Factory Quality System

1.0 Factory Facilities and Environment

1.0.1 There is sufficient lighting on: Production, revising, finishing, inspection, packing and loading areas? 

1.0.2 The facility maintains clean and organized production, finishing and packing areas.

1.0.3 Facility has separate inspection area with inspection table and proper ventilation.

1.0.4 Facility has documented pests/mildew and moisture control program, which includes frequent inspections. (In-house or 3rd party)

1.0.5 No broken windows or leaking roofs that may result to product contamination was observed during audit. 

1.0.6 Factory has metal detecting unit. (Scoring will not apply (N/A) if factory does not need this machine.)

1.0.7 (Critical) Factory implements strict sharp tools control procedure to prevent scissors, knives, blades, broken glasses and needles to be mixed with product.

1.0.8 Factory has back-up power supply available. “Generator”

1.1 Machine Calibration and Maintenance

1.1.1 Factory machines and equipments are appropriate to produce Wal-Mart products. 

1.1.2 Factory has documented system and procedure for scheduled equipment cleaning and repairs. 

1.1.3 Factory machines and equipments appear to be clean and in good running condition.

1.1.4 Machines, equipments and tools are properly labeled with date of last maintenance/calibration and schedule.

1.1.5 Machines, equipments and tools that needs to be repaired are properly labeled to avoid accidental use. 

1.1.6 Factory has proper, clean and organized storage area of critical tooling (i.e. injection moulds) with labeled shelves. 

1.1.7 Factory has proper documentation and updated inventory of machines, tools, spare parts and equipments.

1.1.8 Factory has maintenance team with suitable skill level and equipments to perform necessary repair and calibration on machines. 

2.0 Quality Management System

2.0.1 Factory has established Quality Management System that is appropriate to their products and procedures. 

2.0.2 Workers & Supervisors are familiar to these quality policies and objectives.

2.0.3 Factory has documented customer complaint system and documented recall program.

2.0.4 (Critical) Factory QC team is independent from Production division.

2.0.5 Production management and QC team discuss and work together in solving Quality issues/ concerns. (Documented)

2.0.6 Factory has systems and procedures in place to control the risk of physical, chemical and biological contamination that may damage the product and personnel as well.

2.0.7 Factory conducts risk assessments to identify hazards from chemicals, raw materials, process equipments and tools. 

3.0 Incoming Materials Control

3.0.1 Proper first in-first out (FIFO) system on materials are practiced.

3.0.2 Factory has procedures for quality inspection on incoming raw materials, accessories and components.

3.0.3 Incoming and outgoing material quantities are monitored and documented.

3.2.4 Factory has specifications for purchased materials.

3.2.5 Factory has documented process and reference samples that ensure incoming raw materials conform to specifications. 

3.2.6 (Critical) Factory has proper system on material segregation to avoid accidental contamination from rejected items.

3.2.7 Factory properly separate good quality items from rejects and identifies non-conforming (rejects) materials for replacement. 

3.2.8 Facility’s storage areas have sufficient lighting, well ventilated and clean surrounding.

3.0.9 Materials, components and accessories are properly stacked and identified with tags / labels and off the floor.

3.0.10 (Critical) Chemicals and maintenance substances are properly marked and stored to prevent risk of contamination.

3.0.11 Color relevant materials such as fabrics, genuine leather and synthetic PU/ PVC, trims and accessories are sorted by lot numbers. 

4.0 Process and Production Control

4.0.1 Does factory PD study and apply product safety features, evaluates patterns, moulds, and samples during product design and development?

4.0.2 Factory has documented Quality procedures (QP) at each stage of operation.

4.0.3 Does factory conduct Pre-production meeting prior to start of production?

4.0.4 (Critical) Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting?

4.0.5 Does factory conduct “pilot-run”, review product quality against specification sheet and document results with corrective actions prior to production?

4.0.6 Was in house lab-testing performed on current production? (Request for test copies)

4.0.7 Does factory QC compare first piece samples with approval sample and specification sheet?

4.0.8 Are there adequate approved samples, first piece samples, reference samples, and work instructions to provide workers with proper guidelines?

