Quality Progress - September 2017 - 72

Above and
Beyond

A refresher on a quality
tool, concept or method

How does risk identification and mitigation affect the auditing function?
The auditing-beyond-compliance model
offers a strategy for assessing and measuring risk. A traditional audit may not
detect risk because it primarily focuses on
compliance, and it typically is not designed
to measure variables outside compliance.
This is a missed opportunity to optimize
the audit function's visibility as a continuous improvement tool.

What is risk?

Risk affects a stakeholder's satisfaction to
varying degrees. Risks sometimes are hidden and difficult to detect. In some cases,
the severity of a risk can be assessed by
measuring the negative effects of the risk.
So how does auditing beyond compliance help evaluate the effectiveness of a
risk reduction program? The following case
study shows the steps.

FIGURE 1

Input-output flowchart
Input with impact on output
* Material-approved
pouch material.
* Machine-calibrated/
capable pouch sealer.
* Method-repeatable/
accurate validated process.
* Measurement-process
parameters (seal pressure).
* Manpower-trained
personnel (clean room
compliance).
* Mother Nature (work
environment)-controls to
prevent introduction of
elements with impact to
seal integrity (clean room).

72 QP

Process

Medical device sealing

Step one-Identify the process to be audited. A pouch sealing process for medical
device sterilization.
Step two-Define the audit scope.
+ Pouch sealing process versus requirements.
+ Assessment of risk reduction controls.
Step three-Identify the inputs that affect the output during the planning
stage. Pre-audit research of the process success factors can be performed by:
+ Interviewing the process owner or conducting a brief survey on the input/output
of the process.
+ Reviewing associated issues and documents.
Any information gathered during the pre-audit research can be used to create a
flowchart similar to Figure 1. The input/output can be determined by asking:
+ What is the desired output of the pouch sealing process? The desired output is
repeatable seal integrity within the seal specifications.
+ What are the variables affecting the desired output? Typical process variables
are the 6Ms: manpower, material, method, measurement involved in the process,
machine and Mother Nature (work environment). Online Table 1 (which can be found
on this article's webpage at qualityprogress.org) shows how the 6Ms affect output.
This short case study shows the simple steps to identifying the potential risks and
measurements that are verifiable during an audit.
Auditing beyond compliance captures improvement
opportunities and waste, and enhances the added-value visibility of the auditing function outside of
compliance verification. The auditing beyond compliance model is a tool that can help you effectively audit
risk reduction programs to ensure continuous alignDesired output
ment between process controls and metrics.

Critical-to-quality
or success factor:
Pouch
seal
process

September 2017 ❘ qualityprogress.com

by Janet Bautista Smith

Repeatable seal
integrity
within the seal
specifications

Janet Bautista Smith is
the director of quality and
continuous improvement
at ProTrans International in
Indianapolis. She holds a
bachelor's degree in chemical
engineering from the University
of Santo Tomas in Manila,
Philippines. A senior member of ASQ, Bautista Smith is
an ASQ-certified Six Sigma Black Belt, quality engineer,
quality auditor and certified manager of quality/
organizational excellence. Bautista Smith is the author
of Auditing Beyond Compliance (ASQ Quality Press,
2012) and The Art of Integrating Strategic Planning,
Process Metrics, Risk Mitigation, and Auditing (ASQ
Quality Press, 2015).


http://www.qualityprogress.org http://www.qualityprogress.com

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

Seen and Heard
Progress Report
Mr. Pareto Head
Career Coach
Expert Answers
Field Notes
Data Disruption
The Deal With Big Data
Better Intelligence
A Study in Measurement
Innovation Imperative
Statistics Spotlight
Standard Issues
ASQ's 2017 Quality Resource Guide
Marketplace
Footnotes
Back to Basics
Quality Progress - September 2017 - Intro
Quality Progress - September 2017 - cover1
Quality Progress - September 2017 - cover2
Quality Progress - September 2017 - 1
Quality Progress - September 2017 - 2
Quality Progress - September 2017 - 3
Quality Progress - September 2017 - 4
Quality Progress - September 2017 - 5
Quality Progress - September 2017 - Seen and Heard
Quality Progress - September 2017 - 7
Quality Progress - September 2017 - Progress Report
Quality Progress - September 2017 - 9
Quality Progress - September 2017 - Mr. Pareto Head
Quality Progress - September 2017 - 11
Quality Progress - September 2017 - Career Coach
Quality Progress - September 2017 - 13
Quality Progress - September 2017 - 14
Quality Progress - September 2017 - Expert Answers
Quality Progress - September 2017 - Field Notes
Quality Progress - September 2017 - 17
Quality Progress - September 2017 - 18
Quality Progress - September 2017 - 19
Quality Progress - September 2017 - Data Disruption
Quality Progress - September 2017 - 21
Quality Progress - September 2017 - 22
Quality Progress - September 2017 - 23
Quality Progress - September 2017 - 24
Quality Progress - September 2017 - 25
Quality Progress - September 2017 - The Deal With Big Data
Quality Progress - September 2017 - 27
Quality Progress - September 2017 - 28
Quality Progress - September 2017 - 29
Quality Progress - September 2017 - 30
Quality Progress - September 2017 - 31
Quality Progress - September 2017 - 32
Quality Progress - September 2017 - 33
Quality Progress - September 2017 - Better Intelligence
Quality Progress - September 2017 - 35
Quality Progress - September 2017 - 36
Quality Progress - September 2017 - 37
Quality Progress - September 2017 - 38
Quality Progress - September 2017 - 39
Quality Progress - September 2017 - 40
Quality Progress - September 2017 - 41
Quality Progress - September 2017 - A Study in Measurement
Quality Progress - September 2017 - 43
Quality Progress - September 2017 - 44
Quality Progress - September 2017 - 45
Quality Progress - September 2017 - 46
Quality Progress - September 2017 - 47
Quality Progress - September 2017 - Innovation Imperative
Quality Progress - September 2017 - 49
Quality Progress - September 2017 - 50
Quality Progress - September 2017 - Statistics Spotlight
Quality Progress - September 2017 - 52
Quality Progress - September 2017 - 53
Quality Progress - September 2017 - Standard Issues
Quality Progress - September 2017 - 55
Quality Progress - September 2017 - 56
Quality Progress - September 2017 - 57
Quality Progress - September 2017 - ASQ's 2017 Quality Resource Guide
Quality Progress - September 2017 - 59
Quality Progress - September 2017 - 60
Quality Progress - September 2017 - 61
Quality Progress - September 2017 - 62
Quality Progress - September 2017 - 63
Quality Progress - September 2017 - 64
Quality Progress - September 2017 - 65
Quality Progress - September 2017 - 66
Quality Progress - September 2017 - 67
Quality Progress - September 2017 - Marketplace
Quality Progress - September 2017 - 69
Quality Progress - September 2017 - Footnotes
Quality Progress - September 2017 - 71
Quality Progress - September 2017 - Back to Basics
Quality Progress - September 2017 - cover3
Quality Progress - September 2017 - cover4
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