CN108846648A - The with no paper monitoring system of production process and monitoring method - Google Patents
The with no paper monitoring system of production process and monitoring method Download PDFInfo
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- CN108846648A CN108846648A CN201810823884.9A CN201810823884A CN108846648A CN 108846648 A CN108846648 A CN 108846648A CN 201810823884 A CN201810823884 A CN 201810823884A CN 108846648 A CN108846648 A CN 108846648A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 271
- 238000000034 method Methods 0.000 title claims abstract description 64
- 238000012544 monitoring process Methods 0.000 title claims abstract description 38
- 238000002372 labelling Methods 0.000 claims abstract description 39
- 238000004806 packaging method and process Methods 0.000 claims abstract description 30
- 238000012790 confirmation Methods 0.000 claims description 110
- 238000012552 review Methods 0.000 claims description 59
- 238000007726 management method Methods 0.000 claims description 21
- 238000012550 audit Methods 0.000 claims description 18
- 238000012795 verification Methods 0.000 claims description 11
- 238000002360 preparation method Methods 0.000 claims description 9
- 230000002159 abnormal effect Effects 0.000 description 5
- 238000012856 packing Methods 0.000 description 2
- 239000002699 waste material Substances 0.000 description 2
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- 238000004891 communication Methods 0.000 description 1
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- 238000011161 development Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000007905 drug manufacturing Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
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- 239000000463 material Substances 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 238000013439 planning Methods 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000011958 production data acquisition Methods 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
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- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
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Abstract
The present invention provides a kind of with no paper monitoring system of production process, the monitoring system includes that production line, data acquisition and supervisor control, electronics batch record generate system and electronic report forms management system, the production line for realizing batch packaging, labeling, divide/is started going to a nursery, mounted box/vanning and electronic supervision code assignment production process;The data acquisition is connect with supervisor control with the production line, for acquiring the creation data during the production line realizes multiple production processes;The electronics batch record generates system and connect with data acquisition with supervisor control, and the electronics batch record of each production process is generated according to the creation data;The electronic report forms management system generates system with the electronics batch record and connect, for checking the electronics batch record of different production process different batches.The present invention also provides a kind of monitoring methods based on the with no paper monitoring system of production process.
Description
Technical field
The present invention relates to production fields, specifically, relate to a kind of with no paper monitoring system of production process and monitoring side
Method.
Background technique
Although current automatic assembly line, which has become, has showed pharmacy automation control, in production data acquisition and monitoring, production
Planning and scheduling automation, manufacturing process data are with no paper etc. to be need to be improved, with the continuous development of informationization technology,
Safety in production will be reached as drug manufacturing process is ensured, efficient output, save energy by implementing automation control and information system management
The inevitable choice of consumption and the comprehensive productive target such as environmental protection, therefore produce and have become urgently to be resolved important ask with IT application in management
Topic.
In order to solve the above problems, people are seeking always a kind of ideal technical solution.
Summary of the invention
The purpose of the present invention is in view of the deficiencies of the prior art, to provide a kind of with no paper monitoring system of production process
And monitoring method.
To achieve the goals above, the technical scheme adopted by the invention is that:A kind of with no paper monitoring system of production process,
The life process monitoring system includes that production line, data acquisition and supervisor control, electronics batch record generate system and electricity
Subreport management system, the production line for realizing batch packaging, labeling, divide/are started going to a nursery, the tax of mounted box/vanning and electronic supervision code
It is worth production process;The data acquisition is connect with supervisor control with the production line, is realized for acquiring the production line
Creation data during multiple production processes;The electronics batch record generates system and data acquisition and monitors control system
System connection, the electronics batch record of each production process is generated according to the creation data;
The electronic report forms management system generates system with the electronics batch record and connect, for checking that different production processes are different
The electronics batch record of batch.
