The objective of ECOs and any other change orders is to legitimately archive the proposed changes for tracebility purposes. Any necessary changes of the design or documentation go through COs. The COs are reviewed and sent to the necessary dpartments for further approval. There is a possibility of alteration of the CO based on the input recieved from various department.The redlined documentation which has been changed is also included so that changes made can be easily evaluated by approvers and auditors.
A series of protocal needs to be followed in order for these changes to go through and for the documents to be verified. The final draft is reviewed by the companys documentation department and then recieves approval for the final change.
An engineering change order is very important to keep track of any change to the initial proposal and product part especially when you don't have a locked BOM list. sometimes your dependant on parts suppliers roadmap and end off live notice. Also, sometimes you can not depend on one vendor or supplier and must qualify more that one. ECO documents help for manufacturing, mass production, even troubleshooting and, failure analysis after deployment. it is very important to keep track and constantly update of PCN and EOL for parts used for your product. from my experience, it always helps PM to better manage the projects.
Engineering change orders provide documentation of corrective actions for faulty components, end of life components, or more efficient components in a medical product, ultimately increasing the product's safety and efficiency. ECO can be used for components that need to be fixed or even recalled, for parts that are reaching their end of life because the manufacturer is either out of business or is phasing out the product, and for components that can be updated which will increase the product's lifespan and reliability. ECOs are done by the operations department and take a very long time. I am sure this varies per product. What I have seen in the industry, for a blood glucose meter, and ECO takes minimally 8 weeks and that is if it is controlled and completed internally. If there is an outside party that is the legal manufacturer, then the ECO process takes much longer due to the communication and approvals needed between both companies. Project management can be very helpful in organizing the priority of ECOs depending on significance in change, the product's priority, it's intended use, and it's market requirements.
ECO gives the chance for a team to see a mistake and have a chance to correct that mistake and document the change. This allows for teams to document changes carefully and also make sure the same mistakes do not repeat again. These changes are essential and are review by the project manager. He/she then reviews them and tries to make sure the team do not repeat them and try to find solutions to avoid such mistakes.
I agree with many of the posts above about how ECOs are a good way to address an issue and mitigate the problem before it becomes any worse. I also believe this can be taken a step further. To sell products in other areas, the product must adhere to the laws and codes pertaining to that location. In some cases, the only item that needs to change to comply with those standards is something small like the addition of a symbol on the label. In this case, it is simple to initiate an ECO and edit the label to include this symbol. Once the documentation is complete, and the label has the new symbol, the product can now be sold to a new population; thus expanding the industry's reach. Using this method, many ECOs can be created to edit small features on the product that do not fundamentally affect its use of it. This way there are more consumers, allowing more feedback, allowing more modifications, if needed.
Hello,
An Engineering Change Order (ECO) is a document used in engineering and manufacturing industries to outline proposed changes to a product, system, or process. It provides a standardized method for initiating, documenting, reviewing, and approving modifications to existing designs, specifications, and processes. ECOs are essential in maintaining product quality, regulatory compliance, and operational efficiency while ensuring that changes are properly evaluated and controlled. The stages of completing an ECO typically involve identifying the need for a change, creating a formal request, evaluating the impact of the change, documenting the proposed modification, reviewing and approving the request, and implementing the change. The initial stage involves determining the nature and scope of the change, including the reasons for the request, its impact on the product, and the desired outcomes. Once the change has been evaluated and documented, it undergoes a review process by a cross-functional team of engineers, quality control personnel, and project managers, to ensure that it meets the necessary standards and requirements. If approved, the change is implemented and tracked through to completion. The benefits of an ECO include improved product quality, increased efficiency and productivity, reduced costs, and enhanced customer satisfaction. By providing a systematic approach to managing changes, ECOs help to prevent errors and defects from being introduced into the manufacturing process. Additionally, they enable organizations to respond quickly to customer feedback and market demands, while ensuring compliance with regulatory requirements. ECOs also facilitate communication and collaboration between various departments, including engineering, manufacturing, quality control, and procurement, helping to streamline operations and reduce production delays.
During my co-op, I created and executed change notices for standard operating procedures (SOPs) and work instructions (WIs). Usually, an engineer would give me the changes that they would like to see updated on the documents and the reasoning behind these changes. These changes ranged from simple clarifications or updating the format of the document, to changes in whole procedures due to an update in the machinery. I also helped create change notices for documents that were merging information and for documents that were no longer used and therefore obsolete. As mentioned by my peers, a big paper trail is created. In the document management system used by my company, similar to others as well, a lot of information needed to be entered correctly for the document to be reviewed. Both the original and redlined documents are attached, the reasons for the change, other documents affected by the document being changed, and then the approvers from each department are listed. Previous changes and their change notices are also linked to the new change notice. This is to make it easier for employees to see the change history for that particular document. While tedious, I believe that this is a good system as it allows for any changes to be documented clearly, concisely, and professionally.
An important benefit of an Engineering change order is that it allows the product development team to be on track and making sure that the product information is as accurate as possible. It may be tedious to put another set of documentation together but an ECO contains the full description, analysis, cost and impact of the change being made.
Stages of an ECO include:
- identifying the issue and scoping the impact
- Creating an engineering change request to be able to examine the possibility of the change and what parts of the project would be affected
- There is then an engineering change request review and discussion among key stakeholders
- Once approved and engineering change order is generated
- Then the ECO is reviewed for approval
- The ECO is then approved and each member is notified of the change
- Finally the change is implemented
https://www.arenasolutions.com/resources/articles/engineering-change-order/
In your opinion, what are the benefits of ECO? And discuss the stages of Engineering change process?
According to my knowledge, the benefits of ECO include improved product quality, reduced costs, and increased efficiency. The stages of the engineering change process typically involve six phases:
- Identification: This is where we identify the need for a change. This can be triggered by customer feedback, design issues, or changes in regulatory requirements.
- Evaluation: Here, we evaluate the proposed change to determine its impact on the product and its feasibility.
- Approval: Once the change has been evaluated, it must be approved by the appropriate stakeholders, such as management or the quality control team.
- Implementation: The change is implemented in the product design or production process. This may require modifications to documentation, software, or hardware.
- Verification: Once the change has been implemented, we can verify that the change has been successfully incorporated into the product.
- Release: The final step is to release the updated product to the market, ensuring that all stakeholders are informed of the changes made.
In summary, the process of making a change to a product involves several steps, which include identification, evaluation, approval, implementation, verification, and release. Each step is crucial in ensuring that the change is effective and meets the requirements of stakeholders. ECOs can give engineers the ability to edit designs and parts when needed.
