Implement the practice of Root Cause Analysis (RCA)
Version 1 - Last updated
24 Sep 2025
If a non-conformity is found in the final product for customer-specific or regulatory reasons regarding restricted substances, facilities should implement a root cause analysis (RCA) that includes:
- Trace the affected batch of finished materials back to the exact input material batches used in its production.
- Identify the supplier(s) associated with those input materials.
- Investigate the identified input material batch and associated supplier for:
- Supporting documentation such as self-declarations, test reports and certifications linked to the input batch.
- Root cause i.e potential contamination or intentional use or other factors.
- Supplier's history of compliance and any previous issues.
- Document all findings and conclusions from the RCA process.
- Identify the root cause and possible solutions.
- Document and execute corrective actions to address the specific issue.
- To avoid similar incidents in the future, take preventive steps.