SQA News | October 2015

SQA Wins & Challenges

I’m really excited heading into the Fall Quarter of another record revenue year with SQA. As of August, we are up an additional 20% from our 2014 record year, cranking on all cylinders and gaining even more momentum heading into 2016 with some really significant recent wins…

SQA’s 20th Birthday
A few weeks ago, I sat with our HQ employees for our quarterly staff meeting. We sat in the very room where my Dad and I started the company 20 years ago. It was surreal and I am insanely proud of what we created and so lucky to do it along with people I respect and admire so greatly. Starting the company wasn’t easy – we knew the climate had changed since my father had sold Intertek in the mid-80s, and we began by thinking about how to sell our services in an arena that wasn’t as focused on military and defense, but instead was targeted towards commercial industry. We knew that we were going to have to sell our services from an ROI standpoint and didn’t have some of the mandated military standards and other environmental market conditions that would help facilitate our growth.

I was 26 and my Dad was 61 back then, and I am blown away by the accomplishments we have made with so many incredible people around the world. Before I spoke to the company to kick-off our birthday celebration, I did a little research about some specific accomplishments. I had no idea that we had created more than 6,000 jobs in more than 25 countries, opened accounts with more than 250 companies [including nearly 100 from the Fortune 500], and have billed our customers nearly $200M since we opened. We rented a 200-square-foot office to get going, and had two desks and a coffee table. I distinctly remember creating our logo, discussing our brand and what we would stand for, and how we would grow. The Internet and email didn’t exist. I had one old Apple computer that held the names and phone numbers of quality assurance professionals around the country, whom I called to be our founding members. I had a map on a corkboard with pins in it, which represented our national coverage, each color satisfying a different industry. We networked with ASQ and other organizations, which helped us immensely in the early years. We wrote our brochures and traveled the country attempting to sell our services.

I have many stories – some good and some hilariously bad – about our successes and failures, none of which I would trade for anything. So THANK YOU to everyone who has supported us along the way. Happy Birthday, SQA!

Our next 20 years
What will we be like? What kinds of services will we sell? Who will be our top customers and in what industries? As they say, “the only constant is change,” so how will we stay ahead of the curve and keep it all going? These are great questions and I call it a major WIN that the people we currently have at SQA Services, Inc. will be able to navigate us. As CEO, I wish I could meet all of the people that work for SQA around the world. I am sure you’d agree that we are in an amazing position, with super leaders emerging everywhere. Our company is a combination of People, Processes, and Technology – and we are continuously improving in each of those areas.


Staying ahead of a changing workforce
When we first started, we had rolodexes and phones. A fax machine was the new device that took over for the Telex machine. Color printing was crazy expensive, and to get it done meant lines at Kinko’s. People, for the most part, worked at big companies for a long time until retirement and then they might have considered consulting a little to stay active. My, how times have changed! Nowadays, people promote themselves using very creative methods; they use LinkedIn and other tools to leverage their own networks, they tend to work for themselves more, and they are less and less likely to build a career of 30+ years at one company. This is a massive WIN for SQA, but it’s also a challenge. It’s tough to keep all of our awesome Associates busy all of the time, so people now market themselves to get new assignments. What’s tough for SQA is the potential confusion that occurs when some of our best Associates are also in business for themselves and promoting their own small business. We love the entrepreneurial spirit, but it can confuse our clients who look up our top Associates on LinkedIn and see that they aren’t only representing SQA. This kind of activity is becoming more commonplace around the world, but it leads to challenges. Instead of fighting this, we at SQA are embracing it. Shortly, Jason Gutierrez, our new Marketing Director, will be going on a speaking tour around the globe, teaching our Associates how to promote themselves and their professional experience. He will speak on tips of how to brand Associates online and share things that we look for in hiring quality professionals. In fact, many former clients of SQA now work for us in the field as Associates, so it’s important to think strategically in this area.

As usual, I appreciate any open feedback you have. Please feel free to send any comments or questions to my email mmckay@sqaservices.com. Enjoy your quality journey and thanks again for supporting SQA!

Mike McKay

The False Medicines Directive

On March 19, 2015, the European Union issued The False Medicines Directive (guidelines per EU Directive 2001/83/EC), requiring that manufacturers (authorization holders) of finished products assess the risk posed to products by their excipient manufacturers (suppliers). The directive states that the risk is to be evaluated in terms of the “quality, safety, and function” of the excipient in the final product. The details of the tool and what elements should be considered in the evaluation are at the discretion of the authorization holder; however, Chapter 2 (sections 2.3 – 2.5) of the guideline provides specifics in terms of what should be considered when developing a risk assessment tool. Section 2.6 defines the minimum GMP elements that should be considered when evaluating the supplier base. Based on the structure of the document, it appears that section 2.6 is mandatory when assessing a supplier’s system. Chapter 3 of the directive requires a gap assessment (audit) of the supplier in order to determine their risk profile. Suppliers should be considered as low, medium, or high risk and should have controls in place commensurate with their rating (as determined by the authorization holder). Chapter 4 of the directive discusses on-going monitoring. This may require re-evaluation of risk categories based on events with the supplier. Again, such a re-evaluation would be at the discretion of the authorization holder.

What does the directive mean to SQA Associates?
The directive indicates that authorization holders should have their assessment tool in place and evaluations underway by March 21, 2016. In the event we are conducting internal audits for clients or audits at third-party CMOs that distribute product within the EU, we should be asking the auditee about their plans for complying with the directive. We should not be writing observations using this guideline until the end of March 2016. As associates, you should be aware of the guideline and be able to discuss with our clients and auditees its contents, if asked about it.

The guideline is not long and is very straightforward. We should always keep in mind that there could be multiple ways in which an authorization holder can meet the requirements of the directive. Here’s a link to the document. Please take some time to open it and become familiar with what is in it. If you have any questions at all regarding the directive, what it requires, what you need to do about it, or anything else, please feel free to reach out to me at 973-229-2066.
Steve Sharf
Field Engineering Director

Associate Spotlight

Dan Salazar resides in Southern California and has been an SQA Expert for one year. Dan is one of our top-performing Senior Quality Specialists, and has extensive expertise in source inspection precision and 35 years of experience in machined parts within the Aerospace industry. In his spare time, Dan enjoys restoring and building Pro-Street classic cars and also engages in sports activities, including bike riding and swimming. Congrats to Dan for being an outstanding professional and SQA Associate!

Associate Referral Winners!

Congratulations to our Associate Referral Campaign Winners!
  1. Rita Silva- Brazil
  2. David Clark- USA
  3. Jeremy Johnson- USA

How can we help you?

SQA provides managed supplier quality services for audits, corrective actions, inspections, and engineering to manufacturers within the healthcare, aerospace, and high tech industries.

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