The DMAIC Approach
In the “assessment” phase of a gap analysis, the DMAIC approach can serve as a powerful method. DMAIC stands for Define, Measure, Analyze, Improve, and Control, and it provides a structured framework for thorough analysis of a process, based on factual data and figures. The primary goal of DMAIC is to facilitate evaluation, analysis, and improvement.
This data-driven improvement cycle comprises five essential steps, as illustrated in the diagram below.

Each step involves crucial activities, tools, and templates that are applied to set up and execute problem-solving initiatives. This framework consists of distinct pillars and originated from the Six Sigma initiative.
These five steps can be further elaborated and documented in project charts. At an early stage of the assessment project, the client’s stakeholders can be granted access for reviews and feedback.
The Total Productive Maintenance Approach
TPM, or Total Productive Maintenance, commonly known as the Toyota Production System (TPS), represents a comprehensive approach to equipment maintenance. The goal of this method is to achieve “perfect production” by promoting greater reliability:
- No accidents or hazards, by creating a safe work environment;
- No quality defects;
- No downtime or slow runs;
- No breakdowns.

In the “solution deployment” phase, the intended goal is to increase uptime, shorten cycle times, and eliminate defects. Implementing a TPM program fosters shared responsibility for equipment, which in turn encourages greater engagement among employees on the factory floor.
By integrating the TPM approach alongside other reliability tools, existing gaps are addressed, resulting in growth and profitability. TPM is a proactive approach that emphasizes preventive maintenance, with the goal of maximizing the operational efficiency of equipment. The method aims to blur the lines between production and maintenance, with a focus on empowering operators to contribute to the maintenance of their equipment.
Reducing Waste
Based on best practices at various pharmaceutical companies and our own successful experiences with improvement initiatives, Yxion endorses the TPM method.
This approach has proven effective, with a positive impact on downtime, especially when production and maintenance work closely together. TPM helps increase knowledge on the front lines, where operators are actively involved, which ultimately results in reducing waste. Technicians can be called upon to optimize and build upon solutions, allowing for more efficient work rather than starting from scratch.
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