The organization shall maintain a documented procedure for the identification of inspection and test status throughout product realization that indicates product conformity or nonconformity.
This section ensures that products are identified with their inspection and test status throughout the production process to prevent the use of non-conforming products.
Key Requirements:
- Identification of Inspection/Test Status:
- Products must be clearly identified with their inspection and test status.
- The identification should provide information on the status of inspections and tests performed at various stages of production.
- Control of Non-Conforming Product:
- Proper controls must be in place to identify and segregate non-conforming products.
- These controls ensure that non-conforming products are not used or delivered until they are reworked and conform to the specified requirements or are properly dispositioned.
- Traceability:
- There must be a system to trace the inspection and test status of products through all stages of production.
- This traceability ensures that only products that have passed the required inspections and tests are used in subsequent processes or delivered to customers.
- Record Maintenance:
- Records of inspections and tests must be maintained to provide evidence of conformity to specified requirements.
- These records should be readily available for review to verify the status of the product.
- Communication:
- The inspection and test status must be communicated to relevant personnel involved in the production process to ensure awareness and compliance with quality requirements.
- This communication helps in preventing inadvertent use of products that have not been approved for use.
Implementation Tips:
- Labeling and Marking: Use clear labels or markings on products to indicate their inspection and test status. This can include color codes, tags, or stamps.
- Documentation: Maintain thorough records of all inspections and tests, including dates, results, and responsible personnel.
- Segregation of Non-Conforming Products: Establish designated areas for holding non-conforming products to prevent their accidental use.
- Training: Ensure that all personnel involved in the production process are trained on the importance of inspection/test status and how to identify and handle products accordingly.
- Regular Audits: Conduct regular audits to verify compliance with the inspection/test status requirements and to identify areas for improvement.
Identification of inspection and test status throughout product realization that indicates product conformity or nonconformity
To conduct the identification of inspection and test status throughout product realization, an organization must implement a comprehensive system that clearly indicates whether products conform to specified requirements or are non-conforming. This system involves multiple steps and practices to ensure accurate identification and effective communication of the inspection and test status. Here’s how an organization can achieve this:
1. Develop a Comprehensive Identification System
- Labeling and Marking: Use clear and consistent labeling methods such as tags, stickers, barcodes, or color codes to indicate the inspection and test status of each product. Labels should include relevant information such as the inspection date, inspector’s initials, and status (e.g., passed, failed, pending).
2. Implement Inspection and Testing Procedures
- Inspection Points: Identify key points in the production process where inspections and tests are required. Document these points in the Inspection and Test Plan (ITP).
- Standardized Procedures: Use standardized procedures and checklists for conducting inspections and tests to ensure consistency and reliability.
3. Recording and Documentation
- Inspection Records: Maintain detailed records of all inspections and tests, including the results, date, and personnel involved. These records should be easily traceable to specific products or batches.
- Electronic Records: Utilize an electronic database or quality management system (QMS) to store and manage inspection and test records. This facilitates easy access, traceability, and data analysis.
4. Identification Methods
- Physical Tags and Labels: Attach physical tags or labels to products at each stage of inspection and testing. These should clearly indicate the current status (e.g., inspected and passed, inspected and failed, pending inspection).
- Color Coding: Use color-coded tags or labels to quickly convey the status of a product. For example, green for passed, red for failed, and yellow for pending.
- Barcodes and RFID: Implement barcodes or RFID tags that can be scanned to provide real-time information about the product’s inspection and test status.
5. Communication and Training
- Training Programs: Train employees on the importance of inspection and test status identification, how to use the labeling system, and the procedures for recording and reporting results.
- Clear Instructions: Provide clear instructions and guidelines on how to mark and identify products based on their inspection and test status.
6. Control of Non-Conforming Products
- Segregation: Establish designated areas for holding non-conforming products to prevent their use. These areas should be clearly marked and access should be controlled.
- Non-Conformance Reports: Generate non-conformance reports (NCRs) for any product that fails an inspection or test. Document the nature of the non-conformance, corrective actions taken, and final disposition of the product.
7. Final Review and Approval
- Final Inspection: Conduct a final inspection and test before products are approved for shipment. Ensure that all previous inspections and tests have been completed and documented.
- Release Authorization: Implement a release authorization process where responsible personnel sign off on products that meet all inspection and test criteria before they are released.
8. Continuous Monitoring and Improvement
- Regular Audits: Conduct regular audits of the inspection and test status identification system to ensure compliance and identify areas for improvement.
- Feedback Loop: Establish a feedback loop where inspection and test results are reviewed to identify trends and implement corrective actions to prevent recurrence of issues.
Example Workflow
- Receiving Inspection: Upon receiving raw materials, inspect and label them with their status (e.g., “Inspected and Accepted” or “Inspected and Rejected”).
