Compliance Documentation FAQs

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:

1. 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
2. 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
3. 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
4. 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
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