FDA Report Released on Restaurant Foodborne Illness Factors
Source : https://foodpoisoningbulletin.com/2018/fda-report-released-restaurant-foodborne-illness-factors/
By Linda Larsen (Nov 9, 2018)
The FDA has released findings from the first phase of a 10 year study that is looking at restaurant foodborne illness factors in fast food restaurants and full service restaurants. The report looked at risk factors from 2013 to 2014. The first 10-year study was conducted between 1998 and 2008.
I n the 2008 study, the FDA found that the restaurant foodborne illness factors that needed the most improvement were poor personal hygiene, improper food holding/time and temperature, and contaminated equipment and protection from contamination.
More than half of all food poisoning outbreaks in the U.S. every year are associated with restaurant food. In 2014, when looking at outbreaks linked to a single location, restaurants accounted for 485 outbreaks, or 65% of the total, and 4780 illnesses, or 44%. Many of these outbreaks led to lawsuits. The FDA at that time stated it needed more research to identify the root causes for these poor retail food safety practices, and to determine effective intervention strategies.
The restaurant foodborne illness risk factors that were listed for this study include employee handwashing, proper temperature control of perishable foods, improper food holding time, hand-to-hand contact with ready-to-eat foods, cooking raw animal foods to safe final and required internal temperatures, contaminated equipment, and food obtained from unsafe sources.
Restaurants were randomly selected using a Geographic Information System database within a 150-mild radius of the locations of twenty-two specialists who conducted the data collection. The sample size was 384 data collection points to provide sufficient observations with a 95% confidence rate.
The specialist arrived unannounced at the restaurants, then explained the purpose of the visit to the person in charge of the facility. If entry was denied, another restaurant was selected. The 2013 FDA Food Code was used as the standard of measurement. Restaurants were marked as being in compliance, out of compliance, or not applicable.
Then, for each of the key elements, the person in charge was interviewed to see if criteria for risk factors were addressed in a food safety management system (FSMS). The answers were rated 1 through 4. One was defined as no system in place, 2 as underdeveloped, 3 as well-developed, and 4 as well-developed and documented.
The results are startling. In Table 9 in the report, in fast food restaurants, 68% were out of compliance for holding refrigerated foods at the proper temperature, 66% were out of compliance for personal hygiene, 49% for cooling foods properly, 41% for sanitizing food contact surfaces, and 37% for foods protected from cross-contamination. For full service restaurants, 86% were out of compliance for keeping perishable foods refrigerated, 82% for employee handwashing, 72% for cooling foods properly, 71% for ready-to-eat foods marked with the date and discarded within a week, and 66% for protecting food from cross-contamination. All of those factors could lead to restaurant foodborne illness outbreaks.
Food safety management systems played a major role in whether or not these restaurants were compliant. In fast food restaurants, if there was no FSMS, an average of 4.5 items were out of compliance. With a well-developed FSMS, only 1.7 items were out of compliance,. Ian full service restaurants, the numbers were similar. Restaurants without an FSMS had 5.8 items out of compliance, and with a well-developed FSMS, there were only 2. 1 items out of compliance.
In the same vein, restaurants with a Certified Food Protection Manager (CFPM) had fewer primary data items out of compliance. And restaurants were the CFPM was the person in charge at the time of data collecting had significantly better food safety management scores.
The two risk factors that needed most improvement to prevent foodborne illness, according to the FDA, were cold holding of foods requiring refrigeration, since bacteria will grow in foods out of refrigeration after two hours, and employee handwashing, since ill persons can transfer bacteria to foods through the fecal-to-oral route.
The best control in fast food and full service restaurants was in ensuring no bare hand contact with ready-to-eat foods, and cooking raw animal foods, such as meat, poultry, and eggs, to the required safe final internal temperature.
