Page 17

eFOOD-Lab_International_01_2016

New US Legislation 1/2016 eFOOD-Lab international 17 inspection. The food plant’s food safety program must contain a written: 1. Hazard analysis 2. Preventive controls program with written procedures for implementation 3. Supply-chain program 4. Recall plan 5. Corrective action procedures 6. Allergen program 7. Verification procedures 8. Record system supporting the food safety plan Preventive controls qualified individual (PCQI) All food plants having to comply with the FSMA Preventive Controls for Human Foods (PCHF) will have to have their food safety plan managed by a “Preventive Controls Qualified Individual (PCQI)”. The PCQI does not have to work full-time at the food plant so a corporate PCQI that serves more than one food plant is acceptable, but the PCQI must be on-site during the FDA inspection to explain the various parts of a food plant’s food safety plan. The PCQI can be qualified by training or experience and knowledge of the FSMA PCHF regulation. Another good idea that is not required is for each food plant to send at least two individuals to the “PCQI” training sponsored by the FDA FSMA Preventive Controls Alliance (FSPCA). This “official” PCQI training must be conducted by a FSPCA “Lead Instructor” in order for the completion certificate to be recognized by any FDA investigator. This FSPCA Lead Instructor has completed detailed training themselves in order to be recognized and qualified to provide the “official” PCQI training. It is important that as food plants evaluate available training for PCQIs, they ensure that the specific trainer has a certificate from FSPCA identifying him/her as having passed the “Lead Instructor” training. Employee training & qualifications Each processing employee and supervisor engaged in manufacturing, processing, packing, or holding food must have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties; and receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties. In addition, each plant must have “Qualified Individuals (QIs)” that are directly responsible for specific tasks. The regulation does not require specialized training for QIs, but they must demonstrate they are qualified for the task they are assigned to perform. Specific QI tasks identified in the regulation include: • Conducting internal audits • Plant processing and supervisory staff responsible for manufacturing, processing, packing, or holding food • A ny other activity required by the Preventive Controls for Human Foods not specifically assigned to a “Preventive Controls Qualified Individual” Specific preventive controls requirements for food plants One of the more confusing parts of the PCHF regulation is the requirement that all food plants are required to have “preventive controls”. The food industry has used prerequisite programs, GMPbased programs and critical control points to control food safety hazards for raw materials, ingredients and processing steps to build an effective food safety program. Now we have to also identify hazards that are required to use “preventive controls” as well. The question is what are preventive controls? The best answer is not to use the formal definition, which is long and lacks specificity, but to use the PCHF regulation details (21 CFR 117.135). See below for practical preventive control details. 1. Process Controls (Practical Definition): Any step where there is a hazard that if not controlled at that step will result in a food safety compromise of the finished product. Examples include: a. Pasteurization processing step – biological hazard controlled by a CCP b. Packaging processing step – biological hazard controlled by a set of prerequisite programs, i.e. equipment sanitation, employee hygiene, etc.) c. Ingredient Blending processing step - biological and physical hazards controlled by a set of prerequisite programs, i.e. equipment sanitation, employee hygiene, etc.) d. T emperature Controls where failing to maintain raw material, ingredient, in-process or finished product temperature could be expected to create a food safety problem. 2. Food Allergen Controls. A food plant’s entire written “Allergen Management Program” would be a preventive control with a number of parts that include segregation of ingredients at receiving, ingredient storage, product processing, product packaging and a label review and verification program. 3. Sanitation Controls. A food plant’s “Sanitation” preventive controls are mostly focused on biological pathogens that could cause foodborne illness through food product consumption. “Sanitation” preventive controls need to be applied to primarily hazards in the following areas: a. Processing Equipment & Utensil Cleaning & Sanitation Program b. Facility Cleaning Program c. Integrated Pest Management Program d. Processing area ventilation to eliminate overhead condensate and air-borne contamination. The use of pressurized air to “push” ingredients and product through the production system must also be addressed. 4. Supply-Chain Controls. A food plant’s Supply-chain preventive control program needs to address hazard(s) in a raw material or ingredient when that specific hazard(s) must be controlled prior to receipt by the food plant. If the hazard of concern is controlled by the food plant, then the PCHF does not require a supply-chain control program to address that supplier. Also, if the hazard associated with a raw material or ingredient comes from a foreign supplier and the supplier has qualified itself under FSMA’s Foreign Supplier Verification Program, the food plant is not required to have a supply-chain control program for that supplier. Any written supply chain preventive control program needs to include: a. List of approved suppliers b. Sampling and testing program for the raw material or other ingredient; c. A nnual onsite audit (see 21 CFR 117.435 for audit requirement details) if there is a reasonable probability that exposure to a hazard will result in serious adverse health consequences or death to humans (SAHCDH). Such an audit needs to be conducted by a “qualified auditor” and contain the following information: 1) The name of the supplier;


eFOOD-Lab_International_01_2016
To see the actual publication please follow the link above