Talent
Description
OVERVIEW Corrective and preventive action (CAPA) is a process of the quality management system which, like other processes, has suppliers (other processes of the QMS), inputs such as corrective action requests and audit findings, a series of clearly defined activities, outputs, and customers. Its deliverables (outputs) include identification of a problem's root causes, corrective or preventive actions to suppress or disable the root causes, and organizational knowledge (ISO 9001:2015 clause 7.1.6) that allows deployment of the lessons learned to related activities. WHY SHOULD YOU ATTEND
Corrective and preventive action (CAPA) is likely to be the most important process of any quality management system (QMS) because so many other activities depend on it. These include not just the traditional processes for handling poor quality, customer complaints, and audit findings but also outputs of the management review meeting and stakeholder-identified risks and opportunities. Inadequate CAPA is a predominant source of ISO 9001 and IATF 16949 audit findings, and also FDA Form 483 observations. The good news is however that the Automotive Industry Action Group's CQI-20, Effective Problem Solving, and the related Eight Disciplines (8D) process, are proven off-the-shelf CAPA processes. They will work on waste (muda) other than poor quality as well as OH&S issues. They are easier to understand and apply than Six Sigma's DMAIC and work on a wider variety of problems. When CQI-20 and 8D are too complicated for a simple issue—we don't have to convene a cross-functional team to decide to put a guard on a machine or move parts closer to the work station so the employee doesn't have to walk to get them—the much simpler Error Cause Removal (ECR) process can be used. ECR is often initiated by a worker or other relevant interested party, and it empowers everybody to identify risk and opportunities to drive continual improvement. Its application to OH&S in the context of near-miss reporting (hiyarihatto, "experience of almost accident situation") supports ISO 45001:2018's requirements for workforce participation in the OH&S management system, and supports OSHA requirements as well. AREAS COVERED
1. Supplier and customer processes of CAPA; the numerous processes of the quality management system that supply inputs and receive outputs from CAPA. • Example: the internal
audit process is a supplier of audit findings and observations to the CAPA
process, whose resulting outputs are deliverables (inputs) for the management
review of audit status reports. 2. CAPA is a leading source of ISO 9001 and
IATF 16949 findings, and FDA audit 483 observations. • Recognize that there is
a problem (awareness) (1) The
occurrence root cause is why it happened. • Identify, and test for
effectiveness, corrective or preventive actions 6. Error Cause Removal (ECR), as described by Halpin's (1966) Zero Defects, is a very simple CAPA process for issues that can be resolved on the shop floor by the process owner without the need for a cross-functional team or extensive root cause identification. Simple case studies will be given. Attendees will receive a copy of the slides and accompanying notes, and also a simple draft ECR process they can modify to meet the needs of their own organization. LEARNING OBJECTIVES
The webinar will provide a comprehensive overview of formal corrective and preventive action (CAPA) and also a much simpler process for issues that can be resolved by a process owner on the factory floor. Both processes are applicable not only to poor quality but also occupational health and safety (OH&S) and the other six Toyota production system wastes (muda). WHO WILL BENEFIT
ISO 9001:2015 and IATF 16949 users, including but not limited to manufacturing and quality managers, engineers, and technicians. SPEAKER
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. Use Promo Code INDA20 and get flat 20% discount on all purchases.
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1:00pm to 2:30pm
Live webinar: $159.00 20 17209961616 UPCOMING EVENTS
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