e-works Digital Enterprise Network: Digital Quality Management System in the Era of Big Data
Opportunities for the Upgrading of Enterprise Quality Management in the Era of Big Data
In today's era when big data is surging forward, data is like a treasure trove brimming with infinite value. If enterprises can skillfully utilize big - data analysis and create algorithms, it's as if they have obtained a key to unlock this treasure trove, which can bring about brand - new transformations and upgrades to quality management.
The emergence of the Digital Quality Management System (QMS) has given enterprises an even greater edge. It endows enterprises with a variety of powerful capabilities.Firstly, when it comes to handling a vast amount of customer information, it can complete the task quickly and with high quality. It's like an efficient information processor, enabling enterprises to promptly understand customer needs and feedback.Secondly, it has the ability to manage data quality and perform data calibration. Just like a precise balance, it ensures the accuracy and reliability of data.Thirdly, it possesses the quality - management ability to implant information into hardware systems, allowing hardware devices to operate in accordance with quality standards.In addition, its predictive quality control and equipment maintenance capabilities are like the enterprise's "clairvoyance". It can detect quality problems and equipment potential hazards in advance, thus avoiding losses.Moreover, its risk - system control ability safeguards the enterprise's quality management, protecting it from various potential risks.Finally, its ability to enhance and meet customer value enables enterprises to serve customers better, improving customer satisfaction and loyalty.
Full - process coverage of the digital quality management system for manufacturing enterprises
For manufacturing enterprises, the digital Quality Management System (QMS) is the key that runs through the entire process of enterprise operations. It encompasses quality management activities in various stages, from research and development, procurement, and production to after - sales services.
R & D quality management is the source control of product quality, ensuring that products meet high - quality standards from the design stage. Supplier quality management is an important link to guarantee the quality of raw materials and components. Only high - quality suppliers can provide high - quality materials.Inspection management includes various types such as Incoming Quality Control (IQC), self - inspection during production, first - article inspection, patrol inspection, final inspection, inspection before warehousing, inspection before shipment, inspection upon return to the warehouse, and periodic tests. Each inspection link is like a line of defense to ensure that product quality meets the requirements.Non - conforming product management can handle products that do not meet quality standards in a timely manner, preventing them from entering the market. Customer complaint management is an important way for enterprises to listen to customers' voices and improve product quality. Corrective and Preventive Action (CAPA) measures can fundamentally solve quality problems and prevent them from recurring.Quality audits (Audit) and Finding problem management help enterprises continuously optimize the quality management system. Quality cost management can assist enterprises in reasonably controlling quality - related expenses. Measuring instrument management ensures the accuracy and reliability of measuring tools. Quality traceability can quickly locate the source of quality problems when they occur and take corresponding measures.
Multi-scenario requirements for quality statistical analysis
Statistics of quality problems in daily meetings
In the daily operation of an enterprise, it is necessary to promptly understand the quality situation during daily morning meetings, Monday regular meetings, and end - of - month summary meetings. We want to know what quality issues occurred yesterday, in the recent week, or in the recent month. Are they appearance issues, safety regulations issues, dimensional issues (specifically which dimension), or functional issues (specifically what function).Meanwhile, it is also necessary to analyze the location where the problems occurred and conduct statistics according to different dimensions such as materials, suppliers, work orders, production lines, processes, work teams, machines, molds, and mold cavities.In addition, the handling methods and proportions of the problems are also crucial. For example, the number of times and proportions of returns, concession acceptance, rework, repair, and scrapping.Finally, the rectification situation of the problems cannot be ignored, including the rectification progress and whether the rectification has been completed.
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Leaders need comprehensive reports to understand the risk points across the entire quality spectrum. The changing situations of the qualification rates, batch qualification rates, and PPM (parts per million) of different suppliers, production lines, processes, and materials over time can reflect the dynamic trends of quality management. Whether there have been quality issues with key and important characteristics and the fluctuation range of their measured values are crucial for evaluating the stability of product quality. Process capability analysis can help enterprises understand the stability and capability of the production process.
