There is no denying the complexities of FSMA and the demands it places on large companies in the food industry. In-depth record-keeping accompanying extensive preventative control measures are a headache for food processors – at best. The real complications enter, however, when the responsibility of large companies increases exponentially with the requirement of an FSVP. It is difficult to know where to begin when 1,000+ suppliers must be accounted for in new, stringent systems. Consolidating suppliers for clear organization and analysis is a great start. Here are a few strategies to make this process both manageable and effective:
1. Standardize data across your supply chain.
Developing a formula that suppliers can fit within will simplify your job as you calculate things like quality and safety. With a myriad of sources communicating their status, it is imperative that they are all speaking the same “language.” HACCP to KPI and metrics should be targeted in this manner with a focus on standard replication from one supplier to the next. In this way, the data presented will be meaningful at first glance for every supplier.
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You will need to develop a strategy to get the information you need to report. One approach is determining the key FSMA items that would be addressed in an inspection. For example, a standard form for hazard analysis might include sections for biological, chemical, and physical hazards (which must be reported by suppliers). Upon the development of such documentation, the question of where it should be stored arises.
2. Manage documentation in a single place.
It is no longer appropriate to keep documentation and records in a variety of places around the office or on a computer. When it comes to keeping track of information for all of your suppliers, there is truly only a single way to ensure that mishaps won’t occur. That is keeping all documentation in one, secure portal. This method will often save hours that would be spent on tracking down particular records or recovering documents that have been lost in electronic failures.
A useful tool for enacting this is eFileCabinet which provides a place to digitally store documentation in a reliable management system. EFileCabinet also includes a search function that makes locating desired data a simple task. An investment in technology to store a substantial mass of documentation for 1,000+ suppliers is worth an investment, serving as the guiding foundation for an organized approach to monitoring suppliers.
3. Stay on top of current and past FDA analytics on your suppliers.
Another aspect to consider with your suppliers is analytics associated with their history of FDA compliance and ongoing performance. FDAzilla offers instant access to this data — allowing for a tiering process, along with options to select suppliers to save for reference and/or constantly monitor. Saving suppliers enables individual analysis and the ability to compare. The ability to assess suppliers holistically as well as individually is critical for an FSVP.
A concentration of data will clarify monitoring efforts — especially when trying to keep up with such a large number of suppliers. Starting on the right foot with organization and direction will keep you ahead of the FDA and away from unexpected complications.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
(NOTE: Want to know what enforcement actions are happening in your supply chain? Get your FREE SUPPLIER ASSESSMENT.)
About the Author
Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.