Why Your Quality Control Process Should Provide Meaningful Feedback

May 29, 2013

  • eTMF Best Practices

There’s always room for improvement, and no industry better encompasses this statement than the pharmaceutical industry. With the mass departure from paper TMFs to the new industry standard of eTMFs, many Clinical Research Organizations, pharmaceutical companies, and regulatory agencies are beginning to have a newfound respect for business metrics. Prior to eTMFs, it was easy for a document (and in turn, its process-related information) to become lost in the Quality Control shuffle. With the inclusion of effective metrics as part of your Quality Control process, it is not only simpler to track a clinical trial’s lifecycle, but more straightforward to get a closer understanding of your internal performance and processes as well.

Metrics should provide meaningful feedback for you and your business, and are a key asset to overall successful performance when used correctly. But how do you ensure your business is properly utilizing metrics? Wingspan interviewed one of our clients for advice on how to achieve an effective Quality Control Process:

Figure Out What is Most Important to You

Metrics should mirror business goals. In fact, metrics should be the quantitative representation of your overall objective. Be sure your eTMF can provide metrics relevant to business process and business strategy. Feedback from your Quality Control process should always be relevant in day-to-day clinical activities, and should be able to address any questions that may be asked on a daily basis: Is our clinical trial complete? Was it completed in a timely fashion? What are the strengths of our Quality Control process? What are the weaknesses?

Wingspan Customer Insider Perspective: “Obviously, our gold star is completeness – do we have everything we’re supposed to have? Quality, I feel, is a measure of our process, but it’s also tied to completeness. You’re not going to have a completed TMF until it’s gone through the Quality Control process and is activated. Even if multiple rounds of revision and Quality Control are needed, the process must continue until the record is completely valid.”

Using Metrics to Help Improve Efficiency

The great thing capturing critical metrics is that it is easy to see where there is room for improvement in your Quality Control processes. With quantitative metrics, there is a high degree of transparency between an action and its outcome. Use your Quality Control feedback as a starting point to address internal issues. With your eTMF, you can view metrics of an individual study, process group, or business unit. Brainstorm on ways to motivate improvement. Consider incentivizing and gamification as ways to reinforce and encourage productivity, which could intern spur internal competition that results in higher levels of quality. Incorporating metrics into interim meetings can be another way to keep your team knowledgeable of what needs to be enhanced.

Wingspan Customer Insider Perspective: “When we pull our data, we look at individual study scores and overall scores. We have different business units, and report out of these units’ performance. We have a very structured environment – results are presented at our control board meeting to be discussed, and we look at the target red areas to see what went wrong and spot errors in our processes.”

Never Underestimate the Importance of Relevant Thresholds

Ensure that your quality thresholds are not only closely tied to your end result, but are also attainable. As tempting as it is to set low thresholds in hopes of always surpassing them, remember that this will stifle evolvement and productivity. Thresholds are not a set end goal, and should always be evolving. It’s important to regularly reevaluate the types of metrics your business uses; changing metric values will become an important exercise for your company and its evolving Quality Control process.

Wingspan Customer Insider Perspective: “For our metrics, we use interim thresholds. As we evolve and our processes evolve as people continue to adopt the system, we may bump our thresholds up, or maybe only focus on a subset of our documents. Then, once we get into green consistently, we have to ask ourselves “What are we going to do next?” We evolve.”

And Finally…Make Sure Your Quality Control Process and Metrics are Understood

When beginning to fully implement an eTMF with Quality Control process metrics, make sure everyone within your organization is on the same page. Clearly define your goals, operational processes, definitions, feedback, potential actions and outcomes, and explain how these are reflected in your metrics. As with every new business process change, there will be period of apprehension and adjustment, but keeping your team involved pre- and post-implementation should alleviate some anxiety.

Wingspan Customer Insider Perspective: “From my perspective, before your start reporting, you have to make sure your users and your audiences have a clear understanding of what the process is first. Our difficulties were that our users didn’t understand the processes and how they contributed to the metrics. Our struggle was with coming from an old system, you just stick your documents up there and you’re done – the documents are filed, and you don’t worry about them because there are no quality checks. With eTMF, it’s really getting people used to those Quality Control rejections, and what this means as an end result. Make sure your process is crisp, your operational processes are clear, and make sure people know not only how it works, but how you can use the metrics to help you improve.”