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Business Plan In A Sphere: Timeline, Operations, Financial Planning, Product Description, Marketing Plan, Mission Statement, Swot Analysis, Competitor Analysis.
Business plan in a sphere: Timeline, Operations, Financial Planning, Product description, Marketing Plan, Mission statement, SWOT Analysis, Competitor Analysis.
Business plan in a sphere: Timeline, Operations, Financial Planning, Product description, Marketing Plan, Mission statement, SWOT Analysis, Competitor Analysis. All plans come as a Standard license, and can be upgraded to an Enhanced license at any time. When checked, Shutterstock's safe search screens restricted content and excludes it from your search results. Each Business has unique circumstances, processes and issues, however a common model can be used as the framework for laying out the Operations Plan.
You will be able to download and print a certificate for PDH credits once the content has been viewed. Gas blowby overpressure scenarios are routinely identified when analyzing vessels with liquid-level inlet control valves. Financial Planning, Product description, Marketing Plan, SWOT Analysis, Strategy, Goals, Slide concept.
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The World Class Operations Model is a framework I developed over years of improving, changing and turning around businesses primarily as an employee at the GM, VP and Director level. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
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It combines the “best of” from multiple disciplines that I have learned, and implemented over many years. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.I. It identifies some, but not all, of the preventive measures that these firms may take to minimize these food safety hazards.
This guidance document is not intended to serve as an action plan for any specific operation, but should be viewed as a starting point.
We encourage each firm from the farm level through the retail or foodservice level to assess the recommendations in this guidance and then tailor its food safety practices to its particular operations by developing its own food safety programs based on the assessment of the potential hazards and its operations.In addition, effective management of food safety requires that responsibility be clearly established among the many parties involved in the production of fresh produce. There may be many different permutations of ownership and business arrangements during the growing, harvesting packing, processing and distribution of fresh and fresh-cut leafy greens. For this reason, it is important to identify which responsibilities rest with which parties, and to ensure that these responsibilities are clearly defined. It is also important that growers clearly identify which party is responsible for each applicable provision of this guidance, such as providing adequate toilet and handwashing facilities and worker training. Approaches to addressing responsibilities include delegating them to individuals within the firm and formally addressing them in contractual agreements when third parties are involved. The GAPs Guide provides recommendations for growers, packers, and shippers to use good agricultural practices in those areas over which they have control to prevent or minimize microbial food safety hazards in fresh produce.
The Fresh-cut Guide provides recommendations to fresh-cut produce processing firms to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards in fresh-cut processing operations. The information included in this leafy greens-specific guidance is consistent with recommendations provided in the GAPs Guide and the Fresh-cut Guide.This guidance also specifically refers to FDA's regulations in 21 CFR part 1, subpart J on the establishment, maintenance, and availability of records and 21 CFR part 110 on current good manufacturing practices in manufacturing, packing, or holding human food.
The recommendations in this guidance complement, but do not supersede, the requirements in those regulations and any associated recommendations. Further, the recommendations in this guidance do not affect the applicability of any other Federal or State requirements and your responsibility to comply with them.FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. Background From 1996 to 2008, eighty-two foodborne illness outbreaks were associated with the consumption of fresh produce.
Of these produce-related outbreaks, 28 (34.1%) were linked to the consumption of leafy greens. During this time period, leafy greens-associated outbreaks accounted for 949 illnesses and 5 deaths. Cyclospora and Salmonella also have been the cause of outbreaks linked to leafy greens (Ref. The GAPs Guide provides general food safety guidance on the production and packing of fresh produce for critical production steps where food safety might be compromised during the growing, harvesting, transportation, cooling, packing, and storage of fresh produce.
For each objective, the plan identifies steps or actions that could contribute to the achievement of the objectives.Many of the steps set out in the Action Plan are relevant to the goal of reducing foodborne illness caused by E.
One such step was to provide technical assistance to industry in their efforts to develop commodity specific guidelines.


