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Creating a standard approach to problem solving

Rachel Doyle,

25th March, 2024


In the world of medical device manufacturing, efficient problem-solving methodologies are essential for ensuring product quality and regulatory compliance. This case study delves into the transformation of problem-solving practices within a medical device manufacturing facility, highlighting the challenges faced, strategies implemented, and the resulting benefits.


The Challenge:

Operating within a highly regulated industry, our manufacturing facility grappled with recurring quality issues despite rigorous investigation efforts. Subject matter experts (SMEs) often resorted to ad-hoc solutions, bypassing structured methodologies. This led to prolonged resolution times, resource drain, and heightened management involvement in issue mitigation.


What We Did:

Recognizing the need for a standardized approach, we embarked on a journey to develop and implement a comprehensive problem-solving framework. Leveraging our expertise and insights gained from extensive experience in life science manufacturing, we crafted a tailored solution adaptable to various complexities.

Utilizing this framework, we addressed a critical quality issue that plagued our operations. Engaging a cross-functional team, we facilitated collaborative problem-solving sessions guided by the newly established standard. The utilization of this structured approach not only expedited the identification of root causes but also fostered a culture of teamwork and accountability.



The adoption of a standardised problem-solving approach yielded tangible benefits for our facility:

  • Swift identification and validation of root causes, leading to targeted remediation efforts
  • Enhanced skill development among team members through active participation and collaboration
  • Increased engagement and enthusiasm towards problem-solving activities, transforming them from burdensome tasks to opportunities for improvement and learning


Key Learnings:

Our journey towards optimising problem-solving practices unveiled several key insights:

  • The importance of establishing clear standards for root cause analysis (RCA) to streamline investigative efforts
  • The need for flexibility within defined principles to accommodate varying complexities and scenarios
  • The significance of ongoing skill development initiatives to empower teams to apply problem-solving principles effectively


Next Steps:

Building on our successes, we are committed to further enhancing our problem-solving capabilities:

  • Continued investment in skill development through targeted training programs and mentorship opportunities
  • Integration of routine problem-solving sessions into our operational practices to foster a proactive approach toward issue resolution


How do we make problem-solving fun? 

A lot of my experience is life science manufacturing, including work on problem-solving, and the processes and skills needed for quality investigations. I love problem-solving, the excitement of learning about something new, working with great colleagues, and the opportunity to make things better permanently. But I have come to realise that isn’t an
opinion shared by everyone, especially when investigating quality issues in manufacturing. In my experience these tasks are barriers to batch release, or even worse are preventing manufacturing, so the pressure is on to come up with an answer and close it down quickly, rather than learning and looking to solve the root cause.
So how do we make this work fun? We recently did an experiment where we ran problem-solving in two adjacent rooms, one where we used digital tools, and people grouped around a screen, and the other where we used post-it notes and flip charts. The difference was immediately noticeable, there was laughter and engagement from the team who had gone analog, whilst the digital team was focused on what was going into the digital tool. I know sometimes digital is necessary, but the human contact and creativity of problem-solving is something that shouldn’t be
underestimated. You also need to remove barriers for effective problem solving, one of those is to create a standard for problem solving. If people are unsure how to tackle something they are less likely to.

Please do contact me if you would like to discuss how we can help you create a standard approach to problem solving.

Rachel Doyle

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