The sample has been taken, the results are in: now what?

My friend Margaret Hardin, vice president of technical services at IEH Laboratories & Consulting Group wrote an excellent column for Food Safety Magazine this month. Excerpts below:

6714HardinMargaret We spend a considerable amount of our time in the food industry collecting data. Data may be quantitative or qualitative, and may be the result of one or more of numerous methodologies from an air settling plate or a swab to the analysis of a sample using high-performance liquid chromatography for the presence/absence of a chemical of concern. Data could also be from microbial mapping using molecular methods such as genetic fingerprinting.

Data are generally the results of measurements, either objective or subjective, which are designed to evaluate the subject matter in a multitude of ways: sensory, physical, chemical, microbiological or particulate. Such information may be obtained to develop and/or verify raw product specifications (ingredients, supplies, water or air) as well as track suppliers, monitor employee hygiene and/or the processing environment to verify sanitation, develop and verify product shelf life, validate products and processes, or verify finished product food safety and quality specifications.

You have gone to all the trouble and expense to develop objectives, outline the plan, decide where and how to take the sample, evaluate the best available, cost-effective method to employ to test the sample, chosen a laboratory to analyze the sample and then waited for the results, oftentimes with a truck at the loading dock or a vice-president on the phone. The results are in, and the worst thing you can do now is to put those results away in a drawer or store them away on the hard drive. The best thing you can do is to put the data to work for you.

star-trek-dataHopefully, you thought ahead and made wise decisions before you even took the sample so that the results would be meaningful and useful. Now it is time to get down to the business of analyzing, tracking and trending your data. While many factors are involved in food production and process control, having an objective measure will help you manage improvements to determine whether something is getting better or worse. Proactive tracking and trending of data can facilitate a root-cause analysis to discover and understand the originating causes of problems, to track the potential source of contamination to avoid delays in product release or to complete investigations, and to identify areas that can benefit from further investigation or process control. Using your data to lead you through activities, such as performing a root-cause analysis, is much more effective than using the apply a band-aid approach to fix issues. Trending of data is important to demonstrate a state of control to identify problems before they get too big (set alert/alarm/threshold limits), to identify process improvements and to determine whether improvements are effective. Trending of microbiological test results, for instance, can make it easier to spot patterns in your data and better manage the risks associated with your process and products. …

Last but not least, there must be proper documentation of the events from the data through the corrective actions, root-cause analysis and verification that the corrective action(s) was effective. Document a timeline, including the date and nature of the deviation, the action plan, the investigation, the results of the investigation, the corrective actions applied, results of any resampling, training records, new SOPs developed or changed, new equipment or construction and conclusions. This is your chance to tell the story and document it for evidence of process control and for future reference. Unfortunately, the precise root cause is not always easy to determine nor is the precise origin of the deviation always that clear-cut. In fact, there may be multiple sources. In addition, and in an effort to get production up and running again, many changes may be made to the process at one time, making it difficult to pinpoint the exact source of the deviation.

Using your data to work for you through tracking and trending guarantees a favorable outcome for everyone involved—particularly the consumer. And, when used, in the case of environmental monitoring and process control of RTE foods, in conjunction with an aggressive and intensive sampling and testing program, it enables the facility to find and eliminate the root cause and verify the sanitary conditions of the production environment, going a long way toward identifying and minimizing the potential for microbial contamination of product through monitoring and management of suppliers and of the RTE process and production environment.