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CORRECTIVE AND PREVENTIVE ACTION (CAPA): OUR MOST IMPORTANT QUALITY PROCESS




 Date : Wednesday Jun 05, 2024  Presented By : William A. Levinson  Time : 1:00
PM EDT  Event Type : Live Webinar  Duration : 90 minutes  Event Category :
Pharmaceutical  Days Left : 19 Days  Order Form : Order Form

For group or any booking support, contact:  cs@ecowebinar.com  + 1 (866)
755-8624 (US Toll Free)


Live $229 Recording $229 Transcript $229 DVD $249 Flash Drive $249 Live &
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DESCRIPTION

Corrective and preventive action (CAPA) is a process for the identification and
resolution of customer complaints, nonconforming products, audit findings,
safety problems, and even more. It consists of definition and identification of
the problem and its root causes, and permanent actions to eliminate the problem
and prevent it from coming back. The lessons learned must also be deployed to
similar activities so we don't end up having to solve the same problem, or a
similar one, more than once.


AREAS COVERED:-

 * CAPA applies to a very wide range of activities in the quality management
   system, as opposed to only nonconforming products and customer complaints. It
   is also vital for internal and external audit findings, and outputs of the
   management review meeting. It can even be used on other Toyota production
   system wastes that do not involve poor quality if we treat as a problem any
   gap between the current state and a desirable future state. Inadequate CAPA
   for complaints, nonconforming products, and audit findings is meanwhile a
   major source of ISO 9001 and IATF 16949 (automotive) audit findings, and FDA
   Form 483 citations.
 * AIAG's CQI-20, Effective Problem Solving, is an evolution of the excellent 8D
   (Eight Disciplines) approach and may well be the best CAPA system ever
   devised. Levinson Productivity Systems recommends this manual (available from
   AIAG) and has no financial interest in resulting sales.
 * The CQI-20 process is as follows:
   * Awareness of the problem; we cannot solve a problem about which we do not
     know. This can come from many sources, and remember that a gap between
     current performance and desired performance can be treated as a problem; it
     need not be related to poor quality.
   * Form an appropriate cross-functional team
   * Define the problem; it is vital to define the problem accurately because,
     if we work on the wrong problem, we will never solve the right one.
   * Contain the problem, if necessary to protect internal or external
     customers. (This applies only to nonconforming work, but not to improvement
     opportunities). Containment is however not correction.
   * Identify the problem's root cause. CQI-20 cites not only the familiar
     occurrence root cause (why it happened) but also the escape root cause (how
     it reached the next internal or external customer if it did) and also the
     systemic root cause.
   * Select and test preventive and corrective actions to ensure that they work.
   * Implement the selected actions.
   * Prevent the recurrence of the problem by deploying the lessons learned to
     similar activities throughout the organization.
   * Recognize the team.
 * Case studies:
   * Quality example adapted from Shingo, Shigeo. 1986. Zero Quality Control:
     Source Inspection and the Poka-Yoke System.
   * CAPA for waste motion adapted from Frank Gilbreth's bricklaying. This
     exemplifies application to a gap between current performance and achievable
     performance, rather than bad quality.
 * A simplified approach when full-scale CAPA is not necessary; this works when
   the problem (or opportunity) can be addressed by the process owner on the
   shop floor without any worries about the management of change (MOC) issue.
   MOC applies when seemingly innocent changes in a process can have undesirable
   side effects.

Disclaimer; no part of this presentation constitutes engineering advice


WHY SHOULD YOU ATTEND:-

Corrective and preventive action (CAPA) is arguably the most important process
of any quality management system because so much else depends on it. It is
applicable not only to nonconformances (poor quality) but also to internal and
external audit findings, outputs of the management review meeting, and more.
Inadequate or deficient CAPA is a leading source of ISO 9001 audit findings, and
also Form 483 citations in FDA-regulated industries. A sample Form 483 violation
notice cited, in fact, "Your response is inadequate because it did not provide
sufficient detail or evidence of corrective actions to bring your operations
into compliance with CGMP." (CGMP = Current Good Manufacturing Practice
regulations).

The good news is that the Automotive Industry Action Group's (AIAG's) CQI-20,
Effective Problem Solving, is probably the best CAPA process ever devised; it is
an evolution of the previous (and similarly excellent) 8D (Eight Disciplines)
process. It can also be used on all forms of waste (such as waste motion, wasted
time, and wasted energy) as opposed to only poor quality if we define a problem
as any gap between the current state of affairs and a desirable and
realistically obtainable future state. This enables us to use CAPA to drive
continuous improvement as well as solve quality problems.


WHO SHOULD ATTEND:-

All ISO 9001:2015 users, including but not limited to manufacturing and quality
managers, engineers, and technicians. In addition, FDA-regulated industries,
including medical device manufacturers, may find this useful.

PRESENTED BY : WILLIAM A. LEVINSON

Bill Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He
is also the author of several books on quality, productivity, and management, of
which the most recent is Reshore Production Now.


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