Fear and anxiety are everywhere, including in the typical biotech workplace. Quality assurance professionals must help to drive out this fear.
This article will present practical advice on how to do this with individuals and groups you interface with as a QA auditor or reviewer, including technical staff, department management, and suppliers.
Anxiety in the world and in the workplace
The global coronavirus pandemic has spread fear across the globe, including offices and labs. Basic acts of human connection such as hugging and shaking hands are now fraught. On top of this, the workplace is inherently a swirl of anxiety. Biotech companies deal with high-stakes production and testing where individuals can expect to be held accountable for everything they write or produce.
Then enters the QA auditor. Seeing this person show up (scheduled or unscheduled) for an audit with a binder in hand and a probing manner, scientists and technicians will sometimes wonder if harsh consequences are coming down on their heads. They know they do good work and they stand by it. But they might feel they are being unfairly questioned for technical challenges they are working hard to overcome, or judged against a standard they were not familiarized with up front.
Even people who appreciate the value of a thorough, independent review can feel a bit of dread when gaps and mistakes are pointed out and enumerated. That’s perfectly natural!
People who are not familiar with auditing, failure investigations and inspection readiness activities may jokingly call QA “the dark side” and fear being exposed or discredited in a place where their livelihood is on the line.
On top of these natural tendencies, consider the finding that anxiety disorders affect 18% of the US adult population. It is highly likely that you work with someone with anxiety disorder or another mood disorder.
As we move as a society from fear and isolation back to connection, hope and rebuilding, QA professionals must help this process along. We must actively allay fears and foster an organizational culture of openness, collaboration, and a unified problem-solving approach.
Recognize the signs of anxiety
Learn to recognize the following signs in coworkers:
- Restlessness and fidgeting
- Irritability and tenseness
- Cracking of the voice or “clamming up” and not speaking
- Being tight-lipped in response to your questions
- Appearing flustered in a task where they are known to be proficient
- Arriving to work poorly rested and tired
- Catastrophizing (overreacting, feeling hopeless, and thinking of the worst case scenario) in response to a fixable problem that is limited in scope
- Having bathroom emergencies, a racing heart, dizziness and lightheadedness, headaches, and needing to leave early during stressful times
- Asking for reassurance excessively
- Perfectionism to the point of wasting time for diminishing returns on effort
- Distractedness and lack of focus
- Finally (and this is a big one), avoidance.
Over the years, internal auditing has largely abandoned the practice of “surprise audits.” Rather, auditors now practice openness. This allows colleagues to put their best foot forward, to learn and become better versed in their standards and procedures, and it helps to set expectations up front.
This means establishing and sharing the audit plan in advance and making clear the standards and written procedures you will be comparing the department’s records and work practices to. If there are to be any interviews of staff, you will want to share this plan with management as well so that you do not put anyone on the spot and cause them embarrassment or difficulty.
Staff should know the general time when you expect to arrive in the lab or department.
If you ask to examine original training binders, curriculum vitaes or resumes, you should return them promptly to the individual.
At the end of an internal audit, and before finalizing the audit report, meet with department management to discuss any audit findings. Share what you plan to put in the audit report and give them a chance to respond. This will help allay anxiety because they will immediately know of any problems instead of waiting for the report.
Lastly, standards should be controlled by QA but shared openly and widely. For example, the ISO 13485 standard that sets forth medical device quality management practices should not be secret. Ask yourself, do staff have to come to you to ask for you to ask for quality system information, or can they readily access it on their own? There is a difference between “authorized to access” and accessible. Everyone should be able to access the information they need to do their jobs. Even the smallest hurdle or friction can cause busy technical staff to make shortcuts that are ultimately to the detriment of the product or the process.
QA needs to step up and exercise their responsibility and authority as bearers of the standards. Take inspiration from the word itself (standard-bearer). Let staff know that you are always available to share and educate about these standards, and to learn alongside them.
When observing technical procedures, share your audit checklist up front. It is not a secret. Staff, including those outside QA, should be able to view it and your inspection procedures in your repository of controlled documents.
If you are watching manual work such as a dosing of cells with a test article and controls, indicate the various reagents, equipment, materials, worksheets and records you will be examining, if appropriate. Doing this up front will give the technician time to prepare and do it right.
