I. Project Background
In today's highly competitive business environment, the company's business has been developing by leaps and bounds in recent years. Its scale has been continuously expanding, and its market share has been gradually climbing. However, behind this prosperous development, some potential problems have gradually emerged. There are numerous uncertain factors in multiple key links such as procurement, production and manufacturing, and after - sales service.In the procurement process, the quality of raw materials from suppliers varies greatly, and the supply stability is insufficient. During the production and manufacturing process, there are occasional equipment failures and minor deviations in personnel operations. In the after - sales stage, the diversity and unpredictability of customer needs, etc. These are all like "ghosts" hiding in the dark, which may cause abnormal product quality at any time.
This abnormal situation in the product quality is like a huge rock being thrown into a calm lake, causing ripples in the entire product lifecycle management and posing significant challenges, especially to quality management. Specifically, there are the following problems:
1.1 The quality data is scattered, and the utilization rate of quality data is low
Currently, the data from various inspection stages such as incoming material inspection, in - process inspection, and finished product inspection are mostly recorded on paper. This traditional recording method is like burying precious treasures in different corners, which makes the sharing of quality information extremely difficult. Relying on manual inspection to determine whether a product is qualified is not only inefficient but also prone to human errors. Quality data is not systematically integrated and lacks structured management. It's like a chaotic library where books are randomly placed, making it difficult to quickly find the required information.
The quality data generated in each inspection process needs to be manually collected and statistically analyzed. During this process, the collection speed is as slow as a snail's crawl. The data sorting cycle is extremely long, and it's difficult to guarantee the accuracy, let alone the standardization. The timeliness verification is also seriously delayed. The quality data is scattered across many different links, just like the pieces of a jigsaw puzzle scattered everywhere. It's very difficult to conduct distribution analysis of defective items from different dimensions in the manufacturing process. As a result, the repetitive problems of quality fluctuations and quality losses are easily overlooked, just like walking in the dark and being unable to detect potential dangers.
1.2 There are gaps in the digital construction of quality, turning quality management into a black box
With the continuous development of enterprises, in other aspects of operation management, digital construction has achieved initial results. Like a tiny spark, it is beginning to show a trend of spreading far and wide. However, in the crucial area of quality management, the level of digitalization is significantly insufficient. As a result, the leadership is like someone trying to view flowers in the fog when it comes to quality management. They are unable to accurately and promptly monitor the progress of quality improvement. Quality management seems to be shrouded in a mysterious "black box," and its internal situation is hard to understand.
1.3 The supply chain quality management is not closed-loop, and there are quality information islands
Quality information across the entire supply chain is widely present in multiple stages such as procurement, manufacturing, quality control, material supply, logistics and warehousing, and customer service, resembling a vast and complex network. However, in the actual operation process, the quality information in each stage cannot be transmitted accurately and promptly. It's as if the connections between the nodes in the network are lost, creating numerous "isolated islands" of quality information. Both leaders and employees have to spend a great deal of time and effort to passively coordinate and manually monitor the flow of quality information. It's like trying to find a way out in a maze, making it difficult to proactively identify and solve problems.
II. Project Objectives
To solve the above problems, the company plans to implement a professional end - to - end quality management system, namely the QMS system. This system will cover quality management aspects involved in procurement, manufacturing, customer complaints, etc. It is like a powerful "housekeeper" that comprehensively manages the enterprise's quality management processes.
An important goal of this system is to enable relevant personnel to view real - time data and achieve traceability of quality data. It's like attaching an "electronic tag" to each product. No matter which stage the product is in, its quality information can be clearly understood.Meanwhile, the QMS system will also be integrated with other systems, such as ERP, MES, OA, PLM, etc., to achieve data interconnection. It's just like different rivers converging into a vast ocean, forming a complete information ecosystem.
Overall, the QMS system will provide strong data support for enterprises to improve quality management efficiently. Through the collection of quality data, the system can automatically generate various quality statistical reports. It is like a precise analyst, controlling product quality and process quality. It provides a solid basis for the quality operation level, quality control level, and quality decision - making level to carry out quality management activities, making the enterprise's quality management more scientific and efficient.
III. Scope of Implementation
According to the actual situation of the company, it is necessary to determine the functional modules and project plan of the QMS (Quality Management System). The main functional modules are rich and diverse, covering all aspects of quality management:
Basic management settings
It includes the work portal, system management, master data, inspection rules, etc. The work portal is like the gate of the system, providing users with convenient operation entrances. System management is responsible for maintaining and managing the operation of the entire system. Master data is the core data of the system, providing basic support for other modules. Inspection rules are the criteria for quality management, ensuring the standardization of inspection work.
Incoming material control
It involves IQC inspection settings, test forms, inspection application forms, inspection data, inspection reports, etc. The IQC inspection settings stipulate the standards and processes for incoming material inspection; the test forms record the information of various tests conducted on incoming materials; the inspection application forms serve as the application vouchers for inspecting incoming materials; the inspection data are the actual data obtained during the inspection process; and the inspection reports summarize and analyze the inspection results.