Meet the rapid query needs for factory audits and reports
When customers come for factory audits or when reporting to leaders, it is necessary to quickly respond to various quality issues. This requires the ability to quickly search for a certain inspection document, as well as its corresponding non - conforming product handling document and corrective and preventive action document. At the same time, data statistics are usually carried out on a natural - month basis. However, if customers want to know the data for non - natural months, it should also be provided promptly.
Real-time query of internal quality meetings
In internal quality meetings, real-time queries with instant results can prevent the recurrence of the cycle of holding a meeting, collecting data, holding another meeting, and collecting more data. This can improve the efficiency of the meetings and the timeliness of decision-making.
Rapid positioning of SQE on-site audits
When the SQE conducts an on - site audit at the supplier's location, they need to quickly identify the supplier's quality issues for timely communication and rectification.
Inspection of management rules and their implementation
Test the flexibility and universality of the inspection rules and standards
The types of inspections are diverse, including incoming material inspection, production self - inspection, first - piece inspection, in - process inspection, final inspection, warehousing inspection, shipping inspection, return inspection, periodic inspection, etc. The QMS system must have sufficient flexibility to support customized inspection rules. Due to different requirements from various customers and different capabilities of various suppliers, different acceptance standards can be set for the same material according to the dimensions of suppliers, customers, processes, and inspection types, achieving "one standard, presented in different categories". For materials of the same family, many inspection items are the same. Therefore, the commonalities can be extracted to establish a "general standard", avoiding the repeated reconstruction of inspection items, which can be directly referenced. Process control is also very important. By connecting all processes through the process flow, it is suitable for the assembly - line operation mode. The QMS system should support conventional sampling plans such as AQL, fixed - quantity sampling (or fixed - quantity gradient sampling), percentage sampling, etc. In addition, an independent inspection item, such as coating thickness, wire diameter, motor speed, etc., can be abstracted to compare the specifications and quality among materials of the same family, suppliers, customers, production lines, and work orders. There is no need for a special SOP document for inspection operations. All requirements are reflected in the inspection standard rules. The sampling quantity, rejection standard, and batch acceptance are all calculated and determined by the system. Inspectors are only responsible for entering data and submitting documents, forming a "fool - proof QMS system".
Inspect the standardization and intelligence of the inspection operation execution
The QMS system involves numerous integrated systems, such as ERP, WMS, MES, APS, OA, PLM, etc. Therefore, standardized interfaces are required to ensure the smooth transmission of data.In terms of inspection task scheduling, the system automatically pushes tasks to the corresponding inspectors based on different factors, including suppliers, material types, warehouse areas, workshops, production lines, and processes. According to the quality status of the materials to be inspected, control measures such as skip - inspection, batch combination, early warning, and escalation should be implemented.IPQC can set inspection plans, including first - piece inspection, in - process inspection, and final inspection, and automatically push the inspection tasks to the relevant responsible persons on time. During the inspection process, inspectors can query the drawings of the materials, historical inspection defect records, historical customer complaint defect records at any time, and view the work instructions online.If there are non - conforming products, inspectors can register them while conducting the inspection, which facilitates the initiation of MRB review. Meanwhile, authority management and control are also crucial. The data of different workshops are isolated from each other and invisible to inspectors, but the management has the authority to view the quality data of some or all workshops.
The comprehensiveness of non-conforming product management
The sources of non-conforming products are extensive, including those identified by IQC (Incoming Quality Control), IPQC (In-Process Quality Control), FQC (Final Quality Control), OQC (Outgoing Quality Control), non-conforming products from customer complaints, and rapid registration in the workshop. Some enterprises require the processing methods and process approvals for non-conforming products to be carried out in OA (Office Automation) or BPM (Business Process Management). At the same time, it is also necessary to manage the quality costs involved in the processing of non-conforming products and the departments responsible for the expenses. During the process of handling non-conforming products, the original inspection records or customer complaint records can be viewed at any time. After the processing is completed, it may be necessary to issue a (S)CAR (Supplier Corrective Action Request) to require suppliers or internal departments to implement corrective and preventive actions (CAPA).
