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QUALITY ASSURANCE

  • Quality Control Phase
  • Quality System
  • Supplier Quality Control
  • Process Quality Control

Several stages of product quality control

      Quality is designed and manufactured, not inspected, good quality first of all to have a good design team, the design of the product will go through the DFM (Design for Manufacturing, that is, manufacturing-oriented design).  In this stage of DFM, the product design needs to meet the requirements of product manufacturing, with good manufacturability, so that the product is manufactured at the lowest cost, the shortest time, the highest quality.  Each battery, starting from the customer demand VOC, must undergo QFD quality function development, the customer or market requirements into design requirements, component characteristics, process requirements, production requirements.  In this way, the positive and negative electrode material system, diaphragm varieties, conductive agent, electrolyte, lugs, shell and other materials and specifications and manufacturing process, the choice of parameters, the design of jigs and fixtures must be in the case of meeting the customer's requirements, to choose the more suitable for the company's manufacturing methods, materials, processes, jigs and fixtures.  And it is very important whether the process capability index CPK can meet the requirements of the design team.The company relies on the early years in the consumer lithium battery technology foundation and strong R & D strength quickly, successfully entered the supply chain of the well-known lithium battery YiWei enterprise, and YiWei enterprise's supply chain is the German veteran high-end automobile enterprises BMW and Daimler, the Korean well-known automobile enterprises Hyundai and one of the three giants of the domestic new force Peng supply chain.


When the design team is designing, through DFMEA (Design Failure Mode Analysis), the design team should discuss with the cross-company team about which failure modes the product has, and strengthen the design of the product by considering the consistency, reliability, and working performance of the battery.  At the same time when the design team in the design, and suppliers should also discuss DFMEA, because the product is not designed by the design team, the supplier process capabilities can be achieved, the design of the tolerance or margin to be able to achieve the supplier's process capabilities, the design can be realized.  When the DFMEA is finalized, our company's team and the supplier's capability can meet the design requirements, and there is no problem with the process capability.


Next, we use PFMEA (Process Failure Mode Analysis), when the design is determined, the company's manufacturing process what failure modes will affect the product, we do a failure mode analysis of the manufacturing process capabilities, corresponding to our improvement measures.  For example, the appearance of flexible packaging batteries often have bad products bumps, we know after analysis that this is caused by dust, it should be possible to lead to dust is rolled into the battery aluminum-plastic film may be the workstation, the cause, the corresponding measures to figure out.  When the DFMEA design and cross-departmental PFMEA design is completed, we will be in the process of product failure mode and the process of encountering the problem of preventive measures, followed by IQC, PMP, CTQ, OQC, MSA, ORT, etc. to do a detailed plan.


Next, the Layout of the production line should be optimized by applying Lean concepts to the line balance, beat time, UPH, and line logistics. In the design process, there should be a lot of anti-deactivation measures for line design, machinery and equipment to avoid some of the problems caused by staff operating errors. In the process of operation is the most difficult to control the staff, because of the new staff, the old staff of different experience, it is inevitable that employees will make some mistakes. In the design of production lines and machinery and equipment with anti-dull measures, employees will avoid mistakes, even if employees make mistakes, machinery and equipment will be timely alarm to remind employees to change in a timely manner.


In the process analysis, mold and equipment tolerance analysis is also very important, in the design of each station must use the concept of flow to do some analysis of input and output. When the production line is designed, whether the UPH of each station matches determines whether the production line is smooth. Each station's inspection measures or inspection methods should have a detailed site plan for all testing equipment in the control plan. Production line or operational staff to 100% inspection, if there are defects, to check it out, to prevent defects flow to the next station or even to the client. So a good quality system, not only to have a good design, in the inspection system should have a perfect ability to detect defective products.


After the product DFM, DFMEA, PFMEA, and production line Layout, the ORT of the product, UPH of the production line, and OEE of the equipments are verified and improved through the four phases of Prototype-EVT-DVT-PVT, and the product can be smoothly produced when it passes through these phases of testing and improvement.


The company's existing product quality control is based on the following stages: DFM-DFMEA-PFMEA-Layout-Prototype-EVT-DVT-PVT.


The Establishment Of The Quality System

The establishment of system documents: In accordance with the requirements of ISO, the system documents are divided into first-order documents quality manual, second-order documents quality control procedures, third-order documents SOP, fourth-order documents inspection records inspection instructions. Different industries have to have a complete setup for the fourth-order documents. After the establishment of a good quality system, each department of the company's operations are based on the quality system to implement. Not that every thing is looking for the boss or manager to go to the board. If there are imperfections in the quality system can be gradually improved, the quality system document is a living document, is the need for continuous review and continuous improvement.


