PLM for Faster Change Request

The importance of business intelligence is not quite understood by many medical device organization. The case introduced here is about a medical device company running so-so operation. The financial performance is negative and struggling to revitalize their revenue structure. This company carried multiple issues associated with organization but one stood out is the lack of utilization of business intelligence. In this article, we focus on eliminating bottleneck using PLM for faster change request.

Underlying Issues

In regulated industry, the change request process is very common practice to leave traceability of change history. Whether it’s related to design or documentation. The organization needs to have a proper way of processing change request. However, this organization failed to establish the system.

The list of issues

1. One of document control personnel generate the the Change Request number manually
2. The document control personnel manually document the ECO number by Excel
3. Someone needs to update the Excel spread sheet, otherwise no way to know the current status of ECO
4. If the document control personnel is absent, ECO number won’t be generated.
5. The excessive amount backlog since all the process depends on the availability of document control personnel.
6. No prioritization of request at all
7. The paper process makes it so lengthy
8. The document needs to be printed and scanned every time it’s updated or signed
9. The response from signatory is substantially slow
10. Hard to get the consensus from approvers

Not surprisingly, the management is not aware of these underlying issues

1. The management is not interested to know what is happening, why the request takes long time
2. No metrics measurement
3. Push their employees to make a process of change request faster
4. The swiftness of change request processing is up to the personal effort
5. If the change request is not as fast as they want, it becomes requester’s fault

This is a truly the management issue. The incompetence of process structure is causing a bottleneck. The management failed to make an effort to resolve structural change.

Engineering Change Request Bottleneck

The number of backlog will grow as time goes by. It is an exponential growth. If the management won’t take any action, the symptom is going to get worse.

Engineering Change Request Backlog Growth

Solutions

After above issues were identified, we educated management of this company that they need to be fully aware of these issues. If the management continues to fail recognizing the situation, the problem never goes away and even exacerbate. Specifically, “be aware of” means that the management constantly needs to probe the factors involved during the change request process.

Metrics Measurement

One of major issues here is that the organization has no means to measure the metrics. The metrics such as processing time per request, personnel involved in the change process, and who were holding up the response unnecessarily were not measured. The maximum, minimum, and mean time as well as the type of change request. Similarly, the characteristics of change request do affect the processing time. For example, the changes on DFU, labeling, and Operators’ Manual require more number of signatory. While correcting the document or drawing expression won’t need that much of effort.

PLM Implementation – Faster Change Request

in light of given circumstance, the implementation of PLM was top priority and we recommended and designed one for them. Subsequently, it allowed organization a sense of transparency and control over the change request process. as a result, it eliminated some of unnecessary tasks.

Alternatively, the PLM provided a traceability of files. Therefore,one change request will be able to pull associated part, sub-assembly, top-assembly, report, protocol, and any other associated documents and files. This also works other way around as well. For instance, figuring out the history of change request from any of associated part or document.

Management Education for Faster Change Request

Another implementation is the improvement of process flow. If the approver didn’t respond in timely manner, the automated notification will be sent to their supervisor. We educated the approvers, typically managers that processing the request in timely manner is part of their responsibility and need to change the perception towards change request process.

Alternatively, approvers to be proactive and aware of content of change request. This reduces the chance of being stagnated at one particular approver. The change request often slows down because one or multiple approvers don’t have knowledge of content. Even if PLM prompts faster change request, it becomes ineffective if the approvers procrastinate their responses. Therefore, the training of personnel involved in the change process is crucial.

Results

PLM For Faster Change Request

At the end, the series of implementation eliminated many factors that slow down the process and improved the change request process. Unlike, manual process, the automated cloud system eliminated the change request number generation and tracking by human. Not only the PLM influences the faster change request, but also it helps to trace the past documents and most, it reduces human labor and mistakes, which cost employer a lot.

The list of improvement

• Elimination of spreadsheet
• Establishment of metrics
• Backlog reduction
• Minimized the human involvement
• Reduced systemic stagnation of approver
• Elimination of paper document
• All electronic processing
• Transition to cloud based solution from local server
• Continuous education of management