The efficiency of supplier collaboration
After the supplier submits the inspection data, it will be automatically synchronized to the customer's internal system. The customer can view the data at any time and compare the data of the same batch of orders. With the passage of time and the accumulation of data, more intuitive comparative analysis can be carried out, such as the comparison of the qualification rates between the supplier and the internal department, the comparison of batch qualification rates, and the comparison of Pp/Ppk. For cost - saving reasons, when ensuring product qualification, suppliers generally try to keep the data of key characteristics as close as possible to the lower tolerance limit. The QMS system can provide an intuitive understanding of the details.When the internal department discovers IQC non - conformities, it can share this non - conformity information with the supplier in real - time. In case of incoming material non - conformities, if the supplier is required to make corrections, an SCAR can be directly issued, asking the supplier to make corrections according to the customer's requirements. After the corrections are completed, the supplier shall submit them to the customer for approval, and the customer can track the progress and status of the corrections in real - time.Regarding the supplier evaluation results, if the supplier needs to know the details of the evaluation, the internal department can make the evaluation record report public to the supplier. For the evaluation findings, an SCAR can also be issued to require the supplier to make corrections and be tracked.
The systematic nature of customer complaint management
Customer complaint types can be categorized, such as process - related issues, R & D - related issues, etc., and there can be an unlimited number of sub - classifications, which facilitates future analysis and statistics. The registration of customer complaint information may be integrated with CRM. The form fields are flexible, allowing for the custom addition of fields. One customer complaint may involve multiple materials, and one material may be associated with multiple defects.The customer complaint escalation mechanism is also crucial. For example, if a complaint is not handled for a long time, the leader should be notified. Different escalation mechanisms can be set according to customer names, material types, severity levels, and complaint types respectively.The methods for handling customer complaints include product replacement, repair, compensation payment, etc., and may require approval. If rectification is needed, a Corrective Action Request (CAR) should be issued to initiate corrective and preventive actions (CAPA).A two - stage approach is adopted for handling customer complaints. In the first stage, a rapid response and containment are required. Every effort should be made to quickly respond to and solve the problems raised by customers, aiming to satisfy customers in the short - term. In the second stage, the root cause of the problem should be thoroughly investigated, and permanent solutions should be sought to eliminate similar issues, thereby improving products and services to prevent recurrence.
5. Corrective and Preventive Actions (CAPA)
5.1 CAR ManagementCAR
The sources of CAR (Corrective Action Report) are diverse. The appearance of non - conforming products often indicates that there are potential problems in the production process. Information such as various parameters and production links of these non - conforming products can serve as important bases for CAR. Customer complaints directly reflect customers' dissatisfaction with products or services, and there may be problems in multiple aspects behind them, such as product quality, delivery time, and service attitude. Problem Findings usually refer to abnormal situations discovered during daily inspections, audits and other activities. In addition, when there are problems with the products or services provided by suppliers, we can issue SCAR (Supplier Corrective Action Report). After issuing the SCAR, we need to continuously monitor the supplier's rectification progress to ensure that the problems are effectively solved. After the rectification of CAR is completed, its closure requires a strict approval process to ensure that the corrective measures are truly effective and the problems will not occur again.
5.2 Associate with historical CARsCAR、
When encountering similar problems, referring to historical Corrective Action Requests (CARs) is an efficient approach. By reviewing historical CARs, one can quickly learn about the corrective measures taken for similar issues in the past and their effects. This not only helps avoid redundant work but also allows us to draw on previous successful experiences, enabling us to formulate more precise corrective action plans this time and enhance the efficiency and quality of the rectification process.
5.3 CAPA Task Template
It is highly necessary to formulate task templates for CAPA (Corrective and Preventive Action) processing in advance. These templates clearly define the specific tasks and completion times for each stage, just like a detailed battle plan. When a problem that needs to be addressed arises, the template can be directly retrieved, and tasks can be distributed to relevant responsible persons with a single click. After each stage is completed, approval may be required to ensure that the tasks are completed as required. If a task is not completed on schedule, the system will automatically activate an escalation mechanism to alert higher - level managers to intervene and promote the resolution of the problem.
