Over a career that spans 40 years, Steve Gruler has struggled with the fact that quality seems to be a soft term. “Companies often say, ‘We’ve got great quality. We’ve got the best quality,’ and they’re looking at customer complaints and certification systems as their primary metrics,” he attests. “Then you look at their results: recalls, illnesses, and death due to poor product performance.” Clearly, they’re doing something wrong.

As the president and CEO of Global Quality Consulting, Gruler has helped companies around the world achieve real quality improvements by understanding and optimizing product performance data. In addition, as the global head of quality for two organizations (the first, an international consumer products company, and the second, a food company), he transformed their quality systems, moving them from cultures of “inspect and reject” to “predict and prevent.”

Here is some advice based on what he did and how he did it.

Don’t wait for the customers to tell you that your products are non-conforming. Be proactive, not reactive.

In Gruler’s estimation, 90 percent of companies today focus on processes, systems, and certifications as their primary metrics to ensure quality. They talk about prevention, but in actuality “prioritize high-risk products and then go out and inspect them.”

While working for the large consumer products company, he often found he had little to report when presenting to the C-suite. “I was the global head of quality for an $8 billion international company and all I could say was, ‘Complaints are down!’” he recalls with a laugh. “If I was the executive team I’d be thinking, ‘Is that at all?’”

What Gruler really wanted to know—and what he suspected the higher-ups might want to know as well—was threefold. “How do we know that our product that went out the back door is going to perform to all of the requirements: regulatory, legal, safety, and customer expectations? And to what level? And how can you determine failure rates when you have mass production, with thousands of parts going out every hour from multiple different lines?”

What Gruler eventually discovered was that if you apply SPC with a business mindset—“which was different than how it’d been applied in every other company I’d worked for and every SPC seminar I’d attended,” he notes—was that you could achieve phenomenal results, and that you actually change a company’s culture from reactive culture to predictive and preventive.

If you come at SPC from a business perspective, “it’s giving you a window into the future based on past performance,” Gruler explains. “It makes a lot of sense. Based on your process performance, with all of the variables that affect it, you can predict what the future is going to be. But when I’d take SPC courses, they’d all try to turn me into a statistician. They’d get into all the mathematics. But what they missed was: How do you run a business with this data?”

Until then, “at the companies I’d worked for, the data we had to determine the performance of our products was consumer complaints. That was it,” he says. “So I’m thinking, ‘That’s clearly ridiculous and reactive. We’re not ahead of the curve. We’re not looking forward. We’re not trying to prevent issues.’ Because, fundamentally, we’re waiting for the consumer to tell us our product is not conforming, or it’s not safe. Shouldn’t companies know that? Shouldn’t they know what those parameters are and what their process can do?”

That’s when Gruler started to look into data-driven SPC software. He asked the CEO of the big consumer products company at the time, “How do you know that our products are high-quality?” The CEO’s answer: Market share and consumer complaints. But he also agreed with Gruler that by the time they would find out there was a serious problem with their metrics, it was too late. So he approved a project for Gruler to try out a handful of SPC software solutions at one of the company’s facilities.

“I said, ‘Let’s see if we can put in forward-looking metrics and predict with accuracy and precision what is going to go out our back door, and what our process is doing,’” Gruler remembers. His goals included optimizing data to predictively manage product quality, preventing recalls, and mitigating risk to brand equity.

Use performance data to determine process capability.

At the outset of the project, Gruler and his team knew SPC was a superb metric for documenting history and process, and “for measuring those key elements that will drive failure in the field.” He also wanted to observe what their process was doing and “see what we needed to do to get it to the level of risk that the company was willing to take.”

Gruler recalls bringing in four or five different SPC companies for a two-month trial; and by the end of the project, “Zontec won, hands down.” Zontec’s SPC software was by far the easiest to use and the most efficient, he says, in that “its design allowed us to do what we wanted to do: collect critical performance data at the point of manufacture, then take that data and translate into PPM quality levels.”

What Gruler also appreciated about Zontec “was that it gave us an opportunity that the others did not: for us to build a training and education piece on what we called ‘common sense SPC.’ We basically set it up so the operator could know, ‘Okay, here’s what you’re supposed to do: collect the data, look at the picture, and make a decision.” Then the QA people would look at the process capability to determine if it would meet their target level of quality. If not, then they’d have to find the problem at its source—for example, a bad pump that was causing the issue.

“Once that took hold, it was amazing,” Gruler recounts. “This company had about six different divisions, and each one of them had a director of manufacturing.” By the end of the project, “we set up metrics for the whole company, the metrics being process capability.” At long last, “we could see from the product, to the line, to the plant, to the division, all the way up to the whole company, what our percent of process capability was.”

One plant Gruler worked on “usually had a Class 3 recall each year.” But after implementing Zontec software, the plant “eliminated those completely.” They could find the root causes of their issues because they knew how to determine their percent of process capability. They also reduced the cost of their goods by 30%. The numbers were so good, in fact, the director of manufacturing in charge of that plant said his phone was “ringing off the hook,” Gruler remembers, and that more divisions wanted Zontec installed “yesterday.”

