How to Achieve Compliance and Quality Management in the Medical Device Supply Chain

You have a special sort of weight as a Supply Chain Director in the medical device arena. It is pressure that extends well beyond logistics, purchase orders, and inventory turns. It is the silent nagging certainty that each part, each process, each and every device that is shipped out of your facility has a human story behind it. It may be a stent that holds an artery open, a diagnostic tool that gives an important answer, or an infusion pump that administers life-saving medication. There is so much at stake.

When we discuss quality standards compliance, this is never merely the matter of a tick in the box to please an auditor. It is not only about making the FDA 21 CFR Part 820 happy or obtaining that glossy ISO 13485 certificate to place on the wall. Frankly, that is only table stakes. The kind of compliance that allows you to sleep at night is not one where you can say that you are compliant in a given area, but the one where you have embedded a culture of quality in your manufacturing and supply chain fabric to the extent that it becomes automatic. It is building a system that is so robust that it does not just detect errors; it is so robust that errors never occur.

And how do you arrive there? What can you do to transition a reactive, audit-based style of thinking to a proactive, quality-first operation? It is a process, no doubt, yet a very possible one. So, let us take a walk through some of the tried and tested tips to make compliance less of a burden and more of a potent business tool.

Is Your QMS a Living System or a Paperweight?

We will begin with the basis of it all: your Quality Management System, or QMS. Each manufacturer of medical devices has it. But what is it? Too frequently, the QMS degenerates into a fixed repository of Standard Operating Procedures (SOPs) and forms which reside on a server somewhere and are largely forgotten until the desperate week prior to an audit. We have all seen it. They all have to scramble to update records and sign training they barely recall training on. It is not a system; that is compliance theater.

An effective QMS is a breathing and living one. It is the nerve center of your whole operation. It must be alive, available, and above all, utilized. Consider this: Is the QMS viewed as a guide to help or a bureaucratic burden by your team on the manufacturing floor? The answer to that question says nearly all you want to know.

In order to make it a living system, you need to incorporate it into the everyday workflow. It is not only about possessing the software but the philosophy. When a new engineer is added to the team, are they simply given a pile of procedures to read, or do they receive a walkthrough of the QMS as the tool that will be used most in their job? When a process changes, is it updated in the system in real time, with training automatically assigned and tracked? This has changed with modern electronic QMS systems such as MasterControl or Veeva. They can integrate documentation, training, change control, and supplier management into a smooth process, removing the grit of compliance. However, this tool is as good as the culture that you create around it. The idea is to ensure that compliance with the QMS is the easy route to travel.

Quality Cannot Be Inspected In—Who Are You Letting In?

This is because a massive amount of your product and consequently your risk begins outside of your four walls. You may have the cleanest manufacturing line on the planet, but when the component supplier you rely on has sketchy process controls, you are building your house on a wobbly foundation. There is no way that you can run quality into a product at the finish line. It must be instilled at the ground level, and that starts with your suppliers.

This is the point where you, as a Supply Chain Director, play such a pivotal role. Qualification of suppliers cannot be a single check of a certificate and a handshake. It must be an intensified, long-term relationship. Do you audit your key suppliers yourself? Not a paperwork audit, but a boots-on-the-ground visit to their facility to observe their processes. Are you putting in place crystal-clear Quality Agreements, which specify every specification, every testing requirement, and every expectation of process change notification?

You can be easily squeezed on price, and procurement teams are often rewarded for saving money. However, this is not the case in the medical device world, where the lowest cost supplier may soon be the most costly you have ever had when a quality failure results in a recall. Consider your supplier relationships as more of a strategic alliance as opposed to transactional purchases. You must have lines of communication. Establish quarterly business reviews which include a lot of quality measures but are not limited to on-time delivery. A good partner will be open to sharing their problems, and a great relationship will see you overcome those issues together. Your supply chain is an extension of yourself, and regulators view it as such.

Unless It Is in Writing, It Never Happened. Sound Familiar?

Ah, documentation. The absolute foundation of medical device compliance and the bane of existence to many. There is a reason why every quality professional has this tattooed on their brain. Nothing that is not documented exists in the eyes of an FDA investigator or an ISO auditor. It is a cruel fact.

