A (Regulatory) Affair to Remember
Guest Blogger, Natalia Olive
Principal, Olive Safety LLC
Quality Regulatory Network Blogs Sponsored by ComplianceQuest Inc.
Remember the good old days? Back when a “regulated product” meant one that was covered under FDA rules, and that was it? We had no idea what was coming…
And come it did, especially starting in 2007 with the all-encompassing REACH in the European Union. REACH, the regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals in the European Union, covers everything from the nastiest toxic substance to the most innocuous crayon. A wide reach for REACH, indeed. Pardon the pun, it couldn’t be helped. Among many other exciting things propelled by REACH, it thrust me forward to one of the most rewarding work experiences of my career.
Lesson #1: All products are regulated
Without exception, all products offered for sale are regulated. By how many regulations is a point to be discussed, sometimes heatedly. This was the most myth-shattering and intriguing aspect of product safety as I approached the discipline in 2007 and the reason I became passionate about it as my career veered firmly in this direction in 2008.
Gone are the days in which a company’s regulatory affairs group could be content with knowing about FDA requirements only. Today, these groups are diversifying and incorporating experts in electrical safety, chemical registration, you name it. And many of these product safety experts come from the rank and file of safety management, as I did.
At the time I took over for REACH compliance in 2008, my career had focused more on Safety Management Systems after several years supporting sites with their day-to-day safety programs. I had some knowledge of products since I’d been managing WEEE (waste electrical and electronic equipment) compliance for about a year, but no real in-depth knowledge beyond that. That was about to change in a hurry.
Lesson #2: Know the products
As REACH regulation itself took form, so did my eventually extensive knowledge of the product catalog. It started shyly browsing the company’s website, asking a few questions to technical service, and culminated in a three-day marathon in which I read through each of the 60,000+ line items of products sold just to be sure we hadn’t missed any that would need extra attention. What a rush!
After a few weeks talking with colleagues from all divisions and departments, it was clear that no function had a full grasp of all products, so it was up to me to learn and compile information. And compile I did, as well as slice, dice and sometimes julienne the data.
Looking at a part number became a fun exercise to see if I could guess the type of product, or the family name. Extra brownie points if I could tell off the top of my head what SVHC (substances of very high concern) it might contain. Geeking out at its best. And such a new world for a former “safety gal” to dive head-first into the company’s heart and soul: its products.
Lesson #3: A fractal approach to publishing regulations
For those in the know, like my dad, fractals are images generated by the infinite repetition of preset parameters expressed as a mathematical equation. You can keep zooming into a fractal and keep finding fractals. Yup, the apple didn’t fall too far from the tree.
For the past four or five years, that’s how regulations have been published, it seems: in an infinite chain, and blooming like New York City tulips in April.
Once GHS (Globally Harmonized System of Classification and Labeling of Chemicals) became law in several key regions such as China and the U.S., all bets were off. Many other key players, like Australia, Brazil, Canada and Singapore, have implemented GHS themselves and you’ll never guess how harmonized they are: they’re not. Hence the fractals feeling: you keep digging into regulatory texts and finding ways your current compliance program needs to change.
Chin up!
It may seem like a bleak picture I’m painting, but the world of product safety regulations is ripe with exciting challenges for even the most experienced professional. It’s a rewarding field for those with a proclivity for details, and it lends itself to honing those elusive “soft skills” every time you teach someone about how far-reaching this can be.
We’re plunging ahead into a world with more regulations and more variations, welcome to the 21st century, product safety style!
What’s your take on product safety regulations?
Sponsored by ComplianceQuest Inc., a Modern Cloud Enterprise Quality Management System providing quality, regulatory compliance, manufacturing and safety solutions for regulated companies.
