CN110046827A - A kind of quality risk management network data base for information sharing - Google Patents
A kind of quality risk management network data base for information sharing Download PDFInfo
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- CN110046827A CN110046827A CN201910330266.5A CN201910330266A CN110046827A CN 110046827 A CN110046827 A CN 110046827A CN 201910330266 A CN201910330266 A CN 201910330266A CN 110046827 A CN110046827 A CN 110046827A
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
- G06Q10/063—Operations research, analysis or management
- G06Q10/0635—Risk analysis of enterprise or organisation activities
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
- G06Q10/063—Operations research, analysis or management
- G06Q10/0639—Performance analysis of employees; Performance analysis of enterprise or organisation operations
- G06Q10/06395—Quality analysis or management
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Abstract
A kind of quality risk management network data base for information sharing, user uses the Database vendors quality risk information, including its affiliated industry, place system or field, possible damage or caused deviation, the description of the seriousness of risk and hazard, risk Frequency, risk detection method, RPN value and risk class reference, the expection of control measure and its validity.After submitting shared application, system is numbered and is arranged management remarks, such as identifies examination result (whether repeat or there are infringement suspicion), the setting transitional period, whether participates in evaluation activity and review result.User is called by shared quality risk information realizes information deduction, the risk information that other people can also be called to share from shared risk database, and generation technique is reported.The epoch intension of kownledge economy is embodied, excitation people pay close attention to quality risk, promote quality upgrading.
Description
Technical field
This patent is related to the quality risk information management database of quality risk management, provides a kind of matter for sharing and sharing
Risk management database is measured, the database platform and its framework method of quality risk management is to aid in, is not quality risk management
Certain operating mode or management method.
Background technique
Risk refers to the combination of a possibility that harm occurs and its seriousness.In the officials such as ICH, WHO guide, drug quality
Risk be defined as risk may cause the seriousness of harm, probability of happening, detectable degree as a result, it is normal using RPN value as
The evaluation index of risk.With 2010 revision " pharmaceutical production quality management practices " implementation, drug quality risk management at
For the important composition content of pharmaceutical production field.
Risk management is the test to the wisdom of humanity and ability.Risk is changing, and Risk Governance is also changing.Past
Over 5 years, the technical report of injection association, the U.S. (abbreviation PDA) increases sharply from 40 original projects to more than 80 a projects, explanation
Recent years human society be to the degree of concern of quality risk it is fairly obvious, result is exactly the various bases that we are seen
In the appearance of the technological guidance's principle, Managed Solution of control quality risk.
It puts into effect or revises successively around the relevant various administrative regulations of medical treatment & health, drawn with " law of medicine management " of revision
The content for entering change management has reached new height, these all embody the depth of domestic and international regulation docking and quality risk management
Degree excavates.
Quality risk is to be widely present, but have great be associated with to the understanding excavation of quality risk information with people.Such as
The quality information that fruit is mined out is not approved widely, is not taken seriously, and fails to pay attention in practice or adopt
Take corresponding risk control measure.Corollary is exactly that the harm of risk and its generation is converted to bitter lesson, risk
The depth of management and risk is excavated also just without in all senses.It the quality management system of version in 2016 and is released after this each
The validity of all abnormal management and risk control measure for having paid close attention to quality risk therein of professional standard.Quality risk management
Urgent need is dissolved into the practical application of industry, rather than flower of the moon in formal Xing Yong or water in mirror.
Along with the Mining Quality risk information that people are deep, put the further problems in face of us are how to evaluate and benefit
With these quality risk information.It cannot say a small number of enterprises or team in work management using quality risk or similar
Way to manage can receive.In entire similar production process, how more effectively easily to be called according to requiring
These quality risk information, really effective control reduce risk, are needed for the first-class task and high quality development of industrial circle
The main task to be completed.For this purpose, a kind of more particularly suitable letter that can be realized the shared calling of various quality risk management informations
Breath framework builds such database in other words just seems very necessary.
Summary of the invention
It is can be seen that from above-mentioned patent background introduction it will be seen that the academia of industrial circle or risk management
More it is desirable that a kind of database platform for helping quality risk management, helps the biography for the quality risk factor excavated
It passs and application control, and is far from a kind of method that quality risk data information sharing is provided or mechanism is so simple.
The invention of this patent, formally the record information based on quality of protection risk data is sufficiently disclosed, is shared extensively, comprehensively
The information sharing mechanism of utilization protects the equity of shared personnel, also promotes the disclosure and transmission of information.Based on such working machine
System, and develop and provide a kind of data information sharing platform of quality risk management, build the network number of quality risk management
According to library.As the core content of quality risk management, the submission quality risk of Database Requirements information sharing personnel specification is commented
Estimate and control information, comprising: affiliated industry, place system or field, possible damage or the deviation that may cause, wind
The seriousness that nearly endangers, risk Frequency, the description of risk detection method, RPN value and risk class reference, control measure and its
The expection of validity.