Process control
It includes IPQC inspection settings, test sheets, inspection plans, inspection application forms, inspection data, inspection reports, etc. IPQC inspection settings standardize the inspection standards and processes in the production process; test sheets record the test situations during the production process; inspection plans arrange regular inspections of the production process; inspection application forms are used to apply for the inspection of products in the production process; inspection data and inspection reports record and analyze the quality situation of the production process.
Shipment control
There are OQC inspection settings, test sheets, inspection application forms, inspection data, inspection reports, etc. The OQC inspection settings clarify the inspection standards and processes for outgoing products; the test sheets record the test information of outgoing products; the inspection application forms are used for inspection applications before shipment; the inspection data and inspection reports are used to evaluate the quality of outgoing products.
Handling of non-conforming products
It includes handling settings, non - conforming product markings, handling methods, non - conforming product registration, reports, etc. Handling settings specify the processing procedures and standards for non - conforming products; non - conforming product markings are used to identify non - conforming products; handling methods clarify the ways to deal with non - conforming products; non - conforming product registration records detailed information of non - conforming products; reports conduct statistics and analysis on the handling status of non - conforming products.
Customer complaints
It involves complaint settings, complaint types, complaint identifiers, handling methods, complaint records, complaint reports, etc. Complaint settings standardize the handling process and criteria for customer complaints; complaint types classify different types of complaints; complaint identifiers are used to identify complaint information; handling methods clarify the approaches to dealing with customer complaints; complaint records document the detailed content of customer complaints; complaint reports conduct statistics and analysis on the situation of customer complaints.
Problem discovery
It includes problem types, problem identifiers, problem records, report analysis, etc. Problem types classify different types of problems; problem identifiers are used to identify problem information; problem records document the detailed situation of problems; report analysis conducts in - depth analysis of problems to find out the root causes and solutions.
Corrective and preventive
There are rectification settings, rectification signs, CARs (Corrective Action Reports), rectification records, reports, etc. Rectification settings stipulate the formulation and implementation processes of corrective and preventive measures; rectification signs are used to identify rectification information; CARs are corrective action reports that record the rectification status of problems; rectification records document the detailed rectification process; and reports evaluate and analyze the rectification effects.
Review management
It involves review settings, review objects, review items, review checklists, review plans, review records, review findings, etc. Review settings standardize the processes and criteria of the review work; review objects define the scope of the review; review items and review checklists list the specific content of the review; review plans arrange the time and progress of the review work; review records document the process and results of the review; review findings point out the problems discovered during the review and propose improvement suggestions.
Quality cost
It includes expense types, expense records, and reports. Expense types classify quality - related expenses; expense records document the expenditure of each quality - related cost item; reports conduct statistics and analysis on quality costs to enable enterprises to control costs reasonably.
Project management
It involves project settings, project identification, project records, report analysis, etc. Project settings stipulate the processes and standards of quality management projects; project identification is used to identify project information; project records document the implementation status of projects; and report analysis evaluates and analyzes the effectiveness of projects.
Measuring tool management
It includes instrument types, instrument identification, instrument ledger, and calibration management. Instrument types are used to classify different types of measuring tools; instrument identification is for identifying the information of measuring tools; the instrument ledger records the basic information and usage of measuring tools; calibration management ensures the accuracy and reliability of measuring tools.
Task management
It involves task setting, team templates, task records, report analysis, etc. Task setting stipulates the task allocation and execution process; team templates clarify the composition and responsibilities of the team; task records document the task execution status; and report analysis evaluates and analyzes the task completion status.
Panoramic tracing
Query all associated quality events based on material numbers, document numbers (such as purchase orders, production work orders, shipping orders, etc.), and batch numbers. This is like a powerful search engine that can quickly and accurately find all quality information related to the products, enabling comprehensive traceability of quality information.
Mobile appappapplicationmobile appAPP
The APP is more convenient to operate and can implement work processes such as message notification, task arrangement, incoming material inspection, production on - site inspection, quality review, and non - conforming product registration. Employees can operate via mobile phones or tablets anytime and anywhere, which improves work efficiency.
IV. Technical Solution
4.1 QMS System Architecture
Technical architecture
The QMS system adopts a microservices architecture combined with a big data architecture. This advanced architectural design is like an efficient team - collaboration model, which achieves the separation of data reading and writing as well as parallel data processing. It divides the system applications into layers, making the functions of each layer clearer and more distinct. At the same time, it realizes the componentization of applications. Each component is like an independent small team, focusing on specific tasks. The applications are connected in a loosely - coupled manner, just as teams can collaborate flexibly without interfering with each other.As business requirements change continuously, the system architecture can be dynamically expanded and achieve dynamic resource balance, ensuring the scalability and openness of the architecture. It is like a building that can be continuously expanded, capable of meeting the requirements of high - concurrency user volume and high - volume user transactions.
Functional architecture
The various functional modules of the QMS system are connected through the workflow, just like an assembly line, realizing multi - dimensional control of quality business. The results of these controls are presented on the portal page, such as pending inspection tasks and quality reports. Users can clearly understand the relevant information of quality management at a glance.The system supports multiple terminal devices such as PCs, pads, and mobile phones, and can run across different browsers. At the same time, it is also equipped with mobile device apps (such as tablets, mobile phones, and handheld PDAs), which is convenient for users to use in different scenarios.
