Paul Mignon is a senior QA auditor for Central Garden & Pet. Previously, he was QC manager of incoming materials at Novartis Consumer Health.
Mignon is responsible for primary and secondary audits, equipment and process validation studies, and is the site preventive controls qualified individual (PCQI). He has performed laboratory management and obtained ISO laboratory certification for previous firms. He works in three product sectors: animal supplements/food, animal drug, and the insecticide business, and is the author of the “Animal Food” chapter in The Certified Food Safety and Quality Auditor Handbook, edited by Steve Wilson. Mignon is an active member in ASQ’s Food, Drug and Cosmetic division and with ASTM. He is a PCQI lead trainer and Exemplar Global principal auditor for food safety management systems. Mignon also holds five certifications from ASQ.
In this conversation, we spoke about how he recognized his talent for auditing, the mindset of a successful auditor, and how prospective auditors can find their way into the industry.
EXEMPLAR GLOBAL: Let’s start at the top… tell me a little bit about how you got started in auditing.
PAUL MIGNON: I was first hired onto a job with an auditing title 10 years ago, so I’ve been doing this work diligently for a decade. Before that, I was in pharmaceutical manufacturing, working within the quality control/incoming materials laboratory. That’s where we analyzed all the chemical and packaging components and working on problem materials or suppliers. That involved a lot of problem solving and sometimes we’d have supplier representatives come on site to put their eyes on the problems.
With this experience working with suppliers and materials, I always thought that I would be a good auditor. So, when the chance came up to get into the field through an opening with a different company, I latched onto it and was fortunate enough to get that position. It’s been a rewarding career.
I focus mostly on supplier auditing, and I do some internal auditing, too. Because I work at a fairly small manufacturing plant, though, I wear different hats. For that reason, I work on creating validation protocols, executing validation, and writing validation reports. I act as technical support for regulatory submissions internationally. I really don’t do any one thing all of the time, which is part of the variety that I’m fortunate to have.
EG: I want to explore this idea of auditing suppliers and the materials that they are sending into your facility. Can you speak to some of the differences between auditing the company’s internal processes vs. auditing a supplier or their materials?
PM: Auditing a supplier is not a regulatory inspection like an agency would do, but I look for some of the same things that an agency would look it. It’s not like a certification body audit, where I make sure I have a completed checklist… although that is an aspect of it. Through experience, me and the auditors that I work with have become experienced in the main critical-to-quality elements that we’re looking for in our suppliers. It’s a combination of regulatory compliance, fulfilling quality management system requirements, and good manufacturing practice aspects that are pretty well understood in the industry. It’s really a combination of all three of those elements. You also want to build a good relationship and keep a good relationship going with that supplier.
A lot of those aspects just aren’t in an internal audit. Usually in those internal audits, we’re just looking for compliance to our quality management system and regulatory aspects, so it’s not quite as dynamic, though internal auditing can be more difficult than supplier auditing. But with the supplier, there’s just a ton of context. Sometimes you’re visiting a supplier before a contract is even signed; other times, you’re in to see a supplier after they may have been supplying product for a few months. And then, with some suppliers, we may have had a relationship for years or even decades. So, really, no two audits are ever the same.
I have become a bit savvier as to how I audit my high-performing suppliers. I’ll really get into some of Bloom’s taxonomy on how well they understand and know what they’re doing. Through asking some open-ended questions, I can gauge whether they’re at the ‘understand’ level, which is the basic level, or whether they’re at the ‘design’ level, which is the very top of Bloom’s taxonomy. Not only has that made this work more fulfilling for me, it’s also enabled me to communicate to those audit clients better. It forces me to give good examples to show how I know that someone is at the design level, or how I know that an organization is more progressive or mature.
EG: To clarify, the suppliers you’re auditing provide raw materials and ingredients, and ultimately, as the manufacturer, your company is responsible for the product that goes out. So, is it fair to say that a lot of this supplier auditing work is for the purpose of traceability? By which I mean, if there is a recall, let’s say, you can then go back and understand and trace where the problematic material came from and prevent it from recurring.
PM: That’s one aspect, but it’s probably a smaller aspect. A lot of the suppliers, I focus on are contract manufacturers who provide us either a bulk product or a finished product. That’s where most of the activity is around, and so we might have either a deviation of a finding on our QC incoming that might trigger an audit, or we might have a lot of feedback from our customer complaint system that might trigger an audit, or we may be trying to touch base with the supplier periodically, like maybe for FSMA, just to make sure that we’ve had eyes on them and that we’re all on the same page.
EG: I’d like to ask you about mentors. Earlier, you talked about how you first discovered an interest in auditing. Were there people along the way who said, ‘Hey, Paul, you would be good at this, and it might be something you want to explore’?
