The government is full of acronyms, and food safety is no exception. With FSMA in full force, some of the common quality control acronyms that have been discussed in-depth are HACCP, HARPC and PCQI. At the Food Safety Summit this May, Donna Schaffer of Rutgers Food Innovation Center gave a great presentation on What Constitutes a ‘PCQI’ that explained these terms and what they mean for food safety professionals. Below is a brief summary.
First, the Background
On September 17, 2015 the FDA released the Current Good Manufacturing Practice Hazard Analysis and Risk-Based Preventive Controls for Human Food with the following key requirements:
- Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls
- The definition of a ‘farm’ is clarified to cover two types of farm operations. Operations defined as farms are not subject to the preventive controls rule.
- Supply-chain program is more flexible, with separate compliance dates established.
- Current Good Manufacturing Practices (CGMPs) are updated and clarified.
The ruling includes the following compliance dates:
- Very small businesses (averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): September 17, 2018, except for records to support its status as a very small business (January 1, 2016).
- Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): September 17, 2018
- Small businesses (a business with fewer than 500 full-time equivalent employees): September 17, 2018
- All other businesses: September 19, 2016
Download the free research report – State of the Market: Food Safety
Hazard Analysis and Critical Control Points (HACCP) vs. Hazard Analysis and Risk-Based Preventive Controls (HARPC)
New Implementations in Your Food Safety Plan
Below is what you need to focus on implementing in your new food safety plan. This embodies the HARPC method, including the key preventive controls step which is upgraded from HACCP (just hazard analysis.)
| Element | HACCP Plan | Added in Food Safety Plan |
| Hazard analysis | Biological, chemical, physical | Chemical hazards to include radiological; consider economically motivated hazards |
| Preventive controls | CCPs for processes | Process CCPs + controls at other points that are not CCPs |
| Parameters and value | Critical limits | Parameters and minimum/maximum values (= critical limits for process controls) |
| Monitoring | Required for CCPs | Required as appropriate for other preventive controls |
| Corrective actions or corrections | Corrective actions | Corrective actions or corrections, as appropriate |
| Verification | For process controls | As appropriate for all preventive controls; supplier verification required when supplier controls a hazard |
| Records | For process controls | As appropriate for all preventive controls |
| Recall plan | Not required in the plan | Required when a hazard requiring a preventive control is identified |
Preventive Controls Qualified Individual (PCQI)
With these new preventive controls comes further management, introducing the Preventive Controls Qualified Individual (PCQI) requirement. The FDA defines a PCQI as someone who has successfully completed training under a standardized curriculum recognized by the FDA (such as the FSPCA-developed 2.5-day course on Preventive Controls for Human Food) or can demonstrate equivalent competency through other training/education and work experience.
First Step
Assemble the Food Safety Team
- Management commitment to resources – supports realistic and executable plan
- Team approach – reduces risk of missing key food safety considerations and encourages ownership of the plan
- Individuals with different specialties and experiences – provides knowledge of daily operations (QA, production, sanitation, maintenance etc.)
- PCQI required – someone within the firm and/or an outside expert that successfully completed the training or otherwise is qualified
Helpful Resources
I already took a HACCP class in the past…am I a PCQI?
- You still need to take a Preventive Controls for Human Food class if you want to become a PCQI
I passed a GFSI-format audit…am I PCQI?
- No, you still need to have a PCQI with a written food safety plan to satisfy the new FDA regulations
Preventive Controls Scientific and Technical Questions from Industry
FSMA Regulation and Policy Interpretation Questions
Donna Schaffer is the Associate Director of Food Safety, QA & Training Programs at the Rutgers Food Innovation Center in Bridgeton, NJ.
Learn more about efficiently documenting your new preventive controls with CompWALK for Food Safety.