By the shared audit of quality risk and call-by mechanism, and language translation mechanism is introduced in database platform,
It helps the excavation personnel of quality risk to be directly realized by economic benefit, directly embodies the epoch intension of kownledge economy, be quality risk
The sharing and utilization of information have established systematic workbench for the abundant cognition of risk information and reasonable utilization.
Database is different from other homogeneous data libraries and is typically characterized by:
(1) registration user can both share the data information of quality risk management by the Database Publishing, can also directly adjust
Shared quality risk is issued with other people and manages data information, and the data after calling directly replicate the number for being loaded into and establishing and using
According in library, by loading document template appropriate, for the fast of the more parts of technical data including quality risk assessment material
Speed establishment.
(2) after completing the registration user that user's registration becomes system, the quality risk independently excavated can be submitted to manage number
It is believed that breath, before submitting information sharing application, submits a electronics explanation, illustrates the original situation of the quality risk management information
Or refer to source.If not original works, the information in former source must not be also indiscriminately imitated, it is ensured that do not cause the knowledge to original works
Property right injures or there are other disputes, and states the other information that platform is not involved in other than the information of platform shares deduction
Management or evaluation activity.
(3) after the shared application that user provides quality risk management data information, system is numbered and management is arranged
Remarks, when as submitted used by language, the shared number of setting, mark examination result (whether repeat to submit or exist infringement
Suspicion), the setting transitional period, whether participate in evaluation activity and review result, and combine shared number to the possibility in risk information
The expection of the seriousness, Frequency, risk detection method, risk control measure and the validity that endanger, endanger is issued.
(4) detect and control that (include: risk factors and its harm are retouched by the multiplicity that quality risk information describes
State, the severity of risk factors, probability of happening, detectable degree is analyzed, the Zhuo measure of risk hole and its validity are expected), realize number
According to not repeating for the quality risk information shared in library, accomplish the uniqueness discussed for information about.And to submitting database for the first time
Registration and evaluation reward is numbered in the risk information supplier of shared application.
If only typing but the shared application of no submission in the database of system, must not enjoy above-mentioned income.Such as
The quality risk data input that fruit is completed before shared application, does not submit the payment of information sharing to system.
(5) due to the distribution of income after information sharing, the information of database must be compared, only in information
The identical information of typing does not need to pay the fees to system before the shared applying date, if being not suitable for system after shared application proposes
The fast calling function of system is identical using reaching 60% in the similar quality risk data information of other function or manual entry,
System can be determined as that substantial information is called, it is desirable that the user of calling pays information usage charges to system.Otherwise generated
File is that obfuscated code covers identical part, while paying after shared information calls charge, also to pay file generated expense again
With and regroup generation data and could eliminate obfuscated code.Only covered during technological document generates using obfuscated code
All identical text informations.
Mechanism of appealing is established, if technical data generated in the data system of user's creation has obfuscated code to have objection,
It can lodge a complaint to system.Screening manually is carried out to the quality risk management information being related to, is confirmed and in customer data base
The result of middle remarks complaint investigation.Further verify the property right of relevant information and the information of creation time.
(6) in view of multilingual using characteristic after quality risk information sharing, the quality risk of this patent manages net
Network Database Systems increase interpretative function.Using the user of non-typing languages language, in addition to normal information calls payment, file
It generates except payment, it is also necessary to which translation charge is paid according to the practical text quantity of typing languages language.
The quality risk of this patent manages network data base, determines quality risk data information used in customer data base
Whether record, which belongs to, is called other people the foundation of shared risk information to have: (1) quality risk data information record and risk information are total
The identical degree of text for enjoying the body matter of the data record of record, if the risk information that information record is required with Database Systems
Identical part in shared content less than 60%, or the quality risk management information record in (2) customer data base creation or
Modification time is the initiation time earlier than information sharing, is determined as the shared information of not essence calling quality risk.
The Assessment principle of identical degree 60% is: whether the inner capacities of shared information is on the low side, duplicate with the 60% of shared information amount
Subject to；In turn, the information content of the risk information record created in database is less, then the database apoplexy used with user
Subject to whether the 60% of dangerous information record is identical.Such setting be avoid user be using database in script is shared
Risk information merge and use, avoid the formal shared information from calling with this.
The quality risk of this patent manages network data base, machine translation automatic function is equipped with, according to information seconded officer
Requirement, provide corresponding cypher text in conjunction with original shared information, and require using it is non-submit language pay information translate
Expense.
Detailed description of the invention
Fig. 1 is the database function tactic pattern figure of this patent, describe complete risk management database use and
The technology workflow of quality risk management.