After the establishment of the system documents, QA engineers or system engineers regularly do system audits on the implementation of the company's system documents. When the company has just established the system documents, generally a quarterly audit to see what the company's various departments in the system documents run in a timely manner to detect inconsistencies and make improvements; mature system is generally half a year or even a year to do a system document audit to ensure that the system documents in the implementation of the various sectors of the good for the implementation of the implementation of the good to be able to find or correct in a timely manner in order to ensure that the quality system of the company's good operation.

Supplier Quality Management

The main materials of the battery include: positive electrode material, negative electrode material, copper foil, aluminum foil, diaphragm, electrolyte, casing (aluminum-plastic film, aluminum casing, etc.), pole lugs, equipment, etc., and each one of them has different degrees of influence on the final performance, quality and cost of the battery. Different suppliers and different batches of materials may have large differences, which requires supplier management. Supplier's quality, cost, delivery time, R&D capability, response time and supplier's strategic positioning are all indicators for assessing suppliers, and quality management is one of the most important assessment KPIs for supplier management.


Supplier quality management has an important concept of win-win, to give suppliers a reasonable profit margin, money to earn them to ensure quality, one-dimensional price will appear to reduce the quality of suppliers or in the personnel training and testing means to do some jerry-building. So in the supplier's offer, should list the cost of materials, manufacturing costs, management costs and reasonable profit margins.


Supplier's regular audit and on-site process control is very important, in Europe and the United States or Apple, there are a lot of engineers are responsible for the supplier's management, process monitoring, to ensure that the supplier's quality control in accordance with our quality requirements to implement. From new product development to sample making to finished product mass production shipment, each supplier has onside personnel to monitor the quality on a regular basis. When the supplier's products are sent to the next supplier, the next supplier will do IQC incoming material inspection, if the material is found to be defective to provide timely feedback, we use the logic of 8D to find the Root Cause, closed-loop control to close the Issue, and even the logic of 8D inside the product or similar products to commit the error, in the similar product or process to do the prevention and improvement, and in the other product or process to do a thorough improvement, to avoid the product or process to improve the quality of the product. process to do a thorough improvement to avoid the same error.


This is the supplier management we are talking about, to ensure that the supplier has good management, to ensure that the supplier process is monitored, to ensure that the supplier material meets the requirements, if there is a problem corrected in a timely manner. Ensure that the supplier's materials meet the company's quality requirements.


Process Quality Control

1. SOP and SIP document establishment.


For each process standard instructions to be drawn up clearly, standard instructions will cover the standard operating procedures, precautions, if there is a significant impact on product quality (CTQ) of the project to be marked with an exclamation point and an asterisk to tell employees can not be illegal to operate, misuse will result in a serious adverse product. Work inspection instructions for the inspection of the sampling frequency, inspection methods, inspection of the use of instruments have a clear definition, training inspectors in accordance with our work inspection instructions to test to ensure that the inspection method is correct and will not be misjudged, as well as for the KPIV, KPOV, and the input and output should be made to identify which process inputs affect the output of the control to do a control to do some of the parameters of the equipment and process parameters with the DOE optimization. Optimization of equipment parameters and process parameters should be done by DOE. For the input and output of the machine to make control, for the key product output control.


2. MSA measurement system.


In order to ensure that the test can truly reflect the product performance, we must ensure that the test system GR&R (measurement system error repeatability reproducibility) meets the requirements, when the MSA GR&R <10% is a good measurement system, 10% 30% of the measurement error is too large, the measurement system needs to do to improve, otherwise it can not be used for product testing. For example, the weighing of the battery, the weighing of the pole piece, the weighing of the dosage of this type of measuring instrument must be strictly calibrated.


3. CTQ


All input and output parameters that affect product quality must be identified in the process. For these CTQ items, to do special monitoring, including input parameters, such as alarms or machinery and equipment design should be considered for real-time monitoring, if the process capability parameter CPK value can reach 1.33, then you can use sampling methods, so the identification of CTQ is very important.


For the process inside the CTQ parameters, to use SPC process statistics to monitor the process input and output parameters are controlled, SPC can react to whether the process is stable, if there is anomaly will be reflected in the SPC control charts, can be investigated in advance and to take preventive measures to avoid loss of control of the production process. For SPC if there are abnormalities, then the abnormalities should be dealt with in a timely manner, the process encountered in a timely manner to solve the problem, to ensure that the process is controlled and stable production.


