JP2000275253A - Validity confirming method for analyzer, analyzer with validity confirming function, and recording medium recording validity confirming program of analyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To confirm the validity that an analyzer is adequate easily and reliably with no omission. SOLUTION: In this validity confirming method, an analyzer 1 is provided with an analysis section 2 and an information processor 3 processing the analysis values from the analysis section 2, various information Dv including multiple inspection items for guaranteeing the quality on the analysis to be conducted and inspection results is recorded by the information processor 3 provided on the analyzer 1, the inspection results cannot be changed by the information processor 3, and the inspection items and inspection results are outputted to prove that the analyzer is adequate.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for confirming the validity of an analyzer, an analyzer having a function of confirming the validity, and a recording medium storing a program for confirming the validity of the analyzer.

[0002]

2. Description of the Related Art Conventionally, there are cases where an information processing device is incorporated in an analyzer. Such an analyzer controls an analysis unit comprising a detector for detecting various state quantities of a measurement object as analysis values, The processing of the analysis values obtained from the analysis unit was performed by an information processing device (computer). That is, a more useful analyzer is provided by reading, calculating, transmitting, and the like of an analysis value from an analysis unit in this information processing apparatus.

In recent years, in order to guarantee the reliability of the analytical value measured by the analyzer and the validity of the analyzer, the reliability of the measured value obtained from the analyzer and the validity of the analytical method have been examined. There is an increasing need worldwide to do validation validation. Particularly when trade analyzers are liberalized and these analyzers are used abroad, it may be necessary to prove the validity of analytical values and analyzers in accordance with the validation standards set by the laws of each country. is there.

FIG. 3 is a diagram for explaining a method of confirming validity in the conventional analyzer 10. Referring to FIG. 3, a conventional analyzer 10 includes an analyzer 11 and an information processing device 12 (computer) connected to the analyzer 11. Also,
The analyzer 10 includes a form 1 on which various decision analyzer types of the analyzer 10, such as specifications and ISO certificates, are described at the time of manufacture.
3 has a storing file F _0, for example in a state where and contents of the shipment test performed at the factory, it matches well as form 14 which describes the contents of the installation test each analyzer 10, analyzer 1
0 is stored at the manufacturer's side.

On the other hand, on the user side of the analyzer 10, files F _1, F _2, F ₃ for storing forms 15, 16, 17 describing the contents of the calibration test, the periodic inspection, and the daily inspection performed by the user.
Have been stored. These files F1 _, F2 _, F
₃ contains a record of details such as a calibration test, a periodic inspection, a test method of a daily inspection, a control standard, and a standard device or a sample used as a standard sample. Had been managing.

[0006] In addition, to prepare the store file F ₄ a form 18 that records the analysis method in addition to these, the analyzer 10
It keeps a record of each measurement taken.
Therefore, whether the analysis is valid by the analyzer 10, when the check for example, once a year, it is sufficient to check the form 15 to 18 using the file F ₁ to F _4. Also, when checking the validity of the analyzer 10 at the time of the introduction, it is possible to check the file F ₀ by the manufacturer is stored.

[0007]

However, in the case of management by the above-described method, in addition to a huge amount of standard documents such as management standards, management based on the management standards is necessary to prove the validity of the analysis. Report 13-1
8 and these had to be kept securely. Accordingly, requires a lot of form 13 to 18, but these need to be stored by such files F ₀ to F ₄ or a notebook, and implementation forgotten user, omission of the recording or the like, the management forgotten or lost And so on could have happened. In addition, since the records of the inspection before the shipment of the analyzer 10 and at the stage of installation thereof are stored by the manufacturer, there is a disadvantage that the user cannot confirm the record.

[0008] The present invention has been made in view of the above-mentioned matters, and it is an object of the present invention to confirm the validity of an appropriate analyzer without fail. An object of the present invention is to provide a method for confirming validity of an analyzer which can be surely provided, an analyzer having a validity confirming function, and a recording medium recording a validity confirmation program for the analyzer.

[0009]

In order to achieve the above object, a method for confirming the validity of an analyzer according to the present invention comprises an analysis section having an analysis section and an information processing apparatus for processing an analysis value from the analysis section. In the analyzer, a plurality of test items that guarantee the quality with respect to the analysis to be performed and various information including the test results are recorded by an information processing device provided in the analyzer, and the information processing device determines that the test results cannot be changed. In addition, the analyzer is characterized by outputting the test items and the test results to prove that the analyzer is proper.

