Parent-subsidiary relationships, Conflict of Interest and FSVP

Parent-subsidiary relationships, Conflict of Interest and FSVP

One of the most common questions we receive regarding FSVP is whether there are limits for parent companies in their ability to assist US-Based subsidiaries with FSVP compliance. This post seeks to answer this question using the preamble to FDA’s FSVP Final Rule, the CFR, current FDA FSVP guidance and a recent response from FDA’s Technical Assistance Network (TAN).

How to develop and organize an internal food safety training program

How to develop and organize an internal food safety training program

Developing an internal food safety training program is difficult if you haven’t first identified the appropriate structure and components. FSG consultants teamed up with Dairy Australia to offer insights into how to develop your own internal food safety training program.

Environmental Monitoring Trending and Reporting 101

Many companies new to environmental monitoring may wonder “How should I report my results?” If you plan on selling to a major food retailer like Trader Joe’s, you don’t really have a choice. They will let you know, specifically, what information to collect and report. In this short article, I discuss the TJ requirements (as of May 2018) as an example of what to expect when selling to large retail accounts and to provide a model for your own Environmental Monitoring Program (EMP) trending and reporting.

Want to learn how to design your own spreadsheet reporting system? Visit the Food Safety Guides Blog at www.foodsafetyguides.com or contact us directly at info@foodsafetyguides.com.

REPORT A: Monthly Overall % Rolling Incidence Rate

For this report, Trader Joe’s wants you to summarize positive swab results by surface type, i.e. by Zone. Zones are divided into two categories: Food Contact Surfaces (FCS) and Non-Food Contact Surfaces (non-FCS). Non-FCS are broken into 3 sub-categories, each determined by proximity to Zone 1:

 Zone 1 = Food Contact Surfaces (i.e. surfaces that directly contact food, like a knife or cutting board)

Zone 2 = Adjacent non-food contact surface (i.e. surfaces that do not directly contact foods but are immediately adjacent to or near enough to Zone 1 surfaces to represent a higher degree of risk than Zone 3 surfaces)

Zone 3 = Non-Food Contact Surfaces (e.g. floors, drains, table legs)

Zone 4 = Non-Manufacturing Non-Food Contact Surfaces (i.e. Surfaces located in areas outside of where food is received, processed or stored, like corridors, ante-rooms, door knobs to the processing area, etc.)

Positive results are reported as a percent of the total swabs for each zone. For example, if 2 positives are reported in Zone 1 out of 100 swabs, the % Incident Rate for Zone 1 is 2%. Report A (and the % incidence rate) is “rolling” and “monthly” because the scope of the report is data collected over the last four weeks. 

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REPORT B: Percent (%) Incidence by Individual Sampling Site

Report B requires reporting all of the results (positive and negative, including a % incidence rate) collected for each individual surface sampled over the last 12 weeks.

Individual sampling sites are assigned a specific code according to the following convention: a capital “Z” followed by a number 1-4, indicating the zone of the surface (e.g. Z1 = Zone 1 surface, Z2 = Zone 2 surface, etc.), then a period and a number indicating that particular surface.

Example:

Z1.1 = Spoon

Z1.2 = Knife

Z1.3 = Cutting Board

A code assigned to a specific surface is permanent and cannot be re-used, even if that surface no longer exists. For example, if a Spoon is no longer used in the facility, then Z1.1 is retired with it and cannot be re-assigned to another surface. 

Individual sampling sites must be identified on a facility map. Sites that are not fixed in a single spot (e.g. mobile equipment) can be identified wherever you want on the site map as long as the surface is clearly communicated.

REPORT C: Overall % Rolling Incidence Rate by Zone & Overall Facility

This report is identical to Report A except the rolling date range is the last 12 months. 

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REPORT D: Percent (%) Incidence by Individual Sampling Site

This report is identical to Report B except the rolling date range is the last 12 months. 

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REPORT E: Map of the facility with historical positive and negative findings located for each swab site

This is of the tougher reports as it requires you to have a facility map that is continuously updated to reflect historical positive and negative findings for each individual swab site. By “historical”, the period could be the last 12 months or longer. Fortunately, Google Sheets and Microsoft Excel integrate with a diagramming software, called Lucidchart, and makes it relatively easy to create a map that automatically updates in real time with log data, provided the data is logged in a friendly format. Lucidchart costs less than $10/months per user, way cheaper than buying a software! To learn how to integrate Lucidchart with a spreadsheet system, please contact us at info@foodsafetyguides.com and we’ll show you how!

PEM Map Demo.png

Want to learn how to design your own spreadsheet reporting system? Visit the Food Safety Guides Blog at www.foodsafetyguides.com or contact us directly at info@foodsafetyguides.com.

