Ralph Hiltebrand is the principal and co-founder of GHR Associates. He has more than 20 years of quality management and technical experience in commercial, electronics, and defense-related companies.
Hiltebrand is a Registrar Accreditation Board (RAB)-certified quality systems auditor, an ASQC quality engineer, and a senior member of ASQC and IES. As quality assurance manager at the Unisys plant in Flemington, New Jersey, he implemented the quality management system that achieved ISO 9001 registration by BSI in 1991. Since joining GHR Associates he has assisted numerous companies to achieve ISO 9001 registration. He has more than 10 years of experience in technical education and has conducted numerous quality technology training courses.
In this interview, we discuss his early involvement with quality management systems, how communications technology has changed the auditing profession, and his advice for people entering this field.
EXEMPLAR GLOBAL: How did you get involved with auditing?
RALPH HILTEBRAND: Well, change brings opportunity, right? Back in the late 1980s, I worked for Unisys, a computer company, and our plant became registered to ISO 9001. We were probably one of the first 100 companies in the United States to get it, and we were probably within the first 10 in the state of New Jersey. Moving along, all of a sudden the company decided that they wanted to move the operations to the West Coast. I had a car pooling friend, and he and my ex-boss formed GHR Associates, because we knew something about ISO standards that other people didn’t know. And with that, we started the business. They’ve since passed away, so it just kind of left me alone. Part of the consulting business was that we had to provide internal auditing support, and that’s how we got into internal auditing. My partner and I, we went to Stat-A-Matrix for a lead auditor training program. Part of the consulting was to provide them with auditing, and that’s how we got into the auditing business. I took a couple other classes with them, too… I trained on ISO 14001 with them, too.
EG: That’s a good lead-in because I wanted to ask you about what training has done for you, what you’ve learned, and how you share some of the knowledge.
RH: I was a teacher once in electronic schools, at RCA Institutes in New York. They were a very big trade school for electronics under the RCA name. That was where I got my skills in training. After we went through the lead auditor training with Stat-A-Matrix, we went out and we trained our clients in ISO 9001 internal auditing and we trained management in ISO 9001, ISO 13485, and ISO 14001. I was the trainer, and I generated the course material. So that’s kind of what we did with training, and I still train. Not as much as before, because I really haven’t had that many new clients, but if a new client came along, I would train them in the appropriate standard.
Any time a standard changes, I’ve gotten trained. I’ve been trained on ISO 14001 and ISO 13485. Obviously, I did ISO 9001, and I’ve been trained on AS9100 as well.
EG: What would you say is the focus of your business in terms of the types of clients and work that you do?
RH: We do a lot of work with machine shops, distributors, and other type of manufacturing companies, mostly on the standards I mentioned—ISO 13485, AS9100, ISO 14001, and ISO 9001. These machine shops are mostly medical device companies.
EG: There are elements of these standards that are specific to a machine shop, an aerospace company, a medical device manufacturer, what have you, but there are also a lot of similarities in terms of how you audit their management systems. So what are some of the similarities that you see regardless of what the background of the client may be?
RH: The similarity is that every client is trying to make money (laughter).
EG: This is true (laughter). But there’s making money, and there’s also saving money. Two sides of the same literal coin, I guess.
RH: That’s what they’re interested in, right? I always try to focus on opportunities for improvement within the company. I push that pretty hard with my clients, asking “What are we going to do better next year than we’re doing now?” And the same thing when the auditors come in, and they ask the same question: “What did you do last year, and what are your plans for this year?” So it’s a standard question that the clients have to think about, whether I ask it or the third-party auditor asks it.
EG: And it’s a different world now, too. Covid has changed a lot of things in terms of auditing and not being able to easily get on site, but many of these changes were happening anyway, in terms of people trying to be more efficient. How have you adjusted or how have you seen people adjust to staying on the cutting edge and using technology?