Based on above-mentioned, it includes input/output module and electronics batch record generating platform that the electronics batch record, which generates system,
The input/output module is used to input basic data to the electronics batch record generating platform and multiple production processes are responsible for
The confirmation of people is signed, and the electronics batch record generating platform acquires respectively with the input/output module, the data and monitoring
Control system connection, according to during the basic data, multiple production processes creation data and multiple production processes it is negative
The confirmation signature for blaming people generates the electronics batch record.
Based on above-mentioned, the electronics batch record includes that batch the packaging record of production, the labeling record of production, production of divide/starting going to a nursery are remembered
Record, mounted box/vanning record of production and electronic supervision code assignment record.
Based on above-mentioned, the generating process of the described batch of packaging record of production is:Compile and edit people by the input/output module to
The electronics batch record generating platform inputs the addition that the basic data carries out batch packaging directive, and in described batch of packaging directive
Confirmation signature is compiled and edit to the electronics batch record generating platform input when adding successfully, the basic data includes the name of an article, specification
And lot number;The correctness of the basic data of auditor's described batch of packaging directive of verification, when the basic data is correct to
The electronics batch record generating platform input audit confirmation signature;Confirmation signature and audit confirmation are compiled and edit approved by described
Approval confirmation signature is inputted to the electronics batch record generating platform in the presence of signature is equal.
Based on above-mentioned, the generating process of the labeling record of production is:Described in the electronics batch record generating platform judgement
Criticize whether packaging directive there is described compile and edit to confirm that signature, the audit confirm that signature and approval confirmation are signed simultaneously, if
Have simultaneously, then generates the basic data of the labeling record of production according to the basic data of described batch of packaging directive;Check people
Before confirming whether the basic data of the labeling record of production is correct and producing whether preparation is completed, and is being all satisfied
In the case of to the electronics batch record generating platform input review confirmation signature;The people that clears out a gathering place clear out a gathering place and clear out a gathering place complete after to
The electronics batch record generating platform input, which is cleared out a gathering place, confirms signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and reach
Mark clears out a gathering place to electronics batch record generating platform input if being all satisfied and checks confirmation signature;In production process, the electronics
Batch record generating platform obtains the creation data of the labeling record of production from the labeling production process of the production line;Labeling production
After the completion of process, process responsible person confirms that production process operating process is errorless, and inputs to the electronics batch record generating platform
Production review confirmation signature.
Based on above-mentioned, the generating process of the described point/record of production of starting going to a nursery is:The electronics batch record generating platform judges institute
State the labeling record of production whether and meanwhile there is review confirmation signature, the confirmation signature of clearing out a gathering place, the review confirmation of clearing out a gathering place
Signature and production review confirmation are signed, if having simultaneously, generate institute according to the basic data of the labeling record of production
State point/the basic data of the record of production of starting going to a nursery, the basic data of review people's confirmation record of production of divide/starting going to a nursery whether correctly with
And whether preparation is completed before producing, and true to electronics batch record generating platform input review in the case where being all satisfied
Recognize signature;The people that clears out a gathering place, which clears out a gathering place and clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input, confirms signature;
Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, inputs if being all satisfied to the electronics batch record generating platform
Review confirmation of clearing out a gathering place is signed;The record of production of divide/starting going to a nursery is obtained in production process from the production process of divide/starting going to a nursery of the production line
Creation data;After the completion of production process of divide/starting going to a nursery, process responsible person confirms that production process operating process is errorless, and to described
Electronics batch record generating platform input production review confirmation signature.
