Rapid technological advancements are availing new technological approaches at an exponential rate and are offering businesses more effective means of implementing food safety systems that are based on holistic models and synergistic to their business goals (the leading of which is improved efficiency).
One of the key aspects of these technological applications is the increased automation of manufacturing processes designed to reduce or eliminate so-called “human errors” from critical processes that may affect product safety from a consumer’s perspective. In the pharmaceutical, biologics and medical device industry, this has been the leading trend in the recent past. One of the key driving forces behind these enhanced technological applications is the increased operational efficiency attributed to the replacement of manual processes from documentation to operations of processes.
However, the new FSMA regulatory requirements do not render themselves as, for lack of better terminology, technology friendly.
Organizations, including many food production and manufacturing businesses, are employing new management approaches in an attempt to keep up with the dynamic complexity of the business world, from rapidly changing consumer trends to new emerging technologies and products in order to gain competitive advantage.
One of the new approaches that is gaining popularity is the approach of systems business dynamics, which employ the concept of systems thinking, whereby the organization tries to gain a holistic end-to-end understanding of its internal business processes and their interrelationships and interactions with the external environments, including its supply chain. Rapid technological advancements are enabling organizations to effectively apply this approach (i.e., the new rage on the application of Big Data and the Internet of Things in the manufacturing field. For example, the distribution centers of Amazon that employ Internet of Things technology in handling customer orders, including groceries).
Food manufacturing organizations or facilities can borrow the systems approach in using these new emergent technological applications in effecting food safety control (Currently applied in some areas of the pharmaceuticals, biologics and medical device manufacturing industry. Disclaimer: I previously worked for a major medical device market leader). Facilities can employ a holistic end-to-end technological approach of implementing and documenting process controls to assure product safety, within the organization using an enterprise-wide application of technology in tracking, handling, monitoring and documenting production processes, from the use of RFID pallets for material handling to the use of smart chips that transmit wireless data on the real-time functioning of the device during its usage. These measures could provide the following benefits:
- Gain a more precise understanding and control of its processing operations and finished goods product movement within the entire food supply chain
- Gain useful real-time data on potential risks that may be presented to the production material either during its movement or processing, and lead to the production of hazardous product, so that effective controls are promptly applied
- Gain important (predictive) information that may inform the facility’s management decisions on the enhancement of its product safety protection measures
Rapid advances in technology are availing similar technological applications to food manufacturers as systems that provide enterprise solutions of enabling efficiency while at the same time enhancing the product safety to assure the wellbeing of its consumers. Most of these technological applications are assuming a holistic approach of employing a technological application in a holistic manner. This includes the use of smart chip ingredient material handling (i.e., smart chip-embedded pallets) and with production processes, the blended use of software programs with minimum human machine interfaces, the use of robotics in packaging and processing, and smart labels and packaging that can transmit real-time data about the condition of a product, providing concise information on potential hazards that may be presented to the consumers.
The current regulatory requirements adopt a reductionist/analytical thinking (linear structured) approach in which food safety controls are to be implemented as stand-alone programs that should be easily discernable for verification at the facility level. This can be inferred from the FSMA regulatory text, which at its core calls for availability of written programs (which sound prescriptive) as opposed to documented programs, which would provide for the application of other technological formats, such as electronic media, in describing the food safety controls of the facility.