RH: A couple of years ago, a client in my region wanted me to do some regular work to get them transitioned to ISO 9001:2015, but it was a long drive away. Well, to be honest with you, I wasn’t too excited about making that trip all the time. I resisted as much as I could, but then it came to the point where I had to decide how we were going to do the work. And with that, I became proficient at videoconferencing. So I became accustomed to the technology, and when Covid hit, I simply said, “Well, that’s what I did before. I know how to do this.” And so with that, since last year I’ve been doing Zoom meeting, Zoom audits, and Zoom consulting.
EG: Which gives you video and sound, and you can record it, and can share documents. That’s really the key thing in a lot of cases, just making sure that people understand what the documents say, I don’t know that you necessarily need to be in a facility to do that.
RH: Not anymore. One of the audits I was involved with, the auditor said, “You got a cell phone? Let’s do Facetime.” And he went around that way and interviewed the employees.
EG: In a manufacturing facility, many of the workers need to be gathered together to do the work but a lot of the back-end functions of the facility are being done remotely. The finance team are probably at their respective homes; they don’t need to be on or near the shop floor to bill and collect, pay taxes, etc.
RH: It’s amazing. I had a friend who was an auditor with a registrar, and he said to me, “At some point the way I do this work is going to have to change because I’m getting tired of the traveling.” This was five or six years ago. And I told him, “Electronics and technology will take over, and we’ll find a better way to do this.” And now here we are.
EG: Everybody has the stories of flying cross-country and back just to do a one-day job. I mean, in the past if the client needed you they needed you and you did it, but what a hassle.
RH: The technology takes a lot of that away, and it will probably extend the working life of some auditors. I have a friend and colleague who was planning to retire, but now he thinks that he doesn’t have to retire so soon. Things have certainly gotten more convenient.
EG: What advice would you give someone as they get into the auditing profession?
RH: I think the main thing is, don’t get too serious. Keep it light and funny (laughter).
EG: I like that (laughter).
RH: You have to see all sides of it and other ways of things getting done. Don’t be a sourpuss!
EG: Having spoken to a lot of auditors, it seems that the ones who do really well have flexibility. Naturally it’s something of a cut-and-dry thing—you have a standard and you have to audit against it, but you don’t have to necessarily say, “Well, you have to do it this way.”
RH: The main thing is to be able to say, “Explain to me how you do this,” and let them talk. If it meets the requirements of the standard you go on and if it doesn’t then you have to probe a little bit more and try to determine how and if they are going to meet the requirement. I had one of my clients who was being audited by another person, and after it was over, my client said to me, “Ralph, I really enjoyed the process with this auditor, because he told me what the requirement was, and he asked me how we were going to meet that requirement.” He knew exactly where the auditor was coming from, and that was very helpful.
EG: So your key takeaway for people new to auditing is to keep it light but also be very strong in terms of letting the client understand what the requirement is and letting them tell you how their process meets it.
RH: Right. As an auditor, you need to be shown the evidence that the client is meeting the requirement, and that’s all you have to ask them. And they’ll come up with it and show the records that substantiate that or whatever may be required at that particular point. We have to be flexible. Rule No. 1: Things never go according to plan.
EG: Very true. And when you’re interviewing different people in the organization, perhaps a junior member of the organization who is responsible for some documents and then following-up with that person’s manager, how much are you looking to make sure that there’s alignment and specific understanding of the processes and procedures?
RH: I think to answer that question you need to consider the size of the organization. Are there a lot of levels and tiers of people or is it a small group where everybody talks to everybody? I think one biggest problem we are going to have is whether people are communicating properly. Especially now, it’s not as easy as it used to be. Communications are a key aspect of the whole thing. So if I was there in the scenario you describe, I would say, “Well, how does your boss communicate with you? What’s the communication path here to make sure that things don’t fall into a crack?”
MR: That is a little harder now. When you had everybody gathered around the proverbial water cooler, it was a little easier to have those conversations and now it’s a little harder, maybe, with Covid.
RH: Very much harder. Well, thank goodness for email and Zoom and other technology, which provides a level of communication that we didn’t have, or maybe didn’t use as effectively as we do today.