Carl Turnquist has several decades of industrial experience, particularly within the medical device sector. He is a subject matter expert on fabrication, extrusion, and the custom compounding of resins for cardiovascular catheters. He was also the co-inventor of a polypropylene hernia repair mesh containing an anti-adhesion barrier.
Since February 2012, Turnquist has been a sole proprietor offering quality auditing services, including conducting internal audits for private client companies that do not have the internal resources to conduct these audits for themselves. He also subcontracts to ISO notified bodies and/or ISO registrars to conduct third-party audits for their management system certification clients. Turnquist is an Exemplar Global-certified quality management system (QMS) lead auditor for ISO 9001:2015 and for ISO 13485:2016.
In this interview, we chat about his career pathway, the people and organizations that have helped him in his career, the auditing industry changes he is looking forward to in the days after Covid, and his advice for people just starting out as auditors.
EXEMPLAR GLOBAL: How did you begin in the field of management system auditing?
CARL TURNQUIST: I worked for most of my career in product development in the medical device field, ultimately with Genzyme. I left there in February of 2012 because medical devices were being de-emphasized following the company’s acquisition by Sanofi, a French pharmaceutical company, at the start of 2011. I joined ASQ in January 2011 where I took a section-led training on the knowledge base needed for the ASQ’s certified quality auditor (CQA) exam. I then took and passed that exam when it was offered in March 2011. A few months later, I took the certified biomedical auditor (CBA) exam, which I passed as well. During 2011, I joined the Genzyme Biosurgery (Framingham, Massachusetts) internal audit team to gain experience doing actual auditing.
Because I had been the auditee at the Genzyme Biomaterials development group for nine years, I sometimes received corrective and preventive actions from internal auditors that I felt were unjust or ridiculous. From this experience, I became passionate about the need to be a reasonable auditor who could point out audit deficiencies in an evenhanded way to clients. My main purpose is to help the auditee learn from their mistakes and to improve their operations.
In 2013, the information in my LinkedIn profile led a former colleague to offer me a temporary a six-month job with a small medical device company in Cambridge, Massachusetts. There I dealt with quality issues for the company as they recruited a new permanent quality manager. At this company, I gained valuable experience in handling day-to-day issues as their consulting quality manager.
I was advertising my availability online using LinkedIn and in-person through my participation at the Worcester Section of ASQ as well as the New England discussion group meetings of the ASQ Biomedical Division. Meanwhile, I landed several small one-time internal audits assignments at various companies in the local Boston area.
During the establishment of new LinkedIn contacts, I reconnected with many people with whom I had worked during the preceding 20 years. It turned out that establishing these contacts was vital in securing additional private clients.
To broaden my contacts in quality auditing, I decided to attend the October 2012 national ASQ Audit Division held in Augusta, Georgia. During that meeting, I connected with Larry Whittington (of Whittington Associates, also based Georgia), who became an important mentor for me in developing my auditing career. I continue to attend national ASQ Audit Division meetings whenever they are offered and my schedule permits.
EG: In addition to ASQ, what organizations have you worked with and what did you learn from them?
CT: In 2013, I enrolled in a BSI course to become a lead auditor for ISO 9001, which was a multi-day remote course.
I found it to be very interesting and the required testing on the presented material was done in-class using my computer. I learned a lot, passed the course, and received my training certificate from BSI. This course was very helpful because it gave me a great framework from which to work.
EG: When did you begin your association with Exemplar Global?
CT: After leaving Genzyme, I noticed I could obtain a certification from Exemplar Global (then known as RABQSA) as a provisional quality auditor based upon my CQA certificate. I only needed to pass a short gap analysis quiz demonstrating my knowledge of important auditing principles, which I completed successfully.
I wondered how I could use this certificate to achieve the Exemplar Global lead QMS auditor registration. I learned from Larry Whittington about the competency option at Exemplar Global wherein I would do an internal audit for an existing private client and at the same time I could be observed by an Exemplar Global skill examiner. The examiner would watch how I conducted the audit and then report the resulting observations to Exemplar Global. Upon inquiring about this possibility with Exemplar Global, I learned of Warren Snow, a skill examiner who lives in Massachusetts as I do. For this expansion of my Exemplar Global certification to lead QMS auditor, I contacted Warren to determine his availability. I then asked one of my private internal audit clients if they would permit him to accompany me to visit their facilities while I conducted an internal audit. Happily, they agreed, and Warren signed a confidentiality agreement with this company. In late 2014, Warren met me in Lexington, Massachusetts, tor this skill examination. He met with me privately several times during the audit, and then he observed and graded my performance. He sent his report to Exemplar Global for their review, and my Exemplar Global registration certification was expanded from provisional quality auditor to lead QMS auditor.
Prior to my certificate expiration, I needed to schedule another skill examination with Warren in 2017. This was much more of a challenge because I had difficulty in finding a private client who was willing to invite Warren to do his skill examination. To Warren’s credit he worked with me through scheduling various dates until I finally found a private client who was willing to have me invite Warren. Thankfully, the skill examination was accomplished successfully (as was the internal audit for my client)!
I use my EG registration certificate as an important credential (for ISO 9001:2015 and for ISO 13485:2016 audits) because I subcontract with two ISO registrars to conduct surveillance and recertification audits for their clients.
As the pandemic subsides, I look forward to doing more private client internal audits in person.
EG: What advice would you give to people beginning their career in auditing management systems?
CT: Most successful quality people usually have experience in other areas of their company’s business, such as operations or product development. In my view, success comes to those people who have a good overview of how their company functions. For people just starting out, I would recommend finding a smaller company to work for, because you can learn a lot of different things and have a positive influence in such a place. In the larger companies, unfortunately, you may be button-holed as a specialist in one thing or another. This usually does not allow you to achieve the overview of how things work at that company (so that you can be effective in making positive change).
I enjoy this auditing work because each client is different and interesting. I have learned a lot about the multiple approaches that are effectively used to do good work. I want to help client to realize their potential; they need to “own” their QMS—when they do that, good things happen (i.e., concise management review minutes, clear evidence [records] that show the QMS is effectively operating, plus effective internal audits). I recommend to my audit clients the need to be efficient; to focus their QMS on only the procedures and records that they need as evidence that their QMS is effective. ISO 9001:2015 is a wonderful tool to organize a company’s work to consistently deliver the product or service that they offer. For ISO 13485:2016 clients who are suppliers to medical device manufacturers, having a clear listing of the clauses in ISO 13485:2016 that are not applicable to their operations is quite important in developing a clear audit scope.
I’d like to offer kudos to those who have supported me during my journey: Larry Whittington, for crucial mentoring; Warren Snow, for working with me and my clients to conduct the needed skill examinations; and my two anonymous Massachusetts medical device clients who allowed Warren to visit their facilities during my internal audits there.