The importance of data integrity and the idea of quality culture—what it is and how to measure and promote it—have been important topics in the dialogue within the pharmaceutical industry and with its regulators for several years. An important question that needs to be explored further is how efforts can promote both and be synergistic.

At the PDA Annual Meeting held virtually in March 2021, ValSource consultant and former Pfizer and Merck executive and PDA board member Chris Smalley provided his insight into the relationship between quality culture and data integrity in a presentation titled, “The Role of Quality Culture in Assuring Data Integrity.”

Smalley began his talk with a discussion of the elements of data integrity and followed up with a discussion of quality culture and how efforts can be aimed synergistically at both.

[Related: Click here for a free 483 observation report on data integrity observations in FY2020.]

ALCOA

Smalley introduced the acronym ALCOA, which stands for attributable, legible, “contemporaneously recorded or true copy,” original, and accurate. He used the definition as the basis for his discussion of data integrity (Figure 1).

Figure 1 ALCOA Definitions
FIGURE 1 | ALCOA Definitions

Smalley acknowledged that many employees are not necessarily involved in the capture or generation of data. Many are instead involved in the review or analysis of data, or may work in the storage and archival of data, disposition, or other steps in the data lifecycle.

Although the focus of his session was on the generation and creation of data, “all the other areas in the lifecycle are directly relatable to the role of quality culture,” he maintained. “And I think that will be evident as we move forward.”

Assessing Quality Culture

As a beginning point for assessing quality culture, Smalley asked, “If you took a poll in your organization, would people provide honest answers to work-related questions? Or would they provide the answers that they think you are looking for?”

A slogan used in a lot of organizations is, “we are all team players.” If you take a poll, he suggested, even though it might be anonymous, many people would be inclined to say, “I am going to answer this in this particular way because I am a team player.”

But if you can get into their heads and really understand how employees perceive the culture, what would they be thinking?

  • Would a person that works in your organization say, “If I get caught making a mistake, I will be disciplined or fired.”?
  • Would an employee say, “That is not really my job. I am going to do my job. And that other activity, that is someone else’s responsibility. And I am not going to get involved in that. I am not going to comment on that. I am not going to help with that because it is not my job.”?
  • Do employees have a perception that they are not important? That they are just at work doing the daily grind day in and day out—just a cog in the wheel who nobody pays attention to?
  • Or maybe you would find employees who believe that they are valued. And one of the reasons they believe they are valued is because the organization gives them the tools and resources they need to be successful at their job.

How do we avoid employees thinking those first three ways or many other variations to those first three, and work our way towards employees who feel that they are valued—that they are appreciated and get what they need to be able to do their job right?

Training and Education are Key

“I am a tremendous fan of training and education,” Smalley emphasized. “I think training and education are necessary to achieve a quality culture. That is one aspect. Saying that I am a big fan does not mean it is the only activity that you should engage in. But it is a key activity—an important aspect of changing your quality culture, if you believe your quality culture is not where you want it to be. And if you do have a good quality culture, it is important in maintaining it.”

Training in a quality culture is not just having people sit at a computer online and read an SOP, and at the end of the SOP click that they have read and understood it, he stressed.

“It is not just a matter of having them assemble in a room and be warm bodies in chairs while someone talks ‘at them.’ I am deliberate in my use of the term ‘at them,’—not talking to them, but talking at them.”

Smalley acknowledged that many employees are not necessarily involved in the capture or generation of data

People do not feel valued when being talked at or lectured, Smalley maintained. People do not feel like you are connecting with them. It makes them feel minimized. It makes them feel that you are valuing convenience over what they are contributing to your organization.

“If you look at your entire organization and you look at your facilities and your equipment, your employees are really a valuable asset,” Smalley stressed. “You take care of your facilities. You take care of your equipment. You need to do the type of job where you take care of your employees where your employees feel that, in fact, they are being taken care of.”

The Right Training in the Right Way Supports Quality Culture

How do you conduct training and education if you want to achieve a quality culture? Instead of employees being online by themselves reading an SOP where maybe they read the words but really do not understand it and click that they read and understood it, or sitting in a room—there is an interactive activity.

Training means conducting interactive workshops. It means providing training and then stopping and allowing people to work in small groups or maybe with people from other departments to talk about what they have experienced or learned.

