The Road To A Culture Of Quality

Source: Pharmaceutical Online

By Joanna Gallant, owner/president, Joanna Gallant Training Associates, LLC

Joanna Gallant

Lately, I’m having a lot of conversations about the culture of quality and continuous improvement.  While it seems like everyone wants a culture of quality, the problem seems to be that we don’t understand how to create it.

The first piece is to understand the drivers.  Without them, the culture won’t change.  Even with them, achieving cultural change takes time and requires effort—it doesn’t just happen, you have to work at it.

So What Drives A Quality And Continuous Improvement Culture?

  • Vision and support from the top. Upper management—all the way up the chain in the company—must set the tone and expectations for the corporate culture.  And they must ensure their expectations are communicated down through the management chain to the individual contributors and technicians in the company.  Then, ensure people throughout the organization—at all levels—are held accountable for their performance against those expectations.
  • Middle management must support the vision in daily operations. Middle management—supervisors, managers, and directors—must manage their functions in alignment with that vision.  Their focus should be on performance of their function and whether it meets upper management’s expectations.  They must understand that their contribution to a culture of quality is communication of expectations, and execution and oversight of the processes they own, ensuring that they work as well as possible in support of upper management expectations. This means that people executing those processes understand the expectations and the operations.

    Execution requires planning and communication. Directors should set the future plans for their organizations in alignment with upper management’s expectations, and assist with turning those visions into action plans.  Managers should develop those action plans into schedules and targets for managing their areas. Supervisors then ensure processes and tasks are executed correctly in support of that schedule. So middle managers focus on what their people are doing, whether they’re doing it right, and how they can be even better—developing their people and ensuring accountability to expectations.
  • Personnel who are engaged with the messages and the effort. The support of individual contributors—operators, technicians, analysts, and others who perform the day-to-day tasks that keep the business running—is critical to make a culture of quality a reality.  These people see the processes for what they are—good, bad, or otherwise—and will have some of the best ideas on how to improve them. A quality culture encourages sharing improvement ideas, and people will—if they know that their ideas will be heard and acted upon in the right way.

What Are The Rules Of The Road?

The main expectation to set and the message to communicate is that quality—and everything associated with it—is the main driver of the business, and without it, the business won’t succeed—period.  Businesses may think cost and quality are at odds, but they’re not: The business benefits when the product/service is good quality, and suffers if it’s not—and costs will mirror these situations.

  • With quality issues, product cost increases. Scrap rate and costs increase, people have to spend more time addressing problems so that the time spent on each product increases, and throughput drops, batches are rejected or held until problems are resolved, which may lead to product not being available—and profit decreases.
  • Without quality problems, product cost is reduced. Scrap rate falls, time is spent as scheduled, throughput often increases, and more product can be produced faster.

So getting the job done right—through existing systems and processes, in compliance with regulations, etc. —is just as important as getting the job done.

Which means integrity—in all forms—is critical to the ability to meet quality expectations.  Integrity must be maintained across the business—in metrics, in documentation and data, and in actions driving to completion of tasks. Lack of integrity invites scrutiny of all work done by that function and can ultimately raise questions about the business as a whole. (See recent FDA warning letters citing data and operational integrity issueslike this oneand they often include this statement: “This demonstrates a general lack of reliability and accuracy of data generated by your firm's laboratory, which is a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm.”)

And finally, the heart of a quality culture is finding ways to continually improve processes and tasks. In essence, quality is not being satisfied with the status quo—even if it’s good, there’s a way to do better! 

What Sets A Quality Culture Off Course?

The drive to a quality culture can go wrong in many ways, such as:

  • Upper management sets business expectations only on costs, sales, and production targets.  Even if upper management understands and implicitly expects quality to be part of these expectations, without explicitly stating a quality expectation and including quality performance targets—along with measuring and reporting on quality performance as well as costs, sales and production performance—the rest of the organization may not see quality being as important as the other business drivers. The focus may then shift away from quality, as people throughout the organization don’t see it as equal to the other elements of the business.
  • The expectations message gets lost and doesn’t make it to the individual contributors/technicians.  One of the more frequent problems is that lower level personnel in the organization don’t directly hear upper management’s expectations.  They get lost in the organization’s middle management and something different than the original message gets shared. It happens through miscommunication, lack of communication, or dilution of the message, but it can also happen if the message isn’t clearly understood or if it conflicts with what a manager communicates about day-to-day operations. If the managers aren’t engaged in the quality process or don’t believe that the whole organization is focused on the quality message, it may not get accurately communicated to everyone—leading to the creation of silos, where sometimes whole groups of people don’t hear the same direction and work at odds to the rest of the organization.
  • We set impossible targets that create integrity issues and quality problems. If you doubt this, visit this article on Dr. Deming’s red bead experiment. At heart, everyone wants to do their job well, and people will do what they think it takes to please their management. Driving people to meet impossible production targets or cost savings also drives people to cut corners, which equates to asking for quality and integrity problems. If we demand that people do the impossible, they will—and integrity issues will very likely arise.  They may appear as data fraud (such as documenting a task was completed when it wasn’t or fabrication of data upon which decisions are made), shortcutting a process, or more.  Any quality or integrity problems can have immediate and long-lasting negative consequences to the entire business.
  • We focus more on the area’s output than the quality of the area/manager. Many managers were technical experts on their tasks/processes who were promoted into management positions, but technical skills don’t equate to management skills.  And many organizations don’t require first time managers to complete training that develops the skills they need to be able to manage people.  However, to be successful, managers must hire the right people, identify the right individual to assign to specific tasks, and mentor, train, and educate their personnel.  These abilities—or lack thereof—directly affect the quality of the area and the work people perform.  And we do a disservice to both the organizations and our managers/supervisors by keeping them embroiled in meetings all day. It keeps them from their areas, meaning they can’t focus on their operations and their people’s performance.
  • Errors and problems are allowed to continue instead of being solved. When a problem occurs, the mindset in many organizations is to address it as quickly and as easily as possible, to get back to producing product. So the process gets a patch that addresses only what just occurred, or additional reviews are added, and the involved individual is always retrained. However, none of these assess the event and the process to identify the root cause of the problem, nor do they address the root cause and fix the process. Worse, it makes problems more difficult to find, because the indicators have been covered over, so problems get worse each time they occur—and the processes ultimately become difficult to follow and use.
  • Processes are difficult to use, making it hard to do the right thing.  Let’s use the documentation change process as an example. Most people know that procedures must be followed for GMP tasks, and that procedures must reflect the activities as performed. Sometimes, though, we find errors or something out of alignment with the task steps in a procedure, and then we have to find a brave soul who is willing to face the change process to fix it. Combine difficult to use systems, reviewers who save up comments and try to get them into someone else’s change, slow reviews that sometimes lack thoroughness, functional areas that don’t want to change practices or take ownership of something, and the whole process is a nightmare that takes just shy of forever. As a result, it’s difficult to do the right thing, because navigating the process has been made as difficult as possible.

Sometimes, those designing processes don’t have the knowledge, skills, or abilities required to do so. Or they work in a vacuum, creating something that works for them but clotheslines others. Worse, making these changes can be viewed as a punishment, meaning that it gets done as fast as possible, and maybe not as thoroughly as it should be.

  • Training is viewed as a non-critical activity. Training is often seen as a necessary evil – nothing more than a box to be checked, as quickly as possible, so the trainee can start performing tasks.  Many organizations look to reduce time spent on training, because of larger workloads and less resources.  Others complain training is too long, contains more than is necessary, or is a waste of time – particularly if it isn’t done well.  We need to look to improve training processes and content so that it adds value, and identify ways that training can help make an individual’s performance and level of knowledge of the operation better. Training is foundational to a quality culture, because it provides the knowledge and skills that enable correct and consistent task performance and prepares personnel to identify operational improvements. 

Now Map Your Route To A Quality Culture

As a first step, honestly analyze your organization. Look at how things are done.  Identify whether the quality messages are present, and spread throughout the organization. Assess which types of problems are working against the quality culture in your organization.

Then, develop and implement a plan to address those problems. It might involve setting appropriate expectations, communicating them, and holding people accountable to them.  Or, it may involve developing various skillsets and reworking processes.

To be successful, individuals at every level of the organization, and in every function, must engage with the concepts of a quality culture.  In the end, this will make or break the culture. 

Understand, as you embark on this voyage to a culture of quality, that it will not happen quickly.  A new culture won’t simply appear. Ingrained organizational behaviors must change, which means how the organization as a whole functions—all the way down to the level of each individual, in some cases—must change.  Depending on the size of the organization, it can take three to five years. And there will be problems along the way, likely requiring performance management processes to rectify them.

Change isn’t easy for a lot of people and organizations—and some succeed while others fail. 

The level of understanding, integrity, and engagement of each individual in the organization makes all the difference. 

And truthfully, aren’t those traits any organization would encourage in their people—because of the value they provide the business?