Specific embodiment
Its technology realization mechanism is introduced below by the process for using of the quality risk management network data base of this patent.
1, user's registration.When registering user, it is divided into enterprise customer and personal user, enterprise customer can create quality risk
The database of management is simultaneously assigned to corresponding personnel.Intelligently the personal quality risk of creation manages database to personal user.
In all user registration courses, it is required to sign following material.1. the letter of commitment promises to undertake corresponding shared risk letter
There is no plagiarism or the infringements or other dispute over copyrights of intellectual property for breath, if being strictly to arrange from other data informations
Quality risk information out is used for systems share, then it should be understood that its source of remarks and including the main contents of original text.2. signing
The power of attorney.3. subscribe to the agreement book, the supervision for consciously receiving system and expense specified by timely payment system.Simultaneity factor will give
The charging standard of every business and specific member privilege out, voluntarily undertake on quality risk database that sharing distribution information can
It can bring consequence.
2, the creation of information record and information sharing application of quality risk management.
Step 1: the information record of creation quality risk management.The complete information for submitting quality risk management, comprising:
1. the affiliated industry of quality risk information；2. system or field where risk information；3. risk information it is possible damage or
The deviation that may cause；4. the seriousness and reference scoring of risk and hazard；5. risk Frequency and reference scoring；6. risk is visited
The description of survey method and reference scoring；7. the RPN reference value and risk class of risk refer to；8. risk control measure and its validity
Expection.
Step 2: the source or source of the clearly quality risk information.Promising to undertake corresponding shared risk information, there is no copy
It attacks or the infringement of intellectual property or other dispute over copyrights, if being strictly the quality for sorting out and from other data informations
Risk information is used for systems share, then it should be understood that its source of remarks and including the main contents of original text.
Same risk information can be described from different angles, despite its source and original foundation complete one
Sample, as long as the repetition amount for meeting its spoken and written languages is no more than 20%, so that it may be considered as complete independently, risk management can be formed
New shared information.
The data information evaluation for whether participating in system and reward activity are submitted while information sharing application step 3: submitting
Explanation, and sign necessary authorized agreement book.
The quality risk information that user oneself writes can not also submit shared application and as personal use.Correspondingly,
Can directly it exempt from the data system of its people there is also such quality risk information record after the shared application of initiation
Take use.
Step 4: being submitted to shared application, system compares the information record of shared data bank, unidentical (identical degree
Reach and 20%) then provides the shared number of quality risk management information.Containing year information to help to distinguish in number information.
Step 5: description of the system manager according to shared information, in conjunction with industry knowledge, and seeks advice from applicant, confirmation
The validity of the information.The quality risk information confirmed the validity issues formal information sharing certificate and concurrently shares storage number.
Step 6: the maintenance of information is revised
According to the actual conditions of industry development, quality risk information may change.User can be in the information shared
On the basis of revise and submit herein shared.Coding shared herein will use former number, year number progress after revision
Replacement.
If 10 years a certain information of system record display is not revised, shared applicant will be contacted, is confirmed whether to need to repair
It orders, if continue to share the information.
3, using Database Systems.
The first step, the database for creating user, enterprise customer assign the job corresponding database personnel.
It is divided according to different function systems, establishes relatively independent quality risk management system, act on enterprise or enterprise
Industry group needs that the division of these systems is assigned to specific staff again.
Second step, the data record for improving quality risk management.
Can be by oneself or staff is independent that understanding of the team to quality risk management is entered into system,
On the basis of the production of enterprise, functional localization, the data information of typing and database is needed to initiate needs when information sharing
The information content of the full-quality risk management of submission is consistent, includes: 1. system where risk information or field；2. risk is believed
The deviation that ceases possible damage or may cause；3. the seriousness and reference scoring of risk and hazard；4. frequency occurs for risk
Degree and reference scoring；5. the description of risk detection method and reference scoring；6. the RPN reference value and risk class of risk refer to；⑦
The expection of risk control measure and its validity；8. specific risk control plan.
It is completed if the risk information used in the database belongs to original creation, shared application can also be submitted.Such case
It is not just that special study for information sharing understands quality risk, is after work by the newest understanding to quality risk
Carry out sharing distribution.
1. -7. the part called in above-mentioned risk information can be shared in the shared data bank of quality risk management,
It can be revised based on the record of the information in shared data bank, it is ensured that when completing this risk information record establishment archive
The identical degree of information be no more than 60%, system will record the deadline of the establishment of risk information record or revision, with this
For one of foundation, the identical degree of combined content determines whether to be formed substantial information and calls.It certainly is more than 60% identical view
For shared information calling, needs to pay corresponding information in the forward direction system of technical data establishment and call expense.
The establishment of third step, technical data.
Shared information will be translated as required language automatically, screened mating by language format required for selecting, system
The technical data template of language.
