Product Safety

Our coaches utilize strategic partnerships with the FDA, USDA, and top industry institutes to promote best practices, improve food safety protocols, and ensure compliance with regulations.

We have co-authored and facilitated the creation and publication of PMMI’s OpX Leadership Network’s “By Industry, For Industry” Best Practices & Guidelines including:

  • Pathogen Reduction Validation
  • Clean-In-Place (CIP)
  • Allergen Cleaning Validation Checklist
  • Hygienic Equipment Design

FSO Institute also provides:

  • Thought Leadership with FDA insights on FSMA 204

Some thoughts you may wish to consider:

Strategic:

Will your company be prepared to identify the key tracking events and data elements needed for traceability in your supply chain when the FSMA 204 regulation is implemented in 2026?

Hygienic Equipment Design:

How do your company’s design standards and equipment selection processes work to ensure you are meeting the regulatory requirements?

Allergen Cleaning Validation Checklist:

What are your internal procedures to ensure your Allergen Control Plan is currently accurate and well communicated?

Is there a question you’d like to ask any of these experts? Don’t miss the opportunity!

Explore these recent articles that can enhance your search and provide valuable insights.

Explore more of the 12 Dimensions of Manufacturing Health

CAP EX

We have extensive program management experience overseeing over $20 billion in capital investments across all sectors of Consumer Packaged Goods (CPG), Food & Beverage, and Life Sciences.

MANUFACTURING

Over 620 years of plant and corporate leadership positions from small and mid-size companies to large multinationals. Applied Science, not Theory to improve throughput, lower COGs, reduce waste, and meet customer requirements.

Asset Reliability

Guided 500 manufacturing plants’ journey to implementing preventive and predictive maintenance systems—operational reliability achieved through uptime availability, significant OEE improvements, and capital avoidance.

Supply Chain

Achieved end-to-end supply chain operational excellence to enhance customer experience by focusing on lean improvements across 50 customer sites and over 250 co-manufacturers. 

Technology

Developed and implemented digital transformation strategies, Industry 4.0 roadmaps, and cyber risk solutions for over 100 companies. Enabling organizations to craft their roadmap aligned with their business needs and technological growth.

Packaging

Designed and implemented packaging lines across all package formats, line speeds, and technologies (Co-bots, AI vision systems, automation) that drove throughput and customer success.  

WORKER SAFETY

Over 80 companies have implemented our employee-driven safety programs, developed under the “Drive to Zero” initiative, resulting in an average reduction of 40% in lost time per company site.

WORKFORCE ENGAGEMENT

Programs like “Win the Day, Every Day” aim to enhance company culture by involving both employees and leaders in continuous improvement. By focusing on Buy-in, Ownership, and Advocacy (BOA), these initiatives have saved companies millions through improved yield, throughput, quality, and employee retention.

PRODUCT SAFETY

Our coaches utilize strategic partnerships with the FDA, USDA, and top industry institutes to promote best practices, improve food safety protocols, and ensure compliance with regulations.

QUALITY

Many of our coaches are trained as internal auditors by the FDA. They utilize lean practices, Six Sigma, and advanced control methods to ensure a quality improvement approach that emphasizes “getting it right the first time.” resulting in an average savings of 30% per site.

PlANT FACILITIES

Experience in designing, building, and managing manufacturing facilities with millions of square feet globally that met the strict regulations required in Life Sciences, Ready to Eat, USDA, and FDA production.

SUSTAINABILITY

Developed and managed sustainability excellence initiatives that achieved reduced carbon footprint in the supply chain, cost reduction of utility resources, and zero waste to landfill.

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