Corrective actions and risk assessment with Unifize
This video showcases how Unifize streamlines corrective actions and risk assessments, enabling more efficient problem resolution and risk management. The speaker emphasizes the platform's role in promoting a proactive approach to identifying, assessing, and mitigating risks, thereby improving overall safety and compliance.
Transcript

00:00 - 00:38
You know, corrective actions and risk assessments are an integral part of an ISO 9001 compliant quality management system. You need to be able to have a process in place that allows you to track any issues that crop up during the manufacturing, during the quality control process, during the entire workflow of delivering a quality product to the end consumer, it needs to be able to take into account feedback from the customer as well, or any customer issues that do arise during this process that can be addressed and documented, accounted for, so that you can maintain the quality of your product.



00:38 - 01:05
And so risk assessments are a huge part of that. You have to determine whenever an issue crops up with the quality of of any given product, what changes right now can we make to fix that issue? What kind of risk is involved? So all the relevant stakeholders, not just the ones directly involved right now, but what kind of downstream effects would that change make to manufacturers, to the consumers, to the purchasing agents.



01:05 - 01:11
All those things need to be considered when doing a risk assessment, when making major changes that affect the quality of a product.



01:11 - 01:23
It could be a very involved process because, you know, a small deviation can sometimes just involve just a few people. But a large non conformance will involve almost every single department in the company.



01:23 - 01:55
So how do you keep all those people on the same page about large scale corrective actions? Well, if you're using a manual system, it becomes a real pain. You need to have a dedicated quality assurance department that’s staying on top of every single action, coordinating communications between different departments as it relates to that large corrective action. And if you don't have those resources in place, then it's very easy for our corrective action case just kind of linger on for a month, two, three, four or five, six months.



01:55 - 02:09
People hate to admit it, of course, but, you know, sometimes you just don't pay attention to it until you know that an auditor is coming in. But then if you're going to wait till that point, then you're not you're not running a quality management system the way it was originally intended.



02:09 - 02:22
Because we were so collaborative in how we address, you know, large corrective actions at Applechem, you know, being able to keep everyone on the same page from multiple departments, those outside of quality assurance or quality control overall even.



02:22 - 02:49
You know, the sales, customer service, being able to loop them in, being able to loop in third party contract manufacturers as well into the conversation has been huge for us. You’re not chasing emails back and forth and, you know, trying to transfer information that one party knows but the other person doesn't. It's all there in a single place. And so we've been able to reduce the time it took for us to complete corrective actions from two, three months down to within just just a few weeks.

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Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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