Based on above-mentioned, the mounted box/vanning record of production generating process is:The electronics batch record generating platform judgement
Described point/the record of production of starting going to a nursery whether and meanwhile there is review confirmation signature, the confirmation signature, the review of clearing out a gathering place of clearing out a gathering place
Confirmation signature and production review confirmation signature, if having simultaneously, according to the basic data of the record of production of divide/starting going to a nursery
The mounted box/vanning record of production basic data is generated, review people confirms the mounted box/vanning record of production basic data
Whether whether the preceding preparation of correct and production is completed, and in the case where being all satisfied to the electronics batch record generating platform
Input review confirmation signature;The people that clears out a gathering place clears out a gathering place and clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input
Confirmation signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, raw to the electronics batch record if being all satisfied
It clears out a gathering place at platform input and checks confirmation signature;Dress is obtained in production process from the mounted box of the production line/vanning production process
Box/vanning record of production creation data;After the completion of mounted box/vanning production process, process responsible person confirms production process operation
Process is errorless, and inputs production review confirmation signature to the electronics batch record generating platform.
Based on above-mentioned, the generating process of the electronic supervision code assignment record is:The electronics batch record generating platform is sentenced
The mounted box/vanning the record of production that breaks whether and meanwhile there is review confirmation signature, the confirmation signature of clearing out a gathering place, described clear out a gathering place
Review confirmation signature and production review confirmation signature, if having simultaneously, according to the mounted box/vanning record of production base
Plinth data generate the basic data of the electronic supervision code assignment record;Whether operator prepares to complete before confirming production, in standard
To electronics batch record generating platform input operation acknowledgement signature after standby completion;Founder creates production task, is creating
At the backward electronics batch record generating platform input creation confirmation signature;Auditor audits production task, and is examining
Core inputs audit confirmation to the electronics batch record generating platform after completing and signs;Collator checks supervision record quantity performed
It is no correct, it signs to the electronics batch record generating platform input nucleus to confirmation after verification;It checks people and carries out quantity review, verification
After carry out review Signature Confirmation;The people that clears out a gathering place clears out a gathering place and inputs after completion of clearing out a gathering place to the electronics batch record generating platform clear
Field confirmation signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, to the electronics batch record if being all satisfied
Generating platform input, which is cleared out a gathering place, checks confirmation signature;The electronic supervision code assignment is inputted by each workshop section responsible person in production process
The creation data of record;After the completion of electronic supervision code assignment production process, process responsible person confirm production process operating process without
Accidentally, and to the electronics batch record generating platform production review confirmation signature is inputted.
The present invention also provides a kind of monitoring methods based on the with no paper monitoring system of production process comprising following
Step:
The production line realizes batch packaging, labeling, divide/starts going to a nursery, mounted box/vanning and electronic supervision code assignment production process;
Data acquisition and supervisor control acquire the production line and realize creation data during multiple production processes;
The electronics batch record management system generates the electronics batch record of each production process according to the creation data;
User checks the electronics batch record of each production process different batches by the electronics batch record management system.
Based on above-mentioned, user checks the electronics of each production process different batches by the electronics batch record management system
When batch record, it is combined inquiry using the basic data of target electronic batch record, and in poll-final according to target electronic
The signed data of batch record confirms the electronics batch record report with the presence or absence of abnormal untreated phenomenon.
The present invention has substantive distinguishing features outstanding and significant progress compared with the prior art, and specifically, the present invention is logical
It crosses to production process progress production plan is specified, production plan is assigned and production plan tracking, realizes medical production batch pipe
Reason;It monitors the linear condition of pharmaceutical production one in real time, the data monitoring of all key links is covered all around;Production process is automatic
Change and the informationization of management system is applied in pharmaceutical production link, there is significant energy-saving effect, while improving and producing
Successful of journey material circulation, reduces the intermediate link of pharmaceutical production, has prevented product in the wave of production flowing link
Take;Promote the market competitiveness.
Specific embodiment
Below by specific embodiment, technical scheme of the present invention will be described in further detail.
The present invention provides a kind of with no paper monitoring system of production process, the life process monitoring system include production line,
Data acquisition generates system and electronic report forms management system with supervisor control, electronics batch record.