5 Tips for Building a Spreadsheet-Based Environmental Monitoring Log

Tracking and trending environmental monitoring with pen and paper is doable, but a pain. Spreadsheets provide many of the benefits of expensive softwares, but without the hefty price tag. Benefits include:

  • Cost effective, less wasteful, no physical storage necessary.

  • Files can be backed up and protected

  • Years of historical data conveniently located in a single electronic file.

  • Reveal trends by filtering columns and creating pivot tables

  • Leverage pivot tables to generate reports, which you can then print and share with your boss, customers, inspectors and auditors.

  • Streamline inspections and audits by inserting hyperlinks to lab reports

5 Tips for Building a Spreadsheet-Based Environmental Monitoring Log

Tip #1: Use Different Colored Columns

The columns with blue headers (left) contain data collected during swabbing; the red columns (right) contain sampling results transcribed from lab reports

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Click here to see my tips on how to select a food laboratory

Tip #2: Include a Column to Indicate Composite vs. Individual Swabs

By selecting “composite” swabs under the column “Swab Type” (see above), the person filling out the spreadsheet can indicate when a single swab is used to sample multiple swab sites. The “Group” shows the number assigned to the composite swab on the particular swab date. Say, for example, 3 composite swabs were collected on April 1, you would record the samples in the PEM Log under 3 groups (1, 2 and 3). By keeping track of the group number and which swab sites were “grouped” together on a single swab, you can accurately trace lab results back to the swab sites that were sampled.

Looking for a food lab? Click here and scroll down to see Food Safety Guides’ Map of ISO 17025 accredited laboratories.

Tip #3: Insert Dropdowns

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Trending spreadsheet data requires inputing data in a consistent manner. For example, if you are trending a column of data where “apples” are identified as “apples” sometimes and “Gala” or “Granny Smith” other times, reports may not capture or trend all the data. Mis-spelling can also throw off data trending. Eliminate these potential hiccups by inserting dropdowns (or “data validation”, as it is called in Excel and Google Sheets). You can also protect the cells from mis-spellings or invalid data by selecting “Reject input” (see figure, right).

Tip #4: Use Hyperlinks

Upload lab report PDFs to the cloud and insert hyperlinks to the reports in the spreadsheet. By doing so, the log becomes a one-stop jump off to all of your lab reports, making it quick and easy to locate lab reports when you need them.

Tip #5: Use Formulas to Automate Reporting

For reporting purposes, you will want to also have columns indicating the zone and surface name, but how can you or your employees remember the codes for dozens of surfaces? And even it you could remember the surfaces, it would be a pain to punch them in everytime you fill out the PEM log or select them from a dropdown, not to mention the risk of mis-spelling and other human errors. Avoid these pitfalls with formulas (or more specifically, a specific type of formula called an “array”). Stay tuned for my next post for instructions!



Create Your Own Custom PEM Log

Want to explore what a spreadsheet can do for your PEM program? Contact us at info@foodsafetyguides.com. We have templates including reports designed to conform with major retailers’ audit criteria (e.g. Trader Joe’s) and GFSI benchmark scheme requirements. Below is an example of what a PEM log might look like.

FSG tips for your Master Sanitation Schedule

A master sanitation schedule defines your sanitation program. It is typically written in a table format. Each row addresses a specific area or piece of equipment while the columns layout the who, what, where when, how.

We recommend moving through your facility, room by room. Start with surfaces far away from food contact surfaces (FCS), like floors, walls and drains (known as zone 3 surfaces, or Z3), then surfaces close to FCS, like tables and racks (zone 2 surfaces, Z2) and finally, FCS (zone 1 surfaces, or Z1)). Once you have completed your master sanitation schedule, you can filter rows (based on frequency of cleaning) to create your sanitation logs and pre-op and post-op checklists.

The master sanitation schedule is used to establish a standard of cleaning, which can then be validated through a history of environmental testing results. When we find harmful microorganisms in our environment, you’ll want to re-evaluate the master sanitation schedule.

Other issues that may affect the performance of a sanitation program are:

  • Employee adherence to GMPs

  • Poor hygienic design of equipment and facility

Regular cleaning and sanitizing can only do so much!

Having difficulty getting started? Visit Food Safety Guides website or select a time to chat with consultant, Michael Kalish.

Increase participation in GMP self-inspections with these Terms

Increase participation in GMP self-inspections with these Terms

QA professionals read the cGMP regulations, but how accessible are these regulations to the rest of your staff? And how can they use these regulations to ensure safe food? In this post, we distill down the 10+ pages of cGMP regulations into (4) easy to remember terms.

