Understanding Manufacturing Information
Manufacturing information provides detailed documentation about the processes used to produce your product, including production methods, assembly instructions, and material specifications. It's crucial for regulatory compliance, quality control, and traceability, particularly under GPSR, CE marking (EU), and UKCA marking (UK).
What is a Bill of Materials (BOM)?
A Bill of Materials (BOM) is a comprehensive list detailing all components, materials, and parts required to manufacture your product. It typically includes:
Component names and specifications
Material types and grades
Quantities and unit measurements
Supplier details and certifications
Why Manufacturing Information and BOM Are Important
Providing accurate manufacturing information and a BOM is essential to:
Ensure compliance with safety and regulatory requirements.
Maintain consistent quality and production standards.
Provide traceability for product audits and potential recalls.
Manufacturing Information & BOM for Different Scenarios
1. Products Manufactured within the EU/UK
When manufacturing products locally in the EU or UK:
Obtain detailed product specifications from your local supplier/manufacturer.
Ensure they provide compliance documentation such as Material Safety Data Sheets (MSDS), Certificates of Compliance, and test reports.
Clearly document your local manufacturing processes.
2. Products Manufactured Outside the EU/UK
If your product is manufactured outside the EU/UK:
Request the full Bill of Materials from the factory.
Obtain test certificates, lab reports, and safety documentation (e.g., REACH, RoHS, CLP compliance).
Ensure the factory provides relevant declarations of conformity or compliance documents for raw materials and critical components.
Documents to Request from the Factory:
Material Safety Data Sheets (MSDS/COSHH) for chemicals or hazardous materials.
Product Testing and Certification Reports (e.g., mechanical tests, chemical analyses).
Quality Control and Inspection Reports from production.
Proof of Compliance with Relevant Standards (e.g., CE, UKCA standards, and GPSR requirements).
Traceability documentation (batch numbers, lot numbers).
Why Ask the Factory for Detailed Documents?
Requesting detailed documentation from your manufacturing partners helps:
Validate product safety and compliance upfront.
Reduce the risk of non-compliance and market recalls.
Facilitate smoother inspections and market entry in the EU and UK.
Using Euverify for Managing Manufacturing Information and BOM
Euverify simplifies the process by allowing you to:
Upload manufacturing processes and BOM directly to your technical files.
Securely store, update, and manage all manufacturing-related documents.
Easily demonstrate compliance to regulatory authorities.
Ensure seamless and consistent regulatory compliance by systematically documenting manufacturing information and your BOM.