FDA audit – these 8 cardinal errors happen every day!
The FDA audit is a controversial topic and a sword of Damocles! Who hasn’t heard of it? If you manufacture and distribute products in the USA that fall under the jurisdiction of the FDA (Food and Drug Administration), you are certainly confronted with this issue. There is always the latent danger that an audit by this agency is imminent. Once the letter announcing the FDA audit arrives, many company bosses literally break out in a sweat, followed by panic attacks in the management team responsible for preparing and conducting the audit. In the worst case scenario, a negative result could result in a product losing its approval for the US market and no longer being allowed to be sold there.
The reasons for an FDA audit can vary widely, from regulatory inspections prior to a product launch to regular GMP (Good Manufacturing Practice) reviews to ad hoc inspections, for example, when critical incidents such as defective products or other so-called „FDA findings“ occur. For standard audits, there is usually two months after the audit announcement to prepare for the day – and as always in life, good preparation is half the battle.
However, in the following, we’re not concerned with preparation, but rather with the audit itself, or rather, with serious mistakes that must be avoided at all costs. As mundane as some of these may sound, they unfortunately occur frequently in everyday business practice. The good news: with a little etiquette and attention, they can easily be prevented.
1. Lies (or not) – Stick to the truth !
Lies have short legs – the old saying applies to audits as well. Likewise, denying obvious facts won’t get you anywhere. Many a small white lie at the beginning, even if it may seem insignificant, will eventually come to light during the audit process, which can sometimes take a few weeks. The result is that, in addition to the now prevailing need for explanation, all your other statements and admissions are suddenly called into question and, as a consequence, doubly questioned – after all, you’ve been caught lying. Why should anyone believe B if you weren’t so truthful about A?
2. Unnecessary discussions
Speech is silver, silence is gold – don’t question the reasonableness of requirements or requests. If something is unclear to you or you are unsure whether you have understood everything correctly, ask calmly and objectively. After all, the communication is in English, which in most cases is the auditor’s native language, but not yours. Only answer the questions you are asked, and do not answer them with assumptions or speculation, but exclusively with
Facts. Don’t present documents you haven’t been asked for, and never describe what you’re not doing or what you plan to do in the future. No discussion is a good discussion.
3. Creating win- lose confrontations
One wins, the other loses – even if that’s your sales manager’s successful motto, this principle won’t help you in an FDA audit. Auditors are only human and don’t want to be fooled or led by the nose. At the end of the day, they have the upper hand and can cause you significantly more trouble than vice versa. Ultimately, they’re just doing their job and certainly don’t mean any harm to the companies they’re auditing. Be helpful, friendly, and professional, and people will treat you the same way.
4. Statements like “That ’s impossible ” or “That never happens to us ”
If there’s one thing you don’t want to do, it’s make the auditor eager to prove you wrong. The real problem is: they’ll succeed, and then you’ll be in even more trouble. „The pleasure of being right would be incomplete without the pleasure of proving others—in this case, unfortunately, you—wrong,“ Voltaire once said. Auditors deal with similar problems and cases day in and day out. They see a lot of „unimaginable things“ that you wouldn’t even dream of imagining. Convincing the auditor of the opposite in your „specific case“ will be difficult, or will simply lead to unnecessary discussions (see above).
5. Comments on the auditor ’s work
Praise, suggestions, criticism – always welcome. While nice and useful in real life, this isn’t very productive during an FDA audit. An auditor doesn’t want to hear how great they are or how well they’re doing their job, nor is they open to well-intentioned suggestions and advice on how they could improve. They also care little if you think – and express this – that they’re stealing your time and that of your employees, wasting your money, and ultimately standing in the way of the company’s success. Warning: You run the immediate risk of creating a win-lose situation (see above)!
6. Unauthorized access – Never leave the auditor alone on the company premises
No unauthorized access! That’s exactly what an auditor is—an unauthorized person on your company premises. You certainly don’t want them, for example, just wandering around your production facilities and asking questions of employees who aren’t authorized to provide information. The mere fact that it’s even possible for an unauthorized person to be unaccompanied in the company raises a host of audit-related questions that you’d rather not be asked in the first place.
7. ( Unauthorized) gifts – Never invite the auditor !
What sounds so simple and everyone knows is nevertheless often ignored. Offering non-alcoholic beverages during the daytime during the audit is not a problem, nor is calling a taxi – however, you may not pay for one under any circumstances, and even an invitation to the company canteen, for example, is not appropriate. Don’t worry, you will not be perceived as a bad host, and it will not have a negative impact on the outcome of the audit.
Audits – the opposite is true. You neither embarrass the auditor by having to decline an invitation, nor is there a risk that you could be accused of inappropriate behavior.
8. Preemptive obedience
Always keep in mind that an FDA audit is the worst possible time to point out deficiencies and problems within your organization. Perhaps you are aware of certain incidents, procedures, or company processes that could be optimized, or you noticed them during audit preparation. However, you shouldn’t simply disclose these findings to the auditor without being asked. Instead, use them internally to continuously improve processes and products and make the company more future-proof. Thus, an FDA audit shouldn’t be viewed solely as a necessary evil, but also as an opportunity.
Conclusion: If you prepare well, avoid the mistakes and situations described above, and work objectively and professionally with the auditor, an audit will be far less frightening—or even less frightening—than you might initially fear . Do n’t worry, there ’s no reason to be nervous —you’re the expert!
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