Keys to a Successful Engineering Change Management Process

Engineering change management (ECM) is a critical process in the lifecycle of any product.

It ensures that changes to a product’s design or manufacturing process are systematically evaluated, approved, and implemented. This article will cover the basics of ECM, the challenges associated with it, and the key elements for successful implementation.

ENGINEERING CHANGE MANAGEMENT BASICS

Engineering change management is the systematic approach to managing changes in product design, manufacturing processes, or other engineering aspects. It is essential for maintaining product quality, reducing costs, and ensuring compliance with industry standards.

Types of Engineering Changes

1. Design Changes: Modifications to the product’s design, such as altering dimensions, materials, or components.
2. Process Changes: Adjustments to the manufacturing process, including changes in equipment, methods, or workflows.
3. Documentation Changes: Updates to technical documents, such as drawings, specifications, or manuals.

The ECM Process

1. Change Request: The process begins with a change request, which can be initiated by anyone involved in the product lifecycle.
2. Impact Analysis: The proposed change is analyzed to assess its impact on cost, quality, and schedule.
3. Approval: The change is reviewed and approved by relevant stakeholders, including engineering, manufacturing, and quality assurance teams.
4. Implementation: The approved change is implemented, and necessary updates are made to documentation and processes.
5. Verification: The change is verified to ensure it meets the desired outcomes and does not introduce new issues.

CHALLENGES WITH ENGINEERING CHANGE MANAGEMENT

Complexity and Coordination

Managing engineering changes can be complex, especially in large organizations with multiple departments and stakeholders. Coordinating these changes requires effective communication and collaboration.

Data Management

Accurate and up-to-date information is crucial for effective ECM. Managing and maintaining changes can be difficult, especially when dealing with multiple systems and manual processes.

Time and Cost Constraints

Implementing changes can be time-consuming and costly particularly when using conventional paper-based ECM methods. Balancing the need for change with budget and schedule constraints is a common hurdle.

Regulatory Compliance

Ensuring that changes are well-documented and that they comply with industry regulations and standards is essential. Noncompliance can result in legal issues and financial penalties.

KEY ELEMENTS OF ENGINEERING CHANGE MANAGEMENT IMPLEMENTATION

Clear Policies and Procedures

Establishing clear policies and procedures for ECM is crucial. This includes defining roles and responsibilities, setting criteria for change requests, and outlining the approval process.

Effective Communication

Providing regular updates to stakeholders, clear documentation, and open channels for feedback ensures everyone remains on the same page and that the appropriate changes are implemented.

Training and Support

Offering employees training is essential for overcoming resistance to change and ensuring a successful implementation. Training should outline the ECM process and onboard employees on supporting tools and technologies.

Documentation and Traceability

Organizations must document changes throughout the entire product lifecycle and ensure that all pertinent engineering change order (ECO) records are current and readily accessible. This serves as a traceable audit trail of product changes and reduces compliance risks.

Continuous Monitoring

Regularly reviewing and updating engineering change policies, procedures, and systems can help identify and address issues before they become major problems. Key performance indicators associated with ECM include:

• ECO cycle time
• Engineering change cost
• Number of open ECOs

Stakeholder Involvement

Involving all relevant stakeholders in the ECM process is crucial for success. Engineering, manufacturing, quality assurance, procurement, and supply chain partners are examples of teams commonly impacted by changes.

Risk Management

Identifying and managing risks associated with engineering changes is essential. This includes conducting thorough impact analyses and developing contingency plans for potential issues.

Digital Technology

By using modern systems to manage and automate ECM, organizations can save considerable time, improve information accuracy, and accelerate product development.

THE ROLE OF TECHNOLOGY IN ECM

ECM Software Solutions

Various enterprise systems are available to help streamline the ECM process. For instance, proven cloud product development solutions like product lifecycle management (PLM) and quality management system (QMS) software enable organizations to:

• Conduct real-time engineering change reviews
• Establish approval roles and routings for different types of changes
• Configure changes to automatically notify all stakeholders
• Set approval deadlines for reviewers
• Provide a convenient dashboard for teams to check outstanding assignments or notifications
• Capture a complete change history with a traceable audit trail
• Monitor ECO cycle times, incomplete ECOs, and other KPIs through business analytics

Automating Change Processes

Automation significantly reduces the time and effort required to manage engineering changes. Choosing a software solution with advanced automation capabilities will help your teams eliminate manual, repetitive tasks, minimize errors, and dedicate more time to high-value work. Some advanced process automations include:

• Automatic review and approval routings
• Generation of an ECO based on an engineering change request (ECR)
• Auto filling of ECO due dates

CASE STUDIES OF SUCCESSFUL ECM IMPLEMENTATIONS

Biotechnology Industry

NanoDx™, Inc., a leading developer of innovative point-of-care, in vitro diagnostic solutions, initially relied on paper and other fragmented systems to manage their ECOs. This resulted in a backlog of open change orders. After implementing a cloud-native QMS solution with advanced automation capabilities, NanoDX experienced a 10X faster ECO cycle time.

Clean Tech Industry

Nextracker, a Flex Company, is a leading provider of intelligent and connected energy systems to solar power plants worldwide. Early on, the company did not have a single source to track and manage its engineering design and development processes. Product information was tracked manually in workbooks, spreadsheets, and personal file folders. After transitioning to a cloud-native PLM solution, Nextracker cut its ECO review and approval times by nearly 60%.

Lessons Learned

These case studies demonstrate the importance of technology in helping businesses streamline their engineering change management process. They also show the real benefits that can be gained like higher efficiency, reduced errors, and a shorter time to market.