Quality Management System What? Theranos Series
What can I say? Quality was not Theranos’s forte per say.
I ran out of fingers counting the FDA deficiencies that Theranos received around their quality practices and Quality Management System, a.k.a QMS.
I could not choose among so many juicy deficiencies because we could learn so much from all of them. Hence, we will have the privilege to read the entire report right here, right now.
#HayDiosMIO
Click HERE to see full report from the 2015 Therano’s FDA audit in Newark, CA.
The madness shown in this report is the exact reason why you should care about your QMS practices and procedures!
#DontBeLOCO
Let’s make the world a better place and do this instead:
QMS Shielding Action – Numero Uno #1
Before getting into the nitty-gritty of Theranos’ QMS, let’s address the elephant in the room once and for all.
YESSSSSS, you do need a Quality Management System!!
I have been asked this question so many times, and I have seen it in so many forums. If you are developing a medical product, as defined by the FDA, you will need a QMS.
The complexity of regulatory controls will depend on your device classification, indications for use, etc. but you will need it regardless of using external contract manufacturers and suppliers that have a QMS, because YOU and ONLY YOU are ultimately responsible as the manufacturer.
#CAPICHE
QMS Shielding Action – Numero Dos #2
For the 12 months that ended in September 2014, the FDA issued at least 972 violations (483 forms) to medical device companies due to inadequate or absence of procedures.
Spoiler alert: Theranos was one of them!
For example, the FDA found that one of Theranos' complaint logs provided to FDA "contained no logged complaints," though a different log included complaints. FDA notes one specific complaint on "Capillary Tube Nanocontainer (CTN) specimen quality" that Theranos "did not investigate" as a complaint.
Ok, I would very much like to COMPLAINT about this!
If you read observations 2 through 9, the FDA auditors are continuously saying that Theranos had inadequate or absence of procedures (Complaint Handling, Post Market Surveillance, Supplier Quality, Validation, etc.). And if they had them, they were just not following them.
#JustCallMeLOCO
The language used to describe these deficiencies clearly shows that it is not only important to have a QMS but to have a robust set of procedures and records that you actually follow and document.
And guess what? it is the manufacturer’s responsibility, meaning YOURS, to establish those adequately.
If you have never done this before, make sure you bring on board the right experts to help you from day one, and not when it is too late and the expensive failure hits you in the face!
#gameOVER
Theranos is the perfect example that being sloppy on quality may result on FDA violations and observations that can cost you tens or hundred thousand of dollars to fix.
Or the worst, a shut down and losing NINE BILLION DOLLARS!
QMS Shielding Action – Numero Tres #3
If you have a heart problem, you don’t go to an orthopedic surgeon hoping that he can treat your heart, right? You go to a cardiologist… makes sense, right?
You also ensure this cardiologist is qualified with certifications, hospital affiliations, reputation, etc. You will do this due diligence
Because it is your freaking heart!
Well, SAME EXACT logic applies when you are working with contract manufactures and suppliers. You must do due diligence and qualify them and ask questions like:
What is the supplier’s risk level? e.g. supplying a label sticker vs. a component that detects cancer
#NoBigDeal
Can they meet your product requirements? use your design specification matrix
#MakeMySpec!
Do they have the required certifications? Make sure it was not acquired from a cereal box (bad actors out there) or that it is not expired
#SHOWMEtheCERT
Theranos was unable to produce documentation that its suppliers met qualifications. Yet the company had purchased supplies used in manufacturing the nanotainers from such vendors, (Observations 4, 6, 7).
Another issue that I often see with early stage med device companies selecting and hiring suppliers is that they may hire suppliers, which do not necessarily meet their requirements but are cheap or promise a short timeline.
#IcallBull** #Mentiras
I PROMISE you this will ended up with the LONGEST bill and timeline
Ok, you made it this far!
You should be proud that you value and respect QUALITY, that you are proactively protecting your genius medical innovation, and that you are doing everything in your power to be confident that it could be used or implanted in your parents, siblings, husband/wife, children, and anyone you love!
if you’d like access to the entire Theranos series and more Shielding Actions, get it HERE
If you need more help and clarity, Book A Call to learn more about how Genius Shield can help you bring your invention to market seamlessly + safely as only the Genius Shield team can!
May the innovation force be with you