I once noticed a technician’s hands shaking during the dosing of an animal. Since the procedure involved a needle, a syringe, and live animals, I asked if she would like a few minutes break. She did want that. I busied myself with examining the study records so far, stood a little farther back from her, and made small talk with the group. The technician proceeded like the skilled pro that she was with minimal discomfort for the animal. I learned two things: 1) That she occasionally had a perfectly understandable case of nerves, and 2) I should stand a little farther back and not loom over anyone!
Correct any misperceptions about the role of QA. A technical staff member once introduced me and another auditor to a new staff member as “the police” of the organization. He was half-joking, but I made sure to correct that impression for the new person. Policing of the organization’s activities is at the lowest rung of a company’s quality development. This is because it connotes crime and punishment and the “catching” of errors. It is in fact counterproductive in many cases. In a mature quality system everyone internalizes quality practices, errors are prevented in the first place, and no one goes to jail!
If you are comparing the activities to a written procedure, ask the technician whether they are following (e.g.) SOP-123, revision 03. Do this instead of asking them “What SOP are you following?”
With colleagues in your own company, do not employ the tactic of the “pregnant pause.” Regulatory auditors will sometimes ask a question and then listen to your answer. Instead of responding with “I see,” or “Thanks for explaining that,” they will then be silent. This delay is a little unnatural and can cause you to second-guess your answer and provide more information than is appropriate.
Although the pregnant pause is used by regulators, do not employ it yourself. They are in a position of enforcing regulations. Regulations are standards with the power of the law behind them. You are a resource within your company and should not use anxiety-provoking techniques such as this.
Instead, offer correction when technical staff responds incorrectly. If this is outside of your scope of practice as an auditor, document the incorrect answer and route it to the appropriate scientific or management staff. It is very important to follow up on any observed deficiencies in training or proficiency. Just do so through the established channels.
Send the audit plan to a supplier before doing an audit there. Bring a copy of your quality agreement and confirm with them that you are both following the same version of this important document. List the records you would like to look at and ask for specific processes you would like to observe. Treat them warmly, like your own colleagues.
Of course, if you uncover problems, you may request more records and dig deeper until your concerns are addressed. But do be upfront about your plan and your expectations.
Handoffs of records, reports and other documents
Always smile and greet your colleagues at handoffs.
This is self-explanatory.
Always build rapport first. Make sure your first interactions are to introduce yourself and learn about the other person. Your first meeting should not be an inspection where you are checking their work (this may not be possible in a supplier audit). Make a personal connection and share a bit about you.
A senior scientist (a man in his 50s and with a long, successful scientific career) once confided in me that he was nervous to get back my review and findings of a lengthy study of his. My mistake was in not chatting with him beforehand. He and I later became collaborators and improved the communication between our teams.
Promote inspection readiness
Promote the idea that it is better to root out problems in-house rather than through costly third-party auditors, or worse, letting the problems get discovered by clients or regulators.
Implement procedures that make inspections routine so that no one will break a sweat when they find themselves being observed and their work checked.
Educate staff on inspection readiness, so that you can handle an unannounced FDA visit without a scramble and without delaying the inspector. Staff will be so accustomed to your thorough and open audits that they will not freeze when they find a regulator is watching them.
Cast yourself and your colleague as problem solvers
Fundamentally, all jobs are about problem identification, resolution, and prevention. Make it clear that your inspection is part of an ongoing effort to root out errors as a team and prevent future ones.
When writing up an audit finding, use objective language and evidence and state the finding in three terms:
- The condition (the error or current state)
- The standard that is not being met
- The consequences of not meeting the standard
Make a careful distinction between the facts uncovered during the audit and your own judgements and recommendations. This will help avoid the appearance and the dread of personal judgement.
To be really helpful (and to allay anxiety), provide a recommendation for the auditee for how to rectify this finding. Don’t just leave it up to them to figure out. Don’t leave them with the impression that you “can’t describe what you want, but you’ll know it when you see it.” This is a much-lamented saying in the creative fields and it has no place in technical disciplines such as biotech.
Practice unified detachment
When you practice unified detachment, you frame yourself and the auditee as two people who are united against the problem, rather than casting the other person as the problem.