Microorganism Confirmation and Identification with Mass Spectrometry: The Rise of MALDI-TOF
Source : https://www.foodsafetymagazine.com/signature-series/microorganism-confirmation-and-identification-with-mass-spectrometry-the-rise-of-maldi-tof/
By Daniele Sohier (Nov 9, 2018)
Microorganism Confirmation and Identification with Mass Spectrometry: The Rise of MALDI-TOF
Microorganism confirmation and identification are critical in a number of industries, including pharma, cosmetics, and food. In the food industry, pressures from regulatory bodies and customers alike are continually tightening, making accurate, rapid microbiology testing crucial for manufacturers to make rapid decisions in regard to quality and safety, for example, to detect possible food spoilage organisms or foodborne pathogens, or monitor environmental contaminants or technological microflora.
A wide variety of technologies are used to detect and identify contaminants and technological organisms in food, from traditional culture-based methods and molecular testing using polymerase chain reaction to increasingly sophisticated analytical technologies such as mass spectrometry (MS). The ability to identify bacteria, yeast, and mold at the genus or species level enables a deeper level of screening. Researchers and test manufacturers are always searching for more advanced methods for faster tests with higher accuracy and sensitivity.
The Benefits of MS
Food safety authorities have fully accepted the AOAC- and ISO 16140-approved rapid testing methods, and their adoption has been acknowledged in regional regulations. The development of new technologies, such as matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) MS, and sequencing offers faster and more accurate confirmation and identification of microorganisms to the food microbiology industry. Time is often the most critical factor in food microbiology laboratories, so MALDI-TOF is becoming increasingly valuable in routine testing.
Comparative studies have demonstrated differences in the percentages of correctly identified bacteria and fungi isolates using MALDI-TOF MS (>99%) and traditional identification panels (94–97%), with speed and reagent costs also representing key benefits of MALDI-TOF MS. MALDI-TOF MS will rapidly establish a robust position for surveillance and monitoring of microorganisms in the complex interwoven network of origin, producers, traders, and consumers. For instance, in 2016, more than 1,200 Listeria spp. strains—in the context of national surveillance in France—were analyzed using MALDI-TOF MS. All isolates were correctly identified by MALDI-TOF MS at the species level, as confirmed by whole-genome sequencing.
MALDI-TOF MS in Practice
In January 2017, the Microbiology Food Laboratory at Q Laboratories in Cincinnati, OH, added Bruker’s MALDI-TOF MS system, the MALDI Biotyper (MBT), to its toolbox of technologies for routine food microbial identification and research and development work. This technology determines a unique protein fingerprint of a microorganism, which is used to reliably identify a particular species by matching the fingerprint with thousands of reference spectra from a comprehensive library (Figure 1). This tool is complemented by existing techniques in the toolbox, such as sequence-based identification with rDNA sequencing.
In the routine laboratory, the incorporation of MS technology into the toolbox enables the laboratory to offer flexible options for turnaround time and cost to fit in with the client’s needs. This is particularly valuable as it creates a completely customizable service and provides the option of same-day results for rapid pathogen identification, for example. This was not available with previous methods. The confidence in results with the MALDI-TOF system and increased sensitivity means that fewer re-tests are required, so when an identification is provided for the first time, the client can make decisions immediately.
The Food Microbiology Laboratory now analyzes samples with the MBT in 15 minutes to less than 1 hour to either confirm presumptive results of a detection or enumeration method or to identify an organism from a plate. This encompasses 20 seconds of handling time, and restricted consumables are required for more than 95 percent of the microbial isolates, providing a cost-effective microbial confirmation and identification solution (Figure 2). There is no need to know the type of microorganism prior to analysis; bacteria, yeast, or mold samples are all analyzed together, following the same workflow.
Validating New Technologies
The Q Laboratories R&D laboratory tests and validates technologies and assays for food microbiology testing. Technology companies and diagnostic partners approach Q Laboratories with a new technology or assay for method validation, for example, for testing Salmonella, Listeria, or Legionella, and to request a proposal for the work. The R&D laboratory establishes a study design with the client and the method validation organization (i.e., AOAC INTERNATIONAL in the U.S.). The study should fulfill the AOAC Appendix J guidelines requirements.
