Moving into 2020, the life sciences manufacturing space is a complex and costly yet also highly rewarding sector. According to a recent Forbes report, the resources required to produce a new drug average $2.6 billion and can be as high as $6 billion.(1)
In the medtech world, the costs of attaining U.S. Food and Drug Administration (FDA) 501(k) approval for a device ranges between $24-31 million for low-to-moderate risk products and in the ballpark of $94 million for a premarket application (PMA) clearance, according to a 2010 Stanford study.(2)
And while it’s true that maintaining a high level of quality and compliance is expensive, poor quality on the production line can be catastrophic for a manufacturer. IBM estimated in 2016 that poor data as a result of shop floor errors due to quality failures at U.S. manufacturers totaled $3.1 trillion, according to Harvard Business Review.(3)
The comparative gains of implementing an effective quality management strategy and system that reduce production nonconformances and deviations far outweigh the costs of poor quality and documentation. A formal corrective action preventative action (CAPA) program can go a long way in helping manufacturers meet regulatory requirements while identifying discrepancies and nonconformances before they become larger, more costly problems and delays which increase product time to market.
Accurate and complete documentation of the CAPA process is essential for companies in meeting the regulatory requirements for a quality management system (QMS) as set out by the FDA, the International Organization for Standardization (ISO) and many others. Proper CAPA documentation shows that a manufacturer’s quality system is effective. It also demonstrates that production staff can quickly identify issues and implement corrective and preventative measures.
A general overview of the seven steps companies need to take to successfully complete and document CAPA, which are elaborated further in the white paper “Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan,” include the following:
#1 – Identification - The initial step begins with clearly defining the potential or actual problem, nonconformity or incident, and describing the situation as it currently exists. The complete written description of the problem should include the specific source of the information that initiated the action, as well as a detailed explanation of the problem and the available evidence that a problem exists.
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#2 – Evaluation - The problem described and documented in Step 1 should be evaluated to determine the need for action and the level of action required. The potential impact of the problem and the actual risks to the company and/or customers must be determined and documented. The document, while concise, must contain sufficient information to ensure that the problem is easily understood.
#3 – Investigation - A procedure should be written for conducting an investigation into the problem, helping to ensure that the investigation is complete and nothing is overlooked. The procedure should include, among other elements: an objective for the actions that will be taken; the procedure to be followed; the personnel that will be responsible and any other necessary resources anticipated.
#4 – Analysis - The procedure created in Step 3 should be used to investigate the cause of the problem. The primary goal of this analysis is to determine the root cause of the problem described, but any contributing causes are also identified. This process involves collecting relevant data, investigating all possible causes and using the information available to determine the cause of the problem.
#5 – Action Plan - Based on the analysis from Step 4, an action plan to correct and/or prevent the problem should be developed. The plan should list, as appropriate: actions to be completed; document or specification changes; process, procedure or system changes; employee training; monitors or controls for preventing recurrence of the problem; and the person/persons responsible for completing each task.
#6 – Action Implementation - The corrective/preventive action plan created in Step 5 can now be implemented. All of the required tasks listed and described in the action plan should be initiated, completed and documented, creating a complete record of the actions taken to correct the problem and ensure it will not recur. Modified documents or specifications should be listed in documentation.
#7 – Follow-up - A thorough follow-up evaluation serves multiple functions, including: verifying the implementation and completion of all changes, controls and training, et al.; ensuring that the actions taken were effective; and adding additional information or comments that may be helpful in understanding CAPA actions. After the follow-up, there should be a formal indication that it has been completed.
But a strong CAPA program is only as good as the tool that a company uses to manage, track and document discrepancies and nonconformances. Since a manual paper-based or hybrid QMS is slow, prone to human data error entry, and disconnect from other systems, it has significantly limited capabilities in helping a company follow and document CAPA processes. A robust, automated QMS solution, however, gives a manufacturer a powerful tool for CAPA management that digitizes production processes and activities in order to reduce liability and losses. A digital CAPA management solution documents in real time nonconformances and other discrepancies so that CAPA processes can be initiated quickly thereby reducing costly quality events.
For more information about how to make your CAPA program more effective, read the white paper “Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan” here.