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Ken Peterson

FDA Compliance

Essential Elements of Effective CAPA Systems

Published: Tuesday, April 22, 2008 - 21:00

From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Because more than half of Form 483 observations and warning letters cite CAPA deficiencies, it’s evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years, the FDA has been promoting the adoption of closed-loop CAPA systems where CAPA is the tool that drives reports and keeps management informed.

The objective of CAPA is a solution to the issue from which the CAPA was generated. If it isn’t driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, all control points flow through to the CAPA system.

Some organizations are suffering from “death by CAPA”—too many elements are included in their CAPA systems. In its most basic form, there are just two fundamental sets of ingredients in a CAPA system. The first set is the experience, expertise, and wisdom of the personnel involved with conducting CAPA processes. If personnel don’t have a prior track record with CAPA, this may be an area where an organization has less control over CAPA activities. The second core element of CAPA, one where more organizational control can be demonstrated, is process. The CAPA process requires critical thinking and an effective determination of the exact questions that need to be asked to come up with proper solutions.

CAPA essentials
Most companies doing business in regulatory environments could improve their CAPA processes by implementing better methodologies and applying effective risk-based filters. At a minimum, a good closed-loop CAPA system comprises the following elements:

  • Identification
  • Prioritization
  • Assignment or acknowledgment
  • Investigation
  • Correction
  • Implementation
  • Verification
  • Close

The first element of a CAPA is the input that opens the CAPA—a customer complaint, a nonconformity report, an out-of-spec finding, an internal audit finding, and so forth. There are four core modules of an open CAPA: issue review, investigation (or failure analysis), effectiveness checks for verification, and preventive action.

Issue review is the evaluation phase, a scoping process where a determination is first made whether or not an investigation is warranted. The three main components of issue review are commonly called CSG: concern, specifics, and gateway.

Issue-review specifics are defined by asking five “W” questions:

  • What
  • Where
  • When
  • Weight (magnitude)
  • Who

An organization’s ability to close a CAPA successfully is directly related to how capably it’s able to narrow down these five dimensions and arrive at a defensible decision.

Designing and utilizing an issue-review worksheet can facilitate CAPA investigations and streamline gathering information on these specifics.

The “gateway” component of CAPA revolves around the effect (safety, hazard, severity, visibility, etc.) and magnitude (i.e., frequency and/or size) of the situation. A gateway score chart can home in on magnitude specifics based on qualitative or likelihood compared with descriptions of the input-event occurrence (continually, frequently, occasionally, rarely, etc.). Likewise, an effect chart can provide a gateway scorecard for the severity of the event: critical, important, minor, or negligible. Most issues will likely be important or minor events. Specific scores can be assigned according to effect and magnitude scales to determine if the event is acceptable (no action required), undesirable (may or may not be put in the formal CAPA system), or unacceptable (CAPA opened and a resolution is required).

Taking action
Once CAPA specifics have been defined, and effect and magnitude scores have been determined, it’s time to take action. Possible actions include:

  • Adaptive action: Actions that allow the organization to live with or adapt to the issue and continue to operate according to organizational objectives.
  • Interim/correction actions: “Band-aid” or containment actions that alleviate the effects of the issue and buy time before a corrective action is implemented. Containment is a backup plan if a problem cannot be resolved.
  • Corrective actions: Problem prevention and containment actions that permanently eliminate the issue.
  • Preventive actions: Actions that anticipate potential problems and eliminate the most likely causes of the problem so they are less likely to occur again.

Approaches to investigations
As in any problem solving situation, there are three basic approaches to the investigation component of a CAPA:

  • Trial and error: This is a risky method that may work for some companies but it also has the potential to exacerbate the problem. You may get lucky, but you also may complicate the problem.
  • Fishboning, design of experiments, and brainstorming: These quality tools are usually better solutions than trial and error, but they are also dependent on past experience and potentially useless if the root cause lies outside the realm of personnel expertise. Scrap and downtime are potential complications.
  • Comparative approach: A deductive thinking approach is the ideal method in that it provides understanding of what the problem is not. Investigators can use a comparative approach to discover what sets the problem apart. A fact-based, objective comparative approach investigation should yield clues that identify the problem’s root cause which will then require a corrective action.

One valuable investigative tactic is sometimes referred to as the PICCC or PI-cubed methodology: Problem, Investigate, Clues, Compare, and Cause.

  • Problem:The first step in the PICCC method is to determine and understand exactly what’s gone wrong.
  • Investigate:Once the problem has been defined, investigators can gather data that can be used in comparisons and determinations of what the problem is not.
  • Comparison:Asking “is not” questions (comparing time periods, locations, types of defects, etc.) furthers refine the investigation.
  • Clues:The clues uncovered during the investigation are inferences of the facts. At this stage of the investigation, the organization is finally formulating some answers as to why the problem has occurred.
  • Cause: Investigators can now take the clues and build a cause that can explain the problem or deviation. An assessment can be made regarding the impact of the event and preventive measures, if necessary, can be identified and implemented.

At this stage, the problem-prevention-analysis model (a modified FMEA tool) can be useful for developing mitigation strategies. The model consists of four basic components:

  • Result
  • Problem
  • Prevent
  • Contain

CAPA verification and documentation
Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system is working. Data tracking is a mandatory component of CAPA so that the organization can ensure that all CAPA-related information can be confirmed, monitored, measured, and, if necessary, corrected.

Documenting CAPAs according to regulatory requirements is another vital CAPA factor to take into account. Because CAPA data must be easy to access and analyze, every phase of a CAPA investigation is forms based. Automating forms-based processes such as CAPA can facilitate regulatory compliance, and save a company time and resources.

Commercial off-the-shelf (COTS) software solutions are available that can comprehensively document CAPA investigations and integrate the CAPA process with other processes critical to regulatory compliance such as change control, customer complaints, and audits. An effective CAPA software solution should be configurable and user-friendly and should include features such as:

  • Automated routing, notification, delivery, escalation, and approval of CAPAs and all related documentation
  • Secure, centralized, and web-based repository for all CAPA documents
  • System oversight of quality incidents that escalate to CAPAs (i.e., customer complaints, audit findings, etc.)
  • Efficient reporting and advanced analytics
  • Form-to-form launching capabilities
  • Revision and approval history features

Best-practice electronic forms and workflow routes that can be used as is out-of-the-box or customized based on company requirements.

Ken Peterson is a senior partner at PathWise Inc., a leading CAPA training and consulting provider and a MasterControl Consulting Partner. He is a frequent speaker for AAMI, PDA, ASQ, and other professional organizations. This article was published originally in GxP Lifeline, the Master Control e-newsletter.


About The Author

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Ken Peterson


Verification of CAPA Effectiveness

Ensuring CAPA effectiveness is such a critical point when it comes to eliminating root cause. Other than the common effectiveness criteria of no repeat occurrences over a period of time, what are some other ways to verify your CAPA has been effective?

CAPA Systems

We have been using CAPA Manager from Adaptive BMS because its cost effective and works well. For us, the use of a CAPA system has saved us a lot of money as well as dramatically improving our product quality.

It has taken about 12 months for the CAPA culture to really take hold. We are now processing about 11 CAPA's per employee per year (all resulting in some improvement for our business).

A very successful system for us. I don’t think I could run a production and engineering company without a CAPA system in place.