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for issue 12, available in full-color
PDF.
Are Your Corrective Actions
Correct?
By Denise Amann
What should you do if you observe a deficiency at your
establishment, such as a deviation from a critical limit as
outlined in your Hazard Analysis and Critical Control Point (HACCP)
plan, the occurrence of an unforeseen hazard, or the direct
contamination or other adulteration of your product?
You’re required to perform and document corrective actions when
you see these deficiencies. Taking corrective actions is
critical because it is a way you are ensuring that adulterated
product does not leave your plant.
Deficiencies that require corrective actions fall into two
general categories – HACCP and Sanitation Standard Operating
Procedure (SSOP). For example, let’s say you have a deviation
from a critical limit. This would require HACCP corrective
actions. Therefore, the actions you need to take must:
- Identify the cause of the deviation;
- Ensure that the critical control point is under control after
the corrective action is taken;
- Take measures to prevent recurrence of the deviation;
- Document that no product that is injurious to health or
otherwise adulterated as a result of this deviation has or will
enter commerce; and
- Maintain detailed records of corrective action.
All five of the corrective action requirements must be
implemented and documented by your plant for each
deviation that occurs.
If there’s an unforeseen hazard, which is defined as a potential
hazard deemed not likely to occur in your hazard analysis for a
documented reason, this is considered a HACCP noncompliance. Because
it’s
typically not related to a critical control point, the required
corrective actions for an unforeseen hazard are more focused on
product acceptability and distribution. You’re required to reassess your HACCP plan to determine if the
unforeseen hazard is likely to occur again and should be
incorporated into your plan.
If your plant fails to prevent direct contamination or adulteration
of product, you’re required to perform SSOP corrective actions.
Examples of corrective actions
include:
- Changing the process and holding the product for further
evaluation.
- Empowering the monitoring personnel to stop the process when
a deviation occurs. They should have the authority to hold all
products not in compliance.
- Relying on an approved alternate process that can be
substituted for the one that is out of control at the specific
critical control point.
“Oftentimes, an establishment may choose
retraining as a method of preventing recurrence,” said Cheryl Hicks,
Executive Associate of FSIS’ Office of Field Operations. “You may
use retraining as a preventative measure multiple times. However, if
retraining sessions do not prevent recurrence of
problems of similar cause, FSIS may not accept training as an
effective preventative measure.” Proposed future training activities
should be properly documented and made available to FSIS inspectors
upon request.
It’s important to remember that the required
HACCP verification activities include the direct
observation of corrective actions. FSIS Directive
5000.1, Revision 3, states that plants should “directly observe
corrective actions frequently enough to verify that these actions
are being performed in a manner that meets the applicable regulatory
requirements.” This
verification activity is documented in a manner similar to other
direct observation verification activities at your plant. If not at
every occurrence, the frequency used to
observe corrective actions directly should be supported with
documentation.
The Interactive Knowledge Exchange (IKE)
provides an excellent resource for you to examine corrective actions
further (see Small Plant News, November 2007). For access to an IKE
scenario related to the direct observation of corrective actions,
visit
www.fsis.usda.gov/PDF/IKE_02-08.pdf.
Finally, you have the right to appeal all or part
of any noncompliance report. This appeal should be addressed with
your inspector. For more information about the appeal process, visit
www.fsis.usda.gov/Regulations_&_Policies/Policies_on_
Regulatory_
Decisions/index.asp or contact the Policy Development
Division at (800) 233-3935 or the Office of Outreach,
Employee Education, and Training at (800) 336-3747.
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Register for Upcoming Regulatory
Education Sessions and “How To” Workshops
By Jane Johnson
Since 2006, FSIS has been conducting regulatory educational
seminars on a variety of topics that have provided owners,
operators, and managers of small and very small plants with
information to enhance the design and
implementation of their food safety systems. In January 2009,
the Agency began conducting a series of “How To” workshops to
provide small plants with the practical tools and methods for
proper application and compliance with FSIS regulations.
According to Stephanie Wilkins, chief training officer for the
FSIS Center for Learning, “We’ve structured these workshops and
their content delivery based on feedback that we received from
small and very small plant owners and operators. Our trainers
enjoy interacting with the small plant personnel at these
workshops, and they provide an opportune time for constructive
dialogue.”
