Why is factory audit an inexhaustible step for OEM contract manufacturing?

Pick OEM contract manufacturing. What's the worst fear? Not high prices, not long cycles, but factory ' real power and propaganda do not match.

Common industry traps:

  • The website claims that factory is owned, actually subcontracted by trading companies.
  • Samples are imported raw materials, mass production are secretly exchanged emerging brands raw materials
  • Alleged "GMP workshop " , actually produced only at normal workshop
  • The quality inspection device that was displayed was borrowed and never used.

Factory audit is the only way to pierce these bubbles. But a lot of brand owner (especially initial brands) do not know what factory audit looks at, how to examine and how to judge. The guide consolidates seven years of factory audit experience into seven steps, and does so.

Step 1: factory audit preparation - information Verify

Before you go to the scene, do "top-to-desk":

5 qualification files to be verified

Operational proposal: factory is required to send the above document scanned copies in advance and to verify the production licence number by item at regulatory compliance (EU / US FDA) website (nmpa.gov.cn).

Step 2: A reservation factory audit — observation factory reaction

When making an appointment for factory audit, watch the factory reaction:

Best factory audit time: Tuesday to Thursday, 10 a.m. to 3 p.m. This is the normal production period of factory, where the most real state can be seen. Avoid Monday (Monday is a cleaning day) and Friday (may close early).

Step 3: On-site inspection - 7 focus areas

At factory, following the following route factory audit:

3.1 Raw material warehouse

  • Whether the raw materials are stored in a classified manner, whether they are controlled by temperature and humidity, and whether there are records of incoming inspection
  • Red flag signal: open pile of feedstock drums, unmarked, no batch number retroactive

3.2 Between Quantities

  • Whether the electronic scales are regularly calibrated, whether there is a double review system and whether the records are complete.
  • Red flag signal: no calibration labels on scales, empty logs

3.3 Production workshop

  • Look at what:
  • Clothes change program: Should we change shoes, change clothes, wash hands, wind
  • Workshop cleanness: 100,000 workshop clean cleanness
  • Status of equipment: emulsification pan, filling machine in operation, clean identification
  • Personnel operations: workers wearing clean clothes and gloves masks
  • Red flag signal: workers do not wear clean clothes, workshop doors open, equipment rusty, ground water accumulated

3.4 filling workshop/

  • See: filling type and accuracy, filling volume sampling logs, pipe clean disinfection logs
  • Red flag signal: filling pipe with residue, clean record

3.5 packaging workshop

  • See: packaging materials for material inspection, packaging for manual intervention (impact consistency)
  • Red flag signal: packaging materials stacked randomly, no material inspection report

3.6 Test Room (QC Laboratory)

  • See: pH meters, viscos, microbiological testing devices, equipment in use
  • Red flag signal: Laboratory equipment covered with dust (not indicating daily use), no detection records

3.7 Product warehouse

  • Whether the finished product is stored by lot-number partition, whether it is to be checked/qualified/unqualified areas, temperature control
  • Red flag signals: finished products are placed directly on the ground, without batch number markings, qualified and disqualified Fuck. Fire!

Step 4: Assessment of the commodity control system - 4 core documents

Factory audit is not just "see," but " ask" and "cha". factory is required to present the following four core goods control documents:

4.1 Quality Management System

  • Is there a complete SOP (standard operating procedure)
  • Is there a authority for quality duty bearers
  • Training records for key positions

4.2 Batch production records

  • Is there a complete production record for each batch?
  • The record includes: batch number of feedstock, quantity, process parameters, operator signature
  • Question: "Show me the records of the last three batches" -- if not, it means that the control of the product is false.

4.3 Inspection report

  • Raw material inspection report.
  • Semi-finished product inspection reports
  • Final product exit inspection report (microbial, heavy metal, pH, viscosity, etc.)
  • Third-party type test reports (at least 1 per year)

4.4 Records of non-conformity

  • Whether there is a system of segregation of substandard goods
  • Unqualified process (repatriation/destruction/repatriation)
  • Question: "When was the last time the unqualified? How was it handled?" -- if it was "never failed," it was either lying or there was no test.

Step 5: capacity and lead time assessment

Capacity verification method

Lead time trap

  • Commitment to 15 days of delivery Actual 30-45 days (production line etc.)
  • Fifty thousand capacity → actually owns capacity 10,000, the rest of the outwards
  • Commitment to free sampling → sampling 3 months still not desirable (locking clients with sampling)

Step 6: Common Red Flag Signal List

During the factory audit process, more than two signals emerged, and it is recommended that careful consideration be given to:

Step 7: Negotiation skills after factory audit

Points for negotiation after the adoption of factory audit

  • Price negotiations: factory audit passed factory, usually 10-15% of quotation. Negotiating chips: minimum order quantity increase, long-term cooperation commitments, percentage advances.
  • Key contract terms:
  • Raw brands and model locking (prevent the diversion of raw materials)
  • Third-party testing reports per batch
  • Lead time default clause
  • Intellectual property confidentiality agreements
  • Unqualified goods in exchange clauses
  • The first orders are recommended: the first orders are recommended to be one or two times more than MOQ, and do not present a single order. After first arrival, complete third-party testing is performed to confirm quality.

QuickOEM platform factory audit service

QuickOEM provides factory audit counselling services for users:

  • Factory pre-screening: factory pre-screened and filtered non-compliance factory
  • Factory audit Accompaniment: factory audit, field assessment of factory strength
  • Factory audit report: Standardized factory audit report with 7-dimensional rating
  • Contract audit: Legal team review OEM contract manufacturing contract to protect client interests

Contact 18144805760 and submit requests through the QuickOEM online request form for factory audit counselling services.

*Sources of data: Code for the Quality Management of Cosmetic Production (2022 edition), regulatory compliance (EU / US FDA) Open data, factory audit Summary of experience of QuickOEM expert team*

*Analyst team: QuickOEM expert team x make-up industry expert xsupply chain analyst x commodity control engineer*

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This article is published by the QuickOEM Make-up OEM Smart Matching Platform. More makeup OEM knowledge, cosmetics contract manufacturing, skin protection private label, make-up customizationontent are available at the Knowledge Centre. If you need advice on OEM contract manufacturing, please contact 1814805760 or submit your request through an online request for quotation.

Keywords: Make-up OEM factory audit, contract manufacturing plant selection, GMP workshop inspection, cosmetics factory audit, goods system assessment, OEM contract manufacturing qualification list, factory factory audit list, make-up OEM knowledge, cosmetics regulatory filing guide, regulatory compliance (EU / US FDA), ingredient compliance, formulation R&D

QuickOEM is a QuickOEM platform for vertical digitization of cosmetics services (known as QuickOEM) focusing on OEM, cosmetics contract manufacturing, skins private label, cosmetics z, brand-wide, ODM contract manufacturing services. AI smart matches the 500+ certification contract manufacturing plant, providing a one-stop package from formulation R&D to regulatory compliance (EU / US FDA) covering skin, makeup, sheet mask, serum, eye patch, category, category, etc.

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