The production line for realizing batch packaging, labeling, divide/is started going to a nursery, the production of mounted box/vanning and electronic supervision code assignment
Process.Specifically, the production line includes automati labelling machine, point support machine, machine of starting going to a nursery, full-automatic box packing machine, strapper, stacking
Machine, patch code turning machine and supervision code printer, it is preferred that the automati labelling machine, described point of support machine, the machine of starting going to a nursery, described
Full-automatic box packing machine, the strapper, the stacking machine, the patch code turning machine and all PLC for supervising code printer
Communication data is both needed to be acquired according to production requirement and record, in principle whole automatic collections, using manual when can not acquire
Input mode is acquired.
The data acquisition is connect with supervisor control with the production line, multiple for acquiring the production line realization
Creation data during production process;Specifically, the data acquisition has full Chinese with prompt with supervisor control
Operation interface provides easy operation for operator by system user-machine interface software, and operator is merely with mouse
Device and cursor can selection operation object or operational orders.
User-machine interface software is also possible that operator carries out State Viewpoint to the monitoring point of position any in system
It examines and parameter monitoring, issues control instruction;Or related controller, monitoring point, Relational database are edited after authorization
Adjustment.In addition, operator can also retrieve the figure and equipment installation position of architectural plane.
The electronics batch record generates system and connect with data acquisition with supervisor control, according to the production number
According to the electronics batch record for generating each production process.
Specifically, the electronics batch record include batch packaging the record of production, the labeling record of production, the record of production of divide/starting going to a nursery,
Mounted box/vanning record of production and electronic supervision code assignment record.
Wherein, the described batch of packaging record of production includes the name of an article, specification, lot number and a variety of signatures.
Described batch packaging the record of production generating process be:It compiles and edit people and is criticized by the input/output module to the electronics
Record generating platform inputs the addition that the basic data carries out batch packaging directive, and when described batch of packaging directive is added successfully
Confirmation signature is compiled and edit to electronics batch record generating platform input, the basic data includes the name of an article, specification and lot number;Audit
The correctness of the basic data of described batch of packaging directive of people's verification, when the basic data is correct to the electronics batch note
Record generating platform input audit confirmation signature;Approved by it is described compile and edit confirmation signature and audit confirmation signature equal in the presence of
Approval confirmation signature is inputted to the electronics batch record generating platform.
The labeling record of production includes basic data and creation data, and the basic data includes the name of an article, specification, criticizes
Number, batch, date of manufacture, shift etc.;The creation data includes neck label amount, above criticizes label clearing amount, labeling yield and loss
Amount etc..
The generating process of the labeling record of production is:Described batch of packaging directive of the electronics batch record generating platform judgement
Whether there is described compile and edit to confirm that signature, audit confirmation signature and approval confirmation are signed simultaneously, if having simultaneously,
The basic data of the labeling record of production is generated according to the basic data of described batch of packaging directive;It checks people and confirms the labeling
Whether the basic data of the record of production is correct and produces whether preceding preparation is completed, and in the case where being all satisfied to described
Electronics batch record generating platform input review confirmation signature;The people that clears out a gathering place clears out a gathering place and after completion of clearing out a gathering place to the electronics batch note
Record generating platform input, which is cleared out a gathering place, confirms signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, if being all satisfied
It clears out a gathering place to electronics batch record generating platform input and checks confirmation signature;In production process, the electronics batch record generates flat
Platform obtains the creation data of the labeling record of production from the labeling production process of the production line;After the completion of labeling production process,
Process responsible person confirms that production process operating process is errorless, and inputs production review confirmation to the electronics batch record generating platform
Signature.
Described point/the record of production of starting going to a nursery includes basic data and creation data, the basic data include the name of an article, specification,
Lot number, batch, date of manufacture, shift etc.;The creation data includes start going to a nursery yield, waste, rejected product amount etc..
