PDXpert PLM Software
Materials management for regulatory compliance
Last update 2016-11-04
Regulatory compliance can be a complex and expensive task. PDXpert offers powerful tools for managing and reporting regulatory compliance, but each company has different needs and constraints, and there's no one-size-fits-all solution. Customer or regulatory agency reporting requirements — as well as vendor data availability and your internal component engineering resources — will dictate the appropriate system configuration. The goal is to anticipate long-term data needs while minimizing the current cost of compliance.
PDXpert attributes for materials compliance
Based on your regulatory reporting needs, compliance information can be managed at a variety of locations.
- File attachments and external links to supplier websites
- Part (home or partner)
- Standard attributes like the Meets regulatory compliance checkbox and the part Materials list, which is different than the BOM (bill of materials) list. Materials management includes supporting collections, such as Materials and Material Categories.
- References (for shared documents and their file attachments or external links to supplier websites)
- Files (for part-specific file attachments and external links to supplier websites)
- Custom attributes (checkboxes, dropdown selections, etc.)
Design options and their effects
Manage by partner organization
This simple, rather inflexible approach says that
- all parts from a given manufacturer either comply or don't; and/or
- your requirement is simply to pass along the manufacturer's compliance status without regard to how it affects the parts used in your product. That is, cumulative substance amounts aren't calculated.
Each PDXpert Organizations member form has current compliance statements attached to its Files list, or entered as standard text statements (Conflict:Yes, ROHS:Yes) in the Notes tab. These text elements can be extracted & reported in custom parts lists and BOM reports.
However, unless you're producing very simple products, this approach may not prove scalable in the long run. Regulatory compliance is normally associated with a manufacturer's parts rather than the manufacturer itself, and regulatory reporting often requires more than a "yes/no" assessment.
Manage by home part
This specifies your own requirements for compliance. Every part on the part's Sources tab has been examined and is shown to comply. If the home part changes to reflect a new regulatory requirement, then the source parts are re-qualified to ensure continued compliance. Requirements may be
- contained in revision or item file attachments & external links on the part record,
- shared across parts by adding a requirements/specification document with file attachment(s) to each affected part's References tab, or
- a series of custom attributes, such as Is REACH compliant and Is RoHS compliant checkboxes.
PDXpert supports this as a compromise approach. The built-in materials content and materials declaration reports assume the home part, not the source parts, contains mass and materials.
This provides an absolute guarantee of compliance, but with less product flexibility (you can't compensate at the assembly level for individual part non-compliance).
Manage by partner (source) part
Each source part contains its own compliance data. You can record all information that the supplier provides, without needing it immediately. For example, if the supplier claims China RoHS but your part does not require it, the partner part can still hold that value; later, when you wish to meet China RoHS, all sources can be queried and only non-compliant sources need to be examined (updated or removed). Compliance information is "passed through" the home parts, so that materials content as well as compliance conformance can be applied directly to an assembly. Percentage / PPM trade-off analysis at the BOM level requires individual part mass and a populated Materials tab.
This is the most flexible approach, but also requires significant investment in data recording, maintenance and reporting. It offers detailed insight into sourcing decisions — for example, having the compliance details for each source part allows desirable, but non-compliant, individual parts to be compensated by other parts in the BOM.
The options presented above can be mixed; for example, conflict minerals compliance could be handled at the home part while environmental compliance is managed on the source part. (Conflict minerals may require absolute compliance by every part on the Sources list, while environmental regulations may require only assembly-level compliance.)
Reconciling competing sources (one meets China RoHS, another meets Conflict Minerals) may require region-specific parts/products.
For more information on PDXpert materials management, see these PDXpert help topics:
- Part window reference > Materials tab (on line)
- Collections reference > Parts > Materials (on line)
- Collections reference > Parts > Material categories (on line)
- Collections reference > Parts > Material constraints (on line)
- Collections reference > Custom attrubutes (on line)
This application note was relevant to the PDXpert software release that was current at time of publication. Product changes since that time may affect its utility. We'd be happy to assist you in assessing the applicability of this note to your situation.