7 CAPA Process Steps to Ensure CAPA Success

Product development in the life sciences is a multimillion-dollar process. A recent study estimated that the average research and development investment to bring a new drug to market is over $1.3 billion.⁽¹⁾ Medical devices are similarly expensive, with costs ranging from $31 million to $94 million, depending on which approval process is used.⁽²⁾

The price of a mistake can be similarly staggering. In April 2021, Emergent BioSolutions, a contract manufacturer, had to discard 15 million doses of the Johnson & Johnson vaccine due to human error at Emergent’s Baltimore-based manufacturing plant.⁽³⁾ The U.S. Food and Drug Administration (FDA) was left trying to determine what to do with approximately 170 million doses of vaccine that may have been contaminated by the error, and shortly after regulators determined about 60 million doses were unusable, the company reported a $41.5 million loss to investors.⁽⁴⁾⁽⁵⁾ In early November, the federal government cancelled their contract with Emergent, and the company had to forego approximately $180 million.⁽⁶⁾

With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential. 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. An effective 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 preventive measures.

A general overview of the seven steps companies need to take to successfully complete and document CAPA include the following:

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.

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.

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.

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.

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.

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.

Follow-up

A thorough follow-up evaluation serves multiple functions, including verifying the implementation and completion of all changes, controls, and training; 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 and helping pharmaceutical and medical device companies deal with the cost of bringing a product to market.

Sources:

1. “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018,” Olivier J. Wouters, Martin McKee, et al, Journal of the American Medical Association, March 3, 2020.
2. “FDA Device Regulation,” Madelyn Lauer, Jordan P. Barker, et al, Missouri Medicine, 2017.
3. “Johnson & Johnson confirms vaccine production problems at Emergent plant in Baltimore,” Christopher Rowland and Laurie McGinley, The Washington Post, April 1, 2021.
4. “The F.D.A. tells Johnson & Johnson that about 60 million doses made at troubled plant cannot be used,” Sharon LaFraniere, Noah Weiland and Sheryl Gay Stolberg, The New York Times, Updated July 29, 2021.
5. “A troubled vaccine plant in Baltimore is given the go-ahead to reopen,” Sharon LaFraniere, The New York Times, August 3, 2021.
6. “Federal Government Cuts ties With Troubled Vaccine Maker,” Chris Hamby, The New York Times, November 4, 2021.