[0010] Therefore, since each test item necessary for validity check and various information including the test result are stored by the existing information processing device, the data can be securely stored without complicating the configuration of the analyzer. . In other words, not only does the user take time, but also the validity of the analyzer is ensured without the user having to perform management work, forgetting to record, forgetting to keep, and losing the recording paper. It can be performed. In the present invention, the operation described as inspection includes a calibration operation and an adjustment operation of the analyzer.

[0011] Further, as various kinds of information for assuring the quality of the analyzer, in addition to the determination analyzer type, shipping test and installation test performed by the manufacturer of the analyzer, a calibration test and a periodic inspection performed by a user of the analyzer. When recording daily inspection and analysis methods, information such as the results of shipping tests, installation tests, and calibration tests before and at the time of installation of the analyzer can also be referred to for validation. That is, the analyzer can be used in any region where the criteria for validation are different.

In the case where information indicating an inspection method, information indicating a control standard, and information indicating a standard device or a standard sample used for the inspection are recorded as the various types of information, a user required when the analyzer is installed. As information on the side, the analyzer's inspection method, management standards, and other information such as standard equipment and standard samples used for analyzer inspection are input and stored in the analyzer's information processing device. It is no longer necessary to keep a huge amount of standard documents such as management standards prepared separately on paper or the like.

The information processing apparatus divides various information into inspection items and displays the list, and an inspector selects an inspection item to be performed from the list to display an inspection method of the inspection item. However, if the inspector saves the inspection results under the direction of the person in charge of the form after performing the inspection according to the displayed method, it is very easy to obtain instructions on the inspection method to be performed when necessary. Since it is possible, the labor can be reduced, and the inspection can be performed under the same conditions no matter who performs the inspection. That is, the validity of the analyzer can be confirmed more reliably. In the present invention, the term "inspector" includes an operator who performs calibration and adjustment of the analyzer.

In each test item of a calibration test, a periodic inspection, a daily inspection, and an analysis method performed by a user of the analyzer,
The user should be able to change the information indicating the inspection method, the information indicating the management standards, the information indicating the standard equipment and standard samples used for the inspection, and the information indicating the form format, and leave a change history of the information. In this case, the contents of the calibration test, periodic inspection, daily inspection, and analysis method can be changed according to the needs of the user, so that the degree of freedom is increased and the change history remains, so it is necessary to confirm the validity. Information can be left.

According to the present invention, there is provided an analyzer having a function of confirming validity, comprising: a computer readable and writable recording medium for immutably recording various information including a plurality of test items for assuring the quality of an analysis to be performed; And a display unit for proving that the analyzer is proper by outputting the recorded information. That is, the information processing device attached to the analyzer can manage everything that needs to be validated, and the reliability of the analyzer and the analysis by this analyzer can be guaranteed.

Various types of information for guaranteeing the quality of the analyzer include:
In addition to the decision analyzer type, shipping test and installation test performed by the analyzer manufacturer, there may be calibration tests, periodic inspections, daily inspections and analysis methods performed by the analyzer user.

Further, the various information may include information indicating an inspection method, information indicating a management standard, and information indicating a standard device or a standard sample used for the inspection. In this case, the display unit divides various kinds of information into inspection items and displays the list, and the inspector selects an inspection item to be performed from the list, thereby displaying an inspection method of the inspection item. The information processing apparatus may be configured such that, after the inspector performs the inspection by the method displayed on the display unit, the information processing apparatus stores the inspection result in accordance with an instruction of the person in charge of the form record.

Further, in each of the inspection items of the calibration test, the periodic inspection, the daily inspection, and the analysis method performed by the user of the analyzer, information indicating an inspection method, information indicating a control standard, a standard device and a standard sample used for the inspection are provided. May be changed by the user, and the change history of the information may be left.

The recording medium on which the validity check program for the analyzer of the present invention is recorded can read and write a plurality of test items for guaranteeing the quality of the analysis to be performed and various information including the test results by the information processing device. Recording on a suitable recording medium, making the recorded inspection results unchangeable,
It is characterized in that it is possible to prove that the analyzer is appropriate by outputting various information.

