Considerations for new production lines
However, new operations with risk potential clearly in need of consideration include component sophistication, footprints, changeover complexity, reduced human oversight and so forth.
That’s what makes the risk and hazard analysis process so critical. If the project manager isn’t given a comprehensive summary of risks, design, oversight and maintenance criteria, the details are left to the judgement of those outside the client organization. Issues of materials composition and appropriate design standards will assumedly be considered and integrated by supplier experts, but the client risk assessment team members must do their homework and anticipate “what else or new can go wrong” in addition to the previously identified and considered calamities documented in existing prior risk potential summaries created by “the team.”
Typically, the food equipment client project manager responsible for executing the project is not an expert in technical disciplines of microbiology, sanitation, food safety and related. Rather, the project manager is tasked with coordination of efforts and delivering an on-time, in-budget completion. In my experience, each cross functional hazard analysis team member should prepare, promote and champion a discipline-specific food safety agenda and once the information and recommendations are disseminated to client management, the “baton is passed.” Recognize that in a marketing-based organization, management makes final decisions and if an aspect of equipment design results in a food safety failure, make sure that your recommendations were communicated so that you or your function does not “own that failure.”
Examples of functional hazard team responsibilities include:
The quality function representative should oversee the hazard and risk assessment teams’ creation of an accurate summary of process activities within which the equipment will function. Focus should be on sensitive ingredients, components, changeovers, sanitation and expected degrees of difficulty.
Maintenance should create a section describing how change parts, inspection, adjustment and other hands-on, maintenance-related activities are expected to occur within the normal work environment.
Technical research should speak to incoming, intermediate and finished product-in-package expectations, limits, variations, risks and in-specification quality.
Operations staff and management representatives should collaborate to document production oversight, human resources and criteria for safe and effective operation. It must be noted that new automation systems represent many unknowns. Therefore, training, oversight and communication must be coordinated within the operations function.
Engineering should explain and document how “new” equipment, components, controls, processes and footprints integrate and synchronize with existing infrastructure, in addition to their typical guidance for regulatory and client-specified design criteria (small parts, delamination, forbidden materials, NEMA ratings, clean-out-of-place (COP)/clean-in-place (CIP) designs, etc). Engineering might also own ideation for redundancies to improve safety and reduce risk (recall the self-driving car human operator example).
Food Safety team members should ensure that there is a draft HACCP/HARPC plan created to identify and mitigate physical, chemical and microbiological risks and hazards associated with the new process. They should also collaborate with maintenance counterparts to identify how best to inspect and approve safe production restarts following downtime for any and all maintenance-related activities.
Sanitation managers need to study documents and manuals supplied by the equipment vendors in order to understand and then challenge how the state-of-the-art equipment can and will be cleaned, sanitized and maintained to create consistent and safe consumables.
Accompanying maintenance, testing, changeover, sanitation, and adjustment manuals need to be written in plain-speak, including technical language and local jargon alike, so that every maintenance and engineering resource can understand expected, unified processes.
In summary, I recommend that the client engineers and project managers approach new and/or complex food equipment design and installation projects based on objectives, requirements and component knowledge designed to deliver safe products.
Every unfamiliar component of a process requires new learning, expert advice and tutorials, a thorough review and the expectations of previously unfamiliar errors, omissions and learning curves. Automation, sophisticated controls, artificial intelligence and other state-of-the-art components will naturally add complexity and challenges to the food safety risk and hazard identification and mitigation process, but, procedurally, the process objectives remain consistent.
Many eyes watch cutting-edge equipment projects initially and a safe, steady-state condition is often not easy to achieve. However, at some point the system is expected to pay for itself by operating “at advertised speed” with reduced human oversight. Thus, all criteria for success used to rate product and process safety during factory acceptance tests and related statistical commercialization assessments need to be comprehensive, well documented and understood by all. Compare the process statistically to odds at the casino. Run the system for enough hours and the product quality results will match the true odds for an error. Hazards and risks do exist and product failures will occur. Long-term success will be proportionate to design efficiency, client oversight and the continuous application of expected suitable resources. High-end equipment will properly perform and sustain safe output of goods when it in kind has been adequately designed and is continuously reviewed, adjusted, supported and maintained through skilled oversight and focused documentation.
You can hear Gary Kestenbaum in person address the topic of food safety considerations in an automated production operation during EastPack 2018 (June 12-14; New York City) on Thursday June 14 10:30-11:00.
Gary Kestenbaum is an independent food packaging safety consultant with 45 years of experience in the food industry as a food ingredient technician with National Starch, a food product developer with General and Kraft Foods, a package developer with Kraft Foods and as a food packaging safety consultant with EHA Consulting Group. He can be contacted at [email protected].