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  1. FSMA, HACCP, and Your Compressed Air System

    HACCP and Compressed Air


    The new rules created by the FDA to fulfill FSMA require that manufacturers must conduct a Hazard Analysis (HA) as part of the revised current Good Manufacturing Practices (cGMP). Hazard Analysis serves to identify and inform Critical Control Points. Critical Control Points (CCP) are steps, stages, or points in a process where a failure of a standard operating procedure or equipment could lead to the contamination of product and resulting harm to consumers. Together, Hazard Analysis and Critical Control Points are referred to as HACCP. Each identified CCP must be monitored, and such monitoring must be documented. The HACCP process informs the frequency and tolerance of that monitoring. For example, if milk must be pasteurized to a temperature of 161 F, the step of the process that heats the milk is a Critical Control Point, and the functioning of the equipment and temperature achieved must be monitored and documented.


    Often, Critical Control Points are less obvious. In the context of compressed air and gas, if a facility uses compressed air to cause a product to flip at a certain point, that compressed air is in direct contact with the food and becomes a potential source for contamination. Compressed air that is used to clean a surface that is used to prepare food has indirect contact with that food. Obviously, air or gas that is in direct contact food poses a more significant risk than gas that only indirectly contacts food, but both are still Critical Control Points.


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    Common utilizations of compressed air or gas that are in direct contact with food include drying, sorting, freezing, moving, carbonating, culturing, inert packaging, and modified atmosphere packaging. Some examples of indirect contact of compressed air or gas with product include cleaning of surfaces, packaging manipulation and pneumatically driven equipment. Each of these represent a Critical Control Point.


    Contamination of Compressed Air


    Depending on the compressed air or gas system, contamination can take several forms and have multiple sources. Common contaminants of compressed air or gas include solid particulates, oil vapors and aerosols, water vapor or aerosol, and viable microbial contamination. Particulates are commonly a consequence of friction within the system. They can originate from unions, valves, seals, and other fittings, as well as the moving parts of the compressor itself. They may also be a consequence of the ambient air the compressor intakes for the system. Oil vapors and aerosols are commonly a consequence of compressor pump oil, but may also originate from cleaning materials, solvents, and contamination of the ambient air the compressor intakes. Water vapor and aerosol originate from the ambient air used by the compressor. Microbial contamination is ubiquitous, and may be present in the ambient air, on the equipment at the time of install, or contamination at the point of use. Microbial contamination is also more common in the higher humidity segments of a compressor system, such as receiver tanks and condensate traps.


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    These contaminants are removed at various stages throughout the compressor system by subsystems such as pre-filtration, condensate traps, driers, and midstream and point-of-use filters. When applying the HACCP process to a compressed air or gas system, the Critical Control Points are most commonly the point-of-use filters, as well as the condition of the point-of-use itself. As such, a risk analysis for each point of use should be performed to identify Critical Control Points. The risk analysis will also inform the monitoring criteria for each CCP, and a monitoring plan can then be developed. Once the monitoring plan is established and documented, records of monitoring the CCP according to the monitoring plan must be maintained. A summary of the FDA guidance for filtration, as well as guidance or compliance requirements from other regulatory bodies can be found here. Some best practices guidelines for microbial contamination can be found here.


    Testing your compressed air and gas:


    Many different options exist for testing a compressed air or gas system exist. These range from expensive in-line instrumentation to relatively cheap single use detector tubes and impactors. However, testing a system in-house opens a whole range of liability and potential hang-ups. Furthermore, any testing done will require quality control and calibration of the testing apparatus.


    Accredited laboratories offer a measure of confidence and simplicity at cost-effective prices to help ensure continuing FSMA compliance. Accreditation to ISO 17025 guarantees appropriate handling and analysis of test items and ensures accuracy and consistency. Trace Analytics ups the ante by providing education and resources to allow operators to make intelligent and confident decisions regarding the scope and criteria for monitoring of their compressed air and gas CCPs. Our analysis reports provide easily referenced documentation of monitoring. Training resources are provided to ensure our customer’s ability to fulfill FSMA training and competency requirements. Our HACCP trained customer service team and long experience in the compressed gas industry are powerful tools for our customers, regardless of whether they are new to HACCP, or seasoned veterans.


    Author Biography:


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    Matthew DeVay
    Quality Assurance Director
    (512) 263-0000 ext. 223
    Trace Analytics, LLC


    Matthew DeVay has over 10 years of experience in Quality Assurance and chemical testing. As the Quality Assurance Director for Trace Analytics, LLC, he oversees and directs compressed air analysis and has helped countless customers successfully troubleshoot compressed air systems. He is a member of the Medical Gas Professional Healthcare Organization, and an expert in GC and GC/MS analysis.


    Trace Analytics is an A2LA accredited laboratory specializing in compressed air and gas testing for food and beverage manufacturing facilities. Using ISO 8573 sampling and analytical methods, their laboratory tests for particles (0.5-5 microns), water, oil aerosol, oil vapor, and microbial contaminants found in compressed air. For over 29 years, they’ve upheld the highest industry standards of health and safety, delivering uncompromising quality worldwide in accordance with ISO, SQF, BRC, and FDA requirements.


    Links and Resources:


    Trace Analytics Resources


    External Resources:

    • May 18 2018 06:33 PM
    • by Simon
  2. The Solution to a Combined HACCP & HARPC System!

    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.


    Author Biography:


    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
  3. Cornerstone of HACCP

    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

    Author Biography

    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
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