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  1. The FSVP is the Next FSMA Compliance Date

    One of the new rules under the Food Safety Modernization Act (FSMA) is the Foreign Supplier Verification Program (FSVP). For most importers of foods into the USA, the FDA has specified that the date they will begin inspecting importers to ensure they are in compliance with the FSVP will be 30th May, 2017. That effectively makes the FSVP the next big milestone of the total FSMA suite of rules.

     

    Americans consume a large amount of imported food. According to FDA, imported food accounts for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans (2013 statistics USDA, Economic Research Service).

     

    Since the mid 1990’s, food borne illness outbreaks associated with imported foods have been steadily increasing, while at the same time, the outbreaks associated with domestically produced foods have declined albeit with a flattening of that decline since 2009.

     

    With the significant amount of food being imported, and a disproportionate increase in food borne illnesses associated with imported products, the FDA reached the conclusion that some steps needed to be taken with respect to imported foods.

     

    The FSVP rule is about ensuring that imported foods meet the same food safety standards that are required of food produced in the U.S., and in addition that procedures are in place that prevent adulterated foods being imported.

     

    Whereas FDA has always recognized that all parties engaged in the production and handling of food have responsibility for ensuring/maintaining its safety, the FSVP rule now requires that importers covered by the rule must have in place a program to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the rules that US based manufactures are required to meet. Importers also must ensure that the supplier’s food is not adulterated under the FD&C Act, nor misbranded with respect to allergen labeling for human food. Allergen labeling is not required for animal food.

     

    Whether the food is imported for humans or animals, either raw or processed, foreign suppliers likely will need to adhere to the Preventive Controls requirements as defined by the Preventative Controls for Human Food rules. These require that facilities that manufacture, process, pack or hold food must implement preventive risk‐based controls to ensure food safety.

     

    Both foreign and domestic manufacturers/processors, packers, and holders of foods now must analyze whether reasonably foreseeable hazards require a preventive control; and if so, implement preventive controls to control those hazards. The process by which this is done is covered within the Preventative Controls for Human Foods, and the Preventative Controls for Animal Foods rules. While the requirements have similarity to HACCP plans that many suppliers are already using, the significant difference under FSMA is that the hazards need to be determined assuming the absence of controls. In other words, the hazard analysis needs to be done assuming your pre-requisite programs are not operating.

     

    The number one principle of the FSVP rule is that food importers must now share the responsibility for ensuring the safety of imported food. This means that U.S. importers of food must verify that their foreign suppliers are meeting the requirements required of them under FSMA.

     

    The definition of an “Importer” is specific to the FSVP regulation (21 CFR 1.500), and is not necessarily the same as the Importer of Record for Customs requirements. The first phrase of the definition says that the importer is the USA based owner or consignee. This highlights the key difference. For the FSVP, the “importer” must be based in the USA. Note that the terms “U.S. owner or consignee” are also defined in the rule as “the person in the United States who, at the time of entry into the USA, either owns the food, has purchased the food, or has agreed in writing to purchase the food.” The FSVP importer has to be identified on the filing documents at the point of entry of the goods into the USA once the FSVP rule is in effect.

     

    To meet the requirements of the FSVP, the Importer will need to;

