AABB News: Maximizing Quality Assurance

This article originally appeared in AABB News, a benefit of AABB membership. Join AABB today to read the rest of this month’s issue.

Quality Assurance Professionals Share Their Insight

Throughout its 76-year history, AABB has remained committed to advancing quality and safety for the blood and biotherapies field and promoting a regulatory environment that drives progress and supports blood availability and safety. Quality assurance is an integral component of blood banking and a mandatory requirement to ensure safe and effective blood transfusion services. Quality assurance professionals play a critical role in assessing each step of the transfusion process, from performing audits and monitoring quality measures, to incident reporting and ensuring all areas of the blood bank are operating in compliance with AABB standards and applicable government regulations. The following AABB institutional members share their insight as quality professionals, including strategies to help facilities maximize quality assurance efficiency while navigating challenges and turbulent times.

The 80/20 Rule: Maximizing Quality Assurance Efficiency

By Edward Griffin MBA, MS, MLS(ASCP)SBB, CLS, CQA- (ASQ), PMP

Director Transfusion Medicine, Ronald Reagan UCLA Medical Center

“The 80/20 rule is a constant reminder that not all tasks are created equal. It helps us prioritize and allocate our resources efficiently to achieve maximum results.” - Darren Hardy

Quality assurance plays a vital role in ensuring the delivery of reliable and high-quality products or services. However, in the fast-paced world of blood and biotherapies, optimizing quality assurance processes and maximizing efficiency is crucial. This is where the 80/20 rule, also known as the Pareto Principle, comes into play. In this article, we will explore the 80/20 rule and how it can be applied to quality assurance, enabling organizations to focus their efforts on the most impactful areas and achieve better results. The 80/20 rule, originally coined by Italian economist Vilfredo Pareto, states that roughly 80% of the effects come from 20% of the causes. This principle has found applications in various fields, highlighting the imbalanced distribution of inputs and outputs. In quality assurance, the rule suggests that a significant majority of issues or defects can be traced back to a small subset of causes or components. By identifying and addressing these critical areas, blood facilities can make significant improvements in the overall quality of their products or services. Here are four ways to apply the 80/20 rule to quality assurance:

1. Identifying critical equipment, supplies and processes: The first step in applying the 80/20 rule to quality assurance is identifying the key components or factors that have the most significant impact on the quality of blood and biotherapy products. By conducting a thorough analysis and gathering data, quality assurance teams can pinpoint the critical areas that require the most attention and resources.

2. Prioritizing efforts: Once the critical items and processes are identified, it is essential to prioritize efforts accordingly. The 80/20 rule suggests that allocating resources, time and attention to the vital few areas will yield the most significant improvements. This prioritization ensures that the most critical issues are addressed first, maximizing the impact of quality assurance efforts.

3. Focusing on root causes: By applying the 80/20 rule, quality assurance teams can concentrate their efforts on addressing the root causes of quality issues. Instead of chasing after every minor issue, the rule encourages a deeper analysis to identify the underlying factors that contribute to the majority of problems. By resolving these root causes, blood and biotherapy organizations can prevent a significant portion of quality deviations from occurring in the first place.

4. Continuous improvement: The 80/20 rule encourages a culture of continuous improvement in quality assurance. By regularly analyzing data, reviewing results and trends and adjusting strategies, organizations can adapt to changing regulatory requirements and emerging challenges. This iterative approach allows quality assurance teams to constantly refine their processes and concentrate on the areas that have the most significant impact on blood and biotherapy product quality.

The 80/20 rule offers a valuable framework for optimizing quality assurance efforts. By identifying the vital few items and processes, prioritizing efforts and focusing on root causes, organizations can achieve higher quality standards while efficiently allocating resources. Applying the rule enables quality assurance teams to concentrate on the areas that have the most significant impact, maximizing effectiveness and ensuring safe, pure and potent blood and biotherapy products. Embracing a culture of continuous improvement further enhances the application of the 80/20 rule, allowing organizations to adapt and excel in an ever-changing environment. By leveraging this principle, blood and biotherapy organizations can strengthen their quality assurance practices and deliver products and services that consistently meet and exceed internal and external customer and regulatory expectations.

 

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The 80/20 Rule: Focusing Our Efforts

By Celia Clifford, MS, MT (ASCP)

Senior vice president, quality, safety and regulatory affairs, American Red Cross 

Are you at times good at doing things that do not need to be done (at all)?

