Product Pathogen Positive?Now What? Devising a plan to determine the steps to follow in case a pathogen is found in the environment, on a piece of equipment, or in a fi nished product, can prove useful. This is known as a CAPA or Corrective Action Preventative Action Plan. When pathogen contamination is suspected, additional testing may be required in order to fully develop the CAPA.

Finished Product Samples: Sample Size ConsiderationIf a composite sample was taken, tested and found to be positive, decide if the individual samples should be tested in an effort to identify the specifi c sample that may have caused the positive test. If testing for Salmonella, draw samples from the individual sample source that would equal a sample size of at least 375 or, better yet, 750 g. Since there is a low incidence rate of Salmonella contamination, a smaller sample size may miss any low level of contamination. If testing for Listeria spp., 25 g samples are adequate but 100 g is better.

Genus and Species Identifi cationIf an individual sample confi rms positive, it is always helpful to identify the species, for future reference. Whether that means a serology for Salmonella or a Pulsed Field Gel Electrophoresis (PFGE) for Listeria, the more information you have about the contaminant, the better. This way, if an environmental sample (i.e. on a motor housing or in a freezer) tests positive, confi rming that it is the same species as a product positive aids in correlating that a cross-contamination occurred; equally, if further testing yields negative results it will indicate that the source was removed.

Disposition of ProductUnless there are full clean-up events throughout the day on the line that was used to produce the implicated product, the entire day’s production (from that line) is at risk. The most conservative approach is either reconditioning the product, with a documented and validated thermal lethality step, or sending it to a land fi ll. Additionally, increasing fi nished product and environmental testing will help prove that other lines are not implicated. It is important to remember that a product positive indicates that there was a post-processing contamination (a pathogen harborage site) lurking in a facility, or that there was a failure in a lethality process. By proactively investigating which situation occurred, you will be able to eliminate the cause and prevent a repeat in the future. Your programs should outline the process for each task.

MICROBIOLOGYAND FOOD SAFETYCONSULTANT’S CORNERVOLUME I • ISSUE 2 • 2015

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Microbiology LaboratoryOur full-service microbiological testing laboratories are ISO 17025 compliant. Service offerings include pathogen and indicator organism screening, probiotic and allergen testing.

SampleKinect®

Our online client portal offers powerful functionalities that allow you to order testing services online, see results as they are posted to your account and download them directly into an Excel fi le to track/trend your data. Our platform features intuitive features to make your day-to-day ordering, shipping and data tracking activities as convenient and fl exible as possible.

How Rigorous is Your Validation? ALT: Step-by-Step Guide to Successful ValidationConducting scientifi cally valid studies is an important step in generating the information you need to develop effective food safety plans.

Process validation, a requirement of FSMA, is defi ned by the Codex Alimentarius Commission (Codex) as “obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling an identifi ed hazard to a specifi ed outcome.”

The fi rst step in any process validation is to conduct a hazard analysis and identify all pathogens of signifi cance for a specifi c food and its specifi c process or control measure. Next, you should develop and maintain food safety control measures in order to eliminate or reduce the microbial safety risk in a fi nished food product to an acceptable level.

Finally, make sure that your validation study focuses on the specifi ed levels of reduction or elimination of the most resistant pathogen, or pathogens, as required by your regulatory body, for the given product or process.

Best Practices:Environmental Monitoring

First and foremost, in any environmental monitoring program, it is crucial to convey the principle of cross-contamination to production, sanitation, maintenance and quality assurance employees. Cross-contamination relative to microorganisms, chemicals or extraneous matter is the act of transferring an item from one place to another. Cross-contamination can occur through different methods.

TABLE 1 - CROSS-CONTAMINATION VEHICLES AND METHODS.