5.4 Task Information Upload and Verification
During the execution of each CAPA (Corrective and Preventive Action) task, relevant personnel can upload materials such as written descriptions, pictures, and attachments. This information can more intuitively and comprehensively display the execution status and results of the task. When closing a task, leadership verification may be required. By reviewing the uploaded materials, leaders can determine whether the task has achieved the expected goals and then decide whether to close the task.
5.5 Printing of the rectification report
The system supports direct printing of rectification reports, such as the common 8D reports. These reports can comprehensively and systematically record information such as the discovery, analysis, rectification measures, and effects of problems. This facilitates communication and exchanges with relevant parties and also provides an important reference for subsequent quality improvement.
6. Quality Audit
6.1 Types of Review
Quality review supports various types of audits. The 5S audit mainly focuses on the sorting, straightening, sweeping, standardizing, and sustaining in the workplace. A good 5S environment helps improve work efficiency and product quality. The system audit is a comprehensive assessment of the enterprise's quality management system to ensure that the system complies with relevant standards and requirements. The supplier audit can assist the enterprise in selecting high - quality suppliers and controlling the quality of products or services provided by suppliers. The layered audit examines the production process from different levels to ensure that each link meets the quality requirements.
6.2 Review Checklist
Establishing audit templates is an important foundation for quality reviews. A review item can be called by different audit templates, which can improve the consistency and accuracy of audits. Meanwhile, the system can collect information such as the number of audits and audit results of this item. Through the analysis of these data, potential quality issues and areas for improvement can be identified.
6.3 Review Plan
Users can customize single or periodic audit plans. A single audit plan is suitable for specific projects or events, while a periodic audit plan can regularly check the enterprise's quality management status. The system will automatically push the audit plans to the relevant responsible persons to ensure that the audit work is carried out on time.
6.4 Review Execution
During the review process, reviewers can record evidence in real - time, including text, photos, videos, etc. This evidence can truly and accurately reflect the situation at the review site. Meanwhile, the historical information regarding the same audit item can be presented during the review, which facilitates reviewers to conduct comparisons and analyses. When review findings are discovered, a Corrective Action Request (CAR) can be directly initiated and integrated with the Corrective and Preventive Action (CAPA) module to achieve rapid problem - solving.
6.5 Review Report
Based on the review results, the system can print review reports according to templates. These reports are detailed, including basic information of the review, audit results, discovered problems and suggestions, etc. They facilitate subsequent tracking and archiving, and provide strong support for the enterprise's quality management decision - making.
7. Quality problem management
7.1 Classification of Problem Types
Classifying quality problems by type is the foundation for analyzing and solving problems. Common problem types include 5S issues, production problems, raw material problems, etc., and an unlimited number of sub - classifications can be set. This detailed classification method facilitates subsequent data analysis and statistics, enabling us to more accurately identify the root causes and patterns of the problems.
7.2 Quality Problem Registration
When creating a new problem record, users can customize the form and add an unlimited number of form fields. This allows for detailed recording of relevant information about the problem according to different problem types and requirements. At the same time, a problem escalation mechanism is configured. When a problem reaches a certain level of severity or remains unresolved within the specified time, it will be automatically escalated for processing to ensure that the problem receives timely attention and resolution.
7.3 Problem Handling
After registering quality issues, it is necessary to assign tasks to relevant responsible persons and supervise the implementation of these tasks. By tracking and monitoring the task execution process, problems can be detected in a timely manner and coordinated for resolution, ensuring that the issues are properly handled according to the predetermined plan.
7.4 Integration with the CAPA module
When a quality issue is discovered, it can be integrated with the CAPA (Corrective and Preventive Action) module to issue a CAR (Corrective Action Request) and initiate corrective and preventive actions. In this way, the handling of quality issues can be combined with long - term quality improvement to prevent the recurrence of problems.
