When I talk with people about their Quality Management System (QMS), or their plans to invest in one, I’m often asked about who would be best to estimate the risk of change. This is especially important when people are making changes to Quality System Documents. It always makes me think of Darwin's finches, a set of 13 different species that had evolved from a single ancestor.
Among the QMS space, some items are commonly found across multiple sectors, however, each industry has its own mix of relevant data to measure tied to unique business problems. This requirement to adapt is going to evolve, and you may find a better event to measure and manage for your quality program over time. Your data needs to be consumed and modified for different needs and conclusions, just like the one finch adapting slightly for 13 different use cases.
The adaptation of your quality program is the foundation of your QMS’ continuous improvement as a core value. So, because of this continuous need for change and adaptation, you will need a QMS tool that can evolve with you for differing needs. This tool should help your QMS program gain insights and interpret the different elements of data as they evolve so you can make conclusions about how to respond.
So, where do you start? If your organization is like most, there should be a standard set of “Quality Terms” which can be used to describe certain types of documents. I’m referring to terms such as Audit Cycle Time, CAPA Time to Resolution, Time to Containment, Master Design, or a History File, for example. These are standard terms you are going to measure over time so you can better adapt them to your needs as your business evolves. But, like with other organizations, you will also have additional important items to measure that will be very industry-specific and/or very process-specific. For example, you might work for a Life Sciences company developing 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.
These unique features are not going to be wild variations, but subtle changes that allow you to see better so you can do better. Just like the finches, these will be minor adaptations that will allow for better results.
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 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 obscure.
I would also suggest that you should be looking for a quality system that can easily adapt, that can host all of that information, and that’s easy to integrate with your quality program. Whether it's "Audit Cycle Time" or a bird's beak size adapting to changing conditions, 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.
This ability for your QMS tool choice to adapt is going to be the key to your business adopting your Quality process faster. The measures and the results of quick adaptation are going to give your business the better insights it needs to truly be impacted and achieve your Quality program goals.
Richard “Rich” Lauwers is a legal and regulatory solutions subject matter expert at AODocs. He has nearly 30 years of experience in the Information Security and Regulatory Compliance space across multiple industries. This experience spans companies including Zurich North America, Biogen, Hewlett Packard Enterprises and Merrill Corporation.
Tags: Compliance, QMS