    • Develop a written hazard analysis for each type of food being imported to determine whether there are any hazards requiring a preventative control. Note that this hazard analysis will need to be documented even if there are no hazards identified. This hazard analysis needs be conducted in the manner defined in the Preventative Controls for Human Foods rules.
    • If there are any Preventative Controls required, ensure this is documented and these Controls are put in place.
    • Determine the Foreign Supplier’s compliance history with food safety regulations, including those of the country of origin, other countries that the Supplier ships to, and the FDA. The compliance history should include results, corrective actions, and verifications of those.
    • Research the food being imported to determine if there are any known or foreseeable risks that have been noted with this or similar foods.
    • Assess the capability and any risks of other food safety factors such as storage and transport practices.
    • Approve or disapprove the Supplier before the food is imported.
    • Establish written Corrective Action procedures should any deviations from the defined procedures and controls are detected, and these procedures need to include the requirement to document the details of any corrective action decisions and activities that are initiated.
    The Importer will also need to develop, implement, manage and document the verification activities designed to meet the requirements of the rule. These include;
    • Establish and follow written procedures to ensure that foods are being imported only from Approved Foreign Suppliers.
    • Maintain a list of Approved Suppliers.
    • Establish and follow written procedures to verify the Approved Foreign Suppliers are complying with the appropriate food safety controls in respect of the imported foods, such as the following examples;
      • On site auditing
      • Sampling and testing
      • Review of records
      • Regular research into the supplier’s food safety performance as determined by local authorities or the FDA.
    • Document the outcomes of these activities including any decisions made as a result of the verification activities or follow up actions taken.
    Note: If there has been a hazard identified during the Hazard Analysis that is deemed to be one which could result in serious adverse health consequences or death to humans or animals (SAHCODA), then the default verification activity should be an on-site audit of the Foreign Supplier’s facility.

     

    Verification activities do not have to be conducted by the Importer themselves. These activities can be conducted on behalf of the Importer by a third party. The rules also allow the verification activities to be conducted by Government employees of the source country.

     

    If any of the verification activities indicate that there may have been a situation where food safety was compromised, the Importer is required to ensure that appropriate Corrective Actions have been taken to ensure that;

    • The food will not pose a risk to consumers.
    • The circumstances that resulted in the deviation have been investigated and changes made to the Food Safety Program to ensure that further deviations do not occur.
    • The circumstances and outcomes of the incident are fully documented.
    • All decisions made and actions taken are assessed and approved by a qualified individual.
    The Importer is required to ensure that the whole FSVP (which includes the hazard analysis, the determination of the appropriate Preventative Controls, all external evaluations, verification activities, conclusions, approval and disapproval decisions), be reviewed and approved by a suitably qualified individual. The specific qualifications of this individual are not defined, but they are required to have the experience, training, and education, or any suitable combination of these such that they are competent to ensure the reliability of the program and the safety of the imported food. The qualified individual must be capable of reading and understanding the language that is used by the Foreign Supplier for their written procedures and the documentation of their day to day production records. The review by the qualified individual, along with any outcomes, decisions and actions taken as a result of that review, also needs to be documented.

     

    The qualified individual is not required to be an employee of the Importer, but does need to be independent from the Foreign Supplier, and be free of any conflict of interest with regard to the outcome of the evaluations.

     

    The Importer will also need to ensure that the FSVP is reevaluated at least every 3 years, when new information becomes available, or when changes or failures occur that may affect the safety of the imported product. That reevaluation, and the decisions and actions arising from that will also need to be documented.

     

    All documents must be signed and dated by the individual who completes them.

     

    The documents need to be held for at least 2 years, and must be made available to the FDA within 24 hours of their request. Note that the FDA is subject to the freedom of information requirements, and as such documents provided to the FDA could be requested by someone from the general public. Given those circumstances, companies that are required to provide documents to the FDA would be well advised to be explicit about the need to protect any proprietary confidential information.

     

    The records and documents must be legible, and they can be stored in a language other than English, provided that an accurate English translation can be provided to the FDA on request within a reasonable timeframe.

     

    There are exemptions that may apply for various aspects of the FSVP. In general, those businesses that are already required to comply with a previously defined food safety plan are exempt.

     

    Examples of the exemptions that exist are as follows;

    • Fish or Fishery products (already covered by mandatory HACCP plan)
    • Juice (already covered by mandatory HACCP plan)
    • Food for research or evaluation (consumers in U.S. not likely to consume)
    • Certain alcoholic beverages
    • Certain meat, poultry and egg products (regulated by USDA)
    • Food imported for personal consumption (consumers in US not likely to consume)
    • Food that is transshipped (consumers in U.S. not likely to consume)
    • Food that is imported for processing and subsequent export (consumers in US not likely to consume)
    • Low Acid Canned Food (covered under separate requirements)
    • Dietary Supplements (required to comply with modified FSVP requirements)
    • Very small importer – sales less than $1million p.a. (required to comply with modified FSVP requirements)
    • Foods imported from a country with a food safety system that is officially recognized by the FDA as equivalent (currently this is only Canada, NZ and Australia, although it is understood that Mexico is well progressed.)
    Key Steps that Should be Considered

