CN114580893A - Control apparatus and design transfer system - Google Patents
Control apparatus and design transfer system Download PDFInfo
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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
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Abstract
The present application provides a control device and a design transfer system, the control device being configured to perform the steps of: s1: in response to the received design transfer operation, acquiring a production flow confirmation plan and result, a product use and after-sales service program confirmation plan and result, and a design transfer verification plan and result of the target system; s2: detecting whether the design transfer of the target system can be successfully received based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result, and the design transfer verification plan and result of the target system, performing S3 if the design transfer of the target system cannot be successfully received, and performing S4 if the design transfer of the target system can be successfully received; s3: sending prompt information of design transfer failure to the user equipment, and executing S1-S2 again; s4: and sending prompt information of successful design transfer to the user equipment. Whether the design transfer can be successfully received or not is automatically detected, and the efficiency of the design transfer is improved.
Description
Technical Field
The application relates to the technical field of automation control, in particular to a control device and a design transfer system.
Background
When a customer approves a sample and agrees to transfer to a mass production, it usually means that the responsibility for the product and process is transferred from the design development department to the operation department, i.e., to the design transfer stage.
The existing design transfer is often transferred and verified manually, the efficiency of the design transfer is too low, and the situations of lying report and missing report of a responsible person easily occur.
Therefore, it is desirable to design a control device to automatically detect whether a design transfer can be successfully received, so as to improve the efficiency of the design transfer.
Disclosure of Invention
The application aims to provide the control equipment and the design transfer system, whether the design transfer can be successfully received or not is automatically detected, and the efficiency of the design transfer is greatly improved.
The purpose of the application is realized by adopting the following technical scheme:
in a first aspect, the present application provides a control device for controlling a design transfer process of at least one neurostimulation system, the control device being configured for performing the steps of:
s1: in response to the received design transfer operation, acquiring a production flow confirmation plan and result, a product use and after-sales service program confirmation plan and result, and a design transfer verification plan and result of a target system, wherein the target system is one of the neurostimulation systems;
s2: detecting whether the design transfer of the target system can be successfully received based on the production flow confirmation plan and result, the product usage and after-sales service program confirmation plan and result, and the design transfer verification plan and result of the target system, performing S3 if the design transfer of the target system cannot be successfully received, and performing S4 if the design transfer of the target system can be successfully received;
s3: sending prompt information of design transfer failure to the user equipment, and executing S1-S2 again;
s4: and sending prompt information of successful design transfer to the user equipment.
The technical scheme has the beneficial effects that: after a production flow confirmation plan and a production flow confirmation result, a product use and after-sales service program confirmation plan and a design transfer verification plan and a product are obtained, whether the design transfer can be successfully received or not is judged based on the three design transfer data, if the design transfer cannot be successfully received, prompt information of design transfer failure is sent to user equipment, a worker can timely know the condition of the design transfer failure and correspondingly adjust the condition to correct influence factors causing the reception failure, the design transfer operation is carried out again, and the control equipment executes the obtaining step of the design transfer data and the judging step of whether the design transfer data is successfully received or not again; and if the design transfer can be successfully received, sending a prompt message of successful design transfer to the user equipment.
The design transfer method does not need manual transfer and verification, can automatically detect whether the design transfer can be successfully received or not based on the three design transfer data, and can send corresponding prompt information to the user equipment no matter whether the design transfer can be successfully received or not, so that a user can timely take corresponding measures according to the corresponding prompt information, the design transfer can be successfully received, and the design transfer efficiency is greatly improved.
In some optional embodiments, the process of detecting whether the design transfer of the target system can be successfully received in S2 is as follows:
detecting whether the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system are successfully completed or not;
if the three results are not successfully completed, determining that the design transfer of the target system cannot be successfully received;
and if all three results are successfully completed, determining that the design transfer of the target system can be successfully received.
The technical scheme has the beneficial effects that: the design transfer is determined to be successfully received only if the three results of the production flow confirmation result, the product use and after-sales service program confirmation result, and the design transfer verification result of the target system are successfully completed, and the design transfer is determined not to be successfully received as long as one result is not successfully completed. Compared with manual judgment, the mode of automatically judging whether the design transfer can be successfully received greatly shortens the time consumed by judgment, reduces the workload of personnel and improves the working efficiency of the personnel.
