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Applying Process-based Analytics to Audit Results for Process Management and Improvement
1. Applying Process-based Analytics
to Audit Results for Process
Management and Improvement
John G. Surak, PhD Jeffery L. Cawley
Surak and Associates Northwest Analytics
Clemson, SC Portland, OR
2. Operational audits and inspections play a critical role in
assuring the effectiveness of food safety system (Table 1).
To achieve maximum effectiveness of these activities,
key process indicators should be identified and plotted on
control charts. The control charts can then be assessed for
trends, so actions can be taken before a food safety
incident occurs.
Preoperational Audit
Facility Audit
Pest Control Audit
Microbial Environmental Monitoring Audit
Table 1 – Examples of Operational Inspections and Audits
3. The GFSI benchmarked audit schemes require that food
processors conduct an internal audit. The internal audit
should determine the conformance of the Food Safety
Management System (FSMS) to plan. It is used to answer
the following questions:
• Is the FSMS implemented?
• Is the FSMS effective?
• Is the FSMS efficient?
• Is the FSMS sustainable?
• Is the FSMS updated?
The internal audit is not a substitute for the other audits.
The primary focus of the operational inspections and
audits is to determine if the food safety activities are being
carried out. The primary focus of the internal audit should
to determine if the FSMS is working as planned.
4. This will cause a shift in the types of audits that are
conducted from a checklist approach to a process
approach.
For example, a checklist for a preoperational audit may ask
the question, “Are the floors clean?” The auditor may
observe that a floor is not properly clean. Using the
process audit concept, the auditor may ask additional
questions that focus on gathering information on why the
floor is not clean.
In addition, the auditor may be also responsible for taking
microbiological environmental samples and reporting the
results to the manager responsible for cleaning and
sanitizing. Individual results of the weekly microbial
environmental monitoring audit, reported as CFUs/inch²,
will summarize the effectiveness of the cleaning program
for that week.
5. The auditor should also plot the microbial data over a
period of time to determine if there are any trends in
the cleaning and sanitizing program.
6. Control charts can be used to display the sanitation
data. Examples of these plots are shown in Figures 1
and 2. Figure 1 shows the plot of environmental
samples over a period of a half of year. The samples
were taken after cleaning and before sanitization.
The graph shows a number of signals as indicated by
the red diamonds. These signals show that there was
a change in the cleaning process.
The auditor responsible for taking and analyzing the
data should provide feedback that problems were
observed in the effectiveness of the cleaning program
so that the cleaning and sanitizing program can be
improved.
7.
8. The function of the internal audit is to verify the
effectiveness of the FSMS or determine that the
organization is functioning according to plan. In the
previous example, the internal audit primary focus is to
determine if the verification system for cleaning and
sanitizing is properly working.
For example, during the planning part of an internal
audit that focuses on cleaning and sanitizing, the auditor
can review records which include control charts. The
internal auditor may conduct further analysis of the
microbial data.
9.
10. Figure 2 show a second control chart of the same
microbial data. In this chart, the control limits were
calculated by each quarter. In addition to the signals that
were observed in Figure 1, the second control chart
indicates that there was an increase in the variation of
microbial levels between the first quarter and the second
quarter.
As part of this audit, the auditor should investigate what
was done with the original environmental sampling
information. Did the auditor who was responsible for
taking the environmental samples provide effective
feedback to plant management responsible for cleaning
and sanitization? Did the plant determine why the
cleaning process deteriorated? If a root cause was
identified, was this knowledge used to improve the
cleaning and sanitizing process?
11. Operational Operational
Verification of Internal Management Certification
Food Safety Food Safety Audits Review Audits
Activities Activities
Figure 3: Linkage between operational activities and the Food Safety Certification Audit
12. Finally the internal audit reports and findings feed into
management review, to assess the effectiveness of the
FSMS, and develop objectives and business plans to
update and improve the FSMS. Figure 3 shows the
linkage of food safety activities linkage to certification
audits.
The proper linkage and operation of the components of
the FSMS allows for successful certification audits and
gives confidence to Senior Management and other
stakeholders that the organization has a robust food
safety management system.
Contact information:
John G. Surak Jeffery L. Cawley
Principal Vice President Industry Leadership
Surak and Associates Northwest Analytics
Clemson, SC Portland, OR
864-506-2190 jcawley@nwasoft.com
jgsurak@yahoo.com 503-224-7727