“The absolute key to our success is that Zontec [gave] us the metrics to be able to manage risks to our business in a professional manner,” Gruler contends. More than 25 years later, the company “still uses the same software, and still has the same process in place.”

Share the data. Visibility is key.

Post-project, Gruler saw the company’s CEO again at the headquarters. The CEO said, ‘Hey Steve, how’s it going? What’s our quality today?’” Gruler recalls. “Before I started this project, I’d say, ‘People aren’t complaining too much.’” But two months later, after they had the new SPC system in place, Gruler had more to say. Last quarter, they had enjoyed 63.4% process capability across the company; and next quarter, they would break into 80%.

The CEO’s response surprised him. “He said, ‘Steve, it wasn’t 63.4, it was actually 67.1% capability, and I’m delighted and can’t wait until we get to 80%.’ And his next question was, ‘When are we going to be at 100%?’”

Stunned, Gruler thought, “This is a grand slam. The CEO actually knew the number better than I did, corrected me. He valued that number. What a powerful role for the quality organization to be able to perform for a company.”

Another benefit that Gruler didn’t quite expect was that every major function involved with a new product at this company, including the R&D and marketing, began using the charts generated by Zontec’s software. “We’d go into a new product development meeting, and the R&D people would be there with the Zontec data,” Gruler says. Using that data, as it turned out, “reduced that company’s time to market with new concepts by around 60%.”

“We began building brand equity,” Gruler continues. “We put more products out that had higher quality at a reduced cost.” They also had a metric, of percent of process capability, “that was forward-looking and predictive—so that when things started to shift on a process, we could adjust and prevent it from falling off the cliff.”

In addition to liking its graphics and general user-friendliness, Gruler thrilled to Zontec’s software as a communication tool: “It lets you know what your processes are doing at any moment in time.” On his office computer, “I’d pull up a line in say, Warsaw, and I could see what the line was running that day, how it was running, and look at the process capability— the control charts—and say, ‘Wow, they’re really on target today.’ I could see the real-time data being charted.”

He also points to one of the biggest points of risk and variability to a quality engineer: the supply chain. “Supply chains today are extremely complex versus what they were 30, 20, and 10 years ago,” he says, owing to so much now being produced oversees. But there is an upside. While he was working at the food company, for instance, Gruler says he and his team would ask suppliers to send their testing data, do statistical analysis on it, and then share the data back with them, to show them what was working well and what they needed to improve.

Gruler was intrigued by what happened next. “A lot of these suppliers went to Zontec, bought their software, and installed it so they could be ahead of the game, so wouldn’t have to get those calls from us where we’d say, ‘Looks like you’re going off the edge here. What’s going on guys?” Apparently, they wanted to be predictive, too.

Always strive for continuous improvement.

As Gruler sees it, Zontec’s philosophy is rooted in continuous improvement. “They’re always staying on top of it, which I like,” he says. “You don’t have to worry about it, like you do with a lot of electronics, that as soon as you walk out of the store you’re outdated. You don’t have to worry about becoming obsolete, because Zontec is on top of it.”

Gruler is not as sanguine about the state of other companies, though. “I don’t see the change that I’d be comfortable with,” he says, without missing a beat. “I don’t see a lot of companies doing what I just described. They will use bits and pieces.”

He has been consulting now for about 10 years now, “and I’ve consulted with more than 100 companies, ranging from Mom and Pop blueberry producers in the Northeast to the largest fast food chains you drove by going to work today,” he says. The approach he takes to most companies, and also how he sees his consulting business as different from the rest, is to first ask the right questions.

Other consultants help companies get the proper certifications, perhaps, and they focus on the process, rather than on the performance and the results of the companies’ products. But “we always look at product performance,” Gruler confirms, “and the first question I ask when I have the opportunity to sit down with the executive team is: ‘How do you define quality?’” He also asks what data they have to support their definition, and what level of quality they require or seek.

“And I’m not trying to be critical of these companies,” he clarifies, “because the marketplace—especially if you’re doing work with big box stores—has directed them into getting being certified by an external body. That’s what they’re managed by and that’s how they spend their time. I go to small and medium-sized companies and they’ve got five or six people working full-time on being compliant with ISO standards or safety standards. That’s where their focus is.”

So, when he tries to nudge them to take the next step with predictive SPC software, they’re often reticent. Typically, they lack the resources, overhead pressures, or financial incentive to pursue it. They might respond with, “Well, we’ve never had a recall,” and leave it at that.

This is precisely what concerns Gruler. When he describes the benefits of SPC software to executives, they usually say it sounds great. “But I don’t see the action,” he says, “because I think that the people running the business are pressured to focus on a different area.” But in his view, it would benefit their business to an incalculable extent if only they were willing to take another look.