The generating process of the described point/record of production of starting going to a nursery is:The electronics batch record generating platform judges that the labeling is raw
Produce whether record has the review confirmation signature, the confirmation signature of clearing out a gathering place, review confirmation signature and the institute of clearing out a gathering place simultaneously
Production review confirmation signature is stated, if having simultaneously, described divide/start going to a nursery is generated according to the basic data of the labeling record of production
The basic data of the record of production, whether the basic data of review people's confirmation record of production of divide/starting going to a nursery is correctly and before production
Whether preparation is completed, and inputs review confirmation signature to the electronics batch record generating platform in the case where being all satisfied;
The people that clears out a gathering place, which clears out a gathering place and clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input, confirms signature;It clears out a gathering place inspection
Whether whether people check to clear out a gathering place and complete and up to standard, clears out a gathering place review if being all satisfied to electronics batch record generating platform input
Confirmation signature;The production number for the record of production of divide/starting going to a nursery is obtained in production process from the production process of divide/starting going to a nursery of the production line
According to;After the completion of production process of divide/starting going to a nursery, process responsible person confirms that production process operating process is errorless, and remembers to the electronics batch
Record generating platform input production review confirmation signature.
The mounted box/vanning record of production includes basic data and creation data, and the basic data includes the name of an article, rule
Lattice, lot number, batch, date of manufacture, shift etc.;The creation data includes mounted box amount, waste, unqualified amount etc..
The mounted box/vanning record of production generating process is:The electronics batch record generating platform judgement is described divide/to be entered
Whether the support record of production has the review confirmation signature, the confirmation signature of clearing out a gathering place, the review confirmation signature of clearing out a gathering place simultaneously
Confirmation signature is checked with the production, if having simultaneously, according to the basic data generation of the record of production of divide/starting going to a nursery
Mounted box/vanning record of production basic data, review people confirm whether the mounted box/vanning record of production basic data is correct
And whether preparation is completed before producing, and inputs and check to the electronics batch record generating platform in the case where being all satisfied
Confirmation signature;The people that clears out a gathering place, which clears out a gathering place and clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input, confirms label
Name;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, to the electronics batch record generating platform if being all satisfied
Input, which is cleared out a gathering place, checks confirmation signature;Mounted box/vanning is obtained in production process from the mounted box of the production line/vanning production process
The creation data of the record of production;After the completion of mounted box/vanning production process, process responsible person confirm production process operating process without
Accidentally, and to the electronics batch record generating platform production review confirmation signature is inputted.
The electronic supervision code assignment record includes basic data and creation data, and the basic data includes the name of an article, rule
Lattice, lot number, batch, date of manufacture, shift etc..
The generating process of electronic supervision code assignment record is:The electronics batch record generating platform judges the dress
Whether box/vanning record of production has the review confirmation signature, the confirmation signature of clearing out a gathering place, the review confirmation of clearing out a gathering place simultaneously
Signature and production review confirmation signature, it is raw according to the mounted box/vanning record of production basic data if having simultaneously
The basic data recorded at the electronic supervision code assignment;Whether operator prepares to complete before confirming production, after being ready to complete
To electronics batch record generating platform input operation acknowledgement signature;Founder creates production task, to institute after creation is completed
State electronics batch record generating platform input creation confirmation signature;Auditor audits production task, and after the completion of audit
Audit confirmation signature is inputted to the electronics batch record generating platform;Whether collator's verification supervision record quantity performed is correct,
It signs to the electronics batch record generating platform input nucleus to confirmation after verification;It checks people and carries out quantity review, carried out after verification
Check Signature Confirmation;The people that clears out a gathering place clears out a gathering place and inputs confirmation of clearing out a gathering place to the electronics batch record generating platform after completion of clearing out a gathering place
Signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, generates if being all satisfied to the electronics batch record flat
Platform input, which is cleared out a gathering place, checks confirmation signature;The electronic supervision code assignment record is inputted by each workshop section responsible person in production process
Creation data;After the completion of electronic supervision code assignment production process, process responsible person confirms that production process operating process is errorless, and to
The electronics batch record generating platform input production review confirmation signature.
The electronic report forms management system generates system with the electronics batch record and connect, for checking different production processes
The electronics batch record of different batches.