4. Process control system (Shop Floor Control)


For the key characteristics of the parameters, in the process control, to use the existing MES to do some monitoring, if the last station test is bad, then in the next station to the bad selection or intercepted, when the production line there are employees operating errors, there will be a system of anti-dumbness to prevent the flow of defective products to the next process or flow to the hands of customers. This system must be in place when doing PFMEA or when controlling the critical characteristics of a product, otherwise the supplier will not be allowed to produce. The process control system is a necessary condition for Apple to audit suppliers, without this system there is no way to become an Apple supplier.


5. Product traceability system


If there are abnormalities in production or customer complaints, it is convenient to recall the products, quickly determine the scope of the impact of the product, easy to trace back, isolate the product, and easy to do quality investigations. Traceability system should at least do people, machines, materials and production time, including the key process characteristics of the parameters, operators, machine and equipment numbers, material batch number, production time, CTQ, etc., all of which should have a system to trace, to facilitate the investigation.


Process control system and product traceability system is the supplier management and quality management of the two major hard conditions, the two systems lack any one Apple will not give him the project. At present, the two domestic enterprises to do very bad, there is no such two systems, a lot of quality problems can not be traced and investigated.


6. the employee's self-inspection and re-inspection


To train employees, each employee must be clear about the current operation of the workstation which are bad products, which are good products, which are qualified, which is unqualified. It must be trained, certified, and qualified for the examination before they can be put on duty. When the production process reflects the bad, employees will be bad inspection isolation, will not flow to the next station, and even customer hands.


7. IPQC Inspection


IPQC is like the police inside the factory, doing regular inspection on the parameters of the production line's machinery and equipment, the operator's operation practice, the operator's compliance with the operation process, the parameters of CTQ, the input/output parameters of the equipment, etc. according to the sampling plan. Inspections are done once every 2 hours, once every 4 hours, or once a shift, depending on the process stability of the product. When doing process control program, the frequency of inspection, sampling frequency, inspection methods have a clear definition.


8. the process of quality record keeping


For each process input/output of some key process parameters, there must be a detailed quality record to save down to ensure that the client or the process to find anomalies, there is sufficient proof of quality records to show that your products comply with Spec, the process is under control. When quality disputes or customer complaints, process quality records as strong evidence to prove that your process control is controlled, abnormal problems are special, not batch problems, production control is in line with quality requirements.


9, the monitoring and improvement of the pass rate


To have data to record the production process of each process pass rate is how much, according to the company's continuous improvement or process yield target to control the process yield. For the projects that do not meet the standard and the defective rate is too high, we should collect data and analyze them with Plato to make continuous improvement. Plato is the principle of two-eight. According to statistical quality analysis, often 20% of the project caused 80% of the bad, then the other way around, we use Plato to analyze, often 80% of the bad is caused by the first two or three, then we will put our energy and resources on the first two or three of the 80% of the bad, with a focus on the improvement. The benefit of Plato is that the process of bad, process analysis will not be generalized, but targeted, which is the application of Plato.


10. Cycle time and UPH monitoring and improvement


What are the benefits of these two, when the Cycle time to do analysis to do to improve the time then your lead time, WIP operation or WIP inventory will be reduced, you can shorten your lead time, shorten the production cycle of the product, you can quickly respond to the customer's delivery. UPH improvement lies in the production capacity of the equipment you will do to improve and improve.


11. preventive maintenance of machinery and equipment


Machinery and equipment bought back, equipment management personnel should be based on the operating instructions for equipment to develop a detailed maintenance program, the development of equipment inspection and maintenance instructions. To clearly list the maintenance methods, maintenance frequency, spare parts replacement cycle, preventive maintenance of equipment to ensure that the equipment is in a good state of operation. Maintenance of equipment is similar to car maintenance, production equipment to do preventive maintenance, can not wait until the bad to repair, otherwise the life of the equipment and the use of spare parts is a great loss.


Product Quality Management (OQC)

           Finished product quality management is a very important point is the sampling plan, according to different quality requirements, the sampling schedule needs to draw up different sampling plan, sampling frequency, the number of samples. When the sampling program to determine a good, measurement system, MSA (inspection and testing equipment capacity), GR&R to do the assessment, if the instrumentation or measurement system does not meet the requirements need to make improvements. Next is the training and assessment of inspectors, inspectors should be trained and qualified before going on duty, on the inspection standards and requirements if you do not grasp the measurement equipment misuse will affect the impartiality of the product inspection. If when the finished product inspection found to be unqualified, Reaction Plan to have, when the discovery of defective products, through the Material Review Board (MRB) timely processing, either downgraded to accept, either rework or scrap, to have a clear plan of action to deal with timely.

