McKesson Specialty Health Achieves over 100 Audits without a Single Observation
Bullet-proof environmental monitoring technology that answers auditors’ questions.
McKesson Corporation, currently ranked 5th on the FORTUNE 500, is a global leader in supply chain management. Named “Most Admired Company” in the healthcare wholesaler category by FORTUNE, McKesson has a reputation as a trusted wholesale distributor and 3rd Party logistics (3PL) provider. McKesson Specialty Health (MSH) is a division of McKesson Corporation that provides integrated technology systems, unites independent providers with manufacturers and payers, and delivers technologically innovative methods of distributing high-value healthcare products. Specialty Health focuses on drugs and biotechnology for complex diseases, serving the commercialization and logistics needs of specialty physicians like oncologists and rheumatologists, as well as pharmaceutical and biotechnology manufacturers. Since 2006 MSH has partnered with a nation-wide vaccination program that serves approximately 1.8 million uninsured and underinsured children. This program is one of the largest national partnerships of its kind, through which McKesson now distributes more than 80 million vaccinations to over 40 thousand providers each year.
One of the ways MSH became a world-class logistics provider was by focusing on facilities management and maintenance, design engineering tailored to GxP regulatory requirements, and extensive system installations, validation, and expansions. McKesson’s 3PL model goes beyond storage and shipping to provide a package of services based on robust reporting, elite information technology systems, and customized logistic solutions. One of the people helping lead the MSH distribution team is Timothy Phelps, Facilities Engineering Manager-Specialty Distribution.
Since installing Vaisala’s viewLinc environmental monitoring system in all three of the facilities he manages, Phelps and his team have experienced a more efficient audit process. “Now we find more companies wanting to partner with us after we walk them through our processes, show our data, the alarming functionality, our validation master plan and other quality documentation,” said Phelps.
“We will sit down in front of a 34-inch monitor, open viewLinc and go through every single environment we have, drilling down into data along the way, checking trends in real-time, or for any historical period. Our auditors – who range from state and federal regulatory bodies, to large drug manufacturers – are always impressed.”
Showing the reports, the raw data, and the live interface of viewLinc is now a standard part of the audit process for McKesson Specialty Health. “Not only does it make the audit process efficient, the transparency goes a long way toward building confidence in potential and existing customers,” said Phelps.
“They can trust that we are going to take care of their product because we give them the evidence.” With audits and customer visits happening on a near-weekly basis, streamlining the audit process is crucial for MSH operations. Using viewLinc and other systems, MSH provides auditors with an information package that includes raw temperature data, reports, MKT over a given period, and other information in anticipation of both standard and in-depth questions. “In the last three years we’ve had zero findings with regard to temperature and environmental related items,” said Phelps. “These days, we can do an entire environmental audit in about four hours.” Zero findings in audits provides significant savings on overhead and resources.Phelps said that the reliability of an environmental monitoring system is also important. Not only is the product portfolio of McKesson incredibly valuable, local climate conditions can be a challenge. For example, in Memphis the humidity can fluctuate from 35% to 90% and the controlled temperature environments range from -80°C to 22°C. Sensors that are reliable, accurate and stable are required to maintain monitoring performance. Proactive notification of out-of-specification conditions prevents product loss or adulteration.
“There are many advantages to maintaining systems that are extremely robust,” said Phelps. “Efficient audits, the trust of our customers, and a strong operational model. But most importantly, the products we handle – including oncology drugs, and complex care items like plasma products, which hospitals can’t keep on-hand – demand reliable technology designed for GxP compliance.” The McKesson Specialty Health Memphis distribution facility alone ships to 70,000 points of delivery including other wholesalers, clinics, doctors’ offices, hospitals, and pharmacies. “With all those products going to end-users, our temperature and humidity monitoring has to be technologically rigorous,” said Phelps.
“After years of working with the system, generating the kind of reports that make auditors happy, we’ve found Vaisala’s viewLinc monitoring system to be bullet-proof.”