Case study - 2

U.S Food and Drug Administration guidelines

Grabbing Pills

A global top five consumer products company that manufactures and markets brand-name food products for consumers throughout the world.

Situation

With a legislative deadline looming over more than $260 million (Net Sales Value) worth of products, Bond Foundation had less than two years to reformulate, test, produce, and distribute over 450 of its products in order to meet the local municipalities deadlines for regulatory compliance using FDA guidelines. The existing internal corporate team was not able to handle the workload. Milestones were being missed, products were falling through the cracks, and the compliance program was behind schedule. Bond Foundation's goal was to complete 80% of the impacted products prior to the regulatory deadline, and meeting this goal was in jeopardy.

How we helped

The company decided that its best course of action was to seek a quick assessment from an outside source. They selected BlackSwan to review their current program management team structure and evaluate their existing methodology against industry best practices and current realities within Bond Foundation. After the assessment, they again called upon BlackSwan to assume management oversight for the compliance program.

 

BlackSwan quickly assembled an onsite team to apply more rigorous program controls relative to scheduling, cost estimating, resource projections and progress reporting (including the development of an executive dashboard with key metrics). To orchestrate an initiative of this magnitude, the program needed to be managed as a coordinated effort.

 

BlackSwan’ onsite team interacted with nearly 150 internal staff and external vendors representing 15 different departments and 9 manufacturing facilities (both owned and co-packing). 

Outcome

The program was completed six months ahead of schedule and $3 million under budget. While approximately 450 products were directly affected by the regulatory requirements, more than 850total products with a Net Sales Value over $275 million were reformulated as part of this initiative due to shared formulations within these products.

 

Under the guidance of BlackSwan’s onsite team, the 70% completion goal was far surpassed, with 95% of the required work actually completed by the regulatory deadline. The remaining work was quickly completed within a month thereafter. These outcomes are in large part attributed to efficiencies created as a result of the coordinated approach put in place and managed by BlackSwan’s onsite team.

 

A structured program process was introduced and implemented, the team was willing to challenge the status quo to simplify the reformulation process, and clear accountability ensured work was being completed as planned. Information was communicated with stakeholders on a regular basis, and timelines were met because the program elements were organized, tracked, and measured against an established baseline.

The work that BlackSwan performed on this program was noticed by another line of business within Bond Foundation. As a result, BlackSwan is currently helping to manage a simplification effort that involves streamlining the division’s portfolio of products and growing brand reorganization.

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