The 2006 industry guidelines provide voluntary recommendations on food safety practices that are intended to minimize the microbiological hazards associated with fresh and fresh-cut leafy greens. The leafy greens industry has since updated and supplemented its 2006 industry guidelines with additional recommendations on the production and harvest of leafy greens that include quantitative metrics and other measures to assist industry in implementing the guidelines (Ref.8 ). The 2006 industry guidelines and subsequent updates, as well as other programs and experience, serve as the basis for this guidance. FDA conducted its own review of the provisions of the industry guidelines and made decisions to incorporate, modify, or exclude specific aspects of those guidelines based on the agency's evaluations. In particular, we are considering the extent to which more specific measures, including metrics, should be utilized to help verify the implementation and efficacy of the federal recommendations and industry practices.
We are also evaluating the extent to which metrics can be applied to diverse geographic areas within the United States and internationally.Another step in FDA's Action Plan was the multi-year Leafy Greens Safety Initiative (Initiative) that began in 2006.
The first year of this Initiative focused on lettuce (Lettuce Safety Initiative) as a response to recurring outbreaks of E. FDA and the California Department of Public Health continued these efforts in 2007 with a focus on a broader range of leafy greens, including spinach, building upon lessons learned in the first year, subsequent outbreak investigations, and FDA's Tomato Safety Initiative . The Initiative is part of a risk-based strategy to reduce foodborne illness by focusing food safety efforts on specific products, practices, and growing areas that have been found to be problematic in the past.
Findings will also be incorporated into this guidance as appropriate.In 2007, the California Leafy Greens Products Handler Marketing Agreement (LGMA) was initiated providing a mechanism for verifying through government audits that leafy greens farmers in California follow certain food safety practices in the production and harvest of leafy greens.
Operators producing and harvesting leafy greens may find useful the LGMA best practices document consisting of quantitative food safety measures useful.
Please note that although FDA provided technical assistance in the development of the document, it is not responsible for the content of the document, which FDA has not verified.In late 2007, USDA's Agricultural Marketing Service (AMS) sought comments via an advance notice of proposed rulemaking on the possibility of a Federal marketing program to regulate the handling of leafy greens throughout the country. As described in a Federal Register notice published on October 4, 2007 (72 FR 56678), AMS is considering, among other options, the implementation of a marketing agreement to reduce the risk of pathogenic contamination during the production and handling of leafy greens. In further response to the 2007 notice, on June 8, 2009, a coalition of produce associations submitted a proposal to AMS requesting the establishment of a national marketing agreement for leafy greens based on the model used in the California and Arizona programs.On March 20 and April 13, 2007, FDA held two public hearings to seek comments and to discuss safer practices for growing, harvesting, packing, cooling, and shipping of fresh produce, including leafy greens.
The information received is being used to inform the Agency's decisions regarding next steps (72 FR 8750, February 27, 2007). On August 22, 2008, FDA published a final rule in the Federal Register amending the food additive regulations to provide for the safe use of ionizing radiation for control of foodborne pathogens, and extension of shelf-life, in fresh iceberg lettuce and spinach (73 FR 49593).FDA also has been actively engaged in developing international standards of hygienic practices for fresh leafy green vegetables. FDA is leading the effort to draft the Fresh Leafy Vegetables Annex to the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables.The Agency is issuing this commodity specific supply chain draft guidance for leafy greens, which is drawn primarily from the 2006 industry guidelines, along with agency experience and information from other recent public and private programs.
This FDA guidance supplements existing, but broader, recommendations in FDA's GAPs Guide and Fresh-cut Guide.