Regional management
Under the same tenant, the master data such as materials, suppliers, and customers in different areas (such as injection - molding workshops, metal - processing workshops, SMT workshops, assembly workshops, etc.) can be shared, just as different departments can share the company's important resources. However, data such as inspection application forms, inspection records, non - conforming product registration forms, as well as data related to quality rectification and reviews are mutually isolated and invisible. This ensures the security and independence of data in different areas and avoids data confusion and leakage.
4.2 Quality Cockpit
Analysis level
Users are supported to customize and subscribe to the reports they are concerned about according to their actual quality management needs. Quality data reports can be presented graphically through the report version of the QMS system, enabling full customization of report functions. It's like users can customize an exclusive "data feast" according to their own preferences, and obtain the required quality information more intuitively and conveniently.
Implementation level
Establish a personal workbench related to quality management. The system automatically pushes employees' daily work content to the portal platform for aggregation, tracking, and querying. It can also automatically push application requests put forward by superiors or other colleagues to the office desktop, such as My Messages, My Rectifications, My Tasks, My Reviews, etc. Just like a considerate secretary, it helps employees manage their work efficiently.
4.3 Inspection Management
It can carry out inspection management for IQC (Incoming Quality Control), IPQC (In - Process Quality Control), FQC (Final Quality Control), and OQC (Out - going Quality Control), input inspection data, and approve inspection reports.
Material inspection standard
Digitization of material inspection standards: Set up basic information such as sampling plans, inspection items, defect code libraries, inspection methods, severity levels, and skip - inspection rules. Convert the current material inspection standards into an electronic format in the QMS system. The inspection standards are bound to the materials. During the inspection process, the corresponding inspection standards can be automatically retrieved based on the material number. Inspection data is entered into the system, and the system will automatically determine whether the materials pass the inspection according to the pre - set inspection rules, which greatly improves the efficiency and accuracy of the inspection work.
Inspection application form
The receiving staff conducts goods receiving operations in the ERP system and generates a material receiving notice. The ERP system then pushes the material receiving notice to the QMS system to generate an inspection application form for the inspection of products that need to be inspected. Inspection tasks are classified and filtered based on dimensions such as product type, supplier type, and incoming material warehouse area, and are sent to the corresponding responsible persons via email, system notifications, and WeCom.In addition, the system can set the logic for various inspection tasks, such as skip-lot inspection (materials or suppliers with a consistent pass record are allowed skip-lot inspection), batch combination (when there are too many or too frequent incoming material batches, batch combination inspection can be carried out), early warnings, and escalation plans (when a task remains unprocessed for a long time, the leader will be notified). This makes the inspection work more flexible and efficient.
Rules for Color Marking of Inspection Application Forms
In the inspection application form list, in order to present the inspection status of the materials on the inspection application forms more clearly and intuitively, the system uses four colors to mark the materials.
First is gray, which represents uninspected reports. This means that the materials have not yet entered the inspection process and are in a pending inspection state. In the entire quality control system, this is the initial stage for materials to enter the inspection process. At this time, relevant staff need to re - confirm the basic information of these materials to ensure its completeness and accuracy, so as to make full preparations for the subsequent inspection work.
The materials marked in blue are undergoing inspection. Once the materials start to be inspected, they will be marked in blue. At this stage, the inspectors will conduct a detailed inspection of various indicators of the materials in accordance with the established inspection standards and procedures. From appearance to performance, from physical properties to chemical characteristics, every factor that may affect product quality is within the scope of inspection. During the inspection process, the staff will carefully record all kinds of data for subsequent analysis and judgment.
Green represents passing the inspection. After a strict inspection process, when all the indicators of the materials meet the predetermined inspection standards, they will be marked green. This indicates that the materials have passed the quality test and can enter the next production or usage stage. These qualified materials should be properly stored and managed to ensure that their quality remains unaffected during the subsequent circulation process.
Red indicates that the inspection has failed. When non - compliance with the standards is found during the inspection of materials, they will be marked red. These non - compliant materials need to be specially processed and analyzed. It is necessary to identify the reasons for non - compliance, whether it is a problem with the raw materials, a mistake in the production process, or a loophole in the inspection standards themselves. At the same time, measures should be taken promptly to prevent non - compliant materials from flowing into the next stage and affecting the entire production process.
Inspection plan
Process inspection encompasses various types such as initial inspection and patrol inspection, and can be further divided into production self - inspection and quality inspection. These two inspection methods have different focuses.Production self - inspection is mainly carried out by production personnel during the production process to check their own work results. It enables them to promptly detect problems in the production process and make adjustments, thus ensuring the continuity and stability of production.Quality inspection, on the other hand, is conducted by professional quality management personnel. They possess more specialized knowledge and skills and can control product quality from a more macroscopic perspective.
Different inspection plans can be set for different types of inspections. For example, the inspection interval can be set to once every 2 hours or once every 4 hours, etc. Such settings can be flexibly adjusted according to the actual production situation and the characteristics of the products. When the production rhythm is fast and the product quality fluctuates greatly, the inspection interval can be appropriately shortened; conversely, the inspection interval can be extended.
