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Aug 23, 2016

If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

Would you pass or fail if 
Taylor Swift audited your company?

by Marci Crane

Localization Manager

MasterControl


Note to the reader: If you’re one of the few Americans or “Planet Earthians” who has not yet heard the sweet stylings of Miss Taylor Swift blasted enthusiastically by excited millennials, then the Taylor humor in this article may not make a whole lot of sense. However, it is still worth reading. After all, you wouldn’t want to be caught off guard if an FDA auditor were to say:

“Saw you there and I thought/ Oh my God, look at that face/ You look like my next mistake.” – "Blank Space"

The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

As an FDA auditor, Taylor would have a lot of advice to share with those being audited. Taylor is known as a fair person and would want her auditees to have every chance at success. Of course, she couldn’t share the deepest and most secret FDA auditor information, but she could offer a variety of tips which are conveniently presented in this article. 


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With that said, the question on everyone’s minds remains: Can Taylor manage to tone down her poetic manner and stop communicating primarily through song lyrics? Probably not, but that doesn’t mean she wouldn’t make a great FDA auditor. 

Your Next FDA Audit With Taylor Swift is Scheduled


If your next FDA audit is already scheduled with Taylor Swift, then there are some tips and translations you’ll need to be aware of as you begin the audit process. The tips shared in this article will help you better navigate the FDA audit process and the Taylor translations will help ensure that you understand the intentions of her commentary on your company’s ability to comply with FDA. 

Tip #1: The Truth


It seems obvious that stretching the truth or outright dishonesty won’t result in success when it comes to audits. FDA auditors have techniques for vetting out the truth and they generally get exactly what they are looking for. For example, it’s common for FDA auditors, such as our hypothetical Taylor Swift, to ask the same questions to multiple people within a company at different times and if the answers vary, it wouldn’t bode well for said company. However, don’t just huddle up with your team(s) and try to memorize the same answers. Honesty really is the best policy. The more transparent you are, and the more effectively your training and quality management processes are managed, the easier it will be for FDA to get to the root of any small issues and move on. 

As Taylor would say:

“Band-aids don’t fix bullet holes/ You say sorry just for show.” – Bad Blood

What Taylor is Really Trying to Say


What exactly does Taylor mean when she says that “band-aids don’t fix bullet holes”? What Taylor is saying is that little lies won’t cover up the big gaping holes of your quality and compliance processes. That’s exactly what she means…nothing more and nothing less.

Tip #2: Don’t Talk Endlessly 


When an auditor such as Taylor Swift asks you a question you should always answer honestly but you should also answer succinctly. FDA auditors know what they are doing and you don’t need to provide them with more information than is solicited. It’s simply not necessary. Sometimes auditors will play the “quiet card” and this tends to make auditees nervous, but again, you don’t have to fill the silence and say more than what is absolutely necessary. Pointless chatter can turn any encounter sour so try not to go there.

As Taylor would say:

“New money, suit and tie/ I can read you like a magazine.” – Blank Space

What Taylor is Really Trying to Say


What Taylor is trying to convey through her poetic words is that it’s easy for her as an FDA auditor to tell if you’re a newbie, a greenie or even a silly gump if you chatter unnecessarily. And although that chatter may not earn you an FDA Form 483 it certainly won’t make the encounter one that the auditor will remember with fondness.

Tip #3: Don’t Make Taylor Ask Twice!


If an FDA auditor the likes of Miss Swift happened to ask for specific information you shouldn’t make her ask for it again, or worse, wait to see if her penchant for said information passes. It won’t pass. When an investigator needs to see information you should gather it as quickly as possible. 

As Taylor would say:

“But I’ve got a blank space, baby/ And I’ll write your name.” – Blank Space

What Taylor is Really Trying to Say


What Taylor is saying is simple: Not providing information in a timely manner to the FDA can result in your company’s name filling the blank space on a 483. Not a desired outcome!

Tip #4: Don’t Argue or Challenge Taylor


An FDA auditor doesn’t arrive on site at your company to be challenged. In the scenario of an audit, the auditor is technically the authority and should be respected as such. An auditor has no interest in becoming your best friend, your debate partner or your cha-cha-cha Romeo/Juliet at the neighborhood ballroom dance night. The auditor is a third-party professional and someone who should be respected at all times. Think about it. You have no real relationship with the auditor except to represent your company and your company’s processes. Challenging, arguing with or trying to befriend an auditor is all a waste of time. In many ways, it can also be considered unethical.

As Taylor would mutter under her breath if you tried any of these antics with her:

“Watch us go ‘round and ‘round each time.” - Style

What Taylor is Really Trying to Say


What Taylor is really implying is that she gets tired of auditees trying to debate silly points with her throughout the audit or constantly buying her muffins, juice or expensive lunches. Taylor doesn’t need muffins and juice. She just wants to do her job!

