Engineering Change Order (ECO): Definition, Types, Process, and Example

An Engineering Change Order (ECO) is a formal document used in engineering and manufacturing to authorize and control modifications to a product’s design, components, manufacturing process, or documentation.

The main purpose of an ECO is to provide a structured, traceable, and compliant way to implement changes. ECO ensures product quality, regulatory compliance, and consistency across the product lifecycle. ECOs play a central role in change control by documenting what needs to change, why it is necessary, and how it will be executed.

There are several types of ECOs, including design changes, material or component substitutions, process updates, corrective and preventive changes, cost-reduction initiatives, compliance-driven updates, customer-requested modifications, and end-of-life adjustments. Common reasons for initiating an ECO include design flaws, regulatory updates, supplier issues, cost optimization goals, safety concerns, and customer feedback.

The ECO process follows a structured workflow including initiation of a change request, review and evaluation, approval and authorization, implementation and execution, and verification and closure. This organized approach helps ensure that every change is formally assessed, documented, and traceable.

Effective ECO management requires following best practices. Best practices include using standardized submission forms, defining evaluation criteria, involving cross-functional teams early, centralizing documentation, conducting impact assessments, and performing post-implementation reviews. Implementing Quality Management System (QMS) software further enhances efficiency by automating workflows, ensuring version control, maintaining audit trails, and supporting regulatory compliance.

SimplerQMS, a life science QMS software, supports the full ECO lifecycle as part of its broader quality management capabilities. SimplerQMS streamlines change control, integrates with related processes like document management and CAPA, and helps companies meet strict requirements under FDA, ISO, and EU regulations.

What Is an Engineering Change Order (ECO)?

An Engineering Change Order (ECO) is a formal document in engineering and manufacturing that authorizes and governs the implementation of modifications to a product design, component, or process.

In the engineering change management process, an ECO serves as the official approval mechanism. ECO specifies what changes are required, why they are necessary, and how they should be executed. The ECO ensures controlled, traceable, and compliant updates across the organization and helps maintain product quality, regulatory compliance, and consistency throughout the product lifecycle.

The primary purpose of an ECO in engineering and manufacturing environments is to provide a structured method for documenting, authorizing, and communicating changes. This approach helps organizations avoid miscommunication, reduce design or manufacturing errors, and ensure proper execution across teams. Organizations often initiate ECOs to improve performance, address safety concerns, correct design flaws, meet regulatory requirements, or respond to customer needs.

An ECO typically includes a description of the change, the rationale behind it, and a list of the parts, assemblies, processes, or documents affected. ECO also defines how to handle work-in-progress (WIP), field inventory, and supplier stock, along with verification and validation requirements to confirm the change’s effectiveness. In addition, ECOs capture administrative details like version numbers, effectivity dates, implementation timelines, impact assessments, and required stakeholder approvals.

ECOs should not be confused with related terms in engineering change management, such as Engineering Change Request (ECR) and Engineering Change Notice (ECN). An ECR is the initial proposal that identifies the need for a change, often raised by engineers, quality teams, or customer feedback. After review and justification, the ECO becomes the formal authorization that approves the change and defines how it will be implemented. Once approved, an ECN communicates the details of the ECO to all relevant stakeholders. The ECN ensures consistent execution, proper version control, and full traceability across the organization. Together, ECR, ECO, and ECN are key components of the engineering change management process.

Why Are Engineering Change Orders Important?

Engineering Change Orders are important because they provide a structured, documented, and traceable system to evaluate, approve, and implement changes without disrupting quality, compliance, or production.

ECOs are essential in product development and manufacturing because they ensure modifications are properly reviewed, authorized, and documented before implementation. This structured approach reduces the risk of design flaws, manufacturing errors, cost overruns, and customer dissatisfaction. A structured ECO process keeps stakeholders aligned, ensures accurate implementation, and preserves historical records for accountability and regulatory purposes.

Implementing ECOs mitigates major risks such as miscommunication between departments, use of outdated specifications, loss of product traceability, and uncontrolled design adjustments. ECOs improve traceability by maintaining a clear history of what was changed, why it was necessary, who approved it, and when it became effective. The documented ECO record strengthens cross-functional communication, prevents duplication of work, and enforces accountability across teams.

