By Joanna Gallant, owner/president, Joanna Gallant Training Associates, LLC
Some think the most critical success element in a GMP environment is the technical knowledge of those who perform the tasks, lead, or make decisions. For those in leadership or management roles, it is important to possess technical strength, but there are additional skills they must also have in order to truly be successful.
There are also different expectations when performing tasks that affect quality as opposed to when supervising the performance of those tasks. A supervisor or manager must not only be qualified to perform their tasks, but also be qualified to ensure that others perform their tasks correctly.
The two sets of requirements below, stated in 21CFR211.25, show support of this claim:
- 21CFR 211.25 (a): Each person … shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions….
- 21CFR 211.25 (b): Each person responsible for supervising … shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
So what specific skills do managers and supervisors need to be successful in a GMP environment? Consider the following questions, which compare how the use, or lack of the use, of these skills by a manager can affect GMP operations:
- Are they technically competent? Do they know how to do what they were charged with managing?
First and foremost, successful managers know what their people do. They’ve had hands-on task experience, and therefore, understand the challenges their people face. Being able to talk about the task, challenges and possible solutions, and participating in improvement efforts establishes credibility and earns respect.
Alternatively, if managers don’t know or can’t do what their people do, they will find it difficult to earn respect, especially if they can’t speak in terms of the quality elements and compliance requirements for the task.
- Do they have personnel and performance management skills?
It’s almost assumed that technical competence includes the skills to manage others who perform the same tasks. However, the “soft” interpersonal skills that allow managers to build relationships and oversee/guide performance are not related to technical competence and must be developed differently.
Successful GMP performance means understanding the “whys”: why the task is done as it is, why following procedures is critical, why it might go wrong and how to react to problems. Finding the right people, matching tasks to capabilities, mentoring to strengthen performance, and providing growth and development opportunities also fall into this skillset.
Additionally, successful managers have skills that include coaching/mentoring, providing feedback, managing performance problems, managing conflict, resource management, and more. These skills ensure the manager is able to direct the performance and develop the mindset of the individuals they oversee. Personnel and performance management skills must be learned and developed through practice. Yet, many companies don’t make personnel and performance management skills training mandatory for new supervisors to teach them the required skills or to assess these skills in experienced managers.
- Do they use their personnel and performance management skills?
Once the manager has these skills, they must then use them. The best managers talk regularly with their people, both as individuals and groups, setting expectations, describing desired behaviors and performance, and providing mentoring and performance feedback. Additionally, they monitor on-floor performance of daily operations, providing guidance and direction in the moment as needed.
Problems occur when managers don’t keep in touch with their people or are too busy to monitor on-floor performance. From a GMP standpoint, these activities ensure the manager knows what is occurring in their operations and can provide any GMP/quality guidance when needed. As stated by Deputy Assistant Attorney General Maame Ewusi-Mensah Frimpong, “Avoiding knowledge of problems in your organization will not shield you from liability.”
Failing to address performance issues perpetuates problems. It’s rewarding—and easier—to deal with good performers, but it’s more important to deal with poor performers in relation to activities with GMP or quality impact.
- Do they support and motivate their people?
Managers must offer support in a variety of forms, such as:
- Identifying what assistance they must provide for the team/person/project to be successful
- Managing politics/roadblocks so that the process can move forward
- Finding/providing necessary tools and resources, such as money, equipment, training, people, or even simply identifying how to give someone the time to work on the task.
Motivation is equally important. People want to know their work is appreciated, understand why it’s necessary, how it will benefit themselves and others, and more. Managers must provide this information, along with necessary support and appropriate recognition of performance (both strong and poor).
Today’s environment often lacks appropriate motivation techniques and support, which becomes problematic when it compromises quality. Many companies face staff reductions, budget cuts, and the like, but there is a minimum standard below which the quality of the operation will be compromised.
Some managers are afraid to ask for needed resources in today’s environments, or, if they do ask, they may be told to make do with what they have for budget reasons. If the available tools, equipment, processes, and personnel are insufficient, task performance and quality will suffer. Managers must be able to craft justifications for needed resources that incorporate both business and compliance impact of lacking those resources.
“Lean” efforts unfairly get blamed for some of this, often as a result of improper implementation. Lean looks to improve processes through reducing waste, but it can wrong if management focuses on cost cutting in the guise of lean process improvements. I once heard an FDA inspector, when asked her opinion of Lean, respond, “I don’t have a problem with Lean; I have a problem with anemic.” If you think about it, it’s a great statement.
