Dear Colleagues –
If I were to ask, “Who is your PCQI?” (Preventive Controls Qualified Individual), there would be three typical responses:
1. What is PCQI?
2. I don’t know – I’ll ask around and get back to you.
3. Yes, we do have a PCQI. (PCQI is a person, not a thing!)
If an FDA investigator or a major customer were to ask this question, then what? I confess, it took me awhile to get the acronym and the concept of PCQI straight in my head, so if that is your situation, you are not alone.
Here’s the good news. PCQI training is here. So, what (remember – it is “who”) is PCQI?
Preventive Controls for Human Foods is one of seven provisions of the Food Safety Modernization Act (FSMA) and the key to a new generation of food GMPs based on the HACCP (Hazard Analysis Critical Control Point) principles of “anticipate, prevent, validate.” The old system was “problem, investigate, fix, repeat.”
Within the Preventive Controls for Human Food rule, a PCQI is required.
After the melamine protein disaster of 2008 and lots of food safety problems with peanut butter, tomatoes, lettuce, cantaloupe, flour with E.coli, sprouts, spinach, and ice cream, both the public and Congress wanted change. That change was FSMA. FSMA is based on HACCP. The origins of HACCP go back to World War II as a solution to a big problem – defective artillery shell firing pins that were blowing up our own soldiers or just not exploding. This problem was solved by carefully examining each possible failure (CP = critical point) and fixing it, until system integrity was confirmed. NASA adopted HACCP to make sure astronauts’ food in space was absolutely safe. Salmonella in a space suit = Houston, we have a problem.
The Preventive Controls (PC) is the process, and Preventive Control Qualified Individual (PCQI) is the person trained to implement the preventive controls developed through a food safety plan.
Who or what falls under the PCQI requirement?
Here is our advice. If you produce, transport, distribute, warehouse, or sell DI/DS (Supplement Facts or Nutrition Facts labels), you are strongly advised to complete PCQI training.
So, this is how it works:
1. Companies designate an individual(s) responsible for the preventive control food safety plan and its implementation.
2. A PCQI 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 as otherwise qualified.
3. The course is 2.5 days with active student participation.
4. Class size is capped at 10 people (or 25 if there are two instructors). The coursework is standardized and approved by an independent body, the Food Safety Preventive Controls Alliance (FSPCA), recognized by FDA to oversee PCQI training. See FSPCA background and copy of the participant manual here.
5. UNPA’s Larisa Pavlick is a lead for FSPCA Preventive Controls for Human Food and can train your staff to be a PCQI.
6. PCQI graduates receive a certificate of training and is specific to the PCQI, not the company.
7. The PCQI is now responsible to create, implement, and maintain compliance through the food safety plan that begins with PCQI training.
8. Each facility (not company) must have at least one PCQI.
9. A food safety plan (FSP) is specific to each product type, and it is not uncommon for one facility to have multiple food safety plans.
10. The compliance date for PCQI implementation is dependent on the company size:
11. Thousands of conventional food and DS/DI companies require training – a huge task. UNPA will be offering PCQI trainings through 2017 in several locations. We have contracted with other PCQI trainers to work with us to increase class size.
12. In the near future (if not already), customers will be asking about your PCQI status – and so will FDA.
13. We are adding a special DS/DI case study to the standard course. (The current case study is for frozen omelets – great for Jimmy Dean, but not too helpful for DS/DI or most functional food companies.)
14. The next PCQI training is July 17-19 in Salt Lake City (Hilton Hotel, downtown). The class size will be 25 students with two instructors. We currently have 13 seats left. We will close registration at 25. You may register for the July training here.
15. There are other parts of FSMA that require a qualified individual with separate training, such as the Foreign Supplier Verification Program (FSVP). We will overview that in a separate memo and will be offering FSVP training as well.
UNPA has set FSMA compliance as a high priority. We are doing all we can to provide the tools, the training, and the resources for member companies to be FSMA compliant. Our goal is to have a 100% FSMA-compliant membership within the next 12 months.
Stand by for additional Expert Insights webinars and news about trainings and updates.