ECOs are also critical for regulatory compliance and quality assurance, since many industries mandate documented change control processes. For example, medical device companies must comply with FDA 21 CFR Part 820 design controls, while manufacturers certified to ISO 9001 or ISO 13485 must maintain documented evidence of controlled product and process changes. Without a formal ECO process, organizations risk serious consequences, including audit findings, regulatory penalties, product recalls, compromised patient safety, increased costs due to rework, and reputational damage caused by uncontrolled or undocumented changes.

What Is the Role of ECOs in Engineering Change Management?

ECOs play a central role in engineering change management by serving as the formal mechanism to review, approve, and implement product or process modifications in a controlled and compliant way. Within the change management process, an ECO is issued after an engineering change request has been evaluated, becoming the official order that authorizes execution. The ECO is the backbone of change control, ensuring changes are systematic, traceable, and aligned with organizational and regulatory requirements.

The specific functions of an ECO in managing engineering changes include documenting the nature and scope of the change, identifying affected parts or processes, defining required actions, and assigning responsibilities to stakeholders. An ECO allows organizations to evaluate potential impacts on cost, quality, functionality, timelines, and compliance before any change is approved, reducing risks from uncontrolled modifications.

ECOs facilitate communication by centralizing change information and ensuring that all stakeholders, including engineering, manufacturing, supply chain, procurement, regulatory, and quality teams, remain aligned. Integrated approval workflows ensure changes are properly reviewed and authorized by designated teams or the Change Control Board (CCB). The structured approval process prevents miscommunication, delays, and errors while providing clear implementation instructions.

ECOs also ensure change traceability, version control, and accountability. Each ECO records who requested the change, who approved it, and when it was executed, creating a complete audit trail. This documentation supports compliance with standards and regulations such as ISO 9001, ISO 13485, AS9100, IATF 16949, and FDA 21 CFR Part 820, while also enabling organizations to demonstrate full control over product design, development, and manufacturing changes.

What Are the Types of Engineering Changes?

The most common types of engineering changes are listed below.

• Design Changes: Modifications to the product’s design, such as dimensions, geometry, features, or functionality. Design changes are often introduced to improve performance, safety, or manufacturability.
• Material or Component Changes: Substitution or replacement of materials or parts due to availability, cost, performance, or compliance considerations. Material or component changes ensure continuity of production and regulatory alignment.
• Process or Manufacturing Changes: Adjustments to production methods, equipment, assembly sequences, or workflows. Process or manufacturing changes are typically made to enhance efficiency, reduce defects, or adopt new manufacturing technologies.
• Documentation and Specification Updates: Revisions or corrections to drawings, CAD (Computer-Aided Design) models, bills of materials (BOMs), device master record (DMR), or technical specifications. Documentation and specification updates ensure accuracy, consistency, and compliance with requirements.
• Corrective Changes: Adjustments made to resolve identified issues, defects, or failures during production, testing, or post-market use. Corrective changes address immediate quality or safety issues.
• Preventive Changes: Proactive modifications intended to reduce the likelihood of future risks, failures, or inefficiencies. Preventive changes are often based on risk assessments or predictive analysis.
• Cost-Reduction Changes: Alterations focused on lowering material, manufacturing, or operational costs. Cost-reduction changes help maintain profitability while preserving product quality and compliance.
• Compliance or Regulatory Changes: Updates required to meet new or updated regulatory, safety, or quality standards, such as ISO, FDA, or EU requirements. Compliance or regulatory changes ensure the product remains legally marketable.
• Customer-Requested Changes: Modifications introduced in response to customer feedback, clinical user input, usability testing, or market demands. Customer-requested changes strengthen customer satisfaction and competitiveness.
• End-of-Life (EOL) or Obsolescence Changes: Changes needed when parts are discontinued, suppliers discontinue components, or a product is phased out. End-of-life or obsolescence changes ensure continuity of supply or controlled phase-out.
• Packaging and Labeling Changes: Modifications to packaging design, labeling content, or artwork to reflect design updates, regulatory requirements, or branding changes. Packaging or labeling changes ensure accuracy, compliance, and proper product identification.
• Supplier or Vendor Changes: Changes involving approved suppliers, materials, or components provided by vendors. Supplier or vendor changes require evaluation to ensure quality, equivalence, and continued regulatory compliance.
• Performance Enhancement Changes: Improvements designed to increase reliability, durability, performance, or efficiency. Performance enhancement changes often extend the product lifecycle and strengthen market competitiveness.

