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发帖数: 1652 | 1 http://en.wikipedia.org/wiki/Corrective_and_preventive_action
Corrective and preventive action (CAPA, also called corrective action /
preventive action) is a concept within good manufacturing practice (GMP).
CAPA focuses on the systematic investigation of discrepancies (failures and/
or deviations) in an attempt to prevent their recurrence (for corrective
action) or to prevent occurrence (for preventive action). To ensure that
corrective and preventive actions are effective, the systematic
investigation of the failure incidence is pivotal in identifying the
corrective and preventive actions to be undertaken. CAPA is part of the
overall quality management system (QMS).
[edit] ConceptsClearly identified sources of data which identify problems
that will be investigated.
Root cause analysis to identify the cause of a discrepancy or deviation and
suggest corrective actions to potentially prevent recurrence of a similar
problem, or preventive action to ensure that discrepancies do not occur.
Remedial corrections of a problem which is identified.
A common misconception is that the purpose of preventive action is to avert
the occurrence of a similar potential problem. This process is all part of
corrective action, because it is a process of determining such similarities
that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential
discrepancies before they occur and to ensure that they do not happen (
thereby including, for example, preventive maintenance, management review or
other common forms of risk aversion). Corrective and preventive actions
both include investigation, action, review, and further action if so
required. It can be seen that both fit into the PDCA (plan-do-check-act)
philosophy as determined by the Deming-Shewhart cycle.
Investigations to root cause may conclude that no corrective or preventive
actions are required, and additionally may suggest simple corrections to a
problem with no identified systemic root cause. When multiple investigations
end in no corrective action, a new problem statement with expanded scope
may be generated, and a more thorough investigation to root cause performed.
[edit] See alsoCAPA:
Implementation of Corrective & preventive actions is the path towards
improvement & effectiveness of Quality Management system. Corrective actions
is nothing but the action/s based on the problem identification. The
problem or a non-conformance can be identified internally through staff
suggestions, management reviews, document reviews or internal audits.
Customer complaints / suggestions, customer rejections, non-conformities
raised in customer / third party audits & recommendations by the auditors
are the external sources which lead to find the ROOT CAUSE of the problem.
Corrective action is a reaction to any of the cause/non-conformance
mentioned above & can be divided in two phases of action: 1) Identification
of root cause: for this purpose TQM tools such as fish-bone or cause &
effects analysis can be practiced. Your CAPA would be appropriate &
effective if & only if you have identified the root cause of problem. 2)
Taking necessary actions: in order to address the root cause take necessary
immediate action/s. The effectiveness of the corrective action taken has to
be verified periodically through a systematic approach of PDCA(Plan - Do -
Check - Act) cycle.
Preventive action is prediction of problem & trying to avoid the occurrence
(fail safe) through self initiated action/s & analysis related with your
processes / products. This can be initiated with the help of active
participation of staff members / workers through improvement teams,
improvement meetings, management review, customer feedback & deciding own
goals quantized in terms of business growth, reducing rejections, utilizing
the equipments effectively etc. |
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