Editor’s note: In this two-part series, compliance and data integrity expert Matt Brawner answers questions to connect the dots between data integrity and organizational excellence. In part one, he explains the two concepts, current trends and mistakes to avoid. In part two, he provides insight into specific regulations.
A. Quite a lot. Organizational Excellence is the constant striving of a company to deliver consistent superior performance through continual process improvement. Lean Six Sigma is often a big part of corporate organizational excellence programs, as it seeks to reduce waste and remove variation.
Now consider data integrity, which is described as the completeness, consistency, and accuracy of data. How could you ever demonstrate removal waste or a reduction of variation without accurate data? It is impossible. Data Integrity is a requirement of operational excellence. Establishing data integrity assurance is one of the first steps companies must take on their path operational excellence.
A. First and foremost, companies need to practice understanding quality/value in the eyes of their customer. For life science companies this is the patient, not the regulator. Define these ‘quality attributes’ for your product and assure you deliver them to a high quality, and as consistently as possible.
The second-best practice is making organizational excellence and data integrity a part of your business processes, a part of your culture. This is not something that can be inspected/audited into your business, it must be a part of your management system(s), something you measure and something you care about achieving.
The third-best practice is one that is slowly gaining traction within the industry – mapping. Value stream mapping of product flows through manufacturing equipment is common in organizational excellence/Lean Six Sigma, but have you considered using it for your critical data flows? How better to align a team in assuring data integrity than to provide a visual representation showing data flows through the various steps of the data lifecycle? While data flow maps do take a little longer create, effort is more than rewarded by being able to quickly focus teams on portions of the data lifecycle for quick analysis, improved inspection readiness, and helping newcomers quickly come up to speed.
A. Absolutely. With trained personnel, the tools I mentioned above will help you deliver compliance, quality and move you down the path toward organizational excellence. The tools I mentioned are my long-time go-to’s when helping clients. Consider this, if you have effective meetings to understand your critical quality attributes and map your processes, then you assess your processes in effective risk assessment and mitigation meetings, then hold people accountable to implement the mitigations and track your progress, what is missing? Of course, this is a simplification, but you now see how these tools work together.
A. First, I have to say that data integrity and organizational excellence is not something that you wake up some day having achieved. Just as an Olympic runner who continually strives to be faster by aligning their training routine, sleep schedule, and diet to optimize performance, a business will align its schedules, processes, and suppliers to continually strive for organizational excellence and perfect data integrity.
I would say the most common mistake organizations encounter in rolling out these programs is not having detailed planning. Incorporating organizational excellence or data integrity into an organization’s ways-of-working is a large initiative and commonly takes years to complete. To frequently program planning focuses on the bigger, longer term deliverables without highlighting the more frequent accomplishments along the way. These accomplishments are key to showing progress and maintaining project momentum at all levels within the organization. Make sure you keep your project, and the benefits it is delivering front-of-mind with your executive team as well as with other groups in your organization.
An equally common mistake to poor project planning is poor executive alignment. Company leaders frequently initiate a project based on a broad understanding of a needed improvement. However, as a project plan is developed, scope and project deliverables become more concisely defined. Project managers must make sure this defined project path still meets the expectations of company leaders, if they expect to maintain executive support. Providing frequent communication of project accomplishments and benefits will also help show the executive team that they are realizing a return on their investment.
All these elements are a critical part of meeting the needs of your customer, and next week we will look at that in the context of regulatory compliance.
Matt Brawner is a compliance and data integrity subject matter expert (SME) in Raleigh Durham, North Carolina. With a passion for helping others achieve success in their data integrity endeavors, he provides data integrity training and consulting. Brawner has over 18 years of experience working with drug and medical device companies within the biopharmaceutical industry. As a Lean/6 Sigma Black Belt with experience holding various roles within quality, engineering, automation, IT, manufacturing and organizational excellence, he strives to deliver innovative and high-value quality solutions. Brawner was most recently recognized for his leadership in a successful regulatory action remediation, as well as consolidating quality systems (QMS) following a merger between two global companies. He attributes his success to the capable teams with which he has worked.
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