Corrective and Preventive Action (CAPA) is a process of the quality management system whose purpose is to

(1) receive notification of a quality problem or audit finding,

(2) contain the problem to protect the customer,

(3) identify and remove the problem's root causes, and

(4) deploy the lessons learned to related activities in the organization. 

The Automotive Industry Action Group's CQI-20, Effective Problem Solving, and the similar Eight Disciplines (8D) process, are the apparent best available CAPA processes in existence. They are easier to understand and apply than Six Sigma's DMAIC, work on a wider range of problems, and will even work on waste (muda) that does not involve poor quality.

Course Objectives:

• CAPA is quite likely to be the most important process in any quality management system due to its interactions with numerous customer and supplier processes. This is probably why inadequate CAPA is a dominant source of audit findings in ISO 9001 and IATF 16949, and also FDA Form 483 observations.
• CAPA is usable against any Toyota production system waste if we define the gap between the current state and a potential or desirable future state as a "nonconformance."
• Overview of the CQI-20 process; the handout's appendix adds an overview of 8D
• The Error Cause Removal (ECR) process for quality, waste, and safety issues that can be resolved on the shop floor by the process owner without the need for the formal CAPA process.

Why Should You Attend:

CAPA plays a central role in any quality management system. Its role goes beyond the traditional applications of poor quality, audit findings, and customer complaints to resolution of issues identified in the management review meeting as well as occupational health and safety (OH&S) and wastes other than poor quality. Inadequate CAPA is one of the leading, if not the leading, source of audit findings because it leaves issues, including previous audit findings, unresolved. The good news is that proven off the shelf CAPA processes (CQI-20 and 8D) are available, they are usable against all seven Toyota production system wastes as opposed to just poor quality, and their diligent application should prevent audit findings and nonconformances.

Course Outline:

• Importance of CAPA
          o Customer and supplier processes of CAPA
          o CAPA as a leading source of ISO 9001 and IATF 16949 audit findings, and FDA Form 483 observations
• Application of CAPA to all seven Toyota production system wastes rather than just poor quality along with audit findings
• Organizational support requirements for effective CAPA
• Overview of AIAG CQI-20, Effective Problem Solving approach
          o Awareness of problems (and opportunities) from multiple channels including but not limited to stakeholders (relevant interested parties) and the management review meeting
          o Cross-functional team with necessary skills and resources to address the problem
          o Accurate working definition of the problem
          o Containment of the problem to protect the customer from poor quality (not required for wastes unrelated to poor quality)
          o Identification of the root causes: occurrence (why it happens), escape (how it reached the next internal or external customer, if it did) and systemic (why the planning process did not anticipate it in advance)
          o Selection and testing of corrective or preventive actions to ensure that they work
          o Implementation of the selected actions
          o Prevention of the problem's recurrence, which includes deployment of the lessons learned to related activities in the organization (read across/replicate process, or best practice deployment)
          o Congratulate the team
• Examples of CAPA for poor quality and waste
• Error Cause Removal (ECR), a simple stakeholder-initiated CAPA process for
          o Quality,
          o Safety, and
          o Waste or muda issues that do not require a cross-functional team or root cause analysis, and can be resolved on the shop floor by the process owner. Examples will be provided.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Control Personnel & Management
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management
• Supplier Quality Personnel & Management
• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers
• Usability engineers
• Risk managers
• Design Engineering Managers
• Medical Device Engineering
• All ISO 9001:2015 and IATF 16949 users, including but not limited to Manufacturing and Quality Managers, Engineers, and Technicians