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Jason@cleanroomequips.com
1. Purpose
Ensure that unqualified raw materials, semi-finished products and finished products covered by the company's quality system are isolated to prevent unqualified products from being misused or leaving the factory
2. Scope of application
Applicable to the control of unqualified products in the entire process covered by the company's quality system.
3. Responsibilities
3.1 The Quality Department is responsible for determining unqualified products and making graded determinations.
3.2 The Quality Department is responsible for organizing the review of unqualified products.
3.3 The relevant departments are responsible for isolating the unqualified products within their scope, and handling and recording them according to the reviewed disposal plan
4. Workflow
4.1 Determination of unqualified products
4.1.1 Determination of unqualified raw and auxiliary materials: The quality inspector shall determine the unqualified raw and auxiliary materials according to the relevant raw and auxiliary material inspection results conducted in the "Incoming Inspection and Test Control Procedure",
4.1.2 Determination of unqualified semi-finished products: The workshop inspector shall determine the unqualified semi-finished products according to the relevant semi-finished product inspection results conducted in the "Process Inspection and Test Control Procedure".
4.1.3 Determination of finished product nonconforming products: The final inspector shall determine the finished product nonconforming products according to the relevant finished product inspection results in the "Final Inspection and Test Control Procedure"
4.2 Classification of nonconforming products:
Nonconforming products can be divided into three levels according to the defect procedures of the nonconforming items.
4.2.1 Level 1 nonconforming products
Refers to nonconforming products with general characteristics exceeding the tolerance, limited to the following scope:
(1) General characteristics exceeding the tolerance that do not affect product performance;
(2) Non-batch general characteristics exceeding the tolerance.
4.2.2 Level 2 nonconforming products
Refers to nonconforming products with important characteristics exceeding the tolerance, limited to the following scope:
(1) Important characteristics exceeding the tolerance related to product performance;
(2) General characteristics exceeding the tolerance of batch,
4.2.3 Level 3 nonconforming products
Refers to nonconforming products with key characteristics exceeding the tolerance, limited to the following scope:
(1) Key characteristics exceeding the tolerance related to product performance;
(2) Important characteristics exceeding the tolerance of batch.
4.3 After the non-conforming products are confirmed,
the Quality Department is responsible for marking and keeping records. The marking method shall be carried out in accordance with the "Inspection and Test Status Control Procedure"
4.4 Isolation of non-conforming products
Once the non-conforming products are detected and confirmed, they should be isolated immediately. Different types of non-conforming products should be stored in separate areas by the relevant departments
4.5 Review of non-conforming products
4.5.1 Level 1 review: Review by the shift leader and on-site inspector
A. Level 1 non-conforming products
B. Obviously scrapped products
4.5.2 Level 2 review: Review by the head of the quality department and leaders of relevant departments:
A. M-level non-conforming products
B. Disputed level 1 non-conforming products
4.5.3 Level 3 review: Review organized by the Quality Management Committee
A. Level 3 non-conforming products
B. Disputed level 2 non-conforming products
4.6 Disposal of non-conforming products
4.6.1 Handling of non-conforming raw and auxiliary materials (1) For level 1 non-conforming raw and auxiliary materials that have not been put into storage, the quality department shall propose disposal opinions, which shall be approved by the general manager and pointed out by the finance department to the subcontractor to avoid the occurrence of the same problem in the next supply.
(2) Level 2 and 3 non-conforming raw and auxiliary materials that have not been put into storage shall be returned or put away.
(3) For the first-level unqualified raw and auxiliary materials that have been put into storage, if they have not completely lost their usability, they can be resold and used for other purposes.
(4) For the M-level and third-level unqualified raw and auxiliary materials that have been put into storage, if they have completely lost their usability, they should be scrapped. The scraps should be stacked and processed in the designated area as required, and records should be kept.
4.6.2 Disposal of unqualified semi-finished products
(1) Rework: All unqualified products that can be reworked should be reworked. After rework, they can be passed to the next process after inspection. Unqualified products are considered defective or waste.
(2) Defective products: The first-level and second-level unqualified semi-finished products that cannot be reworked shall be submitted to the quality department for review by the production department and approved by the general manager before they can be passed to the next process. However, the finished products produced can only be treated as defective products, stored in isolation and marked. Defective products are generally used within the enterprise.
(3) Waste products: The third-level unqualified semi-finished products are treated as waste if they have no rework value. Scrap products should be stacked and handled in designated areas as required, and records should be kept.
4.6.3 Disposal of unqualified finished products
(1) Defective products: Level 1 and 2 unqualified finished products are defective products, which are limited to internal use and strictly prohibited from export.
(2) Scrap products: Level 3 unqualified finished products are considered scrap products, which are destroyed and recorded.
4.7 Handling of job responsibilities
4.7.1 When the product is handed over, the delivery unit is responsible for any problems found during inspection, the receiving unit is responsible for any appearance defects found after receipt, and the inspector is responsible for any missed inspections.
4.7.2 If errors or omissions in process and technical documents result in unqualified products, the document preparer shall bear direct responsibility, and the reviewer and approver shall bear leadership responsibility.
4.7.3 The responsible department shall be responsible for quality accidents caused by poor internal management.
4.7.4 If unqualified products are transferred to the next process without inspection or are not handed over for inspection, the operator and the supervisor shall be responsible. If problems occur during production and are not reported or handled, the inspector and the operator shall be jointly responsible