In some optional embodiments, the determining that the design transfer of the target system can be successfully received if all three of the above results are successfully completed includes:
and if the three results are successfully completed, determining that the design transfer of the target system can be successfully received when the design transfer verification result of the target system and the design transfer verification plan meet the similarity condition.
The technical scheme has the beneficial effects that: the design transfer is judged whether to be successfully received or not by using the detection process of the two stages, when the three results of the first stage are successfully completed, the design transfer is not directly determined to be successfully received, but the detection of the second stage is carried out, when the design transfer verification result and the design transfer verification plan are detected to meet the similarity condition, the design transfer is determined to be successfully received, the detection process of the two stages can play a role of double insurance, and the situation that the design transfer verification result of the target system enters the production stage when the design transfer verification result of the target system does not reach the standard is avoided, so that great loss is caused.
Specifically, in the first stage, whether the three results of the production flow confirmation result, the product use and after-sale service program confirmation result and the design transfer verification result of the target system are successfully completed or not is detected, and when the three results are successfully completed, the second stage is started; and in the second stage, detecting whether the design transfer verification result and the design transfer verification plan meet the similarity condition, and determining that the design transfer can be successfully received when the design transfer verification result and the design transfer verification plan meet the similarity condition.
In some optional embodiments, the design transfer verification result of the target system and the design transfer verification plan satisfy a similarity condition, including:
for each parameter in the design transfer verification plan of the target system, a result parameter value of the parameter in the design transfer verification result of the target system and a plan parameter value of the parameter in the design transfer verification plan of the target system satisfy: the ratio of the absolute value of the difference between the result parameter value and the planned parameter value to the planned parameter value is not greater than a preset value.
The technical scheme has the beneficial effects that: for each parameter in the design transfer verification plan of the target system, whether the design transfer verification result and the design transfer verification plan meet the similarity condition or not can be judged by calculating the ratio of the absolute value of the difference between the result parameter value and the plan parameter value to the plan parameter value and comparing the ratio with a preset value.
Generally speaking, a design transfer verification plan of a target system has a plurality of parameters, and if a result parameter value and a plan parameter value corresponding to each parameter are manually compared, heavy workload is generated, the design transfer method can automatically calculate the ratio of the absolute value of the difference value between the result parameter value and the plan parameter value corresponding to each parameter and the plan parameter value, and compare the ratio with a corresponding preset value, so as to judge whether a similarity condition is met, thereby reducing the dependence on manual work and further improving the efficiency of design transfer.
In some optional embodiments, the S3 further includes:
and generating prompt information of design transfer failure including the three confirmation results based on the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system, and sending the prompt information of the design transfer failure to user equipment.
The technical scheme has the beneficial effects that: when it is detected that the design transfer of the target system cannot be successfully received, prompt information of design transfer failure including the three confirmation results can be automatically generated and sent to the user equipment, that is, the user can know which confirmation results are successfully completed and which confirmation results are not successfully completed through the prompt information of design transfer failure.
The whole design transfer process can be automatically completed without manual interference, corresponding prompt information can be automatically generated, and the automation degree and the intelligent degree are higher.
In some optional embodiments, the S4 further includes:
and generating a design transfer report based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result of the target system.
The technical scheme has the beneficial effects that: when the design transfer of the target system is detected to be successfully received, the prompt message of the successful design transfer can be sent to the user equipment, and a design transfer report can be automatically generated based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result of the target system.
That is, when the user starts the design transfer, whether the design transfer of the target system can be successfully received or not can be automatically detected, when the design transfer can be successfully received, prompt information that the design transfer is successful can be sent to the user equipment, a design transfer report can be automatically generated, manual report making is not needed, and the automation degree is high.
In some optional embodiments, the S4 further includes:
acquiring one or more of the following information of the target system: supplier qualification plans and results; planning and obtaining the quality of the material; packaging, storage and transportation and shipping plans; defects and failures in design transfer; product main record; product history records;
and generating a design transfer report based on the production flow confirmation plan and result of the target system, the product use and after-sales service program confirmation plan and result, the design transfer verification plan and result and the acquired one or more information.
The technical scheme has the beneficial effects that: when the design transfer of the target system is detected to be successfully received, sending prompt information of the design transfer success to the user equipment, simultaneously acquiring one or more information of the target system, and automatically generating a design transfer report based on a production flow confirmation plan and result of the target system, a product use and after-sales service program confirmation plan and result, a design transfer verification plan and result and the acquired one or more information.