Tip #5: “If It Isn’t Documented, It Doesn’t Exist”


One of the most common adages you’ll hear from an FDA officer or from other regulatory experts is that “if it isn’t documented, it doesn’t exist.” The importance of this advice can’t be overstated. Trying  to implement any type of quality compliance or audit process without a clear record of documentation is extremely difficult and according to FDA, would probably be considered impossible. Don’t try to talk about the existence of events or happenings that have not been documented. FDA can’t and won’t accept events that haven’t been penned on papyrus (old-fashioned), paper (not environmentally sound) or in digital archives (best option). Period.

As Taylor will tell you if you don’t document your processes:

“Hey/ Now we got problems/ And I don’t think we can solve them/ You made a really deep cut.” – Bad Blood

What Taylor is Really Trying to Say


What Taylor is saying in this example is simple to understand. If you don’t document the auditable aspects of your quality processes, it’s likely that serious problems will be raised during the audit itself. And many of these problems very likely won’t be able to be solved quickly enough to save your company’s site. Not being prepared with documented evidence of your quality processes can feel like a painful wound! 

Tip #6: Stick to Facts and Not Opinions


FDA auditors like to hear language that reflects facts and not opinions. Using phrases such as the following is NOT recommended during the proceedings of an FDA audit:
  • “I think…”
  • “I’m not sure but…”
  • “In my opinion, it should…”
  • “What you are saying is not true…”
  • “Honestly…”
  • “Usually…”
  • “Typically…”
  • “As I recall…”(1)

These phrases, as you can tell when you read them, sound weak compared to clear facts. Practice saying what you need to say without using these expressions. You may even find that rethinking the language that you use to describe your processes may even help you see where your own understanding isn’t quite complete. 

As Taylor Swift might say when her auditees don’t appear to be focused:

“You got that James Dean daydream look in your eye.” - Style

What Taylor is Really Trying to Say


In this case, what Taylor is saying is that during an FDA audit, it doesn’t pay to speak with vague language or use unclear body language (see next tip). And it certainly doesn’t pay to walk around with a daydream look in your eye. It’s important to be present, aware and direct during an FDA audit. And remember, even if you look like James Dean, FDA isn’t going to give you any extra points. Be honest, plain and straightforward and it will pay off when the audit results are presented.

Tip #7: Clear and Confident Body Language


Almost everyone has heard the  reports that body language is even more critical to meaningful communication than is verbal language. During an audit, this is just as true as it is during other interpersonal interactions. When an FDA audit is at hand, make sure to present yourself to Taylor with the following genuine postures:
  • Upright
  • Open and relaxed
  • Lean forward on occasion
  • Aligned with auditor
  • Casual posture changes (2)

Avoid presenting yourself with the following deceptive postures:
  • Retreating
  • Slouching
  • Frozen
  • Not aligned with auditor
  • Barrier posture
  • Abrupt, repetitive posture changes
  • Head and body slump (3)

As Taylor Swift might say if you choose to present yourself deceptively:

“’Cause, darling, I’m a nightmare dressed like a daydream.” – Blank Space

What Taylor is Really Trying to Say


Taylor’s message here is that if you present yourself with misleading body language it’s very likely that even a daydream of an auditor may turn into a nightmare. Proceed with care and present all information (and yourself) with clarity and dignity.

Tip #8: When in Error, Communicate That Error Immediately


During an audit, miscommunications are bound to happen. If you believe for whatever reason that you may have inadvertently miscommunicated with an FDA auditor or that he or she may have misunderstood something, clarify immediately and be sure to explain your reasoning in a professional manner.

As Taylor would say, if you don’t communicate effectively and within an appropriate timeframe:

“It’ll leave you breathless/ Or with a nasty scar.” – Blank Space

What Taylor is Really Trying to Say


What Taylor is saying is that an audit can be scarring or knock the wind out of you if communication isn’t clear and doesn’t happen in a timely way. Errors should be addressed immediately. 

Be Prepared


Doing research on FDA audits and investigations, knowing what is likely to be considered acceptable during an audit, and preparing to meet each need or query from an auditor are the keys to passing an audit or investigation. The truth is that the formula for success is rather simple, but it does take time, intention and focused action to achieve. 

Remember, you never want to use Taylor’s own words against her by feeling sorry for yourself and saying:

“Did you have to hit me, where I’m weak? Baby, I couldn’t breathe.” – Bad Blood
or
“So it’s gonna be forever/ Or it’s gonna go down in flames.” – Blank Space

Rather, what you want Taylor to say to you is:

“We never go out of style.” – Style

References


1. Slide 22 of 31 on this page: http://www.slideshare.net/complianceinsight/fda-audit-the-do-and-dont-list
2-3. Slides 17 and 18 of 31 on this page: http://www.slideshare.net/complianceinsight/fda-audit-the-do-and-dont-list

Other Links and Articles of Interest

1. http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm237624.htm (“What should I expect during an inspection?)
2. http://www.arenasolutions.com/resources/articles/fda-audit-tips/ (“5 Tips to Pass Your FDA or ISO Audit with Confidence”)



Marci Crane is MasterControl’s Localization Manager and a marketing communications specialist. Marci’s favorite Taylor Swift songs are “Blank Space” and “Shake it Off.” It isn’t uncommon to find Marci singing pop songs at shocking volumes behind the wheel of her car despite her professional status and depth of maturity. 








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