8. Measuring tool management
8.1 Types of Measuring Tools
Common types of measuring tools include coordinate measuring machines, vernier calipers, hardness testers, etc. Different measuring tools play important roles when measuring different physical quantities and meeting various precision requirements. Enterprises need to select appropriate measuring tools according to their own production and inspection needs.
8.2 Measuring Tool Ledger
Establishing a measuring tool ledger is an important part of measuring tool management. The measuring tool ledger records the basic information of measuring tools, such as model, specification, purchase date, etc. The resume of each measuring tool can also be directly viewed on its form, including calibration records, maintenance records, repair records, etc. This resume information can help enterprises understand the usage and performance status of measuring tools, and conduct maintenance and management in a timely manner.
8.3 Measuring tool calibration, maintenance, repair plans and implementation
To ensure the accuracy and reliability of measuring tools, it is necessary to formulate plans for the calibration, maintenance, and repair of measuring tools. Periodic plans can be set up with a pre - reminder function to remind relevant personnel to carry out calibration, maintenance, and repair work on time. At the same time, when performing these tasks, relevant costs should be recorded to facilitate cost control and management.
8.4 Statistical reports of the measuring tool module
The system provides statistical reports for the measuring tool module. Through the analysis of these reports, enterprises can gain insights into information such as the usage frequency, calibration status, and maintenance costs of measuring tools. This information serves as a basis for decision - making regarding the procurement, management, and optimization of measuring tools.
9. Project management
9.1 Project Templates
Taking R & D quality project management as an example, the project is managed in a phased manner. The project template defines the specific content of each phase and the list of subordinate tasks, just like a blueprint for the project. Clear phase division and task definition help the project team clarify goals and responsibilities, and improve the efficiency and quality of project execution.
9.2 Task Association and Initiation
Tasks in the project can be associated with or initiate activities such as inspections, reviews, problem registrations, and rectifications. This association method tightly integrates project management with quality management, enabling the timely identification and resolution of quality issues that arise in the project and ensuring the smooth progress of the project.
9.3 Requirements for project phases
For each project phase, a completion time can be specified, and a phase upgrade mechanism and approval process can be set up. Clear time requirements can ensure the timely progress of the project. The upgrade mechanism can enable timely adjustment of resources and strategies when problems arise in the project, while the approval process can ensure that the deliverables of each phase meet the requirements.
9.4 Project Report
The system can print reports with a single click for all tasks, inspection records, review records, issue records, rectification records, etc. These reports can comprehensively reflect the execution and quality status of the project, providing an important basis for project summary and evaluation.
10. Panoramic tracing
10.1 Quickly retrieve quality events
Through the QMS system, for key products, customers, or suppliers, all relevant quality events can be quickly retrieved. The system links all quality management activities, such as IQC (Incoming Quality Control), IPQC (In - Process Quality Control), FQC (Final Quality Control), OQC (Out - going Quality Control), non - conforming product handling, customer complaint management, quality problem discovery, corrective and preventive actions, and review management, to achieve one - click quality traceability. Users can query quality events such as inspection records, non - conforming products, customer complaints, corrective measures, quality problems, and tasks through information like part numbers, supplier codes, customer codes, order numbers (purchase orders, work orders, shipping orders), and batch numbers.
10.2 Quality event tracking and associated query
When querying quality events, you can also learn about the subsequent follow - up situations and associated relationships of each quality event. For example, you can check whether there are non - conforming products generated in a certain inspection record, how these non - conforming products are handled, whether there are corrective measures in place, and who is responsible for the follow - up. This detailed query function helps to gain an in - depth understanding of the ins and outs of quality problems and provides strong support for quality improvement.
10.3 Dealing with Factory Audits and Meetings
When customers come for factory audits or the enterprise holds internal quality meetings, the panoramic traceability function can quickly find out whether the material has been complained about, whether there are corrective measures, who is in charge of tracking, and what the current status is. Timely understanding of these situations and providing feedback to customers can enhance customers' trust in the enterprise. Meanwhile, it also helps the enterprise formulate the next - step work plan.