Quality Progress - March 2017 - 43


machine parameters were set per procedure and that the validated settings would
be recorded in the device history record
(DHR), also known as a batch record.
The CAPA owner, in conjunction with
the CAPA team, used the SMART method
to develop the VOE check, and they
decided on the following VOE:
Adapter 1674 Revision C critical characteristic No. 3 produced on Acme Press
112 will be monitored for conformance to
specifications over three consecutive days
of production (three lots) using a tightened level of inspection per the sampling
procedure.
The CAPA will be deemed effective
if critical characteristic No. 3 is within
specification for three consecutive days
of production (three lots), the operators
are unable to select parameters outside
of the validated range, the operators were
retrained, and the proper validated settings are recorded in the batch record.

Evaluating the VOE

The next step is to evaluate the VOE and
determine whether it's SMART.
Specific-Is the VOE unambiguous,
clear and focused? Yes:

+ Adapter 1674 revision C critical characteristic No. 3 produced on Acme Press
112 will be monitored for conformance.
+ Operators are unable to select parameters outside the validated range.
+ Operators will be retrained to ensure
validated machine parameters are set
per procedure.
+ The validated settings are recorded in
the DHR.
Measurable-Are quantifiable data
being used to assess the VOE? Yes:

+ Critical characteristic No. 3 will be
monitored for conformance to specifications for three consecutive days
of production (three lots) using a
tightened level of inspection per the
sampling procedure.

+ Training records will be reviewed to
ensure the operators were retrained.
+ Batch records will be reviewed to ensure
the proper validated settings were
recorded and used.
Achievable-Is the VOE feasible or
practical? Yes:

+ There will be monitoring for conformance to specifications for three
consecutive days of production (three
lots) using a tightened level of inspection per the sampling procedure.
Relevant-Is the VOE appropriate for
the level of risk? Yes:

+ Tightened level of inspection per sampling procedure will be used to monitor
critical characteristic No. 3.
+ Time bound-Does the VOE have a
deadline? Yes:
+ The VOE will occur over three consecutive days of production (three lots).

Results

Acme Press 112 produced Adapter 1674
revision C for three consecutive days
(three lots). Critical characteristic No. 3
was verified using the tightened inspection plan. All inspected manufactured
product was found to be in conformance.
It was confirmed that the operators
were able to set parameters only within
the validated range. The training records
indicated the operators were retrained.
Additionally, the batch records were
reviewed to ensure the proper validated
settings were recorded and used. The

CAPA team decided the CAPA was complete and effective. The team also shared
its success with other departments so
similar actions could be implemented.
The example demonstrates the
appropriate use of the SMART method
to verify CAPA effectiveness and ultimately provide CAPA closure. Adapting
the SMART method can help improve the
effectiveness of your CAPA program and
demonstrate compliance with regulations,
standards and expectations.

REFERENCES
1. U.S. Food and Drug Administration, "CFR-
Code of Federal Regulations Title 21,"
Accessdata.fda.gov, 2015, http://tinyurl.com/
fdagov-qp.
2. International Organization for Standardization
(ISO), ISO 9001:2008-Quality management
systems-Requirements, subclause 8.5.2.
3. Ibid., subclause 8.5.3.
4. ISO, ISO 9001:2015, Quality management
systems-Requirements, subclause 10.2.1.
5. ISO, ISO 13485:2016, Medical devices-Quality
management systems-Requirements,
subclause 8.5.2.
BIBLIOGRAPHY
Breyfogle, Forrest W., Implementing Six Sigma,
second edition, John Wiley & Sons, 2003.
Doran, George T., "There's a S.M.A.R.T. Way to
Write Management's Goals and Objectives,"
Management Review, Vol. 70, No. 11, pp. 35-36.
ISO, ISO 13485:2003-Medical devices-Quality
management systems-Requirements for
regulatory purposes.
Kelly, Larry, "Quality Management System-
Medical Devices-Guidance on Corrective
Action and Preventive Action and Related QMS
Processes," Global Harmonization Task Force,
Nov. 4, 2010.
Rodríguez-Pérez, José, CAPA for the FDARegulated Industry, ASQ Quality Press, 2010.

Mark Durivage is managing principal consultant at Quality
Systems Compliance LLC in Lambertville, MI. He earned his
master's degree in quality management from Eastern Michigan
University in Ypsilanti. He is an ASQ fellow and holds several
ASQ certifications, including quality auditor, biomedical auditor,
HACCP auditor, pharmaceutical good manufacturing practices
professional, Six Sigma Black Belt and manager of quality/
organizational excellence. Durivage also authored and edited
several ASQ Quality Press books.

qualityprogress.com ❘ March 2017

QP 43


http://www.tinyurl.com/fdagov-qp http://Accessdata.fda.gov http://www.qualityprogress.com

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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