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FCCA Audit Outline

Source: 2019-10-11 11:42 by admin FCCA Audit Outline Read: 1343

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.

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