Section 1: Control Of Measurement And Test Equipment
1. 1. Has the organization a documented procedure to ensure control, calibration and maintenance of inspection, measuring and test equipment? (This includes gages and test equipment used by operators, inspectors, testers, tool-room, maintenance and labs.)
Yes
No
N/A
2. 2. Are testing and measuring equipment able to meet the precision and tolerances of the intended testing methods?
Yes
No
N/A
3. 3. Are calibration program with schedule setup for regular checking of testing equipment? Are labels showing the calibration status available on each piece of testing equipment?
Yes
No
N/A
4. 4. Are equipment calibrated either in-house with proper calibration procedures or through outside competent bodies? Are calibration reports maintained and traceable to national or international standards?
Yes
No
N/A
5. 5. Are laboratory staff properly trained and knowledgeable to perform testing and calibration?
Yes
No
N/A
Section 2: Control Of Non-Conforming Products
1. 1. Are procedures established for control of non-conforming raw material lots?
Yes
No
N/A
2. 2. Are rejected lots or lots pending for rework, sorting or scrap clearly identified with labels or tags and segregated from other accepted lots?
Yes
No
N/A
3. 3. Are designated areas assigned for holding non-conforming lots and clearly marked?
Yes
No
N/A
4. 4. Is there procedure for releasing non-conforming lots for production or shipment? Are the releasing criteria do not compromise product safety in any way?
Yes
No
N/A
5. 5. Are records for releasing of non-conforming lots for production or shipment maintained and with proper approval?
Yes
No
N/A
6. 6. Is there procedure established for rework and sorting of rejected lots to ensure they are properly re-inspected or verified by testing for acceptance?
Yes
No
N/A
7. 7. Are records available for scrap with quantity matching with the rejected lot?
Yes
No
N/A
8. 8. Is there control to prevent any defect parts or process throw-offs from being mixed or returned to the normal production output?
Yes
No
N/A
Section 3: Lot Identification And Traceability
1. 1. Are lot numbers or batch codes assigned and clearly marked on raw material, semi-finished, and finished product lots for traceability purpose?
Yes
No
N/A
2. 2. Are production records maintained for identifying all raw materials for each lot?
Yes
No
N/A
Section 4: Production Facilities And Equipment
1. 1. Does the factory possess production facilities for the major manufacturing processes of the type of toys to produce?
Yes
No
N/A
2. 2. Are machines and equipment in good working conditions and well maintained? Are they capable and properly set up to perform the operation as intended?
Yes
No
N/A
3. 3. Are appropriate tools and fixtures available to perform the operation as intended?
Yes
No
N/A
4. 4. Are production machines and equipment periodically maintained, calibrated and checked for proper running?
Yes
No
N/A
5. 5. Does the factory have a maintenance team with adequate skills and technical knowledge? Are they ready for any emergency repair works at the production areas?
Yes
No
N/A
6. 6. Has the factory established a preventive maintenance program for all major production facilities?
Yes
No
N/A
7. 7. Are machines, equipment or work stations under maintenance properly identified for work stoppage?
Yes
No
N/A
Section 5: Plant Layout, Housekeeping And Workflow
1. 1. Are manufacturing processes and production lines set up with adequate space, proper layout and workflow as necessary?
Yes
No
N/A
2. 2. Is the work areas clean, tidy and free of excessive dust and odors?
Yes
No
N/A
3. 3. Is there adequate space for aisles, transportation of materials, and storage areas available in the production areas?
Yes
No
N/A
4. 4. Is there adequate lighting and ventilation in production areas? Is temperature and environment control exercised in areas where special process requirements are necessary?
Yes
No
N/A
5. 5. Are designated containers available in the work areas to store defect parts or throw-offs from the workstations or production lines?
Yes
No
N/A
6. 6. Are raw materials, semi-finished goods and packed cartons stored away from walls and off the floor on pallets?
Yes
No
N/A
7. 7. Are designated areas for employees’ eating, drinking or smoking well identified and separated from production areas?
Yes
No
N/A
8. 8. Are drinking cups, eating utensils or other personal belongings stored properly and away from the work areas?
Yes
No
N/A
Section 6: Material Handling And Storage
1. 1. Are materials warehouses enclosed, clean and tidy?
Yes
No
N/A
2. 2. Are materials stored in appropriate containers with adequate protection from damage or contamination?
