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Quality professional with over 12 years of industry experience in Quality Engineering and Quality Systems.
Comprehensive background focusing on product quality, design and development of electronic, electrical, software/ hardware manufactu...
Quality Engineer with the technical expertise and commitment to accurately design, evaluate, and maintain electrical, mechanical/electromechanical/electronic systems. Led quality initiatives to meet objectives for business growth, customer satisfaction, and continuous quality improvement.
Diversified background in Lean Six Sigma, Quality Control/Assurance, Project Management, Process Improvement, Production and Industrial Engineering. (Supply Chain, Oil & Gas, Automotive, locomotives, Elevators, Telecom, Healthcare).
Extensive knowledge of ISO 13485 and ISO 9001 requirements including practical implementation and management experience. Subject Matter Expert in FDA Quality System Regulation, ISO 14971 Risk Management and cGMP for both drugs and devices.Show More
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Established quality control process for Product Inspection Document (PID)
Project Goal: Established quality control process for Product Inspection Document (PID) and increased better communications/mitigate risks using QDM principles and tools.
Root Cause or Opportunity Analysis: The team identified the primary source of the problem using a fishbone diagram. QDM tools Fishbone diagram and Five Whys was used to analyze root cause, we have examined various scenarios, brainstorm and asked questions why there is a difference between the desired state and current state. As a team lead, I have challenge teammates on initial causes and effects on finding during the brainstorming sessions. The team did monitor Product Inspection Document (PID) process-related issues to improve and did focus on one issue at a time. We have developed the Alcatel Product Inspection Document (PID) process and established a quality control measurement for PID.
The initial issue was capture in the fishbone diagram and all-cause/ effect was capture during our brainstorming session. Teammates have gathered data, graphs, diagram, plot during each meeting and solutions was generated based on the finding and results, revised current state of Product Inspection Document (PID) process. We had prepared an implementation plan of procedures and plan on training and communicating with teammates. The procedures were implemented, and training was provided to teammates and a training sign-in sheet was generated. Solution address the root cause of the Product Inspection Document (PID), we also decided to monitor the process for at least 6 months to mitigate risks and stability of the process.
During the evaluation phase of the project, the innovation team has evaluated the process and its results. Operation management and supervisor recognized the success of the project and the results. The outcome was a success and it has reduced PID related issues by 75?cording to data and analysis.
The project was a success according to operation management, the quality of new procedures streamlines the entire Product Inspection Document (PID) process. The process owners were identified using QDM RACI tools and teammates were engaged during the implementation planning phase. All the activity of implementation was monitor using a checklist. Major problem was to gather teammates in their busy schedules, but our backup plan was to let the management know the task of absence teammate and the management coordinate with the teammate completing the task.Show More Show Less
Standardize Electrostatic Discharge (ESD) program
Project Goal: The goal was to Standardize Electrostatic Discharge (ESD) program for DFW and FW Technology and train ESD program to all teammates throughout DFW and FW facilities.
Root Cause or Opportunity Analysis: The project was implemented due to not consistency in ESD procedures, training and roles and responsibilities of each stakeholder by facilities. First, the group identified key issues in the current status of ESD. Then the team defined the desired state for each key issue. Based on the analysis, the team was able to establish initiatives needed to move from the current state to the desired state.
A brainstorming session was conducted to identify the current status of the ESD process. After putting the problems in rank, ideas are selected in a meaningful order. Keeping the standardizations process for ESD in mind the group of people was selected using RACI chart to understand the role of each stakeholder who has provided support implementing ESD program. RACI helped define the role and responsibilities.
Solutions: The completed set of corporate-level Standardize Electrostatic Discharge (ESD) procedures was implemented and a lot of nonvalue added procedures were removed from Master Control, I have provided ESD training to almost 300 teammates throughout DFW and FW facilities. A quarterly audit program was implemented and in place to conduct ESD audit. Standardize Electrostatic Discharge (ESD) was a success due to QDM ABLE methodology. The team decided to monitor the process for at least 6 months to mitigate the risks and stability of the process.
Results: The evaluation phase of QDM allows us to evaluate and analyze the performance data to see the plan and the goals were achieved, based on the progress made and failures data and the results, the current state is stable and has significant stability.
Applicability: The project was a success according to operation management and data, the quality of new ESD procedures streamlines the entire Standardize Electrostatic Discharge (ESD) program.Show More Show Less