Developing this guidance is one step among others that the Agency may take to minimize the microbiological hazards associated with fresh and fresh-cut leafy greens.back to topIII. Such leafy greens may be grown in and harvested from open fields, shade houses or greenhouses. Examples of leafy greens include iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula and chard. Leafy greens do not include herbs such as cilantro and parsley.This guidance addresses microbiological hazards that may be associated with fresh and fresh-cut leafy greens produce and appropriate control measures for such hazards. Consistent with the GAPs Guide and Fresh-cut Guide, this guidance emphasizes the importance of employing prevention rather than elimination strategies to address microbiological hazards. Once fresh produce has been contaminated, removing or killing the microbial pathogens while maintaining the fresh attribute of the produce is very difficult. Prevention of microbial contamination at all steps in the field-to-fork continuum is preferable to treatment to eliminate contamination after it has occurred.Although this guidance to industry does not specifically include a section for consumers, it is critical that consumers also handle fresh produce safely and not contaminate it.
Within each operation, general recommendations regarding issues relevant to that operation are made to raise awareness and allow individuals and firms involved in the field-to-fork continuum to consider actions that are appropriate to their operations.
The identified issues in each section focus only on leafy greens, as defined above, and may or may not apply to other specialty crops. Firms are encouraged to use this guidance to evaluate their operations and develop their own individual company food safety programs.Figure 1. Leafy greens are marketed as either a raw agricultural commodity, as indicated by the solid arrow, or a fresh-cut product, as indicated by the dotted arrow. Leafy greens that are not field cored may enter the value-added processing and cooling step to be processed into fresh-cut products before entering the retail chain.
Fresh-cut produce does not require additional preparation, processing, or cooking before consumption, with the possible exception of washing or the addition of salad dressing, seasoning or other accompaniments.For different commodities, the fresh-cut form may vary.
Environmental Assessments and Risk Reduction PracticesAn environmental assessment is intended to identify any food safety issues in the environment in and around the produce field that may increase the risk of contaminating the crop with pathogens. WaterWater used in production and harvest operations may contaminate leafy greens if it contains human pathogens and contacts edible portions of leafy greens or transmits pathogens by means of water-to-soil and soil-to-leafy greens contact (Ref. Using maps, photographs, drawings, or other means to communicate the location of permanent fixtures and the flow of the water system (including any water captured for re-use). Documenting permanent fixtures, including wells, gates reservoirs, valves, returns and other above-ground features that make up a complete irrigation system, so as to enable location on the field.
Considering issues such as the potential for irrigation methods to deposit soil on the crop or cause pooled or standing water that attracts animals.Considering the impact of storm events on surface waters used to irrigate crops.
Testing the water source regularly to ensure that it is of appropriate microbial quality for its intended use.Evaluating risks of using reclaimed (primary or secondary) water, including use in operations such as road dust abatement. Reclaimed water may be subject to State and local requirements.Crop Protection Sprays (Pesticides)It is important to be familiar with and follow all applicable requirements for crop protection sprays. Soil AmendmentsSoil amendments may be incorporated into agricultural soils used for leafy greens production to add organic and inorganic nutrients to the soil as well as to reduce soil compaction. Soil amendments that contain animal manure are of concern because human pathogens may persist in animal manure (particularly aged manure or inadequately composted soil amendments) for weeks or months (Refs. Proper composting of animal manures via thermal treatment will reduce the risk of potential human pathogen survival.


However, the persistence of human pathogens in agricultural soils depends on many factors such as pH, temperature, soil type, and native microflora and continues to be under extensive investigation (Refs. Leafy greens may be contaminated through contact with contaminated soil amendments if soil amendments containing human pathogens are applied after plant emergence. Field soil contaminated with human pathogens may also provide a means of leafy greens contamination. Therefore, establishing suitably conservative pre-plant intervals, appropriate for specific regional and field conditions, is an effective step towards minimizing risk (Refs. Machine HarvestThis section addresses harvest and harvest aid equipment used for leafy greens that will be further processed into a ready-to-eat (RTE) product. Mechanical or machine harvest has become increasingly prevalent and provides opportunities for increased surface contact exposure.
Hand Harvest - Contact with Soil During HarvestAfter manual harvest of leafy greens, placing or stacking product on soil before the product is placed into a container may expose the product to human pathogens if the soil is contaminated. Research has demonstrated that microbes, including human pathogens, can readily attach to cut leafy greens surfaces (Ref.
