Corrective and Preventive Action (CAPA) has been a mandatory element of quality management systems for decades. Identification and elimination of a problem’s root cause makes it unnecessary to solve the same problem more than once, and preventive action makes it unnecessary to deal with a quality or safety issue even once. The only difference between corrective and preventive action is, in fact, the need for containment of a quality problem that has already occurred.
The traditional off the shelf CAPA processes such as 8d problem solving process and effective problem solving can however be applied to opportunities to remove waste (muda) from the organization and its supply chain. This gives it a key role in lean manufacturing, especially if workers and other relevant interested parties are empowered to identify the waste in question.
Few if any modifications are necessary because the gap between the current performance state and the desired future state can be treated as a “nonconformance,” for which root cause analysis can then be performed, and improvements then tested and verified. This makes corrective and preventive action (CAPA) a powerful process for not only correcting and preventing problems, but also enhancing bottom line performance in the language of money.
Learning Objectives:
This presentation will cover generally accepted corrective and preventive action (CAPA) procedures including the
Ford Motor Company’s Team Oriented Problem Solving, 8 Disciplines (8D) method, AIAG’s similar Effective Problem Solving Guide (CQI-20), Toyota’s A3 process, and Error Cause Removal, along with their role in ISO 9001:2015.
The webinar will stress the superiority of engineering controls (error-proofing, poka yoke) over administrative controls that rely on worker vigilance for effectiveness.
Areas Covered in the Session :
ISO 9001:2015 and IATF 16949 require CAPA, and CAPA plays a key role in deployment of ISO 9001 clause 6.1, Actions to address risks and opportunities. Risks and opportunities, however, include not only the traditional ones related to poor quality but also the Toyota production system’s other six wastes. These also are removable by the CAPA process.
Ford’s Team Oriented Problem Solving, 8 Disciplines (8D) method (TOPS-8D), AIAG’s similar Effective Problem Solving process, and Toyota’s A3 process use similar structured plan-do-check-act (PDCA) approaches to identify and then remove a problem’s root cause.
Standardization of the solution makes it permanent, and best practice deployment extends it to related activities. The solution also becomes part of a lessons learned data base to support organizational knowledge.
Error cause removal (ECR), or the hiyari hatto (“experience of almost accident situation”) empowers workers and other interested parties to initiate CAPA for safety and quality risks, and also waste or muda. A formal CAPA process such as 8D is not required if the process owner can easily resolve the problem on the shop floor.
The superiority of engineering controls, poka-yoke, error proofing, or what was known as “Can’t rather than don’t” (as in “Can’t do it wrong” rather than an admonition “Don’t do it wrong”) at the Ford Motor Company, over administrative controls that rely on worker vigilance, cannot be overemphasized.
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Everybody with CAPA responsibilities under ISO 9001:2015 or IATF 16949