- In-Process Inspection: At key production stages, conduct inspections and update the status labels accordingly (e.g., “In-Process Inspection Passed” or “In-Process Inspection Failed”).
- Final Inspection: Perform a comprehensive final inspection. Products that pass receive a “Final Inspection Passed” label, while those that fail are labeled “Final Inspection Failed” and moved to the non-conforming product area.
- Product Release: Only products with a “Final Inspection Passed” label and proper documentation are authorized for release and shipment.
By following these steps, an organization can effectively manage the identification of inspection and test status throughout the product realization process, ensuring product conformity and addressing non-conformity in a systematic and controlled manner.
Examples of Procedure for the Identification of Inspection and Test Status Throughout Product Realization
Objective: To ensure clear identification and communication of inspection and test status throughout the product realization process, indicating product conformity or nonconformity.
Scope: This procedure applies to all products and materials undergoing inspection and testing within the organization, from receipt of raw materials to final product release.
1. Introduction: This procedure outlines the steps for identifying the inspection and test status of products to ensure that only conforming products proceed through production and are delivered to customers.
2. Responsibilities
- Quality Control (QC) Inspectors: Conduct inspections and tests, label products with status indicators, and document results.
- Production Personnel: Ensure products are correctly labeled and segregated according to their status.
- Quality Assurance (QA) Manager: Oversee the procedure’s implementation and ensure compliance through regular audits.
3. Procedure Steps
3.1 Receiving Inspection
- Inspection of Raw Materials: Upon receipt, QC Inspectors perform an initial inspection of raw materials against the specifications.
- Status Labeling:
- Accepted Materials: Attach a green label marked “Accepted” with the date, inspector’s initials, and any relevant inspection details.
- Rejected Materials: Attach a red label marked “Rejected” with the date, inspector’s initials, and reason for rejection.
- Documentation: Record inspection results in the Receiving Inspection Log and update the electronic database.
3.2 In-Process Inspection
- Inspection at Designated Points: QC Inspectors conduct inspections at critical control points as outlined in the Inspection and Test Plan (ITP).
- Status Labeling:
- Passed Inspection: Attach a yellow label marked “In-Process Passed” with the date, inspector’s initials, and inspection details.
- Failed Inspection: Attach an orange label marked “In-Process Failed” with the date, inspector’s initials, and reason for failure.
- Documentation: Record results in the In-Process Inspection Log and update the electronic database.
3.3 Final Inspection
- Comprehensive Final Inspection: QC Inspectors perform a thorough final inspection and testing of the completed product.
- Status Labeling:
- Passed Inspection: Attach a blue label marked “Final Inspection Passed” with the date, inspector’s initials, and relevant details.
- Failed Inspection: Attach a red label marked “Final Inspection Failed” with the date, inspector’s initials, and reason for failure.
- Documentation: Record results in the Final Inspection Log and update the electronic database.
3.4 Handling Non-Conforming Products
- Segregation: Move non-conforming products to a designated “Non-Conforming Product” area, clearly marked and segregated from conforming products.
- Status Labeling: Ensure red “Rejected” labels are prominently displayed on non-conforming products.
- Non-Conformance Report (NCR): Generate an NCR for each non-conforming product, documenting the nature of the non-conformance, corrective actions, and final disposition.
3.5 Product Release
- Authorization for Shipment: Only products with a blue “Final Inspection Passed” label and complete documentation are authorized for shipment.
- Release Approval: Obtain final approval from the QA Manager, who reviews inspection records and status labels before signing off on the release.
- Documentation: Update the Product Release Log with the date of shipment, product details, and release approval signature.
4. Record Keeping and Documentation
- Inspection Logs: Maintain detailed logs for Receiving, In-Process, and Final Inspections, including dates, results, and inspector details.
- Electronic Database: Use an electronic quality management system to store and manage all inspection and test records for traceability and analysis.
- Non-Conformance Reports: File NCRs for all non-conforming products and ensure corrective actions are documented and implemented.
5. Training and Communication
- Employee Training: Provide training for all relevant personnel on this procedure, including the use of labels, documentation requirements, and handling non-conforming products.
- Visual Aids: Use visual aids like posters and status boards in the production area to reinforce the identification system.
6. Audits and Continuous Improvement
- Regular Audits: Conduct regular audits to ensure compliance with this procedure and identify areas for improvement.
- Feedback Loop: Review inspection and test data periodically to identify trends, address recurring issues, and update procedures as necessary.
7. Conclusion
By following this procedure, the organization ensures that the inspection and test status of all products is clearly identified and communicated, maintaining high quality standards and preventing the use of non-conforming products.
