FDA Audit Preparation

Can I use my audit company to remediate our Quality Systems?

Can I use my audit company to remediate our Quality Systems?


You want to be ready for that upcoming FDA or Notified Body audit, right?  You want to sail through with few, if any non-conformities, look good to your boss, and be able to ensure your continued position or promotion in the company, don’t you?

So, you hire an independent auditor or a professional auditing firm to come in and have a look at your quality system records and implementation before the official audit takes place.  Invariably, they find at least a few “opportunities for improvement,” and graciously offer to remediate those gaps for you.  Besides, who better to remediate the gaps than the regulatory / compliance expert who found them in the first place, right?
This may seem like an expedient solution to an urgent need, but you may be missing something.
There is an inherent conflict of interest in having the same individual or firm provide auditing services and remediation services for you.  The auditor is likely to mine your quality system for opportunities to generate remediation business for the firm, and therein lays the problem.
Remediation services should be provided by a different company than the one you hired to perform your audit.

First, hire a terrific auditor

It’s essential that you hire a certified auditor with medical device (not just pharmaceutical or laboratory) experience to perform your quality systems audit.  Though there are several quality systems in effect for medical device manufacturers worldwide, the most common are the Quality System Regulation (21CFR 820) in the US, and EN ISO 13485:2003/ISO 13485:2012 in Canada, Europe and much of the rest of the world.  Though many people are familiar with auditing to these standards, you’ll want to ask the auditor to produce proof of good standing of their certification as an RABQSA Certified Lead Auditor or as an ASQ Certified Quality Auditor.

Then, gather strategic advice and create a CMP

Some auditors are former FDA investigators, which can be valuable, as they can often suggest remediation strategies that are likely to align with Agency expectations.  Most of the time, when you hire an auditor, he performs the audit, delivers the audit report, and collects his check.  But keep in mind that a quality systems audit is not a complete analysis of your systems and documentation; rather it is a sampling.  Therefore, you may want to follow the audit with a full gap analysis of your quality system to be sure your remediation plan is robust.  Having a complete picture of the gaps in your quality system enables you to develop a CMP, or roadmap for achieving compliance within a specified budget, timeframe, and with a risk-based approach that regulatory agencies expect.
Inquire with the auditor or with an independent group about their skill in working with you to perform a complete gap analysis and develop a robust CMP.

Now, hire a different company to remediate those gaps

Eliminate conflict of interest.  Don’t allow the fellow who profits most from finding problems fix those problems.
So what are your options?  Your CMP is drafted, and FDA is already overdue for your surveillance audit or pre-approval inspection audit.  Sure, you could pull staff from product development or that new manufacturing initiative, but then your product pipeline will be impacted or yield losses may not be up to par.  The C-level people in the organization are not going to like that.
Instead, consider hiring an independent firm who was not involved with your gap analysis or your audit to remediate the gaps.  There’s no need for regulatory strategy input at this point, and those seasoned strategists are not always the most expedient, cost-effective, tech-savvy executors around anyway.
A young, tech-savvy engineer will be more cost effective, with a likely higher output of deliverables, and they take direction well, with few bad habits.  If you can find an already – established team of such engineers, even better.  If they’re used to working together as a team, they can be self-managing, with consistent output, balanced for cost and skill sets, and accountable to a common compliance goal.  At the end of the remediation project, perhaps you can hire some of them to ensure sustainable knowledge transfer within your organization.

Are you struggling to get traction?

Are you dissatisfied with your progress remediating technical documentation, out-of-date process validations, or FMEAs that are no longer current?  Do you believe an individual or a team of “evangelists” is more interested in espousing wisdom than in writing protocols or filing CRs?
Perhaps you’ve brought in a group of “chiefs” at a premium hourly rate to execute deliverables better suited to a team of indians.
Hire a top-of-the-line auditor and gather strategic compliance advice from him whenever possible.  Then wave goodbye.  Avoid a conflict of interest by bringing in a new organization to fill those compliance gaps.
Remediation is more effectively accomplished with a balanced team of appropriately-skilled engineers at competitive rates.
Want to discuss?  Reach out to me on Twitter or join the discussion on Google-Plus.
About the Author:  Roberta Goode is a biomedical engineer and CEO of Goode Consulting International (GCI), having worked with medical device manufacturers like Biomet, Abbott, and Boston Scientific to boost revenue through avoidance of FDA compliance burdens.  Get more from Roberta and GCI on Twitter.

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