[0020]

FIG. 1 is a view showing an example of an analyzer 1 having a validity checking function according to the present invention. In FIG.
An analysis unit 2 determines the content of trace carbon or sulfur contained in a sample to be measured, for example, by infrared gas analysis of the burned gas, and an information processing device 3 (hereinafter referred to as a computer) connected to the analysis unit 2 ). The computer 3 has a CPU 3c, a memory 3m, a hard disk 3h as an example of an auxiliary storage device, a display 3d as an example of a display unit, and a keyboard 3k. It goes without saying that the present invention does not limit the type of the analyzer 2.

The computer 3 inputs a measured value Dd from the analyzer 2 via the communication cable C and processes the data Dd, and a control program Pc which outputs a control command Dc for controlling the analyzer 2 Then, a validity confirmation program Pv (hereinafter, referred to as a validation program) for proving that the analyzer 2 is appropriate is executed. Each of the programs Pd, Pc, Pv is executed while being read from a computer-readable recording medium such as the hard disk 3h and written into the memory 3m.

Dv is validation data stored by the validation program Pv. Note that the validation data Dv is not only stored in the memory 3 but also stored in an auxiliary storage device such as a hard disk 3h or a non-volatile memory so that its contents are not lost.

FIG. 2 shows a display example of a screen displayed on the display 3d. In this example, a list T showing a plurality of inspection items for guaranteeing the quality with respect to the analysis to be performed and the inspection results is shown. To display. Further, this list T shows the processing contents by the validity check program Pv. As shown in the list T, the validation data Dv has a system which is roughly divided into eight.

That is, the validation data Dv
Is the required specification Dv1 for the analyzer 1 on the user side, and the determined analyzer type Dv of the analyzer 1 determined by the manufacturer corresponding thereto.
2. Shipping test D performed when analyzer 1 is delivered to the user
v3, installation test Dv4, calibration test Dv performed by user
5, periodic inspection Dv6, daily inspection Dv7, and analysis method Dv8 indicating an analysis method determined by the user.

The validation data Dv1 of each of the above systems
To Dv8, a plurality of items are prepared according to the type of the analyzer 1. For example, in the case of this example, as the decision analyzer type Dv2, not only various information items such as an ISO quality system acquisition certificate and a software declaration, but also standard sample parallel accuracy, standard sample linearity, analysis element and analysis range, It has an inspection item V ₀ such as sensitivity - vibration.

The validation data includes information V ₁ indicating an inspection method, information V ₂ indicating a control standard, information V ₃ indicating a standard device or a standard sample used for the inspection, and information V ₃ indicating an inspection method, corresponding to each inspection item V _0. disclose the results of responsible information V ₄ and form recording showing the manner of the form has information V ₅ for identifying.

As shown in the above-mentioned list T, out of the eight systems described above, each test item V of the decision analyzer type Dv2, shipping test Dv3, installation test Dv4 and calibration test Dv5
_0, a method of inspection, control standards, the content of the information V _1, V _2, V ₃ showing a standard instrument or standard samples for use in testing is defined by the manufacturer at the time of shipment of the analyzer 1, which is a memory 3m or external It is recorded (saved) in the storage device 3h or the like. The information V ₁ of the respective test item V ₀ which above, V _2, V
_{The fact that} the contents of No. 3 are stored, for example, by the inspector on the manufacturer side, that is, the quality system manager Sm, is indicated by writing “Sm” in the list T. (The same applies to the following items)

The record of the information V ₄ indicating the form in each inspection item V ₀ is recorded by the manufacturer's equipment inspector Im.
Done by The recording of information V ₅ showing the test results of the inspection item V ₀ is responsible for form printing, i.e., carried out by all responsible Am or the manufacturer's equipment inspector Im manufacturer side.

On the other hand, the required specification Dv1, the calibration test Dv5,
The contents of the information V ₁ , V ₂ , and V ₃ of each test item V ₀ of the periodic test Dv 6, the daily test Dv 7, and the analysis method Dv 8 are the analyzer 1
This is determined and stored by the inspector on the user side, ie, the system administrator Su and the worker Ou. The recording of information V ₅ showing the test result of each test item V ₀ is performed by an instruction of all responsible Au is responsible for the document records the user's side.

In the example shown in the above-mentioned list T,
And each inspection item V of the calibration test Dv5₀Information V₁~ V_Four
The contents of the data are pre-set at the time of shipment from the manufacturer's quality system for analyzer 1.
System administrator Sm and equipment inspector Im
Information V₁~ V _FourIs the user's quality system
Can be revised or modified by the system administrator Sm or the worker Ou
Noh.