What Are the Common Reasons for Engineering Change Orders?

The most common reasons for issuing an ECO are outlined below.

• Design Flaws or Errors: Corrections are required when mistakes are discovered in product designs, drawings, or specifications. Design flaw corrections prevent functionality issues, safety risks, and performance problems.
• Manufacturing Constraints: Adjustments are necessary due to limitations in equipment, tooling, or assembly processes. Manufacturing constraint changes ensure production efficiency and accuracy.
• Supplier Issues or Discontinuation: Changes are triggered when a material or component becomes unavailable, discontinued, or fails to meet quality and compliance requirements. Supplier-driven changes secure continuity of supply and compliance.
• Regulatory or Compliance Updates: Modifications are required to align products with updated safety, environmental, or industry standards such as ISO, FDA, or EU requirements. Regulatory update changes ensure products remain compliant and legally marketable.
• Cost Optimization Goals: Adjustments are introduced to reduce production, material, or operational costs. Cost optimization changes support profitability while maintaining compliance and quality.
• Quality Improvement Initiatives: Updates are implemented to enhance durability, reliability, or overall performance. Quality improvement changes allow organizations to exceed customer and regulatory expectations.
• Customer Feedback or Complaints: Modifications are made in response to reported issues, user requests, or market demands. Customer-driven changes improve satisfaction, usability, and competitiveness.
• Product Lifecycle Management: Updates are introduced during different stages of the product lifecycle, such as scaling production, extending service life, or preparing for obsolescence. Lifecycle-driven changes ensure smooth product transitions and continuity.
• Safety Concerns or Incident Response: Rapid changes are implemented to eliminate hazards, address risks, or respond to safety incidents. Safety-driven changes protect users, reduce liability, and ensure compliance with safety regulations.
• Testing and Validation Failures: Adjustments are required when prototypes or production units fail performance, compliance, or stress testing. Testing-driven changes prevent defective or nonconforming products from reaching the market.
• Standardization or Harmonization: Changes are introduced to unify parts, processes, or designs across multiple products or facilities. Standardization changes reduce complexity, lower costs, and improve efficiency.
• New Technology or Innovation: Updates are applied to adopt emerging technologies or integrate innovative features. Innovation-driven changes enhance competitiveness and extend product relevance.

What Is the Engineering Change Order Process?

The engineering change order process is a structured workflow that ensures all product or process modifications are properly reviewed, authorized, and executed.

The steps of a typical ECO chronology are listed below.

1. Initiation of Change Request: A change request is raised to identify the need for modification.
2. Review and Evaluation: The proposed change is analyzed for impact on cost, quality, compliance, and schedule.
3. Approval and Authorization: Stakeholders or the CCB review and approve the ECO.
4. Implementation and Execution: Approved changes are applied to products, processes, or documentation.
5. Verification and Closure: The change is validated, documented, and officially closed to complete the cycle.

1. Initiation of Change Request

The first step in the engineering change order process is the initiation of an engineering change request. At this stage, the need for a modification to a product, design, or process is formally recognized and documented.

Capturing change requests in a structured format prevents uncontrolled updates and ensures a clear starting point for the workflow. ECRs may be raised by engineers, quality teams, customer service, or suppliers.

Engineering or quality managers typically review ECRs for completeness and accuracy. Supporting information often includes drawings, specifications, bills of materials (BOMs), defect reports, or customer feedback. A typical request describes the proposed change, provides justification, and attaches supporting evidence such as test results or compliance concerns.

Many organizations use PLM (Product Lifecycle Management) or QMS software to log and track requests, but the key outcome remains the same – a documented change request with sufficient detail for evaluation.

