share | What exactly should the quality management department do? What to do?

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The unclear responsibilities of the quality management department not only affects work efficiency, but misplaced responsibilities can also easily lead to instability. This article attempts to answer these questions seriously, and is not responsible for the actual results. Part 1 Management points, responsibilities and position settings of the quality management department 1. Internal management points of the quality management organization: There should be documented quality control organization and affiliations ； Personnel within quality control must have a clear division of responsibilities (job description) ； Documented quality control authority - such as raw material, semi-finished product, finished product release rights, etc. ； Have training plans and training execution records ； There is an internal reward and punishment system, which is linked to salary ； It is necessary to collect and analyze product quality data and link it with the performance of departments and responsible persons. 2. General responsibilities of the quality management department: Incoming material inspection - raw materials, auxiliary materials, packaging materials, etc. ； Process monitoring - people, machines, materials, methods, environment ； Finished product inspection - personnel, timing, basis, authority ； Calibration and management of surveillance measuring devices ； Quality Assurance Capability - Establishment and Promotion of Quality System ； Quality plan - product standards, work instructions, process documents, records ； Management of customer complaint-related processes - cause analysis, corrective measures, and procedures ； Sample management. 3. The main position of the quality management department is the raw material/auxiliary material/packaging material acceptance officer (raw material specialist) ； Quality Controller - process monitoring and supervision, handling and tracking of customer complaints ； Quality inspector - sensory inspection of semi-finished products and finished products, sampling of testing samples ； Laboratory Technician-Laboratory Testing ； Shipping and loading supervisor ； System promotion and assessment ； Standardization administrator - reception and processing of official documents, drafting and filing of enterprise standards, drafting and revision of third-level documents of the department, and management of measuring instruments. 4. What is the setup and division of labor of the quality department? Quality inspection work: Process (production process) quality inspection (IPQC), incoming quality inspection (IQC), assembly quality inspection, outgoing quality inspection (OQC) ； Quality System (QS), Quality Engineering (QE), Quality Assurance (QA), Supplier Quality Management (SQA). 5. Main assessment items and indicators of the quality department’s work: (1) Main projects: Whether the quality management and quality inspection systems are complete ； Whether product quality inspection and production process control are complete and effective ； Whether measurement and inspection equipment is regularly calibrated and quality standards are implemented ； Implementation of quality inspection system for key production processes ； Whether the quality inspection of raw materials, purchased parts and finished products is in place and whether there are records ； Whether the quality management system operates comprehensively and effectively. (2) Main indicators: Product quality qualification rate ； Manufacturing defective rate ； Monitoring and measuring instrument calibration rates ； Product inspection status marking rate ； Quality plan indicator completion rate ； Completion rate of management review and corrective measures ； Sampling defective rate ； effectiveness of corrective actions ； Raw material consumption reduction rate ； Quality cost indicator completion rate. 6. Standards that the quality department should meet: Quality management requirements run through all activities of enterprise management, and quality inspection runs through the entire process of product production and operation to ensure that product status labels are easy to identify and traceable. ； Establish standardized methods for the identification, identification, recording, review and disposal of non-conforming products ； Develop effective preventive measures to eliminate potential causes of nonconformity and prevent the occurrence of nonconformity ； Develop effective corrective action standards to eliminate the causes of nonconformities and customer dissatisfaction ； Establish and implement procurement inspection standards to ensure that purchased products meet specified quality requirements ； Quality records are complete and standardized, internal audits and management reviews are carried out as planned, and management objectives are achieved in good condition. Part 2 Specific contents of various tasks of the quality management department 1. Incoming material management: Have clear inspection standards ； The acceptance process should be clear ； Sampling methods need to be correct ； On-site assessments of suppliers should be carried out regularly ； Regularly collect statistics on the quality of raw materials supplied by suppliers ； If the supplier's product quality is abnormal, the supplier should be promptly communicated with it. ； There should be clear supplier assessment methods ； Suppliers should have corresponding handling measures if quality problems occur continuously. ； Supplier product quality must be tracked promptly after improvements are made ； Clearly stipulate the liability for losses caused by the supplier's raw material quality problems, and make it clear in the corresponding contract ； The personnel of the incoming material inspection team should have the necessary professional knowledge and professional qualities ； Incoming material inspection reports must be clear and properly preserved ； When the raw materials have minor quality problems and are urgently needed in the production workshop, there should be clear special procurement procedures and specify the special procurement approver. ； Emergency release should have clear procedures and specify the emergency release approver ； Unqualified raw materials must have clear disposal methods ； It is stipulated that products returned to supply should be returned promptly. 2. Process management—properly staffing process inspection and monitoring personnel ； The ability and quality of process inspection and monitoring personnel should meet the requirements ； The intensity of process inspection and monitoring must meet the needs of enterprises to prevent defective products. ； There must be clear measures to deal with non-conforming products in the process. ； When a product fails, information must be transmitted promptly ； It is necessary to identify who will analyze the causes of defective products. ； The statistical techniques used in the process should meet the needs of the business ； Process inspection and monitoring personnel must have good communication channels with each workshop, and form the concept that product quality is manufactured, not inspected. ； Special requirements for product orders must be communicated to process monitoring personnel in a timely manner. 