Responses to our last post were quite positive (Thank You.), so I wanted to provide more details around building a “Voluntary QA” Culture. The first lesson:
- “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?
While simple in concept, the challenge is to ensure regular daily practice. It’s about setting expectations, educating people about those expectations, and holding them accountable in ways that doesn’t make them feel as if they are being “stopped and frisked” daily.
How do we get there?
Take the Opportunity to be the Student Instead of the Teacher
Most of our day in Quality Assurance is spent reviewing documentation (notebooks, batch records, analytical data, SOPs, etc.). It’s easy to get into the habit of “flagging” suspected errors or areas of question and return documents back to owners emblazoned with an assortment of rainbow colored post-its.
Instead, I recommend noting suspected errors or areas of question in an Excel spreadsheet and arranging a meeting to sit down with the document owner to review your list and get answers to questions face to face. This affords you the opportunity to:
- Listen—critical to the success of this process
Your document owner becomes the subject matter expert and teaches you the hows and whys of what they do. This is extremely valuable because you learn how they perceive themselves and their work in the overall Quality picture, and what gaps may exist (through no fault of their own) in their interpretation of the Quality Systems. - Learn more about what they do
Sounds simple, but think about it—they are constantly bombarded with training in various aspects of Quality. To take the time to return the offer, you demonstrate that what they do is important too. It shows that you value and care about their time and perspective. - Build relationships, and trust over time
This can result in discussions and dialogues that pay huge dividends later on in improved efficiencies and compliance.
Put the “WHY” Back in QualitY”
I can’t tell you how many times I ask for data or a document—something as innocuous as a CV—and people respond with “Why?” It could sound defensive, or it could mean people don’t understand and want to know more.
“Why” is always a great question. Why? It opens up vast opportunities to:
- Explain to people how they and Quality fit into the larger picture.
- Explain how they can become sensitive to, and aware of, Quality and take proactive steps to do better (read: remain compliant).
- Practice “What If” scenarios.
When someone asks the Big “Why,” I say “Great Question. It makes sense to wonder why it’s important to have a current CV that shows your proper training, or why we have to correct our own errors.
Here’s an example ripped from the headlines of my own recent experience. While onsite for a pharma client, I learned of a documentation error in a batch record—the operator didn’t initial and date an entry properly. I brought this to the attention of the supervisor, who then asked someone at the facility to make the correction because the operator whose error it was wasn’t at that facility at the time. When I explained that the preferred approach would be to directly contact the operator to explain the need for them to correct the error themselves, the supervisor sent an email to the entire department stating that this incident occurred and we can’t correct other people’s errors anymore.
Such “low-hanging fruit” errors can be landmines. Were an inspector to see a minor error, they might think “what else is here that I am not seeing?” (When conducting many audits myself, such thoughts arose).
This is where coaching comes in. Making time for phone calls or face-to-face encounters will have a greater effect than curt emails (Many people see “warning” emails like parking tickets: they can annoy, yet don’t prevent people from parking where they shouldn’t in the future).
Instead of sending a “don’t-do-this-anymore” email, make the time and take the opportunity to explain the “Why” and still hold them accountable in positive manner. “Hey, I noticed in this batch record, it wasn’t initialed properly. This is important because “What If” we have a client doing an audit in that facility tomorrow? I will be at your location later this afternoon, so I can bring the record for you to fix. How does that sound? What time works for you?”
What is the result?
- People feel part of the process.
- You demonstrate the acknowledged value of both roles in the success of Quality.
- People learn that Quality is part of the team—not a policing organization. You are coming with a solution rather than just stating the problem.
Award Quality, Quality Behavior
Call out people who are practicing quality and compliance with flying colors. One Christmas, there were stories about Texas Sheriffs handing out gift cards to drivers who were driving properly and “doing the right thing.”
When was the last time anyone in a quality role did that? Ever? You may surprise people beyond belief.
What ways can you think of helping researchers think about Quality proactively (Time to be the student and you to be the teacher).
Look forward to comments/thoughts.