That is to say, when the user starts the design transfer, whether the design transfer of the target system can be successfully received or not can be automatically detected, when the design transfer can be successfully received is detected, prompt information that the design transfer is successful can be sent to the user equipment, a design transfer report can be automatically generated, manual report making is not needed, and the automation degree is high.
In a second aspect, the present application provides a design transfer system comprising any one of the control devices described above.
In some optional embodiments, the design transfer system further comprises an interaction device communicatively coupled with the control device, the interaction device configured to receive the design transfer operation.
The technical scheme has the beneficial effects that: the interaction device and the control device can be integrated in a design transfer system, so that the design transfer system can have the functions of human-computer interaction and design transfer at the same time.
In some alternative embodiments, the interaction device comprises one or more of a microphone, a keyboard, a mouse, a key, a touch screen.
The technical scheme has the beneficial effects that: the form of the interactive device may be varied to meet the needs of different users. For example, for users who are not typing conveniently, speech may be output through a microphone to receive a design transfer operation.
Drawings
The present application is further described below with reference to the drawings and examples.
Fig. 1 is a schematic flow chart of a design transfer method provided in an embodiment of the present application;
FIG. 2 is a schematic flow chart illustrating a process of detecting whether a design transfer can be successfully received according to an embodiment of the present disclosure;
FIG. 3 is a schematic partial flow chart diagram illustrating a design transfer method according to an embodiment of the present disclosure;
fig. 4 is a schematic flowchart of a design transfer implementation method provided in an embodiment of the present application;
fig. 5 is a block diagram of a design transfer system according to an embodiment of the present disclosure.
Detailed Description
The present application is further described with reference to the accompanying drawings and the detailed description, and it should be noted that, in the present application, the embodiments or technical features described below may be arbitrarily combined to form a new embodiment without conflict.
Referring to fig. 1, an embodiment of the present application provides a design transfer method applied to at least one neurostimulation system, the method including:
s1: in response to the received design transfer operation, acquiring a production flow confirmation plan and result, a product use and after-sales service program confirmation plan and result, and a design transfer verification plan and result of a target system, wherein the target system is one of the neurostimulation systems;
s2: detecting whether the design transfer of the target system can be successfully received based on the production flow confirmation plan and result, the product usage and after-sales service program confirmation plan and result, and the design transfer verification plan and result of the target system, performing S3 if the design transfer of the target system cannot be successfully received, and performing S4 if the design transfer of the target system can be successfully received;
s3: sending prompt information of design transfer failure to the user equipment, and executing S1-S2 again;
s4: and sending a prompt message of successful design transfer to the user equipment.
Therefore, after the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result are obtained, whether the design transfer can be successfully received or not is judged based on the three design transfer data, if the design transfer can not be successfully received, prompt information of design transfer failure is sent to the user equipment, a worker can timely know the condition of the design transfer failure and correspondingly adjust the condition to correct influence factors causing the reception failure, the design transfer operation is carried out again, and the control equipment executes the obtaining step of the design transfer data and the judging step of whether the design transfer data is successfully received or not again; and if the design transfer can be successfully received, sending a prompt message that the design transfer is successful to the user equipment.
The design transfer method does not need manual transfer and verification, can automatically detect whether the design transfer can be successfully received or not based on the three design transfer data, and can send corresponding prompt information to the user equipment no matter whether the design transfer can be successfully received or not, so that a user can timely take corresponding measures according to the corresponding prompt information, the design transfer can be successfully received, and the design transfer efficiency is greatly improved.
In some embodiments, user devices may include, but are not limited to: smart phones (such as Android phones and iOS phones), tablet computers, portable personal computers, Mobile Internet Devices (MID), and the like, which are not limited in the embodiments of the present application.
The embodiment of the present application does not limit the form of the neurostimulation system. In some embodiments, the neurostimulation system may include any one of an implantable neurostimulation system, a Spinal Cord Stimulation system (SCS), a Deep Brain Stimulation system (DBS), a Peripheral Nerve Stimulation system (PNS), and a functional electrical Stimulation system (FES).
In a particular application, the target system may be an implantable neurostimulation system, which may include an implantable neurostimulator, an extension lead, and an electrode lead. The implantable neurostimulator may be a rechargeable implantable neurostimulator.
The rechargeable implantable nerve stimulator is an implantable programmable multi-program medical device and provides controllable electric pulse stimulation by means of a sealed battery and a circuit. One or two controllable specific electric pulse stimulations are provided for specific areas of the brain through the implanted extension leads and the implanted electrode leads. Compared with a nerve stimulator using a primary battery, the rechargeable implantable nerve stimulator using the rechargeable battery as a power supply has the following advantages: the volume is smaller, the weight is lighter. The rechargeable battery has longer service life and reduced medical cost and pain.