Tools & Tips for Estimating your Environmental Monitoring Costs

New to environmental monitoring? Don't have much money to spend or an internal laboratory? Well, you better sit down for this.

Regardless of company size, sampling and testing requires a significant investment of money, time and energy. So how much should you expect to spend? The answer is complicated, but our PEM Calculator is a good place to start.

 

Additional Costs to Consider When Preparing a PEM Estimate

Routine environmental testing (“Not For Cause”)

In FDA's draft guidance "Control of Listeria monocytogenes in Ready-To-Eat Foods", FDA recommends "that even the smallest processors collect samples from at least 5 sites of FCS (Food Contact Surfaces) and 5 sites of non-FCS (non-Food Contact Surfaces) on each production line for RTE foods" (p.36).

A minimum of 10 swabs at FDA's recommended weekly sampling frequency for high risk foods (i.e. foods that are capable of supporting Listeria growth) totals 520 swabs per year. If you're lucky, your lab may charge as little as $20/swab for Listeria species testing. Assuming you have one production line and find zero presence of Listeria species in your environment, the total annual cost of lab services (not including equipment and materials costs) is around $10,400.

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The above is a very liberal estimate given:

  • Most companies may swab more than 10 surfaces per week

  • Companies are likely to face higher lab costs than $20/swab as well as ancillary expenses (e.g. equipment, materials, consulting and training fees)

  • The estimate does not factor in follow-up costs associated with a positive result (“For Cause” sampling, covered below)

Fire Fighting (“For Cause”) Sampling and Testing

When a sample tests positive (a result known as a “presumptive positive”), the company must:

  1. Determine whether or not the positive indicates the real presence of the target organism at the swab site(s) or if it is a "false positive" (one must assume the result is positive unless proven otherwise); AND

  2. If the target organism is assumed or demonstrated to be present, to take appropriate action, which can vary depending on the type of organism, surface, etc. In other words, you must have a plan for corrective action.

For Cause testing can increase expenses by orders of magnitude, so best to be prepared. To give you an idea of what For Cause testing entails, a good starting point is John Butts’ article “Seek & Destroy: Identifying and Controlling Listeria monocytogenes Growth Niches.”

Total Cost of Environmental Sampling (“For Cause” and “Not For Cause”):

So back to the original question: how much does a PEM program cost? It will depend on your product, facility, and numerous other factors. Two things are for sure:

  • Assume you will find positives

  • Sampling and crisis management (and crisis preparedness) come at a significant price tag, one which can be substantially diminished through due diligence and preparedness, but never eliminated.

Find a Laboratory

Looking for a lab or just trying to get quotes? Food Safety Guides put together a Google Map of the U.S.'s major food laboratories as well as a few local, ISO 17025 accredited labs. Click on the image below, then click sites near you to get contact information for the lab of your choice.

Clients keep asking me if I know of a good food lab, so I put together a Google Map

Clients keep asking me if I know of a good food lab, so I put together a Google Map of major U.S. food labs whose services include pathogen testing. Map includes large, corporately-managed labs and smaller, independently managed labs, so take your pick! Click on a flag to display contact information. 

When I checked, all of the labs listed in the map were ISO 17025 accredited, but these accreditations have expirations so check with the lab to make sure their accreditation is current. Don't take my word for it! More labs to come, so bookmark and share. : )

Learn more: Tools & Tips for Estimating your Environmental Monitoring Costs

PEM Calculator

Need to estimate the cost of a Pathogen Environmental Monitoring (PEM) program? Use our handy dandy PEM Calculator! If you like it, please let us know and feel free to share : ) Scroll down for our 2-Step Instructions.

 

Procedure

STEP 1: In Sampling Schedule table (top)Enter estimates for the number and type of samples (by zones, pathogen, indicator organism) per month.

STEP 2:  Get cost/swab info from labs you may want to work with and plug into Pricing table.

That's it! Be aware that in addition to the cost of materials (e.g. swabs) and shipping costs (swabs submitted to a laboratory are generally shipped overnight), additional costs could result from:

  • Follow-up testing to confirm a presumptive positive (labs have a rate for this)
  • Multiplication of follow-up testing in response to a presumptive positive found in a composite swab*
  • Multiplication of follow-up testing beyond an original swab site(s) to locate the source of a confirmed positive (this can be a very expensive and frightening goose chase)

IAFP 2018 Wrap Up

We had a great time at this year's IAFP Annual Meeting re-connecting with colleagues and making new connections while navigating the dozens of symposia and professional development groups. And the cherry on top: we made it into IAFP's 2018 Recap video! (3:04 and 3:44)

Highly recommend attending this conference, exceptional opportunities to learn and grow professionally and expand one's network. Next year the Meeting is in Louisville, Kentucky. We can't wait.