Product's ORT reliability test management

ORT test is very important, the product performance sampling test, such as high temperature, high humidity, impact and other test items, according to different industries and different industry requirements to develop different ORT test items, after some extreme testing and simulation of extreme conditions in the use of the customer, to ensure that the product meets the requirements of any defects can be found in a timely manner to make some improvements.


ORT management is also very important, your sampling plan, the number of tests, frequency, test items, measurement system, tester training and assessment, ORT bad Reaction Plan, testers found bad timely report to the supervisor, do timely assessment, do bad analysis, do improvement measures.

How to improve quality awareness

Quality is divided into product quality, work quality and service quality

Product quality: that is, the degree of product quality, that is, the performance and characteristics of the product to meet the user's requirements. So how to measure the quality of products? We are looking at the product to meet the needs of users have the characteristics of the requirements for different users have different requirements, so the product has different characteristics and requirements. Product characteristics to achieve the purpose of use must have, that is, the characteristics of the product, used to measure the quality of the product. Product quality is the degree of satisfaction of the product to the standard or to the specification.

Work quality: work quality is the enterprise in order to achieve product quality standards, the level of management and organization of the degree of perfection, that is, the degree of work. To ensure the quality of their work, each employee must do their job well, every product quality, in accordance with the standard operating instructions to complete each process, found that the problem of timely reporting, shall not take the initiative or ignore.


QUALITY ASSURANCE


Quality is manufactured, not tested; therefore, the quality of work determines the degree of quality of products, each employee must realize that the defective and substandard products are manufactured in the production process, not tested. Not QA or IPQC to check the product is bad, but in the production process to create a bad product. Good or bad product quality and the production process of each and every one of them are closely related. Employee quality requirements are familiar with the inspection standards, attributes of the operating standard SOP requirements, establish the “quality is produced, not tested” idea, strict compliance with the quality assurance of the three do not policy and the principle of three do not let go.

Three no policy:

1. Do not accept defective products - self-inspection, re-inspection.

2. Do not manufacture defective products - self-inspection.

3. Not to flow out defective products - self-inspection and re-inspection.

Three don't spare principle:

1. The cause of the incident is not clearly analyzed.

2. The person responsible for the incident and the group who have not been educated will not be spared.

3. No preventive measures will be taken for the incident.

Service quality: It is the combination of product quality and work quality. In today's society, every industry provides the best service for customers. Customer service departments to do a good job before the sale of products, sales, after-sales service, to provide customer satisfaction services, so that customers can consume happy. Products can not be 100%, when product quality problems occur, then the attitude of service personnel and the quality of service will determine the customer's evaluation of the company, will affect the company's reputation, so the quality of service is very important.

Quality consciousness: to ensure that our products are qualified, the product meets the specifications, the production process control in accordance with the standard operating instructions to perform. Employees are not only passive acceptance, but also constantly put forward ideas for improvement, all staff to form the concept of continuous improvement, to promote quality improvement. Cooperation between departments and division of labor. Quality awareness is an enterprise's knowledge and understanding of quality and quality work from top management to middle management to front-line employees. Quality awareness is embodied in the work of each employee's position, but also in the work of the highest decision-making level of the enterprise. Quality awareness has been improved, can consciously to ensure that the enterprise produced by the delivery of customer demand for product quality, quality of work and quality of service to improve the awareness of the enterprise to quality of survival and development.

Quality consciousness is established through the improvement of enterprise management level, quality education and quality responsibility training to establish, through the top and grass-roots management staff training to influence the formation of staff. As the company's top management through the quality incentive mechanism, affecting all employees self-regulation, and gradually into; as the person in charge of the quality department, to influence the quality concept of the senior management and even the boss; as the middle management, quality managers, quality engineers in charge of the daily work through the work of the middle management or other departments related to the impact of the supervisor, to instill quality awareness; as the IPQC, quality management personnel Through the daily work of the front-line staff to influence, instill quality awareness of the front-line staff. Quality awareness of all employees to improve product quality will improve, the quality of work will improve, the quality of service will improve.

Quality management is very systematic and complex, and all people need to be involved in quality management in order to really improve quality.

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