     

    If you or your business is involved in importing foods into the USA, you should review these steps to ensure that you are ready for the coming compliance date;

    • Determine if your business would be deemed the Importer for each of the items that are imported into the USA, item by item.
    • Ensure that the defined Importer and each of the Foreign Suppliers they source from have registered with FDA
    • Assess the nature of the food safety documentation that is already in place for each of the items imported to enable you to do a gap analysis against what is still needed.
    • Work with the Foreign Supplier to close the gaps identified.
    • Determine who will be the Qualified Individual that has the qualifications, training, and experience to review and approve the plans and documentation associated with the FSVP.

     

    Author Biography:

     

    Bruce is an independent Food Science consultant and advisor, providing advice and hands on support to food businesses in the areas of Product Development, organizational design, quality systems and food safety. During all of 2016, Bruce was the Chief Strategy Officer for Actionable Quality Assurance where he lead the commercialization of software specifically designed for restaurant companies to help make their Quality Assurance and Food Safety processes more efficient and effective.

     

    Prior to joining AQA in February 2016, Bruce was the Chief Research and Development Officer at Pizza Hut. Before joining Yum! Restaurants in 2005, Bruce served in various leadership roles with Master Foods, a division of Mars, in Australia, and also served in R&D and QA management roles at HJ Heinz (Australia).

     

    He is a Certified Food Scientist, a certified HACCP practitioner, and is a Certified Manager of Quality and Organizational Excellence from the American Society for Quality. He has also completed the FSPCA Preventative Controls Qualified Individual training.

     

    Bruce earned his B.Sc. in Pharmacology and Biochemistry from the University of Melbourne, and has a Post Graduate Diploma of Clinical Nutrition from the International Academy of Nutrition, Australia.

     

    He is married and has three children. In his spare time Bruce runs, reads, roasts coffee beans, and travels as much as possible to new places so he can experience new foods and cultures.

     

    (Arthur) Bruce Perkin
    1613 Byrn Drive, Allen, TX| 469 563 6981 | brucep@actionableqa.com

    • Mar 22 2017 09:00 PM
    • by Simon
  2. Achieving FSMA Compliance with BRC Certification

    BRC Food Safety Standard was first published in 1998 and was Food Safety Standard to be benchmarked by the GFSI. The current version of the standard is Issue 7 which was published in January 2015. In Issue 7 the BRC proactively tackled two major issues in the food industry; food fraud/substitution and product labeling.

     

    This was reflected in the additions to the fundamental requirements* as additional fundamental requirements in Issue 7 were clause 3.5.1 Management of suppliers of raw materials and packaging and clause 6.2 Labelling and pack control.

     

    * Appendix 1 BRC Global Standard for Food Safety Issue 7 Fundamental Requirements

     

    The BRC Global Standard for Food Safety is one of the most established and comprehensive food safety standards published. The standard includes requirements in 7 sections (See Appendix 2 for full list of sections/clauses):

     

    1. Senior Management Commitment
    2. The Food Safety Plan – HACCP
    3. Food Safety and Quality Management System
    4. Site Standards
    5. Product Control
    6. Process Control
    7. Personnel

     

    Due to the comprehensive nature of the BRC Global Standard for Food Safety it is no surprise that a recent study commissioned by the BRC concludes that ‘BRC Global Standard for Food Safety Issue 7 is almost in complete alignment with the expectations in FSMA’.

     

    The FDA Food Safety Modernization Act (FSMA) is the most exhaustive reform of food safety laws in the US in more than 70 years. The Act was signed into law by President Obama on January 4, 2011. It primary aim is to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

     

    To assist all BRC Food certificated sites BRC Global Standards commissioned The Acheson Group (TAG) to assess the BRC Global Standard for Food Safety Issue 7 against the final rule for Preventative Controls for Human Food. The results of the analysis show that certification to the BRC Global Standard for Food Safety Issue 7 is almost in complete alignment with the expectations in FSMA. Source: BRC website.

