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Posted by Rich Lauwers ● 5/19/21 10:20 AM

Is Your QMS Software Adjustable?

When I talk with people about their Quality Management System, or their plans to invest in one, I’m often asked about data modeling and what aspects are important to know when managing risk. This is especially important when people are making changes to Quality System Documents.

Some items are commonly found in multiple sectors, but in any one industry, the unique mix of relevant data to measure is going to vary. You’re going to want to account for those unique elements. Also, you’re obviously going to want to learn from your data to make improvements to your QMS. That means you’re going to need a method to interpret that data to make sense of it.

What Data is Important to Your Business?

So, where do you start? If your organization is like most of the others, then there should be a standard set of “Quality Terms” that can be used to describe certain types of documents. I’m talking about terms like Audit Cycle Time, CAPA Time to Resolution, Time to Containment, Master Design, or a History File, things like that.

But also like with other organizations, you’re going to have important things to measure that are going to be very industry-specific or that will be very process-specific. You’ll likely have a mix. For example, yours might be a Life Sciences company working on a vaccine that must be kept frozen at all times until use. It’s likely, then, that part of your quality measurements would include monitoring temperatures.

Your first move, then, should be to gain a clear understanding of what the most important measurements are for your specific business processes. These could include time measurements like elapsed time or a calendar date. You might need to know what role a person might play or who approves certain actions. And you might also need to know the temperature of the product.

Do this right, and you’ll soon have the key metrics that you should be using as you model your quality management program.

These metrics truly influence the quality, so these are the things you must measure your quality against. This will help you to better understand and calculate the cost of quality.

To be able to understand what the data means, I suggest that you consider looking at a solution with an intuitive dashboard. Easy-to-understand data visualizations make it so that even laymen can see relationships and gain insights that were otherwise obscured to them.

I would also suggest that you should be looking for a quality system that is easy to customize, that can host all of that information, and that’s easy to integrate with your quality program. All of this will put you in a great position to better understand your data, and how it can be used to improve your processes and quality.

To almost quote Tzu, “If you know your data and you know your quality program you need not fear the result of a hundred battles.”

Learn more about AODocs QMS

Topics: Compliance, QMS