1. Quality Policy
The quality policy is the top - level declaration of an organization's quality strategy. It is formulated and officially promulgated under the leadership of the top management (such as the enterprise leader or CEO), and is a core part of the enterprise's overall business policy. It is not an abstract slogan but needs to be anchored to the organization's long - term goals and customer needs. For example, if the enterprise's general policy is to "become a globally leading medical device supplier", the quality policy should correspondingly be to "provide safe and reliable medical devices to meet the core needs of clinical users for product quality and patient safety". In essence, it provides a unified quality action plan for all employees. From "defect prevention" in R & D and design to "process control" in production and manufacturing, from "quality control of raw materials" in procurement to "problem response" in after - sales service, all quality decisions in every link need to be guided by the quality policy to ensure that the organization's quality behavior is consistent with its strategic direction.
2. Quality management
Quality management is a closed-loop management system that covers the entire process of an organization and involves all employees. The core logic is "define quality objectives → implement quality activities → verify quality results → continuously improve quality". It is not the responsibility of a single department:
- The Design Department needs to use DFMEA (Design Failure Mode and Effects Analysis) to prevent defects at the source.
- The purchasing department shall ensure the quality of raw materials through the "List of Qualified Suppliers".
- The production department needs to use SPC (Statistical Process Control) to monitor process fluctuations.
- The sales department needs to collect customer quality feedback - everyone is a quality manager.
The role of top management is the "promoter of quality strategy": They need to allocate resources (budget, personnel, technology) for quality management and regularly review the achievement of quality objectives (such as holding quality meetings monthly), rather than shifting the responsibility to the quality department. Meanwhile, quality management needs to balance "quality level" and "economic benefits". For example, aerospace parts require "zero defects" (because the cost of failure is life or huge losses), while disposable tableware only needs to be "safe and hygienic" (because customers do not need higher quality and high costs are meaningless). The feasibility of quality improvement needs to be judged through "input-output analysis" (for example, spending 1 million on equipment improvement can reduce the loss of defective products by 2 million annually).
3. Quality planning
Quality planning is the starting point of quality management. Its core is "transforming abstract quality requirements into executable specific plans" and focuses on "determining quality objectives and implementation paths". Its content is divided into three major modules:
Product planning: Identify the "key quality characteristics" of the product (e.g., "battery life ≥ 12 hours" and "screen does not break when dropped from 1 meter" for mobile phones), and classify them (key characteristics need to be strictly controlled, while secondary characteristics can be moderately relaxed). At the same time, clarify the quantitative goals and constraints (e.g., "battery capacity ≥ 5000mAh, cost ≤ 200 yuan").
Management and operation planning: Prepare resources and processes for the implementation of the quality system—for example, establish a cross - departmental quality team (R & D, production, quality) and formulate a schedule (complete the design review in the 1st - 2nd months and conduct trial production of prototypes in the 3rd - 4th months).
Quality plan and improvement prediction: Output the "Quality Plan" (specify the goals for each stage, responsible departments, and verification methods - for example, "The qualified rate of parts in the prototype trial - production stage should be ≥95%, which is the responsibility of the R & D department and verified by coordinate measuring machine"), and reserve room for improvement (for example, consider "The battery life of the mobile phone can be improved through software optimization in the future") during the planning process.
4. Quality control
Quality control is the "firewall" in the process, and its core is to "ensure process control and eliminate quality defects through operational techniques and activities". It is not "post - event inspection" but "pre - event prevention + in - process intervention":
Process monitoring: Use tools such as SPC and visual management boards to monitor key parameters (e.g., injection molding machine temperature, welding current). When the data exceeds the control limits (e.g., the injection molding temperature rises to 210°C), make immediate adjustments to avoid producing defective products in batches.
Cause elimination: Analyze the root cause of defective products using 5W1H (Why/What/When/Where/Who/How) — for example, the high defective rate is due to new employees not operating according to the operating instructions, and the solution is "training + installation of an automatic controller".
Economic benefits: By controlling process fluctuations, reduce the losses caused by defective products. For example, the defective product rate has decreased from 1% to 0.1%, saving 500,000 yuan in defective product handling costs annually.
Quality control is closely related to quality assurance: The SPC data and operation records generated during the control process are the key evidence for quality assurance to "prove that the process is under control" (for example, when being audited by customers, presenting the SPC chart can prove that "the production process is stable").
5. Quality Assurance
Quality assurance is a "trust transfer tool". Its core is to enable internal and external stakeholders to believe that the organization can meet quality requirements through "planned and systematic activities". It is divided into two types of scenarios:
Internal quality assurance: Prove to managers that the quality system is effective — for example, through internal audits (checking whether each department operates in accordance with the system documents) and management reviews (reviewing the achievement of quality objectives), to make the enterprise's person - in - charge convinced that our quality system is okay.
External quality assurance: Prove to customers or third parties that "the products meet the requirements" — for example, through ISO 9001 certification and on-site customer audits (presenting test reports, SPC data, and internal audit records) to make customers believe that "our product quality is reliable".
It should be noted that the effectiveness of quality assurance depends on "the consistency between quality requirements and user needs". If the quality requirement is set as "the mobile phone battery life is ≥ 10 hours" while the customer needs "≥ 12 hours", the customer will not trust even if numerous assurance activities are carried out.