2. Review and Evaluation

Once logged, the change request is reviewed and evaluated by cross-functional teams. The goal is to assess whether the proposed change is necessary, feasible, and beneficial, while considering impacts on cost, quality, timelines, and compliance.

The analysis typically involves representatives from engineering, manufacturing, procurement, quality, and regulatory affairs. The team completes an impact analysis to identify all items affected by the change, such as drawings, BOMs, labelling, and procedures. The evaluation includes a technical rationale and risk assessment for the change, considering regulatory, quality, and cost implications and the requirement for verification and validation activities. Inputs may include cost-benefit analyses, technical and risk assessments, and regulatory checklists. A preliminary implementation timeline is developed.

Teams examine technical implications, weigh alternatives, and evaluate risks before deciding whether the change should move forward. If the change request is approved, an Engineering Change Order is created to formalize the approved modification. The ECO captures detailed change information, including affected components, implementation plans, assigned responsibilities, and approval requirements, ensuring the change is executed in a controlled and traceable manner.

The outcome of this stage is a clear decision to approve, modify, or reject the change request based on technical, quality, and regulatory considerations.

3. Approval and Authorization

The third step in the ECO process is approval and authorization of ECO, where formal decisions are made to allow the proposed change to proceed. This stage ensures that only justified and fully evaluated proposals are implemented.

Approvals are typically performed by engineering managers, quality leaders, or regulatory representatives. In many organizations, final responsibility lies with a Change Control Board, which provides collective oversight and ensures consistency across projects. Inputs include the ECO form, documented evaluation results, and applicable compliance requirements such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820.

At this stage, approvers review the ECO package, sign off electronically or manually, and record the rationale for their decision. The approved ECO becomes an authorized instruction ready for execution in production or documentation systems.

4. Implementation and Execution

After approval and authorization, changes are implemented across relevant products, processes, and documentation. The objective is to apply modifications consistently, accurately, and in line with the authorized plan.

Operations, manufacturing, supply chain, and quality assurance teams typically lead this step, with support from suppliers or external partners when required. Implementation may include updating controlled documents, revising specifications or BOMs, training staff, and making adjustments to production processes.

By the end of this stage, changes are fully embedded across all affected areas and traceable within organizational records. The implementation and execution step is directly connected to verification and closure, which confirms that execution meets both quality and compliance expectations.

5. Verification and Closure

The final stage of ECO processes focuses on verifying that the change was executed correctly and achieved the intended results. Supporting evidence is reviewed to confirm that all actions within the implementation plan have been successfully completed. This may include verification and validation reports and/or regulatory submissions or updates, as required.

Quality assurance, engineering, and regulatory teams verify outcomes through testing, inspections, or audits. They confirm that objectives were met, no new issues were introduced, and all relevant documentation reflects the approved change.

Closure also includes issuing an Engineering Change Notice to formally communicate the modification across the organization. Once verified, the ECO is officially closed, leaving behind a complete audit trail and revision history.

Some companies use PLM or QMS systems to store these records, ensuring they remain accessible for compliance and future reference. Verification and closure secure accountability, demonstrate compliance, and provide a reliable foundation for continuous improvement.

Who Are the Stakeholders in the ECO Process?

Listed below are the main stakeholders in the ECO process.

