Factory Audit
A Factory Audit is the systematic assessment of a Manufacturer‘s production conditions within the framework of certain Conformity Assessment procedures. In EAC Certification, an assessment of the production conditions may – depending on the applicable Technical Regulations (TR EAEU / TR CU) and Certification Scheme – form part of the certification of serially manufactured products.
The primary objective of a Factory Audit is to assess whether the existing production conditions enable the consistent manufacture of certified products in accordance with the specified requirements. Both technical and organizational aspects of production as well as, where applicable, the Quality Management System are taken into account.
Depending on the product and Certification Scheme, a Factory Audit may include, among other things, the following areas:
- assessment of the production processes,
- review of internal quality control and, where applicable, the Quality Management System,
- assessment of the testing and measuring equipment used,
- review of production-related records and documentation,
- review of incoming, intermediate and final inspections,
- assessment of traceability,
- handling of non-conforming products,
- as well as review of other production conditions relevant to Product Compliance.
Unlike Product Testing, which examines and evaluates specific characteristics of the product, a Factory Audit focuses in particular on the production conditions and their ability to ensure consistent Product Compliance. The requirements for a Factory Audit depend on the respective Technical Regulation and the applicable Certification Scheme. In particular, as part of a Serial Production Certification, an assessment of the production conditions may be required before an EAC Certificate is issued.
This may be relevant, for example, for machinery and equipment, equipment for use in potentially explosive atmospheres, pressure equipment and low-voltage electrical equipment. Whether a Factory Audit is actually required must, however, be determined on the basis of the specific product, the applicable Technical Regulation and the intended Certification Scheme.
As part of the Audit, sections of the Technical Documentation as well as production-related evidence may also be taken into account. Of particular importance is whether the documented technical requirements correspond to the actual production conditions and whether consistent Product Compliance can be ensured.
The results of the Factory Audit are documented and taken into account by the responsible Certification Body as part of the Certification Procedure. If significant non-conformities are identified, corrective actions may be required before an EAC Certificate can be issued.
A Factory Audit as part of the initial certification should be distinguished from Inspection Control during the validity period of the certification. Where such control is provided for by the respective Certification Scheme, it serves the purpose of Production Surveillance and verifying whether the conditions for the existing certification continue to be fulfilled. Depending on the respective procedure, Inspection Control may also include an Inspection Audit.
Careful preparation for the Factory Audit can help avoid delays in the EAC Certification Procedure. This includes, in particular, reviewing production documentation, ensuring the availability of relevant testing and measuring equipment, and maintaining traceable documentation of quality-relevant production processes.
We support Manufacturers in preparing for Factory Audits as part of EAC Certification. This includes reviewing the required Technical Documentation, coordinating regulatory requirements and liaising with the responsible Certification Body.