     

    FSMA BRC/TAG Report Conclusion

     

    As a general observation, TAG has concluded that sites certified under the BRC Food Standard are in a very good position to meet and exceed the requirements Preventive Controls. The systems and documentation required in BRC provide a foundation of information that can be used to complete the analysis on the need for “Preventive Controls” in any operation. In some cases there will be additional documentation, verification validation required to the Preventive Control Rule, however, this should not require significant change to existing BRC based food safety programs. Source: BRC website.

     

    Also note that the BRC are offering a free webinar The FSMA BRC Connection for BRC Certificated Sites

     

    The webinar will define the comparison between the Global Standard for Food 7, FSMA Preventative Controls, and how the addendum for certificated sites will work, including audit timelines, protocol and site guidance in satisfying the FSMA PC requirements.

     

    Appendix 1

     

    BRC Global Standard for Food Safety Issue 7 fundamental requirements:

     

    1.1 Senior management commitment and continual improvement
    2 HACCP - Food Safety Plan
    3.4 Internal Audits
    3.5.1 Management of raw materials and packaging
    3.7 Corrective and preventive actions
    3.9 Traceability
    4.3 Layout, product flow and segregation
    4.11 Housekeeping and hygiene
    5.3 Management of allergens
    6.1 Control of operations
    6.2 Labelling and pack control
    7.1 Training

     

    Appendix 2

     

    BRC Global Standard Food Safety Issue 7 Sections/Clauses:

     

    1 SENIOR MANAGEMENT COMMITMENT
    1.1 Senior management commitment and continual improvement
    1.2 Organisational structure, responsibilities and management authority

     

    2 THE FOOD SAFETY PLAN – HACCP
    2.1 The HACCP food safety team – Codex Alimentarius Step 1
    2.2 Prerequisite programmes
    2.3 Describe the product – Codex Alimentarius Step 2
    2.4 Identify intended use – Codex Alimentarius Step 3
    2.5 Construct a process fl ow diagram – Codex Alimentarius Step 4
    2.6 Verify fl ow diagram – Codex Alimentarius Step 5
    2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards – Codex Alimentarius Step 6, Principle 1
    2.8 Determine the critical control points (CCPs) – Codex Alimentarius Step 7, Principle 2
    2.9 Establish critical limits for each CCP – Codex Alimentarius Step 8, Principle 3
    2.10 Establish a monitoring system for each CCP – Codex Alimentarius Step 9, Principle 4
    2.11 Establish a corrective action plan – Codex Alimentarius Step 10, Principle 5
    2.12 Establish verification procedures – Codex Alimentarius Step 11, Principle 6
    2.13 HACCP documentation and record keeping – Codex Alimentarius Step 12, Principle 7
    2.14 Review the HACCP plan

     

    3 FOOD SAFETY AND QUALITY MANAGEMENT SYSTEM
    3.1 Food safety and quality manual
    3.2 Documentation control
    3.3 Record completion and maintenance
    3.4 Internal audits
    3.5 Supplier and raw material approval and performance monitoring
    3.6 Specifications
    3.7 Corrective and preventive actions
    3.8 Control of non-conforming product
    3.9 Traceability
    3.10 Complaint handling
    3.11 Management of incidents, product withdrawal and product recall
    3.12 Customer focus and communication

     

    4 SITE STANDARDS
    4.1 External standards
    4.2 Security
    4.3 Layout, product flow and segregation
    4.4 Building fabric, raw material handling, preparation, processing, packing and storage areas
    4.5 Utilities – water, ice, air and other gases
    4.6 Equipment
    4.7 Maintenance
    4.8 Staff facilities
    4.9 Chemical and physical product contamination control Raw material handling, preparation, processing, packing and storage areas
    4.10 Foreign-body detection and removal equipment
    4.11 Housekeeping and hygiene
    4.12 Waste/waste disposal
    4.13 Management of surplus food and products for animal feed
    4.14 Pest control
    4.15 Storage facilities
    4.16 Dispatch and transport

