Question

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. Our contact information is on each bag.

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. This is not our first such visit.

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). DKI rev Jan 2019 copyright 2 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 of the 17 states reporting illnesses. All raw spinach is suspect, regardless of brand. Since 1998, this is the 21st food-poisoning episode linked to either spinach or lettuce; 8 of those were traced to CA. Women account for 75% of all the cases of illness. 60 people have been hospitalized.

1. List 3 specific questions you should expect to get from the FDA.

2. List 3 specific questions you should ask the FDA.

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

Answer 1

Information supplied to FDA

1) Inventory levels of spinach at each distribution centre.

2) The shipments to retail stores between september 1 and 18.

3) The quantity of spinach processed between sept. 1 and sept. 18 and shipped to distribution centers.

4) The source of the spinach i.e. the place of origin of the spinach procured in last one month.

5) Results of laboratory tests done on samples of spinach.

The above infromation will be collected from within the organisation as a record is maintained of the production, shipping and lab test processes.

Information needed from FDA

1) Which insecticide or pesticide can be sprayed on raw spinach to decontaminate it

2) Among the customers who have fallen ill, how many bought Good-4-U spinach.

3) Product information fromt the retail stores like bar code of products that were sold and their day codes.

Guesses for root cause

1) The sampling process for testing spinach samples is inadequate and more robust sampling process needs to adopted so that disease affected or unfit spinach gets detected before packaging.

- The company can inform the FDA about the past records of such instances and the trace of the source of contamination. There have been 20 such instances happening in the past since 1998. Out of the 20, 8 instances had their roots in CA. Also women seem to be more prone to the attack caused by the contamination. FDA can use this information to investigate the problem as well as spread awareness among the public.

- The company can ask from FDA about the specific instances of contamination, happening from places where they deliver their spinach. This will give a direction to the company to investigate the matter and check the production process in the specific regions.

- The root cause of contamination may be the fertilizer used for the spinach fields. E-coli bacterium is present in the fecal matter of mammals. They form a primary source for the development of fertilizers. Hence, they could have been the root cause of contamination of spinach.

2) In fields which are nearby pastures, the livestock can be one of the reasons for bacteria affected spinach.