In the highly competitive, highly regulated medical device industry, the path to becoming a winning contract manufacturer requires a dual-pronged approach. The first aspect is top of mind for most businesses: having the technical abilities to deliver on the manufacturing promise. The business has to have the fundamental plant and equipment, engineering talent, and operating personnel to build the device.

Less obvious, but equally important, is a second requirement: having the business practices and controls in place to assure that certified products are delivered on time. The good news is that contract manufacturers can streamline and automate many of the processes required to support this demand by tapping the functionality in their enterprise resource planning (ERP) systems.

Let’s look at eight critical business processes and controls and how medical device contract manufacturers can use their ERP systems and related software to provide the superior services that are the hallmarks of preferred providers.

Maintain Certifications and Compliance with Standards

At their core, certifications are commitments that good quality management practices are in place and that audits and controls are being applied to ensure their day-to-day application. Maintaining compliance to the full scope of certifications for standards—such as ISO13485 and the Federal Drug Administration’s 21 CFR parts 11 & 820—using only paper-based systems is possible. However, it’s very time-consuming, and for many companies, perhaps a bit of a mirage. Instead, a comprehensive quality management system (QMS) can ensure that the quality procedures, follow-ups, and risk mitigation strategies that have been defined are actually followed and audited.

A QMS, or better yet, a manufacturing ERP system with a fully integrated quality management system, can automate two key elements of maintaining certification standards. First is taking process controls that require inspections and enforcing their execution through management alerts and exception reporting. Second is automatic and organized record keeping, which enables a manufacturer to document quality processes and their proper execution.

A good example is CFR Part 11, which requires dual signatory approval for significant design and process modifications. Originally, CFR Part 11 was meant to ensure that companies had adequate electronic signature measures in place that could reliably replace signed paper documents. Today, dual-authenticated electronic signatures are far more reliable than older hand-signed documentation, and enforcement is automatic.

Provide Lot and Item-Level Traceability

Medical products place exacting demands on raw material inputs, so processes that ensure the validation of raw materials are imperative. A contract manufacturer must be certain that incoming raw materials are validated before being used in production, and the continuity of their use must be certified throughout the entire production process.

A manufacturing ERP system can be configured to insist that when lot or item-level traceability is required by a product’s specifications, no manufacturing can take place before the proper raw material lot numbers are validated by supervisors, material handlers, and operators. Failure to properly sign off on raw material inputs will cause the ERP system to alert management of the missed step and make a notification before production can proceed. In addition, records will be kept that can easily be recalled and presented as evidence to a customer that the proper procedures were followed.

Creating and enforcing traceability is the first and essential step in providing traceability services. But an equally important step is the ability to quickly and accurately backtrace an item through its production lifecycle. In ERP software, this functionality is known as track and trace, and it works by searching based on the unique identification of the item in question. This could be a part number and date of production, the lot number, or a serial number. With this information, track and trace functionality can walk a manufacturer backwards through the product life cycle to find out what material was used, what machines and operators handled production, what quality inspections were made, and even the machine process parameters at the point of production.

Manage Certification Requirements

Alerts and notifications are an excellent safety net for missed production steps, but they are just that, a safety net. It’s far preferable to do things right in the first place. So, operator training and certification are essential not only for managing production but also for complying with ISO certification. For example, contract manufacturers in the medical device sector often need to address questions, such as: Does the operator have the credentials to allow the job to start? When does an operator need to be re-certified on a job? 

The manufacturing execution (MES) features of an ERP system can assist on multiple fronts. It can validate that only certified operators can perform a task. Additionally, the MES software can enforce rules, such as operator certification at the point of production. And it can enforce and document procedures during production. Such capabilities add value and elevate a manufacturer from a contractor to a full business partner.

Record and Report Manufacturing Process Data

Many of the tasks in a manufacturing operation are highly influenced by management, supervisors, and operators following procedures and doing the right things. But a great deal of influence also comes from the production equipment itself.

For example: Is the machinery operating at the right speeds, pressures, and voltages? It’s hard for operators to instantly track such process parameters. However, real-time process monitoring software, often found bundled with a manufacturing ERP system, can capture streams of data from sensors and machines to track process variables in real time.

Real-time process monitoring provides multiple benefits both during and after production. Throughout production, process monitoring can deliver advanced warnings if the equipment is trending towards a boundary-level operating parameter—for instance, if a stamping pressure is too high, a barrel is too cool, or a voltage is cycling. All are warning signs that a machine could soon start producing bad parts or even fail. The point: process monitoring can prevent problems before they happen.

Meanwhile, postproduction process monitoring offers two added benefits. First, if bad parts are discovered in the post-production quality assurance inspection, the historical process data can be studied using statistical process control (SPC) techniques to determine if equipment issues were the root cause of the problem. Second, parts passed onto customers as having passed quality assurance inspection can not only be accompanied by the inspection documents but also by the digital trail of information documenting that the production equipment was running within specification at the time of production.