3. Process management - documents and standards have accurate, appropriate and sufficient work instructions ； Have accurate, appropriate and adequate process inspection standards ； Have clear process inspection procedures and quality control points ； There are process inspection records/supervision and monitoring records that are real and feasible ； Procedures for documented process exception handling ； The right to release semi-finished products should be clearly defined ； There are documented process inspection status standards and distinctions, and they are effectively implemented ； There are related quality issues and statistical analysis. 4. Finished product management must have clear finished product inspection standards ； The ability and quality of finished product inspection (including laboratory technicians) personnel must meet corresponding requirements. ； The sampling method for finished product inspection must be reasonable ； The special requirements of each customer/order are accurately communicated to the relevant personnel ； There is a document stipulating the marking method of finished products and it is effectively implemented ； There are effective ways to prevent missed inspections of finished products ； There are documented procedures for handling product exceptions, such as handling methods and approval authority. ； Who approves the finished product inspection results? ； Whether the finished product can be specially released? If so, to what extent can it be specially released? The approval authority must be clearly defined. ； The finished product inspection report must be clear and properly preserved. The finished product inspection report can be traced back to the corresponding production group, batch number, date and important raw materials, etc. ； There must be delivery and installation supervision records and the records must be complete ； It is necessary to form a regular reporting system for long-term backlog of inventory ； Products with overstocked inventory must be re-inspected and confirmed before leaving the factory. 5. Monitoring and measuring device management, measurement/testing equipment, should form unified management of ledgers, and ledgers should be dynamically managed and updated regularly. ； Each quality inspection process must clearly specify the name of the instrument used ； The accuracy of measurement/detection equipment must meet the measurement requirements ； Measuring/testing equipment must be calibrated regularly as required (external/internal) ； The usage status of measuring equipment should be clearly marked ； The environment used by the measuring equipment must meet the environmental conditions required by the equipment itself. ； For complex measuring equipment, operating instructions should be formed to guide employees on how to operate them. ； Testing equipment must be maintained regularly and documented. 6. Quality Assurance - System promotion and assessment to establish a complete quality management system (from design to trial production to production to testing to shipment to service) ； The overall management structure must be complete and management functions at all levels must be clear ； Quality objectives are defined in a documented form and are understood by employees, broken down into various departments and implemented. ； All relevant units must control the collection, distribution, and borrowing of quality records. ； The status of each product during the production process is marked and traceable ； Customer complaints are handled in a timely manner and customer satisfaction surveys are conducted regularly ； Conduct regular assessments and improvements on system operation. 7. Quality Assurance - Quality Plan There is a complete quality plan before production (operation instructions/processing techniques/quality records/sanitary assurance measures/determination of quality control points), especially whether there are any special regulations for special products. ； Customer requirements are well known to relevant quality management personnel ； All relevant personnel have received on-the-job training and must pass the exam before they can take up the job, and have corresponding records. ； Analyze and identify possible anomalies and take preventive measures ； Carry out 5S, QC and other activities that help improve quality ； If product changes are involved, written confirmation must be countersigned, and the corresponding quality must be re-inspected and confirmed with corresponding records. ； Each stage of quality control ensures that no missed inspections occur, and is supported by corresponding methods or procedures. 8. Quality assurance - systems, documents and other internal systems must have clear reward and punishment systems ； The job responsibilities of each employee should be clearly defined ； Reasonable and clear provisions should be made for various work processes ； This department has access to the latest versions of technical documents ； The storage of files is safe and reliable, easy to index and use, and prevents misuse of files ； Employees are provided with appropriate training to ensure that they are qualified for their jobs ； The company's superior documents and ideas are communicated to the downstream in a timely manner ； Established good communication with other departments. 9. Customer complaints. Every customer complaint must be responded to as quickly as possible and try to satisfy the customer. ； The process for handling customer complaints and who will handle them must be clearly defined ； The content of the customer complaint reply must be appropriate, and there must be a document that clearly stipulates the approver ； Each customer complaint must be analyzed accordingly, necessary corrective and preventive measures formulated, and standardized ； Regular statistics and analysis of customer complaints should be carried out ； Complaints about timeliness of delivery and other aspects should also be counted and managed. 10. Physical samples (or pictures) When it is inconvenient or unclear to express in words, a physical sample should be sealed or taken as a reference. ； Whether physical samples (pictures) are divided into qualified limit samples and unqualified limit samples so that employees can clearly judge the criteria ； Are physical samples (pictures) regularly confirmed and updated? ； There are physical samples (pictures) for easy reference wherever needed in each process of incoming materials, manufacturing process, and finished product. ； Store physical samples (pictures) properly to prevent them from deteriorating. - End -