Ensuring Compliance at a Nutritional Health Manufacturer
An innovative global leader in the development, manufacturing, and commercialization of science-based nutritional health products, with 7 manufacturing sites, 13 brands, and over 1,300 employees worldwide faced flaws in processes and infrastructure at one of their European factories.
These flaws were hindering compliance with internal corporate and public administration standards – while at the same time, other issues forced production and packaging lines to come to a standstill in the face of strongly increased customer demand.
This situation caused grave concern and a high sense of urgency at Headquarters and the controlling private equity firm, as the imminent sale of the organization to a major industrial conglomerate became contingent on the mitigation of these risks.
RESULTS AT A GLANCE
Ended gross violations and achieved compliance with HSE and GMP requirements
Supported sale by controlling PE to a major industrial conglomerate
The global and local operations team asked ARGO-EFESO to help them rapidly and thoroughly mitigate the issues with very limited resources. We jointly identified 4 workstreams that had to be addressed simultaneously:
- Exchange ventilation systems: regulations prohibited further upgrades to obsolete ventilation systems that generated insufficient air flow and excessive cleaning.
- Emergency Response: Health, Safety, and Operational Emergency processes, policies, and procedures did not ensure employee safety and 24/7 plant operation.
- Explosion Risk: the overall infrastructure and procedures did not been analyzed, monitored, and brought into compliance with safety audits (this was exacerbated by the poor ventilation noted above).
- Deviations from GMP: an audit from the public health & safety authority identified 60 deviations from “good manufacturing practices” (GMP) that would lead to production being limited or stopped if they were not eradicated within 6 months.
After developing comprehensive project charters, the joint team aligned with all parties about each one’s urgency, importance, approach, and requirements. “Charter Champions” were appointed and detailed workstreams outlined to deliver the specific charter goals under the following challenging (but not uncommon) conditions:
- Our projects were to run alongside others already planned or underway
- Little to no relevant data was available, and decisions were thus made after “surprises”, rather than proactively on timely data
- Equipment supplier involvement needed to be vastly expanded