Guest Column | April 14, 2021

How to Ensure Your Quality Culture Assures Data Integrity

By Chris Smalley, ValSource


Data integrity (DI) is receiving greater attention, and deservedly so. Data, given appropriate context, become knowledge, and knowledge of the processes and products is invaluable. To be able to rely on that knowledge, data must have integrity. One solution is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

First, let’s review: What is data integrity?

  • Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA.
  • Data must be complete, consistent, and accurate throughout the data life cycle, according to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceutical Inspection Co-operation Scheme.

The industry has accepted an expanded definition of DI, ALCOA+, which adds complete, consistent, enduring, and available. For this article, the focus will be on the original ALCOA expectations because that is squarely where data generation/capture is addressed.

Many employees are not involved in the capture or generation of data, but rather are involved in the review, analysis, storage/archival, disposition, and other steps in the life cycle. Although the focus here will be on capture/generation, these other areas will also relate to the role of quality culture.

As a beginning, it is important to review the definitions of those terms that constitute ALCOA:

  • Attributable: It should be possible to identify the individual or computerized system that performed the recorded task. The need to document who performed the task/function is, in part, to demonstrate that the function was performed by trained and qualified personnel. This applies to changes made to records as well: corrections, deletions, changes, etc. 
  • Legible: All records must be legible – the information must be readable in order for it to be of any use. This applies to all information that would be required to be considered complete, including all original records or entries. Where the “dynamic” nature of electronic data (the ability to search, query, trend, etc.) is important to the content and meaning of the record, the ability to interact with the data using a suitable application is important to the “availability” of the record. 
  • Contemporaneous: The evidence of actions, events, or decisions should be recorded as they take place. This documentation should serve as an accurate attestation of what was done, or what was decided and why, i.e., what influenced the decision at that time. 
  • Original: The original record can be described as the first capture of information, whether recorded on paper (static) or electronically (usually dynamic, depending on the complexity of the system). Information that is originally captured in a dynamic state should remain available in that state. 
  • Accurate: Ensuring results and records are accurate is achieved through many elements of a robust pharmaceutical quality system. This can be composed of: 
    • Equipment-related factors such as qualification, calibration, maintenance, and computer validation
    • Policies and procedures to control actions and behaviors, including data review procedures to verify adherence to procedural requirements 
    • Deviation management, including root cause analysis, impact assessments, and CAPA 
    • Trained and qualified personnel who understand the importance of following established procedures and documenting their actions and decisions.

Together, these elements aim to ensure the accuracy of information, including scientific data that is used to make critical decisions about the quality of products.  Keeping these elements in mind, let’s now move to the role of quality culture.

What Is The Quality Culture In Your Organization?

If you took a poll in your organization, will employees be honest or provide the answer they think you are looking for? After all, aren’t we all team players? Organizations have embraced faddish phrases that superficially seem good but have little to no impact on the quality culture.

So, how do your employees perceive the culture? In fact, what if you could get in the heads of your employees?  Would they be thinking:

  1. If I get caught making a mistake, I’ll be disciplined or fired;
  2. It’s not my job;
  3. I’m only a cog in the big machine; or
  4. I’m a valued employee who has the resources I need to succeed at my job?

If you think their perception is anything other than #4, then read on!

Training Is One Aspect Of Changing And Maintaining The Quality Culture

Training in quality culture is not having employees read SOPs online, nor is it having them sit in a classroom or, worse, an auditorium to be lectured at. What training in a quality culture means is:

  • Conducting interactive workshops;
  • Using facilitators who are not their supervisors or managers; and
  • Seeing that their management is committed to the training.

A key element in the training is to explain not just the what but the why. Reading SOPs and hearing lectures does not engage the team members in a way that helps them understand the why. Interactive workshops, made even more valuable when conducted as a multidepartment activity, will assist in providing the team members with a broader perspective of the process and an understanding of their role. Training that is led by supervisors or managers many times will not result in questions from team members, who may think they will be judged for asking an “obvious” question. With a facilitator (from another department, from a trained member of your HR team, or a third party), however, the group can relax and ask those questions that can lead to deeper understanding. Seeing that management is committed to training, not just by paying lip service but by demonstrating commitment by attending the training, devoting the time and resources to provide quality training, and using feedback from training, will improve processes and procedures. For team members who understand the importance of their job, not only the process but the final product and the impact on the patient who receives it, we see a tremendous difference in their attitude toward data integrity. Why? Because they understand the importance of their role, their contribution.

The key here is communicating to everyone involved an understanding of their role in the product that is passed to the next step (our “customer”), as well as their role in the product that the clinician or patient receives (our final goal).

Ensuring Employees Have Needed Resources

Ensuring appropriate resources means:

  • Equipment is available, qualified, and calibrated: Having equipment available when the team member needs it means their time is valued. Having equipment that is qualified and calibrated means they have the tools they need to do a good job, and the data generated will be correct.
  • There is adequate time to perform the task: Adequate and appropriate resources contribute to a good quality culture. For example: Adequate time to perform the task means they are not rushed, and they have the time to perform the task correctly.
  • They have a “buddy” checking on them: This doesn’t mean a supervisor checking up on them. It means someone stops by periodically if they are working alone, to see if they are safe and to ask, “Do you need a hand with anything?”

A Hypothetical Case Study: A laboratory chemist receives samples from two batches toward the end of the day on Friday. This chemist made a promise to their child that they would take them to their soccer game. By the time the tests are completed on the first of the two batches, it is very close to the time the chemist would need to leave at the end of their regular workday. The organization has made clear that it doesn’t like samples stored and tested later. The chemist rationalizes that both batches were made by the same team on the same equipment on the same day, so they rerun the test results report after resetting the batch number and time and, consequently, can leave on time to get to the game.

Who is in control of the quality culture? In this example, it is the people responsible for scheduling and workload. If samples are scheduled to come into the lab late in the day, perhaps there should be a second shift. Maybe if the scheduler/planner added another batch to the Friday schedule, then overtime should have been planned and people could make the choices in their work/life balance. But understand that putting a person into the predicament described above can result in poor choices, leading to issues with data integrity and questionable quality.

Do your team members have the resources? Do your team members have the time to do their jobs properly? Do your team members have quiet space to concentrate when needed in performing tasks like document review? Do team members, when working on a prolonged task have someone perform a buddy check to see that they’re doing OK and they’re not some forgotten cog in the machinery? These examples illustrate the intersection of quality culture and data integrity that prevents team members from having to make bad choices.

In conclusion, as management, data integrity is important – it provides knowledge of the process and is a compliance item. A quality culture will ensure DI, and you can build a quality culture by helping team members feel valued, understand their role/contribution to the product and that the ultimate customer of the product is the patient, and by providing the resources they need to perform well.

About The Author:

ChrisChris Smalley, Ph.D., is a consultant for ValSource, Inc. focused primarily on compounding pharmacies. His expertise includes single-use systems and aseptic operations. Previously, he was director of quality operations for Wyeth Pharmaceuticals for 12 years, responsible for setting validation standards and validation activities globally. His research experience includes responsibility for quality in the U.S. operations of the Sanofi Research Division, and earlier he worked for Johnson & Johnson as a plant manager. Smalley has been a member of the PDA Board of Directors and the PDA Science Advisory Board. Currently, he is a member of the ISPE Disposables Community of Practice.