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What are HACCP and HARPC?
HACCP – Hazard Analysis of Critical Control Points
The Hazard Analysis Critical Control Point system has become the universally recognized and accepted method for food safety assurance. Concern has increased about food safety from public health authorities, food industry and consumers worldwide which led to the creation of this system.
The large increase in the incidence of foodborne diseases in many countries also prompted the enacting of the HACCP. Over the last 30 years, this system has been internationally recognized as a leader in development and prevention of foodborne diseases.
Today, it is the internationally-recognized and accepted method for food safety assurance. While it was originally developed to ensure microbiological safety of foodstuffs, it has been further broadened to include radiological, chemical and physical hazards in foods. Its main aim is to identify hazards in the production processes and design procedures to reduce/eliminate these risks.
For effective implementation of this system, Organizations to keep in mind that HACCP certification process starts with the formation of an internal HACCP Team within the facility as pertinent and select a Team Leader to develop HACCP plans, flow charts, guidelines and Food Safety System. The Team leader follows HACCP Principles and HARPC Principles in developing HACCP Plans.
For effective implementation of HACCP food safety system, QSE recommends the use of HACCP guidelines for creating simple and effective templates for developing flow charts and determining critical control points.
A sound HACCP system leads to successful HACCP Certification and eventually supplement all food safety standard certifications
HARPC – Hazard Analysis Risk-Based Preventive Controls
HARPC stands for Hazard Analysis Risk-based Preventive Controls. As per final rule of Food Safety Modernization Act (FSMA) in “Docket Folder FDA-2011-N-0920 provides the full text of the Rule”. “This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.” ( Source: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food. )
FDA has granted a time of 3 Years from the date of publication for all small and big companies to implement the rule which ended in September 2018. It is now imperative that all facilities falling within food chain must implement this HARPC rule if they are manufacturing, processing, handling, storing, transporting, or packaging any of Animal feed or Human food.
Food Safety Inspection Services (FSIS) from FDA focus on HACCP/HARPC plans in all food joints including restaurants and fast food joints related to the application of 7 Principles and 12 Steps of Implementing HACCP along with the application of HARPC Principles and related implementation steps
For effective implementation of HARPC, Organizations to keep in mind that HARPC certification process starts with the formation of an internal HARPC Team within the facility as pertinent and select a HARPC Team Leader to develop HARPC plans, flow charts, guidelines, and Food Safety System. The Team leader follows HARPC Principles in developing plans and templates.
The Team leader may combine both HACCP and HARPC flowcharts and plans for simplistic depiction and ease of use during implementation process for HACCP Certification and HARPC certification
A sound HARPC system leads to successful HARPC Certification and eventually supplement all food safety standard certifications
HACCP and HARPC are mandatory conditions prescribed by Food Safety Modernization Act (FSMA) by Food and Drugs Authority (FDA) of USA, as a part of Current Good Manufacturing Practices (cGMP). HACCP is a global requirement for food safety where as HARPC is a FDA directed preventive control mechanism for all identified critical control points. HARPC is an upgrade to HACCP.
