Optimizing Workflow on the Machine Floor

Without a streamlined approach in place to track the thousands of parts and hundreds of jobs that come through a medical device manufacturer’s machine shop, the process can be like watching a “Three Stooges” episode: ensuing chaos, people bumping in to one another and confusion about what’s happening.

To keep the workflow composed, organized and efficient, it’s important to have a coordinated system for thoroughly documenting the journey of a job—and its associated parts—from beginning to end. Whether a company follows Kaizen, Six Sigma or any other Lean manufacturing principle, the following strategies can be implemented to assure adherence to ISO 13485 requirements, maintain the highest level of quality and maximize the expertise of the production team.

Designated Dispatcher
Once a work order is issued, a critical first step to ensuring successful completion of a job is to have a designated point person, or dispatcher, review it, verify that all the information is correct (e.g., that the revision on the router matches the print) and document all relevant information in a shared database.
The dispatcher provides early, consistent quality control and efficiently communicates all pertinent job-related information to the machine floor supervisor. This includes the priority of the job (i.e., whether it’s past due or urgent), which machine is required to complete the job, what parts are needed, the quantity requested, etc.

An effective way for the dispatcher to convey this information to the machine floor supervisor and machinists is by color-coding documents, boxes and display board magnets so the status of a job can be seen from anywhere on the machine floor.

Color Coding
In a busy machine shop, color-coded files and visual references help the machine floor team expedite efforts to efficiently complete jobs.

For example, a wallboard that is organized in columns according to the machines on the floor and uses color-coded magnets to illustrate the priority of each job in queue (e.g., green = normal timeframe; yellow = past due; red = “hot” or urgent jobs). The magnets are verified and updated daily by the dispatcher and display the part and work order numbers, quantity and due date.

When the machine floor supervisor begins a shift, he or she can go straight to the board and immediately see what jobs need to be the focus of that day’s work, saving time and accelerating workflow.

The color-coded magnets on the project board also can correspond with color-coded folders that contain all the information related to the job. This keeps important documentation such as work
orders, certifications, number of iterations, and setup histories together so that they are easy to find and access on the machine floor.

It’s also important to keep a history file that documents all machines on the floor and tracks information about their setups. Every time a part is made it would be recorded in the file, along with the date it was made, the machine that was used, who did the setup and how long it took, and any quality issues that may have occurred.

This history gives the machine floor supervisor insight into who is most efficient at machine setup, thus expediting the manufacturing process, who might need more cross-training to enhance their capabilities, and notice of any recent corrective actions.

Diligent Documentation
After the shop floor supervisor designates an operator to setup and run a machine, the first article documentation process continues the effort to ensure quality, reliability and efficiency.

Each work order has a corresponding drawing with all the dimensions that need to be manufactured, allowing setup operators to check the part against the original specifications. Every time a revision is made to a part, a new first article is created to reflect the new revision level on the drawing.

The operator completes his or her first article by documenting the part’s current dimensions and tolerances on a first-article sheet. A designated operator then confirms the operator’s evaluation, verifies that the dimensions and tolerances match and signs off on the job, allowing production to begin.

Once the part starts running through the machine, the in-process inspection is performed consistently throughout the cycle to monitor and ensure that the part meets drawing specifications.

Individual medical device contract manufacturers will have different quality control parameters for analyzing the part throughout a run. For example, we have established procedures and process controls for most machined parts. Every 20th part is inspected in its entirety during a machining cycle. For parts with especially tight tolerances (+/- .0003 inches), each part is 100 percent inspected.

Lean Tool Room
Some jobs require a lot of cutting tools and complex work-holding fixtures, and a disorganized, confusing, haphazard tool room significantly can impede machine setup and delay job completion.
One way to keep the tool room compatible with the machining process is to create small, job-specific toolboxes and special work-holding fixture locations. This organized, systematic process helps the tool crib attendant or dispatcher quickly and easily locate the tools needed for each job, which ultimately reduces setup time.

Close-knit Collaboration
Medical device contract manufacturers with an in-house prototype department offer notable advantages to their customers. But the benefits are magnified when the prototype shop is in close proximity to both the engineering and manufacturing department.

The challenge with using outside prototype houses—and even some in-house shops—is that they are separated from other critical departments within the medical device company. The prototype machinist simply makes a model based on the engineer’s design, but dispenses little to no feedback to other team members about their observations during its development.

For example, insights about whether or not the device effectively can be machined using in-house capabilities or efficiently manufactured in higher production quantities often are not communicated. Yet this knowledge can be critical to compressing production times and staying within budget.

If the prototype shop is near the machine floor—even steps away—better communication and collaboration develops between cross-functional departments. When the prototype machinist is tasked with creating a brand new part, they quickly and easily can coordinate with operators on the machine floor about what tooling, fixturing, and materials the part will require.

These early discussions also help ensure that the device is designed and developed with regard to in-house manufacturing capabilities and resources, keeping the process from design to production efficient and economical.

Systematic Synergy
It can be surmised that most medical device contract manufacturers integrate some type of system to keep their production process moving forward. But if communication and cooperation between the production team is strained, or lacking between various organizational departments, then even the most theoretically efficient manufacturing processes will fall short.

While vigilant organization on the machine shop floor supports consistent workflow and proper job execution, a harmonious work environment is what distinctly sets one company apart from another. When associates develop a constructive system based on respectful, good-humored teamwork, they are more likely to raise and solve potential issues above and beyond ISO 13485 requirements. Combined with simple, visually impactful tools as those outlined, a manufacturing team helps to reinforce consistent and noticeable results.

As a result, costs associated with making superior parts are reduced considerably, delivery timeframes are accelerated and customers get more value from their contract manufacturing partnership.