Quality Progress - March 2017 - 41


F E AT U R E

CAPA

Not Harder
Make your CAPA verification of effectiveness SMART | by Mark Durivage
As an auditor, I frequently write findings for
corrective and preventive actions without an adequate-or even well thought out-verification of
effectiveness (VOE) that demonstrates effectivity.
The purpose of a VOE is to ensure that the actions
taken yield the expected result and that there are not
unintended consequences as a result of the corrective action. Despite their good intentions, many VOEs
frequently fall short of adequately or thoroughly
assessing CAPA effectiveness.
The CAPA process generally consists of eight
distinct phases (see Figure 1, p. 42): problem identification, impact assessment, correction and
containment, investigation and root cause analysis
(RCA), corrective action, implementation, VOE and
closure. The VOE phase is also called effectivity.

Regulations and standards

U.S. Food and Drug Administration (FDA) regulatory
requirements and many International Organization
for Standardization (ISO) standards require a review
of the effectiveness of implemented CAPAs. These
regulatory requirements and standards, however,

Just the
Facts
The specific,
measureable,
achievable,
relevant and
time bound
(SMART) method
can ensure an
organization's
corrective and
preventive actions
(CAPA) are truly
effective.
The method
requires asking
five basic
questions that
can help quality
practitioners
improve the
effectiveness
of their CAPA
programs and
demonstrate
compliance with
regulations,
standards and
expectations.

provide little, if any, guidance on what constitutes an
acceptable VOE.
The VOE requirements for quality system regulation, which can be found in the FDA's Code of Federal
Regulation (Title 21, Part 820.100 Corrective and
preventive action), says: "Each manufacturer shall
establish and maintain procedures for implementing
corrective and preventive action. The procedures shall
include requirements for ... verifying or validating the
[CAPA] to ensure that such action is effective and
does not adversely affect the finished device." 1
The requirements pertaining to VOE in ISO
9001:2008 are: "The organization shall take action
to eliminate the cause of nonconformities in order
to prevent recurrence. Corrective actions shall be
appropriate to the effects of the nonconformities
encountered. A documented procedure shall be
established to define requirements for ... reviewing
the corrective action taken and its effectiveness."2
ISO 9001:2008 states: "The organization shall
determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence.
Preventive actions shall be appropriate to the effects

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Table of Contents for the Digital Edition of Quality Progress - March 2017

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Field Notes
Innovation Imperative
Hard Wired
Propel Forward
Life After Disruption
Work Smarter, Not Harder
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - March 2017 - cover1
Quality Progress - March 2017 - cover2
Quality Progress - March 2017 - 1
Quality Progress - March 2017 - 2
Quality Progress - March 2017 - 3
Quality Progress - March 2017 - 4
Quality Progress - March 2017 - 5
Quality Progress - March 2017 - Seen and Heard
Quality Progress - March 2017 - 7
Quality Progress - March 2017 - Expert Answers
Quality Progress - March 2017 - 9
Quality Progress - March 2017 - Progress Report
Quality Progress - March 2017 - 11
Quality Progress - March 2017 - 12
Quality Progress - March 2017 - Mr. Pareto Head
Quality Progress - March 2017 - Field Notes
Quality Progress - March 2017 - 15
Quality Progress - March 2017 - 16
Quality Progress - March 2017 - 17
Quality Progress - March 2017 - Innovation Imperative
Quality Progress - March 2017 - 19
Quality Progress - March 2017 - 20
Quality Progress - March 2017 - 21
Quality Progress - March 2017 - Hard Wired
Quality Progress - March 2017 - 23
Quality Progress - March 2017 - 24
Quality Progress - March 2017 - 25
Quality Progress - March 2017 - 26
Quality Progress - March 2017 - 27
Quality Progress - March 2017 - Propel Forward
Quality Progress - March 2017 - 29
Quality Progress - March 2017 - 30
Quality Progress - March 2017 - 31
Quality Progress - March 2017 - 32
Quality Progress - March 2017 - 33
Quality Progress - March 2017 - Life After Disruption
Quality Progress - March 2017 - 35
Quality Progress - March 2017 - 36
Quality Progress - March 2017 - 37
Quality Progress - March 2017 - 38
Quality Progress - March 2017 - 39
Quality Progress - March 2017 - Work Smarter, Not Harder
Quality Progress - March 2017 - 41
Quality Progress - March 2017 - 42
Quality Progress - March 2017 - 43
Quality Progress - March 2017 - Statistics Spotlight
Quality Progress - March 2017 - 45
Quality Progress - March 2017 - 46
Quality Progress - March 2017 - 47
Quality Progress - March 2017 - Standard Issues
Quality Progress - March 2017 - 49
Quality Progress - March 2017 - Marketplace
Quality Progress - March 2017 - 51
Quality Progress - March 2017 - Footnotes
Quality Progress - March 2017 - 53
Quality Progress - March 2017 - 54
Quality Progress - March 2017 - 55
Quality Progress - March 2017 - Back to Basics
Quality Progress - March 2017 - cover3
Quality Progress - March 2017 - cover4
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