Medical device manufacturers tend to constantly improve their processes and systems for various benefits such as cost-saving, regulatory requirements, increasing market share, and many more. The change or improvement in the medical device industry must be carried out systematically by following appropriate regulations.

One critical requirement is an engineering change order.

This article will guide you through the definition of engineering change order (ECO) and its role in the overall engineering change control process. It also outlines some trigger points for ECO and, in the end, details some of the many advantages of using a software solution for managing engineering change orders.

Jump to sections:

• What is an Engineering Change Order (ECO)?
• What Can Trigger Engineering Change Order (ECO)?
• The Role of Engineering Change Order in Change Control Process
• Engineering Change Order (ECO) Process Steps
• Common Challenges with Engineering Change Order Processes
• Streamlining the Process With Engineering Change Management Software

What is an Engineering Change Order (ECO)?

An engineering change order is an official document describing the change required in an existing process or product. It also helps the manufacturer to acquire regulatory approval for the changed system or process.

The change control board (CCB) is authorized for issuing all engineering change order approvals.

For this purpose, engineering change orders must be sent to all change control board members. Typically change control board members include a representative from engineering, procurement, manufacturing, quality, and suppliers.

For example, if a medical device manufacturer decides to change the material of a critical component that comes in direct contact with the human body. The engineering first initiates an engineering change Order to describe the relevant information about the change, such as the cause of change, the advantages of the proposed change, and the process of executing change. Then, upon approval from the change control board, engineering proceeds with the change.

What Can Trigger Engineering Change Order (ECO)?

It is essential to accurately determine the need for an engineering change order to uncover all advantages and avoid resource waste. Otherwise, frequent engineering change orders can negatively impact the company’s production capability.

Some typical reasons for engineering change order are:

• Product change
• Regulatory change
• Documents change

Let’s discuss each in detail.

Product Change

Out of many, change in product design is a primary reason for an engineering change order.

Product changes can be triggered due to:

• Sourcing of new low-cost raw materials
• Modified product design that significantly reduces the product cost
• The necessity to improve the product performance due to new research, innovation, or complaints received from any stakeholders.
• The need to remove any flaw in the product that affects the device’s safety or its users.
• Change in customer or user requirements

For example, the product development team has found a cost-effective alternative for a specific material. For its implementation, an engineering change order is first issued. After approval from all the stakeholders, production is then allowed.

Regulatory Change

It is common for the regulatory bodies to change their regulations in response to different observations, complaints, and new research. When they change the regulatory requirements, it becomes necessary for the accredited manufacturers to update their processes and systems according to the revised requirements.

In this case, the change in response to the regulatory requirements is implemented through an engineering change order.

For example, if a regulatory body amends its guidelines and bans specific material in the manufacturing of a medical device, the manufacturer will execute the change through an engineering change order.

Document Change

An engineering change order is also initiated when any changes in the process documentation or a product are made.

Documentation change occurs in response to a change in product specification, regulatory requirements, or a significant structural change in a medical device company.

For instance, if a sterilization time for a specific medical device has been changed in response to a regulatory requirement, the template for the temperature record is also updated by utilizing the engineering change order procedure.

The Role of Engineering Change Order in Change Control Process

The change control process plays an important role in the life sciences, especially the medical device industry, and helps find new ways to improve the process performance.

Implementation of a change control process is divided into several sub-sections, including the engineering change order.

An engineering change order (ECO) is carried out after initiating the proposed change in a format called an engineering change request (ECR), in other words, a request for the change. An engineering change request (ECR) is then reviewed for its justification, scope, and how it impacts the overall product performance by the stakeholders.

After approval by the change control board (CCB), an engineering change order (ECO) is created. The ECO is then reviewed for final authorization by all stakeholders, who check to see whether their approved process is followed or not.

After all necessary approvals and authorizations, an engineering change notice (ECN) is issued. An ECN is a formal announcement for implementing the proposed change to all the relevant persons or departments. It contains the details of the change and supporting documents for its successful implementation.

More on the overall process steps in a bit…

Moreover, because every part of an engineering change order (ECO) must be executed in an approved and controlled format an audit trail is essential for tracking changes.

An audit trail is a set of records that provide documentary evidence of the order of activities that have affected a specific operation, procedure, event, or device, at any time.

An audit trail helps gain insight into the changes as a result of the change control process. It keeps track of all the changes from the beginning. Critical information such as the reason for the change, change impact, and change initiator can be easily traced using the audit trail.

The benefits of keeping an audit trail are the following:

• Allows an organization to quickly reverse back the changes and correct errors
• An audit trail is a critical regulatory requirement from many bodies such as the ISO and FDA
• Protects records from being misused due to human error
• Allows an organization to have stress-free audits

Engineering change management software integrated into an all-in-one eQMS solution like SimplerQMS makes it easy for an organization to track and implement changes. It features a time-stamped audit trail of every document that is changed and creates a detailed report to be presented during regulatory audits.

Engineering Change Order (ECO) Process Steps

As mentioned above, an engineering change order (ECO) must be authorized by the change control board (CCB). For this purpose, the ECO goes through different steps to effectively implement the change.

Below is an overview of all the typical steps in an engineering change order process:

• Identification
• Investigation of the need for change and justification
• Engineering change request (ECR) creation
• Engineering change request (ECR) review
• Engineering change order (ECO) creation
• Engineering change order (ECO) review
• Engineering change order (ECO) approval
• Communication and training
• Implementation

Let’s discuss each step in more detail.

Identification

This is the first step of the process, where you will need to identify the need for the change.

Try to ask yourself the following questions:

• What is the reason for the change?
• What will be the advantage after the implementation of change compared to the existing setup?

