Senior Vice President, Corporate Quality & Compliance, Coghlin Companies
In general, one of the biggest challenges to continuous improvement, successful problem solving, and the maintenance of cGMP (current Good Manufacturing Practices) in a contract-based, finished medical device environment is selecting the most appropriate performance measures or metrics.
This is a challenge for many medical device companies in the industry. We collect so much data and then struggle to understand or, more importantly, consistently take action with it to ensure continuous improvement.
The difficult question for most people is what performance measures or metrics to use for their quality system, their processes, or their particular step or operation within a process. These are known as KPIs (Key Performance Indicators) or KPMs (Key Performance Metrics).
The easiest way to respond to this question is to ask what is important to the customer that can be measured or counted, and why is it so important?
We all know metrics are important. They help report progress and guide our decision making in a cGMP environment. Used properly, metrics can provide key insights into our quality and business goals that make the difference between success and failure. As our capacity to track everything increases and the tools to do so become more prevalent and easier to use, the question remains: What KPI or KPM is a worthwhile metric to track and why am I tracking it? What action will I take with the data?
Before answering these questions, though, we first need to understand the foundation of metrics. There are, in fact, valuable and not-so-valuable metrics. There are metrics that don’t help and metrics that might save your company.
The first step is to determine your goals. If you don’t know where you’re going, metrics aren’t going to help you get there. Your business and quality goals need to be clear and aligned. We then need to identify our KPIs or KPMs that align with our goals. This step is critical because we so often get stuck on what I call ego or self-serving metrics, that we get sidetracked and lose focus on our main goals.
Let’s talk about meaningful metrics for a moment. I think we have all seen the effects of not-so-meaningful metrics.
A meaningful metric can measure progress when we compare it across time periods, groups of users, or products; it helps you understand which way things are moving.
A meaningful metric can identify problems. Defining the right metrics in this case requires a little detective work. What are the numbers or data saying? Is there a trend in the data? Is there a shift in the data? What evidence can be found and how exactly does it show up?
A meaningful metric can be understood. Take the numbers you’re currently tracking and the ones you think are the most important and then show them to others who don’t know your business. That’s a good way to tell if someone can see and understand what you are trying to accomplish.
A meaningful metric can use a ratio or rate. Ratios and rates can be used to compare a daily metric to the same metric over a month; you’ll see whether you’re looking at a sudden spike, a shift, or a long-term trend. Ratios and rates can give you a more realistic check on your quality and business goals and, as a result, are easier to act on.
A meaningful metric can be a change agent. This is by far the most important category for a metric. What will you do differently based on changes in the numbers? This will not only adjust the course you take toward your goals, but may change your culture and mindset when it comes to your company vision or mission.
In summary, contradicting goals, distorted behaviors, and a misguided sense of success can be good indications of the wrong metrics in your organization. So, start with your goals and KPIs or KPMs and begin seeing the results of meaningful metrics in the medical device industry.
Also be sure to check out Paul Dunleavy’s blog on Cogmedix DFcx™ – Design for Compliance and Excellence (Part 1). Paul Dunleavy is the Vice President of Engineering at Cogmedix.