a quality record and the contents of each database are subjected to management review directly or with the support of management review processing support means. Quality record registration means for registering the obtained execution result as a quality record in the quality record database means,
A discard target extraction unit for extracting a quality record to be discarded from the quality records registered in the quality record database; and a support of the management review processing support unit for the extracted quality record to be discarded. by a quality recording system comprising a means for registering the result of the management review further <br/> as a new quality recorded in the quality record database means by said quality records registration means, re-review of quality records It has the effect of providing support and updating.

[Procedure amendment 10]

[Document name to be amended] Statement

[Correction target item name] 0030

[Correction method] Change

[Correction contents]

FIG. 1 is a conceptual diagram of an audit management system according to the first embodiment of the present invention. In FIG. 1, a nonconformity case database 11 is a database that holds audit items of internal audits and a template for corrective actions for nonconformities. The nonconformity case database 12 of the center is a database that holds the audit items of the internal audit provided in the center and a template of the corrective action of the nonconformity.

[Procedure amendment 11]

[Document name to be amended] Statement

[Correction target item name] 0036

[Correction method] Change

[Correction contents]

After the completion of the internal audit processing, the audit items of the internal audit newly registered in the nonconformity case database 11 by the template adding unit 17 and the template of the corrective action of the nonconformity found corresponding thereto are electronically copied. The template is transmitted by e-mail in the template transmitting unit 15 and stored in the nonconforming case database 12 of the center.

[Procedure amendment 12]

[Document name to be amended] Statement

[Correction target item name] 0037

[Correction method] Change

[Correction contents]

Next, in the preparation stage from the planning stage, the inner
The flow of the department audit data will be described with reference to FIG.
Determine the distribution schedule and annual schedule, prepare an internal audit annual plan, and apply to the approver. The approver checks the contents of the plan and selects approval or resubmission. The approved plan is sent to the recipient.

[Procedure amendment 13]

[Document name to be amended] Statement

[Correction target item name] 0043

[Correction method] Change

[Correction contents]

Specific examples of the check items and the points to be pointed out will be described. For example, if the check item is " Managed overseas
"Select two types of laws and regulations, and investigate the procedure for managing the latest version ", and point out that " IEC standards are out of control ."
However, it is included in the document management list . "

[Procedure amendment 14]

[Document name to be amended] Statement

[Correction target item name] 0044

[Correction method] Change

[Correction contents]

The check item is " Contents of authentication work ".
And how to manage the record of certification results
Investigate whether the license is
If the procedure is not documented for the post- delivery process, it will be non-conforming.

[Procedure amendment 15]

[Document name to be amended] Statement

[Correction target item name] 0045

[Correction method] Change

[Correction contents]

The check item is “ Internal quality auditing ” .
The results are reported receiving or investigation are ", he pointed out that matters," but confirmed the results of previous internal quality audit, audit main
What is not an inspection is confirming the corrective action. "
Non-conforming.

[Procedure amendment 16]

[Document name to be amended] Statement

[Correction target item name] 0046

[Correction method] Change

[Correction contents]

The check item is " Internal quality audit " .
Investigate whether nonconformities have occurred as a result, and take corrective action
Check the situation '', and the pointed out item is `` Report of corrective action ''.
Notice is on April 1 and the procedure will be revised by April 20
It has already been revised on March 24. "
If so, it is non-conforming.

[Procedure amendment 17]

[Document name to be amended] Statement

[Correction target item name] 0049

[Correction method] Change

[Correction contents]

The mechanism for sharing the nonconformity corrective action information between the user and the center will be described. At the time of audit, the Failure database that the center has, accessed by using, for example, e-mail, audit check items, to obtain the correct method for the discovery nonconformity.

[Procedure amendment 18]

[Document name to be amended] Statement

[Correction target item name] 0051

[Correction method] Change

[Correction contents]

The nonconformity and corrective action found on the user side are registered by e-mail or the like in a nonconformity case database in the center. At this time, by filtering the data to be transmitted , registration of unnecessary information can be suppressed.