MicroVal and AFNOR Certification are the certification bodies in Europe, and method performance is assessed using the ISO 16140 standard.[5, 6] The "Expert Laboratory" (in this case, Q Laboratories) is the party that prepares the protocol, in collaboration with the technology provider, and submits the protocol to the certification body for the technical reviewers to approve. Q Laboratories is the only North American laboratory to be an Expert Laboratory for all three of the major certification bodies: AOAC, MicroVal, and AFNOR Certification. This enables the design of combined AOAC/ISO validation studies and fulfillment of all client requirements.
Q Laboratories conducted AOAC Official Methods of Analysis (OMA) studies and ISO 16140 validation studies with MicroVal certification body for the Bruker MBT. By combining existing guidelines—such as the AOAC Appendix J guidelines and the new ISO 16140 part 6 standard—an optimal study design was created to validate the use of the MBT for food microbiology analysis. These studies were the first of their kind, as the designs for validating a confirmation and identification method had not caught up with the newest technology. Fifty percent of the data were produced in the U.S. and the other half in Europe, by collaborating with a second Expert Laboratory, ADRIA (France). This enabled the laboratories to test the relevant biodiversity of strains from various origins to verify the reliability of the MBT. In addition, four collaborative studies involving laboratories from two different regions were run to assess the reproducibility and robustness of the MBT. Various selective culture media were tested (Table 1), as well as two instruments, the MBT and MBT-smart.
Q Laboratories served as the lead laboratory for two separate studies, gaining AOAC-OMA status for the MBT in December 2017. The first was for confirmation and identification of Salmonella spp., Cronobacter spp., and other Gram-negative organisms (OMA#2017.09). The second was for the confirmation and identification of L. monocytogenes, Listeria spp., and other Gram-positive organisms (OMA#2017.10) in food microbiology.[7, 8] In the meantime, the scope of the AOAC-OMA 2017.09 method has been extended to the confirmation of Campylobacter spp. (awaiting publication). Q Laboratories was also involved in the ISO 16140-6 approvals by MicroVal. Together with the MicroVal technical committee members, the proof of concept was presented with a poster and a symposium at the International Association for Food Protection event in Stockholm in April 2018.[8, 9] Pioneering studies were organized and four certificates were obtained early in 2018.
The AOAC-OMA 2017.09 and 2017.10, and the MicroVal Certificates 2017LR72, 2017LR73, 2017LR74, and 2017LR75 cover the confirmation of selected foodborne pathogens and quality indicators, that is, Salmonella spp., Cronobacter spp., Campylobacter spp., Listeria spp., and L. monocytogenes. In addition, the AOAC-OMA 2017.09 and AOAC-OMA 2017.10 include the identification of microbial isolates. The designs and results summary of pre-collaborative and collaborative studies run for the AOAC-OMA and ISO 16140 approvals of the MBT are presented in Tables 2 and 3. The results fit with the requirements of the AOAC Appendix J guidelines and the acceptability limits of the ISO 16140-6 standard.
Having validation at the level of an AOAC-OMA and ISO validated/MicroVal certified methods is acceptable to the U.S. Food and Drug Administration (FDA) for pathogen confirmation and the European regulations EC 2073/2005. Both FDA and European regulations require a third-party certification body to have approved the validation data and deem that as an equivalent alternative confirmation/identification method to their own methodology, which is considered the gold standard.
Food Microbiology in the Future
MS has historically been an analytical chemistry tool, but the robustness of the MALDI-TOF MS technology in the hands of microbiologists has enabled the Food Microbiology Laboratory to successfully generate spectra and obtain confirmations and identifications within 4 weeks of installing the equipment. Q Laboratories is expanding its identification capabilities and is looking to increase its environmental testing offering, as the need for identification of food and environmental contaminants continues to rise.
