Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Performing Quality Audits is not Optional

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Guess what happens if an offending device establishment is awarded with a number of Form 483 observations? If your answer begins with the word “warning” and ends with the word “letter” a.k.a., “warning letter” then you would be correct.

This week Dr. D is going to expand on the virtues associated with performing quality audits. You see ladies and gentlemen, the execution of audits are not optional. In fact, not performing audits, rest-assured, will result in your friendly FDA investigator pulling out his or her pen and writing that infamous Form 483 observation during an inspection. 

 
Guess what happens if an offending device establishment is awarded with a number of Form 483 observations? If your answer begins with the word “warning” and ends with the word “letter” a.k.a., “warning letter” then you would be correct. For this week’s guidance, the doctor was able to extract a warning letter from the agency’s enforcement page that cited the failure to establish a procedure for audits and the actual execution of quality audits in accordance with §820.22. Seriously, folks performing quality audits should be considered one of the fundamental requirements of any quality management system. In fact, it makes no difference in regards to the industry: (a) medical devices; (b) pharmaceuticals; (c) aerospace; (d) defense; or (e) automotive, audits are a salient requirement. Additionally, audits are a salient requirement needed to support compliance with ISO 9001, ISO 13485, and AS 9100. Trust the doctor when I emphatically state; “ The FDA is not going to give your organization’s Chief Jailable Officer (CJO)  “plaudits” (look-it-up) for their failure to establish an internal audit program and actually perform audits. At the end of the day, audits are needed to help drive compliance and continuous improvement for device manufacturers. Simply stated, audits identify problems that need to be fixed!  Enjoy!

This week’s offending device establishment was visited by the FDA earlier in the year and received eight (8) Form 483 observations. For those frequent visitors to the Devine Guidance Blog, the doctor will visit a few of the other Form 483 observations in next week’s guidance. Dr. D feels obligated to do so because the agency was clearly displeased with this organization’s quality management system. There is simply no excuse for not performing quality audits. If an organization does not have the resources to perform these quality audits you can always subcontract this work out to either Dr. D or other consulting firms that are capable of providing effective audit support. 

FDA Warning Letter – 08 May 2014

“Failure to 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, as required by 21 CFR 820.22. For example, no procedures for quality audits were available for review by the investigator.” 

21 CFR, Part 820

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 reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(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 reaudits shall be documented.” 

Steps for Compliance

Just for clarification purposes, if any part of the Quality System Regulation (QSR) starts with a “shall establish” this comment means the FDA expects: (a) the device establishment to define procedural content; (b) actually script a well-written procedure; and (c) implement said procedure; a.k.a., actually use it! For those of you that are not well-versed in the QSR, the FDA actually provides some regulatory relief in regards to audits in the form of an exception noted under §820.180(c). However, just because device establishments do not have to share the results of audits with FDA, they still must present objective evidence that the audits are actually being performed.

“(c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.”

Besides, if audits are resulting in CAPAs, rest-assured the agency will enter via the CAPA system. However, documented evidence of compliance better be in the form of an audit schedule supported by audit agendas and sign-in sheets. As a minimum, Dr. D recommends the following elements are placed into the written procedure or should be considered for inclusion in support of the quality audit program.

  • Device manufacturers should script a well-written procedure that meets the intent of the QSR and other regulatory requirements as dictated by the device establishment’s business model, e.g., 21 CFR, Part 820; ISO 13485; 93/42/EEC, SOR/98-282, etc.
  • Device manufacturers should create an audit schedule, preferably an annual schedule to support objective evidence of compliance.
  • Device manufacturers must have trained and qualified auditors. Dr. D recommends reading ISO 19011. Note: auditors do not have to be certified.
  • Audits must be documented: (a) dates; (b) area(s) audited; (c) person performing the audit; (d) auditee(s); (e) corrective action(s) assigned; (f) need for a re-audit; (g) recommend an audit checklist; and (h) the actual written audit report.
  • Dr. D recommends the use of an audit agenda, audit plan, and sign-in sheet to support the claim of compliance through objective evidence.
  • Auditors must be independent of the area or function being audited, but must possess sufficient knowledge to be effective.
  • It is an acceptable practice to employ a 3rd-party supplier to perform audits.
  • Corrective action must be pursued to correct deficiencies.
  • Problem areas warrant a re-audit once the corrections are made.
  • The result of quality audits shall be reviewed by management. In fact, the result of internal audits better find their way into management review.

Takeaways

For this week’s guidance, Dr. D will leave the readers with four takeaways: One – device establishments are required to establish a procedure for quality audits. Two – device establishments must actually perform the audits. Three – the results of audits do not have to be shared with FDA, only documented evidence that they are being performed. Four – corrective action must be pursued to correct non-conformances noted during audits. 

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. (2013, 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. FDA’s enforcement page. (2014, May). FDA.gov Website. Retrieved May 9, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm397732.htm

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Dr. Christopher Joseph Devine, President, Devine Guidance International

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