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.