The following are the motivating factors for introduction of HARPC:
- Product Recalls & Outbreaks Compelled FDA for Public Hearing
- FDA Sought Opinions from Public, Scientists & Industry Leaders
- Problems Faced by Very Small Business Houses were Heard
- Decision Taken to Amend Food Safety Modernization Act (FSMA)
- HARPC Emerged as an Addendum to FSMA act
- HARPC made Legally Enforceable and a Mandatory Requirement
- HARPC was Published as Final Rule by FDA in Docket Numbers FDA-2011-N-0920 to 0922 between September 2015 to November 2017
- Extended time granted by FDA for implementing HARPC ended in September 2018
- HACCP & HARPC implementation documentation is mandatory for all facilities within the food chain
- HACCP and HARPC are effective control methods of ensuring food safety
- All Food Safety Management Systems such as BRC, FSSC 22000, IFS and SQF require HACCP and HARPC as fundamental foundation to achieve Food Safety Certifications. Having HACCP certification along with HARPC certification strengthens foundation required for effective implementation of all Food Safety Management Systems
- Any organization that deals with potential hazards in foods
- Any organization that wants to increase their food safety
- Any company in the food sector that would like to improve quality
- Any business or company that would like to deliver a safer food product to the consumers and producers
- Any organization in the food sector that would like to reduce costs of product recalls
- All organizations seeking certification for Food Safety Management Systems require HACCP compliance and HARPC compliance as a fundamental requirement
7 Principles of HACCP are as listed below:
(1) Conduct Hazard Analysis
(2) Determine the Critical Control Point (CCP)
(3) Establish Critical Limits
(4) Establish a System to Monitor Control of CCP
(5) Establish Corrective Actions to be Taken When Monitoring Indicates a CCP is not Under Control
(6) Establish a Procedure for Verification to Confirm that HACCP is Working Effectively
(7) Establish Documentation Concerning the procedures and Records Appropriate to These Principles and Their Application
QSE has devised methods of identifying control points, creating critical limits and methods to verify if the program is working well or not. QSE does not tell what to do, but QSE holds the hand and demonstrate how it can be done. QSE creates necessary documentation which serves as evidence to show that the HACCP is implemented successfully.
- Identify Hazards
- Risk Based Preventive Controls
- Monitoring of Effectiveness
- Corrective Actions
- Record Keeping and Documentation
- Requirement to Reanalyze
QSE ensures that the 7 HARPC requirements are met through their documentation and operational control methods devised by them. This is yet another demonstrative process by QSE to fulfill the FDA obligations and meet requirements of FSMA.
- Assemble HACCP team
- Describe product
- Identify intended use
- Construct flow diagram
- On-site confirmation of flow diagram
- List all potential hazards; Conduct a hazard analysis and Consider control measures
- Determine CCPs
- Establish critical limits for each CCP
- Establish a monitoring system for each CCP
- Establish corrective actions
- Establish verification procedures
- Establish documentation and record keeping
- Asses the Hazards: Product Specific Hazards
- Institute Risk Based Preventive Controls (RPC) : Sanitation Procedures, Food Contact Points, Hygiene Training and Environmental Monitoring
- Monitor Effectiveness of the Controls: Evaluate Risk Based Preventive Controls (RPC)
- Establish Corrective Action Measures: Prevent Reoccurrence and Prevent Occurrence of Unsafe Nonconforming Food Product or Food Packaging
- Establish Verification Measures: Verify Food Safety Standards on a Consistent Basis
- Retain Pertinent Records: Unless Recorded the Activity is Considered Not Performed
- Analyze and Reanalyze HARPC Plan every three Years: Changes Require HARPC Reevaluation
By leveraging vast experience, it has, QSE organizes the entire HACCP/HARPC certification process into micro activities and help its customers at each step of the entire process
- Forming the Team and Identification of the Team Leader:
HACCP/HARPC certification process starts with the formation of an internal HACCP and HARPC Team within the facility as pertinent and select a Team Leader to develop HACCP plans, flow charts, guidelines and Food Safety System. The Team Leader follows HACCP Principles and HARPC Principles in developing plans
- Gap Analysis:
QSE conducts extensive gap analysis. The gap analysis is conducted based on HACCP checklist and HARPC checklist to assess the organizations’ existing practices and documented system to meet HACCP Compliance and HARPC Compliance requirements
- HACCP Training and HARPC Training:
QSE trains on methods to design an HACCP and HARPC management system and device methods for determination of critical control points for the Processes within the organization
- Design/Develop HACCP/HARPC Management System:
QSE can prepare comprehensive documentation under Food Safety Management Systems to create evidence on HACCP/HARPC implementation
- QSE has a simplified single level documentation system which is unique, for HACCP/HARPC Food Safety Management Systems
- Documentation developed by QSE guarantees HACCP compliance and HARPC compliance for processes applicable in the facility.