As well as at Q Laboratories, there are more than 3,000 MBTs currently running worldwide in various microbiology frameworks. For example:
Pathogen surveillance at the Pasteur Institute and U.S. Centers for Disease Control and Prevention (CDC) of Atlanta; CDC offers free access to its MicrobeNet library in addition to the Bruker library
Culture collection curating, such as the Dutch Centraalbureau voor Schimmelcultures, the China Center of Industrial Culture Collection, the Collection de l'Institut Pasteur, the Deutsche Sammlung von Mikroorganismen und Zellkulturen
For routine testing and quality control purposes
For more information on Q Laboratories, please visit QLaboratories.com.
For more information on Bruker’s MALDI Biotyper, please visit Bruker.com.
Elbehiry, A, et al. 2017. "Application of MALDI-TOF MS Fingerprinting as a Quick Tool for Identification and Clustering of Foodborne Pathogens Isolated from Food Products." New Microbiologica 40(4):296–278.
De Koster, C and S Brul. 2016. "MALDI-TOF MS Identification and Tracking of Food Spoilers and Foodborne Pathogens." Curr Opin Food Sci 10:76–84.
Thouvenot P, Vales G, Bracq-Dieye H, Tessaud-Rita N, M. Maury M, Moura A, Lecuit M, Leclercq A (2018), MALDI-TOF mass spectrometry-based identification of Listeria species in surveillance: A prospective study, Journal of Microbiological Methods Vol 144, pp 29-32.
Official Methods of Analysis (2016) 20th Ed., AOAC INTERNATIONAL, Rockville, MD, Appendix J. http://www.eoma.aoac.org/app_j.pdf (accessed September 2017)
ISO 16140-2:2016, TC 34, Microbiology of the food chain—Method validation—Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.
ISO/DIS 16140-6:2017, TC 34, Microbiology of the food chain—Method validation—Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures.
Bastin, B, et al. 2018. "Confirmation and Identification of Salmonella spp., Cronobacter spp., and Other Gram-Negative Organisms by the Bruker MALDI Biotyper Method: Collaborative Study. First Action 2017.09." J AOAC Int 101(5):1593–1609.
Bastin, B, et al. 2018. "Confirmation and Identification of Listeria monocytogenes, Listeria spp. and Other Gram-Positive Organisms by the Bruker MALDI Biotyper Method: Collaborative Study, First Action 2017.10." J AOAC Int 101(5):1610–1622.
Bastin, B, et al. 2018. "Validation of a Confirmation Method According to ISO/DIS 16140-6:2017 A MicroVal Pilot Study using the MALDI Biotyper as an Alternative for Salmonella spp. Confirmation." International Association of Food Protection event, Stockholm, Sweden, Poster P2–16.
Arbault, P, et al. 2018. "Turning Sequencing and Mass Spectrometry into Routine Testing Tools for Microbial Strain Characterization." International Association of Food Protection event, Stockholm, Sweden, Symposium S19.
COMMISSION REGULATION (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.
Daniele Sohier is the global business development manager, Industrial Microbiology at Bruker Daltonics (Microbiology & Diagnostics business area). With a Ph.D. in biological and medical sciences, Daniele has over 20 years of experience in molecular biology, and has spent the last 15+ years focusing on food microbiology, safety, and quality.
What Is the Best Way to Wash Fruits and Vegetables?
Source : https://foodpoisoningbulletin.com/2018/best-way-wash-fruits-vegetables/
By Linda Larsen (Nov 7, 2018)
Consumers are understandably nervous about the new romaine lettuce growing season in the Yuma, Arizona region after the large E. coli O157:H7 outbreak that was linked to that product earlier this year. In that outbreak, 210 people were sickened, and 96 people were hospitalized. Five people died. So how should you, and can you, wash fruits and vegetables to help get rid of pathogens?
The FDA and CDC never did solve this outbreak, and never identified a single farm or product that caused the illnesses. They did, however, find that canal water that may have been used for irrigation or to dilute crop chemicals was contaminated with the outbreak strain.