When the set inspection time arrives, the system will automatically send inspection tasks to the relevant inspection supervisors. This function greatly improves the efficiency and accuracy of the inspection work and avoids situations where inspections are not carried out in a timely manner or are overlooked due to human negligence. After receiving the tasks, the inspection supervisors should conduct a comprehensive and detailed inspection of the production site in accordance with the specified inspection routes and standards.
Quality management personnel can check the daily inspection records at any time. Through the analysis of the inspection records, they can promptly understand the quality status in the production process and identify potential quality problems. For the problems found during the inspection process, quality management personnel should handle and track them in a timely manner to ensure that the problems are completely resolved. Meanwhile, they can also optimize and improve the production process based on the inspection data to enhance the product quality and production efficiency.
Verify data entry
When the inspection supervisor receives an inspection task, they need to inspect the materials according to the requirements on the inspection form. During the inspection process, the inspectors will enter the obtained inspection data into the QMS system.
The QMS system has powerful data analysis and judgment functions. It automatically determines the inspection results based on the inspection data entered by inspectors and the standards set in the inspection criteria. When the inspection result meets the standard, the system will display green, indicating that it is qualified; when the inspection result does not meet the standard, the system will display red, indicating that it is unqualified.
If unqualified products are found during the inspection process, inspectors have two options for handling them. One option is to choose to automatically register the non - conformities. The system will automatically record relevant information about the non - conforming products, including the material name, specifications, inspection items, reasons for non - conformity, etc. The other option is to conduct manual registration in the non - conforming product management module later. Manual registration allows inspectors to record the situation of non - conforming products in more detail for subsequent analysis and processing.
Early warning notice
During the inspection process, when the metrological data triggers the warning value set in the inspection standard, the system will automatically issue a warning notice. This warning value is usually within the specification range but close to the tolerance limit. It is set to detect potential quality problems in advance and prevent the problems from deteriorating further.
After receiving the early warning notice, the person in charge needs to confirm and analyze the data. It is necessary to determine whether any abnormal situation has occurred, whether it is an accidental fluctuation or a systematic problem. If any abnormal situation is found, corrective and preventive measures should be taken in a timely manner. For example, adjust the production process parameters, strengthen the inspection of raw materials, and conduct maintenance on the equipment. In this way, the company can take measures before problems occur, implement preventive control over quality, reduce quality risks, and improve the qualified rate of products.
Inspection approval
After the entry of inspection data is completed, the person in charge of the inspection can submit the inspection data and the inspection application form. In accordance with the pre - set approval process, relevant personnel will review the submitted inspection data and the inspection application form.
The setting of the approval process is to ensure the accuracy and reliability of inspection results. The approvers will conduct a strict review of the inspection data, checking whether the inspection process complies with the standards and whether the inspection data is true and valid. During the approval process, the approvers can put forward opinions and suggestions according to the actual situation, and require the inspectors to further verify and confirm certain data.
Meanwhile, products that have passed the inspection can also be exempted from approval according to requirements. This can improve work efficiency, reduce unnecessary procedures, and enable qualified products to enter the next stage more quickly.
Inspection Report
Based on the inspection data entered by the inspectors, the system can automatically generate inspection reports. This function greatly improves the efficiency and accuracy of generating inspection reports and avoids possible errors and omissions that may occur when manually compiling reports.
The system offers two report templates for selection. One is the default inspection report format built into the system. This format is concise and clear, containing the basic elements of an inspection report and is suitable for most situations. The other is a report template custom - developed by the customer. Customers can customize the report template according to their own needs and preferences to make it more in line with their business characteristics and management requirements.
The person in charge can send the generated inspection reports to relevant internal personnel and those outside the organization through the system. This enables relevant personnel to promptly learn about the inspection results, providing a basis for decision - making. Meanwhile, it can also strengthen communication and collaboration among different departments and improve work efficiency.
Analysis report
The system can automatically generate charts for different occasions based on the set parameters. These occasions include weekly meetings, monthly meetings, annual summary meetings, etc. It can also generate analysis charts for continuous improvement projects. This function provides a convenient data analysis tool for quality management personnel, eliminating the need to spend extra time collecting and organizing data and creating analysis charts.
By selecting parameters with the mouse, the system can quickly generate the required charts. Quality management personnel can use these charts for rapid analysis to identify information such as the main suppliers, materials, production lines, and processes that affect product quality. Through multi - dimensional analysis and comparison, quality management personnel can focus their main efforts on the analysis and improvement of major and key quality problems, achieving twice the result with half the effort.
For the inspection module, there are currently a variety of analysis reports available for use. These include inspection application form status, ranking of defect items, material defects, defect Pareto chart, PPM, DPMO, qualification rate, batch qualification rate, statistics of non - conforming product handling, high - level severity scores, metering box plots, metering trend charts, metering histograms, single - value scatter plots, etc. These reports analyze and present the inspection data from different perspectives, providing quality management personnel with comprehensive and accurate quality information.
