Monday, October 31, 2011

Auditing and the Food Safety System - Post Listieria-in-Cantaloupe

In the post-analysis of the Listeria outbreak related to cantaloupes, many have questioned how an auditor could have given passing scores to a facility responsible for so many illnesses, especially in light of the FDA audit of that facility during the outbreak investigation.   Face it, when an issue occurs in a facility, those auditors are going to find a lot of issues.

The recent outbreak of Listeria from cantaloupes should become one of those significant events with regard to food safety in the United States.  While this was the first for this pathogen in the produce related item, it certainly was not an issue that defied logic.   In the FDA investigation report, there appears to be a reasonable explanation behind the contamination scenario – product produced in an environment that allowed for the growth of listeria, a system that did not prevent contamination of the food item, and conditions that allowed it to grow on the product.   But its significance was that it is yet another tragedy that demonstrates the problems in our food chain.

As we have seen in other outbreaks, the companies that produced the food had recently passed a food safety audit.  They not only passed it, but passed with high scores.  Cleary, this is an issue.  However, is it right to put a beat-down on this auditor, and put all responsibility on them?

Clearly, it is the responsibility of the company management to ensure the safety of the product.  Companies should know their process better than anyone.  How can you expect an outside auditor, who is unlikely to know everything about every process they encounter, to hold full burden on passing judgment for the safety of a process during a one day audit? 

The problem is that some company decision makers do not know their own processes as well as they should, and often time, they are not willing to spend the time or money to do so.

·        Training – Are people trained in HACCP?  Do they understand the true risks associated with the process and the product?  Do these companies have people on staff trained in food science and technology, or if not, are they willing to hire a consultant with the proper training and experience to perform a real risk assessment? 

·        Verification testing – Do companies do ample testing to ensure the products they make are safe?  Are they testing their equipment to make sure that it is operating as it should?  Are they testing their environment for the presence for hazards that can be associated with the product or process?

·        Validation – Do companies properly validate their processes when they put them in place or make changes?  Do they have scientifically based research to support what they are doing?  Has in-plant testing been done when they commission the process?
Third-party audits are part of the food safety system, but they are by no means the entire system, especially when it comes to verification of food safety of the process.  Currently, third-party audits should provide a snapshot of how well a company is meeting the auditing standard, and hopefully will be able to catch glaring food safety issues.    Granted, with additional training, they will be better able to identify if validation documentation is present for the process and if it appears to make sense, but until these companies are willing to make the effort to truly understanding their process, there will be those companies who experience the ‘unexpected food contamination issue’.

So it is easy to pile-on the food safety auditor or even a government inspector after the fact.  Perhaps we can give them some extra training so they can identify issue better, or have them paid by someone besides the company they are auditing.  But it is important to remember that the company who makes the product is responsible for the safety.  And until that message is received by owners and company presidents who make final decisions for the products and processes, we will continue to face these same issues regardless of who pays for the audit.

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