As climate change continues to wreak havoc worldwide, the focus on complying with environmental regulations is also increasing. This focus is not restricted to only international or national-level organizations; companies (local and multinational) are also moving proactively to ensure regulatory compliance. Agile PLM PG&C products are vital to this entire process.
Not acting proactively often delays product launches; hence it is imperative for companies to have a system that ensures compliance.
Reasons for Compliance Importance
Following are some of the reasons why compliance is becoming increasingly important:
- Corporate Standards set by the International Organization for Standardization (ISO 9000, 14000, 13485).
- Environmental and safety regulations, like the ones set by the U.S. Food and Drug Administration (FDA).
- Industry-specific regulations, such as those set by the U.S. Securities and Exchange Commission (SEC) or the U.S. Department of Defense (DoD).
- REACH (Registration, Evaluation, Authorization, and Restriction of Chemical Substances) – Provides a high level of protection for human health and the environment from using chemicals.
- RoHS (Restriction of Hazardous Substances) – Defines the restriction of the use of certain Hazardous Substances in Electrical and Electronic Equipment.
- WEEE (Waste of Electrical and Electronic Equipment) – Aim to minimize the impact of such equipment on the environment during the products’ life span and when they become waste.
- Restriction of Hazardous Substances (China RoHS).
- Waste of Electrical and Electronic Equipment (China WEEE).
- Japanese Green Procurement Survey Standardization Initiative (JGPSSI).
- Joint Industry Guide (standards adopted by international companies, including IBM, Dell, Hewlett-Packard, and others).
Oracle Agile Product Governance & Compliance (PG&C) enables organizations to manage all kinds of product compliances against government and industry standards/regulations. It integrates compliance into product development and new product introduction processes.
Thus, compliance is given due importance from the beginning, and all the key stakeholders are involved. The system ensures that new products and revisions to existing ones are compliant before they are released or moved to production.
Agile PG&C in the Product Lifecycle
The ideal time to implement product compliance is during the product design stage. If you implement compliance post-launch or at a later stage, it may lead to the following:
- Delay in time to market the product.
- Increased product cost.
- The increased cost of rework.
- Reduced product success rate.
- Reduced overall product portfolio value.
The Oracle Agile PG&C (Product Governance & Compliance) solution allows you to integrate substance information relevant to substance regulation into the Agile PLM system. Thus, this information is immediately made available to the engineering, manufacturing, purchasing, quality, sales, and regulatory personnel, thereby ensuring comprehensive product compliance.
Compliance Information-Gathering Process
Data for the substance information declaration for the components can be obtained from the following:
- Supplier
- Manufacturer
- Third-party content provider
- Internal teams
The supplier can load the substance declaration directly into the Agile PG&C application. For example, substance data in the Institute for Printed Circuits’ Materials Declaration Management format (commonly called the IPC 1752A standard) can be exported from or imported into the Agile PG&C.
Similarly, you can also import other formats into the application. You can use Microsoft Excel to calculate compliance. Use the ‘Calculate Compliance’ button or run a scheduled request to roll up all the BOM (bill of materials) levels in one go.
Compliance data can also be exported to Excel and rolled up using scenarios. Moreover, besides informing you about the compliant/non-compliant status, Oracle Agile PLM also indicates whether the information is missing specifications, is partially declared, or is fully declared.
Key Agile Product Governance & Compliance Features
- Compliance is linked to the product record.
- Declaration of compliance at the product level, component level, MPNs, or part groups.
- Full Material Disclosure Support.
- Substance & Bill of Substance, Compositions.
- Ability to define exemptions.
- Ability to exclude components/documents from the compliance rollup process.
- Manage material declarations and certificates of compliance.
- Automated compliance validation.
- Access to industry and third-party compliance data.
- Environmental compliance functionality.
- ROHS, WEEE, etc.
- Due diligence support.
- DOD, ISO guidelines, Conflict Minerals, etc.
Compliance Reports
The following predefined Compliance Reports are included in Oracle Agile PG&C:
- Compliance Report.
- Part Groups Compliance Report.
- Parts with Compliance Issues Report.
- Some parts with Substances Report.
- Parts with Substance over PPM Report.
- Supplier Compliance Report.
- Missing Substances Report.