Yes
No
N/A
3. 3. Are materials properly marked with identification labels in the storage areas?
Yes
No
N/A
4. 4. Are materials in the warehouse in good conditions without damage, dirt, rust or other defects?
Yes
No
N/A
5. 5. Are hazardous chemicals stored separately in a dangerous goods warehouse with restricted access?
Yes
No
N/A
6. 6. Has shelf-life been established for degradable raw materials such as paints and chemicals? Are expiry dates marked on the containers?
Yes
No
N/A
7. 7. Does the factory adopt First-In-First-Out (FIFO) policy for raw materials consumption?
Yes
No
N/A
8. 8. Are proper inventory records maintained?
Yes
No
N/A
Section 7: Material Safety Control
1. 1. Supplier should establish appropriate procedures to the control limit of toxic substances to meet LC’s requirement.
Yes
No
N/A
2. 2. The supplier shall define and implement procedures to ensure all materials meet all quality and safety requirements.
Yes
No
N/A
3. 3. Whether the supplier signed the DOC to ensure all materials conform to LC’s requirements.
Yes
No
N/A
4. 4. Has Certificate of Compliance from Supplier for every raw material Batch
Yes
No
N/A
5. 5. Every batch of raw material must have a passing 3rd party test report
Yes
No
N/A
6. 6. Is there a specified area for quarantining incoming?
Yes
No
N/A
7. 7. Every paint batch must have individual batch code
Yes
No
N/A
8. 8. Follow receiving quality control procedures including; inspection, labeling, recording and verifying
Yes
No
N/A
9. 9. Follow batch paint segregation procedures including; identification and labeling
Yes
No
N/A
10. 10. Only passed material allowed in factory production floor
Yes
No
N/A
11. 11. Follow record keeping procedures including traceability and filing for 5 years minimum
Yes
No
N/A
Section 8: General Factory Information
1. 1. Factory Name:
2. 2. Factory Address:
3. 3. Factory Representative (Title):
Yes
No
N/A
4. 4. Production Area / Blocks / Floors:
5. 5. Number of Staff / Production Workers:
6. 6. Years in Operation:
7. 7. Major Types of Produced:
8. 8. Major Production Facilities:
Section 9: Summary Of Major Audit Findings
1. 1. Finding 1
2. 2. Finding 2
3. 3. Finding 3
Section 10: Conclusion
1. 1. Overall Rating
Excellent
Good
Average
Poor
At Risk
Section 11: Quality Management System And Document Control
1. 1. Has the factory established a quality management system covering applicable elements of the ISO9000 standards?
Yes
No
N/A
2. 2. Is the quality management system certified by third party?
Yes
No
N/A
3. 3. Is the quality functional head of the factory independent of other production functions?
Yes
No
N/A
4. 4. Are quality records available, complete and update?
Yes
No
N/A
5. 5. Are internal audits planned and documented?
Yes
No
N/A
6. 6. Are internal audits conducted to verify compliance and effectiveness of the quality management system? Are corrective actions proposed and implemented?
Yes
No
N/A
7. 7. Does factory management periodically review the quality management systems and set targets for continuous improvement?
Yes
No
N/A
8. 8. Are quality trends reported and analyzed to find out the root cause of major quality problems? Are corrective and prevention actions proposed and implemented?
Yes
No
N/A
9. 9. Has the factory established a document control procedure for quality related manuals, procedures, work instructions, specifications, records, etc.?
Yes
No
N/A
Section 12: Procurement
1. 1. Is there a dedicated department for procurement of raw materials and other indirect materials used for production?
Yes
No
N/A
2. 2. Is there a complete bill of materials (BOM) or part list available for each item manufactured?
Yes
No
N/A
3. 3. Are approved specifications available for raw materials and components purchased?
Yes
No
N/A
4. 4. Does the raw material or component specification include requirements of applicable safety standards and client’s specific requirements?
Yes
No
N/A
5. 5. Are purchasing staff aware of the safety and client specific requirements in the specifications and able to communicate them effectively to the suppliers?
Yes
No
N/A
6. 6. Does the purchase order or sales contract always include or make reference to the relevant requirements of the approved raw material specifications?
Yes
No
N/A
7. 7. Is there procedure for approving suppliers and tracking of their quality performance? Are supplier evaluation records available and complete?
