QUALITY ASSURANCE & COMPLIANCE

Inspection and Release Management Regulations

Standardizing our inspection activities across the entire product lifecycle to ensure all delivered laboratory equipment meets established technical standards and international industry regulations.

1. Purpose

1.1 Ensure Product Quality Conformity
Standardize the company's inspection activities throughout the entire lifecycle, from material receipt and manufacturing to finished product delivery, ensuring that all products put into use and delivered meet established technical standards, customer requirements, and national/industry regulations.
1.2 Clarify Quality Inspection & Release Responsibilities
Clarify the quality judgment and release authority of different positions such as shift leaders, inspectors, and inspection supervisors, preventing unauthorized and blind releases, and ensuring the independence and seriousness of quality control.
1.3 Prevent Circulation of Non-conforming Products
Establish a rapid-response mechanism for the detection and circulation of non-conforming products, strengthening quality defenses at each process stage to prevent non-conforming raw materials from being used in production, non-conforming work-in-process from circulating to the next process, and non-conforming finished products from being delivered to customers.
1.4 Improve Quality Traceability System
Standardize the completion and retention of inspection records, providing accurate and complete written traceability information for product quality analysis, customer complaint handling, and quality system audits.

2. Scope of Application

2.1 Applicable Materials and Products

  • I. Incoming Materials: All purchased raw materials, outsourced processed parts, hardware components, electronic core components, core consumables, and packaging materials.
  • II. Process Materials: Work-in-process, machined semi-finished products, and modular components at each production stage.
  • III. Finished Products: All instruments and equipment that have completed final assembly, calibration, and packaging.

2.2 Applicable Business Links & Processes

  • Applicable to the entire inspection chain, including IQC (Incoming), IPQC (In-Process), and FQC/OQC (Final/Outgoing).
  • Applicable to normal release of qualified products, special acceptance/concession release under abnormal conditions, and the isolation/handling of non-conforming products.

2.3 Applicable Personnel

  • Applicable to all inspection personnel in the Quality Department (including supervisors at all levels).
  • On-site management and operational personnel in the Production Department.
  • Relevant personnel in the Purchasing and Warehousing Departments.

3. Inspection Release Regulations

  • 3.1

    Products that pass inspection according to the inspection standards can only be released after the shift leader (or authorized inspector) signs the inspection record.

  • 3.2

    When inspected products are abnormal or do not meet the inspection standards, but the deviation is minor and does not affect safety or core performance, the inspection supervisor (or quality manager) must make final confirmation and sign the special acceptance/concession acceptance opinion before release.

  • 3.3

    Products confirmed as non-conforming shall be strictly handled in accordance with the "Non-conforming Product Control Procedure," including isolation, labeling, and circulation.

4. Inspection Non-conforming Handling Regulations

4.1 Incoming Material Inspection Non-conforming:

The inspector fills out a "Quality Defect Notification Form (Raw Materials - Incoming Materials)", which, after confirmation by the inspection supervisor, is circulated to the purchasing department, and subsequent return, replacement, or corrective measures are implemented in accordance with the "Non-conforming Product Control Procedure".

4.2 In-process & Final Product Inspection Failures:

The inspector fills out a "Quality Defect Notification Form (Finished Product)", which, after confirmation by the inspection supervisor, is forwarded to the production department and processed according to the "Non-conforming Product Control Procedure" for subsequent rework, repair, or scrapping.

5. Inspection Record Regulations

5.1 All inspection records (including electronic records and paper forms) must be authentic, complete, legible, and traceable.

5.2 The storage, archiving, borrowing, and destruction of inspection records shall be strictly managed in accordance with the "Documentary Information Control Procedure".

5.3 Retention Periods:

  • Routine inspection records, patrol inspection records, and incoming material inspection reports shall be retained for at least 3 years.
  • Records involving core components and final product inspection and release shall be retained for at least 5 years (or extended according to industry and customer-specific agreements).
labcarta Technology Co., Ltd.Ilabcarta Technology Co., Ltd.

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