     

    5 PRODUCT CONTROL
    5.1 Product design/development
    5.2 Product labelling
    5.3 Management of allergens
    5.4 Product authenticity, claims and chain of custody
    5.5 Product packaging
    5.6 Product inspection and laboratory testing
    5.7 Product release

     

    6 PROCESS CONTROL
    6.1 Control of operations
    6.2 Labelling and pack control
    6.3 Quantity – weight, volume and number control
    6.4 Calibration and control of measuring and monitoring devices

     

    7 PERSONNEL
    7.1 Training: raw material handling, preparation, processing, packing and storage areas
    7.2 Personal hygiene: raw material handling, preparation, processing, packing and storage areas
    7.3 Medical screening
    7.4 Protective clothing: employees or visitors to production areas

     

    Author Biography
    Tony Connor, Chief Technical Advisor, IFSQN

     

    Tony received an honors degree in Molecular Biology and Biochemistry from Durham University before embarking on a successful 20-year career in the UK food industry in a variety of roles including Laboratory Manager, Production Manager, Quality Assurance Manager, Technical Manager, Technical Development Manager and Group Technical Manager. Tony qualified as a Lead Audit Assessor in 1994. Since 2009 Tony has been Chief Technical Advisor to the International Food Safety & Quality Network.

     

    BRC Food Safety Issue 7 Implementation Package
    IFSQN offer a comprehensive documentation package suitable for Food Manufacturers looking to achieve certification to BRC Food Safety Issue 7. All document templates are fully editable to suit your process and are provided by download in standard Microsoft Office formats. Find Out More >>

    • May 17 2017 03:21 PM
    • by Tony-C
  3. Comparing FSSC 22000 against FSMA Preventive Controls Rules

    The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates (See Appendix 4) for some businesses begin in September 2016. Key Requirements include:

     

    1. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:

    • Hazard analysis
    • Preventive controls
    • Monitoring
    • Corrective actions and corrections
    • Verification
    2. The definition of a ‘farm’ is clarified to cover two types of farm operations. Operations defined as farms are not subject to the preventive controls rule.
    • Primary Production Farm
    • Secondary Activities Farm
    3. Supply-chain program is more flexible, with separate compliance dates established. The rule mandates that a manufacturing/processing facility have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control.

     

    4. Current Good Manufacturing Practices (CGMPs) are updated and clarified. Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties.

     

    Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.

     

    Note that there are similar requirements related to preventive controls.

     

    The FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.

     

    The FSSC 22000 Food Safety System Certification scheme was first published in 2009 and is one of the main certification schemes recognized by the Global Food Safety Initiative (GFSI). 12.000+ organizations in over 140 countries have now achieved FSSC 22000 certification*. Certification to the scheme is widely recognized and provides assurance that an organization has implemented a robust food safety management system.

     

    * Source www.fssc22000.com

     

    The FSSC 22000 Certification scheme for food manufacturers is based on:

    • ISO 22000 Food safety management systems - Requirements for any organization in the food chain
    • ISO Technical Specification 22002-1 - Prerequisite programmes on food safety Part 1: Food manufacturing
    • FSSC 22000 Additional Requirements (See Appendix 3)
    ISO 22000 stipulates the food safety management system requirements of the scheme and covers key elements of food safety management including; Documentation Control, Management Responsibility, Food Safety Policy, FSQMS Planning, Communication, Resource Management, Traceability, Corrections/Corrective Actions, Handling of Potentially unsafe products/Withdrawals, Monitoring and Measuring, Validation and Verification, Internal audits, Management Review and Improvement (see Appendix 1 for a full list of sections).

