Practical Solutions: Increased Regulatory Authority

The Food Safety Modernization Act (FSMA) may be a tip of the iceberg with greater regulatory authority for the food industry. More registrations, fees, inspections, accreditations, records, accessibility, mandatory recalls and administrative detention authority, third party certifications, supplier audits and import requirements all lead to a greater regulatory authority. Approximately 18,000 new FDA personnel may be hired during the next few years. Greater regulatory authority in the hands of the inexperienced might lead to undesirable results for food plants. Far-reaching GMPs, HACCP and related food safety prerequisites will now enter food markets on the farm and global ingredient sources. What are some practical solutions to prepare for the new law?

1. Be ready for the oncoming regulatory and/or third party visits/inspections. What is your plant’s first impression? Does your street view indicate good food safety? What does your lobby show you are committed to? How are visitors received? Now is the time to better manage a regulatory visit/inspection. Develop a procedure, define the roles, identify the most responsible person (and backup), provide a secured office for meetings, identify the inspection purpose (routine or for cause), identify a tour escort (and backups - each visitor must have an escort), deal with logistics (multiple days), plan for a closeout meeting and rehearse. There are many regulatory visit/inspection documents available for reference including: http://www.gmplabeling.com/news_letters/news0907.pdf 
   http://www.compliancearchitects.com/CABlog/2010/03/179/ 
   http://carl1anderson.files.wordpress.com/2010/02/investigator_final_reports_tool_fda_inspection.pdf
   http://www.fdainspections.com/ 
2. The basics to establish are a single spokesperson and prepare him or her. The spokesperson should always be honest but not offer more than what is asked. In addition—if you don’t know the answer say so, convey your intent to comply with regulations, refer to written procedures as best as you can, have an employee be a note taker, retain copies of any provided documents and samples (ask what tests will be conducted on samples) and make no promises other than a written response to form 483, preferably within five days. After the closeout meeting, conduct a planning meeting to identify who will do what, where, how and by when. A regulatory inspection is a stressful time. If you prepare, it can be a means to confidently mend minor deficiencies.
3.  The FDA now has the authority to suspend food operations and recall products. This is a wake-up call to those without sound quality assurance and food safety systems in place. What in the plant keeps you up at night? Now is the time to adhere to policies, procedures, standards, specifications, audit reports, etc. It is only a matter of time before a phone call (“The FDA is here.”) could keep you up at night for many nights. Are you ready? Have you done a GMP Compliance audit?
4. If you use imported ingredients, a certification process or other form of assurance for high-risk food products will become necessary to keep the FDA from potentially refusing import. One solution might be to seek more domestically produced ingredients from approved, third-party-audited suppliers that are regularly visited by your company or designate.
5. The FDA will gain expanded access to food production records based upon “reasonable belief.” Document what you do, not what you should do; and document all corrective action to any non-compliant items. The four basic rules of good documentation are: do it legibly, do it now, do it right and do the organization. Remember the journalism words—who, what, when, where, why and how. All of this information could be important later which makes it very important now.

Considering another documentation source, it is likely the FDA will challenge a no photos policy; a challenge waiting for the right place, right company, right time and right incident. A challenge they will take into the court system for a win and then legal precedent for others to follow for years.

Non compliant GMPs, HACCP and essential food safety prerequisites now have consequences never before seen. An ounce of prevention is worth a pound of cure is an old saying that applies more so today. The food industry has faced crises before that have disturbed the sleep of managers, and we have always overcome them. We will overcome this challenge as well.