Criterion: Materials Restrictions
Requirements for compliance with prohibited and restricted substances in products
Full Description
E2. Materials Restrictions
Code 7.0
Participants are to adhere to all applicable laws, regulations and customer requirements regarding 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. Statements and/or certificates of conformance and analytical data are provided to its customers upon request.
3. Controls & Monitoring
Controls & Monitoring should include:
- a. How conformance with Material Restriction requirements is ensured, including the detail of the formal program in place including product testing and documentation requirements.
4. Records
Records are maintained including:
- a. Chemical composition of products is on record.
- b. Specifications, statements and/or certificates of conformance from its Suppliers.
- c. Monitoring & reporting records from the past 3 years are available and ready for review.
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. Additional assistance
The following practices provide additional assurance but are not required minimum elements for conformance:
- a. Regular audits and assessments of the procedures are performed to verify conformance.
- b. A formal process is in place to address discovery of non-compliant materials or components and corrective actions are tracked and implemented.
- c. Additional actions taken to ensure completion at due date if corrective actions are not on track.
- d. Analytical data from material/parts Suppliers is requested/required.
6. Serious conditions that will result in a severe finding
- No program is in place AND a product has been subject to regulatory action.
Profiles using this criterion
RBA Assessment Program
- VAP Full Assessment | 7.0.0
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 (2021-01-01)
Changed
- Initial historical baseline — Materials Restrictions (RBA Code of Conduct 7.0, then C6): Earliest imported version. Participants adhere to all applicable laws, regulations and customer requirements on prohibition/restriction of specific substances in products and manufacturing, including labeling for recycling and disposal. Binding conformance covered a documented program to measure/document chemical composition, customer-requirement comparison, supplier conformance documentation, and 3-year records. Regular conformance audits, the corrective-action process for non-compliant materials, off-track follow-up actions, and supplier analytical data were non-binding 'Additional assistance' only. Explicit Major/Minor rating bands applied (Major = no program OR two or more minimum elements missing/ineffective; Minor = one element missing).