Question:
When compiling Full Materials Disclosure (FMD) data from suppliers, what percentage of completion is sufficient for risk assessment purposes?
Answer:
Gaps in material data — whether the result of a part without an FMD or the omission of certain proprietary information — can introduce risk. To ensure their full bill of materials is covered with some form of valid supporting documentation, companies often use a combination of FMDs and negative declarations, which are documents providing evidence that a product has no negative effect on the environment.
If a gap in material data still remains, companies must assess the possibility of material risk based on the ingredients and processes used to manufacture the product. Companies should ask a few questions regarding suppliers:
- Are there processes and contractual obligations in place to support supplier reliability and consistency in raw material or component selection?
- Is there a robust quality management system in the manufacturing process?
- Are storage controls in place to prevent mixing compliant and non-compliant materials and components?
In cases where the answers to these questions raise red flags for non-compliance, companies may test product composition as a final resort to ensure they are covered.
Article current as of 2019-11-08.
See also: FMDs and Confidential Information; FMDs, Tolerance Limits, and Data Requirements; Supplier Survey Completion under REACH and RoHS
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