4.0.9 (Critical) Does Quality Control has authority to stop production if quality of products did not meet specification?

4.0.10 In-line inspections (IPQC) are performed by QC at every operation process.

4.0.11 Is quality of item acceptable on current production? (Check 8 finished products taken from factory final inspected goods and check for major defects on the item.)

4.0.12 Factory QC inspects per standard AQL or as per industry standards.

4.0.13 Factory performs 100% functionality check on final products?

4.0.14 Does factory use corrective actions and root cause analysis methods? (Please provide examples)

4.0.15 Does factory have guidelines in place to ensure packaging is correct for product?

4.0.16 Does packing area have enough space to perform packing functions properly? Is it clean and organized?

4.0.17 Packed cartons are stored in enclosed area not exposed to sunshine and wet weather.

4.0.18 Does factory track and document on-time ship performance?

5.0 In-House Lab-Testing

5.0.1 Does factory perform in-house lab testing and are facilities appropriately equipped? (Please refer to the FCCA attachment for in-house lab testing requirements.)

5.0.2 All gauges and test equipments have valid calibrations.

5.0.3 Testing manuals of various industry standards are available as reference.

5.0.4 In-house Lab Technicians are properly trained to perform testing functions.

6.0 Final inspection

6.0.1 Does factory have procedure and working instruction for final QC?

6.0.2 Factory QC conducts final inspection per standard AQL or as per industry standards.

6.0.3 An approved sample or reference sample with packing list and shipping marks are available as reference for factory QC.

6.0.4 Are there formal written final inspection reports? Are they properly filed and traceable to review quality of products?

6.0.5 Does factory final QC perform internal mechanical tests to ensure the safety of product?

6.0.6 Where appropriate, are inspection and testing equipment used by the inspector in good condition and calibrated?

6.0.7 (Critical) Failed inspections are properly corrected prior to final inspection by customer.

6.0.8 Factory does not ship goods unless subjected to release procedures from customer.

7.0 People Resources and Training

7.0.1 (Critical) Factory conducts, documents, maintains on-job training for all personnel, or conducts pre-hire testing of skilled workers prior to hiring.

7.0.2 2. Factory conducts and documents technical training programs for Electrical/ Mechanical Engineer, Machinist, QC and Lab Test Technician.

7.0.3 Records of trainees and all regular personnel with corresponding performance records are kept and maintained.

Required documents for FCCA factory production capacity assessment inspection:

1. Factory introduction

2. business license

3. Quality manual

4. Operating procedure

5. Organizational structure

6. Job description

7. Quality meeting record

8. Prenatal meeting record

9. Production plan and production schedule

10. Supplier Management

11. Production process flow chart

12. File Control Program

13. Incoming inspection specifications and records

14. Production operation guide

15. Customer complaint record

16. Corrective and preventive measures

17. Production equipment list

18. Maintenance record

19. Measuring instrument calibration record

20. Test instrument for measuring instruments

twenty one. Test procedure, record

twenty two. Control procedures and records for nonconforming products

twenty three. First sample evaluation confirmation procedure

twenty four. Staff training record (job, skills)

25. Outgoing product inspection report

26. Production inspection report

27. Shipment inspection report

Onsite requirements:

1. Internal laboratory (impact, tolerance, free fall, surface adhesion, color difference, etc.) test equipment

2. Color card

3. Workshop luminosity (60-70)

1. Who gets the results of FCCA and then what happens?  

QA receives the FCCA report from the 3rd party auditor. Corp QA will conduct the final Audit. Upon approval, Retail Link is updated to a normal factory status and an email with the results is sent to the supplier, merchandising and sourcing from ES coordinators.  

2. For a new supplier, how do we know if an FCCA is required?   

FCCA is required for all new factories of A suppliers.

3. When should a factory be assessed thru FCCA? 

The new factory should be pre-qualified for FCCA before order commitment.  

4. If an existing factory fails FCCA for 1 department, would it affect orders for other departments?  

Yes, because the factory ID will be inactivated.  

