If you’ve ever wondered how enterprise resource planning (ERP) can establish predictable, repeatable, processes and reduce variability in medical device manufacturing, consider the following case: A lead inspector of XYZ medical device manufacturing company just finishes a quality check process on a lot of 250 pieces but found that there was a quality issue.
Before formally rejecting the lot, the lead inspector speaks with the director of quality to get to the bottom of the issue: “I just don’t understand it," he says. “The last two lots came out nearly perfect – but this lot? The adhesion is sloppy and some don’t even have electrical connectivity.”
The director asks: “Can you put your finger on any difference between each lot? Did the same employees work on each of them? What about the assembly time; was it too fast, or was the work rushed?” Time was short, and they needed to obtain answers to these questions before they could start the manufacturing process again to meet an order from an important client.
Over the next few days, the director and the inspector begin their investigation to determine the key issues. They interview employees in production and materials and they look at the incoming inspection records from components delivered by suppliers. Together they compile a list of requirements that will deliver more consistent quality and that will make deliveries much more predictable. In reviewing the list, they considered how much easier it would be to execute these requirements with the control offered by an ERP solution:
1. Ensure all materials needed for an operation are available.
Jobs that stop and start because of shortages in components are one important cause of variations. An ERP solution enables users to query the amount of available material so that the information can be factored into production planning.
2. Make certain that all process steps are well documented.
Every production job from ERP must give the exact sequence of steps to be followed for proven best results. No production worker should need to wonder how two pieces fit together. Some operations, such as plastic extrusion, can yield good results at different pressures by adjusting the temperature and feed rate. Decide how your company will extrude and require all operators to use the same method defined in the ERP solution.
3. Reduce the length of paper trails.
Some prefer printed paper records and keep their own file of work instructions – don’t let this happen. To keep things organized, attach the most current work instructions within an ERP system to ensure that only the required steps are on screen and comfortably visible from the workstation.
4. Verify that only fully qualified personnel are working.
ERP can track the experience, training, and certifications of all personnel. By setting experience standards in an ERP solution, you can separate the workers that can log onto a job or operation from those that should not.
5. Shift final inspections to in-line process validations.
By the time a job is complete, it likely is too late to fix production issues. Include in work instructions a requirement to check key measures of previous work. Only if those pass, will a worker go on to perform their work. Then, after each worker completes their work step, they make measurements of their work, record the before and after measurements in the ERP system as each piece moves along the process flow. Multiple checks can lead to one part per million accuracy.
6. Avoid variability of measurement.
Provide your workers with high-quality company-owned tools. Train the users to properly use them and keep them calibrated. Use tools that can feed their measurements directly into the ERP database through a cable or wireless connection rather than typing the result into ERP system to reduce variability.
7. Move component inspections to suppliers.
Use gauges to verify cavity-to-cavity precision. Use cameras or other electronic inspections to ensure no variation from the drawings. Your suppliers will provide the data with or before deliveries and your ERP will keep the data intact.
8. Don’t over schedule, but reschedule frequently.
Whether your production run time is an engineered value or an average of recent operations, there will be difference from worker to worker and day to day. Your schedule might say a job will begin at 10:23 am. However, it will start only when the previous work is complete, cleaned up, and the necessary components needed for that job are on hand at that workstation. Frequent rescheduling allows the next operator to better know when their work must begin and allows management to check if any jobs are in danger of finishing late with a good degree of accuracy.
Driving the requirements defined by the lead inspector and the director of quality in the above scenario, are Good Manufacturing Practice (GMP). These standards require medical device manufacturers to document their processes and do what is documented. Using an ERP system, it's possible to communicate these documented processes to workers and to record what was done throughout the workflows.
It has been said that ERP could also stand for Easily Repeatable Processes. It’s true, you can use an ERP system to ensure your production processes are easily repeatable, but more importantly, having the ability to deliver predictable results, both in quality and on time, will lead to greater customer satisfaction and ultimately profit. If you'd like to learn more about how ERP can help medical device companies reduce variability, download Vision33's Top 5 Reasons to Implement ERP When Scaling Your Medical Device Company eBook.