In Part One, we discussed using transparencies on the receiving dock as an easy way for personnel to quickly ascertain whether or not the incoming ingredient (at least its ingredient statement) was the same as your specification. See our earlier blog posting. In this post, we want to discuss some of the steps a facility may take to ensure that allergens are controlled through product formulation and batching, and finished product labeling.
Formulation and Batching Process
A key in ensuring that your product does not contain an undeclared allergen is to make sure that the “batch sheet” being used at the batching station is correct. With today’s technology, many companies use computer systems that only permit the most recently-approved batch sheet to be the one available. There are, however, many facilities still using a hard-copy that was printed off by the Supervisor or designated personnel. Unfortunately, many times these “hard-copies” find their way into lockers or files where they are “available” the next time that product is run – or three months from now after a formulation change was made.
Many recalls have been the result of an old formulation print-off being used with a new finished product label. Usually this occurs because someone accidentally used an obsolete batch sheet they had tucked away in a file or in their locker.
Facilities need to ensure that no one maintains copies of batch sheets where one can be inadvertently used.
Personnel should be notified that copies are not to be maintained and all of those “batch sheet hiding places” should be checked for obsolete copies. Anyone who has spent time dealing with this will know where these places are. These have included the normal locations – batch employee’s locker – to the not-so-normal – above the suspended ceiling over the batching station. Make it a point to have a procedure to issue batch sheets as needed and make this easy for those authorized employees needing the batch sheets. If it is difficult for the employees to get the batch sheet, they will find ways to make it easier – which usually involves making an “unauthorized copy.”
All batch sheets should contain a revision date or formula version number. When schedules are printed, this information on the formula version should be included. All responsible personnel should be trained to check that the batch sheet is the correct version listed on the schedule. This should be a mandated step required to be completed before any actual ingredient batching begins.
Another procedure that will assist in ensuring the proper formulation is used is to have two different employees responsible for staging and batching. For example, the employee responsible for staging the necessary ingredients uses a batch sheet issued to him and marks this off to ensure the proper ingredients have been staged. The batching employee then checks off ingredients on his batch sheet. This provides two (hopefully independent) checks that a batch is being properly formulated and will match its finished product ingredient statement.
Finished Product Labeling
Another reason for undeclared allergens is the use of the wrong finished product label. While many facilities have this as a CCP, it is still easy to miss a change in an ingredient statement. I was gloomy when I had an entire shift of beef hotdogs produced using the packaging for a combination beef and pork formula on one of four production lines. The printing on the beef hot dogs was all in red while the combination product was printed in green. The QA technician checked the film on all four lines every hour and marked that it was correct on each line – even though the film was green, the product name was wrong, and the formula was different on one line. Moreover, the two employees on that line packing the hotdog packages into the cases also “looked” at the film. Remember, people sometimes see what they expect to see, not what is actually there.
One way to prevent a very gloomy day is to train personnel to read the label information out loud during packaging checks. When you read out loud, you will be concentrating on what you are actually looking at – not what you “expect” to be there. If the technician had read the product name on the hotdogs out loud, he would have not said the word “beef” on the line in question. Chances are that the mistake would have been identified at the first check. This also holds true for ingredient statements or any information that must be reviewed routinely. Read it out loud to increase your chances of ensuring it is actually correct.
Finally, verification checks should also be done at some frequency to ensure that the batch sheets in use have the latest version number or revision date, and that these also agree with the finished product labeling. Have a program in place to control formulation changes so that everyone is aware when they will occur. Control your finished product labeling: if you receive in “new” film with an updated ingredient statement, literally keep it under “lock and key.” Do not keep it in regular inventory as there is a good chance it will get used by accident. Likewise, if you do not use all “old” labeling up before you change your formulation, lock up the remaining inventory. An employee will need a partial roll of labels and grab that which is the easiest to get. Make it difficult to grab the “wrong” labels by keeping these (“old” or “new”) out of reach.
About “Ms. Gloom”
In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew. In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.
Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician. In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends. Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.