Open Letter to FDA on Adoption of Systems Approach to FSMA
The new FSMA regulations are primarily intended to enhance the protection of public health through promotion of adopting a modern, preventive and risk-based approach to food safety regulation. The general consensus industry-wide is that the new regulations will increase the capacity of firms in the industry to develop effective food safety management system at facility levels that will be effective in preventing distribution of food-related hazards to the general public, which may result in foodborne illness.
There is widespread consensus that the development and implementation of a food safety system whose primary purpose is to prevent the distribution of hazardous product to the general public and hence prevent or reduce foodborne illness is a much more effective and practical approach towards this end. This is especially the case when compared to past approaches, among which many programs were quality control based and focused on end-product testing given the highly fluid and dynamic complexity in the food industry, which is being fueled by technological advancements that occur at the speed of light.
Having stated consumer safety as the primary stakeholder of a facility’s food safety system, there are other secondary stakeholders whose requirements are subservient to the consumer’s health requirements, but they play key roles in determining the architectural structure of the food safety system:
- Regulatory requirements. Primarily serve the public and act on its behalf in ensuring that all food products distributed in the market are safe for consumption. However, the regulatory requirements have their own innate requirements (i.e., the uniformity of the structure of a food safety system) at the most basic level for the purposes of compliance, which enables a harmonized structure that conveniently lends itself to a uniform approach in the inspection of facilities by FDA agents.
- Organizational requirements. There are existential risks to an organization should a facility ship out contaminated product, as can be seen from the recent cases widely reported by the media. These range from market share reductions to rattled shareholders, and to employees, it becomes a job security issue. In fact, this is one of the key points I always bring out during trainings: The consumer is the ultimate boss, and if the consumer complains, it’s bad for our jobs as food manufacturers. If they are outright sickened/angry/mad by our job performance, we should expect the pink slips (I’m sure a number of employees at the Blue Bell Creameries will support this opinion).
From a regulatory requirement perspective, uniformity is a key aspect of the requirements, as can be inferred from regulatory text on the preventive rules, which describe the fundamental elements that must be implemented by a facility in order for it to be compliant with FDA registration. The lifecycle of regulatory requirements are long term—the last time comprehensive changes were conducted on cGMPs was in the mid-1980s. And hence the analytical/reductionist approach of focusing on food safety at the facility level is complementary to its enforcement strategy (i.e., facility-based registration and inspection).
From the organizational perspective, given that the food safety system serves an existential purpose to the business, organizations are leveraging the best available resources to endure its proper design and implementation, including employing the use of the latest available technologies. From the organizational perspective, the organizational requirements are highly dynamic and often tied to consumer and market trends. And as such in most corporate organizations, the food safety system adopts a holistic approach, whereby plant facility food safety systems are often nested within larger hierarchical corporate food safety systems. One of the fundamental reasons for this holistic set up is to enhance efficiency of these programs, especially given their key functional roles in mitigating or preventing organizational risks that may be presented through distribution of contaminated product.
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.
The ISO/TC 176 took notice of the impact of requirements for written programs in an organization’s quality management systems. Organizations had to essentially establish parallel quality management systems that lead to the implementation of inefficient and redundant manual documentation systems just to satisfy the standard requirements and electronic-based documentation. This requirement for a written quality plan/policy was dropped in the newly released ISO 2000:2015 quality management standard, which now calls for the documentation of processes that are key towards the achievement of the organizational quality objectives. I’m certainly sure a similar scenario is playing out with the roll-out of the FSMA regulations—whereby organizations that have invested in some of these technological applications that provide a modular holistic approach in the management of their food safety systems will be forced to bend over backwards to meet the regulatory requirements by trying to transcribe their complex enterprise-based food safety systems into linear structured written food safety plans—a very difficult feat to achieve!
At its core, the new FSMA preventive controls rules call for the development of a written Food Safety Control Plan by all the qualified facilities as a conditional requirement towards the fulfillment of the requirements. Does this mean that a facility cannot employ new technological applications, such as a modular approach (use of models), in describing its food safety systems (especially if it’s food safety system is nested within the an enterprise corporate food safety program in a complex structure)? For example, if it develops a computerized model depicting its entire food supply chain (internal and external processes) with the capability of providing the granular interactions and interrelationships within and among all the processes involved in the manufacture of its product as a means of enabling an efficient end-to-end visibility of its manufacturing operations from supplier to consumers (including all the non-linear interrelationships that interplay at the boundaries of the facility food safety system and the larger corporate food safety system) and all the controls that have been effected to assure the safety of its product, does it still have to create redundant manual interpretations of this model in a written document that is formatted per the current regulatory requirements in order to maintain its registration? Will that add to inefficiency, negatively impacting on business goals? Further to this, inefficient processes, however effective they may be, may not be sustainable from a business point of view!
My opinion is that flexibility should be incorporated into the regulatory text to make room for adoption of future technological applications by facilities. This would require the revision of the regulatory text of the key elements at the heart of the HARPC; instead of mandating facilities to have written food safety plans, it should adopt a more accommodative approach of requiring facilities to have documented food safety plans that would allow room for application of electronic formats, such as use of food safety models, to describe the food safety control measures in those enterprise facilities that have complex organizational food safety systems.
On a parting shot that is just a food for thought: In the medical industry, new technological applications such as computer-generated simulation models are employed by teams of surgeons when preparing to undertake complex surgeries. No documentation is used, all the team members’ suggestions and evaluations of the potential risks related to the operation procedures under study are captured in the electronic models and can be available at the click of a button (in case a review is needed), thus no such “written plans” are required.
This is the trend of the future!
The views presented in this article are the author’s opinion and are not representative of the Hershey Company.
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