For Medical Device

"Standard Work" for Problem Solving
by Chris Tsai, President of Global Productivity, Inc. and Certified Six Sigma Black Belt


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When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonstrate compliance?

Are investigations and the resulting documentation providing the objective evidence needed to demonstrate compliance?

Problem complexity has the variability and dynamic range of a rainbow and yet many companies treat every problem in the same way - one common process with little guidance or structure with respect to tools, techniques, or analytical rigor. In medical device companies, this often comes in the form of Standard Operating Procedures (SOPs) written in a way that accommodates every problem without constraining the problem solvers to a specific approach. This leads to solutions that fail to address the true root cause and exhibit unpredictable effectiveness. The Lean practice of "standard work" can be applied to problem solving to reduce the variability of approach and improve the probability of an effective solution.

Standard work is defined as the "current, best known way to complete work." Standard work consists of three key elements: work content, the proper sequence of that work, and the timing of those activities. These elements align very well to the expectations of SOPs and can serve to improve the effectiveness of those procedures. Given the problem variability mentioned above, standard work cannot practically be too prescriptive in its approach. Standard work for problem solving can, however, provide valuable structure and predictability through application in three key elements of the problem solving process: problem escalation, problem categorization, and root cause analysis.

The purpose of problem escalation is the timely engagement of appropriate resources to investigate a problem and make decisions about the problem solving approach. Specific resources are engaged as time elapses from the instance of problem discovery and information critical to determining root cause is gathered and analyzed as close in time and space to problem occurrence as possible. Decisions made include investigatory actions, containment and interim actions, problem categorization, and roles and responsibilities for the ensuing problem solving process.

Problem categorization enables the grouping of problems by their complexity and/or risk and alignment to a set of analytical expectations appropriate for those problems. Simple, less risky problems would be dealt with quickly while more complex, higher risk problems will engage analytical techniques to ensure root cause discovery. Categories can also take into consideration common risk assessment attributes (i.e. severity of impact, frequency of occurrence, etc.) Grouping the problems helps simplify and clarify the situation, helps to establish priorities and manage workload, and sets consistent expectations for the path forward. Categorizing problems can also enable faster determination and implementation of appropriate interim actions.

The third element is root cause analysis for which many tools and techniques exist. Standard work is deployed to provide guidance and set expectations for the use of tools and techniques that are appropriate for the complexity and severity of the problem. Documentation requirements can be defined and enforced as well.

By deploying standard work for problem escalation, problem categorization, and root cause analysis, the appropriate people will be involved in the investigation and problem solving process, they will be called upon in an expedient and predictable way, the problem solving process will utilize the appropriate techniques and analytical rigor to solve the problem, and identification of the true root cause - and subsequent effectiveness of the resulting corrective action will be dramatically improved.

Chris Tsai President of Global Productivity, Inc., has professional achievements spanning both the Life Science and Technology industries. He brings a rich understanding in CAPA, Six Sigma, Lean deployment and related change management techniques. Prior to partnering with PathWise, Chris spent 21 years with the Eastman Kodak Company in a variety of roles ranging from tooling and product design to manufacturing engineering to training development and delivery.

Chris has a Bachelor's Degree in Mechanical Engineering from Purdue University and a Masters Degree in Manufacturing Engineering from the Rochester Institute of Technology. He was certified as a Six Sigma Black Belt in 1999.

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