Reliability built in, not bolted on

Site transformation for reliability at Janssen Biologics, Ringaskiddy. Delivered with a cross-functional team, via Life Science Associates.

The situation

The same Cork biologics site that rebuilt its new-product-introduction process also needed its operations to become reliable enough to take on far more: more products, higher volume, and eventually a major expansion of the site. Reliability of that kind is not a single number to chase. It is the quality of a stream of operational decisions made every day, how events and deviations are responded to, how equipment is maintained, how capacity is judged across production and the functions that feed it. Made well and consistently, those decisions let a site be planned around and grown with confidence. Made ad hoc, they quietly cap how much a site can safely take on.

The work

Over the course of a year, and with a cross-functional team, Kinetica built a reliability programme on four pillars:

• Production process reliability: monitoring events and deviations and tying them to live root cause analysis and structured problem solving, so issues were understood and removed rather than absorbed.
• Capacity modelling across production and the key feeding processes, including quality, NPI and engineering, so the site could see where it could and could not commit.
• Reliability-centred maintenance, with a strong FMEA focus, moving maintenance from reactive to anticipated.
• Structured frontline training, using Training Within Industry (TWI), so the new ways of working lived in the people running the line, not just in the documentation.

The point of the four together was not a one-off clean-up. It was a way of running that kept making reliability decisions well after the programme ended.

The result

The programme helped make Ringaskiddy a Centre of Excellence and a flagship site within Johnson & Johnson’s biologics network, and it built the foundation for BioCork2, the major expansion that followed and went on to win the ISPE Facility of the Year award in 2021. In 2020 the World Economic Forum named the site a Global Lighthouse, citing a 50% improvement in reliability.

Reliability was treated as a capability, not a campaign. The site did not just become more reliable for a while. It became able to decide and maintain its way to staying reliable as it grew.