Auditing The Auditing System: Calibration For Quality Control
Posted on: 3 February 2021
Quality control is a necessary part of any manufacturing, medical process, and any other situation in which something or someone is held to a standard. You have to be sure the thing being evaluated actually meets that standard so people know that the results of processes or tests are correct. What a lot of people don't realize is that the quality control processes also have to go through quality control themselves, often through audits, such as those done to ensure the quality of medical devices is up to par. Think of it as a recalibration process for your own quality control team. This is not a step anyone can really skip because one mistake can ripple through the entire quality control process in the industry.
Standards Change
Standards change, and even if your company has tried to stay up to date with all the changes, you need someone to evaluate how you've done. You are no doubt doing your best, but after the past several months, especially, you could have missed something. Maybe part of your quality control team was unable to come in because of quarantines and the remaining staff forgot to check a certain piece of equipment, for example. While the chances of that may be small, they can happen, and auditing your quality control process lets you know if it did.
Familiarity Leads to People Slacking Off a Bit
There's also the issue of familiarity with the machinery making people subconsciously slack off a bit. A particular model might have some quirks that your quality control team is so familiar with that they end up missing a very tiny change in the quirk that could affect equipment function. This can happen even in great quality control systems, by the way — it's human nature. It does not mean your quality control team is irresponsible.
It's Not Enough to Assume
It's just really not enough to assume that because your team is paying attention to changes in quality control standards that making the changes is proceeding without a hitch. It's also not enough to assume that the changes were made correctly. Your team is making the effort, for sure, but they need to prove it. An audit of their quality control processes is really the only way to do that.
When you know your quality control team is using procedures that are accurate and up to the latest standards, you can be confident that your medical devices are also functioning properly and up to the latest standards as well. This enables customers to trust that your company can provide them with items that work properly.
Contact a medical device quality system auditing service near you to learn more.
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