A Tough Lesson in the Importance of Risk-Based Thinking

Even though the airline lost my luggage – for three days, the entire conference! – I’m glad I attended the 2017 ASQ World Conference on Quality and Improvement.

Ironically, one of ASQ’s high-interest topics was risk management or, to use a broader term, risk-based thinking. Go figure.

According to the Air Travel Consumer Report by the U.S. Department of Transportation, the risk of losing my luggage was slim -- less than one percent. So the idea that bad things can and do happen to good people who do everything right was top of mind for me during the conference.

In the end, what did I learn at ASQ? A lot. Here are some of my key takeaways.

1. The September 2018 deadline to implement the 2015 revision of ISO 9001, which includes a new requirement related to risk-based thinking, has everyone diligently occupied.

2. ISO 9001 has advanced significantly by replacing preventive actions with risk-based thinking, a smart decision that I think will positively impact industry.

3. This new requirement ensures top management involvement. It will benefit product, process, and customer.

Risk-based thinking is not intended to be a one-off activity, but a process used within all quality management processes and throughout all levels of company personnel. It is an integral part of the QMS.

So why is risk-based thinking so important?

Using my MIA luggage as an example, let’s apply ISO9001:2015 Sub-clause 5.1.2 – Customer Focus:

“Top management must demonstrate leadership and commitment with respect to customer focus by ensuring that the: …risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; focus on consistently providing products and services that meet customer and applicable legal requirements is maintained; focus on enhancing customer satisfaction is maintained.”

The airline could benefit from risk-based thinking by asking, “What is the risk of losing a customer’s bag, and not knowing where it is -- at all?”

Risk to reputation? Check!

Customer-satisfaction risk? Check!

Financial risk? Check!

All these risks have serious implications for any company in any industry. But the upside is that these also present opportunities for improvement -- opportunities to make your customers happy, save money, and save your reputation.

I could also employ my own risk-based thinking. I could choose to pack light and never check in luggage, or get “smart” luggage that I can track myself. But I’d really prefer the airline figure this out.

In the end, my bag was found at my home airport with no tags, identified only by the description of the internal contents that I provided, and delivered to Charlotte on my last night.

I am now a little more skeptical and not as enthusiastic about this airline, but this conference’s message was really driven home to me, as a negative experience always leaves a deeper impression than a positive one.

Sophia Finn has over 10 years of quality experience in regulated industries. She began her career with the FDA working in CBER’s vaccine lot release program and later moved to the FDA’s office of regulatory affairs as a regulatory microbiologist. Additionally, Sophia has managed CAPA, complaints, audit, and deviation programs in the medical device industry. Sophia has a master of science in bioscience in regulatory affairs from Johns Hopkins University and is an ASQ Certified Quality Auditor.

Sophia Finn

Posted by Sophia Finn

Sophia Finn manages the customer success program. Prior to her adventure at Veeva, she worked for the FDA as a microbiologist testing flu vaccine efficacy and food samples for bacterial contamination. She also worked for various medical device manufactures where she remediated quality processes, and managed CAPA, complaints/MDR, and deviation programs. Prior to all of this, Sophia served 7 years in the Air Force as a medic, and we thank her for her service.