You Catch More Flies with Honey

I would like to introduce you to one of McCormick LifeScience Consultant LLC’s most brilliant (Mark, if you’re reading, please take a bow) consultants, Mark Goodsell. Mark has worked within the Quality field for over 20 years, with GXP experience in both biologics and small molecule from development through commercial stages. Mark is currently a consultant specializing in establishing Quality Systems within development organizations that are registration driven.

Drumroll please . . . Mark . . . take it away!

In an effort to employ only qualified professionals, many pharmaceutical companies search for auditors that have been certified by the American Society for Quality (ASQ). Individuals with the Certified Quality Auditor (CQA) designation undergo a 5-hour exam to demonstrate that they are technically competent. I just received the latest copy of the ASQ Auditing Handbook (Fourth Edition, 2013, J.P. Russell, editor), which claims to have the entire body of knowledge necessary to provide you with all the information you need to pass the exam. The book is very systematic (in addition to being able to cure insomnia) but doesn’t really recognize that experience breeds different audit styles that can’t be captured in the book.

The entire audit process tends to make the participants on both sides of the table tense (kind of like a trip to the dentist for me). After being involved in a few regulatory inspections early in my career, I quickly realized that being the one who performs the audits is much better than being the party that receives the audits (shear genius or effective blood pressure medicine?). People who host audits on a regular basis are open to a constant barrage of attacks-kind of like a hockey goalie before they wore masks (unfortunately, I remember this time period). Although it’s not a hockey puck to the teeth, too many auditors think that it is their job to inflict some type of mental anguish upon the company representatives that are hosting the audit. At the same time, many companies have overreacted negatively to previous audits and decided that they will dictate the conditions of the audit.

I have been to audits with co-auditors like Gary Gotcha, Charlie Checklist, and Terry Talker, but nothing is worse than Dr. Jekyll and Mr. Hyde. I once accompanied two other company auditors to a facility with a problematic past. We were hosted by a QA management team that was fairly new, and they promised to address previous compliance issues but acknowledged it would take some time. They went out of their way to work with us and were everything the previous management team was not. Unfortunately, Dr. Jekyll found a problem in a document that occurred four years prior to our visit. He starting questioning our hosts, and when they apologized because they were unfamiliar with the issue, he quickly transformed into Mr. Hyde. Belligerent, insulting and practically foaming at the mouth, Mr. Hyde had succeeded in turning the audit ugly. The room became deathly silent for the rest of the day as our hosts went defensive and replaced the rabbits retrieving documents for us with turtles.

Sometimes the negative atmosphere isn’t created by the auditor but by the audit host. In one recent incident, my colleague was losing her patience with the audit hosts. We had to request permission to go to the restroom (just like grade school), and they would stand right outside of the door the entire time (not the first time for me). After she had just returned from her third closely accompanied bio-break of the day (she could have done without the second venti mocha latte), she waited until we were alone and exploded into a tirade about this invasive policy. She then turned her frustration on me and asked why I was able to go the entire day without having to suffer the same humiliation (I had carefully only sipped on my bottle of water and was essentially dehydrated-a good natural defense). With her attitude the rest of the day, I am glad she wasn’t auditing me.

The point of these stories, and I have too many to count, is that an audit is a two sided process that when executed correctly builds a trusting relationship between the two parties that allows for a free flowing exchange of information.

There is no reason to create a negative environment.

I begin all of my audits by telling my host that I am very informal and will not try to trick them or mislead them in any way. I also tell them that I will not raise my voice (unless lunch is the tofu plate) and that any issues I encounter will not be a surprise at the closeout meeting, as we will have discussed the issue in detail prior to me forming an opinion.

Toto's Tips

  • In many cases, a vendor’s first personal interaction with a sponsor will be the QA Auditor. The auditor has the opportunity to set the tone for the relationship between the two companies at the outset.
  • Companies hosting audits should work to create an atmosphere where the auditor can immediately recognize they are working in a cooperative environment.
  • Auditors must remember that they are guests of the company they are auditing and behave in a professional and cordial manner.
  • Companies that audit their suppliers and vendors on a regular basis should look at them as partners and not adversaries.
  • If issues do arise, don’t complicate them by introducing personality conflicts. Work to resolve issues by maintaining a professional demeanor.