Corrective and Preventive Action (CAPA): Our Most Important Quality Process

Corrective and preventive action (CAPA) is a process for the identification and resolution of customer complaints, nonconforming products, audit findings, safety problems, and even more. It consists of definition and identification of the problem and its root causes, and permanent actions to eliminate the problem and prevent it from coming back. The lessons learned must also be deployed to similar activities so we don't end up having to solve the same problem, or a similar one, more than once.

• CAPA applies to a very wide range of activities in the quality management system, as opposed to only nonconforming products and customer complaints. It is also vital for internal and external audit findings, and outputs of the management review meeting. It can even be used on other Toyota production system wastes that do not involve poor quality if we treat as a problem any gap between the current state and a desirable future state. Inadequate CAPA for complaints, nonconforming products, and audit findings is meanwhile a major source of ISO 9001 and IATF 16949 (automotive) audit findings, and FDA Form 483 citations.
• AIAG's CQI-20, Effective Problem Solving, is an evolution of the excellent 8D (Eight Disciplines) approach and may well be the best CAPA system ever devised. Levinson Productivity Systems recommends this manual (available from AIAG) and has no financial interest in resulting sales.
• The CQI-20 process is as follows:
  • Awareness of the problem; we cannot solve a problem about which we do not know. This can come from many sources, and remember that a gap between current performance and desired performance can be treated as a problem; it need not be related to poor quality.
  • Form an appropriate cross-functional team
  • Define the problem; it is vital to define the problem accurately because, if we work on the wrong problem, we will never solve the right one.
  • Contain the problem, if necessary to protect internal or external customers. (This applies only to nonconforming work, but not to improvement opportunities). Containment is however not correction.
  • Identify the problem's root cause. CQI-20 cites not only the familiar occurrence root cause (why it happened) but also the escape root cause (how it reached the next internal or external customer, if it did) and also the systemic root cause.
  • Select and test preventive and corrective actions to ensure that they work.
  • Implement the selected actions.
  • Prevent the recurrence of the problem by deploying the lessons learned to similar activities throughout the organization.
  • Recognize the team.
• Case studies:
  • Quality example adapted from Shingo, Shigeo. 1986. Zero Quality Control: Source Inspection and the Poka-Yoke System.
  • CAPA for waste motion adapted from Frank Gilbreth's brick laying. This exemplifies application to a gap between current performance and achievable performance, rather than bad quality.
• Simplified approach when full-scale CAPA is not necessary; this works when the problem (or opportunity) can be addressed by the process owner on the shop floor without any worries about the management of change (MOC) issue. MOC applies when seemingly innocent changes in a process can have undesirable side effects.

Disclaimer; no part of this presentation constitutes engineering advice

Corrective and preventive action (CAPA) is arguably the most important process of any quality management system because so much else depends on it. It is applicable not only to nonconformances (poor quality) but also internal and external audit findings, outputs of the management review meeting, and more. Inadequate or deficient CAPA is a leading source of ISO 9001 audit findings, and also Form 483 citations in FDA-regulated industries. A sample Form 483 violation notice cited, in fact, "Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP." (CGMP = Current Good Manufacturing Practice regulations).

The good news is that the Automotive Industry Action Group's (AIAG's) CQI-20, Effective Problem Solving, is probably the best CAPA process ever devised; it is an evolution of the previous (and similarly excellent) 8D (Eight Disciplines) process. It can also be used on all forms of waste (such as waste motion, wasted time, and wasted energy) as opposed to only poor quality if we define a problem as any gap between the current state of affairs and a desirable and realistically obtainable future state. This enables us to use CAPA to drive continuous improvement as well as solve quality problems.

All ISO 9001:2015 users, including but not limited to manufacturing and quality managers, engineers, and technicians. In addition, FDA-regulated industries, including medical device manufacturers, may find this useful.