Managing PFAS Risk: Secure Operational Assessments

Risk Assessment, Liability Assessment, and Material Substitution

The PFAS Operational Assessment process, led by Ramboll, focuses on identifying potential risks and liabilities arising from the current or historical presence, use, and/or environmental release of per- and poly-fluoroalkyl substances (PFAS) associated with products and facilities. 

The role of SES/Force-4 (a Division of Stress Engineering Services) is to support material substitution related to PFAS abatement. SES/Force-4 has more than 3 decades of experience developing design and materials solutions for products, devices, and process equipment in the medical device, pharmaceutical process, pharma drug delivery, and consumer products industries.   

Data Security is Paramount 

The Operational Assessment Process (OAP) includes a series of workstreams that are designed to extract data regarding the composition of all chemistry that makes its way into a product and the environment, both intentionally and unintentionally. Because all the data is highly confidential to the manufacturer and the suppliers to the manufacturer, the backbone of the process is the SafeChainTM private blockchain. SafeChainTM is an immutable ledger that leverages AWS’ private blockchain architecture. SafeChainTM offers a secure data management solution that is immutable, traceable, and transparent.

Ultimately, regulatory requirements will require proof of compliance and supply chain partners will be asked to make data available to their customers that is typically confidential. SafeChainTM  is designed to be a “firewall” between the manufacturer and their supplier’s data via a managed blockchain service where the data is maintained confidentially by the Ramboll/SES team, on behalf of both parties, in a confidential, immutable ledger.  

PFAS Operational Assessment Process

The OAP Process begins with four parallel workstreams.

1. SDS Data Sheet Mining

Most corporations maintain records in the form of SDS documents to memorialize the chemical composition of their products and materials used in their manufacturing operations. At present, because of the diversity of chemistry that falls under the PFAS umbrella, the majority of suppliers may be unaware of whether or not a compound or constituents being used violates PFAS regulation somewhere. For this reason, Ramboll has developed an automated, software-based tool that analyzes data from SDS documentation and identifies suspect chemistry. If identified, further investigation can be initiated to leverage the diverse subject matter experts at Ramboll and SES. 

2. Confidential Supply Chain Data Mining

PFAS compounds can make their way into a product along a multitude of pathways from anywhere in a supply chain. These situations require a deep dive into the supply chain and the chemistry of products that may be used by the suppliers themselves. To that end, the Ramboll/SES team will manage an effort to work with your suppliers as a confidential interface to help them uncover all information necessary upstream of their commercial relationship with our client to characterize the constituents of the products they supply. SafeChainTM is critical to the successful completion of this workstream. 

3. Internal Manufacturing Operations Review

PFAS contact can occur indirectly, outside of product chemistry or formulation. Common substances used as manufacturing aids, such as “line lube” on filling lines, mold release in injection molding, grease/lubricants, o-rings in process, and reaction vessels, to name a few, can introduce PFAS. Based on the priority established by the Client Leadership Team, a technical team of engineers and chemists will visit client facilities and “walkdown” the manufacturing operations with client manufacturing staff and identify potential sources of PFAS introduction. Working with the client’s manufacturing organization, a process will begin to assess materials and consumables that have been identified and supplied by vendors to the manufacturing organization. The process of investigation is identical to that described in (2) above, with all data and results being secured in the SafeChainTM blockchain architecture.

4. Regulatory State, System Status and Risk Assessment 

Risks and liabilities are dynamic in the present PFAS regulatory environment. This workstream begins by assessing a manufacturer’s risks and liabilities based on the local and global markets they serve. Differing requirements are emerging at state and federal levels in the US, as well as differing regulations in global markets. 

Results of this workstream are completed at the beginning of a project and updated continuously as the investigations and data from Tasks 1,2,3 and 4 are completed. Post-completion of the initial OAP, monitoring services are offered to enable manufacturers and product owners to maintain a current PFAS risk assessment for individual products, complete product portfolios, and facilities. 

Maintaining a Grasp on PFAS Regulatory Exposure

The PFAS Operational Assessment Process is designed to provide secure data acquisition, management, and reporting capabilities, and Risk Prioritization and Strategic Implementation Plan development to enable companies to meet the requirements of the rapidly evolving regulatory framework associated with PFAS.