What is your best guess as to root cause of contamination

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Reference no: EM132224815

We are the Good-4-U Spinach Company, established in 1946, in Modesto, CA. We grow, harvest, processes, bag, case, and ship fresh spinach to 83% of the retailers in the USA and to 58% of the nation’s food service enterprises. We co-pack and private label, in addition to distributing our own brand, “Good-4-U”. In all, we produce 34 different brands and 180 SKUs (different labels and sizes of packages). The contents are all the same - raw spinach.

This AM, the United States Food and Drug Administration (FDA) showed up at our door and ordered us to cease all production and shipping of our products. Confirmed reports of E. coli have been linked to the consumption of raw spinach in 17 states.

The spinach producers must find the cause of the contamination and the location of potentially contaminated products or risk closing their doors. You, as the Operations Manager, have been asked by the FDA to trace the sources, inventories and shipments of all spinach processed between September 1 and September 18. You are also chair of the problem-solving team assigned to find the root cause.

Stuff you need to know:

Good-4-U leases fields from many different farmers in addition to fields we own. We grow only spinach. Neighboring fields, not belonging to us, have other crops growing in them e.g. lettuce, greens, peppers, radishes. Pastures containing livestock are also nearby.    

States having confirmed illnesses linked to raw spinach include MI, OH, IN, WI, MN, PA, ID, MT, ND, WY, UT, CO, AZ, NM, ME, VT, NH. One person in WI has died.

Our customers are located in all 50 states. We ship directly to our customers’ distribution centers, not individual retail stores.   

Inbound raw product is shipped from growing fields via company trucks, in bulk. Employees are allowed to use the trucks for personal use, as long as it does not interfere with production.

We ship outbound finished goods via common carrier, refrigerated trucks.

E. coli bacterium is present in the lower intestines of mammals and their fecal matter (doo-doo).

Spinach Recall

Spinach fields are harvested by guest workers from Mexico and Central America.

Spinach fields are irrigated using surface water.

Flooding sometimes occurs in this watershed.

Processing wash water is treated with chlorine, chilled and then recycled.

Every four (4) hours of production our laboratory procedures call for sampling and testing for the presence of harmful bacteria on the spinach. Those test results are on file.

Individual bags, as well as shipping cases, are coded with a “better if used by” date, including the exact minute each bag was filled.

We use a bar code system (tags, labels, scanners, RF transmitters) for identifying and tracking all raw materials from each field and for all finished goods.

Our shipping documents include the “day codes” of the products shipped.

Good-4-U is not the only supplier of raw spinach to the marketplaces in the 17 states reporting illnesses. All raw spinach is suspect, regardless of brand, at this time.

Since 1998, this is the 20th food-poisoning episode linked to either spinach or lettuce; 8 of those were traced to our region of CA.

Women account for 75% of all the cases of illness. 60 people have been hospitalized.

Corrective Actions/Problem Solving:

What important information can you supply to the FDA? Where will you get it?

What important info

We are the Good-4-U Spinach Company, established in 1946, in Modesto, CA. We grow, harvest, processes, bag, case, and ship fresh spinach to 83% of the retailers in the USA and to 58% of the nation’s food service enterprises. We co-pack and private label, in addition to distributing our own brand, “Good-4-U”. In all, we produce 34 different brands and 180 SKUs (different labels and sizes of packages). The contents are all the same - raw spinach.

This AM, the United States Food and Drug Administration (FDA) showed up at our door and ordered us to cease all production and shipping of our products. Confirmed reports of E. coli have been linked to the consumption of raw spinach in 17 states.

The spinach producers must find the cause of the contamination and the location of potentially contaminated products or risk closing their doors. You, as the Operations Manager, have been asked by the FDA to trace the sources, inventories and shipments of all spinach processed between September 1 and September 18. You are also chair of the problem-solving team assigned to find the root cause.

Stuff you need to know:

Good-4-U leases fields from many different farmers in addition to fields we own. We grow only spinach. Neighboring fields, not belonging to us, have other crops growing in them e.g. lettuce, greens, peppers, radishes. Pastures containing livestock are also nearby.    

States having confirmed illnesses linked to raw spinach include MI, OH, IN, WI, MN, PA, ID, MT, ND, WY, UT, CO, AZ, NM, ME, VT, NH. One person in WI has died.

Our customers are located in all 50 states. We ship directly to our customers’ distribution centers, not individual retail stores.   

Inbound raw product is shipped from growing fields via company trucks, in bulk. Employees are allowed to use the trucks for personal use, as long as it does not interfere with production.

We ship outbound finished goods via common carrier, refrigerated trucks.

E. coli bacterium is present in the lower intestines of mammals and their fecal matter (doo-doo).

Spinach Recall

Spinach fields are harvested by guest workers from Mexico and Central America.

Spinach fields are irrigated using surface water.

Flooding sometimes occurs in this watershed.

Processing wash water is treated with chlorine, chilled and then recycled.

Every four (4) hours of production our laboratory procedures call for sampling and testing for the presence of harmful bacteria on the spinach. Those test results are on file.

Individual bags, as well as shipping cases, are coded with a “better if used by” date, including the exact minute each bag was filled.

We use a bar code system (tags, labels, scanners, RF transmitters) for identifying and tracking all raw materials from each field and for all finished goods.

Our shipping documents include the “day codes” of the products shipped.

Good-4-U is not the only supplier of raw spinach to the marketplaces in the 17 states reporting illnesses. All raw spinach is suspect, regardless of brand, at this time.

Since 1998, this is the 20th food-poisoning episode linked to either spinach or lettuce; 8 of those were traced to our region of CA.

Women account for 75% of all the cases of illness. 60 people have been hospitalized.

Corrective Actions/Problem Solving:

1. What important information can you supply to the FDA? Where will you get it?

2. What important information do you need from the FDA or the marketplace?

3. What is your best guess as to the root cause of contamination?

Reference no: EM132224815

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