Regulatory

Tackling regulations can feel like swimming through  regulatory soup. Requirements and regulations are confusing and often conflict with each other. However, complying with regulations is not an end in itself. The goal of manufacturing is high-quality, profitable production. BFK Solutions helps companies successfully manage regulatory concerns in:

Worker Safety (eg. OSHA)
Community Safety/Local Environment (eg. SCAQMD)
Federal, Global Environmental  (eg. EPA)
Patient/Public/Product Safety (eg. FDA, RCRA, NADCAP)
Product Performance (eg. FIFRA, GMP)
Military specifications
Industry standards and guidance documents (eg. ASTM, ISO)
Customer specifications (eg. aerospace)

Activities

Review regulatory climate
Minimize hazardous waste
Set up favorable permits
Coordinate with legal advisors
Interact with regulatory agencies
Provide reports, declarations, testimony

Engaging the elephant
Far too often, regulatory compliance becomes the ‘elephant in the room;’ and manufacturing productivity suffers. Components manufacturers become trapped in a Catch-22 situation; they may jump from the frying pan into the fire by trading one hazard for another. They may analyze their way into paralysis. They may end up with a cleaning process that performs poorly. They may end up with processes that are dangerous to workers, with processes that are harmful to the environment, with processes that to not meet even minimum regulatory requirements.

BFK Solutions help you engage the elephant. We assess the regulatory situation; we clarify the regulations, and, sometimes with your permission, we head off problems by having you sit down with someone from a regulatory agency. BFK Solutions helps our clients achieve critical cleaning and other manufacturing processes that are effective, defendable, and that meet or exceed regulatory requirements.   We work with individual companies, with the military, and with trade associations.

Resolving regulatory problems
Sometimes, even careful, conscientious companies come under serious regulatory scrutiny. BFK Solutions helps resolve the problem as quickly and productively as possible.

We review your manufacturing and monitoring activities. We may suggest performance or analytical tests. We coordinate with your safety/ environmental professionals and legal advisors.

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