The question to be answered here is really one of balance. Is the operational testing sufficiently connected to the SOPs as written? What does the QC charting reveal about process control? What does the laboratory testing indicate about the HACCP plan and the adequacy of the Critical Control Points identified in that plan? What do the environmental microbiological results and product shelf life failures observed say about the sanitation protocols now in place? Is the pasteurization process that was developed last year still adequate (or inadequate, or overkill)? The Food Safety Modernization Act (FSMA) is all about the prevention of problems. The time to take a close look at such interrelationships is well before a problem arises. An evaluation of the manufacturing process, which shows that process under good control should be taken as a positive, documented quality assurance event. An evaluation that shows otherwise is a HACCP correction that must (according to FSMA) be considered at least once a year or as frequently as necessary.
Different products will differ in their manufacture so each process audit is expected to differ as well.
Copyright © 2012 by M. Mychajlonka, Ph. D.