I asked Jerry Rosenthal this question in last week’s podcast: A few years ago, Lean sort of butted heads with ISO and it was like we kept 2 separate books. Is that what happens with food safety and the USDA and FDA protocols or are you explaining that there is common ground because they have given us that flexibility to operate Lean and meet the requirements?
The answer is an excerpt from this Related Podcast and Transcription: Using Lean in Food Processing
Jerry Rosenthal: I’ve seen over time on a company by company basis that compromise if you will the collaboration that these things can work hand in hand without being too much of a burden to a company. The example I like to talk about is, in any manufacturing site you go to, almost anyone, you certainly see there’s a certain level of conflict between production and quality. Right, production says, “We need to make a thousand cases of X today” and quality sometimes has the perception of “what, I’m the police force here. I’m going to look on that production line and I’m going to see, anytime I see something that’s a defect, I’m going to stop the production line and we’re going to get it fixed because we want to make it right. In more mature organizations, they find ways to be collaborative. How can production quality work together to ensure they get that thousand cases out every day, that is the finest product possible that the consumer is going to pay for that’s of value because it’s a good price and the company can be profitable.
I see the same thing co-existing here, with me with the different regulatory bodies. I think they go hand in hand. I think again if you go to ISO and the different standards that are out there, again, they set out the guidelines of what you should do, you should have a recall program in place. They don’t tell you how to do it. They certainly set out the elements of a recall program, but it’s up to a company to put a process together, that should there be an unfortunate event such as a recall, great, what are we going to do? How are we going to stop production? Who do we notify? Where do we pull our batch records or our documentation for, when was this lot made, what were the raw materials that came in, who are the employees that worked that day, where are the sanitation records located? How can we gather the documentation in the most efficient cost-effective way possible to address the needs of the agency? I think as time goes on, there’s a tremendous amount of balance out there. Is it perfect? No, but it’s trending in my opinion in the right direction and, certainly, I can see over the last 10 or 15 years tremendous strides moving in the right direction.
Joe: In manufacturing, I’ve seen where continuous improvement, especially with TPS, has just become the way we do the work, and that’s how it’s driven. In the food industry, I still see in food safety a process that is event-driven, “Oh, I have an audit.” Maybe we’re not there yet, but are we moving towards where it’s just part of the way we do business.
Jerry: That’s a big philosophy shift for a lot of companies. I mean, I’ve certainly touched base, either consulting or had an engagement with companies. They’re certainly in that reactive mode. They’ve called me up, and they’ve said, “We’ve got an audit coming up. We know AIB is coming in a month. Can you help us get ready?” It’s a scramble until 5 minutes they walk in the door. Certainly, a mindset of always being prepared, always doing the right thing is much less stressful, that should anybody an agency walk-in; everything is in place, it’s no, it’s minimal stress. There’s certainly some stress. Nobody wants the agency to just walk in his or her door. I mean they certainly think, “What happened? Something’s wrong.”
If you can get management and leadership to a point of being always ready, it’s certainly more advantageous and I do see a trend of more and more companies being less reactive, being more proactive, always having their documentation ready, and doing the right things all the time. If our procedure says we’re going to do internal audits on our incoming fruit, process, whatever that might be, if our SOP says we’re going to do it every month, great, let’s do it every month and let’s document it and not worry about it. Again, the agency doesn’t say “You will do it every month.” It would be a self-determined process. You can say you’re going to do it every week. You can say you’re going to do it every month. You can say you can do it, at quarterly but whatever you set out. Do what you said you were going to do. When the agency comes in, that’s what they’re going to look at. If your procedure says we’re going to do it weekly, but then, your documentation shows you’ve had weeks and weeks of weeks of not doing anything. Make the change ahead of time. Don’t set yourself out for failure. This is the trend a lot more companies are going towards.
Another trend that we see is, you’re hearing the news more and more the USDA, the FDA, they just simply don’t have enough auditors to do all the work that’s out there and there’s more agencies that are going along the lines of what’s called risk-based auditing. If they get phone calls, if they get complaints, if they get letters that, “Hey, I had this product, and it just wasn’t right. I could smell bleach. It didn’t taste right. The company didn’t respond to my request.” The FDA, they’re trying to, the USDA, they’re trying to get to the point of risk-based auditing. They’re going to look and see where are the complaints, what’s the information they’re hearing, “I better go visit that peanut plant in Georgia because there’s been a lot of complaints about product coming out of that environment.”
If there are companies that are quite compliant, they’re doing what they need to do. They’re staying on top of their documentation. There are no customer issues; they’re reducing their frequency; they’re going to reduced inspection if you will, of those facilities. Those facilities that are having challenges, having issues, they’re going to spend more time and more attention on those areas, to protect food supply in the United States. It really has been a long time coming. But, I’ve seen within the last year or 18 months that gaining a little more steam and heading in that direction, and I think that’s really good for all of us.
Jerry Rosenthal started on his process improvement journey where he entered the world of medical device and worked with such companies like Cardinal Health. Jerry’s expertise is primarily in regulated environments such as food, beverage and pharmaceutical production and packaging. He also has experience in plastics, printing, logistics and IT in both local and enterprise-wide organizations. Jerry has been successful at taking principles and tools from manufacturing and applying them to a commercial business practice, and he does that at Lean Six Sigma Expert.
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