Quality You Can Trust: Step-by-Step Factory Audit for Private Label Cosmetics Manufacturing

Quality You Can Trust: Step-by-Step Factory Audit for Private Label Cosmetics Manufacturing

Autor:Kasey Schönheit Zeit:2025-6-22

If you plan visiting a cosmetics factory and would like to assess the factory’s production quality system, you can refer to the following step-by-step guide. This checklist will help you systematically observe and evaluate the factory’s quality assurance and risk control practices during your site visit.


Suggested On-Site Factory Observation Sequence

Warehouse → Environmental Protection Equipment → Laboratory → Retention Sample Room → Raw Material Room → Production Area → Office → Issue Inspection Results


Step-by-Step Observation Guide

1. Check the Warehouse

  1. Inspect the storage area: Ensure packaging materials are stored in the designated area, qualified and unqualified products are stored separately; check handling records for unqualified items.
  2. Examine flammable, explosive, toxic, or corrosive hazardous materials: They should have a dedicated storage area and dual-person, dual-lock management, as well as inventory records. For cream-based companies, check alcohol; for perm and dye companies, check thioglycolic acid.
  3. Randomly select 3 finished products in the product warehouse and review their registration/filing status (to be cross-referenced with batch production records in the office).

2. Inspect Environmental Protection Equipment

Check wastewater and waste disposal: Look for environmental impact assessment reports, wastewater treatment equipment, and treatment records. Confirm whether there are waste residue disposal agreements, valid certificates, and records with qualified companies.

3. Check the Laboratory

(Where documents or systems are involved and not checked onsite, mark for further verification in the office.)

  1. Review the equipment list (obtain and verify in the office), laboratory management system, and inspection management system: make sure relevant instruments are available.
  2. Interview inspectors: Ask what tests are performed and how. Focus on product release testing methods, workshop and water treatment equipment microbial inspections, conformity between raw material inspections and internal controls, and how lab environmental conditions are ensured.
  3. Randomly inspect 3-5 items among raw materials, packaging materials, intermediates, and finished products: Verify existence of standards, compliance with internal standards, inspection reports, and original records. For shampoo and hair care, confirm active ingredient testing.
  4. Check sample management regulations: Sample labels must be clear and complete, and the sampler should be identified; ensure sampling rules are consistent.
  5. Inspect 3-5 pieces of equipment: Verify identification, calibration certificates, and whether precision and vibration/heat-intensive instruments are stored together.
  6. Review purchase records and supplier qualifications for reagents, solutions, and media: Review standard solution and media preparation records, paying attention to validity and preparation dates; assure all are sourced from qualified suppliers.
  7. Examine over-limit management procedures: Ask how over-limit results are handled, whether reports are issued, and if root cause analysis and corrective action are required.
  8. Review agreements with third-party test labs, their institution list, and all related test reports from the past three months.

4. Inspect the Retention Sample Room

Check if the three samples reviewed in the office are in retention, whether quantities meet at least six times the smallest sales unit, and if labels are clear. Retention samples should be in a dedicated space, with tracking of inspection records (including corrective actions for non-conformities).

5. Inspect the Raw Material Storage Room

Assess raw material storage: Some compounds (like hyaluronic acid) require refrigeration or dark storage at room temperature. Confirm label requirements match actual storage, and check for expired raw materials.

6. Inspect the Production Area

(For procedures and documents not checked onsite, mark for further verification in the office.)

