Frequently Asked Questions – Compliance Documentation Services
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:
Why is good Compliance Documentation important?
- 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 stop 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
What is required as Compliance Documentation?
Specific requirements vary based on the regulations, but generically:
- Declarations of compliance or material content in components and end products
- Information on risk analysis of materials, parts, and assemblies/sub-assemblies
- Technical documents to show the relationship of conformity documentation between materials, part, 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
What are the responsibilities of a manufacturer to document compliance?
The responsibilities vary with the industry and regulations, but generally, Manufacturers should:
- Identify applicable regulation 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 level of compliance for materials used inhouse during manufacturing
- Perform regular risk analysis, internal and external audits to evidence conformity
- Generate reports based on the documentation, on status of compliance
- Retain compliance documents for reporting purposes
How can I improve the quality of compliance documentation?
- Define documentation requirements clearly internally as well as to suppliers.
- Conduct compliance training to 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 certification requirements into vendor qualification and onboarding process
- Establish record retention processes to ensure compliance documentation is maintained and refreshed as needed to stay compliant