Remediation in the medical device industry often adopts a similar saying you’ll hear motorcyclists say when referencing laying their bikes down [accidents], “it’s not if it will happen, it’s when”.
With so many companies over the years going through major remediation efforts one would think by now most people in the business would have a good appreciation for what a successful process looks like to navigate through FDA remediation projects. Yet, many people will tell you the remediation projects they’ve been a part of were messy, unorganized and a galactic waste of money. Unfortunately, when we’re faced with remediation there is no choice other than to mend our broken wings before flying home for the summer.
One of the biggest issues with remediation projects is many people in the company look at it as a ‘quality’ issue. Meaning, “it’s the quality departments problem, let them deal with it because we have our own projects and deadlines.” Shocking as this may be, I literally was told this several years ago from an R&D Director whose company was going through a sizable remediation overhaul. Needless to say he wasn’t operating as a team player and certainly wasn’t aligned with what was best for the company.
Which sparks an interesting question – if I have a remediation project ready to get underway, what are the things I can do in order to ensure it succeeds? Regardless of the project size, these are the four things you must consider as a top priority in your next remediation effort:
1.Establish clear, consistent and easy internal communication protocol for the project
This is one of the most overlooked parts of a large scale project. It’s especially important when considering cross functional company divisions and the people accountable to working towards successful completion. When people are misinformed or don’t know what’s going on you can be certain it will slow your project down and cause further product quality and procedural issues down the road.
2.Get a GREAT ‘lobbyist’
You’ll need someone acting as the liaison between your company and the FDA. Typically, this person comes from your QA/ RA group, but is that the right person? Don’t assume your de facto executive in QA / RA is the best for the job. Ensure your company aligns itself with a proven individual who has relationships within the FDA and knows how to play the game. This will pay off huge dividends in the end as they’ll know how to navigate delicate situations, get continuances and or leniencies where able.
3.Ensure your entire company (especially executive management) is onboard
Everyone in the organization, bottom up, needs to understand why this project just went to the top of the work list. Everyone needs to be bought in and rowing in the same direction, otherwise you’ll experience cumbersome internal issues as mentioned above, which waste time, money and energy.
4.Learn how to manage cost early on
Often companies will use a consulting group to lead or help work through their remediation efforts. All to often the selection process for that supplier comes down to a key relationship within the company which basically side tracks any formal vetting process of other possible suppliers. Cost becomes a 2nd or 3rd consideration over a relationship. This can be disastrous as selecting the wrong supplier to help you with a remediation project can end up costing you thousands, if not hundreds of thousands, of dollars extra down the road. Case in point – when you use suppliers that fly in consultants to project work you are literally paying more than double the cost for that service just because those resources weren’t local. Flights, housing, food, per diems, auto travel, etc. adds up incredibly fast. I’ll admit, sometimes the best solution is an out of town supplier, however be sure to do your homework here before you settle on the one supplier that’s going to get your company back on track.
Key Take Away:
If you’re heading into a FDA remediation project it is paramount to set up a company wide communication protocol which provides detail to everyone
Remember – it’s not ‘if’ but ‘when’ you’ll find yourself in a situation where you’re stuck going through FDA remediation. Therefore, you must be proactive. Before you need the help, begin compiling data on suppliers that could help with a possible remediation projects. Compare their capabilities, learn how they would approach a potential project, how do they charge, etc. Once you’ve done your homework you’ll then have all the necessary information upfront to make a strategic and informed decision when it comes time to dive into remediation.
[Note] this article intentionally does not cover the tactical approaches to FDA remediation as there are hundreds of articles and sources providing that information. This article covers the intangible parts of projects of this nature, the ones that most often go overlooked.
12/21/2022 04:01:36 pm
I appreciate that you explained that FDA remediation projects should have enough appreciation for their efforts. My friend informed me they were hoping to find a compliance consulting provider that could help them with the quality system of their CBD oil project. He asked if I had thoughts on the best option to consider. I'm thankful for this helpful article, I'll tell him it will be much better if they consult FDA regulatory consultants as they can provide details about how their services work.
12/22/2022 12:29:59 pm
Hi John Carston - thanks for the comment. I'd recommend your friend talks with a Quality Engineer and or Quality & Compliance specialist (could also be a regulatory affairs person) who is well versed in quality management systems (QMS) and has a pharma background. CBD is typically listed as an approved prescription drug, it can't be legally included in foods or dietary supplements. CBD can only be included in "cosmetic" products. But there are still CBD products on the market that are labeled as dietary supplements. As a result, having someone who knows and understands these differences and how that impacts the regulations your friends CBD product falls under is critical.
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About the Author
Travis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.