Root Cause Analysis and CAPA using 8-D Problem Solving Method
OVERVIEW
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.
WHY
SHOULD YOU ATTEND
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.
AREAS
COVERED
- 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.
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.
WHO
WILL BENEFIT
Quality
and manufacturing engineers and technicians, and everybody with CAPA
responsibilities under ISO 9001:2015 or IATF 16949.
Training Doyens presents Christmas and New
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till January 5th, 2019.
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