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From: Food Quality & Safety magazine, August/September 2006

Creating Standard Operating Procedures

by Jim Carter

Standard operating procedures (SOPs) are the mainstay of any manufacturing operations, chemical, mining, automotive, etc., but for the purposes of this discussion, the focus will be on food operations. SOPs differ from cGMP’s (current Good Manufacturing Practices) in that one comprises detailed work instructions, and the other is a list of “do’s and don’ts.”

Standard operating work instructions are beneficial, regardless of the complexity or simplicity of the process. SOPs are also beneficial for standardization of work between hourly associates, between shifts or between different branch plants. Keep in mind that every plant branch may have some particular characteristics that may require fine-tuning of corporate derived SOPs, even if using the same manufacturing equipment. SOPs can be used to ensure that management clearly knows what they want done and how to do it. In order to write an SOP, managers must clearly know the process. Often it is helpful to have experienced workers give input on the best ways to perform tasks.

Written SOPs can benefit in disciplining troublesome employees. In one particular facility, an hourly associate was going to be suspended for an action he had taken. However, he was able to claim he had never been told that particular action was not to be taken, and the company had no records to validate.

In industries which operate under ISO requirements, all procedures will be written in great detail, for both safe equipment operation, and the actual manufacturing process, following formulations and step-by-step recipes.

Thirty years ago, there were four types of records; shipping and receiving, production, personnel and QC (quality control). Nowadays, records comprise of the above and include HACCP, recall programs, preventive maintenance, cleaning and sanitation, cGMPs, SPC if applicable (Statistical Process Control) and security protocols.

Many of these programs may be required by regulatory agencies or large customers, while others can stand on their own merit. In the case of HACCP and recall programs, there can be assigned responsibilities for managers in crisis management teams, up to and including who has authority to talk to the media.

Standardized work instructions and SOPs can function as training protocols for new hires and serve as a way to prevent tenured workers from taking short cuts. In certain equipment intensive process industries, like soybean oil or HFCS, in which a centralized control computer operates the plant, it may take months, or longer than a year, for an operator to become proficient in operating the plant.

Simple operations, such as warehouse distribution centers, can have SOPs for receiving and shipping (checking trailers and inbound product for evidence of pests, damages, cleanliness, odors, close dating, seals and temperatures if applicable).

Basic operating procedures for manufacturers can include corrective actions for incidents when a process becomes out of control. After a review of numerous HACCP programs throughout the industry, and frequently, on the risk assessment worksheet, the column for corrective actions simply says, “contact supervisor.”

While it is true that sometimes an experienced supervisor can use his best judgment to rectify a situation, it can be impractical to write a protocol for every scenario that can occur. In this case, SOPs for corrective actions can be of value. At several companies where I have worked, there was one experienced manager, and when that manager left the company, he took all of his knowledge with them. Certain industries, pharmaceuticals for example, would have written procedures for all occurrences.

There are benefits for having written SOPs and ensuring they are followed. Day-to-day variations in product can be minimized; one of the benefits of SPC. There can be less product output with being put on hold or on quarantine, or having to be reworked or reprocessed. Potential for product contamination can be minimized. There can be more efficient use of time, personnel and material resources. Clearly, an SOP specifying detailed cleaning at product changeovers between allergen containing product and non-allergens could eliminate potential customer health problems and prevent costly litigation. An SOP defining how much chemical is to be diluted with water (cleansers, for example) is recommended. It is unwise to assume an hourly worker would read the instructions on a bottle. I have been in facilities where quat sanitizer is being overused, considerably over the 200 PPM limit. I asked the worker how much he used. He poured several seconds worth from the gallon jug, and said, “About that much.”

Written procedures for following certain sequences in operations can prevent expensive mistakes. For instance, in a certain process industry, an operator turned on a pump, without opening the outlet valve on the other end of the transfer line, causing all the gaskets to blow on the heat exchanger. In another incident, a receiver at a plastic bottle plant, unloading a rail car of resin pellets, transferred them into the wrong silo, contaminating both resins, and tying up a silo that could no longer be used. The manufacturer also had to find someone who would take all the contaminated resin out of their silo.

Following written SOPs can ensure that injuries and accidents can be avoided. Written SOPs can also prevent hourly associates from taking short cuts in their operations; in some cases these short cuts may not be intentionally to cause difficulties, but workers may feel they have a better way to do a task, and may be unaware of unintended consequences.

It is also beneficial to periodically review SOPs to ensure they are accurate and up-to-date, reflecting any product or process changes. In one warehouse distribution center, during a discussion of cleaning procedures, the general manager asked whether he really needed a written procedure, stating to “take a broom and sweep.” Depending on the quality of his workforce, he may need a written SOP, as workers cleaning would sweep aisles and wide open spaces, but would not sweep corners, behind and beneath equipment and pallets.

It is also true that in fairly small plants with a small workforce, many actions will be handled more casually and verbally than having all work instructions documented. It is a manager’s discretion when determining how detailed to make SOPs and operational methods.

Jim Carter is a senior consultant with ASI Food Safety Consultants (St. Louis, Mo.). Reach him at 800-477-0778.

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