To be or not to be, that was the question. Now, in more modern times, the question has changed. Like Hamlet, many have been waffling back and forth, wondering whether or not they truly need a PCQI to help them build their food safety plan. However, unlike Hamlet’s question, this one is far more easily answered.
Do I Need A PCQI?
For the most part, yes.
While there are a few exemptions to this rule, the generally accepted answer to this question is a definitive yes. The FSMA Preventive Controls Rules necessitate the guidance of a PCQI for almost all facilities that were required to register under section 415 of the Federal Food and Drug Cosmetic Act.1 Read here to see if your facility is one of the rare few exempted.
What Is A PCQI?
As it turns out, a PCQI is yet another acronym to be added the food industry, standing for a Preventive Controls Qualified Individual. For clarity on more government abbreviations, read about Hazard Analysis and Risk-Based Preventive Controls. As defined by the FDA, a PCQI is an individual who either has been qualified through an FDA approved course involved in developing risk-based preventive controls or has the equivalent of such training that has been gained through years of job experience.1
What Are the Responsibilities of a PCQI?
When working at your facility, a PCQI has four basic responsibilities.
- Preparation of the food safety plan
- Validation of the preventive controls
- Records review
- Reanalysis of the food safety plan
These tasks operate in a cyclical fashion, allowing your PCQI to evaluate the efficacy of your current food safety plan and, from that, fashion the best food safety plan for your facility. In addition to these duties, it is also up to the PCQI to handle any other activities that have been deemed relevant to the food in question.2
There are a few ways to become qualified as a PCQI, the most common of these being the completion of the training offered by the Food Safety Preventive Controls Alliance (FSPCA). While this is the easiest way, it is not required that a PCQI be trained through this course, as FSMA’s rules concerning PCQIs demand no specific certifications. Instead, the reliability of your PCQI and their qualifications can be determined based on the FDA’s assessment of your facility’s food safety plan. If the evaluation of the plan results in a less than satisfactory report, additional training may be needed by your PCQI before the creation of a new food safety plan.3 To avoid this problem, click here to see listings on classes and training courses to become a fully certified PCQI.
1,3 https://www.fda.gov/food/guidanceregulation/fsma/ucm247559.htm
2 http://www.22000-tools.com/pcqi.html