It is good if the employee comes back and presents to the rest of the group so the trainers understand what their interpretation was, what happened, and how they processed the information that was presented to them and understood it.

It is important with this sort of training that facilitators are used who are not the employees’ supervisors and managers. Because when people are being trained by their supervisor and manager, it can discourage questions.

People do not want to say to their supervisor or manager, “I do not understand. I do not understand that procedure,” because they are afraid that the supervisor or manager will say, “Well, this is just a revision of an existing procedure. You should have been following this all along. Are you stupid?”

They do not want to take the chance. Maybe their supervisor or manager is more empathetic than that, but they do not want to take the chance that the supervisor or manager is going to think that they are not smart, that they do not understand. They are not going to ask that question. So, use a facilitator. The employees need to see that management is committed to the training.

Training in a quality culture is not just having people sit at a computer online and read an SOP

All too often, training is thought of as just a budget item, and opportunities for important training are missed because there is not enough money in the budget.

Obviously, there cannot be an unlimited pool of money for training. But it should not just constantly be a situation where the department only has limited resources to support the employees and train them.

Management should be in a position to say, “That might not be the right training for you, so we are not going to send you to that conference. Or we are not going to send you to that course. But when the right training and the right course comes along for your job and your role, and it helps develop you, you are certainly going to be sent to that course. You are certainly going to have an opportunity to take that training, because we value you as an employee.”

How Does What I Do Make a Difference?

Another aspect of training and education under the umbrella of a quality culture is employees’ understanding of the importance of their particular job, how that activity relates to the final product, and how it contributes to a product that the patient finally receives.

If a patient is going to receive a vaccine—for example, a COVID-19 vaccine—it is not because of the training at their company and their quality culture that the employee understands their importance. They understand it simply by going home and looking at the news and talking to their families.

Because in the news and in their family, they are hearing, “I am doing an important job. I am contributing to something that is really important in this worldwide pandemic.” And they are proud to say, “I work for this company. I am a contributor.”

The employees need to see that management is committed to the training

It does not matter whether they are responsible for cleaning the aseptic processing rooms or washing equipment or are involved in the process or compounding or filling or inspecting or labeling or packaging or working in the warehouse—every job is important. And every person should know that his or her job is contributing to the product getting to the patient.

“They need to hear that. They need to hear that in their training, in their education, from their management, that their job is an important part of supplying the patient with the product.”

How My Job Matters

The importance of someone cleaning the aseptic filling room is assuring that that vaccine is not going to be contaminated, either microbiologically or cross-contaminated with another product, should be explained.

The person in the warehouse needs to understand the importance of assuring that materials that are rejected, materials that are quarantined are kept separate and are controlled, and only approved material is shipped and gets to the patient.

The person who is responsible for clean equipment is going to understand the issues of cross-contamination and the issues of equipment operating properly, because they clean it and reassemble it.

And the employee actions are going to be documented. That documentation is going to be part of the data integrity system. In every step of the process, people should be proud of their job, and they should welcome the opportunity to record that they did their job, Smalley maintained.

Taking Pride in the Job

At a company with a strong quality culture, employees are proud to be part of the company and take pride in their contributions.

For example, a cleaning technician might think or say, “I cleaned this room, and I signed that I cleaned this room. Or this is how I compounded the cleaning solution, how much cleaning concentrate I used, how much water for injection I used to compound the solution. Or this is how I cleaned this piece of equipment. I followed the process. I followed the SOPs and inspected the equipment. And I labeled the piece of equipment as clean and moved it to the right location.”

Everyone is contributing to the final product. And when they contribute to the final product, they then have a tremendous difference in their attitude towards data integrity—towards the importance of their job and what they sign.

Know the Customer

Everyone should understand the importance of their role. Everyone in the process should know who their customer is—specifically, their internal customer.

“I am not talking about the patient or the clinician,” the Valsource consultant pointed out. “I am talking about their internal customer.”

In every step of the process, people should be proud of their job, and they should welcome the opportunity to record that they did their job

“The person who cleans the aseptic filling room knows his or her customer is the team that is going to go in and use that room and perform the aseptic process in that room. The person cleaning a piece of equipment should know that the customer is going to be the team that goes in and uses that piece of equipment for compounding.”