Transfer of Human Pathogens by Field Workers, Visitors, and Other Field PersonnelLeafy greens are handled by harvest crews during harvest. It is possible that persons working with produce in the field may transfer microorganisms of significant public health concern. Using signs that are multilingual or pictorial, as appropriate to the workforce.Providing drinking water with either fountain or single use containers. Either removing the decayed or damaged portions or not using the leafy green.GlovesIf leafy greens are handled with bare hands, hand washing procedures should be documented. Equipment Facilitated Cross ContaminationFarm equipment that has contact with soil, soil amendments, or water that is likely to contain microorganisms of significant concern to public health may spread microbial contamination to other production lands or water sources. Of particular attention is equipment that may come into contact with raw untreated manure, untreated compost, waters of unknown quality, wildlife or domestic animals and other potential human pathogen reservoirs.
FloodingFlooding (flowing or overflowing of a field with water outside a grower's control) may contaminate crops that are in close proximity to soil, such as leafy greens, if there is contact between flood water or contaminated soil and the edible portions of leafy greens (Refs. FDA is not aware of any method of reconditioning these crops that will provide a reasonable assurance of safety for human food use or otherwise bring them into compliance with the law.
Therefore, FDA recommends that such crops be excluded from the human food supply and disposed of in a manner that ensures they do not contaminate unaffected crops during harvesting, storage or distribution. Adulterated food may be subject to seizure under the Federal Food, Drug, and Cosmetic Act, and those responsible for its introduction or delivery for introduction into interstate commerce may be enjoined from continuing to do so or prosecuted for having done so . Water Usage to Prevent Product DehydrationLeafy greens may be sprayed with small amounts of water during machine harvest or in the field container just after harvest to reduce product water loss.
Greenhouse ProductionFor the purposes of this guidance, a greenhouse is presumed to be enclosed.
Note that the recommendations in this section do not apply to shade houses or other open structures. Shade houses and other open structures should follow recommendations on field production and harvesting.1.
GreenhouseFDA recommends:Utilizing a foot dip station at all entrances or other measure to prevent the introduction of harmful microorganisms or agents. Documentation and RecordsAs a general practice, it is important that firms that produce and harvest leafy greens maintain documentation and records related to operational information about the product and practices, as well as tracing information about the product. The records that must be kept are specified in the regulations and are needed to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging. The recommendations below complement, but do not supersede, existing recordkeeping requirements in part 1, subpart J. First, such records help ensure consistency of production, packing, and processing operations and end-product quality and safety. They are more reliable than human memory and serve as a useful tool to identify areas where inconsistencies occur in operations and corrective actions or employee training, may be needed.
Tracing information about the product facilitates tracking the physical movement of a product between its original source through intermediate sources to its final recipient and tracking product from the final recipient back to its source. WaterWater used in post-harvest operations may contaminate leafy greens if water containing human pathogens contacts edible portions of leafy greens. Re-Use of Field ContainersRe-use of field containers (such as bins or totes) provides the potential for product cross contamination if they are not stored, transported and re-used in a sanitary manner. Condition and Cleaning and Sanitation of Transportation VehiclesWhole and fresh-cut leafy greens may be transported to the cooling and cold storage facilities by numerous modes of transportation.
Employee HygieneLeafy greens are rarely handled by employees in cooling and cold storage facilities.
However, it is possible that persons working with produce in a cooler or cold storage facility may transfer microorganisms of significant public health concern.
Documentation and RecordsAs a general practice, it is important that firms involved in postharvest operations relating to leafy greens maintain documentation and records related to operational information about the product and practices, as well as tracing information about the product.
Tracing information about the product facilitates tracking the physical movement of a product from its original source through intermediate sources to its final recipient and tracking product from the final recipient back to its source. The CGMP regulations include both binding requirements and non-binding recommendations relating to personnel, buildings and facilities, equipment, and production and process controls.
The practices provided in this guidance, including those applicable to fresh-cut processors, are recommendations that complement, but do not supersede, the requirements and recommendations in part 110.A.



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