Align CAPA to ISO 9001:2015
OVERVIEW
While preventive action is now covered by ISO 9001:2015 clause6.1, 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 "nonconformances" 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 8D 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.
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| Corrective & Preventive Action Procedure |
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 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 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
(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"
(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 (TOPS-8D), AIAG's similar Effective
Problem Solving, 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.
For more detail please click on this below link:
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