We know that FDA's Quality System Regulation requires registered device firms to have regular internal quality audits. Let's see what the regulation says.
"Sec. 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."
I have highlighted the section regarding how FDA describes the individuals who perform the audits. Most mid to large companies attempt to meet this requirement by hiring one or more internal auditors and assigning them various systems to audit, so that over a year all major quality systems have been audited. But this is not what the regulation requires. Their is no requirement to hire internal auditors. As a former VP or RA/QA at several large companies I now how much it costs to employ just one internal auditor. Lets assume the annual salary of the auditor is $60,000, add the that the normal 30% overhead and you have a annual cost of $80,000 for one internal quality auditor.
Are you getting your moneys' worth? Lets assume the internal auditor has 5 years of auditing experience and training in Part 820. Using that knowledge they can know what procedures are necessary and determine if employees are following the procedures. Audit observation are typically reference to not following a procedures. You get all of this for $80,000 per year.
Now let look at using a well qualified outside quality auditor. Typically this person will have 20+ years of experience (In my case 40+ years). That experience will come from several employers and allow the auditor to dig deeper. A bonus would be for the auditor to also have experience with FDA, thus very familiar with FDA expectations and procedures. For deep audits of major systems the outside auditor would require two weeks. But more importantly the outside auditor will not be limited to observing if procedures are being followed, the outside auditor will comment on deficient procedures, which is beyond the scope of almost all internal quality auditors.
The typical two week outside audit would cost the firm $35,000. Two of these two week audits would then be a $70,000 annual cost, but more importantly you will receive an expert opinion your FDA compliance. The numbers speak for themselves, the company can save money and have a higher level of auditing coverage, and greater possibility of FDA compliance, by using outside quality auditors rather than employing internal quality auditors.
Give us a call at 314-499-5148, or email larry@fdadeviceexpert.com. We can talk more about this.