Compliance Documentation
Frequently Asked Questions
A well-established process to collect, store and refresh compliance documentation plays a very important role in compliance, while giving a competitive edge while entering new markets. Here are some of the frequently asked questions about Compliance Documentation:
- Documentation is a fundamental requirement to meet regulatory requirements globally.
- Compliance documentation is critical from a liability standpoint, to establish due diligence.
- Helps avoid compliance risks such as stopping shipments, fines, and fees.
- Be ready for compliance audits and inspections by authorities.
- Establish a strong footprint across the globe and explore new market opportunities.
Specific requirements vary based on the regulations, but generally:
- Declarations of compliance or material content in components and end products
- Information on risk analysis of materials, parts, and assemblies/sub-assemblies
- Technical documents show the relationship of conformity documentation between materials, parts, assemblies/sub-assemblies.
- Manufacturing documents and production records relating to material usage and processes followed.
- Reports indicating how compliance assessments were made for the end products.
- The responsibilities vary with the industry and regulations, but generally, manufacturers should:
- Identify applicable regulations for their products in different regions and countries.
- Collect and validate compliance documents such as Full Material Disclosure (FMD) and Certificates of Compliance (COCs) for the parts and materials they buy from third parties.
- Ascertain the level of compliance for materials used in-house during manufacturing.
- Perform regular risk analysis, internal and external audits to evidence conformity.
- Generate reports based on the documentation, on the status of compliance.
- Retain compliance documents for reporting purposes.
- Define documentation requirements internally as well as to suppliers.
- Conduct compliance training for all stakeholders, to improve understanding of regulations and documentation requirements.
- Establish well-defined supplier engagement programs, ideally with multilingual and multi-time zone coverage. This is usually more efficiently done by a service provider like ComplianceXL.
- Include compliance and certification requirements into the vendor qualification and onboarding process.
- Establish record retention processes to ensure compliance documentation is maintained and refreshed as needed to stay compliant.