• Engineering: Engineering is responsible for initiating ECOs, defining the technical requirements, and providing detailed design or specification updates. Engineering also conducts feasibility assessments and verifies the technical accuracy of proposed changes.
• Quality Assurance (QA): Quality assurance evaluates the impact of proposed changes on product quality and compliance. Quality assurance ensures corrective and preventive actions are integrated into the ECO process to maintain reliability and regulatory conformity.
• Operations / Manufacturing: Operations and manufacturing assess how changes affect production workflows, tooling, equipment, and assembly lines. Operations and manufacturing ensure the ECO can be executed without disrupting efficiency or product output.
• Supply Chain / Procurement: Supply chain and procurement evaluate the availability, cost, and sourcing of replacement materials or components. Supply chain and procurement also coordinate with suppliers to secure compliant and approved resources.
• Product Management: Product management aligns ECOs with overall product strategy, customer requirements, and market timelines. Product management also assesses the impact of changes on product roadmaps, launches, and customer commitments.
• Regulatory Affairs / Compliance: Regulatory affairs and compliance verify that changes meet applicable standards and regulations. Regulatory affairs and compliance also prepare or update submission documents for authorities when required.
• Finance: Finance analyzes the cost implications of changes, including tooling, labor, materials, and potential savings. Finance ensures budget alignment and supports decision-making on ECO approvals.
• Customer Support / Service: Customer support and service provide customer insights and feedback related to complaints or issues that drive ECOs. Customer support and service also update service manuals, training, and support processes affected by approved changes.
• IT / PLM System Administrators: IT and PLM system administrators manage the digital platforms, such as PLM and QMS software, used to route and track ECOs. System administrators ensure traceability, data integrity, and version control.
• Change Control Board (CCB): The CCB reviews, evaluates, and formally approves or rejects ECOs. The CCB acts as the primary decision-making authority, balancing input from multiple functional areas.
• Executive Management: Executive management oversees high-impact ECOs that affect business strategy, budgets, or regulatory risks. Executive management provides final approval for significant changes that cross organizational or departmental boundaries.

What Content Should an Engineering Change Order Include?

An engineering change order should include a number of key elements as follows.

• ECO Number and Title: The ECO number and title provide a unique identifier and descriptive label for tracking and reference. The ECO number and title ensure every change is clearly traceable in organizational systems.
• Date of Creation: The date of creation is the date when the ECO is initiated, which establishes a timeline reference for audits, compliance, and project management. The date of creation helps organizations maintain accurate historical records of product changes.
• Change Description: The change description provides a detailed explanation of the proposed modification, specifying what is being changed and why. The change description ensures all stakeholders understand the scope and purpose of the modification.
• Reason for Change (Rationale): The rationale documents the justification for the modification, such as improving quality, reducing cost, or meeting compliance requirements. The rationale ensures that the ECO is supported by business, quality, and technical objectives.
• Affected Parts, Documents, or Assemblies: The affected parts, documents, or assemblies list identifies impacted components, drawings, BOMs, or procedures. The affected items ensure all dependent documentation and materials are updated consistently.
• Proposed Modifications or Revisions: The proposed modifications describe the specific design, material, process, or documentation updates. The proposed modifications provide clarity on exactly what must be implemented.
• Impact Assessment (Product Quality, Compliance, Cost, Schedule, Production): The impact assessment evaluates how the proposed change may affect the product’s functionality, performance, and safety, as well as its influence on quality, regulatory compliance, cost, and production. Assessing product impact is critical to ensure that all potential risks are identified and managed before implementation.
• Implementation Plan and Timeline: The implementation plan defines responsibilities, steps, and deadlines for executing the change, including a phase-in plan for the change. The implementation plan and timeline ensure changes are applied in a structured, coordinated, and timely manner.
• Required Approvals and Sign-Offs: The required approvals and sign-offs document stakeholder reviews and authorizations before implementation. The approvals and sign-offs guarantee accountability and compliance with internal procedures and regulatory change control requirements.
• Supporting Documentation (Drawings, BOMs, Specs): The supporting documentation includes attachments such as updated drawings, CAD models, specifications, or test reports. The supporting documentation provides reference material to support execution.
• Revision History: The revision history logs all previous ECOs or related revisions linked to the product. The revision history ensures proper version control and traceability throughout the product lifecycle.
• Assigned Stakeholders or Departments: The assigned stakeholders identify the functions responsible for execution and oversight, such as engineering, QA, or procurement. The stakeholders ensure accountability and ownership for the change.
• Compliance or Regulatory References: The compliance references cite applicable standards and regulations, such as ISO, FDA, or EU requirements. The compliance references demonstrate alignment of the ECO with mandatory requirements.
• Verification and Closure Information: The verification and closure information provide evidence that the change was implemented correctly, verified for effectiveness, and formally closed. The verification and closure information confirm that the ECO lifecycle is complete and auditable.

What Are the Benefits and Constraints of Engineering Change Orders?

The benefits of engineering change orders are listed below.

