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Your industry. Our Focus

Factory Audits and Product Inspections

Your industry, our focus

Index

  • Factory Audits
  • Product Inspections
    • Initial Production Inspection
    • During Production Inspection
    • Final Random Inspection / Pre-Shipment Inspection
    • Loading Check
    • Other related or customized services
  • Factory Inspections (linked to Certification programs)

 

Factory Audits

European, American, Asian and Australian authorities impart civil and penal liability upon importer and brand owners, considered to have the same responsibilities as the manufacturers.

It is therefore crucial for internationally operating corporations to understand their suppliers’ organizations and manufacturing processes in order to bridge potential gaps between sales arguments and practices on the production site.

A factory audit is a systematic and independent examination of your supplier’s management, organizational, operational and quality systems, along with the protocols defined in the sort of Audit of your choice.

Factory Audits Standard Process

  • Initial Audit performance
  • Assessment & Gap analysis
  • Process audit
  • Product audit
  • Periodical (annual, biannual…) evaluation, assessment and monitoring

Fields of Focus

A full audit would consist of a combination of below modules, that can also be served independently, partially or tailor-made in a so call “Customized Audit”:

Technical

A technical factory audit provides you with an objective picture of your supplier’s capacities and capabilities on:

  • Quality Management system
  • Production line capacity, process and flow
  • Product qualification
Environmental
  • Energy Efficiency management
  • Sustainability

 

Ethical (also known as “Social Audit”

Corporate Social Responsibility (CSR)

CSR includes issues such as environmental sustainability, life-cycle analysis (impact on the environment from cradle to cradle) and social compliance (child labour, overall conditions for employees, etc.).

As a leading, objective arbiter of safety, quality, health and sustainability, we want to engage in meaningful market conversations about these important trends.

If you intend to build long-term brand value, CSR should be a crucial component of your company strategy.

Every Audit report includes a Corrective Action Plan with timeframes for implementation and recommended schedule for re-audit, where needed.

Customized audits

Capitalizing on experience with customers, in-depth knowledge and upstream approach, Eurofins can help you maximizing your QA budget and resources by applying a customized global audit protocol including elements of Management, Technical, Environmental and Ethical Audits.

The objective of such customized Audit, other than saving cost and time, is to provide an unbiased global image of your supplier’s organization in all relevant fields.

Product Inspections

European inspection service is one of the youngest business lines, currently in process  of quick expansion.

Nowadays Eurofins covers extended geographical areas in China, India and Vietnam, in locations close to the main production hubs.

Inspection standards

ISO 2859-1

  • Unless otherwise required by the client, inspections are performed according to the sampling methods on the ISO 2859-1 standard and sampling method MIL-STD-105E.
  • By default, the general inspection sampling plan shall be level GII for the overall inspection and S2 - special inspection level - for the onsite thorough check.

Level of acceptable quality (AQL)

  • Following the default AQL GII and S2, above mentioned and according to market standards, Eurofins follows the below indicated Defect Classification ratios:
    • Minor: 0
    • Major: 5
    • Critical: 0% (not allowed)

Determination of the sampling size

  • The sampling size is determined in accordance with ISO285
    (Eq. MIL-STD-105E).

Acceptance or rejection of a batch

  • Based on the code letter as deducted from the previous chart and the corresponding sample size (here, on the rows) and the AQL determined for each concerned product category (here, in the columns headers), the matrix at the right throws the numbers of items for a batch to be accepted or rejected (pass or fail).

Inspection criteria

Basics

  • The check list for each product category is thoroughly worked out according to industry best standards.
  • Such check lists can be divided into the following sub-categories: quantitative, qualitative, product packaging and functionality.
  1. Quantitative check
  • Each batch is compared against the P/O transmitted by the client in order to ensure compliance with the ordered quantities.
  1. Qualitative check
  • Quality of the production process.
  • General appearance of the product and packaging.
  • Compliance with the approval sample or product specifications.
  • Compulsory shipping marks and labelling in accordance with the country of destination.