One of the issues with that outbreak was that most of the illnesses were caused by chopped romaine. Lettuce from many different farms was processed together, which helped spread the contaminated lettuce around the country.
It is true that less processed produce may be safer, although contamination can occur anywhere on any food. The large centralized processing and distribution centers can get contaminated foods to more people. If you choose to purchase unprocessed produce, can you make it safe by proper cleaning?
The answer is yes and no. Washing fruits and vegetables can reduce the risk of foodborne illness. But it’s impossible to completely remove all bacteria from these products through washing.
The University of Maine Cooperative Extension has published a bulletin about the best ways to wash fruits and vegetables that contains valuable information and step by step instructions.
First, wash your hands with hot soapy water before you start working in the kitchen. Then clean your countertop, cutting boards, and utensils. It’s a good idea to clean your sink took since bacteria can linger there and cross-contaminate other foods. Do not use soaps or detergents to wash produce.
Produce with thick skin should be scrubbed with a vegetable brush. Produce that has a lot of nooks and crannies, such as cauliflower, broccoli, or lettuce, should be soaked in a bowl of clean cool water for 1 to 2 minutes. Don’t soak those items in the sink, which could be contaminated. After washing, dry the produce with a clean paper towel. This action can help remove more bacteria. Wash fruits that are more delicate, such as raspberries and strawberries, just before you eat them.
And remember that homegrown fruits and veggies, produce bought at the farmers market should also be thoroughly washed. Most experts recommend that you don’t wash any produce that is labeled “ready to eat,” “washed,” or “triple washed” because you could re-contaminate it.
And once the produce is cleaned, refrigerate it as soon as possible. That goes double for any fruits and veggies that are sliced or chopped.
Food safety: simplified approach to make food donations easier
Source : https://www.efsa.europa.eu/en/press/news/181107
By efsa.europa.eu (Nov 7, 2018)
EFSA has developed a new food safety management approach that makes it simpler for small retailers to donate food.
The simplified system would mean that retailers are not required to have detailed knowledge of specific hazards. It includes steps for checking that donated food is safe, such as shelf-life control, maintenance of the cold chain and ensuring communication between the donor and recipients.
Under the new system, retailers need only to be aware that biological, chemical and physical hazards or allergens may be present and that a failure to undertake key control activities – such as separation of raw from cooked products – could pose a risk to consumers.
The approach is intended for food distribution centres, supermarkets, pubs, restaurants and other small retailers. Ensuring the safety of donated food is particularly challenging because it may be nearing the end of its shelf life and also because several actors are involved in the food donation chain. The scientific opinion will assist food donors and recipients (food banks and other charity organisations) by defining simplified food safety management systems to ensure redistribution of safe food to those in need.
Marta Hugas, EFSA’s Chief Scientist, said: “This simpler approach, which the European Commission asked us to develop after the positive experience of the previous scientific advice on the matter, should make it easier for small retailers to donate food. It should also help to reduce food waste – a priority for the EU.”
The new approach uses clear flow diagrams to summarise the stages of production, and simple tables to take retailers through the food safety management process from hazard identification to control measures, in line with existing regulations. The diagrams and tables are generic and can be adjusted by food business operators to fit their own business activities.
In a previous scientific opinion EFSA developed a simple food safety management system for other five types of small food business – butcher’s shops, bakeries, fishmongers, grocery stores, and ice cream shops.
Only a small proportion of surplus food in the EU is redistributed. In 2017, the European Federation of Food Banks network provided 44 700 frontline charity organizations with 4.1 million meals each day for the benefit of 8.1 million people.
The revised EU waste legislation, which was adopted in May 2018, calls on the EU countries to take action to reduce food waste at each stage of the food supply chain, monitor and report on food waste levels, based on a common EU methodology for measuring food waste to be adopted by the Commission.
Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion
FSMA Produce Safety Rule Meetings in Albany, Anaheim, Atlanta, and Portland
Source : https://www.foodsafetymagazine.com/news/fsma-produce-safety-rule-meetings-in-albany-anaheim-atlanta-and-portland/
By Staff (Nov 1, 2018)
FSMA Produce Safety Rule Meetings in Albany, Anaheim, Atlanta, and Portland
The U.S. Food and Drug Administration (FDA) will hold four one-day public meetings to discuss the recently published draft guidance created to help farmers meet the requirements of the Produce Safety Rule.
The draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Draft Guidance for Industry,” is a compliance and implementation guide that gives information and examples to demonstrate how farmers can meet the rule’s requirements in various ways. Established by the FDA Food Safety Modernization Act, the rule requires that domestic and foreign farms use science and risk-based preventive measures to protect their fruits and vegetables from contamination.
The four meetings will be held in Portland, OR, Anaheim, CA, Albany, NY, and Atlanta, GA.
Information presented at each meeting will focus on: general provisions; personnel qualifications and training; health and hygiene; biological soil amendments of animal origin; domesticated and wild animals; growing, harvesting, packing and holding activities on a farm; equipment, tools, buildings, and sanitation; records; and variances. Stakeholder panels will discuss various issues. There will be opportunities for questions and open public comment.
Those interested in attending any of the four in-person meetings can register online. Questions should be directed to:
1775 Eye Street, NW, Suite 1150
Washington, DC 20006
Attendees are encouraged to register online to attend any of the meetings in person.
For questions about registering for the meetings or to register by phone, contact For general questions about the meeting, or to request special accommodations due to a disability, contact:
FDA, Center for Food Safety and Applied Nutrition
PORTLAND, OR MEETING
November 27, 2018, 8:30 am – 5:00 pm
The Hilton Portland Downtown
921 SW Sixth Ave.
Portland, OR 97204
ANAHEIM, CA MEETING
November 29, 2018, 8:30 am – 5:00 pm
Doubletree Suites by Hilton/Anaheim Resort Convention Center
2085 S. Harbor Blvd.
Anaheim, CA 92802
ALBANY, NY MEETING
December 11, 2018, 8:30 am – 5:00 pm
40 Lodge St.
Albany, NY 12207
ATLANTA, GA MEETING
December 13, 2018, 8:30 am – 5:00 pm
Embassy Suites Atlanta at Centennial Olympic Park
267 Marietta St.
Atlanta, GA 30313
Be sure to visit the official meeting page for details on registration deadlines and requests to make comments at the meetings.
ISO 22000: Tips and Updates, Part 2
Source : https://www.foodsafetymagazine.com/enewsletter/iso-22000-tips-and-updates-part-2/
By Nuno F. Soares, Ph.D.(Nov 6, 2018)
ISO 22000: Tips and Updates, Part 2
This is the part 2 of an article about the new ISO 22000:2018, which was published in June 2018. If you have not yet read the first article, please check it out here. In the present article, changes to clauses 4–7 are discussed. Part 3 will discuss clauses 8–10.
Clause 4 – Context of the Organization
This clause is nearly all new and is mainly focused in defining how organizations shall establish the Food Safety Management System (FSMS) scope. For that, according to the standard, there are three things organizations must do/know (Figure 1).
From these items, the one that is the most straightforward for food safety practitioners is the definition of requirements. For that, organizations must first determine who the interested parties are and then gather their requirements regarding food safety.
To identify the interested parties, it is essential to consider all the participants that have an impact on food safety, whether internal or external components of the organization. For example, employees, management, and owners can be considered internal interested parties; suppliers, society, government, customers, and consumers are examples of external interested parties.
The new approach where organizations must understand their context and how those issues are relevant to their purpose and ability to achieve the FSMS results may pose a challenge to organizations, not only in defining it but also in how to audit it. One option would be to seek advice from people that have other ISO management systems implemented (or have experience in implementing it) since this approach is common to all ISO management system that have adopted the High Level (e.g., ISO 9001 or 14001).
