While preventive action is now covered by ISO 9001:2015 clause 6.1, Actions to address risks and opportunities, no change to existing CAPA processes is necessary to fulfill this requirement. These processes can also be extended to address opportunities by treating gaps between the current and desired states as "non-conformances" that the CAPA process can easily address. The CAPA process also supports numerous ISO 9001:2015 clauses that range from performance evaluation (9) to organizational knowledge (7.1.6), the latter in the form of a lessons learned data base.
The hiyari hatto ("experience of almost accident situation") or error cause removal (ECR) process is meanwhile an employee-initiated CAPA process. It begins when a worker, or indeed any relevant interested party, identifies a potential safety or quality risk, but the context can be easily expanded to improvement opportunities. A formal CAPA process such as 8 Disciplines (8D) method is not required if the process owner can implement a simple solution on the shop floor, although the problem and solution should still be documented in a lessons learned data base.
As stated by Henry Ford, "The benefit of our experience cannot be thrown away," and Ford also credited his hourly workers for most of his productivity and efficiency improvements.
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.
• 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.
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.
Quality and manufacturing engineers and technicians, and everybody with CAPA responsibilities under ISO 9001:2015 or IATF 16949.
Years of Experience: 30+ years
Areas of Expertise: Statistical Process Control, Lean Manufacturing, Quality, ISO 9001, Design Of Experiments, Non-Normal Distributions, Quality Management Systems
William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, ISO/Lean Six Sigma World Conference, and others.View all trainings by this speaker