In terms of motivation, it’s not always easy to provide recognition in “do more with less” environments. Companies may not support recognition programs or financial rewards, but those aren’t the only options. For example, take the person to lunch as a thank you. They’ll see their manager making the effort to thank them and will appreciate the manager for doing something specifically for them. This provides an added benefit of getting the good performer additional one-to-one time with their manager, which may be hard to come by otherwise. Even simply saying “thank you” more frequently means more than you realize.
Lack of support can make it difficult for people to do the right things, which has the ultimate effect of encouraging poor performance!
- Do they walk the walk and talk the talk?
The underlying concept to the “management responsibilities” in a quality management system is that management is visible and leads by example. This means managers should frequently discuss quality and compliance, why they are critical to business success, and what they look like in each area/operation.
But talk isn’t enough. A good manager models what they expect from their people. People must hear the compliance and quality messages and then see their manager demonstrate those behaviors and integrity in their role.
People quickly identify what their management values are, and they use this to determine how to get ahead (or at least not be identified as a problem). Meeting production and business performance targets is important, but it must be done the right way. Rewarding people who meet targets by violating quality and compliance expectations will frustrate those who try to do things right, leading to disengaged personnel.
- Do they address and solve problems with a continuous improvement mindset?
Another key management success factor is how problems, like deviations and their associated CAPAs, are dealt with when they happen. The involved individual is usually tagged with fixing it, which may feel like a punishment. It creates more work for the person, and it’s a constant reminder that the problem occurred. It’s worse when the CAPAs relate to internal audit or regulatory inspection observations because they’re that much more visible.
Successful managers encourage a blame-free culture and train people to view these as improvement opportunities. Managers must set the expectation that the root cause of the problem will be identified and corrected, positioning this as a process improvement undertaking that will prevent future errors as well as prevent future compliance issues and reduce future costs. Managers must ensure appropriate timelines are set for these activities and that people meet them.
Failures can happen if the “punishment” perception is not addressed. People may not report problems out of a fear of “getting in trouble.” If the manager’s focus is, or is perceived to be, addressing the problem as quickly as possible in order to continue with the operation/process, then the documentation, root cause identification, and CAPAs become purely a paper exercise only completed to move forward to the next process step. Sometimes CAPAs are viewed as a lower priority than daily tasks, particularly troubling when they’re intended to address inspection/audit observations.
Dealing with personnel performance issues is the hardest problem a manager must deal with, due to the level of stress and the need for confidentiality. The ultimate goal is improvement to the business. With luck, the individual can change their performance to align with expectations. If they can’t, the manager must have what they need to manage the person out.
Handling these can go wrong in so many ways. At a bare minimum, managers should:
- Never have performance management conversations in public settings
- Document everything thoroughly and consistently
- Always involve Human Resources personnel when trying to manage a problem performer
Finally, are they more concerned about meeting numbers than the quality of their group’s work?
Good managers understand that you don't manage to metrics; instead, you use metrics to assess how well the process is working. If the job is done right, the numbers will reflect it. Efficiencies and performance will come if the focus is on the quality of the operation.
These managers communicate what quality looks like, learn from their people what could detract from quality, and undertake the improvements necessary for the work to meet the appropriate quality standards. They delegate tasks to trained, trusted personnel and set expectations and provide appropriate support, while regularly checking on progress. This makes it clear they’re available to help as needed and do when issues or questions arise. These are the managers people want to work for. They mentor and assist their people as needed, but trust them enough to get out of their way, knowing they will be notified of any issues or situations that could become problems.
Contrast them with a “meet the numbers” manager, who may display some or all of these traits:
- They don’t want to hear anything that detracts from meeting production targets and getting product out. Issues that do arise are dispatched as quickly, and sometimes as quietly, as possible.
- They may do whatever it takes to look good, or at least not appear negative, such as reporting out good information while keeping problems or weaknesses quiet.
- They are afraid to ask for resources, because they fear it will make them look bad or incompetent. They don’t want to be the squeaky wheel.
- They may use fear, intimidation, misinformation or sabotage as management tactics.
- They may roadblock improvement initiatives because they fear being seen differently or losing power if the status quo changes.
People in their groups may exhibit similar traits, such as cutting corners, not reporting problems, or worse, stay off their manager’s radar, so they don’t come under attack themselves.
Obviously, this isn’t a complete management skill guide. However, the items discussed have a major impact on the quality of practices and personnel performance in a GMP environment, in both positive and negative ways.
There’s a common saying that people don’t leave jobs, they leave managers. This may be even truer in the GMP environment, where management skills may be more critical to proper task performance and the success of a company.
Bottom line: managing is not easy and not everyone is cut out for it. No one’s perfect, but the key is to understand what improvement is needed and work on making those improvements, just like we ask our people to do.