Wayne Sander is the president of Dove Quality Consulting and a longtime electrical/electronic manufacturing engineer.
Sander had his initial exposure to ISO 9001 early in his career. He also has extensive process experience in medical devices, machining, fabrication, plastic injection molding, blow molding, hydraulics, electro-mechanical assembly, electronics, welding, and coatings.
Sander is an expert facilitator of quality systems and disciplines in achieving continuous improvement of product and process quality. He is trained and skilled in statistical process control, advanced product quality planning, failure mode and effects analysis, design of experiments, and more. He also has extensive internal and third-party auditing experience with ISO 9001, ISO 14001, ISO/TS 16949 (IATF 16949 as of 2016), ISO 13485, and FDA 21 CFR Part 820.
In this conversation, we chatted about his career pathway, developing and utilizing new skill sets, and the personal attributes of successful auditors.
EXEMPLAR GLOBAL: How did you find your way to management system auditing?
WAYNE SANDER: I worked at Kearney & Trecker as a machinist for 13 years, and I attended school during that time. Eventually, I ended up with a master’s degree in engineering management. I found my way to a company called Broan Manufacturing, where I started my quality career as a senior quality engineer, and then onto another manufacturer, Danfoss Fluid Power, where I stayed for three years. I helped them become registered to ISO 9001 in 1992. They were one of the first organizations in Wisconsin to register to the standard.
EG: That was very early on in the history of ISO 9001.
WS: Yes, it was one of maybe 50 companies in Wisconsin to register to ISO 9001 that early.
After that, I contracted with General Electric, auditing their clients that were certified to their quality system. I traveled across the country doing that work for General Electric for three years. I eventually formed my own company because I got to know some of these clients very well. A couple of them in the Milwaukee area asked me, ‘Do you think you could help us with our quality management system?’ That started me doing consulting. I also reached out to registrars like SAI Global, NQA, and Verisys, and began work as a contract auditor. That’s what I’ve been doing ever since, going back to 2000, so it’s been 21 years.
EG: Hearing your story and how your career pathway has developed, it’s interesting how all your experiences built on one another to get you where you are today. It seems that you have always found a way to learn and apply new skills.
WS: When you say that, I think about working from home, which I first did many years ago. It worked out pretty well then, and it still does. When I audit remotely, I just get the auditee’s records, write up reports on my findings, and we go from there.
EG: As you were talking about your career, I thought about the engineering function. Many very successful auditors, yourself included, have that training as part of their background. What skill sets do engineers have that make them particularly good at auditing?
WS: I think listening is number one. It’s not important to do a lot of talking… it’s better to do more listening and hear what the auditee has to say. If you do that, they’re going to tell you what you need to know. That also allows you to then go out into the production area, or look at the records, and confirm if the actions and documents match what they said while you were being an effective listener. I look at a lot of records when I do an audit. For example, when it comes to management review, I’ll look at three or four of their management reviews. In the production area, I’ll walk around, talk to people, stop not just one place at but multiple ones. I put all of that into the report.
EG: Engineering carries with it a certain discipline and many engineers have an orderly, process-based mindset. I would have to imagine that carries over very well to auditing.
WS: Yes, I agree with that. I’m pretty systematic. As I said, I’ll look not just at one record, I’ll look at three, four, or five. I need to see the evidence that what they say they’re doing is reflected in their procedures, their manuals, and in their work instructions. I also like to talk to the operators, those who are doing the work, to get their opinion. I’ve been on audits with other auditors who will just sit and talk to the quality manager. That doesn’t work for me. Because I was an operator at one time, I like to go out there and talk to them and see what they do. They show me how to make a part, and I make sure they’re making it correctly and following the instructions. And the same thing with management. I like to hold their feet to the fire and make sure that they’re doing what they should be doing.
EG: Do you think that, as an industry, we’re doing enough to bring younger people into careers in auditing?
WS: To be honest, I don’t know if there are enough younger auditors coming up. I know that with the companies I audit, there are some young people in charge of their management systems who could potentially be great auditors.
EG: And do you ever look at one of those people and say to them, ‘Hey, you have a good perspective on this system, and you should consider auditing’?
WS: Yes, sometimes. Again, I do like to talk to the people out there doing the work, and sometimes I’ll ask them, ‘Hey, have you ever thought about doing internal audits with the company?’
EG: It’s a good career. People can really succeed as an auditor, provided they have the right kind of discipline and personality type.
WS: You’re right about the personality type. Some auditors aren’t particularly friendly or they’re just shy. You can’t be afraid of asking the hard questions. I’ll give you a perfect example that happened not to me, but to another auditor that I know. This auditor went in to interview the president of the company being audited. He was asking all of these tough questions, and the president eventually said, ‘You’re going too far. I think that we should just stop at this point unless you’re going to ask me some easier questions.’ I couldn’t believe it! (laughs).
EG: It seems that those in top management (not all, but more than a few) just want to get that cert on the wall, and they don’t always know or care as much about improving the organization’s processes. But the goal of registering to a standard like ISO 9001 isn’t getting registered itself, it’s to improve output and efficiency.
WS: Very true. When I was auditing in person, at the opening meeting, I would say that 90 percent of the companies would have the president there along with most of the top executives. Sometimes there would be 20 or 30 people in the room for the opening meeting and for the closing meeting, too. Other times, you’re just with a quality manager. But I would say that most of the time, management is pretty good and supportive.
EG: Training is always a topic of interest to our readership. What are some of the trainings that you’ve had?
WS: I have been trained as an ISO 13485 lead auditor and an ISO 13485 supplier quality systems auditor. I also have an IATCA RAB lead auditor training certificate, plus certificates in quality management, quality manufacturing, and statistical process control.
EG: And as you take those courses and build up your knowledge base, the possibilities of this career really swing wide open. That’s good for young auditors to know
WS: Yes, I agree. This has been a good career for me. The lessons I learned and the people I met along the way have helped me get where I am. It’s been a great journey… and it’s not over yet!