CAPA and Root Cause Analysis

Recent FDA Warning Letters have cited insufficient corrective and preventive action (CAPA) programs as major compliance weaknesses. How does one ensure one’s CAPA is on the right track? Doug Bartholomew interviews industry QA professionals and leading consultants for the answers.

By Doug Bartholomew, Contributing Editor

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Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do — some more frequently than others. The more comprehensive and structured the investigation process is, the more effective it will be.

That’s the consensus of consultants and other experts in the corrective and preventive action (CAPA) field. While CAPA is handled differently at many pharmaceutical manufacturers, best practices for handling complaints and investigations revolve around certain core activities, a basic process and, more often than not, some enabling technology.

The CAPA complaint “root cause” investigation process is paramount. “Having a successful CAPA is more a cultural thing for a company than merely having the technology for CAPA,” says Simon Jacobson, research analyst for manufacturing operations at AMR Research in Boston.

In Jacobson’s view, most large pharmaceutical companies have more trouble “breaking down the silos” — in which they might have several different CAPA processes and technologies being used in different departments and plants — to achieve a single managed view of the process. Many pharmaceutical companies have installed several CAPA solutions, “but there is no common way for them to do trending and put preventive action in place across the company,” he says.

Surprisingly, smaller pharmaceutical firms often take a more systematic approach to handling CAPA complaints than larger companies. “At single-site operations, people are more inclined to work together, so that, for instance, the R&D chief knows the manufacturing guy,” Jacobson observes. “But with the bigger companies, there are more silos and there is a greater need for a common, systematic approach to CAPA.”

Often, CAPA problems can be traced to the lack of consistent process requirements and written procedures. Because of these inconsistencies across sites, companies may have to chase the same complaint at multiple facilities. “This is preventing organizations from halting what could be systemic inefficiencies,” Jacobson says. In addition, he says, “The lack of an organization-wide systemic management process prevents a company from successfully auditing their processes and taking effective preventive actions, such as trending across multiple sites.”

The four-step method

In most cases, a CAPA investigation is set in motion by an event — either a laboratory investigation, a manufacturing inconsistency, a regulatory or internal audit, or a customer complaint. “Any of these investigation records are entered into a CAPA system, which can spawn a related CAPA investigation,” explains Robert Fetterman, president of Technical Business Solutions (Royers Ford, Pa.).

“The majority of companies initiate their CAPA processes once a complaint or field failure is discovered,” says AMR’s Jacobson. “This is not only too late because the patient is already at risk, but companies are hard pressed to comply with the FDA’s CAPA requirements because they lack insight into the root cause of the device malfunction.”

The CAPA process, of course, is broader than just the investigation of complaints. But investigation of the root cause of problems lies at its core. As Jacobson says, “At the heart of a successful CAPA is a definition of the problem and an assessment of who, what and where is at risk, as well as the potential impact on the organization should the problem grow.”

In general, CAPA experts recommend that root cause investigations follow a four-step process:

  1. Identify
  2. the problem.

  3. Evaluate
  4. its magnitude, which includes assessing risk.

  5. Investigate
  6. and assign responsibility.

  7. Analyze
  8. and document the root cause of the problem.

Tracking best practices

Fetterman is nearly completion of a project to install a CAPA solution globally at a major pharmaceutical firm. “We’re developing the system and rolling it out to all their 30 sites worldwide,” he says. The firm is using Sparta Systems’ (Holmdel, N.J.) TrackWise quality management software package because it is easily customized, Fetterman says. “It lends itself to quick configuration of workflows and modifications to meet the business needs.” It also runs on the Oracle systems that are in use at many pharmaceutical companies, he says.

With any CAPA investigation, having a prescribed workflow or set of activities with designated people assigned to carry them out is essential. “You can track a CAPA event and the multiple activities required throughout the workflow process,” Fetterman says. Each CAPA record is linked to the original “parent” quality event, so that a supervisor or manager can check the system and quickly see that the event has been tracked through to closure, or if not, exactly where it is stalled or held up.

“This is important to CAPA complaint investigation, that there be a system to make sure that these problems are tracked all the way through to completion,” Fetterman says. “This way, the plant manager knows that appropriate actions were taken . . . and that the corrective actions taken are, in fact, solving the problem.”

The software’s workflow capability helps to ensure that each step is taken in a timely fashion. The system assigns investigation tasks to team members, tracking each task through to completion. Each investigator documents his or her findings in the system, with results and attachments electronically included. The lead investigator is notified as each step is completed or, conversely, unduly delayed.

Unfortunately, many companies have yet to computerize their CAPA complaints and investigations. The danger of manually documenting CAPA problem investigations is that it has proven to be unreliable, Jacobson points out. “The FDA has addressed CAPA as the number one good manufacturing practice (GMP) deficiency,” he says. “And the FDA is more insistent than ever that manufacturers maintain consistent files and procedures across their organizations and embed FDA regulations into company standard operating procedures regarding the CAPA process.”

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