The revision or correction of the content of each test item V ₀ in each of the systems Dv 1 to Dv 8 is performed by adding or deleting the test item V ₀ by the above-mentioned designated persons Sm, Im, Su, and Ou. Information V ₁ to inspection item V ₀
Such as the revision or modification of V ₄ can be carried out. Then, the validation program Pv running on the computer 3 automatically leaves a history of this revision or modification.

[0032] On the other hand, when recording the test results V ₅ is,
Validation program Pv that runs on the computer 3, after the inspection of the inspection item V _0, responsible Au of the form recording confirmed by password and ID input, Am, only by receiving an instruction Im , it is configured to store information V ₅ showing the test results automatically.

Further, it is configured that anyone can display information V _{1 to} V ₅ of each inspection item V ₀ in each of the systems Dv _{1 to} Dv 8. The information can be displayed by, for example, displaying a screen on the display 3d as shown in FIG. It goes without saying that the display may be made by printing on paper by connecting a printer or the like.

Next, an example will be described in which calibration for maintaining and managing the analyzer is periodically performed. The following example shows an example in which the analyzer users Su, Ou, and Au perform the operations, but the following operations may be performed by the manufacturers Sm, Im, and Am.

At this time, based on a chronological system of a periodic inspection including maintenance and a daily inspection, an inspection item V ₀ for each item, a test method for each item, a management standard by the test, and standard equipment used for the test. The form for recording the standard data and the test results is determined in advance, or the analyzer 3 is used in accordance with the user of each analyzer 3.
Has been revised or modified according to the environment in which it is used.

The inspection results obtained by the operator performing the inspection in a time series system of the periodic inspection including the periodic maintenance and the daily inspection are instructed by the person in charge of the form record Au, Am, Im. It can be carried out. In this case, the validation program Pv is, call the form style from information V ₄ of each test item V _0, the automatic capture and input of data, test results recorded in the document record of the person responsible for Au, Am, the approval of the Im If you don't get it, you can't do it. In addition, any person may test result V ₅ that has been saved, additional lexical, deleted so as not be performed at all.

The calibration, periodic inspection, and daily inspection necessary for the maintenance and management of the analyzer 1 are notified to the operator by displaying a screen on the display 3d when it is time to carry out the calibration. . That is, such as by flashing the portion of the test item V ₀ should be performed in the table in T, can be notified of the test period the operator. Further, the present invention does not limit the method of notifying the inspection time. For example, various methods such as making analysis impossible are possible.

[0038] By configuring as above, when checking the validity of the analyzer 1 by operating the computer 3, a plurality of test items V ₀ and the inspection results to guarantee the quality with respect to the analysis to be performed a variety of information, including the V _5,
It can be taken out very easily. At the same time, the validity of the analysis method performed by the user can be confirmed. In addition, once not only information V ₅ of the stored test results not be changed, it eliminated all is a possibility such as a recording forgotten or lost. That is, the reliability of the quality of the analyzer 1 can be reliably guaranteed.

In the above-described example, the infrared gas analyzer is illustrated, but it goes without saying that the present invention does not limit the type of the analyzer 1. Further, the configuration of the analyzer 1 is not limited to a configuration in which the analyzer 2 and the information processing device 3 are separately provided, and the information processing device 3 may be built in the analyzer 1.

Further, the analyzer of the present invention may constitute an analysis system in which one information processing device 3 controls a large number of analysis units 2. In this case, the information processing apparatus 3 separately in each analysis unit 2, stores various information including a plurality of test items V ₀ and the inspection result V ₅ to ensure its quality.

In addition, the validation program P
v and the validation data Dv managed by the program can be easily incorporated into the current configuration of the analyzer 1 by recording it on a computer-readable recording medium. In this case, there is an advantage that the analyzer having the validity checking function of the present invention can be configured very easily.

[0042]

As described above, according to the present invention,
Each test item necessary for validity check and various information including the test result are stored by the existing information processing device.
Data can be reliably stored without complicating the configuration of the analyzer. In other words, it is possible to store not only multiple inspection items that guarantee the quality without troublesome users and various information including the inspection results, but also to forget to carry out management work by the analyzer user, forget to record, forget to keep, Further, the validity of the analyzer can be surely confirmed without losing the recording paper.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing a configuration of an example of an analyzer having a validity check function of the present invention.