The electronics batch record defers to the specification of FDA and GMP completely, so that paperless management is realized in entire production, it can
According to the operation of SOP operating process accurate instruction producers, the maloperation bring loss of production is effectively avoided;Usually also
Formula and the production procedure of each product can be determined according to the SOP process of user, the access track of crude drug needed for determining.
After determining demand, pass through the production process for designing, instruct, controlling and checking product further according to demand.
The electronic report forms management system is using batch as core, and production workshop section is unit, such as extraction, concentration, alcohol precipitation, purification
Each production line production process data, production status, equipment state, fault message, lot data, operation are remembered by workshop section etc.
Record etc. acquires in real time, files, storing, counting, summarizing, analyzing, and is not only able to satisfy the requirement of GMP, but also by these data
Arrangement, can analyze product quality, improve technological level, optimization production, improve production efficiency, and continuously save 3 years or more
Historical data.
Specifically, the electronic report forms management system is when checking the electronics batch record of each production process different batches,
Inquiry is combined using the basic data of target electronic batch record.The basic data includes the name of an article, specification, lot number, opens
Begin time, end time, querying method can be combined according to the option oneself of inquiry, be looked into after the corresponding query option of typing
It askes, and can check and check out corresponding detailed data.
The present invention also provides a kind of monitoring methods based on the monitoring system, and this approach includes the following steps:
The production line realizes batch packaging, labeling, divide/starts going to a nursery, mounted box/vanning and electronic supervision code assignment production process;
Data acquisition and supervisor control acquire the production line and realize creation data during multiple production processes;
The electronics batch record management system generates the electronics batch record of each production process according to the creation data;
User checks the electronics batch record of each production process different batches by the electronics batch record management system.
Further, user checks the electronics of each production process different batches by the electronics batch record management system
When batch record, it is combined inquiry using the basic data of target electronic batch record, and in poll-final according to target electronic
The signed data of batch record confirms the electronics batch record report with the presence or absence of abnormal untreated phenomenon.
Such as in the detailed data of the inquiry batch packaging directive record of production, if compiling and edit people, auditor, approved by this three item number
According to all existing, then it can determine whether that the data belong to complete data;Otherwise illustrate that this batch of report data is temporarily imperfect, Ke Nengcun
Abnormal untreated;
Such as when inquiring the labeling record of production, divide/starting going to a nursery the record of production or mounted box/vanning record of production, if checking people, clearing out a gathering place
People, the scrutineer that clears out a gathering place, process responsible person this four item data all exist, then can determine whether that the data belong to complete data;Otherwise it says
Bright this batch of report data is temporarily imperfect, it is understood that there may be abnormal untreated;
Such as inquire electronic supervision code assignment record when, if operator, founder, auditor, collator, check people, the people that clears out a gathering place,
Clear out a gathering place scrutineer, process responsible person this eight item data all exists, then can determine whether that the data belong to complete data;Otherwise illustrate this
A batch of report data is temporarily imperfect, it is understood that there may be abnormal untreated.
Finally it should be noted that:The above embodiments are merely illustrative of the technical scheme of the present invention and are not intended to be limiting thereof;To the greatest extent
The present invention is described in detail with reference to preferred embodiments for pipe, and the those of ordinary skill in the field should understand that:Still
It can modify to a specific embodiment of the invention or some technical features can be equivalently replaced;Without departing from this hair
The spirit of bright technical solution should all cover within the scope of the technical scheme claimed by the invention.
Claims (10)
1. a kind of with no paper monitoring system of production process, it is characterised in that:Including production line, data acquisition and monitoring control system
System, electronics batch record generate system and electronic report forms management system,
The production line for realizing batch packaging, labeling, divide/is started going to a nursery, mounted box/vanning and electronic supervision code assignment production process;
The data acquisition is connect with supervisor control with the production line, realizes multiple productions for acquiring the production line
Creation data in process;
The electronics batch record generates system and connect with data acquisition with supervisor control, raw according to the creation data
At the electronics batch record of each production process;
The electronic report forms management system generates system with the electronics batch record and connect, for checking different production processes not
With the electronics batch record of batch.