Example of Inspection Status Record
Product Information
- Product Name: High-Pressure Valve
- Product ID/Serial Number: HPV12345
- Batch/Lot Number: 2024-HPV-B001
- Date of Manufacture: 2024-05-25
1. Receiving Inspection
| Date | Material/Component | Inspector | Inspection Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|---|
| 2024-05-26 | Steel Casting | AA | Dimensions within spec | Accepted | – | Green “Accepted” |
| 2024-05-26 | Gasket Material | GG | Defects found | Rejected | Tears in material | Red “Rejected” |
2. In-Process Inspection
| Date | Process Stage | Inspector | Inspection Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|---|
| 2024-05-27 | Machining | CCC | Tolerances met | In-Process Passed | – | Yellow “In-Process Passed” |
| 2024-05-28 | Heat Treatment | DDD | Hardness below spec | In-Process Failed | Requires rework | Orange “In-Process Failed” |
| 2024-05-29 | Heat Treatment | Eee | Rework successful | In-Process Passed | After rework | Yellow “In-Process Passed” |
3. Final Inspection
| Date | Inspector | Inspection Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|
| 2024-05-30 | Bbb | Pressure test passed | Final Inspection Passed | – | Blue “Final Inspection Passed” |
| 2024-05-30 | Bbb | Visual inspection: No defects | Final Inspection Passed | – | Blue “Final Inspection Passed” |
| 2024-05-30 | Bbb | Functional test: Operational | Final Inspection Passed | – | Blue “Final Inspection Passed” |
4. Non-Conforming Product Report (if applicable)
| Date | Product ID | Non-Conformance | Inspector | Corrective Action | Disposition | Comments |
|---|---|---|---|---|---|---|
| 2024-05-28 | HPV12345 | Hardness below spec | Aaa | Rework | Reworked | Successfully reworked on 2024-05-29 |
5. Product Release
| Date | Product ID | Released By | Approval | Comments |
|---|---|---|---|---|
| 2024-05-31 | HPV12345 | QA Manager | Approved for Shipment | All inspections passed |
Summary
- Product Name: High-Pressure Valve
- Product ID/Serial Number: HPV12345
- Overall Status: Conforming
- Release Date: 2024-05-31
Notes
- All inspection and test records are stored electronically in the QMS for traceability.
- Non-conforming products are handled according to the Non-Conformance Report (NCR) procedure.
- Regular audits ensure compliance with the inspection and test status identification process.
This example record provides a detailed trace of the product’s inspection and test status throughout the realization process, indicating conformity at each stage.
Test Status Record
Product Information
- Product Name: High-Pressure Valve
- Product ID/Serial Number: HPV12345
- Batch/Lot Number: 2024-HPV-B001
- Date of Manufacture: 2024-05-25
1. Material Testing
| Date | Material/Component | Test Conducted | Tester | Test Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|---|---|
| 2024-05-26 | Steel Casting | Chemical Composition | John Smith | Within Spec | Conforming | – | Green “Conforming” |
| 2024-05-26 | Gasket Material | Tensile Strength | Jane Doe | Below Spec | Nonconforming | Material Tear Found | Red “Nonconforming” |
2. In-Process Testing
| Date | Process Stage | Test Conducted | Tester | Test Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|---|---|
| 2024-05-27 | Machining | Dimensional Check | Mike Johnson | Within Tolerance | Conforming | – | Yellow “Conforming” |
| 2024-05-28 | Heat Treatment | Hardness Test | Sarah Lee | Below Spec | Nonconforming | Requires rework | Orange “Nonconforming” |
| 2024-05-29 | Heat Treatment | Hardness Test | Sarah Lee | Within Spec after Rework | Conforming | Successful rework | Yellow “Conforming” |
3. Final Product Testing
| Date | Tester | Test Conducted | Test Results | Status | Comments | Label Applied |
|---|---|---|---|---|---|---|
| 2024-05-30 | BBB | Pressure Test | Passed | Conforming | – | Blue “Conforming” |
| 2024-05-30 | BBB | Visual Inspection | No Defects | Conforming | – | Blue “Conforming” |
| 2024-05-30 | BBB | Functional Test | Operational | Conforming | – | Blue “Conforming” |
4. Non-Conforming Product Report (if applicable)
| Date | Product ID | Non-Conformance | Tester | Corrective Action | Disposition | Comments |
|---|---|---|---|---|---|---|
| 2024-05-28 | HPV12345 | Hardness Below Spec | AAA | Rework | Reworked | Successfully reworked on 2024-05-29 |
5. Product Release
| Date | Product ID | Released By | Approval | Comments |
|---|---|---|---|---|
| 2024-05-31 | HPV12345 | QA Manager | Approved for Shipment | All tests passed |
Summary
- Product Name: High-Pressure Valve
- Product ID/Serial Number: HPV12345
- Overall Status: Conforming
- Release Date: 2024-05-31
Notes
- All test records are stored electronically in the Quality Management System (QMS) for traceability.
- Non-conforming products are handled according to the Non-Conformance Report (NCR) procedure.
- Regular audits ensure compliance with the test status identification process.
