Understanding the Differences
There are some fundamental differences between HACCP principles and the HARPC requirements, a couple of the most controversial may be that the Preventive Control Rule does not recognize CCPs, or mention the use of a process flow diagram.
The rule also does not specifically state that a scope, including product description, intended use and intended user is required. The rule however, does imply that these elements would be needed, as the inherent hazards from the raw materials and finished product need to be included, plus those around the intended use.
When producing a system that complies to both sets of standards, CCPs, a process flow diagram, a scope, product description and details of the intended use and user are still going to be required.
Tackling the Contradiction in the Systems
There is one fundamental contradiction in the methodology of the two systems, which is all based on how likelihood is assessed.
Both systems require significance of the hazards to be determined, based on a risk assessment of severity and likelihood. The assessment of severity is aligned in HACCP and HARPC and does not pose a problem. The problem arises when the hazards are assessed for likelihood, as shown below:
HACCP: severity is assessed with the current controls taken into account
HARPC: severity is assessed in the absence of any controls
This small change, has massive implications.
In a typical HACCP system, we would include all the hazards that you could possible think of – so that all possible eventualities are covered. If we continue this approach into a HARPC system, and then assess these hazards in the absence of any controls, the number of significant hazards produced would be huge. More importantly, they would not be truly focused on the key food safety risks.
Therefore, when thinking about the hazards that should be included in a HARPC system, using the mind-set of less is more is the right way to go. Pertinent hazards should not be missed, but a structured approach of pin-pointing which hazards should be included is essential.
In my new book ‘Combine Your HACCP & HARPC Plan’ I have included a whole section about how this can be achieved, called the Hazard Extraction Stage. It uses some the elements of HACCP that we are used to, so it’s familiar, but utilizes them effectively to extract the really pertinent hazards for the specific product and process being assessed.
So What About the CCPs?
Once the hazard analysis has been carried out, using severity and likelihood (without the controls being taken into account) to determine significance, all significant food safety hazards must have a preventive control assigned.
In any combined HACCP and HARPC system, CCPs are still going to an essential element. Once the preventive controls have been established, we need to determine which of these preventive controls actually need to be CCPs.
So, to do this we need to have a way of determining them. The typical CCP decision tree is no longer applicable, because if we used it, we would end up with most, if not all of our preventive controls becoming CCPs.
We don’t want to go back to the time when we had loads of CCPs and we lost sight of what process steps are really critical to food safety.
To enable us to establish which of the preventive controls need to be ‘raised up’ to become CCPs, we need to understand the difference between a preventive control and a CCP.
The definitions can be broken down, so just the really key points from them remain. Then they can be compared side-by-side, so the distinction between them is clear.
The definitions are shown below:
Preventive controls prevent or significantly minimize the hazard
CCPs eliminate or reduce the hazard to an acceptable level
A preventive control is something that either prevents a hazard from occurring, or stops accidental contamination from reaching the customer.
A CCP as something that eliminates or reduces inherent contamination in the product.
So, to establish whether each preventive control should actually be a CCP, we need to ask if that preventive control eliminates or reduces the hazard to an acceptable level. Or, is the hazard an inherent contamination risk, and which the process step eliminates or reduces to an acceptable level. If it does, then it is a CCP.
By asking the right question of each of the preventive controls, the CCPs can be determined and they can still be focused on the really critical food safety risks.
If you’d like to learn more about the book ‘Combine Your HACCP & HARPC Plan’, please go to http://www.techni-k.co.uk/HARPC_Book
I’d also be happy to answer any questions you have on HARPC, if you would like to add them to the comments below.
Kassy Marsh is the author of Combine Your HACCP & HARPC Plan, step-by-step. Kassy started her career in the food manufacturing industry in 1998 and has developed an exceptional ability to implement simple and practical solutions, which can be effectively implemented into the factory environment. She is well known for her best practice risk assessments and specializes in food safety principles.
In 2015 she co-authored the book ‘Assessing Threat Vulnerability for Food Defence. This pioneering methodology is now one of the leading risk assessment tools in use for the assessment of food threats.
To meet the increasing demand for a methodology to assess food integrity, in early 2016 Kassy developed and co-authored her second publication ‘Assessing Error Vulnerability for Food Integrity’. This system is now used by a leading UK retailer as a training tool for their supply base.
Since starting her own consultancy business in 2012, she has become well regarded in the field of food safety risk assessment for her ability to provide simple, practical and easily understood step-by-step solutions.