Yes
No
N/A
8. 8. Is an approved supplier list maintained? Are purchase orders placed on the approved suppliers only?
Yes
No
N/A
Section 13: Management Of Supplier/Subcontractors
1. 1. Has the factory established procedure and criteria for selection and approval of subcontractors? Is an approved supplier/subcontractor list maintained?
Yes
No
N/A
2. 2. Has the factory communicated with the supplier/subcontractors all product requirements to ensure they understand and are capable of meeting them?
Yes
No
N/A
3. 3. Are supplier/subcontractors provided with update safety and quality specifications, approval samples and other relevant quality information for production?
Yes
No
N/A
4. 4. Where materials and components are consigned for subcontractors, are they inspected or verified for acceptance before delivery? Are inspection and testing records maintained?
Yes
No
N/A
5. 5. Where materials and components are sourced by subcontractors, are inspection and testing reports provided by the supplier/subcontractors for showing conformance to the quality and safety specifications?
Yes
No
N/A
6. 6. Is procedure established for incoming inspection and testing of production lots from supplier/subcontractors? Are inspection and testing records maintained?
Yes
No
N/A
7. 7. Are supplier/subcontractors evaluated regularly for performance and quality? Are evaluation records available and complete?
Yes
No
N/A
Section 14: Incoming Quality Control
1. 1. Has the factory established incoming inspection procedures to assure all incoming materials conform to approval samples or specifications?
Yes
No
N/A
2. 2. Is there a segregated area with sufficient space, appropriate equipment and environment to perform incoming inspection?
Yes
No
N/A
3. 3. Are inspection criteria clearly defined and available for immediate reference? Do they match with the approved specifications?
Yes
No
N/A
4. 4. Where it is not possible to verify the quality and safety characteristics by inspection, is there procedure for suppliers to provide testing documents for lot acceptance?
Yes
No
N/A
5. 5. Are procedure and criteria established for raw materials and components exempt for incoming inspection check? Can the exemption criteria adequately safeguard the final product safety?
Yes
No
N/A
6. 6. Are incoming QC staff properly trained and knowledgeable to perform incoming inspection?
Yes
No
N/A
7. 7. Are inspection records available, complete and with conclusion of acceptance or reject?
Yes
No
N/A
8. 8. Are records maintained for incoming raw material lot verification, disposition or return to suppliers?
Yes
No
N/A
9. 9. Are incoming materials come from the approved suppliers only?
Yes
No
N/A
Section 15: In-Process Quality Control
1. 1. Is there a manufacturing flowchart or production plan for each product?
Yes
No
N/A
2. 2. Are all materials, production operations and check points included?
Yes
No
N/A
3. 3. Are work instructions posted for each operation and approval samples available in the work area for immediate reference by the production workers and QC staff?
Yes
No
N/A
4. 4. Are machine settings and parameters defined and checked regularly by in-process QC? Are check records available?
Yes
No
N/A
5. 5. Are critical manufacturing processes defined with proper operation set-up and quality control measures to ensure output quality?
Yes
No
N/A
6. 6. Does the factory have effective measures in the assembly lines for preventing missing part defects in the finished products?
Yes
No
N/A
7. 7. Does the factory have a procedure for controlling the use of regrind materials in the injection molding process?
Yes
No
N/A
8. 8. Are in-process inspection criteria clearly defined and available for immediate reference by in-process QC? Are they matched with the safety standards and client’s requirements?
Yes
No
N/A
9. 9. Are in-process QC staff properly trained and knowledgeable to perform incoming inspection?
Yes
No
N/A
10. 10. Are in-process inspection records available, complete, traceable to the production lot, and with conclusion of acceptance or reject?
Yes
No
N/A
Section 16: Final Quality Control
1. 1. Are inspection procedures established for final inspection?
Yes
No
N/A
2. 2. Do the acceptance criteria match with applicable safety standards and clients’ requirements?
Yes
No
N/A
3. 3. Are approval samples and product specifications available for immediate reference by QC?
Yes
No
N/A
4. 4. Is the sampling plan used for final inspection adequate for assurance of product quality and safety?
Yes
No
N/A
5. 5. Are inspection staff properly trained and knowledgeable to perform final inspection?
Yes
No
N/A
6. 6. Are final inspection records available, complete, traceable to production lots, and with conclusion of acceptance or reject?
Yes
No
N/A