• Traceability: ECOs ensure every modification is documented, creating a complete history of decisions, actions, and approvals. ECO documentation supports audits, regulatory compliance, and long-term traceability.
• Quality Assurance: ECOs enforce structured review and approval workflows that reduce errors, improving product quality, reliability, and customer satisfaction.
• Regulatory Compliance: ECOs provide documented evidence of change control activities. ECO records help organizations demonstrate compliance with FDA 21 CFR Part 820, ISO 9001, ISO 13485, and other requirements.
• Cost Control: ECOs enable early evaluation of cost implications before implementation, avoiding expensive rework, production delays, or scrap.
• Process Standardization: A formal ECO process ensures consistent procedures across departments and projects, reducing confusion and streamlining operations.
• Cross-Functional Visibility: ECO workflows involve multiple stakeholders across engineering, manufacturing, quality, and supply chain. ECO collaboration fosters communication and alignment.
• Risk Mitigation: ECOs help identify and evaluate potential risks before implementation, reducing the chance of unintended consequences such as safety issues, product failures, or regulatory non-compliance.
• Documentation Accuracy: ECOs centralize all records within controlled systems or repositories that the organization uses to manage documentation. Maintaining documentation accuracy ensures records are complete, consistent, and readily available for audits or inspections.

The constraints of engineering change orders are listed below.

• Process Delays: ECO review and approval steps can slow development or production. ECO delays often occur when workflows are overly complex.
• Administrative Overhead: ECO management requires extensive documentation, reviews, and approvals. ECO administrative overhead is higher in manual, paper-based systems.
• Increased Complexity: ECO processes involve multiple steps and stakeholders. ECO complexity makes workflows harder to manage without the use of digital platforms.
• Resource Allocation: ECOs demand additional time and effort from engineering, quality, and operations teams, potentially straining organizational capacity.
• Change Fatigue: Frequent ECOs can overwhelm employees, reduce engagement, and create resistance to new updates.
• Resistance to Change: ECO requirements may be resisted by staff reluctant to follow new processes. ECO resistance can create bottlenecks and slow implementation.
• Risk of Miscommunication: As ECOs span multiple teams and departments, miscommunication can result in lost information, errors, or misaligned execution.
• Approval Bottlenecks: ECO approvals can stall when reliant on manual sign-offs or overloaded approvers. ECO approval bottlenecks delay critical change implementation.

What Are the Challenges in Managing ECOs?

The most common challenges in managing ECOs are outlined below.

• Communication Gaps: Ineffective communication between departments can cause delays, misunderstandings, and incomplete execution of approved changes.
• Approval Delays: Lengthy review and authorization steps can create bottlenecks, slowing down product development and production schedules.
• Inconsistent Documentation: Poorly maintained or incomplete ECO records reduce traceability, complicating audits and increasing compliance risks.
• Lack of Standardized Processes: Without formalized ECO procedures, teams may follow different workflows, leading to inefficiencies and errors.
• System Integration Issues: Disconnects between PLM, ERP, and QMS systems can cause data silos, duplicated work, or inaccurate change tracking.
• Resource Constraints: Limited availability of engineering, quality, or manufacturing staff can delay ECO processing and implementation.
• Change Impact Misassessment: Inadequate evaluation of potential effects may introduce unforeseen costs, risks, or quality problems.
• Version Control Errors: Using inaccurate or outdated design files and specifications can result in production errors and nonconformities.
• Cross-Department Misalignment: Poor coordination across engineering, procurement, manufacturing, and quality teams can create conflicting priorities.
• Overlapping or Duplicate Changes: Multiple ECOs addressing similar issues can lead to redundancy, confusion, or contradictory updates.
• Prioritization Issues: Lack of clear prioritization criteria can delay critical ECOs while minor changes consume resources, causing inefficiencies and compliance risks.

What Are the Best Practices for Effective ECO Management?

The best practices for effective ECO management are listed below.

