Expert Tips on Enhancing CAPA Through Innovation


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The value of an innovation in corrective and preventive action (CAPA) management is completely dependent on its practical application as a solution. But the quality sphere has no use for innovation purely for innovation’s sake.

According to quality guru Ken Peterson, sometimes the best tactic for going beyond rudimentary CAPA management is to ignore the past and invent the future. In an enlightening white paper and corresponding two-part webinar series, Peterson shows how analytical thinking and creative ideas can be combined to develop new solutions that have practical applications. The key, he says, is not letting an investigation mindset take over the “innovation mind.”

Never Mind What Went Wrong. What Needs to Go Right?

Peterson, a veteran quality management architect who has dedicated decades of expertise to improving processes at companies like IBM and Pfizer, asserts that the bulk of quality event management efforts are too often focused on analyzing failures. He suggests that organizations are typically so busy conducting rudimentary CAPA investigations into the causes of problems that they ignore less apparent or unorthodox problem-solving options.

Innovation begins with a concise statement of intent that clearly articulates your objective, according to Peterson. It’s the inverse of the “problem statement” approach: instead of clarifying what has gone wrong, focus on articulating what you want to go right. Not until you’ve fine-tuned this central objective statement can you begin to refine the vision of your expected results and start shaping the criteria that will guide your prospective solution.

The Hazards of Leaping Headlong Into Problem Solving

As human beings, our first impulse is usually to jump in and immediately slap Band-Aids on problems whenever they occur. In quality scenarios, though, this impetuous approach tends to backfire. Making a conscious effort to establish design requirements as the first phase of problem solving — before bias has any chance to creep into your analysis — is the initial key to the successful development of a deployable solution that can meet the demands of both management and the market. Any subsequent modifications or adaptations that may be required can always be made down the road if conformity or risk issues become apparent.

To avoid the pitfalls that commonly occur with half-baked quality management solutions, Peterson posits the following four questions to inspire innovation:

  • What are the requirements of the solution?
  • What should the finalized solution ultimately do?
  • Who will be affected by this innovation?
  • What would be the impact of a solution in this area?

Peterson recommends implementing a mind-mapping technique to effectively categorize ideas into natural categories that make it easier to sift through mass quantities of data. This methodology begins by first asking critical, prescriptive questions that incorporate a holistic view of the matter for which a solution is needed. Once a framework for a viable solution has been developed, it can be compared with the established design requirements and further refined. If there are compulsory criteria, adjustments can be made to accommodate the solution’s critical elements to prevent potentially significant problems down the road.

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Enjoying this article? You may also enjoy this White Paper:

Advancing Beyond CAPA Using Innovation for Growth and Improvement

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Bringing Innovative Ideas to Fruition

To take an innovation from a seed of an idea to a full-fledged solution, Peterson recommends following six sequential steps for evaluating, categorizing and executing new initiatives:

  1. Opportunity: Ask prescriptive questions to identify opportunities
  2. Scope: Reintroduce the initially defined design requirements to understand the parameters and verify the solution’s feasibility
  3. Requirements: Determine which of the solution’s requirements are fundamentally necessary for it to meet the mark of success
  4. Improve: Define any elements that are important but not critical to the solution and create a clear vision of intent
  5. Refine: Adjust and fine-tune the solution to meet prioritized, mandatory requirements
  6. Sell: Obtain organizational approval and acceptance among decision-makers and stakeholders

3 Phases of Building a Repeatable Innovation Process

To create an innovation-friendly environment and a reproducible practice for developing creative solutions, Peterson says organizations can successfully satisfy the “core principles of effectual innovation” by duplicating the following three-stage process:

  1. Develop and implement a step-by-step procedure to transform concepts into business-focused outcomes.
  2. Implement practical tools that work for your specific environment, products, production schedules and other organizational requirements.
  3. Get the internal “buy-in” necessary to implement your solutions effectively by securing commitments needed from the applicable personnel. Peterson warns that this final step in the process can be just as difficult as the development of the solution itself if key individuals are resistant to the disruption of the organization’s status quo.

Peterson encourages organizations to continually maintain a growth-focused mentality when attempting to develop innovative solutions. “Remember that you may just learn more through your efforts when you fail occasionally than you might have if you succeeded initially,” he says. “Not every solution needs a problem.”

For a further examination of creative tactics for enhancing the CAPA solution development process, you can access both parts of the “Advancing Beyond CAPA Compliance Using Innovation for Improvement and Growth” video series here. Audio recordings of the presentation are also available in podcast format (Part 1, Part 2). To fully explore Peterson’s six-phase innovation methodology and learn more about his pioneering CAPA advancement techniques, download the white paper.


James Jardine is a marketing communications specialist at MasterControl Inc. He has covered life sciences and regulatory issues for more than a decade and has a bachelor’s degree in journalism from the University of Utah. 
 






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