The economy as we know it depends on consumer trust. No one would order a product from Amazon, pick an item off of the grocery store shelf, or order up a meal at a restaurant if they thought there was a better-than-average chance that the product would harm them.
If consumers take for granted that the products they buy are safe, it's because they expect manufacturers to implement adequate safety processes. Indeed, ensuring the safety of their products is paramount for any manufacturer, especially manufacturers in heavily-regulated industries like food production and pharmaceuticals. These manufacturers have not only consumer trust, but regulatory compliance to consider when making their safety plan.
Here are three important safety processes for manufacturers to implement.
HACCP
Many industries could benefit from a HACCP plan, but the HACCP standard originated in the food industry and remains especially applicable to that industry.
It was pioneered to meet NASA's need for pathogen-free food in space. As it turned out, HACCP procedures resulted in a reduction of pathogens in earth-based foods as well and it gained widespread adoption throughout the 70s and 80s.
A failure to properly implement or update HACCP has been found to have contributed to outbreaks of E coli infection traced back to contaminated patties at Jack N' The Box in 1992-1993 and E coli infection traced to packaged salad products at grocery stores in 2019.
HACCP can be broken down into two key imperatives:
- Hazard Analysis (HA). A kind of risk analysis that accounts for all potential safety hazards affecting the product.
- Critical Control Points (CCP). Identifications of all potential points of failure that have to be controlled or supported to prevent safety hazards.
HACCP plans will vary from company to company, but they can be broadly broken down into seven steps:
- Perform a Hazard Analysis. Identify potential hazards, making sure to address every step of the manufacturing process.
- Identify Critical Control Points. These might include product formulation, temperature processing, chilling, and testing for contaminants.
- Set Critical Limits. Identify the parameters acceptable for each CCP, like minimum or maximum temperatures, humidities, or pressures.
- Establish Monitoring Protocols. Create procedures to monitor the CCPs.
- Define Corrective Actions. Develop response plans to correct CCPs that exceed or fall below the established critical limits.
- Establish Verification Protocols. Define procedures to verify that the HACCP plan is in effect and critical limits are being observed.
- Establish Documentation Protocols. Create procedures to record CCP conditions and document them for quality assurance.
Again, every HACCP will differ in the details, but manufacturers, especially in the food industry, should address all seven steps of HACCP protocol as a key component of safety processes.
IQ OQ PQ
Most manufacturers depend on machinery and equipment in the production process. Whether or not those machines perform to expectations is a key element of safe manufacturing. " IQ OQ PQ " refers to a three-stage quality management process to validate the proper functioning status of new equipment.
The system progresses as follows:
- IQ: Installation Qualification. IQ is the process that validates the proper installment of new equipment, in accordance with manufacturer recommendations.
- OQ: Operational Qualification. OQ involves a test run of the equipment to validate whether it is likely to perform to expectations.
- PQ: Performance Qualification. PQ requires the operation of the machinery under actual production conditions to determine that it functions according to manufacturer specifications.
Each stage in the process is a chance to discover and correct inconsistencies that might become obstacles to a safe manufacturing process.
Temperature Mapping
Many manufacturing practices depend on optimal temperatures for safety and quality assurance. However, a sprawling production or storage facility, with hot machines scattered throughout, is bound to have variations in temperature throughout the facility. Some of them may be quite extreme.
To make matters more complicated, facilities located in geographic regions with extreme swings in seasonal climate may fluctuate in temperature, dramatically colder in the winter than in the summer.
One temperature reading in one position of the facility on one day is insufficient. To maintain quality assurance, you need to know what temperature variations the facility is subject to.
Temperature mapping involves a detailed, three-dimensional mapping of a controlled space such as a warehouse or chamber, according to this article from Dickson. Also known as "thermal mapping," temperature mapping also takes place over a period of time to account for seasonal shifts.
Reasons to implement thermal mapping include:
- Protecting products from spoilage and lost revenue.
- Maintaining regulatory compliance by confirming products were produced or stored in optimal conditions.
- Understanding the performance capability of your HVAC system.
- Creating a data-based foundation for ongoing temperature monitoring plans.
Facilities that would benefit from temperature monitoring include warehouses, freezers, refrigerators, cold rooms, transportation equipment, processing areas, stability chambers, sterilizers, ovens, and incubators.
Temperature mapping is performed in eight steps:
- Create a test plan. Identify potential points of temperature variance as places to take temperature readings, as well as critical times and dates.
- Calibrate data loggers and sensors. Make sure thermometers are adequately sensitive, and data loggers have adequate resolution to obtain the necessary precision of measurement.
- Take data measurements. Collect data in accordance with the test plan.
- Retrieve data measurement equipment. Take note of any equipment that has been moved or shifted.
- Download the data. Retrieve the record from the data loggers, either by hard plug or cloud-based wireless collation-whatever the data logger is capable of.
- Post-calibrate the data loggers and sensors. Recalibrate the sensors and data loggers to identify any discrepancies or degradations.
- Create a mapping report. Summarize the results and deviations.
- Make recommendations. Suggest remedial action, such as temperature management, rearrangement of facility use, or further temperature mapping and testing.
While temperature-sensitive data loggers can help confirm compliant conditions throughout a factory or storage facility, temperature mapping helps manufacturers understand where to place those data loggers, and what subsections of their facilities are best suited to which uses.
Each industry has different safety needs. Each business will implement the above safety processes in different ways. However, understanding these processes is key to manufacturing and distributing products with the safety specifications consumers depend on.