• Standardize ECO Submission Forms: Utilize structured forms to capture consistent information, including change description, affected parts, and rationale. Standardization reduces ambiguity and ensures no critical details are overlooked.
• Define Clear Change Evaluation Criteria: Establish objective criteria for evaluating ECOs, including technical feasibility, cost impact, regulatory compliance, and risk factors. Clear criteria allow teams to prioritize and approve changes effectively.
• Involve Cross-Functional Teams Early: Engage engineering, manufacturing, quality, supply chain, and regulatory teams at the beginning of the ECO process. Early collaboration ensures all perspectives are considered and reduces late-stage conflicts.
• Assign Role-Based Access and Approval Rights: Clearly define responsibilities for initiating, reviewing, and approving ECOs. Defined access rights strengthen accountability and streamline decision-making.
• Use Quality Management System (QMS) Software: Leverage QMS software to streamline the engineering change order process with automated workflows, centralized documentation, and enforced approval controls. QMS software enhances efficiency, ensures traceability, and provides possibilities to integrate with PLM, ERP, or CAD systems to maintain data consistency across the organization.
• Conduct Thorough Change Impact Assessments: Evaluate the potential effects of a change on design, production, cost, timelines, and compliance. Comprehensive assessments prevent unforeseen risks and disruptions.
• Centralize All Change Documentation: Store ECO records, drawings, BOMs, and specifications in a single repository. Centralization improves accuracy, version control, and audit readiness.
• Enable Tracking and Notifications: Implement automated alerts and dashboards to monitor ECO status, deadlines, and pending approvals. Tracking provides transparency and keeps stakeholders aligned.
• Train Teams Regularly on ECO Procedures: Provide continuous training on ECO workflows, compliance requirements, and system usage. Regular training promotes consistency, reduces errors, and ensures adoption across teams.
• Perform Post-Implementation Reviews and Audits: Review completed ECOs to confirm objectives were achieved and assess Corrective and Preventive Action (CAPA) effectiveness. Post-implementation audits identify opportunities for continuous improvement.
• Establish Clear Implementation Timelines: Define realistic timelines with specific milestones, due dates, and responsible parties while considering available resources and dependencies. Clear timelines help monitor progress, facilitate follow-up on actions, and ensure timely delivery of changes.

In Which Industries Are Engineering Change Orders Used?

Below are the main industries where ECOs are commonly used.

• Life Sciences: The life sciences industry, including medical devices, pharmaceuticals, and biotechnology, relies on ECOs to manage design updates, process improvements, and controlled documentation changes. ECOs ensure compliance with requirements such as FDA 21 CFR Part 820, EU GMP, and ISO 13485, while maintaining product safety and effectiveness.
• Automotive and Aerospace: Automotive and aerospace sectors depend on ECOs to control design modifications, material substitutions, and production process updates. ECOs help ensure compliance with safety and quality standards such as IATF 16949 and AS9100, while reducing risks in highly regulated environments.
• Electronics and High-Tech Manufacturing: Electronics and high-tech manufacturers operate in fast-paced markets where rapid design iterations and component obsolescence are common. ECOs enable efficient management of design revisions, supplier-driven changes, and version control to maintain product integrity and traceability.
• Industrial Equipment and Machinery: The industrial equipment and machinery sector uses ECOs to update complex assemblies, replace discontinued components, and adapt equipment for new operational requirements. ECOs streamline changes while ensuring documentation accuracy and compliance with technical standards.
• Consumer Goods and Packaging: The consumer goods and packaging industry applies ECOs to manage packaging modifications, design updates, and material substitutions. ECOs help reduce production costs, improve market appeal, and maintain compliance with labeling and environmental regulations.
• Energy and Utilities: The energy and utilities industry uses ECOs to implement equipment upgrades, safety improvements, and infrastructure modifications. ECO processes ensure reliable operations, minimize risks, and maintain compliance with environmental and safety regulations.

What Are the ECO-Related Standards and Regulatory Requirements?

Listed below are ECO-related standards and regulatory requirements.