The extension lead can be used in combination with a rechargeable implantable neurostimulator and used as a pulse transmission medium for transmitting stimulation pulses generated by the neurostimulator to the electrode lead.
The electrode lead transmits the stimulation pulse generated by the implanted nerve stimulator to a specific region of the brain through a plurality of stimulation contacts.
Referring to fig. 2, in some alternative embodiments, the step of detecting whether the design transfer of the target system can be successfully received in S2 may include steps S201 to S203.
Step S201: detecting whether the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system are successfully completed or not;
step S202: if the three results are not successfully completed, determining that the design transfer of the target system cannot be successfully received;
step S203: and if all three results are successfully completed, determining that the design transfer of the target system can be successfully received.
Therefore, the design transfer can be successfully received only if the three results of the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system are successfully completed, and the design transfer can not be successfully received as long as one result is not successfully completed. Compared with manual judgment, the mode of automatically judging whether the design transfer can be successfully received greatly shortens the time consumed by judgment, reduces the workload of personnel and improves the working efficiency of the personnel.
In some optional embodiments, the step S203 may include:
and if the three results are successfully completed, determining that the design transfer of the target system can be successfully received when the design transfer verification result of the target system and the design transfer verification plan meet the similarity condition.
Therefore, whether the design transfer can be successfully received or not is judged by using the detection process of the two stages, when the three results of the first stage are successfully completed, the design transfer can be successfully received instead of being directly determined, the detection of the second stage is carried out, when the design transfer verification result and the design transfer verification plan are detected to meet the similarity condition, the design transfer can be successfully received, the detection process of the two stages can play a double insurance role, and the situation that the design transfer verification result of the target system enters the production stage when the design transfer verification result of the target system does not reach the standard is avoided, so that great loss is caused.
Specifically, in the first stage, whether the three results of the production flow confirmation result, the product use and after-sale service program confirmation result and the design transfer verification result of the target system are successfully completed or not is detected, and when the three results are successfully completed, the second stage is started; and in the second stage, detecting whether the design transfer verification result and the design transfer verification plan meet the similarity condition, and determining that the design transfer can be successfully received when the design transfer verification result and the design transfer verification plan meet the similarity condition.
In some embodiments, the design transfer verification result of the target system and the design transfer verification plan satisfying the similarity condition may be that a similarity of the design transfer verification result and the design transfer verification plan is not less than a similarity threshold.
For example, when the similarity threshold is 80% and the similarity between the design transfer verification result of the target system and the design transfer verification plan is 85%, the design transfer verification result and the design transfer verification plan satisfy the similarity condition, and it is determined that the design transfer of the target system can be successfully received.
In some optional embodiments, the step S203 of determining that the design transfer verification result of the target system and the design transfer verification plan satisfy the similarity condition may include:
for each parameter in the design transfer verification plan of the target system, a result parameter value of the parameter in the design transfer verification result of the target system and a plan parameter value of the parameter in the design transfer verification plan of the target system satisfy: the ratio of the absolute value of the difference between the result parameter value and the planned parameter value to the planned parameter value is not greater than a preset value.
Therefore, for each parameter in the design transfer verification plan of the target system, whether the design transfer verification result and the design transfer verification plan meet the similarity condition or not can be judged by calculating the ratio of the absolute value of the difference value between the result parameter value and the plan parameter value to the plan parameter value and comparing the ratio with the preset value. When the ratio corresponding to each parameter is not greater than the preset value, it is indicated that the design transfer verification result of the target system is relatively fit with the design transfer verification plan, and it can be determined that the design transfer verification result of the target system and the design transfer verification plan meet the similarity condition.
Generally speaking, a design transfer verification plan of a target system has a plurality of parameters, and if a result parameter value and a plan parameter value corresponding to each parameter are manually compared, heavy workload is generated, the design transfer method can automatically calculate the ratio of the absolute value of the difference value between the result parameter value and the plan parameter value corresponding to each parameter and the plan parameter value, and compare the ratio with a corresponding preset value, so as to judge whether a similarity condition is met, thereby reducing the dependence on manual work and further improving the efficiency of design transfer.
