Ch. 1 Develop an Implementation Strategy --G︣et Trained! --2︣016 Implementation Theme: Get a PCQI Certificate --C︣ompliance Will Follow --T︣ime, Resources, and Budgets: How Much Is Enough? --L︣essons Learned in Year 1 --M︣anagement's Understanding of FSMA's Requirements --R︣esources and Budgeting --S︣tep 1 Verify Your Compliance Requirements --S︣ubpart A --G︣eneral Provisions --S︣tep 2 Identify All Roles and Training Needs in the Regulation --S︣ubpart C: [']117.180 Requirements Applicable to a PCQI (Qualified Auditor too) --S︣ubpart C: [']117.310 Additional Requirements Applying to the Food Safety Plan --I︣mpact on Food Safety --J︣ob Training --F︣ood Safety Training Options --I︣dentify Training Objectives --T︣raining Delivery --E︣valuation of Training Effectiveness --B︣enefits of Training --c︣h. 2 Preparing for the Hazard Analysis --D︣evelop a Product Profile --F︣ive Preliminary Tasks of HACCP/Preventive Controls --P︣CQI --F︣ood Safety Team --T︣raining the Team --F︣orms, Forms, and More Forms --P︣ractical Approach to Document Management --P︣urpose of Document Control --D︣ocument Control Procedures --P︣rocess Tailored to the Environment --I︣mplementing a Document Control Process --U︣nderstanding Hazards: Information Resources --R︣eportable Food Registry --C︣hemical Hazards --U︣napproved Food Colors and Additives --P︣hysical Hazards --c︣h. 3 Hazards, The Hazard Analysis, and The Food Safety Plan --F︣SMA Hazard Updates --R︣adiological Hazards --I︣ntegrating Other Regulations and Resources Into the FSP --H︣azard Analysis --C︣onducting a Hazard Analysis --P︣otential Sources of Biological Contamination --H︣azard Evaluation --M︣easuring Risks --R︣isk Assessment --E︣valuating Severity --E︣stimating the Likely Occurrence --H︣azard Evaluation Factors --E︣xamples of In-Process Controls --c︣h. 4 Preventive Controls and Process Controls --W︣hat Are Preventive Controls --P︣reventive Controls Management Components --[︣'] 117.150 Corrective Action Procedures --C︣orrections --[︣'] 117.155 Verification --V︣alidation as a Verification Activity --[︣'] 117.160 Validation --P︣rocess Controls --C︣ooking --T︣emperature Ranges for Microorganisms --R︣efrigeration as a Time --T︣emperature Process Control --C︣ooling After Heating/Cooking to Prevent Spore Growth --I︣ntrinsic Factors as Controls --F︣ormulation as a Control --S︣torage to Prevent Mold Growth --E︣xclusion Process Controls for Physical Hazards --V︣alidation of Metal Detection --P︣rocess Control Management Components --M︣onitoring --C︣orrective Actions and Corrections --c︣h. 5 Sanitation Preventive Controls and Sanitation Basics --S︣anitary Design Principles --N︣onproduct Contact Surfaces --F︣ood Equipment Installation and Relocation --N︣iches and Harborages --I︣dentify the Target Organism --W︣et Processes --D︣ry Processes --U︣se of Sanitation Controls for the Cleanliness of FCS --F︣CS Management --B︣asic Sanitation Steps and FCS Management --C︣leaning Drains in the RTE Food Handling Areas (Hygiene Zone) --S︣anitation Controls --E︣stablishing the Hygiene Zone --S︣anitation Preventive Control Management Components --c︣h. 6 Allergen Preventive Controls --I︣n the Zone and Beyond --P︣ersonnel Practices --L︣abeling as a Preventive Control --c︣h. 7 Supply Chain Program --S︣ubpart G --S︣upply Chain Program --[︣'] 117.405 Requirement to Establish and Implement a Supply Chain Program --[︣'] 117.410 General Requirements Applicable to a Supply Chain Program --U︣pstream Hazards --O︣utside the Comfort Zone --S︣upply Chain Controls for Chemical Hazards --S︣upply Chain Controls for Pesticides --S︣upply Chain Controls for Drug Residues --H︣eavy Metals --S︣upply Chain Controls for Mycotoxins --R︣isk Assessment Example --V︣erification Activities --L︣ooking at Audits in a New Light --A︣uditor Training and an Audit Checklist --E︣nough to Audit? --F︣DA Accredited Third Party Certification --S︣upply Chain Controls Management Components --N︣onconformances and Corrective Actions --V︣erification Records --c︣h. 8 Verification Activities --[︣'] 117.165 Verification of Implementation and Effectiveness --E︣nvironmental Monitoring Program --P︣ostpackaging High Pressure --E︣MP Sampling Plan --D︣efining Sampling Sites --P︣roduct and/or FCS Testing: Contamination Events --F︣actors Contributing to Pathogens in the Environment --D︣efining Growth Niches --M︣anaging and Controlling Growth Niches --I︣nvestigation of a Positive Result --N︣iche or Transient? --I︣nvestigation Test Results --D︣NA Mapping --c︣h. 9 Recalls, Records, and Reanalysis --R︣ecalls --R︣ecords --F︣orms and Format --[︣'] 117.190 Implementation Records Required for This Subpart --R︣etention and Review --R︣eanalysis.

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 systemsWritten by industry experts with direct experience in the formulation of the HARPC regulationsPresents insights into the underlying approach of FSMA's preventative controlsTransitions readers from HACCP to HARPC using GAP assessment to adapt existing food safety programs to the FSMA preventative controls requirements.