Non-conforming product management
Registration of non-conforming products
For non - conforming products discovered in quality activities such as incoming material inspection, in - process inspection, outgoing inspection, and customer complaints, detailed information registration and list display are required. The registered information includes the name, specification, batch, discovery time, discovery location, cause of non - conformance, etc. of the non - conforming products. Through detailed registration, relevant personnel can conveniently trace and analyze non - conforming products to find out the root cause of the problems.
A list presentation allows relevant personnel to clearly understand the situation of non - conforming products at a glance, facilitating statistics and analysis. Meanwhile, it can also provide a basis for the subsequent handling of non - conforming products.
Non-conforming product handling
The person in charge of non-conforming product handling leads the handling process of non-conforming products. They need to select an appropriate handling method based on the specific situation of non-conforming products and approve the handling method. The handling methods include rework, downgraded use, scrapping, etc.
If necessary, the CAPA process can be initiated. The CAPA process, which stands for Corrective and Preventive Action process, can help enterprises conduct an in - depth analysis of the causes of non - conforming products. Subsequently, corresponding measures can be taken for correction and prevention to avoid the recurrence of similar problems.
The approvers will receive a notice to approve the handling method for non-conforming products. They need to review the handling method to ensure its rationality and feasibility. When all the approval processes are completed, the handling of non-conforming products will be closed.
During the process of handling non - conforming products, information such as quality costs and the departments responsible for the expenses can be recorded. In the case of incoming material inspection, this non - conformity information can also be directly disclosed to the suppliers so that they can understand the details of non - conformity in real - time. This can prompt suppliers to take measures to improve product quality and enhance the quality level of the entire supply chain.
Report analysis
Regarding the management of non-conforming products, the system provides a variety of report analysis functions. These include the status of non-conforming products, the distribution of non-conforming products, defect statistics, defect Pareto charts, material defects, handling results, severity level ratings, etc.
Through the analysis of these reports, quality management personnel can understand information such as the distribution of non - conforming products, main defect types, and processing results. In this way, they can identify the key points and weak links of quality problems and take targeted measures for improvement. At the same time, they can also evaluate the quality performance of suppliers, providing a basis for supplier selection and management.
Supplier collaboration
To strengthen the quality control of suppliers, the company can provide suppliers with accounts for the Quality Management System (QMS). Suppliers are required to enter inspection data (Supplier Out - going Quality Control, Supplier OQC) as per the company's requirements before shipment.
In the future, the data entered by suppliers can be compared with the in - house IQC (In - coming Quality Control) data of the company. Through this comparison, the differences between the inspection results of suppliers and the company can be identified, and potential problems can be found.If the differences are significant, further analysis of the causes is required. It could be due to different inspection standards, problems with the inspection methods, or actual fluctuations in the product quality of the suppliers.
Meanwhile, it is also possible to achieve real - time sharing of non - conforming information with suppliers. When the company discovers that the products provided by the suppliers are non - conforming during the inspection process, it can promptly feedback the non - conforming information to the suppliers. Suppliers can take timely measures for rectification based on this information to avoid the recurrence of similar problems. This is a necessary method for supplier quality control, which can enhance the suppliers' quality awareness and management level and ensure the quality stability of the entire supply chain.
Panoramic tracing
Users can query the original information of materials with a single click through information such as material numbers, batch numbers, document numbers (purchase orders, production work orders, delivery notes), supplier codes, and customer codes. This function provides great convenience for real - time query of quality data.
During the production process, if any issues with product quality are detected, the full - view traceability function can be used to quickly locate the source of the problem. Whether it is a problem with the raw materials or a mistake in a certain production process, answers can be obtained by querying the original information of the materials. Meanwhile, the flow of the products can also be tracked to understand their sales and usage situations, and potential quality risks can be detected in a timely manner.
Periodic testperiodic、test、Periodic test Periodic tests
Periodic tests can be used to manage non - daily inspections. For example, reliability tests, type tests, submission of RoHs reports, etc. These tests usually need to be carried out at a certain frequency to ensure that the quality and performance of products always meet the requirements.
Test management can also be carried out in the IQC/IPQC/FQC processes. When inspectors need to conduct tests, they can submit test applications. After receiving the applications, laboratory staff will arrange the inspection work according to the test requirements and priorities.
Test template
You can set the templates for the tests in advance. The test templates contain information such as test items, methods, and standards. When conducting the tests, the responsible personnel only need to carry out relevant tests according to the items required by the templates and input the corresponding results, and then they can complete the tests. This can ensure the standardization and accuracy of the tests and avoid test errors caused by human factors.
Generate test tasks
The test tasks need to be set up. Based on different requirements, the test tasks can be cycled by quantity or time. The QMS system will automatically calculate the quantity or time, and then send reminder notifications for the tasks according to the set notification mechanism.
The notice will be sent to the person in charge. If the test task is to be carried out by the supplier, the notice will also be sent directly to the supplier. This can ensure that the relevant personnel can be informed of the arrangement of the test task in a timely manner and make preparations for the test.
Task Notification
Notifications can be set for each task. When a task is generated, the person in charge will receive a task notification. Based on the configured reminder date, the system will send out a reminder before the task deadline. This function can prevent delays in experimental tasks caused by forgetting or negligence, ensuring the smooth progress of experimental work.