In a specific application, the parameters for designing the transfer verification plan may include amplitude, frequency and pulse width output by the rechargeable implantable neurostimulator, where the resulting parameter values of the amplitude, the frequency and the pulse width are 0.2V, 45Hz and 54 μ s, the planned parameter values of the amplitude, the frequency and the pulse width are 0.2V, 40Hz and 60 μ s, the ratios of the absolute values of the difference values between the resulting parameter values of the amplitude, the frequency and the pulse width and the planned parameter values are 0, 0.08 and 0.1, the preset values of the amplitude, the frequency and the pulse width are 0.15, 0.15 and 0.2, the ratios of the absolute values of the difference values between the resulting parameter values of the amplitude, the frequency and the pulse width and the planned parameter values are not greater than the corresponding preset values, and the design transfer verification result of the target system and the design transfer verification plan satisfy the similarity condition.
In some optional embodiments, the S3 may further include:
and generating prompt information of design transfer failure including the three confirmation results based on the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system, and sending the prompt information of the design transfer failure to user equipment.
Therefore, when the design transfer of the target system is detected not to be successfully received, the prompt message of design transfer failure including the three confirmation results can be automatically generated and sent to the user equipment, that is, the user can know which confirmation results are successfully completed and which confirmation results are not successfully completed through the prompt message of design transfer failure.
The whole design transfer process can be automatically completed without manual interference, corresponding prompt information can be automatically generated, and the automation degree and the intelligent degree are higher.
The design transfer failure may be that one or more of the production flow validation result, the product use and after-market service program validation result, and the design transfer verification result is not "successfully completed".
The design transfer failure prompt information may include text information, voice information, picture information, or video information of the production flow confirmation result, the product use and after-sales service program confirmation result, and the design transfer verification result, and the text information may include one or more of chinese, english, numerals, symbols, and special symbols, such as "production flow confirmation result: unsuccessful completion "," after-sales service procedure confirmation result: successful completion of the "or" design transfer verification result: n'.
In practical application, the failure of design transfer does not necessarily mean that all three items can not be successfully completed, and a situation of partial successful completion may exist, and the prompt information containing the three confirmation results is sent to the user in time, so that the user can directly know which items have been successfully completed through the prompt information, and thus, the inspection items which can not be successfully completed can be checked in a targeted manner.
In some optional embodiments, the S4 may further include:
and generating a design transfer report based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result of the target system.
Therefore, when the design transfer of the target system is detected to be successfully received, prompt information of successful design transfer is sent to the user equipment, and meanwhile, a design transfer report is automatically generated based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result of the target system.
That is to say, when the user starts the design transfer, whether the design transfer of the target system can be successfully received or not can be automatically detected, when the design transfer can be successfully received is detected, prompt information that the design transfer is successful can be sent to the user equipment, a design transfer report can be automatically generated, manual report making is not needed, and the automation degree is high.
The design transfer report has the function of ensuring that the product design is implemented in purchasing, production, installation and after-sales service and can stably meet the design requirement.
In some embodiments, the design transfer report may include a production flow validation plan and results, a product usage and after-market procedure validation plan and results, and a design transfer verification plan and results for the target system. The specific form of the report may include a chart, a table, etc., and the user may choose to automatically generate a bar chart, a pie chart, an asahi chart, a line chart, etc., based on the numerical table.
In some embodiments, it may be the responsibility of a product engineer to create and update a production flow validation plan for the target system, resulting in the results of the production flow validation plan. The production flow validation plan may include a production flow verification plan and the results of the production flow validation plan may include a production flow validation report.
Specifically, a production flow verification plan may be created and executed by a product engineer, and a production flow verification report may be created by the product engineer.
The target system's production flow validation plan may include a list of key processes and special processes in the product assembly process. Wherein, the list of key processes and special processes can be shown as the following table:
the target system production flow validation plan may include, for example, one or more of a rechargeable implantable neurostimulator kit production process validation plan, an extension lead kit process validation plan, a laser seal welding system reconfirmation plan, a laser spot welder welding process reconfirmation plan, and a soldering iron welding process reconfirmation plan.
In some embodiments, the production flow validation plan for the target system may be as shown in the following table:
| file numbering | Document description |
| 01 | Product 1 production process validation plan |
| 02 | Product 2 production process validation plan |
| 03 | Product 3 production Process validation plan |
| 04 | Product 1 production process reconfirmation plan |
| 05 | Product 2 production process reconfirmation plan |
| 06 | Product 3 production process reconfirmation plan |
All production flow validation plans should have been created, executed, and approved prior to formal production. And the actual production executes the production according to the production flow confirmation plan of the target system, and the production flow confirmation report is completed.
