“Do we really have to do that? Isn’t there some sort of ‘QA-lite’ solution?”

Having been asked this question many times, I see it as a red flag, but to be fair, this question comes from people with the perspective that GMP is burdensome and as such translates to “Great Mounds of Paper.”

The better question is, “How can we meet FDA requirements, remain in compliance, yet still be nimble and use resources efficiently? (read: Less process).”

FDA requirements can be open to interpretation, but do have an expectation of standards. There are ways to meet standards while engaging with staff so Quality is not seen as another burden they must shoulder. The best goal for Quality is to become engrained in a company’s culture so it develops as second-nature—less obligatory and more voluntary.

Here are five ways I’ve found that build and maintain effective “Voluntary QA” systems and cultures.

1. Think like a coach instead of a cop.
   Encourage and engage people the way a basketball team coach does. Find out what people think. Understand what they know and how they think about Quality. Do they understand the “Whys” of Quality or do they see QA as something that is a mandatory part of their job they hate?
2. Spend more time on fire prevention and less time on fire fighting.
   Time invested on the front end is better than spending it on the back end creating documentation to say why your systems are out of compliance. Investing time up front to understand processes and procedures allows you to write well thought-out SOPs. Getting it right up front can prevent you from spending time churning on resolving issues.
3. Think like a teacher rather than a dictator.
   Be ready to answer the question: “Why do we have to have that?” In fact, pretend you are asked it even if you aren’t. Education (i.e., helping people understand the “why” rather than enforcing the “how”) can be one way to get people to engage and understand Quality. Start with the strong list of requirements that everyone must meet so there is a buy-in on the how to meet them, so that you help shape a process that has consensus. Focus on the “what,” but get the group to work on the “how” together.I remember asking a chemist for his CV and his suspicious reply of “Why do you need my CV?” He really said, “You don’t trust me so why should I trust you?” I then informed the chemist that—having CVs of existing chemists (not just him but everyone in the lab) provided the necessary documented evidence to an auditor that the company had qualified individuals who were properly educated/trained to conduct the required work. He hadn’t known that.
4. You are part of a team that succeeds or fails together.
   If Quality takes the “laying-the-hammer-down” approach and puts knee-jerk controls in place, it communicates loudly that “Quality doesn’t trust you,” and reveals an “Us-vs.-Them” dynamic. If you throw people under the bus, that is one less person who can help stop the bus. Instead, work with team members to focus on remaining compliant, working safely, and resolving issues rather than affixing blame.
5. Get out of your office and do some “Retail politics.”
   Retail politics is a style of campaigning in which candidates attend local events to target voters on a small-scale or individual basis. Go out and meet with people in labs or on manufacturing floors so you create opportunities for teaching and coaching about Quality in a less formal, non-threatening environment.

If 20+ years in pharma and biotech has taught me anything, it was that collaboration, communication and cooperation builds trust and allows for better understanding and acceptance of Quality measures that are appropriate to, and complement, an organization, while aiding growth or innovation.

So get out of your cube and go “Campaign for Quality.”