Finally, the organization must define the FSMS boundaries so that the scope may specify the products and services, processes, and production sites included in the FSMS. In the 2005 version, services were not included in what the scope should specify. The scope must also consider the context of the organization and the needs and expectations of the interested parties, so that the FSMS will be established in an objective and consistent way to the reality of the company.
Clause 5 – Leadership
In this clause, the new standard presents a list of actions that top management should do to demonstrate its commitment towards the FSMS. The role of top management with respect to the FSMS is reinforced in the new version, since not only commitment (2005 version) but also leadership shall be demonstrated.
Regarding policy, there are no major differences when compared with the last version, although it includes an interesting reference to the importance of communicating policy with interested parties.
Clause 5.3 presents details on which responsibilities and authorities top management shall assign and introduces the idea that the responsibility of top management is not limited to assigning and communicating responsibilities and authorities, but also ensuring that they are understood. Besides defining what the food safety team leader shall be responsible for (that was also present in the 2005 version), it also clarifies other responsibilities and authorities that top management shall define (e.g., reporting on the FSMS performance, ensuring that the FSMS conforms to requirements). It also encourages sharing more responsibility over the entire organization to achieve the effectiveness of the FSMS, designating persons with defined responsibility and authority to initiate and document actions(s).
Clause 6 – Planning
In clause 6.1, the concepts of risks and opportunities are introduced as something that the organization must determine, considering relevant issues (internal or external) and requirements from the interested parties. Then the organization must plan, not only actions to address these risks and opportunities, but also how to integrate, implement, and evaluate the effectiveness of these actions.
The responsibility for establishing objectives and retaining documented information on them is set on clause 6.2. There is a higher emphasis on the importance of objectives than in the last version. Objectives shall be consistent and measurable, take into account the requirements, and be monitored, verifiable, communicated, and updated.
When planning how to achieve objectives, the steps shown in Figure 2 should be taken in consideration.
Clause 7 – Support
Clause 7 presents requirements regarding several supporting activities like resource management, people competence and awareness, communication and documented information management.
Resources in clause (7.1) are divided into:
• People (7.1.2),
• Infrastructure (7.1.3),
• Work environment (7.1.4),
• Externally developed elements of the FSMS (7.1.5),
• Control of externally provided process, products or services (7.1.6)
Resources can be approached by the prism of external or internal resources. Clause 7.1.3 and 7.1.4 manage internal resources, and clause 7.1.5 and clause 7.1.6 manage external resources. People (clause 7.1.2) can be either internal or external. Internal people are addressed in clause 7.2 (Competence) and 7.3 (Awareness), mainly to imply that the organization determines and ensures the competence and awareness (e.g., policy, objectives) of relevant persons. When assistance from external people is needed (e.g., experts), the organization shall retain documented information (e.g., contracts defining competencies). Retaining relevant information is also mandatory when the organization opts to:
• develop elements of the FSMS externally – guaranteeing that they are applicable, adapted, and updated
• use external providers of processes, products, and services – guaranteeing communication, evaluation, and monitoring
When comparing clause 7.4 (communication) with clause 5.6 in the 2005 version, the new version adds that the organization shall not only ensure that the requirements for effective communication are understood but also determines the details shown in Figure 3.
In terms of managing documentation, there is a different approach in the new version. Instead of dividing the clause into control of documents and control of records, it is presented as creating, updating, and controling documented information. Another significant change is the fact that a formal written procedure to control documents and records is no longer mandatory. This seems to be in line with the guidelines of ISO 9001:2015, promoting a more process-focused management system than document-based. This new version gives a focus on protection of confidentiality and integrity of documented information, reflecting the increasing importance of these issues to organizations and to society as a whole. In a note, it is explained that control of access to documented information may imply defining different permissions (view only or view and change).
Stay tuned for Part 3, which will round out the updates to this important regulation.
Nuno F. Soares, Ph.D., is an author, consultant, and trainer in food safety. He has over 20 years experience in food industry as quality and plant manager. He is the author of “ISO 22000:2018 Explained in 25 diagrams.”
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