Being able to provide a digital history of production to an upstream medical device customer is a clear differentiator between an average manufacturing contractor and an outstanding one.

Enforce Quality Control Procedures

Another key competitive distinction for contract manufacturers rests in the difference between having processes in writing and actually putting those processes into action. Consider: Are inspections really happening at the right time, or are they being pushed out to future dates, or perhaps not happening at all? Manual recording and enforcement of quality inspections has been the norm for years, but it is a hit-and-miss procedure susceptible to errors.

By contrast, automated inspection procedures are very reliable because the MES/QMS features of an ERP system are expecting them to happen and will alert management when a scheduled inspection hasn’t occurred. Not only does the ERP system watch for mis-inspections, it also flags values that are so far out of specification as to be suspect data entries. In addition, it digitally records and files the inspections for future reference and customer documentation.

Provide Repeatable, Documented, Transferrable Quality and SPC Records

For quality and SPC records to be trusted, they must be repeatable, documented, and transferable. Elements of these qualities have been discussed in earlier sections of this article. However, they are so critical to establishing a contract manufacturer as a trusted partner, they warrant special attention here.

When manufacturing and inspection processes are executed under the supervision of an ERP system, they are inherently automatically recorded and documented. This data capture can take the form of a timestamp signature, the date of a material validation, the name of an operator, or a histogram of process parameters. If the ERP system is running the workflow, it also knows what happened and when.

The records captured by the ERP system are extremely valuable to internal operations—for example, facilitating the effort to back-trace the root causes of problems or build continuous improvement programs. Additionally, they serve as proof positive for customers that the contract manufacturer has the procedures, controls, and documentation in place to keep their commitment to building quality products, and as we soon shall see, delivering those products on time.

Deliver Timely and Accurate Product Delivery Information

Much of the discussion so far has focused on quality and quality assurance. But there is another dimension to becoming a first-call contract manufacturer: being transparent and easy to do business with. One major aspect of transparency is predictability—to be able to answer the simple question, “When will the product be ready?” and then to deliver to that promise.

The answer for product availability starts with the initial quotation and sales order. Working from the engineering drawings and product specifications, a bill of materials (BOM) is built. This not only includes the raw materials that go into the final product; it also covers the tooling, machinery, labor, and secondary operations that are required to build the product. All these items have lead times, competing demands, and other various constraints that require comprehensive consideration and analysis before an accurate delivery date can be promised.

The functionality required to perform this detailed analysis is called capable-to-promise (CTP). CPT is an AI-like tool that uses the material resource planning and scheduling capabilities of an ERP system to traverse all the potential procurement and production scenarios for a product and produce a promise date that has considered all the constraints. Moreover, it suggests areas where changes to constraints could enable production to be completed earlier. Examples include expediting a material, freeing up a piece of equipment, or bringing in additional labor. In this way, CPT ensures that the original promise date is executable based on thorough consideration of all the events that need to line up to deliver on time.

Once the BOM and the delivery date have been set, it is the responsibility of the material resource planning (MRP) and scheduling system to set the plan in place to procure, allocate, and disposition the resources necessary to run production. But this leads to a new set of questions that both management and the customer will want answered during the course of the project: Is the job running on time? What are the actual cycle times? Have any unexpected delays occurred? Tracking production progress from step one to the end of the job is the role of production monitoring.

Production monitoring uses sensors to note and time-stamp the production cycles of a job. It can be as simple as the opening and closing of the jaws of an injection molding machine or more complex, like the visual recording of assembly steps. In either case, the two important data points are whether the process is running and what the cycle times are.

The seemingly simple data points from production monitoring yield a wealth of information. For instance: When did the process stop? How long did it stop? How does this impact the completion time? Are the cycles running fast or slow? How will this impact delivery time? The results of production monitoring, which is an essential MES function, are backflushed into ERP to automatically update schedules and completion times.

The information is then available in real time to inform management and customers about the status of projects and when they can be delivered. In the drive to become a vendor of choice, being able to speak to the exact status of a job and answer delivery questions with real-time information is a highly valued differentiator.

Conclusion

Achieving excellence as a contract manufacturer requires not only having the basic production and engineering talent necessary to build the product; it also demands the ability to build the product to exacting specifications and document the manufacturing execution process. In addition, excellence means delivering a quality product on time with the proper certifications so it can easily and reliably enter the downstream medical device supply chain. Ultimately, by addressing all these facets, contract manufacturers can evolve from tactical outsourcing options to strategic, trusted partners in enabling safe and reliable patient care.

Steve Bieszczat is responsible for DELMIAWorks brand management, demand generation, and product marketing. Before DELMIAWorks, he held senior marketing roles at ERP companies IQMS, Epicor, and Activant Solutions. Steve’s focus is on aligning products with industry requirements as well as positioning DELMIAWorks with the strategic direction and requirements of the brand’s manufacturing customers and prospects. Steve holds an engineering degree from the University of Kansas and an MBA from Rockhurst.