Technical data template appropriate is selected, data establishment expense, written historical materials translation expense, shared letter are normally being paid
After ceasing calling expense, corresponding skill can be quickly worked out in systems according to the information record in risk management database
Art data.If not paying translation expense, language is used when the generation data of system is by with shared information typing, if do not had
It pays information and requires expense, in institute's generation technique data, identical segment word will be shown with obfuscated code.In systems just
Often display, and there are calling suspicion with which shared information for prompt.
It should be particularly noted that, the description of this patent is to manage the operating mode of data by quality risk to discuss the number
According to the composition in library, ontology is specific database schema, rather than the working method of pure sense.All working principle and technology
Main points feature describes substantially identical or containing this patent foregoing description database project with this patent and is accordingly to be regarded as to originally special
The infringement of benefit, each falls within the protection scope of this patent.
Claims (4)
1. a kind of quality risk for information sharing manages network data base, feature includes: (1) user can be in this patent
Quality risk management network database system in issue and share the data information of corresponding quality risk management, shared risk
It includes: the 1. affiliated industry of quality risk information that shared complete information is submitted needed for management information；2. system where risk information
Or field；3. deviation risk information possible damage or may cause；4. the seriousness of risk and hazard and reference are commented
Point；5. risk Frequency and reference scoring；6. the description of risk detection method and reference scoring；7. the RPN reference value of risk and
Risk class reference；8. the expection of risk control measure and its validity；(2) quality risk of this patent manages network data base
System also can be carried out necessary setting after user provides shared information, when as submitted used by language, the shared volume of setting
Number, mark examination result (whether repeat to submit or there are infringement suspicion), setting the transitional period, whether participate in evaluation activity and comment
It examines as a result, and combining shared number to the possibility harm in risk information, the seriousness of harm, Frequency, risk detection side
The expection of method, risk control measure and validity is issued, and remarks can also whether there is altogether in the data that user creates
Enjoy the investigation result that information is called and appealed；(3) user manages network database system management by the quality risk of this patent
Quality risk, the quality risk information that other people can be called to share from shared risk database can also oneself creation quality
Risk information for generating the multiple technologies report including quality risk assessment report, and decides whether to initiate to be created
Crisis management information shared application；(4) the quality risk management network database system of this patent can be according to language
Whether the quality risk information that similarity degree assesses in determining customer data base automatically, which records to belong to, calls other people information, right with this
The information calling of user is managed.
2. the quality risk described in claim 1 for information sharing manages network data base, it is characterised in that user submits matter
The letter of commitment is submitted while measuring the data information sharing application of risk management, promising to undertake corresponding shared risk information, there is no plagiarize
The either infringement of intellectual property or other dispute over copyrights, if being strictly the quality wind for sorting out and from other data informations
Dangerous information is used for systems share, then it should be understood that its source of remarks and including the main contents of original text, submits information sharing application
The data information for whether participating in system evaluation is submitted simultaneously and rewards movable explanation, and signs necessary authorized agreement book.
3. the quality risk described in claim 1 for information sharing manages network data base, it is characterised in that determine number of users
Whether belong to according to the record of quality risk data information used in library and other people is called the foundation of shared risk information to have: (1) quality
The identical degree of text of risk data information record and the body matter of the data record of the shared record of risk information, if information is remembered
The risk information that record is required with Database Systems shares the identical part in content less than 60%, or the matter in (2) customer data base
The creation for measuring crisis management information record or modification time are determined as not essence calling earlier than the initiation time of information sharing
The shared information of quality risk.
4. the quality risk described in claim 1 for information sharing manages network data base, it is characterised in that system outfit is turned over
Function is translated, according to the requirement of information seconded officer, provides corresponding cypher text in conjunction with original shared information, and require using non-
That submits language pays information translation expense.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910330266.5A CN110046827A (en) | 2019-04-23 | 2019-04-23 | A kind of quality risk management network data base for information sharing |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910330266.5A CN110046827A (en) | 2019-04-23 | 2019-04-23 | A kind of quality risk management network data base for information sharing |
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| Publication Number | Publication Date |
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| CN110046827A true CN110046827A (en) | 2019-07-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201910330266.5A Withdrawn CN110046827A (en) | 2019-04-23 | 2019-04-23 | A kind of quality risk management network data base for information sharing |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116562627A (en) * | 2023-05-19 | 2023-08-08 | 中国电信股份有限公司湖州分公司 | Security risk management method, system, equipment, medium and product |
-
2019
- 2019-04-23 CN CN201910330266.5A patent/CN110046827A/en not_active Withdrawn
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116562627A (en) * | 2023-05-19 | 2023-08-08 | 中国电信股份有限公司湖州分公司 | Security risk management method, system, equipment, medium and product |
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