Manufacturing Processes

Written production and process control procedures shall be followed in manufacturing and shall be documented at the time of performance.  Any deviation from these procedures shall be recorded and explained or justified.

3.2.1 Manufacturing Best Practices

The Basics: Quality Control

• Product meets specifications
• Quality Assurance
  • Systems ensure control and consistency
  • Validation, validation, validation
• Documentation
  • If it is not documented, it did not happen
  • Production and control records shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Product Impact Assessment
  • Trend Analysis
  • Distributed Product

3.2.2 Work Environment

The work environment should be clean, organized, and otherwise protect products from environmental damage.

 Sewing Factory Procedures

Sewing quality and efficiency are achieved by applying engineered methods and thorough training. Equipment must be correctly adjusted and maintained and machine operators trained in the proper use. Regular in-line quality checks must be performed to verify that standards are being met.

Sewing Work Area:

• The sewing production area must be clean, free of excessive waste, and with sufficient space to allow easy movement of workers and material handling equipment.
• It should be lighted to around 100 foot candles at the work surface, with task lighting where required.
• Personal Safety Equipment must be available and in use by relevant associates.
• Material handling equipment must be appropriate for maintaining the integrity of the product.
• Equipment must be checked daily for proper lubrication and Preventative Maintenance must take place regularly with individual equipment records maintained by the technicians.
• All equipment guards must be in place and adjusted correctly.
• Broken needles must have all pieces collected and accounted for before a replacement is issued.
• Cuttings trimming and other waste from production should be swept frequently to prevent build up of debris on tables or floors.
• Sharp tools should be tied to workstations and inventoried to prevent accidental dropping, loss, or mixing with products that could cause harm to workers or products.

Poor workplace examples:

3.2.3 Work Instructions/Tech Packs

Workers need to be provided with appropriate work instructions to ensure consistent production and adherence to product specifications.

• Apparel Tech Packs should at a minimum contain the following information for each style in production:
  • Style name/number or other specific identification.
  • Bill of Material (BOM): For Fabrics, Trims, Labels, and Packaging. Each section should include Placement (the location of the element in the garment), Comments, Material (the fiber content, weight, identification number, or substance of the material), Supplier, and Color Number.
  • Sizing information and Point of Measure (POM): Precise measurement on each section of the garment such as — total length, chest, sleeve length, etc.
  • Technical sketches: At a minimum this should be the front image, and include back, side, or detail sketches for any design elements like embellishments, stitching, and trim detail.
  • Pack method and packing instructions.
• First piece verification should be recorded, and first piece sample should be displayed for workers reference during production.

Good work instruction examples: