The preventive controls rules place great emphasis on the use of outside expertise. A quick look at the preventive controls qualified individual role shows that FDA wants you to get help in areas that may be beyond your scientific skill level, such as designing and performing validation studies, rather than attempt to do something that is not in your area of expertise.
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While FDA does provide information on resources such as those available via universities, extension offices, and other major resources, a great many of you will end up in the private sector for help, which brings to light the challenges involved in selecting a competent consultant. Someone who knows everything there is to know in one sector may not know nearly enough to advise in another. Some, sadly, probably should not be advising anyone, but there is no grading system out there to help you choose between the good, the bad, and the ugly.
The FDA regulated industry covers an amazing spectrum of products, from applesauce to zagnuts. Finding an expert that knows everything about anything would be nearly impossible, so avoid anyone that claims to know it all. The first step is to identify experts in your arena, then you can begin the selection process from within that pool. Beyond the trade associations though, what else can be done to quantify experience in a given product mix?
This is an area where the auditing industry can be used as an example. There are several places in this sector where groups have attempted to create general product categories that might help distinguish experts in one area versus another, such as GFSI recognized schemes. However, even those illustrate the diversity of the food industry; some have as many as 30 product groups, others as few as 18—so perhaps this is not the most valuable help after all.
Before entering the food safety testing arena, I worked in the meat industry. As the meat industry underwent the challenging period of the ‘90s, E. coli and Listeria emerged and the industry entered the world of microbiologically driven food safety. I had the good fortune to work among some of the icons of that period and was exposed to the landmark events of the time. Key lessons learned include:
- Make food safety a non-competitive issue;
- An environmental monitoring program (EMP) works better than end-product testing;
- Targeted, operational sampling works better than randomized, pre-op sampling;
- Incentivize testing, don’t “punish” a plant for finding environmental positives; and
- Sanitary design—plant and equipment—is critical to micro food safety.
If wanting to identify examples of broad experts capable of working with high-risk products across multiple industry sectors, then the best approach is to find one with a background in the meat industry. Much of what we know works today comes from the school of hard knocks that is the meat industry. Previously ignored, there is new emphasis on the skills/experience from that sector.
The preventive controls rules require an EMP for ready-to-eat products exposed to the environment prior to package closure, unless there is a post packaging treatment. An EMP requires a well thought-out plan that includes gathering baseline data to support sampling plan design, as well as addressing the regulatory challenges that surround pathogen testing of contact surfaces. When a sample tests positive for a pathogen, the plan should include steps to prove the effectiveness of the corrective actions. The industry has seen the potential for criminal prosecution for inadequate programs, so this is not an area to skimp on outside support.
Below is a summary of five basic rules to keep in mind when searching for a qualified food safety consultant.