PM: I did get some positive feedback, not specifically about being an auditor, but positive feedback about how I was doing the right things in the quality system, and I was doing the right things in a regulatory context. I was getting positive feedback through those routes rather than specifically for auditing, and that gave me the confidence to go for auditing. I knew that I would be good just from being exposed to it.
EG: It’s a mindset, isn’t it? Auditors tend to be organized thinkers and systems thinkers.
PM: I would agree with that.
EG: The work is more science than art because it seems that there aren’t many people with an artistic bent who find themselves in auditing careers.
PM: Right. I would say that there’s always room for growth and continuous improvement in the field, too. I like that aspect, and I also like getting feedback from the auditees afterwards. That’s helpful and as I think about, ‘How can I do this better?’ or ‘What am I really looking for in the supplier?’
The goal is not necessarily to just dive deeper, but also to find better ways to ask questions. Even after 10 years, I’m still trying to get auditees to be freer with their information and more relaxed so that we can have a dialogue. A lot of folks are on the defensive right from the get-go, so I want to break that down a little bit. Just like in life, no two situations are ever the same, so you have to try different things.
EG: Auditing is really a people business. Of course, there’s a large technical aspect to it, but getting the best out of the process, as you say, involves using good interviewing techniques. It’s not an inquisition, it’s an exploration of fact, and being able to talk to people on that level and relax them to efficiently access the information you need is a big part it.
PM: Yes, and that may be where the art comes in.
EG: Good point. So, how do you continue to develop within your career? What are some of the training courses that you’ve taken, and what have you gotten out of them as you continually build your knowledge base?
PM: Last year, I was able to achieve recognition as an ASQ Certified Supplier Quality Professional, which took a lot of study. When I started this career path 10 years ago, I didn’t have any ASQ certifications or Exemplar Global certifications. Now I have five ASQ certifications and I’m also certified as a lead auditor for food safety through Exemplar Global. So that shows that I’m very much interested in continuing to educate myself and challenge myself. As they say, if you’re not improving, you’re probably falling behind. I believe that.
One of the best was trainings I ever had was an Exemplar Global-certified course through DEKRA. It was for the food safety management system, ISO 22000. That involved being in the classroom for four days, demonstrating auditing techniques, and doing role-playing examinations. When I got done with that training and passed, I felt like I had really accomplished something.
I’d also like to put in a plug for being involved with ASQ certifications. Every exam ASQ offers goes through a regular development and continual improvement process. One year I was able to be involved with their Certified Pharmaceutical GMP Professional exam, reviewing the body of knowledge, and helping to create exam questions. Participating in those workshops really helped me validate my experience and knowledge through collaborating with other experts in the field at the senior management level. It was extremely fulfilling and so I encourage involvement in opportunities of that nature. These may not seem like formal education experiences, but in the end, they can be very fulfilling and worthwhile—and you learn something with them, too.
EG: Yes, and doing work like that is not just theoretical, because these are things that you can apply pretty much right away in your career.
PM: Oh, absolutely. I’ve used the content and knowledge in every single one of those certification exams.
EG: Before we close, I’d love your perspective about where we are as an industry, where we’re going, and any advice you would give to people who are just getting into this career for the first time.
PM: Auditing needs people, first of all, who have technical expertise in the industry in which they’re auditing, I think having that expertise goes a long way in legitimizing the auditor.
I think there some really good aspects to some of the changes we are seeing in auditing. For example, I like aspects of remote auditing, which has allowed me to shorten my on-site audits. I’m not quite all the way there yet where I’m going to have my auditee hold the camera and do a completely remote audit. For me, there’s just something very important about being on-site and experiencing a supplier’s environment.
As far as advice goes, I have seen folks with a few years of experience who are interested in getting into auditing. From my personal experience, someone isn’t likely to earn a certification and get hired as an auditor right away, although that might happen some of the time. What I want to encourage younger people to do, if they’re interested in the field and are in an environment where auditing is taking place, is to try to participate in any kind of auditing.
At our plant we have safety audits, and we’ll have folks participate from all different parts of the organization: people from procurement, line handlers, material handlers, frontline people, office people, and all kinds of management. Participating on something like that is a great way to be able to say that you’ve done some auditing. You’re expected to use observation and checklists—it’s a real basic entry into getting audit experience. In my case, in the laboratory, we performed internal laboratory audits where we check how complete logbooks are, how complete notebooks are, we check calibration dates, and we check expiration dates on reagents. These are basic things, but we did a lot of it. There are always those kinds of entrees into auditing that will help you get some experience, and even though it might not be a major lead auditor-type experience, it is auditing. To try to change a career or shift or pivot, I think there’s ways that a person can get into auditing just to get their foot in the door, and it can go a long way.