The FDA’s Preventive Controls for Human Food regulation was published on September 17, 2015. It applies to facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act, and these facilities must comply if they manufacture, process, pack, or hold human food. Compliance with this rule became mandatory for large firms in September 2016, and compliance deadlines for “small businesses” (September 18, 2017) is quickly approaching. For this particular FSMA regulation, food companies are required to have a food safety plan in place, and this plan needs to be developed by a Preventive Controls Qualified Individual (PCQI).
According to the FDA’s definition, a PCQI is someone who has “successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.”
Although there are some activities that are exempt from the Preventive Controls rule, most facilities will need to have a PCQI to complete certain activities. But a PCQI is not a one-size-fits-all position. The other tenets of food safety (ISO 22000, HACCP, all elements of BRC, SQF, and FSMA) are also common areas of expertise to be expected from PCQIs.
By title these PCQI individuals can be:
- Quality Assurance/Quality Control Supervisors and Technicians
- Corporate Food Safety Managers, Directors, and Vice Presidents
- Production and Plant Management/Personnel
- HACCP Coordinators, Plant HACCP Team Members
- Regulatory Affairs Supervisors
- In–house Lab Personnel
A careful examination of current PCQI positions to be filled starts to identify what food manufacturing employers and HR departments are expecting.
For example, one job description for a quality assurance manager for a manufacturing company in Omaha reads:
“In addition to being PCQI certified, the qualified candidate must have experience with HACCP Programs, GMPs, SSOPs, SOPs, USDA & FDA, and SQF experience.”
Another for a manager of food safety in New Jersey reads:
“Must be PCQI qualified with at least 3 years of experience in food safety related to manufacturing, or distribution, knowledge of Good Laboratory Practices and laboratory skills, possess a working knowledge of GFSI standards, and internal or lead auditor certification (SQF, FSSC22000, and BRC) are a plus.”
And another out of Florida reads:
“This candidate must be a PCQI and is responsible for supporting certifications of distribution centers and business units in the U.S., as well as supporting the regulatory and food safety compliance for our businesses and products under license. The winning candidate will support the implementation and maintenance of GFSI, coordinate and schedule with certification bodies the annual BRC and Organic audits for the distribution centers, and maintain regulatory compliance regarding FSMA.”
Looking at the job descriptions listed above, it is clear that companies are looking for well-rounded food safety and quality assurance folks, and obtaining a PCQI certificate is just something else to add to the list. This gets back to a point we made in a previous post. With the wishy-washy definition of the “otherwise qualified” aspect to the PCQI requirement, it makes sense for folks to just go ahead and take the courses offered by numerous companies. Check out this post for discount codes.
Too often technology decision-makers in the food sectors are attempting to solve a particular pain point or challenge. Whether by job function or necessitated by regulatory compliance, there are competing interests. Only with a single version of the truth, real-time data, can these silos of functionality create a solution that allows all to access data quickly, accurately, and effectively.
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