  1. Review the changing room at the plant entrance: Check for visitor management protocols and visitor log records.
  2. Inspect the plant area: Ensure cleanliness and rational layout, absence of pollution sources.
  3. Examine dressing rooms: Should offer lockers for clothes and shoes, separate storage of personal and work items, proper hand washing and disinfection facilities (no-touch type).
  4. Check personnel and material flow: Should follow rational routes; ensure no toilets are located in the workshop.
  5. Verify the establishment of sanitation and disinfection procedures: Check purchase and usage records for disinfectants.
  6. Examine area zoning: Production areas should be divided into clean, quasi-clean, and general zones; look for environmental monitoring plans and valid reports.
  7. For production of eye-care, baby, and child skincare products: Ensure filling and clean-container rooms meet class 300,000 cleanroom standards; check differential pressure gauges (clean areas should have positive pressure, powder workshops negative), and review temperature and humidity records.
  8. If producing flammable, explosive, corrosive, dust-generating, hard-to-clean, or solvent-containing products: Check for explosion-proof devices (solvent areas) and dust removal/exhaust equipment (powder units).
  9. Check clean zones: Ensure corners between walls, floors, and ceiling are curved; check pipe integrity.
  10. Review lighting equipment: Ensure there are valid illumination testing reports.
  11. Inspect pest control: Ensure existence of pest control protocols and records, mouse-proof boards, screens, and a list of insecticide usage. Immediate penalty for pest presence onsite.
  12. Review the equipment list: Ensure equipment design matches technological requirements.
  13. Observe equipment cleaning and disinfection: Ensure protocols exist. Verify cleaned equipment has proper status labels, is stored appropriately to prevent contamination, especially checking grinders and fillers.
  14. Review equipment calibration: Check lists for pressure gauges, electronic scales, vacuum meters on emulsifiers, verification plans and records.
  15. Assess equipment maintenance and upkeep records and systems.
  16. Evaluate water treatment equipment: Check for clear identification on pipes and sampling points, regular cleaning & disinfection records, process water standards, production logs (including water pressure, flow, conductivity), water system diagrams; inquire about defined sampling points & frequencies; require valid third-party water quality reports.
  17. Review batch production orders onsite: Coding must match actual product batch numbers.
  18. Review sanitary disinfection processes and plans for the production area; verify operators check and confirm batch order details and that incoming materials are disinfected or sanitized. Review disinfection method documentation and validation records.
  19. Confirm all material and intermediate product labels are clear.
  20. Check completeness and double-signature verification of batching, weighing, and feeding records. Production records should be filled out in real-time, and storage requirements/duration for intermediates should be defined.
  21. Review cross-contamination risk points in production; ensure protective measures are in place.
  22. Ensure first-piece inspection exists and records are retained for filling operations.
  23. Verify establishment of in-process inspection procedures (including first-piece, patrol, and completion inspections); ask employees about their inspection activities.
  24. Check for cleaning records after each production stage.

7. Check the Office

  1. Check organizational chart; ensure responsibilities are clearly stated.
  2. Interview the quality manager: Verify full-time status, academic credentials, relevant work experience, and familiarity with procedures (non-compliance if unable to answer per city bureau requirements); ensure procedures are signed.
  3. Interview the production manager: Verify qualifications and responsibilities.
  4. Examine personnel files: Employment records, labor contracts, and health files (health management system, health certificates, routine check records). Inspectors must have professional certificates or training records and be assessed on-site.
  5. Review training system: Randomly check training and assessment records for 3-5 employees involved in production quality.
  6. Review company quality policies and objectives: Ensure there is a reviewed policy and track goal achievement (e.g., raw material acceptance rates).
  7. Review quality management system: Including document management, material supply, inspection, release, facility/equipment, production process, sanitation, sample retention, internal inspection, traceability, nonconformance, complaint and recall, and adverse reaction management systems.
  8. Examine document control: Check for lists of external documents and procedures for handling obsolete documents.
  9. Random checks: Randomly select 3 production batches (from computer/warehouse/sample room) and review batch production, inspection, and nonconformance records. Check sales records (name, specifications, batch number, quantity, shipment date, customer and address), to be retained for at least one year after product expiry.
  10. Review material and release systems: Check release sign-off sheets (signatures, test reports, and production records required).
  11. Confirm nonconforming product management: Ask whether there are nonconforming products, if records exist, and if corrective actions are recorded; check for use of expired raw materials and special storage areas for all nonconforming materials, intermediates, or finished goods.
  12. Examine records of rework, if any.
  13. Review traceability system: Ask how traceability is managed; verify existence of batch numbers for raw materials, material labels, and the ability to trace through the full production process.
  14. Review internal audit systems: The system should be consistent with your documented procedures and require feedback signatures from the top management representative.
  15. Check if materials and products meet national standards, and for compliance assessment records.
  16. Inspect supplier management protocols: Supplier evaluation records and files.
  17. Review certificate/invoice collection system: Obtain raw material test reports; check for third-party inspection reports or certificates for risk substances, and records of incoming material package integrity inspections (how damaged packaging is handled and recorded).
  18. Verify material and product storage systems: Check for routine inventory records (at least annual inventory sheets).
  19. Check for expired materials and evaluation processes.
  20. Review material issuance and usage: Verify personnel signing materials off, and records of material returns, if any.
  21. Review production management system: Ensure production procedures cover all key points, including formulation, weighing, preparation, filling, packaging, etc. For formulas, check consistency of preservative use with filed formula.
  22. Inspect product quality complaint management policies.
  23. Review adverse reaction monitoring: Verify case records are available and complete.
  24. Examine recall system: Confirm existence of emergency contact directory; if previously recalled, check for investigative reports and recall documentation (especially nation-level notifications), including how recalled products were handled. If none, prepare a simulated recall report.

 

 

By following this on-site observation and inspection guide, you can ensure a comprehensive, systematic, and objective evaluation of a cosmetics factory’s quality management system. Such a structured approach not only helps identify potential risks or weaknesses, but also builds mutual trust and communication with the factory, laying a solid foundation for future cooperation and product quality assurance.Quality You Can Trust: Step-by-Step Factory Audit for Private Label Cosmetics Manufacturing

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