Vehicle Method

Air ▶ Air hoses▶ Vents▶ Fans to cool workers▶ Cooling units

Water ▶ Sanitation hoses that are >40 psi▶ Drain backups▶ Roof/door leaks▶ Leaking hoses and pipes▶ Equipment

DirectContact

▶ Forklift tires or any vehicular traffi c leaving a production room and re-entering

▶ Shoes coming in from the exterior of aproduction room into the production room

▶ Pallets▶ Employee gloves, aprons▶ Dust (especially during construction)

Secondly, a robust environmental monitoring system must include a site list consisting of product contact (Zone 1), non-contact (adjacent to product contact; Zone 2) and indirect contact (fl oors, motors, chain drives, walls; Zone 3) for each piece of production equipment. Test all vehicular traffi c and traffi c ways into/out of a post-lethality and/or exposed product production room. Additionally, the program should identify specifi c activities to be conducted when there is an out-of-specifi cation result, such as an investigationby a multifunctional team, and provide for corrective andpreventative actions.

A corrective action is an activity conducted immediately to reduce a risk, such as an intensifi ed cleaning procedure, and must be applied above and beyond the routine cleaning and sanitizing. A preventative action is an activity that will prevent future adverse results. We refer to preventative actions as one of the four “Rs”: repair, redesign, replacement and/or removal. All too often, an adverse event only results in the site being cleaned and sanitized, in accordance with the usual procedure. However, by recognizing it as a call to investigate, you will have the opportunity to immediately reduce risk, and implement one of the 4 “Rs.” Furthermore, by documenting all activities in compliance with regulatory requirements, you will create records and new insights for future reference.

HACCP Training OfferedHazard Analysis and Critical Control Point (HACCP) certifi cation and training are key components of any company’s food safety plan. When you choose our education program, we will work together and give you tools that help you:

▶ C omplete the requirementsfor HACCP certifi cation and understand HACCP principles

▶ I dentify the resources needed to develop, implement and maintain an HACCP plan

▶ Understand and identify process stephazard assessment and steps required to determine critical control points

Our Introductory and Advanced HACCP certifi cation courses are approved by the International HACCP Alliance. Courses run as a 2-day program that can be customized to your products/processes and held at your facility. Alternatively, you can attend one of our standard HACCP courses held in Madison, WI or Battle Creek, MI and, when you send more than one employee, you will benefi t from our volume discounts.

Clarifying Study Design

Can’t fi nd the technical or scientifi c information you need to determine whether your preventative controls will be effective against the hazards that are reasonably likely to occur? Several types of challenge studies are available to help you validate food safety processing procedures, product storage and shelf life. Shelf life studies focus on product quality and will not be directly addressed here. However, many of the principles used in food safety-related studies apply to quality studies.

Start by defi ning your objective clearly, as it is going to drive the study design.

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CONTACT USCovance Microbiological Laboratories

855-83 MICRO(855) 836-4276

NCFS-Client_Services@covance.com

UPCOMING EVENTS HACCP Training

Madison, WIJune 16–18

IFT Annual Meeting & Food ExpoChicago, ILJuly 11–14

IAFP Annual MeetingPortland, ORJuly 25-28

Food & Dietary Supplements SymposiumMadison, WI

August 24–26

Do you expect your product to inhibit the growth of pathogens? Pathogen growth inhibition studies will help you determine whether a product formulation, combined with specifi c processing and packaging, will inhibit the growth of certain bacterial pathogens stored under specifi c conditions for a specifi c amountof time.

Is it more appropriate to ask whether the food formulation or manufacturing practice, or their combinations, will inactivate pathogens? Pathogen inactivation studies evaluate the impact of variables, such as product characteristics, processing, packaging and storage.

Sometimes studies need to combine inhibition and inactivation concepts. Designing a combination study could prove useful when a food or process is intended to inactivate certain bacterial pathogens while inhibiting the growth of others; or when a certain level of inactivation is achieved and you expect continued inhibition of the growth of survivors or contaminants introduced after processing.

Want to talk about study needs and options? Our qualifi ed scientists at Covance can help you design a study and fi nd solutions to your needs. Let’s start the conversation.

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