Where Do I Start (Beginning the Investigation)?

Abstract

No doubt some will open directly to this chapter, because your product is contaminated with an undesirable microbe, or perhaps you have been asked to do such an investigation for another company’s facility not previously observed by you and naturally you want tips on how to find where the contaminant is getting into the product stream. This chapter takes the reader through the process of beginning the investigation including understanding the process including the production schedule and critically reviewing previously generated laboratory data. Understanding the critical control points and validity of their critical limits is also important. Scoping the extent of the problem is next. It is always a good idea for the factory to have a rigorously validated cleaning and sanitation procedure that provides a documented “sanitation breakpoint,” which can be useful in the “scoping” process, although some contamination events may extend past these “break-points.” Touring the facility is next wherein preliminary pre-selection of areas for future sampling can be done. Operational samples and observations in non-food contact areas can be taken at this time. Then the operations personnel need to be consulted and plans made for an appropriate amount of time to observe equipment break down for “post-operational” sampling and “pre-operational” investigational sampling. Hence the chapter further discusses preparing operations personnel for the disruptions that go along with these investigations and assembling the sampling team. The chapter concludes with a discussion of post-startup observations after an investigation and sampling.

Most impediments to scientific understanding are conceptual locks, not factual lacks …Stephen J. Gould (Bully for Brontosaurus)