http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Hazard analysis and risk based preventive controls
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.
Machine generated contents note: ch. 1 Develop an Implementation Strategy -- Get Trained! -- 2016 Implementation Theme: Get a PCQI Certificate -- Compliance Will Follow -- Time, Resources, and Budgets: How Much Is Enough? -- Lessons Learned in Year 1 -- Management's Understanding of FSMA's Requirements -- Resources and Budgeting -- Step 1 Verify Your Compliance Requirements -- Subpart A -- General Provisions -- Step 2 Identify All Roles and Training Needs in the Regulation -- Subpart C: [ʹ]117.180 Requirements Applicable to a PCQI (Qualified Auditor too) -- Subpart C: [ʹ]117.310 Additional Requirements Applying to the Food Safety Plan -- Impact on Food Safety -- Job Training -- Food Safety Training Options -- Identify Training Objectives -- Training Delivery -- Evaluation of Training Effectiveness -- Benefits of Training -- ch. 2 Preparing for the Hazard Analysis -- Develop a Product Profile -- Five Preliminary Tasks of HACCP/Preventive Controls -- PCQI -- Food Safety Team -- Training the Team -- Forms, Forms, and More Forms -- Practical Approach to Document Management -- Purpose of Document Control -- Document Control Procedures -- Process Tailored to the Environment -- Implementing a Document Control Process -- Understanding Hazards: Information Resources -- Reportable Food Registry -- Chemical Hazards -- Unapproved Food Colors and Additives -- Physical Hazards -- ch. 3 Hazards, The Hazard Analysis, and The Food Safety Plan -- FSMA Hazard Updates -- Radiological Hazards -- Integrating Other Regulations and Resources Into the FSP -- Hazard Analysis -- Conducting a Hazard Analysis -- Potential Sources of Biological Contamination -- Hazard Evaluation -- Measuring Risks -- Risk Assessment -- Evaluating Severity -- Estimating the Likely Occurrence -- Hazard Evaluation Factors -- Examples of In-Process Controls -- ch. 4 Preventive Controls and Process Controls -- What Are Preventive Controls -- Preventive Controls Management Components -- [ʹ] 117.150 Corrective Action Procedures -- Corrections -- [ʹ] 117.155 Verification -- Validation as a Verification Activity -- [ʹ] 117.160 Validation -- Process Controls -- Cooking -- Temperature Ranges for Microorganisms -- Refrigeration as a Time -- Temperature Process Control -- Cooling After Heating/Cooking to Prevent Spore Growth -- Intrinsic Factors as Controls -- Formulation as a Control -- Storage to Prevent Mold Growth -- Exclusion Process Controls for Physical Hazards -- Validation of Metal Detection -- Process Control Management Components -- Monitoring -- Corrective Actions and Corrections -- ch. 5 Sanitation Preventive Controls and Sanitation Basics -- Sanitary Design Principles -- Nonproduct Contact Surfaces -- Food Equipment Installation and Relocation -- Niches and Harborages -- Identify the Target Organism -- Wet Processes -- Dry Processes -- Use of Sanitation Controls for the Cleanliness of FCS -- FCS Management -- Basic Sanitation Steps and FCS Management -- Cleaning Drains in the RTE Food Handling Areas (Hygiene Zone) -- Sanitation Controls -- Establishing the Hygiene Zone -- Sanitation Preventive Control Management Components -- ch. 6 Allergen Preventive Controls -- In the Zone and Beyond -- Personnel Practices -- Labeling as a Preventive Control -- ch. 7 Supply Chain Program -- Subpart G -- Supply Chain Program -- [ʹ] 117.405 Requirement to Establish and Implement a Supply Chain Program -- [ʹ] 117.410 General Requirements Applicable to a Supply Chain Program -- Upstream Hazards -- Outside the Comfort Zone -- Supply Chain Controls for Chemical Hazards -- Supply Chain Controls for Pesticides -- Supply Chain Controls for Drug Residues -- Heavy Metals -- Supply Chain Controls for Mycotoxins -- Risk Assessment Example -- Verification Activities -- Looking at Audits in a New Light -- Auditor Training and an Audit Checklist -- Enough to Audit? -- FDA Accredited Third Party Certification -- Supply Chain Controls Management Components -- Nonconformances and Corrective Actions -- Verification Records -- ch. 8 Verification Activities -- [ʹ] 117.165 Verification of Implementation and Effectiveness -- Environmental Monitoring Program -- Postpackaging High Pressure -- EMP Sampling Plan -- Defining Sampling Sites -- Product and/or FCS Testing: Contamination Events -- Factors Contributing to Pathogens in the Environment -- Defining Growth Niches -- Managing and Controlling Growth Niches -- Investigation of a Positive Result -- Niche or Transient? -- Investigation Test Results -- DNA Mapping -- ch. 9 Recalls, Records, and Reanalysis -- Recalls -- Records -- Forms and Format -- [ʹ] 117.190 Implementation Records Required for This Subpart -- Retention and Review -- Reanalysis.
FDA Food Safety Modernization Act (United States)
Hazard Analysis and Critical Control Point (Food safety system)
London ; San Diego, CA : Academic Press, [2017]