Conduct an experimentconduct、conduct an experiment、carry out an experiment
When it's time to conduct the experiment, the person in charge should carry out the experiment as required and record the corresponding experimental data and results. Data can be entered according to the template, which can ensure the standardization and integrity of the data; alternatively, the inspection report can be directly uploaded to improve the efficiency of data entry.
Meanwhile, activate the calculation mechanism for the next round of the test cycle. If the supplier is responsible for the test, the supplier can also directly operate in the system. The prerequisite is that the company has granted system access rights to the supplier. In this way, real - time sharing and management of test data can be achieved, and the efficiency and quality of test work can be improved.
Customer complaint management
Customer Complaint Registration
Centralized management is required for customer complaints. Users can manually register customer complaints or upload them in batches via Excel. During the registration process, complaints can be classified either by the type of customer complaints or by the customer complaint identifiers.
Enter the basic information of customer complaints, including problem description, customer name, person - in - charge, severity, priority, and detailed defective information of the products complained about by the customer. The accurate entry of this information is very important for the subsequent handling of customer complaints. After completing the information, simply submit it, and then the customer's person - in - charge will initiate the process of handling the customer complaint.
Customer complaint handling
The person in charge of customer complaint handling processes customer complaints on time according to the registered complaints. For example, they send replacement parts to customers for replacement to solve the problems customers encounter. During the process of handling customer complaints, information about non - conforming products can be registered simultaneously, because the customer complaint handling module is integrated with the non - conforming product module.
If necessary, a Corrective Action Request (CAR) or Supplier Corrective Action Request (SCAR) can be initiated for customer complaints. Based on this, a Corrective and Preventive Action (CAPA) process can be launched. The customer complaint module is integrated with the CAPA module. This ensures in - depth analysis and handling of customer complaints, and the implementation of effective corrective and preventive measures to avoid the recurrence of similar issues.When all processing tasks are completed and approved, the customer complaint can be closed. This indicates that the customer complaint has been properly resolved and the customer's satisfaction has been improved.
4.8.3 Report Analysis
In the functional system of the platform, to fully meet the diverse analysis needs of different customers, a wide variety of analysis report templates are specially built - in. These templates are like a master key that can unlock the door to data insights for different customers. Take the customer complaint module as an example. A series of practical analysis charts have been carefully designed in the system.
The complaint status chart is like a precise weather vane, which can intuitively reflect the distribution of customer complaints at different stages. Through this chart, enterprises can clearly understand which customer complaints are in the pending state, which have been processed, and which are still in the process of being handled. In this way, they can reasonably allocate resources and improve the efficiency of handling customer complaints.
The customer complaint distribution charts are presented in the forms of pie charts and bar charts. Pie charts can vividly show the proportion of different types of customer complaints in the total, enabling enterprises to quickly identify the main sources of customer complaints. On the other hand, bar charts can compare the number of customer complaints in different time periods or different regions, which helps enterprises discover the changing trends and concentrated areas of customer complaints.
The customer complaint handling time chart focuses on the duration from the acceptance to the resolution of customer complaints. It can assist enterprises in evaluating the efficiency of their own customer complaint handling processes, identifying the stages with excessively long handling times, and then optimizing the processes, shortening the handling time, and enhancing customer satisfaction.
Defect statistical charts can comprehensively count various defects involved in customer complaints. Based on these statistical data, enterprises can conduct in - depth analysis of the problems existing in products or services, providing a strong basis for subsequent improvement.
Defect Pareto is an analysis tool based on the 80/20 rule. It can help enterprises identify the key factors that cause the majority of defects. Enterprises can concentrate their resources on resolving these key factors, thereby effectively reducing the defect rate.
The material defect chart is specifically designed to analyze the material issues involved in customer complaints. Through this chart, enterprises can identify which materials are prone to problems, communicate with suppliers in a timely manner, and improve the quality of materials.
The PPM (parts per million) chart is used to measure the quality level of products or services. It takes the number of defects in every million products or services as an indicator, enabling enterprises to intuitively understand their own quality status and compare it with industry standards.
The severity level scoring chart quantifies the severity of customer complaints. Based on the scoring results, enterprises can adopt different handling strategies for customer complaints of varying severities to ensure that key issues are resolved on a priority basis.
The charts of handling results show the final outcomes of customer complaint handling, such as successful resolution, partial resolution, and non - resolution. Enterprises can summarize experiences and lessons by analyzing these results and continuously improve their work in handling customer complaints.
4.9 Corrective and Preventive Actions (CAPA)
The CAPA module plays a crucial role in the system. It is like the engine of an enterprise's quality improvement, capable of driving the enterprise to continuously enhance the quality of its products and services. This module has two core functions. One is to carry out quality improvement, and the other is to track improvement tasks.
After a CAR (or SCAR) is generated, the person in charge of rectification shoulders an important mission. They need to track the rectification measures throughout the whole process. This is like a relay race. The person in charge of rectification must ensure that each link proceeds smoothly until the problem is completely resolved.