Hopefully your organization is a decent place, full of fair minded people. But some of your staff may have come from a dysfunctional company where a single mistake was grounds for dismissal. They may have a fearful response and try to paper over errors or pretend they did not notice. You need to recognize that and explain that your organization is a different kind of place, where we practice “unified detachment,” and view ourselves as partnering together to address what went wrong in the spirit of continuous improvement.
Without minimizing mistakes (people should be held accountable and in fact they often crave this accountability), show how you can give people the tools they need to do their job. Identify pain points. Make their job easier for them so that they are not pressured to cut corners.
Model yourself after a leader who has a warm, inclusive and compassionate approach
Is there a manager, director or executive in your company who you look up to? Someone with a charismatic, easygoing style, who always has a warm word and a handshake (or elbow bump) for you? This is a great person to model yourself after.
When you walk into a room for an inspection or an audit closing summary, remind yourself of this leader’s interpersonal style. Address your own discomfort, if any, before entering. Be present, warm and focused. Make it clear that there is no troubling subtext to the audit findings and that no one present is incompetent or unworthy. Rather, they are tractable problems that you are going to sort out as a team.
Practice confidentiality. Without taking on the role of therapist, be positive and accepting when people confide their mental health challenges in you. Never breach the trust they have lent you. View their anxiety as one aspect of a complex, multifaceted individual.
Their anxiety may in fact fuel positive traits such as their attentive and detailed work, their warmth and agreeableness, and their deep thinking on the far-flung repercussions of certain work problems. And do not judge their work based on what you know about their mental health. Instead judge the work according to the objective, well-documented, and openly disseminated standards you as a QA professional are responsible for upholding.
Share quality guru Deming’s advice to drive out fear
Statistician and quality expert W. Edwards Deming wrote extensively on the importance of driving fear out of the workplace.
Not only is this important psychologically, it also advances quality goals.
QualityAssuranceSolutions.com outlines three methods for removing fear:
- Don’t reprimand people if they make mistakes. Instead teach them to learn from the mistakes.
- Encourage employees’ feedback from all levels. Use the Pareto principle to focus on the most important problems.
- Involve the employees in solving problems. They are the experts at their station. Use their knowledge to implement sound change. When you involve employees, this naturally reduces fear.
I would add to this that QA people can channel complaints and suggestions productively. Suppose a technician complains about all the manual transcription they do. Their worksheet or batch record may be structured such that they fill out the same reagent, material and equipment information on dozens of consecutive pages. If this is a pain for them, it’s also a pain from a quality perspective! It is unlikely they are copying that info straight from the label. Instead, they have the equipment numbers memorized and they copy from one page to the next, which is totally reasonable and expedient but defeats the goal of concurrent documentation.
Help them out by flagging these issues in a recommendation section of your inspection report. Identify it as an area that has not yet caused a problem, but could lead to one in the future. In this way you help to drive improvement and you ally yourself with the technical staff who do the important work of science, engineering and production.
An example where I screwed up but ultimately fixed a much larger issue
I once made a mistake that resulted in repeating a short (three-day) scientific study and a delay to the client. Basically I failed in a logistical, paper-based handoff. The error was mine and I felt totally answerable for it.
But when we looked into it as a team involving my manager and my peers, we began to question the system we had been following of handing off sticky notes with handwritten study identifiers in a chain of transcription that started with technical staff and then was passed to us. Basically, we were passing sticky notes with handwritten (but critical) information.
We immediately started rethinking this process. The final result was a redesigned system that we linked to an even larger lean operations project. This amounted to a breakthrough change in the efficiency of our audit scheduling system, its incorporation into the master study schedule (a GLP requirement), the assignment of a dedicated staff person to do this scheduling, better defined responsibilities in this process, a greater ability to identify missed audits, and smoother handoffs.
It all began with a screw-up that I answered for (with a brief spike in anxiety and guilt). But by the end we had united as a team to do away with a laborious and error-prone process.
My message of hope and acceptance
Encourage everyone to bring their whole selves to work. Take to your role with professionalism, but also with gentleness and compassion. Recruit others in practicing discrimination (sorting out the good from the bad) and not recrimination (blaming individuals).
Drive out fear from your biotech organization to make it a place where people are accepted even as we continually strive for better.
About the photo
The photo is from the Columbia Slough Trail in North Portland in May 2020. In my regular visits I see belted kingfishers, bald eagles, cedar waxwings, swallows, wood ducks and cormorants.