Kassy can be contacted at www.techni-k.co.uk
- Jun 02 2016 07:50 PM
- by Simon
The HACCP Plan is a document which is based upon the principles of HACCP and which delineates the procedures to be followed. The HACCP System is the result of the implementation of the HACCP Plan thru the creation of the HACCP team: a multidisciplinary group of members who are responsible for developing, implementing and maintaining the system.
The production of safe food products entail that the HACCP plan and HACCP system are built upon a solid base of prerequisite programs. Prerequisite programs are procedures that concentrate on operational conditions providing the cornerstone for the HACCP system.
The most important point is that each section of the food chain supply management must provide the conditions necessary to defend food while it is under their control. Prerequisite programs originated from food regulations and intended food industry organizations accomplish this through the proverbial prerequisite implementation of the Good Manufacturing Practice (GMP) regulations enforced by the US Food and Drug Administration (FDA), under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS § 351). The regulations use the phrase "current good manufacturing practices" (cGMP) or as usual name GMPs; GMPs were established to help define for the food industry the minimal sanitary conditions for processing safe food products. They include such areas as personal hygiene, operational practices, cleaning and sanitation, water safety, foreign material control, and sanitary design.
These conditions and practices (cGMPs) are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the essential environmental and operating conditions that are necessary for the production of safe food. Many of the conditions and practices are specified in federal, state and local regulations and guidelines.
In addition to the requirements specified in regulations, food industry sectors often adopt policies and procedures that are specific to their own operations. HACCP plans are reduced in scope, being limited to ensuring safe food for human consumption. Critical Control Points (CCPs) are normally used to address significant food hazards, but even this varies from one industry sector to another. In one industry segment, a certain prerequisite may be of minor importance, while in another the same prerequisite may be essential to ensuring food safety.
The existence and efficiency of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and recurrently audited internally or externally by a third party auditor. Prerequisite programs are established and managed separately from the HACCP plan.
In order to select the most suitable prerequisite programs, food industries must consider the following: their type of organization and their own unique circumstances; the capabilities of their suppliers and service providers; customer needs and expectations; statutory and regulatory requirements; and good practices in their segment of the food chain, including all relevant standards and guidelines.
Variety of Prerequisite Programs
Different categories have been developed for prerequisite food safety programs. From a regulatory HACCP perspective, six prerequisite programs should be implemented: good manufacturing practices, pest control, trace and recall, chemical control, cleaning and sanitation, and customer complaints.
Sperber W.H., et al., describes eight prerequisite program categories: raw material controls, facilities, sanitation, training, production equipment, production controls, storage and distribution, and product controls.
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) provides impartial, scientific advice to federal food safety agencies and establishes eleven prerequisite programs: facilities, supplier control, specifications, production equipment, cleaning and sanitation, personal hygiene, training, chemical control, storage / shipping & receiving, traceability & recall, and pest control.
The International Organization for Standardization (ISO) specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3 in its standard ISO/TS 22002-1:2009: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene. k) Other aspects as appropriate. In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to food manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.
It does not matter the variety or number of prerequisite programs necessary to implement to assure the production of safe food in the food chain supply; most importantly it is how management properly implements the CORNERSTONE OF HACCP within the facility.
U.S. Food and Drug Administration ( FDA ) . Managing Food Safety: HACCP Principles, HACCP & Managerial Control of Risk Factors. Retrieved August 20, 2013, from http://www.fda.gov/F...lFoodProtection /ManagingFoodSafetyHACCPPrinciples/default.html.
Sperber, W.H. et al., “THE ROLE OF PREREQUISITE PROGRAMS IN MANAGING A HACCP SYSTEM”, in Dairy, Food, and Environmental Sanitation 1998, vol. 18, no7, pp. 418-423
U.S. Food and Drug Administration ( FDA ). Hazard Analysis and Critical Control Point Principles and Application Guidelines, Adopted August 14, 1997, NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS. Retrieved August 18, 2013, from http://www.fda.gov/F...nes/default.htm
ISO (International Organization for Standardization), ISO 22000 - Food safety management. Retrieved August 19, 2013, from http://www.iso.org/i...ds/iso22000.htm
Martin W. Torres: ASQ HACCP Auditor, SQF Auditor High Risk, BRC Auditor and SQF Consultant High Risk.
B.S. Industrial Engineering, B.S. Food Science. MBA-Quality. M.S. Food Safety. Member: ASQ Chicago, ASQ Division Food, Drug and Cosmetic.
- Jun 16 2014 08:32 AM
- by Simon