For example, if there are customer complaints related to infusion pumps due to irregular flow control, the quality department will generate a corrective action and preventive action (CAPA) for the engineering team. This will become the main reason and issue for initiating the change.

Investigation of the Need for Change and Justification

This step includes a detailed study of the change, its impact, and the requirements.

Ask yourself the following questions:

• Is the made hypothesis actually correct?
• Will the product serve its function as desired?

Engineering Change Request (ECR) Creation

An engineering change request (ECR) outlines the entire life cycle of a proposed change.

It explains the need for change and how it will impact the product, and benefit the organization.  The primary purpose of ECR is to help all stakeholders to decide on either approving or disapproving the change.

For example, in case of a problem with the infusion pump, the engineer decides to change the valve design rather than the pump. An engineering change request (ECR), in this case, will demonstrate why it is necessary to change the valve and not the pump. It will explain what are the advantages of the new design valve. As well as, describe how will the proposed change benefit the company.

Engineering Change Request (ECR) Review

After engineering creates a detailed engineering change request (ECR), it is sent to all the stakeholders for review and approval. They should review it according to their standards and make comments if needed.

The purpose of this step is to make changes before proceeding toward the final implementation stage.

Continuing our example, the supplier will determine whether the particular valve is readily available or not and evaluate whether the valve’s future availability is possible or not.

Engineering Change Order (ECO) Creation

An engineering change order (ECO) describes the practical implementation of the proposed change.

It includes the entire change cycle, such as updating the changed assemblies, components, diagrams, and operating procedures. 

For example, suppose the changed item is a valve. In that case, the ECO can include material description, any calibration requirements, maintenance procedures, and instructions for manufacturing the new design of the infusion pump.

Engineering Change Order (ECO) Review

In this stage, an engineering change order (ECO) is sent to the change control board (CCB) for final review.

Thereafter, the change can be practically implemented.

Engineering Change Order (ECO) Approval

The change control board (CCB) thoroughly studies different aspects of the process, such as the necessity of change, post-change scenario, and overall impact on the performance of the product and company.

Each member analyzes from their angle of expertise. After mutual consensus, an engineering change order (ECO) is approved. Otherwise, the change is not implemented and is sent back for revision.

Communication and Training

This stage includes informing all the concerned personnel about the approval of the change, to start implementing the change per the approved plan.

This is executed in an engineering change notice (ECN) format.

An engineering change notice (ECN) contains all the relevant information, such as steps and processes to successfully perform the relevant change, according to the approved plan.

After the engineering change notice (ECN) has been issued, training is conducted for all the concerned personnel involved in the implementation of change. The main purpose of conducting training is to follow the approved plan, specifications, and requirements. The training also ensures the implementation of change according to the desired deliverables.

Using an eQMS software to document training is a proven method for implementing training effectiveness after a change, and to present during regulatory inspections.

Implementation

Lastly, the implementation stage is the practical form of the change that has been discussed from the beginning. It includes resource allocation, task implementation, and monitoring performance.

At this stage, the engineering change order (ECO) and the engineering change notice (ECN) are the guiding rules and principles to be followed.

As you can see, implementing the change process is not a simple task.

It involves a high level of coordinated correspondence, such as taking inputs from various sources and combining all the relevant data in a simplified report.

The complexity of the engineering change process can be reduced by using a digital solution for managing the engineering change process. It helps to reduce human errors by keeping control of all changes. More importantly, a digital solution such as SimplerQMS provides pre-configured workflows that help you ensure compliance with engineering change control requirements.

Common Challenges with Engineering Change Order Processes

An engineering change order is a complex task involving many activities, communication, gathering data from various sources, and many more. These activities can generate a massive workload when using a manual paper-based system.

Some prominent challenges that these manual paper-based or legacy systems include but are not limited to:

• Redundant information and documentation – since manual systems cannot operate with multiple processes simultaneously because the data is collected and reviewed by a single person, department, or stakeholder at a single time.
• Poor accountability and tracking can make it challenging to achieve the deadline.
• Wastage of time on unnecessary tasks and actions, such as, manually checking approvals and signatures.
• Documentation problems such as missing documents, signatures, and duplication of records.
• Delay in approval from the change control board (CCB), as the manual system will load each member reviewing, studying, and finalizing the decision process.
• Lack of visibility regarding the impact of every change, resulting in unrealistic problem statements, solutions, and deadlines.

Streamlining the Process With Engineering Change Management Software

In today’s world, many life science organizations are starting to implement different software solutions in their entire processes and systems to increase efficiency, reduce costs and ensure regulatory compliance.

Similarly, using a software solution for managing engineering changes is one of many solutions available to help medical device manufacturers maintain synchronization between manufacturing and engineering.

So, for the reasons mentioned above, an investment made in an integrated eQMS like SimplerQMS with powerful engineering change management capabilities is a worthwhile investment. It automates your entire engineering change order by document routing, follow-ups, escalation, and approvals.

As a result, you can see, understand, and manage every change appropriately within a fully traceable and centralized system.

Final Thoughts

Engineering change orders are essential for every medical device manufacturer and indicate the organization’s willingness for continuous quality improvements.

Adopting the latest approach in the engineering change order (ECO) process increases the likelihood of regulatory approvals, improved products, and efficient change implementation.

The QMS software solution by SimplerQMS with pre-configured and fully validated engineering change order (ECO) workflows enables its users to focus more on design and development rather than handling complex documentation. It also eliminates the communication gap between different stakeholders to help them achieve mutual consensus.

If you are interested in streamlining an engineering change management process in your organization and wonder if SimplerQMS can help, we recommend you schedule a personalized demo and talk to our specialists.