[Procedure amendment 19]

[Document name to be amended] Statement

[Correction target item name] 0056

[Correction method] Change

[Correction contents]

FIG. 7 is a conceptual diagram of a hierarchical review system according to the second embodiment of the present invention. Review by hierarchy
The stem is a database for each department as shown in Fig. 7.
, Departmental management review database and top
Department management review database and department manager
Management review section 22 and the
The view processing unit 24 is configured. Database structure and
Therefore, it is realized by a logical hierarchical structure. For each department
Database of the quality management system
Texts that require a review are accumulated.
In FIG. 7, a database 21 is a database for each department. Departmental Management Review Processing Section 22
Helps to implement the individual management review to the departmental database group corresponding to the organization department of
It is a means to do. The section-specific management review database 23 is a means for holding the results of the management review performed by the section-specific management review processing unit.
The upper section management review processing section 24 supports the execution of the management review corresponding to the upper section with respect to the execution results of each section management review in the section-specific management review database for each section .
That is a means. The upper section management review database 25 is a means for retaining the results of the management review by the management review of the upper section management review processing section.

[Procedure amendment 20]

[Document name to be amended] Statement

[Correction target item name] 0057

[Correction method] Change

[Correction contents]

The operation of the hierarchical review system according to the second embodiment of the present invention configured as described above will be described below. For departmental management review database
The departmental management review processing section 22
Departmental management review from database for each gate
The target information and the results of the review are registered.
In addition, management reviews are also performed in the database for each department.
Is stored.

[Procedure amendment 21]

[Document name to be amended] Statement

[Correction target item name] 0058

[Correction method] Change

[Correction contents]

The upper section management review database
The management review processing section 24
From the departmental management review database
Information on department management reviews and implementation of reviews
The results are registered and a database for each department
The result of the management review is also stored.

[Procedure amendment 22]

[Document name to be amended] Statement

[Correction target item name] 0060

[Correction method] Change

[Correction contents]

Next, a review support function for each tier will be described.
This will be described with reference to FIG. In Step 1, each
Review departments from the information stored in the database for each department
The necessary information is registered as an agenda item. In step 2, based on the information (agenda) registered in step 1, the department
Create a notice to hold another review meeting
Then, notify the relevant parties. The date and time, location,
Participants, describe the agenda. Information on registered agenda items to be considered
Method to select from information, and method to register as new agenda
To help.

[Procedure amendment 23]

[Document name to be amended] Statement

[Correction target item name] 0061

[Correction method] Change

[Correction contents]

In step 3, the examination results for each agenda item are
Support input management. Instructions to related departments according to the results
It has a function that can notify you After the meeting, enter the examination results for each agenda item. Division managers can give instructions and comments on the results of each agenda item as necessary. After inputting the results of the review on all the agenda items and giving instructions and comments, the division manager completes the review meeting. In Step 4, the conclusion of the departmental review meeting
Results as information for higher management reviews.
Provide support. Step 3
Is the same as The results of the departmental review meeting (primary review) will be used as management review material. The management performs a management review based on the review results given by each department. The procedure for holding the management review is the same as that for the department review meeting.
The results are submitted to each department.

[Procedure amendment 24]

[Document name to be amended] Statement

[Correction target item name] 0062

[Correction method] Change

[Correction contents]

The function of the hierarchical review system will be described. Basically, the main function is to prepare each format so that information from other databases can be registered in a consolidated format, and automatically registered in the management review database when certain conditions are met in each database. You. Stored in the database for each department
Information registered as agenda from information includes the following
And trigger at the timing indicated in the trigger item.
Registered in the management review database.

[Procedure amendment 25]

[Document name to be amended] Statement

[Correction target item name] 0072

[Correction method] Change

[Correction contents]

As described above, in the second embodiment of the present invention, the hierarchy-based review system includes a department-based database group, a department-based management review processing unit, a department-based management review database, and a higher-level department management. A review processing unit and a higher-level department management review database are provided, so that the function of setting the review results of lower-level departments as review agendas in the higher-level departments allows for efficient reviews that match the organizational structure. Can provide assistance .

[Procedure amendment 26]

[Document name to be amended] Statement

[Correction target item name]

[Correction method] Change

[Correction contents]

FIG. 10 is a conceptual diagram of a quality recording system according to the third embodiment of the present invention. In FIG. 10, a database 31 is a database for each department. The quality record database 32 stores data that holds information as a quality record.
It is a base. Quality records registration unit 33, each database
The management review directly or
-A management review was conducted with the support of the processing unit 35.
The performance results obtained from the
This is a means that has the function of registering as a record. The discard target extraction unit 34 has a function of extracting a quality record to be discarded from the quality records registered in the quality record database.
Is a means to have. The management review processing unit 35
The management records against the quality records
Support the implementation of the review
New items in the quality record database by the quality record registration unit
This means has the function of registering as a quality record.