- Declaration Workflow Metrics Report.
- BOM Compliance Report.
Key Benefits
- Track and maintain full compliance.
- Advanced workflow-based change-controlled process.
- Prevents costly delays and product recalls.
- Increases data transparency.
- Compliance information is maintained in the core Product Design Repository and can be linked to the product release process.
- Serves as a single source of truth for all compliance declarations and certificates.
- Flexibility to customize the solution based on organizational needs.
- Flexibility to generate custom reports.
- Ability to roll up compliance information from BOM.
- Flexibility to change the rollup process.
Product Governance & Compliance Process
Here is the process of how the basic compliance process in Agile PLM PG&C works.
Product Compliance Scenarios
To enter different markets, a product needs to comply with different standards. Some of these standards are simple, while others are quite complex. The Agile PG&C module helps businesses deal with both simple and complex scenarios.
Simple Compliance Scenarios
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Finished Good Level Compliance
Product-level compliance is the disclosure of compliance information at the finished goods level. Such cases usually fall under safety compliance, where only the top-level assembly is required to disclose instead of the entire BOM of the product.
In this case, PG&C can directly mark your finished goods as compliant using either a declaration or process or by intentionally marking the product as compliant based on the compliance certificates an organization receives from the manufacturers.
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Assembly Level Compliance
Part-level compliance refers to providing compliance information for the product assemblies used in the product BOM structure. PG&C delivers the capability to create declarations for the top-level assemblies where compliance information from their child components is ignored.
Also, a user can only provide compliance information for that specific product by creating a single declaration for each assembly or by adding multiple assemblies into a single declaration.
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Part Group Level Compliance
Part group-level compliance is the disclosure of compliance for a set of parts that share common properties. PG&C allows businesses to group similar parts into a part group and declare them all in one go instead of creating multiple declarations for each of the similar components. The system will roll up PLM software to assembly and finished goods levels.
Complex and Detailed Compliance Scenarios
When it comes to disclosing compliance information at the material or substance level, the organization’s suppliers or manufacturers must provide slightly detailed and comprehensive information.
Standards provide the threshold mass in parts per million units at this level and require the organization to disclose the material and substance composition used in their products. Agile PLM PG&C provides this capability to disclose your products at the Bill of Substances level and when the need arises.
There could be the following two scenarios:
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Substance Level Compliance
When all the substances used to manufacture a product’s components must be disclosed, PG&C provides the capability to add the component to the declaration and disclose all substances mandated by the governing body.
The system allows you to select the standard, map it against the component, and automatically add all the substances mandated by the selected standard. Then the compliance engineer or the supplier – whoever is the collaborator on that specific declaration object – must provide the mass information on those substances.
The system then automatically calculates the compliance status against the provided mass and the threshold defined by the selected standard. If the disclosed mass is under controlled limits, the system marks that component as compliant or considers it non-compliant.
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Homogenous Material Declaration
To disclose product compliance with environmental standards, it is usually mandatory to examine the product in depth, from the BOM (Bill of Materials) structure to the BOS (Bill of Substances) structure.
This structure follows the Components, Materials, Substance Groups, and Substances hierarchy. In such cases, the mass at the substance level must be disclosed, which will then rise to the substance group level and aggregate to the material level.
It will finally identify the component’s compliance state, which will be the ultimate deciding factor for the finished good’s compliance. PLM offers a separate class of “Homogeneous Materials Declaration” to deal with such scenarios and some OOTB (Out of the Box) automation to ease the compliance calculation process for compliance engineers.
Conclusion
Product governance and compliance is a rich tool for gathering, tracking, and reporting compliance from every aspect of industrial needs. The tool is also flexible in implementation; it helps organizations pick and choose according to the complexity of their processes.
Regardless of the business’s complexity, Agile PG&C allows users to implement the approval process in the compliance information-gathering process with fully customizable workflows. This helps push only the approved content to the item master.
PG&C effectively binds the objects involved in the compliance process, like Items, documents, standards, and certificates, by introducing simple checks and notations to view the compliance information directly from the finished goods level.
Companies have benefited from implementing the Agile PLM PG&C module by utilizing it as a single source of truth for product ideation, product management, compliance information gathering, record-keeping, and reporting.
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