A Q&A with Robert Burgh, Founder and CEO, Nexcor Technologies
It seems not a week goes by without hearing about a plant closure, recall, or 483 observation caused by failed quality systems. With these increased regulatory pressures, it’s important that each process within your facility runs efficiently, with little room for error. One of many areas that require tight quality control is sanitation. It’s a constant challenge to keep up with standard operating procedures, cleaning, self-audits or inspections, and corrective actions.
Pharmaceutical Online turned to Robert Burgh, founder and CEO of Nexcor Technologies, for advice on addressing the issues related to sanitation. Nexcor Technologies has provided software solutions that focus on compliance readiness for manufacturing facilities in the areas of drug safety, food safety, quality, sanitation, production, and maintenance
Burgh is a sixth-generation baker who has used his experience with sanitation quality management in the food industry to help pharmaceutical manufacturing facilities become compliance-ready.
In this Q&A, Burgh discusses challenges associated with sanitation quality systems, reasons why quality managers need to let go of their log books, and how the right system can tie the many facets of your system together —to save time and money.
Describe some of the challenges your customers face in tracking sanitation quality.
The legacy documentation method, even for those facilities using computer spreadsheets or documents, means people are spending more and more time on paperwork that doesn’t add any value to their day-to-day operations. This method typically consists of multiple three-ring binders that contain volumes of paper reports, because of the constantly increasing documentation requirements by their customers, corporate QA/safety standards, and government regulations. A clean plant used to be acceptable proof. Now there are increased documentation requirements for sanitation because of the "it hasn’t been cleaned unless you can prove it" philosophy.
In addition, a facility must be inspected. These audits are conducted by third parties, like customers, government agencies, corporate auditors, as well as internal staff. In order to keep up with the documentation from these audits, the corrective and preventative actions have had to increase drastically over the past 30 years. To put increased pressure on the department and plant managers over the years, they have to accomplish this with typically less sanitation staff.
How did you and your team go about uncovering these issues?
I practically grew up in a wholesale food production plant, until the family decided to close it two decades ago. While designing and working my own production lines, I discovered that retrieving information quickly and accurately about line downtime, training schedules, allergens, sanitation, and more was absolutely necessary to run a more efficient line. We visited facilities of all sizes. I quickly learned to put aside our preconceptions, and to listen to needs of the internal departments to satisfy the requirements of the other department or outside auditors.
What pitfalls did you encounter along the way, and what steps did you take to overcome them?
The greatest challenge is breaking the cycle of the "manager playing secretary." There is a great deal of ownership to a company’s log books, and it has been tough to eliminate them, because that is how it’s always been done. However, by continuing to work with the early adopters of our solution, they begin to realize that the content was the same and the retrieval was much easier, quicker, and more efficient. Managers started to find that the program allowed them to be hands-on leaders back on the floor again. They could create and follow up on corrective actions, track and encourage training schedules, and be more valuable to the company, because they could once again manage people, protect their line, and deliver accurate business intelligence throughout the chain of command. This alone encouraged greater cooperation among all the groups in the process.
Our KLEANZ system adapts to the needs of your organization. How many enterprises can collect and compare plant operations sanitation and maintenance records in minutes — company-wide?
What are some of the other advantages of using a software-based approach to sanitation compliance documentation?
On example is an audit may uncover a reported infraction. This typically would require several days to weeks to respond to with the paper log book, especially if the infraction was months previous. Our clients can immediately pull a record, by any one of a hundred searches, to show that they were aware of the condition, reported it, and created a corrective action. This report will also include who worked on it, how long, what was the cause and result, who inspected it, signed off, and in many cases a before-and-after picture — in less than five minutes.
It is also relatively easy to find equipment history and sanitation records by technician, date, machine, warranty, cost of downtime, cause of interruption, and more.
Explain how the KLEANZ software system works.
The software is Windows-based. Our people, processes, and tools incorporate the existing sanitation requirements into easy-to-use desktop and mobile presentations. We are currently preparing to release a tablet version of KLEANZ which will operate on the iPad and other ruggedized tablets. The software takes the current paper, as well as potential requirements, and imports them into a database, which is easily convertible to meet plant needs. However, historical information cannot be altered further, guaranteeing the approval of audit teams.
The KLEANZ solution can be software as a service (SaaS), hosted, or self-hosted infrastructure. KLEANZ will also provide further consulting opportunities to establish good sanitation procedures and processes.