The process flow confirmation report is shown in the following table:
| file numbering | Document description |
| 01 | Product 1 manufacturing process confirmation report |
| 02 | Product 2 manufacturing process confirmation report |
| 03 | Product 3 manufacturing process confirmation report |
| 04 | Product 1 manufacturing process reconfirmation report |
| 05 | Product 2 production process reconfirmation report |
| 06 | Product 3 production process reconfirmation report |
In order to ensure stable and consistent product quality, related tools, clamps, measuring equipment, facilities and the like need to be managed and controlled in a unified manner in the production process of products, so that an equipment list and a product jig list are formed.
The list of devices is shown in the following table:
the product fixture list is shown in the following table:
after the production process is confirmed, related personnel need to be trained, the personnel are sufficiently familiar with the assembly content and the attention, products meeting the quality requirement and the traceability requirement can be produced, and the problem left in the production process is solved by the research and development part and the production part together in the subsequent production. The details are shown in the following table:
| product type | Batch/number of tests | Number of pass | Number of misapprovals | Passing rate |
| A1 | 20 | 20 | 0 | 100％ |
| A2 | 66 | 66 | 0 | 100％ |
| A3 | 6 | 6 | 0 | 100％ |
| A4 | 34 | 29 | 5 | 83％ |
In some embodiments, an after-market service program validation plan may be created and executed by an after-market leader, resulting in an after-market service program validation plan. The after-market service procedure validation plan may include an after-market service procedure verification plan, and the results of the after-market service procedure validation plan may include an after-market service procedure verification report.
Specifically, an after-market service flow verification plan may be created and executed by the after-market leader and defects occurring during the verification process may be recorded, and an after-market service flow verification report may be created by the after-market leader.
In some embodiments, a design transfer verification plan may be formulated and executed by the quality department, resulting in a design transfer verification plan. The design transfer verification plan may include a certification test plan, and the result of the design transfer verification plan may include a certification test report.
In particular, certification test plans may be created by quality engineers and certification test reports created by quality engineers, with the design transfer plan reviewed by a quality representative prior to performing the transfer activities.
The certification test plan may include one or more of a rechargeable implantable neurostimulator suite certification test plan and procedure, an extension lead suite certification test plan and procedure, and an electrode lead suite certification test plan and procedure.
The certification test plan is shown in the following table:
| file numbering | Document description |
| 01 | Product 1 certification test plan and program |
| 02 | Product 2 certification test plan and program |
| 03 | Product 3 certification test plan and program |
The certification test report may include one or more of a rechargeable implantable neurostimulator suite certification test report, an extension lead suite certification test report, and an electrode lead suite certification test report and procedure.
The certification test report is shown in the following table:
| file numbering | Document description |
| 01 | Product 1 certification test report and program |
| 02 | Product 2 certification test report and program |
| 03 | Product 3 certification test report and program |
Referring to fig. 3, in some alternative embodiments, the step S4 further includes steps S301 to S302.
Step S301: acquiring one or more of the following information of the target system: supplier qualification plans and results; planning and obtaining the quality of the material; packaging, storage and transportation and shipping plans; defects and failures in design transfer; product main record; product history records;
step S302: and generating a design transfer report based on the production flow confirmation plan and result of the target system, the product use and after-sales service program confirmation plan and result, the design transfer verification plan and result and the acquired one or more information.
And when the design transfer of the target system is detected to be successfully received, sending prompt information of the design transfer success to the user equipment, acquiring one or more kinds of information of the target system, and automatically generating a design transfer report based on the production flow confirmation plan and result of the target system, the product use and after-sales service program confirmation plan and result, the design transfer verification plan and result and the acquired one or more kinds of information.
That is, when the user starts the design transfer, whether the design transfer of the target system can be successfully received or not can be automatically detected, when the design transfer can be successfully received, prompt information that the design transfer is successful can be sent to the user equipment, a design transfer report can be automatically generated, manual report making is not needed, and the automation degree is high.
In some embodiments, the procurement director may complete the audit activities for the new supplier prior to the design transfer, and may also be responsible for the application of the first inspection of all new materials and parts.
Specifically, a material procurement plan and a supplier qualification plan may be created by a procurement leader.
