8 Attributes to Look for When Auditing a Coatings Supplier
Several factors determine whether a company that applies coatings to medical instruments and devices can meet a healthcare organization’s needs. A provider must have all of these attributes. If a company fails to meet even one of the requirements, problems can result.
These issues cover the spectrum from minor inconveniences caused by delivery delays to major risks when a poorly coated instrument is used in a procedure. And, of course, there is no way to know when they will occur.
Careful and Thorough Assessment is Key
One of the challenges in auditing a coatings provider is that it is easy to be swayed by subjective descriptions. For example, when a company claims to produce high-quality work, the measure being used is its own definition of quality, which may or may not align with that of its customers.
Consequently, while subjectivity cannot ever be completely eliminated from an evaluation, it is important that a decision also be based largely on objective measurements. For example, claims about quality can be backed up by a documented figure like acceptance rate. If a coatings provider says that it does exceptional work but has a notably low acceptance rate, that should be a cause for concern and further research.
Essential Characteristics for an Instrument Coatings Provider
When auditing a medical instrument coatings provider, an organization may have some unique expectations based on the type of instruments its users need, the procedures they perform, etc. But, in general, a provider should achieve high marks for the eight characteristics below.
- Process control. Any reputable coatings provider can produce one item that is flawlessly coated. But can they deliver hundreds, thousands, or more that are exactly the same? The only way to do that is to have well-documented, precisely controlled processes that can result in highly consistent output.
- Lead times. How long does it take on average, for a company to get started on a project? They may do good work, but if they cannot begin a project until three months down the road, that can be a problem for a healthcare provider that has an ongoing and urgent need for coated instruments and devices.
- Turnaround times. Once a project is underway, how long does it take a provider to deliver coated instruments in sufficient quantities to meet existing needs? Turnaround times are a good indicator of how streamlined and efficient a company’s processes are, from production to quality assurance.
- Industry experience. Does the provider have experience in coating medical instruments? Experience in other industries—even closely related ones—is no substitute for the specific expertise needed to meet the very exacting standards of medical instrument users.
- Material testing. For a coating to adhere and perform as desired, the material has to be formulated to meet rigid industry standards. A provider must have a defined process for testing the material regularly to ensure compliance with those standards.
- Product quality assurance. What are the tests that the provider conducts to ensure that coated items meet any set of specifications and requirements? Here again, industry experience is essential.
- Customer acceptance rate. What is the company’s documented customer acceptance rate? A rate of 100% is unachievable for all intents and purposes since even one rejected part out of a million lowers the rate. But the higher a provider’s rate is, the better. For example, ME-92 Operations maintains an acceptance rate of approximately 99.8%.
- Support and communication. Does the provider have defined procedures for supporting customers and providing timely communications? A “We’ll be in touch as needed,” approach is not sufficient, particularly for healthcare organizations that cannot be left unsure about when instruments will arrive, how a particular issue will be resolved, etc.
A Culture of Exceeding Customer Expectations
A final criterion for auditing a coatings provider is determining from your research and conversations with them that the goal of exceeding customer expectations is ingrained in their culture. Simply being able to “check the box” on some standard quality assurance processes or delivery timeframes is not enough.
Every person in an organization—from leadership to operations and support—must be continually asking the question, “How can we serve our customers better?” It must be second nature for employees to think, “We delivered ahead of schedule by three days on this order. Great. How can we get to four days on the next one?”
No coatings provider is going to get a “perfect score” on an audit. The objective should be to find a company that scores very well today and that will settle for nothing less than a better score tomorrow.