4.9.1 Initiate CAPACAPACorrective and Preventive ActionCAPA
With the help of the system's powerful functions, users can easily initiate the CAPA process. During the initiation process, the system will accurately assign rectification tasks to task owners according to specific circumstances. If the root cause of the problem lies with the supplier, the system will also reasonably assign the rectification tasks to the supplier. Once the task assignment is completed, the person in charge of the rectification task will immediately receive a task notification sent by the system. This notification is like a clarion call, reminding the person in charge to take prompt action and engage in the rectification work.
4.9.2 CAPA Monitoring
During the rectification process, the person - in - charge of the rectification tasks can directly operate in the system. They can add detailed cause analysis, deeply dissecting the root causes of the problems. At the same time, they can formulate practical rectification measures and track the rectification progress in real - time. The system is like an intelligent assistant. Based on the relevant information input by the person - in - charge, it will automatically generate an 8D report. This report is like a detailed diagnosis record, comprehensively documenting the process of problem discovery, analysis, and solution, providing a strong reference for the enterprise's quality improvement.
4.9.3 Report Analysis
The report analysis function of the CAPA module provides enterprises with multi - dimensional data analysis perspectives.
The rectification status report can clearly show the current status of rectification tasks, such as completed, in progress, not started, etc. Enterprises can use this report to promptly understand the progress of rectification work and urge the slow - moving tasks.
The CAR distribution report is presented in the form of pie charts and bar graphs. It can help enterprises understand the distribution of CAR across different departments, products, or time periods. By analyzing these distribution patterns, enterprises can identify areas with a high incidence of problems and take targeted measures for improvement.
The CAR completion time report focuses on the time taken from the initiation to the completion of the Corrective Action Request (CAR). Based on this report, enterprises can evaluate the efficiency of the rectification work, identify the factors affecting the completion time, and then optimize the rectification process.
The rectification distribution report is also presented in the form of pie charts and bar charts. It can reflect the distribution of rectification measures in different aspects, such as technological improvement and management optimization. Enterprises can allocate resources reasonably based on this report to ensure the full implementation of rectification measures.
The rectification identification rate report is used to measure the clarity and enforceability of rectification measures. By increasing the rectification identification rate, enterprises can ensure that the rectification work is more precise and efficient.
The rectification completion time report specifies the completion time nodes for each rectification task. Based on this report, enterprises can conduct strict time management of the rectification work to ensure that the rectification tasks are completed on time.
4.10 Review Management
The review management module plays an important supervisory and improvement role in an enterprise's quality management system. It can conduct comprehensive review management in multiple aspects, including on - site factory reviews, process audits, product audits, system audits, 5S management, and manufacturing preparation status. The review checklist can be customized by customers according to their own needs and standards, which makes the review work more targeted and flexible.
4.10.1 Set up a review checklist
Setting up a review checklist is the fundamental work of review management. Customers can formulate a detailed review checklist according to the actual situation of the enterprise and quality management requirements. This checklist is like a guide for the review, clarifying the review content and standards, and providing a strong basis for the subsequent review work.
4.10.2 Review Plan
When formulating review plans, the system offers two flexible methods. Users can choose to set up review plans individually, making arrangements for specific review objects and time periods. Alternatively, they can set up review plans in batches, planning multiple review tasks at once. Meanwhile, users can also set the list of people to be notified about the review plans. Once the review plans are finalized, the system will automatically send notifications to the notified individuals to ensure that relevant personnel are informed of the review arrangements in a timely manner.
4.10.3 Conduct a review
During the review process, reviewers can make full use of the convenient functions of the system. They can record evidence in the review in real - time, including written descriptions, photos, and videos. This evidence is like the eyes of the review, which can truly reflect the actual situation of the reviewed object.Meanwhile, reviewers can also record review findings and promptly identify problems and potential risks. When conducting a review, the system will display the information of the previous five reviews of the same reviewed object. This is like a historical archive. Reviewers can understand the improvement and development trends of the reviewed object through comparative analysis.The system also centrally manages review records and review findings, making it convenient for reviewers to query and analyze. Based on the review findings, if serious problems are discovered, the system can initiate a CAR (integrated with the CAPA module) to take corrective and preventive measures in a timely manner.
4.10.4 Review Report
After the review is completed, based on the review results, the system can print the review report according to a preset template. This report is like a summary of the review, which details the review process, the problems discovered, and the improvement suggestions. It facilitates the enterprise's subsequent tracking and archiving work and provides an important reference for the enterprise's quality management.
4.10.5 Report Analysis
The report analysis function of the review management module provides enterprises with a rich variety of data analysis dimensions.
The review distribution report presents the distribution of reviews in different regions and of different types in the form of pie charts and bar charts. Enterprises can use this report to understand the key points and weak links of the reviews and allocate review resources reasonably.
The review record report details the specific circumstances of each review, including the review time, reviewers, review objects, etc. Enterprises can review this report to understand the historical situation of the review work and summarize experience and lessons.
The review findings report focuses on the problems and potential risks discovered during the review process. Based on this report, enterprises can classify and analyze the problems and formulate corresponding improvement measures.
The review event status report shows the current status of review events, such as completed, in progress, not started, etc. Enterprises can use this report to promptly understand the progress of the review work and urge the tasks with slow progress.
The review plan completion rate report is used to measure the implementation of the review plan. By improving the completion rate of the review plan, enterprises can ensure the full implementation of the review work.
