Food Safety Analysis, LLC


Construction of Standard Operating Procedures (SOP)

A set of Standard Operating Procedures basically amounts to the operating manual for a plant. Even the simplest of these quickly becomes a complex, "bureaucratic" document. That is because each SOP must simultaneously accomplish many things: (a), It must specify the chain of command under which it was written in order to establish its authority; (b), It must clearly and unambiguously specify each step to be taken for the successful execution of the procedure being undertaken; (c), The procedural steps it contains must clearly indicate adherence to all applicable regulatory affairs; (d), Any SOP must contain specific provision to all controls needed to demonstrate that any data being recorded is valid and accurate; (e), The SOP must not only contain a detailed listing of all data to be gathered in the course of executing the procedure but must also exactly specify one or more repositories where each datum is to be entered; (f), The SOP should specify the personnel qualified to run the procedure along with mention of the completion of any training modules, acquisition of certifications, etc., which must be met before the employee following a given procedure may be considered qualified to run that procedure; (g), An SOP must be capable of easy revision and also contain a mechanism whereby a history of the revisions made to each SOP may be securely maintained in the event that a need for historical review of an SOP arises and (h), The SOP must be as short as it is possible to make it given all the foregoing necessities.

Most of the time, it makes good sense for anyone about to undertake a task to begin at the beginning and follow through to the end. When writing an SOP, however, attention must first be paid to the interconnections this document must have. Therefore, when constructing an SOP, it may be advisable to begin in the middle and then work out in all directions.

Obviously, a company's employees must be the ultimate source for the information contained in an SOP and the structure of an SOP must integrate with and follow the organization of the company itself. Nevertheless, there is a real advantage to the company when a set of SOPs are written by an outside consultant. The outsider will have an easier time seeing the interrelations of all parts of a company than any one partisan of just one part of that company. At the same time, employees using an SOP should be comfortable with it. Since any SOP must be constructed so as to be easily revised, a company's employees should revise any SOP as needs and perceptions change. However, revision of SOPs that were never an integrated set of documents to begin with runs the risk of having a company's operating manual become just a collection of isolated documents, useful in themselves but not part of a whole.

Copyright © 2012 by M. Mychajlonka, Ph. D.