The 80/20 principle is one of the greatest secrets of highly effective people and organizations, and we can utilize the 80/20 rule to increase quality assurance efficiency. As quality professionals, we naturally gravitate to the premise that everything is a priority and spend many hours being reactive versus proactive. We can be more effective and proactive with less effort by learning how to identify and leverage the 80/20 principle: that 80% of all our results in business and in life stem from a mere 20% of our efforts. 

The simplest approach is to create a risk framework within your department and apply quality tools available. Workload planning and management is critical. Data supports that 20% of our time accounts for 80% of the work we accomplish. The 80/20 principle shows how we can achieve much more with much less effort, time and resources, simply by identifying and focusing our efforts on the 20% that really counts. For example, integration of the quality management systems for workflow, power of automation and returning defective supply demonstrate that if you apply the principle in a systematic and practical way, you can vastly increase your effectiveness, and improve your value to your organization. The unspoken corollary to the 80/20 principle is that little of what we spend our time on counts. But by concentrating on those things that do, we can unlock the enormous potential of the magic 20%, and transform our effectiveness in our jobs, careers, businesses and lives.

 

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Navigating Turbulent Times

By J. Wade Atkins, MS, MT(ASCP) SBB, CQA, CABP(H)

Supervisor, DTM QA/RA, National Institutes of Health

All organizations face uncertainty with adequate staffing due to external or internal forces. Often the quality activities are prioritized lower than other more direct operational needs. When faced with the issue of not enough staff to do all that is required for the planned quality activities, applying quality principles such as risk assessment and mitigation to the staffing (quality unit and operational divisions) issue can be a valuable approach. This activity need not be as robust as the action needed to introduce a new process or policy around actual manufacturing or testing, but it may be helpful identifying the quality assurance tasks that are most likely to mitigate problems or issues. It can then become an evaluated prioritization plan.

For example, error management could become the top priority for staff attention as an effective approach to preventing a repeat of errors that create a threat to the quality of products or services and lead to a lot of time-consuming work. A focus on change control for ideas that may come from finding forced efficiencies may also become a priority. Careful planning and a strong transition plan can head off unexpected and time-consuming efforts to correct unintended outcomes. These activities could be prioritized over other quality functions, such as auditing, validation or verification planning for new equipment or processes that may be placed on hold until more operational and quality staff are available. Use your quality assurance tool kit, apply it to your quality plan and activities and let prioritization from a risk assessment perspective help you navigate these turbulent times.

 

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The Importance of Quality Assurance: Five Crucial Processes

 

By Rajiv Kumar Senior Manager, Quality Assurance Cryoviva (Singapore) Laboratory Services Pte. Ltd.

When it comes to cord blood banking, the role of quality assurance is of paramount importance as it encompasses several key processes and tasks that ensure the highest standards of safety and quality. Quality assurance in cord blood banking involves the implementation of various specific jobs and procedures that contribute to the overall quality management system. Here are five crucial processes that underscore the significance of quality assurance:

1. Development of quality indicators: Quality assurance specialists in cord blood banking establish and monitor quality indicators that serve as measurable parameters to assess the quality of cord blood units. These indicators can include factors like cell viability, sterility and potency, among others. By continuously tracking these indicators, quality assurance ensures that cord blood units meet predefined quality standards.

2. Internal audits: Quality assurance professionals conduct regular internal audits to assess compliance with standard operating procedures (SOPs), regulatory requirements and industry best practices. These audits help identify areas for improvement, address any deviations and ensure that cord blood banking processes are consistent, efficient and in line with established protocols.

3. Documentation and recordkeeping: Quality assurance plays a crucial role in maintaining accurate and comprehensive documentation and recordkeeping practices. This includes tracking and recording all aspects of cord blood collection, processing, storage and distribution. Robust documentation ensures traceability, allows for retrospective analysis and supports transparency and accountability.

4. Risk management: Quality assurance specialists are responsible for implementing risk management strategies in cord blood banking. They identify potential risks and develop mitigation plans to minimize their impact. This proactive approach helps ensure the safety and quality of cord blood units throughout the entire process, from collection to transplantation.

5. Validation and verification: Quality assurance professionals validate and verify all critical processes, equipment and methodologies used in cord blood banking. This includes validating storage systems, testing procedures and equipment functionality. By conducting rigorous validations, quality assurance ensures that all components of the cord blood banking workflow are reliable and accurate.

These are just a few examples of the specific jobs and processes within quality assurance that highlight its crucial role in cord blood banking. By maintaining quality indicators, conducting internal audits, ensuring meticulous documentation, managing risks and validating procedures, quality assurance professionals uphold the highest standards in cord blood banking. 