The “How To” workshops are being held in various locations
throughout the country and cover topics such as developing food
defense plans, effective sanitation practices, humane handling
of livestock, and controlling Salmonella and Campylobacter in
poultry plants, just to name a few. For more information or to
register for one of the workshops or regulatory educational
seminars, visit FSIS’ Web site at
www.fsis.usda.gov/News_&_Events/Outreach_Sessions_SVS_
Plants/index.asp. Or, call the Office of Outreach, Employee
Education, and Training at (800) 336-3747 for further
assistance.
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Food Safety Resources
By Sally Fernandez
Supporting Documentation for HACCP Decisions is a resource
designed especially for operators of small plants to aid in the
scientific documentation of HACCP decisions during hazard
analysis, validation of plans, and
corrective action. The book is organized by HACCP process
category so that you can validate and demonstrate the
effectiveness of the process steps once you have identified specific hazards
and critical control points.
The information is organized in easy-to-read tables of process
steps, potential hazards, process parameters, decision criteria,
and scientific documentation. Where available, a
Web site is given to allow Internet access to the scientific
publications.
This edition was updated in early 2007, but new research and
documentation is constantly evolving. Regular updates are
made to the
online version on the Ohio State University Meat Science Web
page at
http://extension.osu.edu/~meatsci/currentprog.html.
To order your free copy, complete and submit the online order
form at
www.fsis.usda.gov/Science/HACCP_Resources_Brochure/
index.asp. You can also fax the order to
(202) 690-6519. For more information, call (800) 336-3747.
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Briefs
By Sheila Johnson
Podcasting
Don’t forget to check out the latest educational
podcasts related to various food safety issues for plants and
consumer education information. If you haven’t signed up yet for
a free subscription, visit
www.fsis.usda.gov. For assistance or details concerning FSIS
podcasts,
send an email to podcast@fsis.usda.gov or call FSIS’
Congressional and Public Affairs Office at (202) 720-9113.
Regulatory Web Seminars
FSIS sponsors a seminar series targeted to owners and operators
of small and very small plants. The seminars cover a variety of
technical topics concerning FSIS policies and new technologies
of interest to industry. The Agency welcomes your participation at these free sessions.
The seminars are conducted via Net Meeting, which utilizes
Internet access for viewing the presentations and a telephone
line for the audio portion. Preregistration is required to
participate in these seminars and online
registration forms are available on FSIS’ Web site at
www.fsis.usda.gov/
News_&_Events/Regulatory_Education/index.asp.
You can view the content of past presentations
by visiting
www.fsis.usda.gov/News_&_Events/Reg_Education_
Videos/index.asp. Here you can
download presentations ranging from a Review of FSIS Compliance
Guidelines for the Production of Safe Meat and Poultry Jerky
Products in Small and Very Small Plants to E. coli
O157:H7 Reassessment and Best Practices. For assistance, either
with registering or to
obtain copies of previous seminar presentations, contact the
Office of Outreach, Employee Education, and Training at (800)
336-3747.
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What’s All the Buzz About Validation?
By Denise Amann
“Validation is that element of verification focused on
collecting and evaluating scientific information to determine if
the HACCP plan, when properly implemented, will effectively
control the hazards.” (National Advisory Committee on
Microbiological Criteria for Foods, 1997)
Simply put, validation is proving that what you’re
doing at a particular step in your process is working to reduce
that hazard to acceptable levels. Validation activities are
typically performed at two different times within the process –
initial validation and ongoing validation.
Initial validation is used to determine if the Hazard Analysis
and Critical Control Point (HACCP) plan is scientifically and
technically sound. This process would include identifying all
potential hazards and documenting
scientific evidence that each potential hazard has been
effectively controlled at your plant.
Ongoing validation should be performed as needed internally or
by an unbiased, independent authority. Situations that may
necessitate ongoing validation include
unforeseen hazards, significant product or process changes, and
evidence of a loss in process control.
