SQA News | Summer 2016


SQA Wins & Challenges

Dear Friends,

I hope everyone is enjoying their summer so far! Ideally summers are synonymous with spending more time with loved ones, relaxing together, and taking some much needed breaks from all the tension that exists in this day and age. It seems tougher and tougher to find these moments of peacetuning out the noise of current affairs demanding our attention. A contributor to our stress is the instant information culture that exists everywhere now. Something big happens and we all know immediatelyusually along with a mix of strong opinions on the matter. The difference today is timing and scale: anyone with a smartphone can capture said events, hit ‘send’ and have their messages go viral globally, impacting thousands or even millions of thoughts and opinions within hours. Appreciating freedom the way I do, I find this ability great, but it comes at a big price. We are constantly inundated with unfiltered, unverified, and often controversial data, and it’s tough to escape. I personally try to make the effort to be a positive contributor to the news (in my own small way) rather than a consumer, and the best way to stay positive is to make sure I turn my devices off on a regular basis for some downtime.

I choose to be with my two families as much as possible—my home family with Carrie, Steph, and Johnny, but also my other family…SQA! The other family I started with my Dad over 20 years ago, before smart phones, widespread texting and email, or the mainstream internet even existed. This family is one that does the simple stuff on a daily basis that makes the world a better place, helping create happy clients and countless jobs around the world. I love this family. It’s so fun to be a part of. We navigate complex and often turbulent waters with what is really a very simple business—one that focuses on always doing the right thing, and while doing so also helps companies save money, time, and even lives. The SQA family is my personal place to balance out my life and keep me happy. But things that make you happy also come with big challenges along with the wins. Let’s start with the good stuff…


New ideas from new team members
We keep adding great people to our team at headquarters and in the field, and the dividends are massive. For new folks, I feel it’s important to seek their objective thoughts before they settle in too much, because sometimes it’s human nature to join a company and naturally start fitting in and conforming to what’s happening around you. The best people are ones that can separate from the fray and always try to do what’s best for the company, not necessarily what is best for their boss or themselves. We’re adding to these ranks daily and I want to acknowledge the spirit behind these great people.

Suppliers taking more initiative
A positive change that we’re seeing more and more is that some suppliers are controlling their own destiny by taking the lead in having SQA audit their capabilities before being asked by their customer to do so. It is great to see this kind of initiative, which often results in a much more positive and productive atmosphere than if mandated by an OEM. The supplier can take a breath, listen carefully to our thoughts about improvement, and then can implement these ideas on their own timetable. Then, when the work is complete and their customers want to knock on the door to verify that everything is going well, the supplier can share with them the recent work, where they scored well, where they had challenges, and what they’re doing to make things better. These suppliers are a step ahead and it’s great to see this trend gaining momentum.


Quality commitment
This might ruffle some feathers out there, but we are still dealing with companies who procrastinate with quality initiatives until they are forced to adopt themusually through regulation, or in response to a failure. I understand that quality budgets aren’t always easy to obtain, but even with a clear, tangible business case, some companies still opt to wait rather than do the sensible thing. This spells danger from our standpoint, and there’s nothing more frustrating than knowing that we could have saved our clients millions of dollars if they simply spent a dollar earlier, instead of hundred later, because they waited too long.
Data demands
More and more of our clients are understandably concerned with the security of data that exists within our exceptional operations platform, STEPQ. Fortunately, STEPQ was built from the ground up with multiple regulatory considerations in mind, but unfortunately, the threats to corporate information environments continue to evolve and require a multitude of counter-measures to mitigate. Recent headlines suggest that cyber-criminals are shifting their focus from OEMs to an OEM’s supply chain, in the hope of finding a weak link and a way in. As a company that provides global quality services, recouping the costs of keeping STEPQ secure has not been foremost in our business relationships. However, as the value of STEPQ increases with our clients, we need to look at ways to fairly account for these rising costs while still focusing on our core competency: quality.

As usual, I stand ready to hear any feedback and love to personally reply to your thoughts, comments, suggestions, etc. Please reach me directly at mmckay@sqaservices.com and thanks to everyone for their continued support!

Yours in Quality,

Mike McKay


Personal Care Products Council

In July, SQA’s Executive Vice President Gerard Pearce and Vice President JB Dowd met with the Quality Assurance Committee of the Personal Care Products Council, seen here on a laboratory tour at Dow in Collegeville, PA. Many thanks to Dow for hosting the group and for a productive meeting on current hot topics, including quality metrics, data integrity, and supplier quality management!

The New ISO 13485: What You Need to Know

You may already be familiar with the new ISO 9001:2015 standard, which went into effect in September 2015. But how much have you heard about the new update to ISO 13485? This is the first time ISO 13485 has been updated since 2003, and there are several significant changes afoot aiming to facilitate global regulatory alignment. Find out more about these updates, and what they mean for you and your Quality Management System, over at the SQA Blog.

Associate Spotlight

Laurel Hacche is a Senior Quality Professional with more than 25 years of experience in the pharmaceutical, device, and biologics industries. Prior to her role as an SQA Associate, Laurel was the Senior Director of Third Party Manufacturing in the Global Sourcing & Procurement department at Allergan, Inc. During her tenure with Allergan, she also served as the Director of Worldwide Quality Assurance with oversight for the corporate CAPA system, annual product reviews, government agency communication records, third-party manufacturers, global audit and stability programs, complaint management, and R&D technology transfer. In addition to the above activities, Laurel has served as the lead corporate QA liaison for the FDA and alternate regulatory agencies. Prior to Laurel’s employment at Allergan, she served as a Postdoctoral Researcher in the Department of Biological Chemistry at the California College of Medicine at U.C. Irvine. Laurel has also held an Associate Faculty position at Saddleback College and served as an Assistant Professor at the Joint Science Department for the Claremont Colleges. Laurel holds a Ph.D. in Physical Polymer Chemistry from U.C. Irvine and an A.B. in Chemistry from Occidental College.

As an SQA Associate, Laurel has served as a Lead Auditor, conducting audits for clients in Northern and Southern California, and Arizona. She has noted that audits for the suppliers on the west coast of the United States routinely include the challenge of assessment against multiple regulations for the same facility (combination of ISO, FDA Drug and Device regulations, and European GMPs). Laurel recently had the pleasure of including SQA Program Coordinator Justin Quattrone on an audit, where Justin had the opportunity to observe audit activities and gain knowledge with respect to the dynamics associated with a compliance assessment. In March 2016, Laurel was elected to the position of Vice President of Programs for the Southern California Chapter of the Parenteral Drug Association, contributing to the successful execution of a Data Integrity Symposium in April 2016, where SQA was a Platinum Sponsor.