Dr. D is going to dive into another somewhat controversial topic for this week, FDA inspection readiness. Just for the record, there is no such thing as minimum compliance or maximum compliance, just compliance. Like many of you that read my weekly column, the doctor is a member of Linkedin and spends a couple of hours each week reading through the advice, some good and some bad offered by our colleagues. Frankly, Dr. D believes that “mimesis” (look-it-up) is a viable way to learn from industry experts. However, make sure you have a good role model before first.
That being said, how do you prepare for an FDA inspection? You don’t! Have you lost your mind Dr. D? Please read on my friends.
The agency expectation is that device establishments are always in compliance with the regulations. Pick one: (a) 21 CFR, Part 820; (b) 21 CFR, Part 801; (c) 21 CFR, Part 803; (d) 21 CFR, Part 806; (e) 21 CFR, Part 807, etc., it does not matter, compliance is not optional. The doctor grows tired of hearing advice such as:
- Focus on CAPAs and Internal Audits;
- Focus on Design Controls and Process Validation;
- Focus on Purchasing, Supplier Management, or calibration;
- Focus on Document Control, Inspection, and Training; or
- Focus on Customer Complaints and MDRs.
Folks, you need to focus on everything. When the FDA shows up in your lobby for a cup of coffee and an inspection they are not going to say; “I just want to look at process validation.” They are going to dive into CAPA and use CAPA as an entry point into your entire Quality Management System (QMS). If any portion of your QMS fails to hold up to the scrutiny of the investigator, a Form 483 observation will be forthcoming. Rack up enough Form 483 observations and a warning letter will be in the proverbial cards for your organization. Especially in 2014, as the agency has announced a new-found interest in quality. A trend that Dr. D noticed in 2013 was an increase in the frequency of unannounced agency inspections. The doctor expects this trend to continue in 2014.
Is there a way to better prepare organizations from the regulatory pain the FDA is capable of unleashing? Absolutely! It begins with scripting well-written procedures that clearly reflect an organization’s compliance with the QSR; not part of the QSR but the entire QSR. Seriously, the best way to preserve the good health and sanity of your Chief Jailable Officer (CJO) is to have a robust QMS that meets regulatory requirements, period! Having established procedures is a given and considered just part of the basic admission price to play in the medical device industry sandbox. The next logical step toward effective compliance is naturally the training of all personnel to applicable procedures. Please do not underestimate the importance of training needed to drive a high-performance QMS. However, do not use training as a crutch. If a problem occurs, it is often too easy to blame the problem on training and use training as a root-cause and re-training as the preferred tool to drive corrective action. Folks, problems typically go much deeper than training. If re-training is determined to be necessary you need to ask why?
Furthermore, CAPA with serious root-cause analysis and aggressive verification of effectiveness can be effective tools for driving QMS compliance. However, the doctor usually sees an appalling lack of depth of analysis when reviewing CAPAs during audits. People, the often used “operator error” is not acceptable root-cause analysis. Questioning why the operator made the error is the direction in which the CAPA investigation must proceed.
Finally, the doctor sees far too-many shortcuts when it comes to the internal audit program. From Dr. D’s perspective it continues to appear that audits are more of a hassle then an actual tool for gaging the effectiveness of a device establishment’s QMS. Seriously people, a strong audit program will drive organizational compliance and hopefully, zero Form 483 observations during FDA inspection time. If there is a viable business need to postpone an audit, make sure the rationale to do so in documented. Remember, not having available resources, e.g., qualified auditors, is not a valid reason to postpone and audit.
For this week’s guidance the doctor will leave the readers with just one takeaway. There is no such thing as minimum compliance or maximum compliance, there is just compliance. The best advice Dr. D can offer is to always be in a state of compliance with all regulatory requirements. If you decide to pick and choose specific requirements to comply with then your CJO should not be surprised when the FDA investigator decides to pick and choose the observations listed on the Form 483. In closing, thank you 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.