Everyone should know who their customer is and what their customer needs are. “And you always want to satisfy the needs of your customer. So, you must get to know your customer. You are not invisible to your customer. Getting to know your customer is part of the quality culture as is your role contributing to the product that that patient or that clinician will eventually see,” Smalley said.

Supporting the Employees

In addition to education and training, it is important to ensure that employees have the resources they need. Education and training are resources. But people need other resources as well.

For example, they need to have equipment available. The equipment needs to be qualified or validated. It needs to be calibrated where appropriate.

They need to have adequate time to do their job, and they need a buddy checking with them.

“I am not talking about checking or verifying that I weighed out the right amount of material before I take it off the balance,” Smalley clarified. That is the second-person verifier, not the buddy.

Sometimes people perform jobs by themselves—for example, a person is in an aseptic filling room alone mopping the room. Or a person in a washroom by himself or herself washing a tank or washing a piece of equipment. They should have people that are coming around and checking on them—a buddy, so to speak.

It is important from a safety standpoint, but it is not just from a safety standpoint. It is to say, “You are a valued employee. You are important to us, and we are not going to let you work eight hours or four hours or even two hours without someone checking on you to see how you are doing because we care about you.” You must make them feel like a valued employee.

Case Study: No Good Choice

Smalley presented a hypothetical case study involving a laboratory chemist who received samples from two batches towards the end of the day on a Friday—a situation that seems to happen all too frequently.

The chemist had made a promise to her son that she would take him to his soccer game. He is going to be playing in the game. She made a promise that she is going to take him to the game and stay and watch.

By the time the tests are completed on the first of the two batches, it is going to be very close to the time that she would ordinarily leave at the end of the workday, which would be the time she planned to leave to go home to take her son to the soccer game.

The organization has made it clear that it does not permit samples to be tested later. She does not have a choice to take that sample, put it in the freezer, and take it out of the freezer on Monday and test it. The chemist rationalizes. This is a rationalization process that can affect data integrity.

She rationalizes, “Both these batches were made by the same production team, on the same equipment on the same day, on Friday—they should be the same. So, I can reuse the test. I can go into the system and I can change the header so the batch number and the time the test was run will look different. I can have two results—one from batch one and one for batch two, but it will only take me the time it took to run one batch. And that way I can leave and go to the game.”

People who are in control of the quality culture are the people who are responsible for scheduling the workload. This laboratory analyst did not have the resources she needed to do the job. Organizations are particularly good about scheduling production, but they do not seem to be as good about scheduling the laboratory sample receipt testing.

Enable Better Choices

If the samples come into the lab late in the day, perhaps a second shift should be arranged, or maybe there should be some sort of split shifts or overlapping shifts for better coverage.

Another batch was added on Friday. When they added that batch, they should have planned for overtime so that the analyst who was going to work Friday would have known that she would have to stay late. And maybe she could have asked for volunteers to work late.

People make choices in their work/life balance. Putting that lab analyst in the predicament described is putting her into a trap. She made a promise to her child. That is important in her life. It is important as a parent.

Part of her job is testing samples. “You are creating a conundrum where she must make a choice. And either choice is going to be a poor choice for her. That is not a quality culture. You do not create that situation. You prevent creating that situation. You tell people that they are a valued resource by planning better,” Smalley stressed.

The production scheduling should work better. The way in which the laboratory is scheduled should be perhaps planned better, or allowances should be made, if possible, for freezing the sample and allowing it to be tested on Monday.

Slow Down and Focus

In your company, if you want to assure data integrity, do you have the time to do your job properly? Smalley asked. Or do you feel you are rushed to do your job?

Do you have a quiet space you can use to concentrate when you need to perform some tasks so that you are not subject to distractions?

There are some companies that run yellow tape across the front of the office or cubicle of an individual who is doing a crucial review such as a batch record review or maybe a review for a CMC section for an NDA. The caution tape tells everyone not to disturb the person—that he or she is involved in something that needs focus and concentration and cannot be distracted.

“These examples that I have given you illustrate the intersection between quality culture and data integrity. Give people training and resources. Give employees the tools to prevent them from having to make bad choices,” Smalley advised.

[Related: Click here for a free 483 observation report on data integrity observations in FY2020.]

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