There is another trap that all too many auditors fall into and that is how they look at the many guidance documents that the USFDA has developed. There are guidance documents for seafood, “Fish and Fishery Products: Hazards and Controls, 4th Edition,” (https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-and-fishery-products-hazards-and-controls); and for juice, “Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition,” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first).
These are just what is stated in the titles: guidance documents. They offer food processors guidance for best practices and the USFDA’s thoughts on different potential hazards and how they may be controlled. They are not mandates and no auditor should ever write up a company for not strictly following what is described in the guidance document.
The last point that a company should look for is whether the audit firm has an appeals process. The auditor is not always right in how they interpret things. If a company disagrees with an auditor’s findings or observations, there is nothing wrong with challenging him or her. And, if a company believes that an audit finding is wrong, they should be able to not only appeal but have that appeal properly addressed.
Let’s look at another example of an auditor being unclear on the concept. A processor of syrups which are high in sugar (60° brix) and have a pH of approximately 4.0 was written up for not having an environmental monitoring program. The company not only provided product specifications but shared challenge study data with the auditor which clearly showed that these products were not only bacteriostatic (inhibitory to pathogens) but bacteriocidal (lethal to pathogens.) The processor even shared the citation in the Preventive Controls for Human Food Regulation found in 21 CFR Part 117.130:
“The hazard evaluation required by paragraph (c)(1)(i) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.”
The company appealed to the home office and got their points back. What was somewhat ironic about this is when the audit firm came back a year later, the auditor wanted to write them up for the same thing. This time the company said, “You are wrong. Contact your company.” The auditor did and the answer was the same as the previous year.
So, the objective of third-party audits should be continuous improvement of a company’s food safety management system. This should be one of the major considerations when selecting an audit scheme and a certifying body. No one really likes the way an audit has the potential to disrupt operations, but when the audit treated as a means of improving operations, it is infinitely more palatable. And, do not be afraid of challenging an auditor. They are not always right. FE