- The documentation can be submitted as a self-audit disclosure by the facility to obtain clearance from certifying body before their visit to the facility
- HACCP/HARPC Food Safety System Documentation Review
- QSE conducts a thorough review on HACCP Food Safety System Documentation and the 12 steps involved in implementing HACCP and 7 steps to implement Food Safety System Documentation for HARPC requirements prior to desk audit by Certification Bodies to ensure adequacy and correctness of the documentation
- Preparation of HACCP/HARPC Checklist for Effective Implementation
- QSE prepares a CCP checklist to be followed by the facilities to ensure that all critical control points are identified and included in HACCP/HARPC Plans
- HACCP and HARPC Audit Checklists that Makes Difference:
- QSE uses HACCP audit checklist and HARPC audit checklist s to ensure HACCP compliance and HARPC compliance used by audit checklists used by HACCP/HARPC certification body auditors for awarding HACCP certification or HARPC certification
- QSE prepared HACCP and HARPC audit checklists helps facilities to effectively prepare for HACCP certification audit and HARPC certification audit
- Assistance to Address the HACCP/HARPC Internal Audits and HACCP/HARPC Desk Audit Deficiencies
- QSE assists the teams on how to address deficiencies related to HACCP internal audits and desk audit to ensure no potential issue during upcoming HACCP certification audit and HARPC certification audit
- Readiness Evaluation for HACCP Certification and HARPC Certification
- QSE ensures that all CCPs are fully evaluated considering risk preventive controls, and all cGMP requirements pertaining to HACCP/HARPC for readiness prior to HACCP/HARPC certification audit
- QSE provides HACCP certification training to ensure HACCP and HARPC guidelines including effective implementation of HACCP
- QSE ensures HACCP Team and HACCP Team leader implements HACCP plans, HACCP flow charts, HACCP guidelines and HACCP Food Safety System.
- HACCP Training and HARPC Training prior to HACCP Certification Audit
- QSE offers HACCP certification training for all employees to successfully prepare for HACCP certification related to HACCP flow charts HACCP 7 Principles, 7 Steps of HARPC, and 12 steps of HACCP principle application
- QSE organizes structured sessions to prepare all the stakeholders to face the final audit comfortably
- Assistance During HACCP/HARPC Certification Audit:
- QSE aids defend HACCP/HARPC food safety system involving HACCP control plans, flow charts, compliance to HARPC critical control measures, corrective actions and Hazard preventive controls during HACCP/HARPC certification audit.
- QSE experts aid facilities during certification/surveillance audits without interfering with HACCP/HARPC auditors
- Demonstrates an actively maintained and continuously improving food safety system
- Meets customer requirements with confidence related to food safety regulatory requirements such as FDA and FSMA
- Assures all hazard critical control points are identified, evaluated, measured, and monitored with application of 7 principles of HACCP and 7 requirements of HARPC
- Provides disciplines in the application of 7 Principles of HACCP in 12 application steps of HACCP and 7 requirements of HARPC in 7 application steps
- Improves control of processes and products related to hazards
- Reduces costs associated with product loss
- Improve food safety
- Eliminate or mitigate food safety hazardous risks
- Enhance Consumers’ confidence in organizations products and services
QSE has been in the business of HACCP Consulting, Auditing, and Training over 27 Years now
There are several institutions providing in HACCP certifications and HARPC certifications which is not a mandatory requirement, but qualification is not equivalent to competence. QSE has a unique feature of consulting for actual implementation of HACCP and HARPC practically on site, QSE shows how they are to be done. QSE creates HACCP and HARPC documentation that withstands scrutiny of any auditor. Evidence-based HACCP and HARPC documentation system ensures that HACCP Food Safety systems are implemented effectively and there is minimum scope of any nonconformity cropping up.