2. the with no paper monitoring system of production process according to claim 1, it is characterised in that:The electronics batch record generates
System includes input/output module and electronics batch record generating platform, and the input/output module is used for the electronics batch record
Generating platform inputs basic data and the confirmation signature of multiple production process responsible persons, the electronics batch record generating platform point
It is not connect with the input/output module, data acquisition with supervisor control, according to the basic data, multiple productions
The confirmation signature of creation data and multiple production process responsible persons in process generates the electronics batch record.
3. the with no paper monitoring system of production process according to claim 2, it is characterised in that:The electronics batch record includes
Criticize the packaging record of production, the labeling record of production, the record of production of divide/starting going to a nursery, mounted box/vanning record of production and electronic supervision code assignment
Record.
4. the with no paper monitoring system of production process according to claim 3, it is characterised in that:The described batch of packaging record of production
Generating process be:It compiles and edit people and the basic number is inputted to the electronics batch record generating platform by the input/output module
According to the addition for carrying out batch packaging directive, and it is defeated to the electronics batch record generating platform when described batch of packaging directive is added successfully
Enter to compile and edit confirmation signature, the basic data includes the name of an article, specification and lot number;Auditor's verification is described to criticize the described of packaging directive
The correctness of basic data inputs audit confirmation label to the electronics batch record generating platform when the basic data is correct
Name;It compiles and edit in the presence of confirmation signature is signed with audit confirmation approved by described to the electronics batch record generating platform
Input approval confirmation signature.
5. the with no paper monitoring system of production process according to claim 4, which is characterized in that the labeling record of production
Generating process is:Described batch of packaging directive of the electronics batch record generating platform judgement compiles and edit confirmation label described in whether having simultaneously
Name, audit confirmation signature and approval confirmation signature, if having simultaneously, according to the basic number of described batch of packaging directive
According to the basic data for generating the labeling record of production;Review people confirms whether the basic data of the labeling record of production is correct
And whether preparation is completed before producing, and inputs and check to the electronics batch record generating platform in the case where being all satisfied
Confirmation signature;The people that clears out a gathering place, which clears out a gathering place and clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input, confirms label
Name;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and up to standard, to the electronics batch record generating platform if being all satisfied
Input, which is cleared out a gathering place, checks confirmation signature;In production process, the electronics batch record generating platform is produced from the labeling of the production line
The creation data of the labeling record of production is obtained in process;After the completion of labeling production process, process responsible person confirms production process behaviour
It is errorless to make process, and inputs production review confirmation signature to the electronics batch record generating platform.
6. the with no paper monitoring system of production process according to claim 5, which is characterized in that described point/production note of starting going to a nursery
The generating process of record is:The electronics batch record generating platform judge the labeling record of production whether and meanwhile there is the review
Confirmation signature, the confirmation signature of clearing out a gathering place, clear out a gathering place review confirmation signature and the production review confirmation signature, if having simultaneously
Have, then generate the basic data of the record of production of divide/starting going to a nursery according to the basic data of the labeling record of production, review people is true
Whether the basic data for recognizing the record of production of divide/starting going to a nursery is correct and whether the preceding preparation of production is completed, and is being all satisfied
In the case where to the electronics batch record generating platform input review confirmation signature;The people that clears out a gathering place clears out a gathering place and after the completion of clearing out a gathering place
It clears out a gathering place to electronics batch record generating platform input and confirms signature;Whether whether the scrutineer that clears out a gathering place check to clear out a gathering place and complete and reach
Mark clears out a gathering place to electronics batch record generating platform input if being all satisfied and checks confirmation signature;From the life in production process
The creation data for the record of production of divide/starting going to a nursery is obtained in the production process of divide/starting going to a nursery of producing line;After the completion of production process of divide/starting going to a nursery, work
Sequence responsible person confirms that production process operating process is errorless, and inputs production review confirmation label to the electronics batch record generating platform
Name.