The report on the timeliness rate of review plans focuses on whether the review plans are completed on time. Enterprises can analyze the factors affecting the timeliness rate of review plans based on this report and take corresponding measures for improvement.
The daily coverage report of the review plan reflects the daily coverage scope of the review plan. Enterprises can arrange review work reasonably based on this report to improve the review efficiency.
The event cancellation classification report conducts a classified statistics on the reasons for the cancellation of review events. Enterprises can identify the main reasons leading to event cancellations based on this report and take corresponding measures to avoid them.
4.11 Mobile APPs
The mobile APP has brought great convenience to the use of the QMS system. Through this APP, users can perform convenient operations on each module of the QMS system, just as if they had the entire quality management system in their pockets. It supports the portable management of quality activities such as on - site inspections and reviews. No matter where users are, they can conduct quality control anytime and anywhere. This APP supports multiple terminal devices such as mobile phones, tablets, and handheld PDAs, meeting the usage needs of different users. At the same time, it also supports quick inspection by scanning codes, which greatly improves the inspection efficiency.
The workbench of the APP is like an information hub, where all the system's pending tasks are automatically pushed. These include my inspection tasks to be completed, my task arrangements, my handling of non-conforming products, my review work, my rectification tasks, etc. Through the APP, users can directly learn about all the quality events that need to be handled. It's as if they have a private quality butler, reminding them to pay attention to important matters at all times.
4.11.2 Example of QC inspection operation
The APP has extremely powerful functions during incoming material inspection or on - site process patrol inspection. The sampling plan, inspection items, and rule standards are clearly presented on the interface, allowing users to have a clear view at a glance. Meanwhile, the APP enables users to directly access the camera. During the inspection process, users can take photos or record videos of quality defects while conducting the inspection. These photos and videos are like a "chain of evidence" for quality issues, which can provide strong support for subsequent handling.
4.11.3 Example of non-conforming product management
The APP also performs excellently in the management of non-conforming products. It supports the rapid registration of non-conforming products at the factory site. Users only need to perform simple operations to enter the information of non-conforming products into the system. Meanwhile, the APP also supports the review and processing of non-conforming products. Users can evaluate and make decisions regarding non-conforming products on the APP, which improves the processing efficiency.
4.11.4 Example of Layered Process Audit (LPA)
Conducting on - site evaluations via mobile devices, the APP enables reviewers to carry out their work more conveniently. Reviewers can record the audit scores and quickly register the problems found during the audit. This information will be promptly synchronized to the system, facilitating the subsequent Corrective and Preventive Action (CAPA). It's like a mobile audit station, ensuring the quality of the enterprise anytime and anywhere.
4.11.5 Task Management Example
Although the specific content of the task management examples is not detailed in the document, it's imaginable that the APP will also offer convenient functions in task management. It may support task assignment, tracking, and feedback, enabling users to manage quality - related tasks more efficiently.
V. Project Schedule Planning
In the implementation process of the QMS system, project schedule planning plays a crucial role. It is like a detailed map that clearly depicts all stages of project implementation, as well as the tasks, deliverables, responsible persons, and completion indicators of the work involved in each stage. By following the system's implementation methodology, enterprises can advance the project in an orderly manner and ensure that the project is completed on time and with high quality.
VI. Technical Requirements
6.1 Computer system support
6.1.1 Software Environment
The software environment of the computer system is the foundation for the operation of the QMS system. The operating system uses the CentOS 7.8 64 - bit server version, which features high stability and strong security, and can provide a reliable operating environment for the system. For the background environment, Nodejs v12 is selected. It is an efficient JavaScript runtime environment that can offer fast response speed and powerful processing capabilities. The database used is MongoDB v4, which is a non - relational database with a flexible data storage structure and high scalability, and can meet the system's requirements for storing and managing a large amount of data. The deployment type is containerized local deployment (Docker). This deployment method can encapsulate each component of the system in independent containers, enabling rapid deployment and resource isolation, and improving the reliability and maintainability of the system.
6.1.2 Hardware Environment
The hardware environment is the physical foundation that supports the operation of the QMS system. There are two servers, which are designed with redundancy to ensure the high availability of the system.In terms of server configuration, the CPU uses a 4 - core 64 - bit 2G processor, which can provide sufficient computing power. The memory is 16G, meeting the system's memory requirements. The hard drives are configured with dual 1T (RAID 1). The RAID 1 technology can achieve mirror backup of data, improving data security. The network adapter is 1000MB (with a fixed IP address), ensuring that the system can communicate with the network quickly and stably.
6.2 Other Instructions
The programming language of the system is JavaScript, which is a programming language widely used in web development. It is easy to learn and highly flexible. The data is stored on the hard disk to ensure long - term storage and security of the data.This system is designed based on the B/S architecture. This architecture has the advantages that clients do not need to install software and it is easy to maintain and upgrade.VSCode is used as the development tool. It has a rich collection of plugins and powerful editing functions, which can improve development efficiency.The background database is MongoDB, which provides efficient data storage and management services for the system.The system runs on the CentOS platform and is deployed in Docker containers, ensuring the system's stability and portability.