• ISO 9001 (Quality Management Systems): ISO 9001:2015 is an international standard for quality management systems applicable to organizations of all types and sizes. ISO 9001 requires organizations to establish documented change control processes to maintain consistency, traceability, and continuous improvement. ECOs support compliance by ensuring that product or process changes are formally reviewed and approved.
• ISO 13485 (Medical Devices): ISO 13485:2016 is a globally recognized standard for quality management systems specific to the medical device industry. ISO 13485 mandates strict change control for design, production, and labeling of medical devices. ECOs are essential to maintaining device safety, regulatory compliance, and risk management throughout the product lifecycle.
• FDA 21 CFR Part 820 (Quality System Regulation – Medical Devices): FDA 21 CFR Part 820 is a U.S. regulation that defines quality system requirements for medical device manufacturers. FDA 21 CFR Part 820 outlines design and document control requirements to ensure product safety and effectiveness. ECOs are required to ensure that changes to design, processes, and procedures are formally reviewed, validated, or verified, and documented.
• ICH Q10 (Pharmaceutical Quality System): ICH Q10 provides a model for an effective pharmaceutical quality system throughout the product lifecycle. It requires a formal, science-based, and risk-based change management process to ensure that changes are evaluated, documented, and implemented without unintended consequences. ECOs align with ICH Q10 by providing a structured framework for managing product and process modifications in a controlled manner.
• AS9100 (Aerospace Quality Management Systems): AS9100 is an international quality standard based on ISO 9001, with additional sector-specific requirements. AS9100 places strong emphasis on structured change management for safety-critical components. ECOs ensure modifications to aircraft and aerospace systems are documented, traceable, and compliant with strict safety and reliability requirements.
• IATF 16949 (Automotive Quality Management Systems): IATF 16949 is a global standard for quality management in the automotive sector, developed by the International Automotive Task Force. IATF 16949 specifies requirements for controlling design and process changes in automotive production and service parts. ECOs provide the structured framework to implement these changes while meeting safety, reliability, and customer-specific requirements.
• EU MDR and IVDR (Medical Device and In Vitro Diagnostic Regulations): The EU MDR 2017/745 and EU In Vitro Diagnostic Regulation (IVDR) are European regulations governing medical devices and in vitro diagnostic devices. These regulations require strict documentation and change control for design and labeling modifications. ECOs help maintain compliance by linking approved changes to the relevant technical documentation, risk management files, and regulatory submissions.
• EU GMP (Good Manufacturing Practice– Pharmaceuticals and Biotech): EU GMP sets quality and safety guidelines for the manufacture and control of medicinal products within the EU and those exported to the EU. EU GMP requires manufacturers to maintain validated processes, controlled documentation, and auditable records of changes. ECOs ensure that design changes, including modifications to equipment, processes, raw materials, or labeling, are reviewed, approved, and traceable, supporting inspections and regulatory audits.

How Does QMS Software Support the Engineering Change Order Process?

QMS software supports the engineering change order process by automating workflows, centralizing documentation, and ensuring traceability across all change stages. QMS software with engineering change order management capabilities streamlines initiation, review, approval, implementation, and closure, making the ECO process faster, more compliant, and less prone to errors.

Listed below are the main features of QMS platforms that support engineering change order management.

• Automated Workflows: Route ECOs through structured review and approval processes with predefined steps and role-based access.
• Centralized Documentation: Store drawings, specifications, bills of materials, and revision histories in a single repository.
• Version Control: Ensure that only the latest approved documents and specifications are accessible to teams.
• Audit Trails: Maintain a complete record of who initiated, reviewed, approved, and implemented changes.
• Notifications and Tracking: Provide real-time alerts and dashboards to monitor ECO progress and pending approvals.

QMS software also promotes compliance by aligning ECO processes with regulatory requirements such as FDA 21 CFR Part 820, ISO 9001, ISO 13485, EU MDR, and IATF 16949. By integrating change control into a centralized quality system, organizations benefit from improved accountability, reduced risks of miscommunication, and audit readiness.

SimplerQMS is a life science QMS software that supports the full ECO lifecycle as part of its broader quality management capabilities. In addition to managing engineering changes, SimplerQMS supports document control, training, CAPA, and other critical QMS processes. The system helps life science companies maintain compliance with strict requirements, including FDA 21 CFR Part 11 and Part 820, EU GMP, ISO 13485, and ISO 9001, among others, while ensuring efficiency and traceability across engineering and quality operations.