Janssen Pharmaceutical Case Study

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Courtesy of Scannell Solutions Limited

Background

Janssen (formerly Centocor Inc), a subsidiary of Johnson & Johnson, runs a state-of-the-art biopharmaceutical manufacturing facility in Cork, Republic of Ireland. The plant consists of a 10,000m² production building along with a central utilities building, a laboratory and administration block, waste water treatment plant and warehousing/storage.

The facility now forms the strategic manufacturing centre of a new global supply chain for the company for many of their existing and new pipeline recombinant mammalian cell fermentation and monoclonal antibody products. The new manufacturing unit at Ringaskiddy produces products for the detection and treatment of many human diseases on a commercial scale but also is used to produce smaller quantities of drug material for clinical trials.
While still completing trials Janssen’s EHS Manager researched a solution to track incidents and observations throughout the plant quoting “We wanted a solution that was easy to use, transparent and paperless.”

The Solution

Prior to opening their state of the art manufacturing facility in Ringaskiddy, Janssen’s EHS Manager and his team searched the market for an appropriate incident management solution. What they found was a solution that could not only handle incidents, but was integrated with a risk management solution, underpinned by a strong legislation module. In total the solution presented by Scannell Solutions incorporated:

  • Legal compliance
  • Risk management
  • Accident/Incident Management
  • Data Collection
  • Auditing

As is the case in most manufacturing environments many people working in the area of EHS were doing so as part of a larger role – for example production or laboratory resources may be spending 20% of their time dealing with EHS issues. If a change needs to be made to an operation users can check on appropriate legislation, they can also monitor and track risk assessments. With respect to incidents, users can track if, and when, they occurred previously and what risk assessments were put in place and followed.

From an audit perspective the ratio of observations to incidents can be easily seen and evidence of continuous improvement and risk reduction can be easily displayed.

Conclusion

From Janssen’s perspective enviroMANAGER has delivered a number of tangible advantages;

  • Integrating issues like law and risk meant that any user working on a risk assessment could easily become aware of the legislative impact of decisions without having toturn to legal experts or members of the EHS team.
  • Janssen now has one system to handle both environmental and health & safetyissues.
  • Users can log incidents on a browser and check the progress of those incidents as wellas monitoring any appropriate risk adjustments and legal obligations.
  • A marked improvement has been recorded in the ratio of observations to incidents.
  • From day one there was no paper. Everything is recorded on the web based system offering management up to date reports on tracking incidents, risk assessments etc. and delivering evidence to auditors of compliance and continuous improvement.
  • The transparency produced by the system ensures incidents, corrective actions, risk assessments and appropriate tasks are dealt with efficiently and effectively.
  • The ease of use of the system ensures that observations are reported before accidents can happen ensuring a reduction in man hours wastage and the risk of environmental and health & safety breaches.

To quote Janssen’s EHS Manager once more “We found enviroMANAGER to be the best tool on the market to suit our requirements. We like the fact that the system is so tightly integrated. On the Scannell “team,” the fact that they are so knowledgeable in the areas of EHS helps us greatly; we weren’t just dealing with another IT company. I would highly recommend Scannell Solutions as providers of robust EHS solutions.”

“The enviroMANAGER solution has saved us huge amounts of time and hassle. Information for our annual environmental reports and quarterly corporate reports are now available at the push of a button.”

EHS Manager Janssen Pharmaceutical, Ireland

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