FIG. 2 is a diagram showing an example of various information displayed on a display unit of the analyzer.

FIG. 3 is a diagram that discloses the configuration of a conventional analyzer and what is performed for validity confirmation.

[Explanation of symbols]

1 ... analyzer, 2 ... analyzer, 3 ... information processing apparatus, 3d ... display unit, Dv ... various information, T ... table, V ₀ ... test item,
V ₅ ... test results.

Claims (11)

[Claims] An analyzer provided with an analysis unit and an information processing device for processing an analysis value from the analysis unit includes a plurality of inspection items that guarantee the quality of an analysis to be performed and various types of inspection items including the inspection results. Information is recorded by an information processing device provided in the analyzer, and the information processing device renders the test result unchangeable, and outputs the test items and the test results, so that the analyzer is appropriate. A method for confirming the validity of an analyzer characterized by proving that 2. Various kinds of information for assuring the quality of the analyzer include: a determination analyzer type, a shipping test, and an installation test performed by a manufacturer of the analyzer, and a calibration test and a periodic inspection performed by a user of the analyzer. 2. The method for confirming validity of an analyzer according to claim 1, wherein the daily inspection and the analysis method are recorded. 3. The validity of the analyzer according to claim 1, wherein information indicating an inspection method, information indicating a management standard, and information indicating a standard device or a standard sample used for the inspection are recorded as the various information. Confirmation method. 4. An inspection method for a corresponding inspection item, wherein the information processing apparatus divides various kinds of information into inspection items and displays the list as an inspection item, and an inspector selects an inspection item to be performed from the list. 4. The method according to claim 3, wherein the inspection is performed by the inspector after performing the inspection according to the displayed method, and the inspection result is stored according to the instruction of the person in charge of the form record. 5. A calibration test performed by a user of the analyzer,
In each inspection item of periodic inspection, daily inspection and analysis method, information indicating the inspection method by the user, information indicating the management standard, information indicating the standard equipment and standard samples used for the inspection, and information indicating the form format, 5. The method according to claim 3, wherein the information can be changed and a change history of the information is left.
Method for confirming the validity of the analyzer described in. 6. An analyzer provided with an analysis section and an information processing device for processing an analysis value from the analysis section, various kinds of information including a plurality of inspection items for assuring the quality of the analysis to be performed, and the inspection thereof. A computer-readable recording medium for recording the result in an unchangeable manner, and a validity checking function characterized by having a display unit for proving that the analyzer is proper by outputting the recorded information. Having an analyzer. 7. Various kinds of information for assuring the quality of the analyzer include a determination analyzer type, a shipping test and an installation test performed by a manufacturer of the analyzer, and a calibration test and a periodic inspection performed by a user of the analyzer. 7. The method according to claim 6, which is a routine inspection and analysis method.
An analyzer having a validation function according to item 1. 8. The method according to claim 1, wherein the various information is information indicating an inspection method,
8. The information processing apparatus according to claim 6, further comprising information indicating a control standard and information indicating a standard device or a standard sample used for the inspection.
An analyzer having a validation function according to item 1. 9. The display unit divides various information into inspection items and displays the list as a list, and an inspector selects an inspection item to be performed from the list, thereby selecting an inspection method of the inspection item. 9. The information processing apparatus according to claim 8, wherein the information processing apparatus stores the inspection result according to an instruction of a person in charge of the form record after the inspector performs the inspection by the method displayed on the display unit. Analyzer with validation function described. 10. In each inspection item of a calibration test, a periodic inspection, a daily inspection, and an analysis method performed by a user of the analyzer, information indicating an inspection method, information indicating a management standard, a standard device or a standard sample used for the inspection. And the information indicating the form can be changed by the user,
10. The system according to claim 8, wherein a change history of information is left.
An analyzer having a validation function according to item 1. 11. A program incorporated in an information processing device of an analyzer having an analysis unit and an information processing device for processing an analysis value from the analysis unit, wherein the program guarantees quality with respect to an analysis to be performed. A plurality of test items and various information including the test results are recorded on a recording medium readable and writable by the information processing apparatus, and the recorded test results are not changed. A computer-readable recording medium on which a validity check program for an analyzer is recorded.