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.