ETQ recently held a webinar with FDA News addressing the lab investigation process in life sciences, food and beverage and medical device markets. Managing non-conforming lab test results is serious business in these markets and can not only impact regulatory requirements, but the safety and health of patients and consumers.
Quality events, such as out-of-specification (OOS) or out-of-trend (OOT) test results happen in even the most advanced, state-of-the-art operations. But what happens next is what determines the likelihood of a safe, successful outcome and the return to full capacity production.
One of the first things to happen next, is that when product defects, process deviations, OOS or OOT results occur, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) have established policies that require manufacturers to investigate and identify the root cause of the problem, create a corrective action plan (CAPA) if needed and document the process.
While companies have always abided by these requirements, they haven’t always been able to conduct lab investigations electronically. That’s why ETQ’s recently unveiled Lab Investigations app is meeting a unique need, helping to document OOS or OOT test lab results. During the webinar, ETQ’s Group Product Manager, Kim Wakeman; along with Eric Dano, Solutions Engineer shared the traditional challenges and how companies can better conduct lab investigations using the new app.
The Problems with Manual Lab Investigations
Before the new app, there really was no way to effectively manage and track the investigation of an OOS or OOT result electronically, so they took much longer and weren’t as accurate in getting to the root cause and addressing it. They also weren’t able to determine if corrective or preventative action was even required, or determine what impact the OOS could have on the product developed or related products in the field.
Consider the steps in a traditional lab investigation when an OOS or OOT is identified:
Typically an initial assessment of key data, such as general information, batch information, test details, and equipment information can provide what’s needed for a full-scale investigation to identify the source of the problem. And, a complete resampling or retesting may be required to confirm initial results.
Then a comprehensive investigation tracks the results of each stage in the lab to identify trends for a root cause analysis, assess risk and determine if a corrective and preventative action (CAPA) plan is required. While the investigations should involve all departments that have a role in quality, including design, manufacturing, process development, procurement, and manufacturing, that wasn’t always possible with manual methods. Finally, each step in the investigation needs to be fully documented and all key stakeholders must be made aware of developing trends.
Investigating the root causes of a quality event, OOS, or OAT requires a systematic, thorough approach that must be documented every step of the way. With ETQ’s Lab Investigation app, the process of conducting a lab investigation is more efficient, since it provides a standardized process for investigating OOS/OOT test lab results to ensure each one is conducted consistently. It also saves data entry time, supporting audits and improving root cause analysis. With the treasure trove of data it collects, it also ultimately improves the quality of products since trends can be identified in the data that can indicate risk.
As Kim points out in the webinar, OOS/OOT test results must be investigated since they can be life threatening, indicating a problem to patients or consumers using related products already released in the market. Taking a quality management approach that automates the process and integrates vital data is the key to effectively sniffing out the source of an issue before it can cause harm.
You can listen to a recording of the webinar to learn more about the benefits of Lab Investigations and taking an automated approach to quality management and QMS Software.