     

    The FSSC 22000 Certification scheme prerequisite programme requirements are stipulated in a combination of ISO 22000 and ISO 22002. Prerequisites are described in ISO 22000 Clause 7.2.3:

     

    When selecting and/or establishing PRP(s), the organization shall consider and utilize appropriate information [e.g. statutory and regulatory requirements, customer requirements, recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of practices, national, international or sector standards]. NOTE Annex C gives a list of relevant Codex publications.

     

    The organization shall consider the following when establishing these programmes:

     

    a) construction and lay-out of buildings and associated utilities
    b) lay-out 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) the suitability of equipment and its accessibility
    f) management of purchased materials, supplies, disposals and handling of products
    g) measures for the prevention of cross contamination
    h) cleaning and sanitizing
    i) pest control
    j) personnel hygiene
    k) other aspects as appropriate

     

    TECHNICAL SPECIFICATION ISO/TS 22002-1 Prerequisite programmes on food safety — Part 1: Food manufacturing elaborates on requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3 in sections 4 – 13 (See Appendix 2 for a full list of sections). In addition the technical specification adds other aspects which are considered relevant to manufacturing operations in the following sections:

    • 14 Rework
    • 15 Product recall procedures
    • 16 Warehousing
    • 17 Product information/consumer awareness
    • 18 Food defence, biovigilance and bioterrorism
    One of the key differences with the FSSC 22000 certification scheme compared to other GFSI benchmarked standards is the requirement for operational prerequisite programmes. When you come to Clause 7.4.3 Hazard assessment onwards you need to decide if control measures for a hazard fall into the category of needing to be controlled through operational PRP(s) or by the HACCP plan.

     

    Clause 7.4.3 Hazard assessment requires the identification of food safety hazards whose elimination or reduction to acceptable levels is essential to the production of a safe food. Clause 7.4.4 Selection and assessment of control measures requires that the control measures selected to control these hazards are categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan. There is a requirement that the selection and categorization of control measures is carried out using a logical approach that includes assessments of the effect of the control measure on identified food safety hazards, any synergistic effects between control measures, the feasibility for monitoring, the likelihood and severity of the consequences of failure of a control measure and whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s). Clause 8.2 Validation of control measure combinations requires that control measures to be included in operational PRP(s) and the HACCP plan are subject to validation.

     

    FSSC 22000 aligns with Preventive Controls for Human Food (Final Rule)

     

    A recent comparison of FSSC 22000 against the FSMA Final Preventive Controls (PC) Rule for Human Food was commissioned by The Foundation FSSC 22000 and conducted by The Acheson Group (TAG), an independent consultancy with expertise in food safety legislation. Although it was intended as a gap analysis, the comparison showed that there are no gaps in the elements required for FSSC 22000 certification when compared with the requirements of the final PC rule.

     

    Source: FSSC 22000

     

    Comparison of FSSC 22000 against the Preventive Controls for Human Food (Final Rule) The Acheson Group

     

    Full details of the Acheson Group report can be found at the link above. Extracts and a comparison table from the report:

     

    Summary: FSSC 22000 as the owner of a GFSI recognized scheme should be very proud of how it compares with the FSMA Preventive Controls (PC) final rule in several areas.Posted ImageSource: http://www.fssc22000...-april-2016.pdf

     

    Conclusion: Based on this analysis, a facility that has achieved FSSC 22000 certification is in an excellent place with regard to compliance with the FDA PC rules.

     

    Appendix 1

     

    ISO 22000 Food safety management systems - Requirements for any organization in the food chain – Sections:

     

