CAPA Management in FDA Regulated Industry

A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future.

Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 requirement.

The ten objectives of CAPA FDA are:

  1. Validate that the CAPA system procedures that deal with the quality system requirements regulation have been specified and documented.
  2. Define if appropriate sources of product and quality problems have been identified and make sure the data sources are analyzed to identify existing product and quality problems that may require corrective action.
  3. Identify the unfavorable trends of product and quality sources and make sure that data from these sources are analyzed to find out potential product and quality problems that may need preventive action.
  4. Verify that the quality data information received by the CAPA system is complete, precise and appropriate.
  5. Verify that accurate statistical methods are operating to detect recurring quality problems.
  6. Determine if failure investigations are implemented to detect the root cause
  7. Determine if suitable actions have been taken for product and quality problems identified from data sources.
  8. Determine if corrective and preventive actions were potent and confirmed or validated prior to implementation and ensure that corrective and preventive actions do not adversely impact the finished device.
  9. Validate that corrective and preventive actions for product and quality problems were executed and documented.
  10. Determine if information related to nonconforming product and quality problems and corrective and preventive actions has been properly distributed, including dissemination for management review.

Root Cause Analysis Methodologies

Fault Tree Analysis (FTA):
This is a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred to as to pevents) at the system level.

Fishbone Diagram:

Also called a “cause and effect” or “Ishikawa” diagram, a fishbone diagram is a visual tool for looking at cause and effect.

A problem or effect is displayed at the the “head” or “mouth” of the fish and possible contributing factors are listed on the “bones” under various cause categories. These models work best when the “head” of the fish contains a very detailed problem statement.

5 Whys:

It is arguably the simplest technique for root cause analysis. When a problem occurs, you drill down to its root cause by asking “why?” five (or more) times. Then, when a countermeasure becomes apparent, you follow it through to prevent the issue from recurring.

Read also:

Resource Person: BARBARA PIROLA

Leave a Comment