 

  1. Product packaging check
  • Assortment and quantitative verification.
  • Control of packaging (outer and inner cartons, gift box…).
  • Control of different markings and labels on product or on packaging (if requested).
  • Correlation between different product descriptions (instruc-tion manuals, plates, labels, etc.).
  • Instruction manuals.
  • Shipping marks and compulsory marking on packaging.
  • Dimension and weight check

 

  1. Functionality check
  • Based by default on AQL Special level 2.
  • Assembly and components fitting check.
  • Dimension and weight check.
  • Functionality and performance (+ endurance, where applicable).
  • Safety check.
  • Carton drop test (see next section).

 

Carton drop test

  • Unless otherwise specified by the client, Eurofins shall follow below criteria:

Defect classification

  • Critical defect

A defect that is likely to result in hazardous or unsafe condition for an individual using the product or that it contravenes mandatory regulations.

The product may endanger its user.

  • Major defect

A defect likely to result in failure reducing the usability of the product or obvious appearance defects affecting the sale ability of the product.

  • Minor defect

A defect that doesn't reduce the usability of the product, but where the workmanship is beyond the benchmarked quality.

Inspection report results

Anti-corruption control

Integrity is a major commandment at Eurofins  and therefore, “corruption prevention” constitutes one of the key focuses of our corporate Code of conduct and ethics.

Our systems & measures to enhance compliance with our Code of Conduct are closely monitored and reviewed.

Systems

  • Stringent labour contract including, among other, the prohibition to accept any gift or special favour.
  • Regular enforcement of Eurofins’ Code of Conduct
  • Signature of “Integrity agreement” prior to commencement of all inspections
  • Regular internal audits of the processess
  • Complaint procedure available for clients to report any suspected impropriety.

Measures

  • Management involvement guaranteed in case any departure from the corporate standard would be revealed.
  • Discipline: stringently imposed. Offenders are systematically weeded out after full-scale investigation.
  • Complaint procedure available for clients to report any suspected impropriety.
  • Liability clauses are displayed on agreements and in our Terms & Conditions.

Initial Production Inspection

Specially advisable in case of complex or high risk products, to make sure the product launched into mass production matches exactly with the product specifications of the approved or validated sample.

To be performed ideally by the time 10% of the production is completed.

The service includes:

  • Raw material check (quality, quantity and origin - if critical) against the approved sample and specifications and the PO (Purchase Order) provided by the client.
  • Random selection of the initial output and semi-finished components to identify possible defects or deviations.
  • Analysis of the process and provision of technical advice (corrective action plan), where applicable.

During Production Inspection (DPI or DuPro)

Typically perform on high risk products in order to prevent errors and to have the time to make modifications before the production would be concluded.

To be ideally performed when approx. 10% to 20% of the production has been completed.

The service includes:

  • Verification about the possible discrepancies from the client’s approved sample or specifications.
  • In case a previous IPI was performed, check that the corrective actions have been implemented.
  • Analysis of each stage of the assembly process.
  • Reporting and presentation of corrective action plan where applicable.

Final Random Inspection / Pre-Shipment Inspection

Also commonly known as Pre-shipment Inspection (PSI), this is an acceptance sampling inspection to be performed prior to shipment.

As a general practice, pre-shipment inspections are performed when 100% of the goods are ready and the packaging status is  at least at 80%.

The service includes:

  • The sampled goods, randomly chosen according to ISO2859-1 (equivalent to MIL-STD-105E) or otherwise if so specified by the client, are then checked piece by piece.
  • The nonconformities found are classified into three categories (critical, major and minor).
  • Based on the selected AQL (Acceptable Quality Level), the client will be able to determine the acceptance or rejection of the products.

Loading Check

Especially advisable in case of new suppliers, not yet completely familiar with your logistics, to make sure the process is performed according to your loading plan and specific requirements.

The service includes:

  • Check on quantities and proper handling of the cargos.
  • Palletization control (if applicable).
  • Physical condition of the container.
  • Monitoring of the loading process.
  • Sealing of the container(s).

Other related or customized services

Picking

  • Random selection of samples out of the production, to be forwarded for lab testing.
  • This service can be performed during any of the inspections (DPI, FRI) or separately, at any stage of the production.

 

Market surveillance picking

  • Check on quantities and proper handling of the cargos.
  • Palletization control (if applicable).
  • Physical condition of the container.
  • Monitoring of the loading process.
  • Sealing of the container(s).

 

Flowchart of the Inspection service process

 

 

 

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