With our nation’s birthday upon us, Dr. D would like to wish all of the readers in the United States a safe and fun Fourth of July as you celebrate on Friday with family and friends. Regardless of how bad the folks in Washington attempt to screw-up this experiment called America, it is still a fabulous place to live. Happy Birthday United States of America!
This week’s guidance will be brief, as the doctor is preparing for a little down time. During the doctor’s visit to the FDA’s website, Dr. D stumbled upon a recent warning letter awarded to a dental company in the North East. Premised on the warning letter’s content, this organization had not taken the time to script the procedures needed to operate in a regulated environment. Seriously? No procedures? There is no doubt when the good folks from FDA started there inspection, quickly noticing that this organization lacked written procedures was surely an “incongruous” (look-it-up) event indeed. Enjoy!
FDA Warning Letter – 06 June 2014
This particular warning letter cited 10 inspectional observations with 7 of the 10 observations commencing with the phrase; “Failure to establish and maintain procedures.” To make matters worse, FDA rejected all 10 of this company’s initial responses with the famous agency response: “We reviewed your firm’s response and conclude that it is not adequate.”
Dr. D has taken the liberty of extracting one of the observations from the warning letter to share with the readers.
Observation One (1) – Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm has failed to implement corrective and preventive action which would include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has implemented written procedures for corrective and preventive action.
21 CFR, Part 820 Section 820.3 – Definitions
In the Quality System Regulation (QSR), the term ESTABLISH or a derivative of the term ESTABLISH is depicted 80 times. FDA’s definition for the term ESTABLISH “means define, document (in writing or electronically), and implement.” That being said, the doctor does not understand what is so darn difficult to understand about this definition. If the QSR states ESTABLISH in a requirement, then might Dr. D strongly suggest that a procedure be scripted. Folks, it does not get any easier than this.
Compliance for Dummies
This week’s guidance is essentially one paragraph. If a section/requirement delineated within the QSR states “shall ESTABLISH” and just about all sections/requirements do, bite the bullet and script a procedure. It makes no sense to argue the point with an investigator during an inspection. Why? Because Form 483 observations will begin flowing like Niagara Falls. The same advice holds true for Parts 801, 803, 806, 807, etc. “Parts is Parts” right?
When writing procedures, the best advice Dr. D can give is to turn it into a family affair, with the entire organization being part of the family. Quality and regulatory should not have to shoulder the full burden of writing procedures. However, they should be reviewing them to ensure they meet statutory and regulatory requirements. For §820.30, get the engineers involved. They need to lead the charge for design controls. For §820.50, it’s time to wake up the buyer(s) and have them earn their paychecks. If a training SOP needs to be scripted (§820.25(b)), put some coffee on the front burner for the HR folks. If production and process controls needs a procedure (§820.70), time to engage the manufacturing and facility maintenance folks. If your organizations do not have the resources available on-site, give Dr. D a call, my organization can help. Regardless, can you see where the doctor is going here? It takes a team, not just QA and RA to ESTABLISH the procedures needed to comply with QSR.
For this week’s guidance the doctor will leave just one takeaway, ESTABLISH equates to scripting written procedures and actually using the procedures to run your organizations. Without written procedures there is nothing but chaos. Chaos is great theater when watching a Godzilla movie; however, not so much when attempting to manufacture medical devices that are safe and effective.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA’s enforcement page. (2014, July). FDA.gov Website. Retrieved July 1, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm401616.htm