According to ANSI/PMMI B155.1-2016 – Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery, safe is “the state of being protected from recognized hazards likely to cause serious physical harm.” Unfortunately, there is no such thing as being absolutely safe (i.e. being entirely free of all conceivable risks), especially in the case of machinery, which will always possess present hazards. That being said, the operation of machinery, such as packaging machinery and packaging-related converting machinery used to produce food, beverage, and pharmaceutical products, is always a necessity.
Therefore, the goal is not to eliminate all hazards but to mitigate them as much as possible in pursuit of a status that objectively can be deemed as safe. This is fulfilled through risk assessment and risk reduction for any group or individual affiliated with packaging machinery.
Responsibility for risk management processes for packaging machinery is held by both the machinery suppliers and the users, who must define and achieve acceptable risk. While their responsibilities do differ, since the supplier is tasked with the design, construction, and information for operation and maintenance of the machinery, and the user’s duty lies solely with operation and maintenance, each party involved uses the same risk assessment process.
The following figure from ANSI/PMMI B155.1-2016 illustrates the machinery lifecycle progression, beginning at concept and ending at decommissioning, all of which must be assessed for risk:
Since the risk assessment process should be identical for both the supplier and the user of the packaging machinery, there are many opportunities for collaborative efforts between the two groups. For example, the user is responsible for the installation or commissioning of the machinery, but they can acquire assistance from the manufacturer of that machinery through labels and guidance that simplify the assessment of risk that emerges during installation.
As for the risk assessment process, an initial factor to consider is scalability to fit the particular organization and its culture. Variables related to this include the size or complexity of the project, location (conducted on or off site), formal (multi-discipline) vs. informal, cultural norms, and potential hazards related to product contamination.
The process itself is a series of logical steps used to systematically examine the hazards associated with the packaging machinery. The fundamentals of risk assessment are to identify hazards, assess risk, reduce risk to an acceptable level, and validate and document the results. These ideas are reflected in the seven basic steps of the risk assessment process: (1) prepare for/set limits of the assessment, (2) identify tasks and hazards, (3) assess initial risk, (4) reduce risk, (5) assess residual risk, (6) achieve acceptable risk, and (7) validate risk reduction measures.
There are two main approaches to this process, as discussed in ANSI/PMMI B155.1-2016: hazard-based and task-based. Each of these is self-explanatory and specific to the needs of the organizations involved.
Ultimately, regardless of the approach used, risk assessment comes down to the fact that risk is a function of the severity of harm and the probability of occurrence of that harm. Due to this, risk must be appropriately scored for proper evaluation.
With this understanding of severity of the risk, along with the probability of its likelihood, users and suppliers are able to take measures necessary to control the hazards. Some potential measures are preferred, such as elimination or substitution of the component or process responsible for the hazards. Others, while not ideal for thoroughly mitigating the hazards, may also be selected, such as using personal protective equipment (e.g. safety glasses, earplugs, gloves). This decision is to be determined by the user or supplier. Where practical, hazards should be eliminated by design.
Like other management processes or systems in other industries, the risk assessment process should incorporate active leadership and competent persons to assure success.
This entire process for risk assessment is covered in the ANSI/PMMI B155.1-2016 standard, which was written and published by The Association for Packaging and Processing Technologies (PMMI), an ANSI-accredited standards-developing organization.
ANSI/PMMI B155.1-2016 – Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery is available on the ANSI Webstore.
1. PMMI The Association for Packaging and Processing Technologies, ANSI/PMMI B155.1-2016: Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery (Reston: PMMI, 2016), 18.
2. PMMI The Association for Packaging and Processing Technologies, ANSI/PMMI B155.1-2016: Safety Requirements for Packaging Machinery and Packaging-Related Converting Machinery (Reston: PMMI, 2016), 28.