Quality Progress - March 2017 - 42


F E AT U R E

CAPA

of the potential problems. A documented
procedure shall be established to define
requirements for ... reviewing preventive
action taken and its effectiveness."3
ISO 9001:2015 addresses VOE requirements: "When a nonconformity occurs,
including any arising from complaints, the
organization shall ... review the effectiveness of any corrective action taken."4
In the recently released ISO 13485:2016,
VOE requirements are explained: "The
organization shall take action to eliminate
the cause of nonconformities in order
to prevent recurrence. Any necessary
corrective actions shall be taken without
undue delay. Corrective actions shall be
proportionate to the effects of the nonconformities encountered ... reviewing the
effectiveness of corrective action taken."5
After reviewing these requirements,
the question you must ask is, "How do

FIGURE 1

The 8 phases of the
CAPA process
CAPA phases

Corrective action
Implementation
Verification of effectiveness
Closure

CAPA = corrective and preventive action

42 QP

March 2017 ❘ qualityprogress.com

Improvement

Management review

Impact assessment

Investigation/
root cause analysis

Make CAPAs SMART

The SMART method sets goals that can be
directly applied to a good VOE using five
questions:
1. Specific-Is the VOE unambiguous,
clear and focused?
2. Measurable-Are quantifiable data
being used to assess the VOE?
3. Achievable-Is the VOE feasible or
practical?
4. Relevant-Is the VOE appropriate for
the level of risk?
5. Time bound-Does the VOE have a
realistic deadline?

VOE example

Problem identification

Correction/containment

I ensure a CAPA is truly effective?" This
raises several additional questions:
+ Do I re-execute the process validation?
+ Do I see whether the issue reappears in
90 days?
+ Do I analyze the next three production
lots?
+ Do I analyze the next three shipments
from the supplier?
While each of these questions may be
valid, their answers may not fully verify
the effectiveness of implemented corrective actions. This is where the application
of specific, measureable, achievable,
relevant and time-bound (SMART) goals
method can be applied to CAPA and VOE
processes.

Consider this example of VOE (names
of the product and organization and the
team's results were changed for confidentiality). Recently, a long-running
stable process on Acme Press 112, which
produces Adapter 1674, revision C, began
producing parts that were out of specification on critical characteristic No. 3.
Acme Press 112 is used only to produce
Adapter 1674. A typical production lot can
be produced in a 10-hour shift, which is a
normal workday for the facility.
A CAPA was opened as a result of the
nonconforming product being produced.
An impact assessment and containment

FIGURE 2

Applying
SMART criteria
Verification of effectiveness checks

S

Specific

M

Measurable

A

Achievable

R

Relevant

T

Time bound

action were performed, production
records for the previous five lots were
reviewed, a root cause investigation was
conducted, and a corrective action was
implemented.
During a review of the batch records,
the CAPA team's investigation revealed
machine settings were set outside the
validated parameters due to new, inexperienced operators. The team concluded
this was the likely root cause of nonconforming product.
The CAPA team decided to address the
root cause by changing the programmable
logic controller user access permissions,
which would restrict an operator's ability
to select parameters that were outside the
validated settings. Additionally, operators were retrained to ensure validated


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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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