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Terrill Harris is the Director of Quality and Regulatory Affairs at Prince, a global chemical manufacturer with sites all around the world. When Terrill first joined the team at Prince a few years ago, he viewed it as a blank canvas and an opportunity to start his long-term quality efforts in one location before expanding globally.

Using Qualtrax, Terrill has created a management of change workflow that has saved his team millions of dollars. I caught up with him a few weeks ago to see just how Prince uses an eQMS to avoid risk and streamline communication across manufacturing sites around the world.

This interview has been lightly edited for length and clarity.

Caleb Guedes-Reed: What makes an eQMS particularly useful for those in the manufacturing industry?

Terrill Harris: You really can’t run a decent quality management system without an eQMS. Otherwise, you’re relegated to doing things via paper trails and trying to get in contact with the right person all the time. ISO is very heavy on knowing who needs to be involved (aka – relevant interested parties). Trying to link all of this together by hand is very difficult. Part of my challenge was that, in the beginning, I had to build a quality system by hand to show people the value and the need. I had to show people that managing compliance manually wasn’t an easy or efficient way of doing things. You can’t run a compliance management program efficiently without an eQMS platform today.

CGR: How did you go from a manual quality system to an eQMS?

TH: I did it slowly over time and, at first, I targeted specific systems that I knew needed to be implemented quickly. For example — customer complaints, management of change processes, and document control. Though there were a lot of advanced systems that I wanted to automate, I scaled it way back and addressed the most critical systems first. The end goal was to automate everything I could over time.

When I first started, I was piloting quality management systems at one site only and I ran the program for a year or so. After I was promoted, I was given another site to manage and I realized, while doing my audits and interviews with site staff, that they already had Qualtrax but hadn’t implemented it yet. I did some research and started to get excited about the possibilities. I saw how powerful Qualtrax could be for the compliance work we were doing and I decided then that this would be our eQMS.

CGR: How did you get Qualtrax to expand to other sites?

TH: I got in touch with Qualtrax to help me automate some of the organic systems I’d already built over the past year. Then, I started a light expansion of Qualtrax to a group of sites I was managing. Whenever I did the soft launch, my team instantly loved it. I was promoted again and then started selling Qualtrax up the ladder. Slowly, use of the software spread to other sites, and finally, with the help of Kayla Rux from Qualtrax, I designed a roll-out for everyone who would need access. I even launched an internal webinar program to help engage people and teach them about the product.

CGR: Why did you choose to focus on a management of change (MOC) process in the beginning?

TH: Before we started this program, changes were made randomly and they were often unplanned. Sometimes the changes weren’t even reported internally or externally so people didn’t know what was going on. As you know, this is a huge compliance no-no for both HACCP and ISO because you’re required to communicate changes amongst relevant and interested parties. Several changes were happening at certain sites that were costing us money because they weren’t planned or communicated properly.

One good example that I like to use happened at one of our plants a few years ago. Our commercial and procurement teams wanted to run a cost-saving initiative by changing a raw material supply in one of our plants. It was supposed to be similar to a raw material they were already using so they didn’t think it would be a huge deal. It was implemented and the raw material ran as it was advertised for about four days. Then, the inevitable happened. Our ICP devices were starting to detect an increase in calcium (which is bad — very bad). It quickly got out of control. They almost had to shut down the plant completely which, as a 24/7 operation, is very difficult because shutting down the plant is very expensive and can damage equipment. We discovered that the new raw material was never vetted or tested and didn’t go through a formal process and it contributed directly to the issue. Because of it, we couldn’t run the plant for several months. I had to run a root cause corrective action event where we isolated all of the direct causes of calcium. Even 6-8 months later, the cause of the calcium problem was still related to the raw material that they weren’t even using anymore. We use this story to tell people why MOC is important. MOC would have caught this potential risk before it was implemented.

CGR: What does MOC look like for your team?

TH: The core function of the management of change process is to address risk and streamline communication. Here’s how the workflow works: It will ask the user to input information like; what is the change? Is there any relevant documentation that is affected by this change? Who are the interested parties? Does it impact our financial teams, our production teams, our commercial teams? And what are the risks to those relevant parties? The implementor will put preliminary notes in the workflow and then it goes to an approval step where a site change coordinator will assess the info, see if it’s eligible for a running change (meaning its quick and has been done before and it just needs to be documented and communicated via a report) or it might be something that needs to go through the full approval chain for our change implementation board. If it’s the latter, which it usually is, the board convenes with the information and specifically addresses implementation requirements. They will ask questions like, who needs to be notified? What are the training requirements? And which documents need to be updated? The implementor gets that list of action items and starts carrying them out after the approval to implement has been made.

Qualtrax helps us manage this process very well. Our relevant documentation is in Qualtrax so documentation changes can be triggered in Qualtrax. We can even tie specific documents to the management of change workflow. Because we have our operators in the system, we can use the training function in Qualtrax as well. It makes it so convenient.

CGR: What have been some of the biggest benefits of MOC for your team?

TH: We avoid risk and save money. The MOC workflow has saved us millions of dollars already.

CGR: What projects are you focusing on next?

TH: We are ISO 9001:2015 certified now and we are moving toward ISO 14001 (Environmental Safety Standard) and ISO 45001 (Occupational Health and Safety Standard) certification. We are using Qualtrax to manage all of these standards across our many sites around the world.

Category: Manufacturing

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