5. How long would it take for any re-audit? How much will it cost? How about follow-up audit?

Re-audit timeline depends on the non-compliance issues and how long the factory can rectify the problem. Re-audit is a full FCCA audit that costs $850. Follow-up audit is for corrective actions based on the initial audit result, which costs around $100~700.

6. How many times can a factory be re-audited?  

There is no limit as to how many times a factory can be re-audited.  

7. What is the process lead time for FCCA? 

Process lead time for FCCA is around 20 working days from supplier equest to final Audit result.  

8. If Buy Trip happened last year and PO is created this year, would the factory be required with FCCA? 

The factory would still be required with FCCA audit.  

9. For an existing toy supplier having a new factory, would it need to pass just ICTI or FCCA or both?

The factory has to pass “both” FCCA and ICTI.

10. If a factory has not been audited for FCCA, can the factory be used in MPA?  

Yes, factory will remain active until the factory fails FCCA and ES Inactivates the factory in Retail Link.  

11. If a factory passes FCCA, how long will the result be valid? 

The FCCA audit is valid for 18 months. Existing factories being inactive or without PO’s over 18 months are required to pass FCCA before the supplier can receive order commitment. 

12. If a supplier is classified as B for one country and being classified as A for another country / department, would FCCA be required? 

All A suppliers with new factories must be FCCA audited.   

13. If an A supplier is using a factory already supplying to B supplier, would FCCA still be required? 

All A suppliers with new factories must be FCCA audited. 

14. If a supplier is going to reactivate a factory that is currently inactive in Retail Link, is FCCA mandatory for this factory? 

FCCA will be required if the factory has been inactive in Retail Link over 18 months. 

15. What’s included in $850 per audit? Does it include all the expenses, such as auditors’ transportation and accommodation? 

Yes. The fee should cover all expense.

The important concerns of the FCCA quality audit are as follows:

1. There is sufficient lighting in the workshops of production, finishing, finished products, inspection, packaging and loading.

2. In the production, finished product and packaging workshops, the FCCA quality inspection factory requires that the tools and equipment should be kept clean and tidy.

3. Tool and equipment have separate calibration areas, equipped with calibration workbench, and have proper ventilation

4. Have written written plans for hazardous/mouldery and wet management of equipment and tools, and records for frequent inspections.

5. There are no window damage and house leaks.

6. Must have a needle detector.

7. The factory must strictly implement the sharp object management program to prevent scissors, knives, blades, broken glass and broken needles from being mixed in the product. (Very important!)

8. The factory has spare power supply equipment: generators, etc.

FCCA Quality Auditing Rating Items:

1. Factory facilities and environment

2. Quality Management System

3. Feed control

4. Process and production control

5. Internal laboratory - testing

6. Final inspection

7. Human resources and training

These are the common requirements of the FCCA quality audit for your reference:

1. There is sufficient lighting in the workshops of production, finishing, finished products, inspection, packaging and loading.

2. In the production, finished product and packaging workshops, the FCCA quality inspection factory requires that the tools and equipment should be kept clean and tidy.

3. Tool and equipment have separate calibration areas, equipped with calibration workbench, and have proper ventilation

4. Having written written plans for hazardous/mouldery and wet management of equipment and tools, and records for frequent inspections.

5. There are no window damage and house leaks.

6. Must have a needle detector

7. The factory must strictly implement the sharp object management program to prevent scissors, knives, blades, broken glass and broken needles from being mixed in the product. (Very important!)

8. The factory has spare power supply equipment: generators, etc.

FCCA Quality Auditing Rating Items:

1. Factory facilities and environment

2. Quality Management System

3. Feed control

4. Process and production control

5. Internal laboratory - testing

6. Final inspection

7. Human resources and training

Wal-mart FCCA factory inspection

FCCA is the abbreviation of Factory Capability & Capacity Assessment, which is the factory output and capacity assessment. The purpose is to verify whether the production and production capacity of the plant meets WalMart's capacity and quality requirements. Including the following aspects:

1. Factory Facilities and Environment

2. Machine Calibration and Maintenance

3. Quality Management System

4. Incoming Materials Control

5. Process and Production Control

6. In-House Lab-Testing

7. Final inspection

8. People Resources and Training