Hazard Analysis and Risk Based Preventive Controls

Building a (Better) Food Safety Plan

Patricia A. Wester

• Publisher: Academic Press
• Year: 2017
• Print ISBN: 9780128111888
• eBook ISBN: 9780128105016
• Topic: Medicine
• Subtopic: Medical Microbiology & Parasitology

Hazard Analysis and Risk Based Preventive Controls: Building a (Better) Food Safety Plan is directed to those food safety professionals charged with ensuring or assisting with FSMA's preventative controls (PC) implementation and compliance in their routine job duties. The target audience includes those currently involved in the development, management, and execution of HACCP and/or other advanced food safety management systems, as well as those interested in advancing their knowledge base to gain a more thorough comprehension of HARPC requirements.FSMA topics covered include: identifying the food safety team and PCQI; creating the HARPC implementation strategy; starting the food safety plan; conducting a thorough hazard analysis; identifying adequate preventive control measures; determining appropriate PC management components; recognizing applicable verification and validation activities; supply chain management program; recall plans. Other operational topics include: document control systems; internal audit programs; third party audit management; regulatory visit preparation; and maintaining compliance.- Provides a step-by-step guide to achieving FSMA compliance for food safety professionals who develop and manage food safety management systems- Written by industry experts with direct experience in the formulation of the HARPC regulations- Presents insights into the underlying approach of FSMA's preventative controls- Transitions readers from HACCP to HARPC using GAP assessment to adapt existing food safety programs to the FSMA preventative controls requirements

Chapter 1

Develop an Implementation Strategy

Abstract

This chapter provides context for the early days of FSMA implementation and gives the reader insight into the challenges faced by everyone trying to absorb these expansive changes to food safety regulations.

Keywords

FSPCA; PCQI; Preventive Controls; HARPC

Get Trained!

The (human) food industry faced the first compliance deadline in September 2016. The PCHF final rule had just been released in November 2015, so the 2016 compliance clock was ticking loudly. Everyone facing this deadline was on a very tight schedule, and the sense of urgency could be felt across the industry. After years of discussion, the final requirements were known, a deadline was finally in place, and compliance preparations could begin in earnest.

The early part of year focused on getting ready for PC implementation, and that meant Preventive Controls Qualified Individual (PCQI) training was a priority for everyone under the deadline. The PCHF rule requires the food safety plan to be prepared (or its preparation overseen) by a trained PCQI, with at least one PCQI per location. It is possible to self-attest that your food safety experience meets this requirement, but this PCQI definition must be clarified with the understanding that the experience must go beyond Hazard Analysis and Critical Control Point (HACCP) and specifically include preventive controls. The other option involves taking the Food Safety Preventive Controls Alliance (FSPCA) PCQI course (or one recognized as equivalent). In the end, most went with FSPCA course to have a PCQI certificate of training completed as part of the food safety plan.

Classes for lead instructors were full within days of opening enrollment, and classes for industry filled nearly as quickly. The first year affected the large companies (500+ FTEs), so many had enough personnel to be trained to warrant private classes for their staff, and a few companies determined it would be more effective to maintain their own team of instructors. Public classes were open to any enrollee and could include as many as 20–25 different product types.

The PCQI training was considered a launching point for Food Safety and Modernization Act (FSMA)compliance. Most assumed the training represented the path to all things FSMA, when in fact the training actually has a fairly narrowly defined scope in the regulation and the FSPCA stuck to that scope.

2016 Implementation Theme: Get a PCQI Certificate—Compliance Will Follow

Everyone understood that the PCQI role had to be identified and someone to be trained before anything else could happen. The required training had to be completed before any food safety plan development, and many understood that concept from existing HACCP experience. But once the training was accomplished, there seemed to be a pause, as if everyone thought, “What do we do next?” The answer to that question varied based on the individual’s overall condition and food safety program status. It may be hard to grasp, but a large part of the FDA-regulated industry still did not even have basic HACCP systems in place; it was only required in Juice and Seafood at this point. On the other end of the spectrum were those that were in the advanced stages of multiyear achievement in third party certification programs, resulting in a large discrepancy in starting points and compliance gaps (Fig. 1.1).

Figure 1.1 FSMA Readiness.

Time, Resources, and Budgets: How Much Is Enough?

In the PCHF final rule preamble (Comments/Responses 736, 737, and others), industry challenged data in the previous proposed rules regarding the cost of implementation. FDA provided estimates that it would take approximately 110 hours to produce the Food Safety Plan for a facility, and that most facilities would only require one plan.

Industry countered that claim by providing multiple examples of facilities that have a wide range of situations that differed from FDA’s supposition. One example claimed as many as 25 HACCP plans. A trade association submitted data to show the average time required to develop a HACCP plan as more than 200 hours per plan. One site noted that over 1385 hours were required to complete their HACCP plans. Others pointed out “preplan work” or preparation took as much as 150–300 hours per plan, and by these examples, FDA’s costs estimates had seriously underestimated the time it would take to create and implement a food safety plan. The PCHF rule does require a minimum of one trained PCQI per location (20 hours); so in reality there are only about 90 hours left to complete the food safety plan and implement it to meet FDA’s estimates.

FDA countered these comments, providing data and arguments to support the earlier claims of 110 hours. Whether it takes 110 hours or 1385 hours, these figures apply to HACCP plan development, and do not directly correlate to developing a food safety plan based on brand new concepts of preventive controls. Since HACCP has been around for decades, obviously there are far more experienced HACCP personnel and facilities have had years to refine these plans.

The actual time needed for FSP development can depend on a great number of variables specific to each location, the type and amount of raw materials used, the risks involved in production, the number of finished products produced, the general level of personnel skill and amount of available resources, and most importantly, the scope of the existing food safety system and overall support for food safety from the top down (Fig. 1.2).

Figure 1.2 Have You Conducted a FSMA Gap Analysis to Determine Current Plan Deficiencies?

Wherever your facility fits in the ranges noted, it does appear that most have vastly underestimated the time it would take to understand the new PC requirements, create the food safety plan, train everyone as needed, and implement the new plan. Bear this in mind as you begin preparations or assess the status of your current plan. Hopefully these numbers will provide some insight into what happened or an explanation for why there may be large shortcomings in your initial plan that needs to be revisited. It stands to reason that any new plan should be reassessed thoroughly and tweaked where needed once the initial development is completed. Moreover, this reassessment should be given a priority status and include any new information that has emerged since the initial plan was completed.

The comments/responses mentioned are just a portion of those related to costs and span several pages that may provide further insight into development and implementation cost estimates if needed.

Lessons Learned in Year 1

Another theme emerged as the initial year reached the deadline. Exempt facilities or sites under modified exemptions were not required to implement Subpart C, and were unsure of what was needed to achieve compliance. Assuming they needed a hazard analysis as described in the PCQI course, many were quite r...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Prologue
• Chapter 1. Develop an Implementation Strategy
• Chapter 2. Preparing for the Hazard Analysis
• Chapter 3. Hazards, The Hazard Analysis, and The Food Safety Plan
• Chapter 4. Preventive Controls and Process Controls
• Chapter 5. Sanitation Preventive Controls and Sanitation Basics
• Chapter 6. Allergen Preventive Controls
• Chapter 7. Supply Chain Program
• Chapter 8. Verification Activities
• Chapter 9. Recalls, Records, and Reanalysis
• Appendix 1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Final Rule Comments and Responses
• Index