Wherein, the supplier qualification plan is shown in the following table:
| material(s) | Categories | Predicted completion time | Suppliers of goods |
| Material 1 | B | 2021/10/30 | Supplier A |
| Material 2 | A | 2021/11/30 | Supplier B |
| Material 3 | A | 2021/10/30 | Supplier C |
In some embodiments, new materials and parts in the target system need to be sorted by importance level.
Review activities for suppliers of critical materials and parts may be performed by supplier quality engineers or quality managers prior to design transfer.
Specifically, a material quality plan may be created by a supplier quality engineer, defects occurring in the product may be monitored and recorded.
Wherein the material quality plan is as follows:
in some embodiments, the design transfer takes into account the product packaging and storage and transportation and standardizes the delivery, thereby creating a packaging, storage and delivery plan according to which the logistics transportation validation is completed.
The packaging, storage and transportation and shipping schedules are shown in the following table:
| file numbering | Document description |
| 01 | Logistics transportation flow scheme plan |
| 03 | Logistics transportation confirmation report |
In some embodiments, defects and failures found during design transfer verification need to be resolved by the relevant personnel in a timely manner.
In a specific application, in the test process, the firmware version of the rechargeable implantable neural stimulator is found to be low, and can be upgraded to the latest version through the firmware version, and the firmware version is verified again and passes all the verification.
In another specific application, the tightness of the electrode lead and the electrical impedance test result are found to be out of the specification range in the test process, and the results are passed through design or process change and proofing verification again.
The way to solve the defects and the unqualified items found in the design transfer verification process is shown in the following table:
in some embodiments, a product engineer may be responsible for creating and updating a master record of a product in a timely manner, and a quality engineer may be responsible for creating and updating a product history in a timely manner.
All production master records and product history records should have been created, executed and approved prior to designing the transfer verification plan.
The product master record may include, for example, one or more of a rechargeable implantable neurostimulator kit product master record, an extension lead kit product master record, and an electrode lead product master record, and the product history record may include, for example, one or more of an electrode lead kit factory inspection specification, an extension lead appearance inspection specification, and an extension lead finished product packaging checklist.
The product master record is shown in the following table:
| file numbering | Document description |
| 01 | Product 1 product master record |
| 02 | Product 2 product master record |
| 03 | Product 3 product master record |
The product history is shown in the following table:
referring to fig. 4, an embodiment of the present application further provides a method for implementing design transfer, where the method includes steps S11 to S12.
Step S11: providing an interaction device, wherein the interaction device is used for receiving design transfer operation and sending the design transfer operation to the processor;
step S12: a processor is provided for implementing the steps of any of the design transfer methods described above when executing the computer program. The specific implementation manner is consistent with the implementation manner and the achieved technical effect described in the embodiment of the design transfer method, and some contents are not described again.
In some implementations, the interaction device may include one or more of a microphone, a keyboard, a mouse, keys, and a touch screen. Wherein the touch screen may include any one of a resistive touch screen, a capacitive touch screen, and a surface acoustic wave screen.
The embodiment of the present application further provides a control device, and a specific implementation manner of the control device is consistent with the implementation manner and the achieved technical effect described in the embodiment of the design transfer method, and some contents are not described again.
The control device for controlling a design transfer process of at least one neurostimulation system, the control device being configured for performing the steps of:
s1: in response to the received design transfer operation, acquiring a production flow confirmation plan and result, a product use and after-sales service program confirmation plan and result, and a design transfer verification plan and result of a target system, wherein the target system is one of the neurostimulation systems;
s2: detecting whether the design transfer of the target system can be successfully received based on the production flow confirmation plan and result, the product usage and after-sales service program confirmation plan and result, and the design transfer verification plan and result of the target system, performing S3 if the design transfer of the target system cannot be successfully received, and performing S4 if the design transfer of the target system can be successfully received;
s3: sending a design transfer failure prompt message to the user equipment, and re-executing S1-S2;
s4: and sending prompt information of successful design transfer to the user equipment.
In some embodiments, the control device may include at least one memory, at least one processor, and a bus connecting different platform systems. The memory may include one or more of Random Access Memory (RAM), Read Only Memory (ROM), and cache memory, among others. The memory stores a computer program that can be executed by the processor. The bus may be any of several types of bus structures including a memory bus, a peripheral bus, an accelerated graphics port, or a local bus using any of a variety of bus architectures.
Referring to fig. 5, an embodiment of the present application further provides a design transfer system, and a specific implementation manner of the design transfer system is consistent with the implementation manner and the achieved technical effect described in the embodiment of the design transfer method, and a part of the details are not repeated.
