Specialty Food Magazine


Specialty Food Magazine is the leading publication for retailers, manufacturers and foodservice professionals in the specialty food trade. It provides news, trends and business-building insights that help readers keep their businesses competitive.

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Page 120 of 139

Most of the records are information that you would keep in the course of doing business. However, there are certain records and ways that these records need to be maintained that are specified by FSMA. If you are a domestic manufacturer with more than $1 million in annual sales, your deadline to comply with FSMA was September 2017. If you are an importer, the deadline for FSVP compliance was May 2017. It's past the due date to get your record- keeping in order. Required Records for Manufacturers There are two types of required records in the Preventive Controls regulation—the Food Safety Plan and Implementation Records. Regulators can request those records for review or to copy at any time. If you have a food safety problem and do not have the proper records, your business is in jeopardy. Records required as part of the Food Safety Plan include: • Hazard analysis • Preventive controls o Process preventive controls o Allergen preventive controls o Sanitation preventive controls • Supply chain program requirements • Recall plan • Monitoring procedures • Corrective action procedures • Verification procedures Your Food Safety Plan must be put together by a "Qualified Individual." This person must meet the FDA definition of "Qualified Individual." They can meet the definition by taking the FDA- recognized training put together by the Food Safety Preventive Controls Alliance (see Editor's Note). Career experience can also make a person a "Qualified Individual" although FDA does not specify what that would entail. Implementation Records prove that you are following the Food Safety Plan. Required Implementation Records include, but are not limited to: • Monitoring records for preventive controls • Corrective actions taken • Verification records: validation, verification of monitoring, product testing, environmental monitoring, records review, etc. • Supply chain program and supporting documentation • Training records Monitoring records document that a food safety hazard has been controlled. These are routine in food manufacturing and could include whether a cook has reached a certain temperature to eliminate a hazard. These records must be recorded at the time the observation is made, and be done by the person making the observation. The record must have an identifier that corresponds to the Food Safety Plan. The signature or initials of the person making the observa- tion and the date and time must be recorded. Since procedures vary significantly from facility to facility, FDA has not specified a format. If there is a deviation from the Food Safety Plan, there must be a corrective action to make sure the food is safe. Records must document what went wrong, why, and the action taken. They should identify the product and whether it is on hold, why it devi- ated from parameters, actions taken to prevent a reoccurrence, final disposition of the product (reworked, destroyed, etc.) and a correc- tive action report. The name and signature of the person responsible for the corrective action and the name of the person reviewing the corrective action is required. Verification records must document that the Food Safety Plan is working properly. These could include logs that verify the accuracy of thermometers and other measurement devices, results of finished product testing, audit records of suppliers responsible for the preventive controls, and so on. Each facility will have different verification records based on its Food Safety Plan. It is permissible for a third party to do these verification procedures but the records must be kept by the production facility. Storing and Presenting the Records FDA has stringent requirements for how the records must be kept. They must be original, true copies, either in written or digital for- mat. The records must be the actual values and observations and be recorded in a method that cannot be changed. Pencil records are illegal. Plus, the records must be specific. For example, if a certain temperature must be reached to eliminate pathogens, that tem- perature must be recorded; a check box noting the temperature was reached is not acceptable. It's past the due date to get your recordkeeping in order. If you have a food safety problem and do not have the proper records, your business is in jeopardy. specialty food maker 118 ❘ SPECIALTY FOOD MAGAZINE specialtyfood.com

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