Manufacturing Practices (GMPs)-raw
area, transitional area, GMP unexposed-product area, and primary pathogen
control area (exposed finished-product
area). Color-code the hygienic zones
on the floor plan map to visualize risk
(Figure 2). Looking at the facility from
this perspective will help assess the risks
associated with the environment, allowing for the design of a robust hygienic
zoning program. Moreover, adding foot
and equipment traffic patterns to the
map can help identify potential routes
of pathogen spread between areas and
determine where to place shoe- and
wheel-sanitizing stations, for example.
Next, divide the plant into distinct areas
within the hygienic zones based on
physical infrastructure or manufacturing activity. Sometimes, for related but
distinct areas, it’s a good idea to add
another level of distinction by further
dividing them into subareas. Each swab
site will fall into an area and subarea—
like a GPS for sampling points. Include
these master data with all sampling
points. This type of hierarchy built into
the sampling sites allows faster filtering
and grouping when analyzing the data
and may bring to light relationships between areas.
Lock In the Sampling Plan
Once hygienic zones and specific
areas to monitor have been identified,
plan the required monitoring activities
to be associated with each. When deter-
mining which sites to swab each week, it
is recommended to randomize the se-
lection of the sampling points from the
site list. However, this selection should
not be completely random. If you are
a betting person, you know that on a
given week, all samples could be in non-
production areas! Therefore, organize
the swab sites into smaller groupings
and randomize within those groupings.
An example of this could be to organize
by proximity to product contact zones
(zones 1, 2, 3, or 4) within a subarea so
that the randomizer selects a sufficient
number for those areas. This will ensure
an adequate snapshot of conditions in
all areas of the plant obtained at each
routine swabbing event—typically each
week. In guidance issued to industry,
the U.S. Food and Drug Administra-
tion (FDA) has recommended weekly
swabbing for Listeria, 5 and the Grocery
Manufacturers Association (GMA) has
recommended for Salmonella that “each
facility should determine the frequency
adequate for its product and process,”
and “A rotation schedule should be
developed to allow all areas of the plant
to be sampled on a periodic basis, e.g.,
weekly monitoring with rotation of sites
between different areas of the plant,
with all sites sampled within a specified
time period (e.g., monthly or quarter-
Environmental monitoring swabs
collected as a verification of pathogen
control programs/hygienic zoning are to
be collected at random hours any time
after 3 hours into production. Docu-
ment the date and time swabs were
collected so they can be available for
trending. Software and services are avail-
able that can assist in storing, organiz-
ing, and managing sample master data,
sampling numbers, and frequencies to
meet program requirements. More on
Secure the Environment and
Strengthen Records with Effective
Mitigation and Documentation
In the event of a presumptive result,
corrective action should be taken upon
Summarize the likely cause for
the environmental positive.
Include what control(s) probably
failed that led to the sampling
point pathogen-positive result.
Write statement summarizing
how/why there is not a route of
contamination to product either
from man or machine from a
zone 2 (Listeria and Salmonella)
or zone 3 (Salmonella) positive
site. State as much as you can for
your rationale. Use photos if
needed to illustrate your point.
See 4. 3. 7. 7. 5 Reporting
Environmental Sampling Results
on the FDA 483
State the short-term corrective
actions taken to eliminate the
If applicable, state the long-term
corrective actions to be
implemented that are intended to
reduce the likelihood of
Give time frame.
Violation of Traffic Controls
Failure of GMPs
Failure of SSOP
MSS not complete/not current
Poor sanitary design
Swab was collected in the raw area–however, there is
a validated kill step for Lm/Salmonella.
The site is located outside of areas where hand
contact could occur.
All tools color-coded for product contact are properly
stored so that FCS tools don’t come into contact with
Tools or equipment never contact this zone 2 site.
Exterior surfaces of transport vessels do not come
into contact with zone 1.
GMP/personnel practices do not allow for transfer of
pathogens from zone 2 to zone 1 (example: when
worker touches zone 3 or zone 2, gloves are changed
before touching product/zone 1).
For USDA plants: Use zone 1 monitoring history.
There is no hand contact of product.
GMPs do not allow workers to rest foot on
equipment frame work, which could transfer
microorganisms from the floor.
Short-term CA examples:
Cleaned implicated site and area.
Removed sandwich areas that created harborage.
Replaced rusted area on equipment.
This also may be written/cross-referenced on a
plant internal document.
EMPC – Root-Cause Analysis & Corrective and Preventive Actions
SAP# City, State Plant:
Sample Site ID# (if assigned)
Hygienic area (PPCA, GMP-
Unexposed Product Area,
Zone (1, 2, 3, 4):
Sample Manager Incident ID:
Sample point description and
Pathogen of concern:
(Salmonella or Listeria):
Incident closing date:
Incident closed by:
Revie w date:
Figure 1. Root-Cause Analysis, Risk Assessment, and Corrective and Preventive Action Data
Capture Template Example