The design transfer system includes any one of the control devices described above.
In some optional embodiments, the design transfer system may further include an interaction device communicatively coupled with the control device, the interaction device to receive the design transfer operation.
Therefore, the interaction device and the control device can be integrated in a design transfer system, so that the design transfer system can have the functions of human-computer interaction and design transfer at the same time.
In some alternative embodiments, the interaction device may include one or more of a microphone, a keyboard, a mouse, keys, and a touch screen.
The touch screen may include any one of a resistive touch screen, a capacitive touch screen, and a surface acoustic wave screen.
Thus, the form of the interactive device can be varied to meet the needs of different users. For example, for users who are not typing conveniently, speech may be output through a microphone to receive a design transfer operation.
While the present application is described in terms of various aspects, including exemplary embodiments, the principles of the invention should not be limited to the disclosed embodiments, but are also intended to cover various modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Claims (10)
1. A control device for controlling a design transfer process of at least one neurostimulation system, the control device being configured for performing the steps of:
s1: in response to the received design transfer operation, acquiring a production flow confirmation plan and result, a product use and after-sales service program confirmation plan and result, and a design transfer verification plan and result of a target system, wherein the target system is one of the neurostimulation systems;
s2: detecting whether the design transfer of the target system can be successfully received based on the production flow confirmation plan and result, the product usage and after-sales service program confirmation plan and result, and the design transfer verification plan and result of the target system, performing S3 if the design transfer of the target system cannot be successfully received, and performing S4 if the design transfer of the target system can be successfully received;
s3: sending prompt information of design transfer failure to the user equipment, and executing S1-S2 again;
s4: and sending prompt information of successful design transfer to the user equipment.
2. The control apparatus according to claim 1, wherein the process of detecting whether the design transfer of the target system can be successfully received in S2 is as follows:
detecting whether the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system are successfully completed or not;
if the three results are not successfully completed, determining that the design transfer of the target system cannot be successfully received;
and if all three results are successfully completed, determining that the design transfer of the target system can be successfully received.
3. The control apparatus according to claim 2, wherein the determining that the design transfer of the target system can be successfully received if all of the three results are successfully completed comprises:
and if the three results are successfully completed, determining that the design transfer of the target system can be successfully received when the design transfer verification result of the target system and the design transfer verification plan meet the similarity condition.
4. The control apparatus according to claim 3, wherein the design transfer verification result of the target system and the design transfer verification plan satisfy a similarity condition, including:
for each parameter in the design transfer verification plan of the target system, a result parameter value of the parameter in the design transfer verification result of the target system and a plan parameter value of the parameter in the design transfer verification plan of the target system satisfy: the ratio of the absolute value of the difference between the result parameter value and the planned parameter value to the planned parameter value is not greater than a preset value.
5. The control apparatus according to claim 1, wherein the S3 further includes:
and generating prompt information of design transfer failure including the three confirmation results based on the production flow confirmation result, the product use and after-sales service program confirmation result and the design transfer verification result of the target system, and sending the prompt information of the design transfer failure to user equipment.
6. The control apparatus according to claim 1, wherein the S4 further includes:
and generating a design transfer report based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result and the design transfer verification plan and result of the target system.
7. The control apparatus according to claim 1, wherein the S4 further includes:
acquiring one or more of the following information of the target system: supplier qualification plans and results; planning and obtaining the quality of the material; packaging, storage and transportation and shipping plans; defects and failures in design transfer; product main record; product history records;
and generating a design transfer report based on the production flow confirmation plan and result, the product use and after-sales service program confirmation plan and result, the design transfer verification plan and result and the acquired one or more information of the target system.
8. A design transfer system characterized by comprising the control apparatus of any one of claims 1 to 7.
9. The design transfer system of claim 8, further comprising an interaction device communicatively coupled with the control device, the interaction device configured to receive the design transfer operation.
10. The design transfer system of claim 9, wherein the interaction device comprises one or more of a microphone, a keyboard, a mouse, a key, and a touch screen.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114949608A (en) * | 2022-07-27 | 2022-08-30 | 苏州景昱医疗器械有限公司 | Program control device, medical system, and computer-readable storage medium |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114949608A (en) * | 2022-07-27 | 2022-08-30 | 苏州景昱医疗器械有限公司 | Program control device, medical system, and computer-readable storage medium |
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