## 3 Methodology  
The proposed methodology derived from the novel flowchart uses combined steps from the LSS, CRISP-DM, and the \"pre-automation\" sequence to find and solve problems related to automation in an industrial process. The novel flowchart enables selection and customization of the required steps used for improving or automating a chosen process. The combined methodology bridges the gaps in individual techniques to allow better understanding and analysis of processes and its data. The general order of the steps that can be used in the integrated methodology chosen from the flowchart is shown in Figure 2, which shows the three basic phases involved in optimizing processes. The combination of the methodologies described, and the order of the steps used in each phase, are other novel aspects of this study, as no other study has outlined the positioning of the steps in the overall methodology to this detail. The methodology is outlined in detail below, in three phases, with the following steps,  
* Phase 1--Process Selection for Improvement 1. Define and business understanding--it is crucial to understand the problems in the current business and recognize useful data. A project charter can then be created as a quality management tool in CRISP-DM to set a clear scope for this study. 2. Measure and data understanding--this step involves mapping out the processes and listing the critical processes based on scrap history or operational records. * Phase 2--Methodology Selection for Process Improvement Based on Flowchart 2.2 involves selection of a combination of methodologies to use for process improvement in a data-rich environment using the novel flowchart shown in Figure 1.
* Phase 3--Selected Methodology Application 3. Data preparation and modeling--if Industry 4.0 data are used for process improvement, then the raw data might require some pre-processing such as filtering, cleaning or data transformation. This step was adopted from the CRISP-DM methodology since LSS cannot assist with Industry 4.0 data. * Analyze and evaluation--this step is used to conduct test for process capability and root cause identification. * Improve and deploy/stabilization/standardization/optimization--once the issues have been identified from step 2, the suggestions for improvement are provided in this step. The tasks that require user management or any causes of instabilities are removed for stabilization. Any modification of equipment, tasks, or processes that allow the task or process to perform or function automatically facilitates standardization of the process. This step also involves an evaluation of the improved task or process for optimization. * Control--this step involves continued process verification. The steps used from the Six Sigma methodology are: define, measure, analyze, improve, and control. Each step requires thorough knowledge analysis and several tools are available to analyze process metrics [53]. The Lean tools are designed to remove wasteful steps from the process. The steps for LSS are data driven where prioritized parameters are used in statistical analysis [75]. These data for LSS traditionally lean on both automated data collection and human centric data collection. The digitization of currently manually collected data could offer further efficiency gains and streamline the DMAIC process further to answer the research question,  
\"Can digitized CNC and CMM data be used to identify, reduce or remove manual non-value added interactions from a medical device manufacturing process using the \"pre-automation\" sequence, LSS and CRISP-DM methodology to automate and improve the process?\"  
The phases in the CRISP-DM framework are shown in Figure 3[78]. Figure 2: Methodology to achieve automation—the steps applicable in each phase. Integrating CRISP-DM with Lean Six Sigma methodology adds more structure to the Six Sigma methodology, in obtaining more accurate results from large datasets [28]. An expert system was developed for a process on the factory floor as a part of previous research using tacit knowledge.