- Unmatchable HACCP/HARPC Consulting, Training and Auditing Experience and Expertise:
- Quality Systems Enhancement Inc. (QSE) is a premier consulting, auditing and training firm engaged in advocating food safety system certifications for over 27 years in the USA
- QSE has extensive experience in assisting packaging facilities in achieving HACCP compliance & HARPC compliance prior to all food safety packaging certifications such as:
- BRC Global Standard for Packaging and Packaging Materials, Issue 5
- Food Safety System Certification 22000 (FSSC 22000) Standard, Ver. 5.2
- Safe Quality Food (SQF) Module 2 for Packaging, Ed.8.1
- IFS PAC Secure, Rev.2
- All GFSI recognized Food Safety Management System Standards such as BRC, FSSC, IFS and SQF have a mandatory requirement to include HACCP and HARPC principles and applications for effective implementation
- QSE provides required HACCP training and HARPC Training to effectively prepare and implement established Food Safety Systems for HACCP/HARPC certification with competent trainers
- Effective HACCP/HARPC Training and Mentoring:
- QSE provides required HACCP training and HARPC Training to effectively prepare and implement established HACCP Food Safety and HARPC Food Safety Systems for HACCP/HARPC certification with competent trainers
- QSE focuses on terms, concepts, and principles as a foundation to effectively implement requirements with interactive style in training sessions. Our HACCP and HARPC training sessions emphasize effective implementation techniques along with principles and concepts
- QSE’s comprehensive HACCP/HARPC training has been proven as an effective foundation for the organizations to implement HACCP/HARPC Plans, flow charts, and related requirements of HACCP and HARPC for successful HACCP certification
- HACCP/HARPC Flow Charts and Plans /Documentation Made Simple:
- QSE provides a unique simplified documentation system to meet HACCP/HARPC requirements which is easy to follow and easy to maintain over the years for compliance to HACCP certification and maintain HARPC certification
- HACCP Audit Checklists and HARPC Audit Checklists that Makes Difference:
- QSE uses HACCP audit checklist and HARPC Checklists to ensure HACCP compliance and HARPC Compliance which is like certification audit checklists used by HACCP certification body auditors for awarding FSSC certification
- Efficiency in Achieving HACP Certification HARPC certification
- QSE helps facilities to get certified in the shortest possible time invariably within 6 months using efficient methods and processes
- FSSC Certification Guaranteed:
- QSE guarantees HACCP certification and HARPC certification to all facilities willing to follow the proven 10 step disciplined path devised by it
- Post HACCP/HARPC Audit Support:
- QSE offers post HACCP/HARPC audit services to advocate the case of the facility to any extent till certification is achieved, which is seldom available with other HACCP Consulting and HARPC Consulting companies
- Guaranteed HACCP certification and HARPC
- QSE’s 10-step disciplined path for certification achieves certification in the shortest possible time. Usually within 6 months
- QSE has assisted over 700 organizations to obtain various ISO certifications and other sector specific certifications such as Automotive, Aerospace and Food Safety
- QSE assisted among others American Carton, Strong Haven for SQF where HACCP have been implemented, American Packaging corporation, Packrite, Utah Paper box for their Food Safety certifications
- American Packaging corporation obtained their certification in less than 5 months
- Training and preparation for HACCP & HARPC can be done independent of certification Program as well.
Please follow the link below to be directed to the Training calendar and choose the course. You may fill in admission form and pay the fees online to be enrolled in the course.
Please call (770) 518-9967 for the discounts mentioned above. If you would like to request a proposal for our services, at your location please submit a Proposal Request
Frequently Asked Questions
No but QSE trains individuals and enable them to obtain certifications from accredited agencies
QSE helps the facility prepare for HACCP and HARPC. QSE offers consultation for all services from concept to certification. The preparation for implementation of cGMP in the facility helps the facilities pass FDA audits without any nonconformity.
We do understand that some consultants do charge by the hour, but QSE Charges by the day or on consolidated price. QSE does not charge extra when work gets extended beyond normal office hours. QSE does not charge for Phone consultation seeking clarifications or advises in implementation