Laboratory research yields valuable information on validation of
controls to guide food processors. Even so, laboratory research
and data are not a true substitute for actual in-plant process
validation [Niebuhr, S.E, Laury,
A., Acuff, G.R., and J. S. Dickson. 2008. “Evaluation of
nonpathogenic surrogate bacteria as process validation
indicators for Salmonella enterica for selected
antimicrobial treatments, cold storage, and fermentation in
meat.” Journal of Food Protection. 71(4):714-718].
That is, there must be data showing the effectiveness of the
controls as applied in your plant. In-plant process validation
will be unique to your system and will document the
effectiveness of your food safety interventions and processes.
How do you obtain the data necessary for in-plant
process validation? Actual pathogens cannot be taken into food
processing establishments for obvious reasons.
Therefore, validation activities typically attempt to predict
the distribution and number of pathogenic organisms before and
after a chosen intervention or process step by monitoring
non-pathogenic indicator organisms. Research
has revealed that certain non-pathogenic indicator organisms
have responses to interventions similar to certain pathogenic
organisms. This fact gives establishments the ability to
validate a process internally with relatively basic laboratory
capabilities. Common, frequently validated steps are carcass
washing, evisceration, prechilling, postchilling, and any
critical control point.
The results of a validation study provide benefits beyond
fulfilling FSIS’ HACCP requirements (9 CFR 417.4). In an
effective HACCP system, validation results give you a real
measure of your control over your process
by mapping the reduction of pathogenic and non-pathogenic
organisms on product at different stages of processing. Ongoing validation results can
also be used to pinpoint the source of a problem and allow you to make necessary
adjustments before the process becomes out of control.
Ultimately, frequent ongoing validation of your system lessens
the need to rely on end-product test results. In the long run,
it’s more cost-effective and will increase consumer
confidence in the safety of your product.
If you have any further questions or need more
information about validation, call the Office of Outreach,
Employee Education, and Training at (800) 336-3747.
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Where You Can Obtain Assistance on Validation
By Beth McKew
Now that you understand what validation is and
recognize the need to validate your HACCP plan, where do you go
from here?
As stated in the previous article, you can validate your plant’s
processes yourself, or you can hire a third party to perform
validation studies for you. If you decide that performing
validation studies yourself is the way to go, there are numerous
resources available to help you decide, for example, what steps
in your process are most appropriate to validate and which
indicator organisms are appropriate for the product and
interventions in your plant.
There are HACCP contacts and coordinators in most States to
provide technical advice, assistance, and resources and to
conduct activities to support HACCP implementation
in small and very small plants. The contact is generally the
State meat and poultry program director or another
representative of the State government. Coordinators are
affiliated with universities and provide additional one-on-one
advice and assistance to small and very small plants.
Coordinators also develop and provide training and HACCP
seminars. You can find a listing of HACCP contacts and
coordinators at:
www.fsis.usda.gov/contact_us/state_haccp_
contacts_&_coordinators/index.asp. Or, if you need assistance
obtaining the list of HACCP contacts and coordinators, call the
Office of Outreach, Employee Education, and Training at
(800) 336-3747.
Additionally, industry organizations such as the American
Association of Meat Processors (AAMP) and the International
HACCP Alliance may be able to refer you to resources in
your area to assist you with validation. To contact AAMP, call
(717) 367-1168 or visit www.aamp.com. The International
HACCP Alliance may be reached at (979) 862-3643 or
www.haccpalliance.org/sub/index.html.
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Commonly Asked Questions & Answers
Q. What is the FSIS form number to
authorize the manufacture of brands by the establishment, and what
is the applicable regulation that pertains to issuing this
certificate?
A. The FSIS form number for the
authorization certificate for brands is FSIS Form 5200-7,
Authorization Certificate [formerly MP-216], and is only available
from the Beltsville Document Center. Requirements regarding the
issuance of a brand authorization certificate are outlined in 9 CFR
317.3 (Code of Federal Regulations).
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Small Plant NEWS
Editor: Keith Payne
Production: Sally Fernandez, Joan Lindenberger
Design: Gordon Wilson
Contact: Small Plant News, USDA/FSIS, Aerospace Building,
3rd Floor-Room 405, 14th and Independence Ave., SW, Washington,
DC 20250. 1-800-336-3747
E-mail: SmallPlantNews@fsis.usda.gov |
