Role of QMS while Implementing DMAIC

Six Sigma is a disciplined, data-driven approach to improving product and process quality. Ever since Jack Welch labelled Six Sigma as one of the most strategic initiatives undertaken by GE, it has seen its adoption increase dramatically across the world.

 

Enterprise quality management systems play a key role in the Six Sigma deployments.

The quality of a process is measured by its ability to consistently deliver products or services within the specification limits. While a company can deliver a good quality product made using an inefficient process, it comes at a very high cost. An inefficient process will generate an unacceptably high number of defects and produce them with a level of variation that hinders the ability to predict process performance.

 

If a process is operating at Six Sigma, its variability is extremely low at 3.4 defects per million. At Six Sigma, the company has a significant competitive advantage in delivering very high levels of quality (nearly zero defects) at dramatically lower costs.

 

The methodology for achieving Six Sigma is an acronym called DMAIC.DMAIC stands for five interconnected phases - Define, Measure, Analyse, Improve, and Control.

 

DMAIC refers to a data-driven approach for improving processes using Six Sigma Quality Initiative. In this paper a manufacturer applies the Six Sigma methodology to improve the on-time delivery process. The details behind the various phases in the Six Sigma implementation in this scenario include:

 

Define: In this phase the Six Sigma team develops a clear definition of the process sponsor expectations and issues, as well as, the scope of the overall project. This phase requires the team to perform the following:

 

1. Define the process to be improved by mapping the process flow in details
2. Capture clearly the expectations of the process sponsor
3. Define project boundaries  the stop and start of the process

 

Measure: This phase requires the Six Sigma team to capture the key issues associated with order-to-delivery process data, as well as, key order-to-delivery metrics. The team uses the audit management capabilities in their quality management system to audit the order-to-delivery process to better understand key issues.

 

The metrics are collected from various systems that touch the order-to-delivery process. The metrics form the baseline for the process performance and help focus on key issues. The baseline metrics also enable the team to quantify the improvements made to the order-to-delivery process at the end of the DMAIC phases. The key steps in the phase include:

 

1. Develop a data collection plan for the order-to-delivery process
2. Collect data from many sources (systems and audits) to determine issues and core process metrics

 

Analyse: This phase requires the Six Sigma team to analyse the data collected to determine the root causes of issues and identify opportunities for improvement. Key steps in this phase include:

 

1. Identify gaps between the current order-to-delivery metrics and goals
2. Perform root cause analysis
3. Identify corrective actions (CAPA) using technology and discipline
4. Prioritize opportunities to improve

 

Improve: In this phase, the Six Sigma team implements the improvements to fix the problems and prevent them for occurring in future. Six Sigma team uses the quality management system to closely track the open corrective actions and to ensure that they are successfully implemented.

 

The team also uses the quality management system for document change control to ensure the new operating procedures and other documents are in use. The steps in this phase include:

 

1. Develop and deploy implementation plan
2. Institutionalize the improvements through the modification of processes and structures (staffing, training, incentives)
3. Implement document change control to ensure process changes are followed
4. Track and ensure closure of CAPA items
5. Monitor corrective action effectiveness with real-time performance data and analysis

 

Control: In this phase, the Six Sigma team ensures that there are controls in place to keep the improved process on the new course. The quality management system allows the team to audit the order-to-delivery process to ensure the improvements have taken hold to prevent the process from reverting back to the "old way". The key steps in this phase include:

 

1. Require the development, documentation and implementation of an on-going monitoring plan
2. Monitor order-to-delivery metrics and perform process audits to ensure improvements are here to stay.

Using DMAIC, supported by an enterprise-wide quality management system, a company can streamline their order-to-delivery process and reap its rich rewards.