Failures are never good, yet they also present opportunities for learning.
GMP Consultant and Genesis Assist Executive Coach Steve Greer, who previously spent 35 years at Procter & Gamble in leadership roles in manufacturing and quality, presented the Redica Systems webinar, “Leadership SOS – Turning Failure into Success,” on April 27.
[Related: If you missed the webinar, you can still download a full recording that includes the slide presentation.]
He provided lessons learned from a case study involving a turnaround at a plant experiencing compliance failures. In addition, he offered insights into how successful leaders use failure to grow.
Using the metaphor of being captain of a boat, Greer said that “regardless of whether you are kayaking your own boat or navigating a huge ship, what is one thing we can count on? Well, it is that storms are going to come up and there are going to be unexpected obstacles and challenges that we face.”
He then recounted his experience preparing a site for a preapproval inspection as a mid-level quality manager—his first-ever leadership role. Here, he failed to delegate tasks to his team, leading to months of late hours. While the plant passed the inspection, he considered this a leadership “failure” as it resulted in negative consequences in his personal life.
“That is what began my journey to help other leaders,” he said. “This is where the concept of Leadership SOSTM came from.”
What is Leadership SOSTM? It is an equation:
Success = Ownership + Systems
To illustrate how this equation can help GMP leaders transform failure into success, Greer provided a case study of how he led the turnaround of a plant in Puerto Rico experiencing significant quality and compliance failures.
Sailing Into Stormy GMP Seas
“When I first arrived at this facility that makes skincare products, things were not in really good shape,” he said. “In fact, the FDA had given us a notice that could have been a death toll for the site and perhaps even for the business.”
One of the major problems with the site lay in human performance issues.
“At least 50% of errors were being assigned as human in nature,” Greer explained. “And that was true in both our laboratory and as well as in our manufacturing operations.”
While the plant passed the inspection, he considered this a leadership “failure”
This amount of human error resulted in major financial impact to the business. It was costing the company $500,000 a month and, as product failed to reach shelves 5% of the time, major retailers were taking it off the product list in favor of competitor products. In addition, morale at the plant was low for all levels of staff.
Greer and his team were able to turn the plant around, leading to tremendous success. Manufacturing quality events fell from 50% to a little over 10%. Laboratory out-of-specification events fell from 50% to about 15% (Figure 1).
“This had tremendous benefit across the board. In fact, we reduced 70% of the errors we were having,” he said.
Not only did quality results improve as shown in Figure 1 but so did virtually every other business result including the annual company survey which increased by 8 points even right after an announcement was made to close the plant. One of the most important aspects of this journey that led to the Leadership SOSTM model is that these concepts not only improved human performance short-term but the reduction in human-related events was sustained for a lengthy period of time (Figure 2).
“Frankly the part of this graph that I am most excited about is the second half because what that shows is that even after the results were achieved, we were able to sustain those results month after month for an extended period of time. And that to me is sometimes the hardest part,” Greer said. “Because it’s easier to make progress when you have a lot of resources, attention, and leadership priority, but how do you sustain it?”
3 Ways GMP Leaders Fail
Before covering how his team turned the plant around, he offered his insights into how GMP leaders can fail. Greer shared that the most common and yet least effective ways to address human performance issues are:
- Disciplinary Actions including Firing Employees
- Retraining
- “Improving” Procedures
While sometimes these may be necessary (sometimes an employee must be fired or placed on an improvement plan), Greer cautions GMP leaders to instead think of ways to build trust among employees. By building trust, a GMP leader can help build a stronger quality culture within an organization.
[Editor’s Note: Steve Greer also provided information for how GMP leaders can use change to build quality culture during our June 2020 webinar.]
To Overcome Failure, Own It
Trust lies at the heart of the first part of the success equation: Ownership.
What does ownership mean? For one, ownership means avoiding the cycle of blame.
Often, when an error occurs, a cycle occurs whereby an employee is disciplined, which leads to reduced trust in the organization. This leads to reduced communication as employees avoid alerting managers to potential issues. With reduced communication and trust, poor organizational practices continue to fester.
“Well, how do we break that?” Greer asked. “How do we move from blaming the employee to taking responsibility ourselves as the leader?”
One way to do this is via “the power of questions,” or changing the questions leaders ask. Instead of asking “Whose Fault is it?”, ask “What Can I Do Differently?”
[Related: For more on the power of questions, check out the following clip from the webinar.]
Better Systems for Success
The second part of the equation is Systems. Greer referenced Deming’s assertion that 96% of failures are due to systems.
“You need to work on the system if you truly want to fix the issue,” he said.
Simplifying things can help reduce the human error rate. Too often quality leaders complicate situations by adding more procedures and steps. Attempts to anticipate every potential quality failure expands the number of checks and balances.
By building trust, a GMP leader can help build a stronger quality culture
“Before we know it, what was not overly simple to begin with becomes overly complex,” Greer explained. He used the example of text-heavy SOPs that is the norm within the industry. He suggests using color, flowcharts, symbols, and photos to better convey critical steps.
“This was one of the key interventions that helped us with success down at that manufacturing facility, to start taking our procedures and really boiling them down to the critical elements and then field testing them and making sure they really worked.”
Before his team approved any procedure, they would go out on the floor and review the procedure with the operators to make sure they could truly follow it.
Checklists are another tool. Greer cited a New England Journal of Medicine study that found that the use of checklists during surgery cut deaths by 50%. These are particularly useful in stressful situations.
“Are we setting our teams up for success by giving them simple tools like clear procedures that are short and easy to follow? Checklists that are easy to make sure that all critical work is taken care of.”
Leaders Walk the Talk
It is also important for leaders to get out on the shop floor. At the plant, ingredients were weighed in plastic bags tied up with clear twist ties. The twist ties started getting into batches. Why was this happening? Well, as part of an effort to get employees to stop using sticky notes to record data before they walked over to enter it into the batch record (a clear data integrity issue), the quality department had trash cans removed from the floor. The thinking is that employees would not use sticky notes if they could not throw them away after entering the data into the batch record. Except now, employees had no place to throw away the clear twist ties after adding the ingredients to the batch.
The solution? A very high-tech and expensive approach… bringing the trash cans back to the floor and switching from clear to black twist ties so they could be easier to monitor. This simple change eliminated the issue with product contamination but developing it required leaders on the floor taking a coaching approach to improving human performance by engaging the operators doing the work.
Ultimately, transforming failures into success requires reframing situations by taking ownership and implementing the right systems to sustain positive outcomes.
At the end of the webinar, Greer posed a question to the audience.
“What is one thing you could do, today, tomorrow, next week, to change how you approach human performance on your team and in your organization related to these concepts? What will help you as a leader and your organization take one step forward in turning failure into success?”
[Editor’s Note: Do you have a response to Greer’s question? Feel free to share your insights in the Redica Systems Discussion Group on LinkedIn. You can also contact Steve Greer directly at sgreer@genesisassist.com to learn more about his speaking, workshops, and leadership coaching services.]
[Related: If you missed the webinar, you can still download a full recording that includes the slide presentation.]
Get a Demo
We can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.