Factory Production Control

In accordance with the Regulation of the European Parliament and of the Council (EU) No 305/2011 of 9 March 2011 Factory Production Control (FPC) means the documented, permanent and internal control of production in a factory, in accordance with the relevant harmonised technical specifications.

Regardless of the applicable assessment and verification of constancy of performance system (AVCP), the manufacturer is obliged to implement and apply factory production control.

In other words, the FPC is a system of permanent, internal supervision over the production process and accompanying processes having a significant impact on the compliance of the product with the requirements of reference documents. All elements of the system, requirements and provisions adopted by the manufacturer should be documented in a systematic manner, in the form of rules and procedures, including test records. Factory production control should be adapted to the production technology and ensure that the declared performance of the product is maintained in series production.

FPC system documentation should include:

• Organization scheme.
• The responsibility, authority and the relationship between personnel that manages, performs or verifies works affecting products conformity shall be defined. Personnel performing work affecting product conformity shall be competent on the basis of appropriate education, training, skills and experience for which records shall be maintained.
• Internal audits, corrective and preventive actions.
• Supervision of documentation and records.
• Raw materials and components testing plans. Requirements. The specifications of all incoming raw materials and components shall be documented, as shall the inspection scheme for ensuring the conformity.
• Plans for control and testing of the finished product.
• Supervision of production equipment.
• Supervision of control and testing equipment. All weighing, measuring and testing equipment necessary to achieve conformity shall be calibrated or verified and regularly inspected in accordance with documented procedures, frequencies and criteria. All equipment used in the manufacturing process shall be regularly inspected and maintained.
• Supervision over the production process, including inter-operation control of the product.
• Descriptions of subcontracted works and way of their supervision.
• Handling with non-conforming products and with complaints.
• Describtion of packaging, transport, storage and product labeling.

The FPC documentation should be supplemented with technical documentation, technical specifications (product standards, testing standards, European or national technical assessments, etc.), legal regulations.

Manufacturers having an FPC system, which complies with EN ISO 9001:2015-10 series and which addresses the requirements of references documents are recognized as satisfying the FPC requirements.