7. the with no paper monitoring system of production process according to claim 6, which is characterized in that the mounted box/vanning production
The generating process of record is:Electronics batch record generating platform judgement is described divide/start going to a nursery the record of production whether and meanwhile there is institute
Review confirmation signature, the confirmation signature of clearing out a gathering place, clear out a gathering place review confirmation signature and the production review confirmation signature are stated, if
Have simultaneously, then the basic number of the mounted box/vanning record of production is generated according to the basic data of the record of production of divide/starting going to a nursery
According to review people confirms whether the mounted box/vanning record of production basic data is correct and whether produce preceding preparation complete
At, and review confirmation signature is inputted to the electronics batch record generating platform in the case where being all satisfied;The people that clears out a gathering place clears out a gathering place
And it clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input and confirms signature;Whether the scrutineer that clears out a gathering place checks and clears out a gathering place
It completes and whether up to standard, clears out a gathering place if being all satisfied to electronics batch record generating platform input and check confirmation signature;Production
Mounted box/vanning record of production creation data is obtained from the mounted box of the production line/vanning production process in the process;Mounted box/
After the completion of production process of casing, process responsible person confirms that production process operating process is errorless, and generates to the electronics batch record
Platform input production review confirmation signature.
8. the with no paper monitoring system of production process according to claim 7, which is characterized in that the electronic supervision code assignment
The generating process of record is:The electronics batch record generating platform judge the mounted box/vanning record of production whether and meanwhile have
The review confirmation signature, the confirmation signature of clearing out a gathering place, clear out a gathering place review confirmation signature and the production review confirmation signature,
If having simultaneously, the electronic supervision code assignment record is generated according to the mounted box/vanning record of production basic data
Basic data;Whether operator prepares to complete before confirming production, defeated to the electronics batch record generating platform after being ready to complete
Enter operation acknowledgement signature;Founder creates production task, inputs and creates to the electronics batch record generating platform after creation is completed
Build confirmation signature;Auditor audits production task, and defeated to the electronics batch record generating platform after audit is completed
Enter audit confirmation signature;Whether collator's verification supervision record quantity performed is correct, generates after verification to the electronics batch record
Platform input nucleus signs to confirmation;It checks people and carries out quantity review, carry out review Signature Confirmation after verification;The people that clears out a gathering place clears out a gathering place
And it clears out a gathering place after completion of clearing out a gathering place to electronics batch record generating platform input and confirms signature;Whether the scrutineer that clears out a gathering place checks and clears out a gathering place
It completes and whether up to standard, clears out a gathering place if being all satisfied to electronics batch record generating platform input and check confirmation signature;Production
The creation data of the electronic supervision code assignment record is inputted by each workshop section responsible person in the process;The production of electronic supervision code assignment
After the completion of process, process responsible person confirms that production process operating process is errorless, and inputs to the electronics batch record generating platform
Production review confirmation signature.
9. the monitoring method of the with no paper monitoring system of production process according to claim 1-8, it is characterised in that:
The production line realizes batch packaging, labeling, divide/starts going to a nursery, mounted box/vanning and electronic supervision code assignment production process;
Data acquisition and supervisor control acquire the production line and realize creation data during multiple production processes;
The electronics batch record management system generates the electronics batch record of each production process according to the creation data;
User checks the electronics batch record of each production process different batches by the electronics batch record management system.
10. monitoring method according to claim 9, it is characterised in that:User passes through the electronics batch record management system
When checking the electronics batch record of each production process different batches, it is combined and is looked into using the basic data of target electronic batch record
It askes, and confirms the electronics batch record report with the presence or absence of different according to the signed data of target electronic batch record in poll-final
Normal untreated phenomenon.
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