Criterion: Materials Restrictions
Requirements for compliance with prohibited and restricted substances in products
Full Description
E2. Materials Restrictions
Code 8.0
Participants shall adhere to all applicable laws, regulations, and customer requirements regarding the prohibition or restriction of specific substances in products and manufacturing, including labeling for recycling and disposal.
Elements to Demonstrate Compliance to RBA Code
1. Policy
Ensure the facility environmental policy includes material restriction elements including:
- a. Adequate and effective program is in place for materials restrictions as a formal part of the procurement and manufacturing processes.
2. Procedures & Practices
Procedures & Practices are in place at the corporate and, as applicable, the facility level.
- a. Assigned responsibility.
- b. Adequate and effective procedures to measure and/or document the chemical composition of products including:
- i. A documented review process for comparing customer requirements to own specifications.
- ii. A documented process to ensure materials, packaging and components procured are in conformance with customer requirements.
- iii. Documented requirements for conformance with the Material Restrictions required to its material/parts Suppliers.
- c. The facility provides documented requirements for compliance with the product content restrictions to its material suppliers/parts suppliers.
- d. Analytical data from material/parts Suppliers is requested/required.
- e. The facility obtains specifications, statements and/or certificates of conformance from its suppliers and these documents are available for customer review.
- f. The facility requires analytical data from its material suppliers/parts suppliers, and the data is available for customer review.
3. Controls & Monitoring
Controls & Monitoring should include:
- a. The facility performs random analytical testing of material suppliers/parts suppliers are audited to ensure compliance with restriction on substances, and the data is available for customer review. Testing methods comply with applicable codes, regulations, and customer requirements.
- b. A formal process is in place to address discovery of non-compliant materials or components and corrective actions are tracked and implemented.
- c. Added actions are taken to ensure completion by the due date if corrective actions are not on track.
4. Records
Records are maintained including:
- a. Chemical composition of products is on record.
- b. Specifications, statements and/or certificates of conformance from suppliers
- c. Monitoring & reporting records from the past 3 years are available and ready for review.
- d. Statements and/or certificates of conformance and analytical data to be able to share with customers and authorities as required/requested.
NOTE: Records then need to be carefully maintained and accessible during a Corporate or facility level assessment. Evidence of the entire effort regardless of where it occurs will be required to be shown in an RBA VAP.
5. Serious conditions that will result in a severe finding
- There no Material Restriction program is in place AND a product has been subject to regulatory action.
Profiles using this criterion
RBA Assessment Program
- VAP Full Assessment | 8.0.2
- VAP Full Assessment | 8.0.1
Pass Threshold Metrics
Metric: Program Absence with Regulatory Action
Type: Regulatory action without program
Threshold: true → Priority
Conformity Alignment
Priority
Pass: No
Definition: "Critical non-conformance requiring immediate action"
Remediation: 30 days
Major
Pass: No
Definition: "Significant non-conformance requiring corrective action"
Remediation: 90 days
Minor
Pass: Yes
Definition: "Non-conformance with limited impact"
Conditions: Corrective action plan required
Remediation: 180 days
Opportunity
Pass: Yes
Definition: "Opportunity for improvement identified"
Conformance
Pass: Yes
Definition: "Full conformance with criterion requirements"
Related Criterion
VAP: Supplier Responsibility
Relationship: Related
Supplier material conformance requirements
Change Log
1.0.0 (2024-01-01)
Initial release.