Today’s quality challenge is how to implement a comprehensive quality program that ensures sustainable regulatory compliance and continual improvement, while contributing to improvements in business process, profitability, and customer satisfaction. Quality Assurance (QA) has a key role to play in achieving the transformation from an approach based on point-solutions to arising compliance issues, to having a harmonized, aligned quality system and culture. To become a valued partner in this transition, QA must adopt a strategic model that provides demonstrated value and constantly improving positive impact. A model that is engaging in its simplicity while retaining the key elements of more complex quality systems is the “Grip/Build/Engage” (GBE) model [1,2]. The system is designed based on the attributes of true effectiveness as demonstrated in various arenas, not just in the professional realm. An example of true effectiveness and impact is visually represented by looking at Tiger Woods’ golf swing, [http://www.youtube.com/watch?v=q3tazW9h7do]. To achieve his undeniably remarkable results Tiger Woods:
• Maintains a solid grip on the ground and on the club at all times
• Pulls the club away from its target, building a tension in his body while aiming and aligning
• Engages effortlessly by releasing the tension and following through completely
This is a powerful analogy for an effective quality system and business approach – the delivery of consistent high-impact results through aligned processes with an elegant simplicity that delights the customer. To translate this GBE approach to QA, an analogy can be made both to Tiger Woods’ golf swing and established quality models such as the Plan-Do-Study-Act (PDSA) cycle used by W. Edwards Deming [3], to describe the three overlapping phases.
Stage 1: Grip
Foundations come first! A solid base is established by defining overall vision, strategy, principles, and values. This is most powerfully expressed by defining story, a narrative description of desired achievements and way of working. Balance is attained, monitoring and control activities are put in place to check results and systems, and mechanisms for taking effective corrective action are instituted. This “Grip” stage equates to the “Study” and “Act” sections of the PDSA cycle, studying first before acting to improve.
Stage 2: Build
Developing people, process and structure, by taking actions that do not necessarily lead directly toward the desired goal. This stage is comprised of “important but not urgent” activities such as training and education, planning, determining strategy, and process improvement. This phase is especially critical to the eventual outcome as it will produce the acceleration and momentum needed to hit the target, minimizing the risk of unanticipated impediments or resistance. In PDSA terms, this is the “Plan” portion of the cycle; ensuring that the details have been studied, instruction and training are available and problems are anticipated.
Stage 3: Engage
Engaging with people, tasks, challenges and opportunities to produce results, the “Do” part of PDSA. The overriding principle of successful engagement is to get better results with less effort through using the following principles:
• Reduce waste and cut all elements that do not contribute to story and goals, or do not relate to the GBE steps. This generates time that can be re-invested more profitably.
• Focus on results by identifying and concentrating on the “elusive 10%” [1, 4] of activities that will provide 90% of results. This includes maintaining efforts to achieve stated objectives in-line with the QA story, and taking care to balance activities around the different steps of the GBE cycle.
• Economy of effort: by not using more resource than is necessary to achieve a given outcome, goals can be achieved more rapidly and with less resource expended.
• Pro-reactivity: using reactive, routine tasks to contribute to longer-term goals, not just completing the task, but also building something bigger at the same time. Identifying and capitalizing on high-leverage activities that create the largest effect per given input.
• Simplification: compliance tends to be inversely related to complexity [5]; a more complex procedure will potentially have a higher occurrence of non-compliance and will require more resource. This is a commitment to using the minimum level of complexity necessary for comprehensive solutions.
By adopting this model and striving to balance activities around the three stages of GBE, a more powerful approach to attaining results is realized. Extending the golf analogy, this prevents repeated ineffective hacking at the ball using a lot of effort (expending resource inefficiently on tasks that do not provide value) and facilitates constant improvements in quality, compliance and profitability. The GBE model is a framework to make QA more rational, principle-based, efficient, and effective. As the workplace becomes increasingly complex, adopting a structured approach allows QA to remain a focused, balanced, and valued partner in making a positive impact on our business and the customers we serve.
References
1. Principles in Quality Assurance, Part 3: Making an Impact. Jones AB. Qual Assur J, 2009; 12, 132–138 (http://onlinelibrary.wiley.com/doi/10.1002/qaj.459/abstract).
2. Principles in Quality Assurance, Part 4: Putting it all Together. Jones AB, Quality Assurance Journal, Qual Assur J 2011; 14, 18–26 (http://onlinelibrary.wiley.com/doi/10.1002/qaj.486/abstract).
3. See: http://en.wikipedia.org/wiki/PDCA.
4. Drucker PF. Managing for Results. New York: Harper and Row; 1964.
5. Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine. John Avellanet, Logos Press, May 2010 (http://www.get2marketnow.com).
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