This is where traceability will be your superpower. Picture this: You receive a report of field failure. What is the fastest you can answer the following:

• What is the finished device lot?
• Which lots of raw materials were used to make that particular batch?
• Who were the individuals operating on the line that day?
• What were their in-process quality checks?
• To where were other devices of the same lot shipped?

Unless the response is in minutes, then you have a traceability issue. That is what the Device History Record (DHR) is all about. It is a full production history of each and every device you produce. Manual compilation of this information is a tremendous, error-prone exercise. It is boring, and to be honest, this is where the errors occur. A paper out of place, a figure misread—and that is all.

Once again, this is where technology can come to save the day. These records can be automatically created by an integrated system that links your ERP and MES (Manufacturing Execution System) to your eQMS. An uninterrupted digital thread is made by barcode reading at each stage, such as when raw materials are received and when the finished product is shipped. This not only audit-proofs you but dramatically reduces the scope and speed of a possible recall, saving millions of dollars, and more importantly, it helps to maintain patient safety and brand image.

Your People Are Not Robots (and That Is a Good Thing…and a Challenge)

You may have the finest systems, the most intensive processes, and the most thorough documentation in the world, but when it comes down to it, people perform quality. And humans are not robots. They become fatigued, distracted; they have good days and bad days. One of the least known parts of compliance is the recognition and control of this human factor.

It is for this reason that training is much more than a yearly reminder of cGMPs (current Good Manufacturing Practices). Training must be continuous, job-oriented, and interesting. An individual in the receiving department requires a varying level of education on material inspection compared to an engineer developing a new fixture. However, more than anything, training must bridge the gap between the what and the why. It is not enough to tell an operator that he or she must sign and date a form in a particular manner. State why that is a legal attestation. Point out that the precision of that record may be the difference between life and death of a patient. When individuals know the rationale behind a rule, they are infinitely more likely to comply.

This can be rolled into the larger concept of a culture of quality. It is sort of a buzzword, I understand, yet in practice, it entails establishing the atmosphere in which every individual employee feels personally accountable for quality. It implies that leadership, including the CEO, is always focused on quality, rather than the number of shipments. It implies the celebration of the team that catches a possible problem before it leaves the building. It implies establishing a psychologically safe workplace where an operator on the line would not be afraid to press the stop button when he or she sees something that does not look right and not be afraid of any blame. It is your final line of defense against compliance failures in this culture.

Don’t Just Treat the Symptom. Locate the Disease.

Regardless of how excellent your systems are, issues will at some point occur. A non-conformance, a customer complaint, an unsuccessful audit finding. What follows is what distinguishes the great quality organization from the mediocre one. The mediocre organization patches the problem with a band-aid and is off. The powerful organization initiates an effective Corrective and Preventive Action, or CAPA.

The majority of companies do a good job of the Corrective Action part. They solve the short-term issue. They quarantine the bad product, they re-train the operator. Done. The actual magic, and the area most examined by auditors, is the Preventive Action. This will need an in-depth and sincere exploration to identify the real cause of the problem. Why did that happen? And more to the point, what system change can you make such that it never happens again?

There is the temptation to rush the closing of CAPAs so that your metrics look good. Never get into that trap. A CAPA that has found the root cause as being human error will almost always be a failed CAPA. The symptom, not the cause, is human error. What was the reason why the human committed the mistake? Did the procedure confuse them? Did the lighting suck? Was the training poor? Did the individual hurry? Tools such as a Fishbone diagram or the 5 Whys are critical in this case. The only solution to transforming a problem into real process improvement is digging to unearth the actual root cause.

Compliance as Your Competitive Advantage

When you add all this together—a QMS that is alive, good supplier relationships, indestructible traceability, well-trained staff, and a solid CAPA process—it can seem overwhelming. However, the thing is this is not the cost of doing business. It is not only about evading warning letters from the FDA.

Compliance ceases to be a crouch of defense when you create this type of operational excellence; you make it an offensive weapon. You are more effective since you produce less waste and rework. Customers trust you more since you have reliable and provable quality. Your brand will mean safety and efficacy. In an environment where trust is the final currency, a bulletproof compliance stance is one of the strongest competitive advantages that you can ever have. It is the basis on which the rest depends. Work is what counts.