[Procedure amendment 27]

[Document name to be amended] Statement

[Correction target item name] 0075

[Correction method] Change

[Correction contents]

The operation of the quality recording system according to the third embodiment of the present invention configured as described above will be described below. The database 31 stores data for each department. In the quality record registration unit 33, each database
The content of 31 is directly registered in the quality record database 32 as a quality record. The discard target extraction unit 34 extracts a quality record to be discarded from the quality records registered in the quality record database 32. Management Review Processing Department
In 35, a management review is performed on the contents of each database 31 and the extracted quality records to be discarded .
The registration result is registered as a new quality record in the quality record database 32 by the quality record registration unit 33.

[Procedure amendment 28]

[Document name to be amended] Statement

[Correction target item name] 0076

[Correction method] Change

[Correction contents]

FIG. 11 is used for the flow of the quality record data.
Will be described. In step 1, register in each database
The information as a quality record is stored in the quality record database.
Stored in 32. New information other than each database
It also has a function to register as a quality record. Quality records include:
Category, person in charge, storage date, scheduled disposal date, storage location, storage period
Limit.

[Procedure amendment 29]

[Document name to be amended] Statement

[Correction target item name] 0077

[Correction method] Change

[Correction contents]

In step 2, when the stored record is one month before the scheduled destruction date set at the time of registration, it is automatically shifted to the classification of "disposal target" and updated . At the same time, by e-mail that it is prior to disposal 1 month for the store personnel
Notify . Quality records to be discarded are entered as
With the help of the power, products from “disposal target” to “disposal”
Shift to quality record data. Discard report based on this updated information
Create a letter. In step 3, the disposal report is registered in the management review database as the subject of the review meeting. By entering the review results,
Registered in the quality record database as minutes
You.

[Procedure amendment 30]

[Document name to be amended] Statement

[Correction target item name] 0078

[Correction method] Change

[Correction contents]

An operation example of the quality record database will be described. Information entered on the system and documents stored in paper or the like are managed in a database as quality records. Upon registration, each database is automatically registered in the quality record database based on a certain trigger. The following is a description of each database subject to quality records.
Here are some examples of documents and triggers:

Claims (6)

[Claims] Claims: 1. An audit management system for setting audit items in an internal audit of an organization's quality system and managing corrective actions for nonconformities found in response thereto, and a hierarchical review for performing a quality system management review. A management support system comprising a system and a quality record system for managing quality records. 2. A nonconformity case database means for holding an audit item of an internal audit of a quality system of an organization and a template for a corrective action of a nonconformity item found corresponding thereto, and a nonconformity case database from an external nonconformance case database system. Means, a template receiving means for receiving and introducing any of the audit items of the internal audit and a template of the corrective action of the nonconformity found corresponding thereto, and the nonconformity case database upon execution of the internal audit process Template presenting means for taking out and presenting a template of the corrective action of the audit item of the internal audit and the nonconformity found corresponding thereto from the means,
Template addition means for selectively introducing, as a new template, the nonconformity case database means, the audit item set by the internal audit process and the corrective action determined for the nonconformity found corresponding thereto, An audit management system comprising: 3. An external audit item newly registered in the nonconformance case database means from the template adding means and a nonconformity corrective template found corresponding thereto are selectively selected from the external 3. The audit management system according to claim 2, further comprising a template transmitting unit that transmits the template to the nonconforming case database system. 4. The apparatus according to claim 2, wherein the template is received or transmitted by electronic mail.
Audit management system described. 5. A divisional management review processing means for individually performing a management review on a divisional database group corresponding to a division of an organization, and holding a result of the management review by the divisional management review processing means. Department-based management review database means, and upper-level department management review processing means for performing a management review corresponding to a higher-level department with respect to the execution result of each department management review in the department-based management review database means for each department. And a higher-level department management review database means for holding a result of the management review by the higher-level department management review processing means. 6. A quality record database means for holding a quality record, and an execution result obtained by executing a management review on the contents of each database directly or by a management review processing means on the quality record database means, to the quality record database means. Quality record registration means for registering as a quality record, discard target extraction means for extracting a quality record to be discarded from the quality records registered in the quality record database, and the extracted quality record to be discarded Means for performing a management review further in the management review processing means, and registering the execution result as a new quality record in the quality record database means by the quality record registration means. Recording system.