Food safety and Managing Health RiskFSMA - Food Safety Modernization Act (FSMA) is to apply HACCP and HARPC (Preventive Controls) in a systematic method that analyze food processing preventive controls and to identify risk-based undesirable / hazardous which includes chemical, physical, biological and radiological agents. Et al, adherence to laws and regulations, as no management system will ever substitute for laws and regulations.

Hazards derive from non-intentional harm for HACCP and intentional-harm and allergens for HARPC (Preventive Controls), with the intent to prevent, eliminate, reduce, or mitigate ("P|E|R|M" - acronym courtesy of and brought by BRS), while fulfilling obligations that includes current 21 CFR 1, 21 CFR 110, 21 CFR 117, 21 CFR 120, 21 CFR 117 (HARPC - Preventive Controls)... recent version of 21 CFR 101 and others. It is the expectation, if not a requirement, that organizations operating within the food supply chain need to identify, analyze, and to prevent, eliminate, reduce (or mitigate) these hazards (dangers) to acceptable levels. HACCP - HARPC are now integral requirement of the FSMA (Food Safety Modernization Act 2011) making a vivid and significant impression of P|E|R|M with emphasis in P (prevention) as management tool for protection against intentional and non-intentional harm. Indeed, FSMA requires protection from intentional harm (Food Defenses) and to this effect enters into an era of commercial certification schemes. Let the results with time determine if the food supply chains are any safer, without having to fudge the statistics.

    HARPC arrives with the advent of the Food Safety Modernization Act (FSMA); Hazard Analysis Risk-based Preventive Controls. FSMA will have significant impact on the food commerce as FSMA is roled out. For training and programs designed and developed by BULLTEK LTD contact us HACCP is to HARPC as cGMP is to HACCP.

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Validation is a key component of HACCP by which verification applies and though Management Systems model including HACCP HARPC MS or dozens of other food safety programs to assure safe foods. This provides organizations with the basic requirements to assist in effective food safety and good practices (cGMPs) and thus to demonstrate competence in food safety in applying 21 CFR 110, 120 and other equivalent regulations and expectations. The principles within HARPC - HACCP are endorsed by the United Nations through "CODEX Alimentarius", USA FDA - USDA and carry over to other world regions (e.g. European Union, Canada, Australia, New Zealand, Japan...). CODEX provides basic safe guidance in process and activities within the food supply chain and includes, but not limited to poultry, meat producers, seafood processors, retail industry, restaurants, airlines, hotels, harvesting, production, transport and handling of food processing for international trade. Now, FSMA takes effect for which the FDA requires numerous inspectors plus contracting of commercial food safety schemes. HACCP Process Control...

Organizations may opt to implement best general acceptable global practices for planning, identification of hazards, acting and improving food-safety processing through HARPC - HACCP Management System as HACCP HARPC MS conveys or may chose ISO 22000, Food Safety Management System - FSMS, and apply ISO 22002-1 which sets the stage for Food Defense (protection from intentional harm). If your organization provides laboratory services the applicable international Management System is ISO/IEC 17025. HACCP MS, ISO 22000 which through FSMA includes Food Defense under ethical, competent and valid purpose certification bodies. Also there are dozens of food safety schemes in the marketplace for organizations to choose such those under GFSI, SQF, Synergy 22000, PAS 220, HACCP MS, HACCP-9000, BRC, IFS, FSSC 22000 and many-many others inclding the advent of the FDA to commerclaize certification schemes in liew of country laws. Yet, no management scheme can susbstitute for applicabe laws and regulations.  

    Note 1: Upon request as a courtesy International Registration Bodies such as BRS, DNV, Lloyd's others provides recognized-accredited HACCP MS equivalent Specification Guidelines as well FSMS ISO 22000 certificate of registration and many other available certification schemes. Some certification bodies posses accreditation from commercial business interest groups and a few others from a public trust. 

The objectives of implementation of "best processing practices" is to identify, analyze and link hazards to critical control points and to assemble the necessary effective and safe controls. To make this happen, the assessment - audit protocol needs to carry competence, impartiality and purpose, as this applies to HACCP HARPC MS for the USA or equivalents (e.g. HACCP-9000, Irish-HACCP...BRC, IFS, SQF...GFSI), ISO 22000 and ISO 9001 (with reference to retired ISO 15161) in adherence to European regulations 852, 853, 864 and others. HACCP MS and equivalents helps small and medium size organizations to validate and to implement safe food practices, and advancing to Food Safety Management System as the FDA may mandate for exporting of foods to the USA.

Key aspects and issues relevant to HARPC, HACCP...

  • P|E|R|M based HARPC
  • Measuring and Control
  • Critical Control Stages
  • Risk Analysis
  • Preventive Action / Preventive Controls
  • Corrective Action
  • Planning
  • Food Defense Techniques
  • HACCP (Managerial) System
  • Surveillance and Monitoring
  • Severity
  • V & V (Verification & Validation)
  • Allergen control
  • FSVP
  • Food Supply Chain Defense
  • Preventive Controls, HARPC

ISO 22000 (or ISO/IEC 17025 for laboratories, as applicable) assist in fundamentally implementing and attaining HACCP managerial certification, which includes the organizations administrative, supply chain, technical, operational aspects.

Is your organization's food management system (or laboratory) for food processing validated?

Our network of professionals includes specialists and authorities in HACCP, FDA Certified HACCP Trainer and SCP (Sanitation Control Procedure) AFDO FDA Instructor in Asia Pacific and the advent of FSMA HARPC. Through review of your organization's practices, methods within the management system concurrently with evaluation and analysis we can verify and validate and assist you to fulfill FSMA.

For downloading ISO 22000 Lead Auditor venue visit our English portal top page.


 The Application of ISO 22000 and ISO 22002-1 for FSMA for the Food and Beverage Industry

ISO 9001 application guidelines are published for the food sector under the Guidance Management Specification to now retired ISO 15161 2001. FSMA Section 103 Preventive Controls (HARPC) implementation can be set through ISO 22000 in combinaton with ISO 220002-1 within the food industry sector involving sourcing, processing, and packaging of food and beverages. For FSMS ISO 22000 and HACCP MS certification visit our accreditation, assessment bodies and Certification Bodies page. ISO 22000 is an effective and viable alternative providing validation of your food safety management system, and systems such as HACCP HARPC MS may be construe by some as a step toward ISO 22000 when adding Preventive Controls.

In reference to Preventive Controls (FSMA Section 103, HARPC - Prevention Controls)

  • Leadership role, actions and effectiveness on the protection of consumers,
  • Applying regulations through a best practices and methods,
  • Prevention focus,
  • Value personnel competence onto proficiency based-PCHF (Preventive Controls for Human Foods),
  • Consideration of hazards to specific nature of the food activities,
  • Appropriateness and effectiveness of the food safe program,
  • In pursuit that the FDA path is being followed, in applying laws and regulations.




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