Company products need to comply with various standards, regulations or tracking guidelines to conduct business in any country. Compliance can slow down product launches into the desired markets and even act as a barrier to entry. Some of the compliance examples are:
- Environment and safety regulations set by the FDA
- SEC regulations
- Substance environmental compliance like 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 allow companies to manage product policies and to use the built-in compliance framework. The Agile PG&C module helps organizations define, track, calculate report and manage the product regulated information and validates that the product meets compliance specification and standards.
Why Implement Agile PG&C
Reasons for compliance initiative may be due to the following reasons:
- New product design or product revisions
- Selling/Shipping the Product to the geographic region requiring compliance
- Special labeling required for certain markets
- High recycling cost
The ideal time to implement the system solution for the product compliance is during product design. Compliance in the late stage or post launch can lead to delay in time to market, increase product cost, increase cost of rework, reduce product success rate and hence reduce the overall product portfolio value. Oracle Agile PG&C solution allows integrating substance information that is relevant to substance regulation into the Agile Product Lifecycle Management system in record time that makes this information immediately available to engineering, manufacturing, purchasing, quality, sales, and regulatory personnel and thereby ensuring product compliance.
Compliance Information Gathering Process
Data for the substance declaration for the components can be from the:
- Third part content provider
- Internal teams
Substance declaration can be loaded by the supplier directly into the Agile PG&C application. For example, Institute for Printed Circuits -Materials Declaration Management format (commonly called IPC 1752) substance data can be exported from or imported into the Agile PG&C. Similarly other formats can also be imported into the application. Compliance can be calculated or rolled up in Excel. All the bill of material levels can be rolled up at once by using the ‘Calculate Compliance’ button or by running the scheduled 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 if the substance information is fully declared, partially declared or missing specifications.
The following predefined Compliance Reports are included with the out-of-the-box Agile PG&C:
- Part Compliance Report
- Part Groups Compliance Report
- Parts with Compliance Issues Report
- Parts with Substances Report
- Parts with Substance over PPM Report
- Supplier Compliance Report
- Missing Substances Report
- Declaration Workflow Metrics Report
- BOM Compliance Report
Compliant records are saved in the database and non-compliant records need to be routed to the non-compliant Environment Engineer or Component Engineer for further action and involves:
- Sending declarations to supplier and manufacturers
- Design engineering group to make changes to the design to make it compliant
The Product Governance and Compliance initiative can improve time to market, reduce product cost, minimize cost of rework, increase product success rate and hence, improve the overall product portfolio value for any company. Regulatory and environment compliance requirements included during the product design stage along with the proactive monitoring can help the companies improve product performance and stay compliant most profitably. Agile PG&C implementation can be a quick way to achieve regulatory and environmental compliance.