As promised, Dr. D is going to expand on the warning letter issues that the doctor started reviewing last week. Thanks again to my evil twin (Mr. Twitchell) for bringing this gem of a letter to Dr. D’s attention.

Similar to the management review issue the doctor reviewed last week, internal quality audits essentially fall into the same bucket. Device establishments do not have to share the results of internal (or supplier) audits with FDA. They only have to provide objective evidence that such audits are being performed. Pretty simple concept, right? Well, Dr. D is guessing that there are establishments out there that lack the expertise needed to comply with 21 CFR, Part 820. If you are a member of one of those quality and/or regulatory challenged organizations, please feel free to contact Dr. D, my organization can help. Otherwise, the next time the agency visits for a cup of coffee and an inspection, your establishment may be on the receiving end of that coveted FDA Warning Letter. Now granted, the QSR has numerous sections that can be viewed as occasionally “longueur” (look-it-up); however, device establishment cannot pick and choose the sections they wish to comply with, including quality audits. Enjoy!

Warning Letter – 05 November 2014

As mentioned in last week’s DG, this particular QSR offender was awarded their warning letter for racking up nine Form 483 observations and a deficient response to FDA. Ouch! It never ceases to amaze Dr. D the level of regulatory and quality incompetence in some establishments. Considering the abundance of consulting help and the plethora of free advice available on the Internet, compliance with some of the fundamental tasks, such as performing internal quality audits, is not rocket science. In fact, a well-documented and effective quality audit program would have probably saved this device establishment from some serious regulatory pain.

Warning letter excerpt

“Observation Eight: Failure to establish procedures for quality audits as required by 21 CFR 820.22. Specifically, your firm has not established procedures for conducting quality audits.”

Subpart B – Quality System requirement

Section 820.22 – Quality Audit

“Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and re-audit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and re-audits shall be documented.”

Compliance for Dummies

Not wanting to state the obvious but obliged to do so, Section 820.22 mentions the word “shall” six times:

(a) shall establish;

(b) shall be conducted;

(c) shall be taken;

(d) shall be made;

(e) shall be received; and

(f) shall be documented.

Considering “shall” is mentioned six times, just maybe an establishment might want to think that quality audits are important to FDA. Although quality audits can be employed as an effective tool for correcting quality management system (QMS) deficiencies, it is also one of the easier requirements to comply with, in Dr. D’s humble opinion. For example, to comply with Section 820.22, an establishment must address all six of the “shall” statements listed in the QSR.

1. The establishment shall establish a procedure or procedures that delineate the requirements of their quality audit program.
2. Audits shall be conducted by individuals removed from direct responsibilities of the area to be audited (note: auditors should be appropriately trained and qualified: recommend reading ISO 19011).
3. When QMS deficiencies are noted during the execution of an audit, the appropriate level of corrective action shall be pursued to remediate the issue(s) identified, including a re-audit if deemed necessary and appropriate.
4. The results of audits shall be documented in a written report.
5. Audit reports shall be reviewed by management and
6. The dates and results of all audits shall be documented.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway; executing quality audits is not rocket science. If an establishment does not have the resources or bandwidth for performing quality audits, it is always an acceptable approach to contract with a third-party auditing firm. Heck, give me a call for some Devine Guidance  and audit support.

However, make no mistake, not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.

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.

References:

1. Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office. 
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA’s enforcement page. (2014, November). FDA.gov Website. Retrieved January 12, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm.