Ira Dave, Sr. Director, Quality and Regulatory, Elixir Medical Corporation
As a newcomer to Elixir Medical Corporation at the outset of 2022, I came with a history of and passion for QS process compliance, improvements, and efficiencies. The low hanging potential improvement areas could not escape my attention; one of which was the CAPA system that includes the nonconforming materials controls system. At Elixir, the investigations were taking longer than expected, i.e., we were not meeting the target for the non-conformity report (NCR) days-to-close goal. Engineers sometimes found themselves investing excessive time and resources for nonconformity investigations with respect to its extent, actions to be taken and verification of effectiveness of actions taken. Luckily, I knew of a resource I was sure could be leveraged for improvement.
Elixir Medical Corporation is a dynamic and innovative organization with products approved in multiple geographies and a product platform demonstrating disruptive technology. Expediency in innovation and market penetration must be complemented with efficiencies in processes supporting such activities. Quality contributes to such success through assurance of process and product quality, and overall regulatory compliance. Quality’s contribution can be more effective and impactful to a company’s success by being proactive in identifying risks related to processes, product, and compliance risk, and by implementing corresponding mitigation and process efficiencies. It is common to see excessive details as part of a nonconformity investigation; peripheral details that are not core to the issue can defocus the actual root cause analysis and may cause sub-optimal action plans, thus causing a higher risk of recurrence of a nonconformity.
To control this situation, the Quality team at Elixir has implemented a risk-based thought process, inspired by the MDIC Case for Quality (CfQ), in evaluating the need for investigation and in performing investigations (so that the team plans and gathers pertinent information to effectively identify root cause). The Quality team has steered towards appreciating that not every problem or nonconformity has the same risk or potential risk.
Based on experience from my initial participation in the NCR discussions related to cause analysis and monitoring NCR closures, I knew the concepts of CfQ would be a game changer. MDIC’s Make CAPA Cool white paper very succinctly demonstrates the use of risk-based approach in determining the extent of actions an organization should take for a given nonconformity. At first, when NCR discussions went in circles, I started asking questions, such as the following, to guide decisions on containing the investigation to the issue and not expanding the scope:
- Is the issue detectable in-house and can it be contained?
- Is the issue indicating any systemic break-down or deficiency?
- What is the patient risk?
- What is the risk that the issue is a regulatory noncompliance?
- Is the issue a product/ process nonconformity that is expected (such as identified through product/process risk assessment)
[These questions reflect the risk-based approach outlined in the Make CAPA Cool white paper.]
Leading change or transformation deliberately is very important. Asking these questions organically and repeatedly has reinforced the concept of risk-based evaluation of issue, thus taking focused actions that are effective and efficient. Along with risk-based approach in addressing NCRs, assigning a dedicated resource (thus encouraging process ownership to monitor NCRs progress) and instituting working meetings instead of status update meetings, has led to sustainable improvement in the process as demonstrated in the chart below. It is noted that although the number of open NCRs was greater in 2023 than in 2022 (based on significant increase in manufacturing), the days to close NCRs was significantly improved from an average of about 90 days in 2022 to 60 days in 2023. Reduction in NCR cycle times has underlying benefits such as better use of resources, quicker disposition of products and hence cost savings.
Part of the process improvement is to utilize MDIC’s approach for risk determination in evaluating the need for formal corrective action upfront for material/product nonconformity. In alignment with 21 CFR 820 that states that “the evaluation of nonconformance shall include a determination of the need for an investigation…”, Elixir has assessed the application of risk-based determination to evaluate the need for an investigation and CAPA for NCR issues. Based on the assessment, only about 20% of NCRs are likely to be escalated to formal CAPAs which in turn means that 80% of the NCRs can be closed with controls such as segregation, correction, and disposition, thus greatly improving NCR closure efficiency.
Going to the next level, I introduced the concept of Fast track vs. Traditional CAPAs. MDIC’s white paper offers the means to present a risk-based approach for the criteria to determine fast track vs. traditional CAPA in a very articulate and logical fashion and presents the steps for implementing the two CAPA tracks effectively. The paper has powerful visuals and statistics on the improvements in CAPA efficiencies. I adapted this information to present this topic cross-functionally on how fast track vs. traditional CAPA will work at Elixir and the benefits of this approach. It was very well received; the team was especially excited about the ability to perform straight-forward root cause analysis and the ability to utilize existing monitoring method for effectiveness verification when fast-track CAPA approach becomes applicable.
It was important not to lose the momentum. And so, in parallel, I encouraged my team to incorporate the CAPA track determination criteria in a flowchart that Elixir can use as a process and for configuring the CAPA module in our electronic quality management system. Upon finalizing the flowcharts, the team validated the criteria for the CAPA track selection using existing CAPAs. Based on the CAPA issues and the corresponding risk, the CAPAs selected for fast-track vs. traditional were acceptable. We expect that the CAPA improvements planned to be implemented in 2024 will yield us better efficiency and a more effective CAPA system, as we have seen with the NCR process.