    4. Food Safety Management System
    4.1 General Requirements
    4.2 Documentation
    4.2.2 Document Control
    4.2.2 Document Control
    4.2.3 Record Control
    5. Management Responsibility
    5.1 Management Commitment
    5.2 Food Safety Policy
    5.3 FSQMS Planning
    5.4 Responsibility & Authority
    5.5 Food Safety Team Leader
    5.6 Communication
    5.6.1 External Communication
    5.6.2 Internal Communication
    5.7 Contingency preparedness and response
    5.8 Management Review
    6. Resource Management
    6.1 Provision of Resources
    6.2 Human Resources
    6.2.2 Competence, Awareness and Training
    6.3 Infrastructure
    6.4 Work Environment
    7. Planning and Realisation of Safe Products
    7.1 General Planning and Realisation of Safe Products
    7.2 Prerequisite Programmes
    7.3 Preliminary steps to enable Hazard analysis
    7.4 Hazard Analysis
    7.5 Operational Control
    7.5 Establishing the Operational Pre-requisites
    7.6 Establishing the HACCP plan
    7.7 Updating of preliminary information and documents specifying the PRP(s) and HACCP plan
    7.8 Verification Planning
    7.9 Traceability System
    7.10.1 Corrections
    7.10.2 Corrective Actions
    7.10.3 Handling of Potentially unsafe products
    7.10.4 Withdrawals
    8. Validation, Verification and Improvement of the FSMS
    8.1 General
    8.2 Validation of Control Measure Combinations
    8.3 Control of Monitoring and Measuring
    8.4 FSQMS Verification
    8.4.1 Internal audits
    8.4.2 Evaluation of Individual Verification results
    8.4.3 Analysis of results of Verification activities
    8.5 Improvement
    8.5.1 Continual Improvement
    8.5.2 FSQMS updating

     

    Appendix 2

     

    TECHNICAL SPECIFICATION ISO/TS 22002-1 First edition 2009 Prerequisite programmes on food safety — Part 1: Food manufacturing Sections:
    4 Construction and layout of buildings
    5 Layout of premises and workspace
    6 Utilities – air, water, energy
    7 Waste disposal
    8 Equipment suitability, cleaning and maintenance
    9 Management of purchased materials
    10 Measures for prevention of cross contamination
    11 Cleaning and sanitizing
    12 Pest control
    13 Personnel hygiene and employee facilities
    14 Rework
    15 Product recall procedures
    16 Warehousing
    17 Product information/consumer awareness
    18 Food defence, biovigilance and bioterrorism

     

    Appendix 3
    FSSC 22000 Certification Scheme Part I REQUIREMENTS FOR ORGANIZATIONS THAT REQUIRE CERTIFICATION
    Appendix I A
    ADDITIONAL REQUIREMENTS
    1. Specifications for services
    2. Supervision of personnel in application of food safety principles
    3. Specific regulatory requirements
    4. Announced, but unscheduled audits of certified organizations
    5. Management of Inputs
    6. Management of natural resources such as water and soil regarding animal production
    7. Food defence, bio vigilance and bioterrorism (extension to animal production)

     

    FSSC 22000 guidance on Appendix IA
    Provides additional information relating to questions arising from the revised requirements

     

    Appendix 4

     

    FSMA Compliance Dates

     

    Compliance dates for businesses are staggered over several years after publication of the final rule.

    • Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years, except for records to support its status as a very small business (January 1, 2016).
    • Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years
    • Small businesses (a business with fewer than 500 full-time equivalent employees): Two years
    • All other businesses: One year
    Compliance dates after publication of the final rule for the requirements of the supply chain program:
    • Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two years
    • Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two years or six months after the supplier is required to comply with the applicable rule, whichever is later
    • Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months
    • Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after the supplier is required to comply with the applicable rule

     

    Author Biography
    Tony Connor, Chief Technical Advisor, IFSQN

     

    Tony received an honors degree in Molecular Biology and Biochemistry from Durham University before embarking on a successful 20-year career in the UK food industry in a variety of roles including Laboratory Manager, Production Manager, Quality Assurance Manager, Technical Manager, Technical Development Manager and Group Technical Manager. Tony qualified as a Lead Audit Assessor in 1994. Since 2009 Tony has been Chief Technical Advisor to the International Food Safety & Quality Network.

     

    FSSC 22000 Implementation Package

     

    IFSQN offer a comprehensive documentation package suitable for Food Manufacturers looking to achieve certification to the FSSC 22000 scheme for Food Safety Management Systems. All document templates are fully editable to suit your process and are provided by download in standard Microsoft Office formats. Find Out More >>

    • Aug 09 2016 07:26 PM
    • by Tony-C