Company products must meet different standards, regulations or guidelines for transaction tracking in each country. Compliance can delay product launches in the desired markets and even be a barrier to entry. Some examples of compliance are:
- Environmental and safety regulations issued by the FDA
- SEC regulations
- Environmental compliance of substances such as RoHS, WEEE, JEDEC, China RoHS and Japanese Green Initiative
The Oracle Agile Product Governance and Compliance (PG&C) module is used in conjunction with the Agile Product Collaboration module to enable companies to manage product policies and use the built-in compliance framework. The Agile PG&C module helps organizations define, track, calculate reports and manage product regulated information and validates that the product meets specifications and standards.
Why implement Agile PG&C
Reasons for the Compliance Initiative may be due to the following reasons:
- New product design or product revisions
- Sell / ship the product to the geographic region that requires compliance
- Special labeling required for certain markets
- High recycling costs
The ideal time to implement the system solution for product compliance is during product design. Late-stage or post-launch compliance can lead to delays in market launch, higher product costs, higher rework costs, lower product conversion rate, and therefore a reduction in the overall product portfolio value. Oracle Agile PG&C solution makes it possible to integrate substance information relevant to substance regulation into the Agile Product Lifecycle Management system in record time, making this information readily available to engineering, manufacturing, procurement, quality, sales and regulatory personnel and thus guaranteeing product conformity.
Compliance Information Collection Process
Data for the substance declaration for the components may come from:
- Third party content provider
- Internal teams
The substance declaration can be loaded directly into the Agile PG&C application by the supplier. For example, fabric data from the Institute for Printed Circuits -Materials Declaration Management (commonly called IPC 1752) can be exported from or imported into the Agile PG&C. Likewise, other formats can also be imported into the application. Compliance can be calculated or aggregated in Excel. All BOM levels can be rolled up at once by using the ‘Calculate Compliance’ button or by executing the planned request. Compliance data can also be exported to Excel and rolled up using scenarios. In addition to the compliant, non-compliant status, Agile also indicates whether the substance information is fully declared, partially declared or if specifications are missing.
The following predefined compliance reports are included with the ready-to-use Agile PG&C:
- Partial Compliance Report
- Subgroup compliance report
- Components with compliance issues report
- Parts with substance report
- Parts with PPM report content
- Supplier Compliance Report
- Report on missing substances
- Report Declaration Workflow Metrics
- BOM compliance report
Compliant records are stored in the database and non-conforming records must be forwarded to the non-conforming Environment Engineer or Component Engineer for further action and includes:
- Send statements to suppliers and manufacturers
- Design group to make changes to the design to make it conform
The Product Governance and Compliance initiative can improve time-to-market, reduce product costs, minimize rework costs, increase product conversion rates and thereby improve overall product portfolio value for any business. Regulatory compliance requirements incorporated during the product design phase, along with proactive monitoring, can help companies improve product performance and remain the most profitable. Agile PG&C implementation can be a quick way to comply with laws and regulations.