With the European Union’s Restriction of Hazardous Substances (RoHS) Directive set to take effect on July 1, manufacturers who ship to Europe must ensure that their products are compliant with the legislation and do not exceed maximum concentration levels of six controlled substances. While most manufacturers are well on their way with assessing Bill of Materials (BOMs) and collecting evidential documentation, many do not have robust data management capabilities in place.
Reliable Data Management
Reliable data management is key in proving compliance or demonstrating due diligence. Many companies use spreadsheets and file servers to track and document compliance.
While at first glance this may seem to be the obvious tool, a recent RoHS readiness survey showed that 78% consider themselves at high or even severe risk based on a lack of robust and scalable document management capabilities.
Others are using Enterprise Resource Planning (ERP) solutions to help document their efforts. Many are finding that ERP, which is more designed for financial analysis and material management, is the right tool for the job but, unfortunately, most ERP solutions do not provide the flexibility to support scalable compliance management, and the extensive customization required would be detrimental to future upgrades.
Instead, many manufacturers are turning to Product Lifecycle Management (PLM) solutions for their ability to track compliance status throughout the development, testing and manufacturing stages of a product’s lifecycle. Managing the mountain of compliance-related information requires manufacturers to develop a robust data management initiative with an automated PLM system at its core.
Seven Tips For RoHS Compliance
Follow these seven tips for using a PLM solution to ensure you have a solid RoHS compliance documentation strategy:
Tip #1: Read the regulations and guidance documents. Then read them again.
As with any industry regulation, a first step to ensuring compliance and the ability to demonstrate it is to understand the requirements, exemptions and the enforcement aspects of the RoHS legislation. RoHS requires manufacturers to know the compliance status for each part and material in their product, by homogeneous material, defined as a single substance that cannot be mechanically disjointed into different materials.
By placing their products on the market, companies are declaring that they are in compliance and have the documentation to support that claim. In the case of non-compliance, for example due to quality problems with a supplier, a company may offer a defense of due diligence by proving it has taken reasonable steps to avoid committing the offense. This can be done by putting proper controls in place and documenting their effectiveness in order to support the defense.
Knowing what to document, and how, is key in dealing with RoHS. Although the legislation does not refer to anything more than a “technical file” and “sufficient evidence,” several guidance documents and articles have been published providing more insight to implementing sound documentation practices.
Tip #2: Centralize all product and compliance records.
Making sure everyone works from a single centralized set of product and compliance data will greatly improve efficiency and reduce errors. Because RoHS applies to the entire product, including non-purchased (i.e. expensed) materials like solder paste, standard fasteners, tie wires and glue, a first step is to have a system where you capture the complete BOM and not just purchased parts.
Secondly, compliance data should be accessible in real-time by engineering to enable efficient design based on dynamic environmental compliance requirements. In addition, purchasing, manufacturing and quality organizations need access to the compliance data in order to implement compliance controls and record results like part screening and supplier audit reports back into the compliance record. Centralizing this information with the manufacturing data can help ensure compliance and save time and resources during an audit.
Tip #3: Understand your full data management needs.
In order to actually demonstrate compliance and, if needed, due diligence, a manufacturer needs to track more than just a compliance checkmark. To maximize efficiency, a compliance management solution needs to be able to capture all relevant compliance information in a reliable and scalable manner. Examples of best practices are:
- Tracking compliance against the internal part number, based on the compliance status of all qualified manufacturer parts on the Approved Manufacturer List (AML). This ensures all parts are accounted for and approved for production. It also enables users to track compliance of non-purchased materials and made-to-order parts for which no manufacturer part numbers are defined from the same system. Thirdly, it allows for compliance roll-up through the assembly levels to the product level, ensuring a greater degree of accuracy.
- Storing compliance evidence directly with the internal or manufacturer part number. Whether the evidence is a Certificate of Compliance, a Material Declaration or RoHS compliance called out in the specifications combined with inspection test reports, it is critical to ensure this information is readily and easily accessible for reporting.
- Tracking attributes like RoHS contamination risk and compliance rationale provide additional context for auditing purposes.
- Tracking compliance status by revision. Every item and assembly may change over its lifecycle, which may affect its compliance status. For example, adding a new manufacturer part to the AML and rolling its revision requires the manufacturer to review the part for RoHS compliance and add new compliance evidence to the compliance record.
Tip #4: Document with reporting in mind.
Compliance is not just about converting BOMs, but about demonstrating compliance upon request. Keep in mind that most auditors won’t understand the nuts and bolts of your product; instead, they may focus on verifying the completeness, accuracy and the documentation process of the compliance report. As mentioned before, a checkmark is not sufficient evidence.
The rationale behind a part number’s compliance must be documented so auditors can understand the relationship between the status and the evidence provided in the compliance report. This practice significantly improves the accessibility of the information, and reduces time-consuming clarification processes. Additionally, it’s good practice to document exemption claims. It may take a minute to capture while determining the exemption, but is significantly more difficult to recall after four years.
Current regulations require the compliance record to be kept for four years after the product has been put on the market. Since it’s not feasible for document control personnel to remember the locations of each evidence file, it’s critical to implement a data management solution that maintains complete product and compliance histories over the long term and is easy to find and access.
Tip #5: Build due diligence into your key processes.
Besides controlling the design process, manufacturers must be prepared to demonstrate other process controls and docum