Final review note.docx

- creates a snapshot of the collective knowledge and consensus of team around a problem - focuses the team on causes, not symptoms Brainstorming -creating bigger and better ideas why use it? - to establish a common method for a team to creatively and efficiently generate a high volume of ideas on any topic by creating a process that is free of criticism and judgement. what does it do? - encourages open thinking when a team is stuck in “same old way” thinking - gets all team members involved and enthusiastic so that a few people don’t dominate the whole group - allow team members to build on each other’s creativity while staying focused on their joint mission. Brainstorming methods: - structured - unstructured - visual brainstorming - analogies/ free word association Things a desicion masker should do: - Develop a Hypothesis to test - Define the goal - Gather relevant data - look at costs and consequences - define problem well - look at alternatives what does a manager need to solve problems under pressure? - stay calm - discuss problem - diplomacy - experience - don’t blame - be objective - use science - good problem analysis skills - systematic DATA AND CHECKLISTS 7 tools of quality - flowcharts - cause and effective diagram - control charts - scatter diagram - check sheets - histogram - pareto diagrams data collection why do we collect data? - actions can be taken on a lot or process on the basis of data gained from the samples. reasons for collecting data - to identify and solve problems that cause inferior products - to monitor and modify processes most of problems are made up of smaller problems, each with several causes data collection can also be used to monitor and modify processes

HISTOGRAM Histograms - It is a graphical way of summarizing data from a process that has been collected over a period of time - It presents the data’s frequency distribution in bar form - Ideally use over 100 data items (50 ok)

a) Centered and well within customer limits. Action : Maintain present state. b) No margin for error. Action : Reduce variation. c) Process running low. Defective product/service Action : Bring average closer to target d) Process too variable. Defective products/services. Action : Reduce variation. e) Process off center and too variable. Defective product/service. Action : Center better and reduce variation What is the difference between a bar chart and a histogram? - Bar charts are used to compare variables. It is a plot of categorical data. - Histogram plot quantitative data with ranges of the data grouped into bins or interval. It shows the distribution of variables.

Systematic: 1. Identifies potential food safety hazards 2. determines the key steps in their operation where the hazards can be prevented, eliminated or reduced to an acceptable level. (These key steps are known as Critical Control Points or CCPs) The 7 Prerequisite Programs - The Foundation of the HACCP Plan 1. Premises (& water) 2. Transportation, receiving & Storage 3. Equipment 4. Personnel 5. Sanitation & Pest Control 6. Recall 7. Operational Prerequisite Programs. Good Manufacturing Practices (GMPs) ● Preventative measures to ensure food safety ● Based on practical experience over a long period of time ● The foundation on which to build HACCP program Standard Operating Procedures (SOPs) ● Say what you do ● Do what you say ● Prove it e.g. Task : How often Who does it How to do it Was it done correctly? Prerequisite Program (steps and procedures) ● universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food. ● Effective Prerequisite Programs: ○ Simplify HACCP Plan ○ Ensure integrity of HACCP plan ○ Ensure safe food ● Processors that have effective prerequisite programs will have fewer Critical Control Points and tend to be more proactive rather than reactive in nature. The company is also likely to be more efficient and produce less products that are substandard in quality. Customers Expectation of Food -Tastes Good -Nutritious

Review Regularly ● A written sanitation program clearly states: ○ the chemicals used to clean the equipment ○ how these chemicals are measured ○ solution strength ○ water temperature ○ application method Recall Program ● Product coding ● Production records ● Distribution records ● Key personnel This Prerequisite Program will run if a recall is necessary. The Recall Plan should be regularly tested to ensure all affected product can be easily located. It is a good idea to set a difficult recall effectiveness test to adequately test the program. An easy problem will not give an adequate indication of problems with the Recall Plan. Two recommended recall tests are: 1. Find affected product if someone goes wrong on the product floor (easiest test) Something has gone wrong at a cook step, a bolt fell off a machine, or an allergen got into a product 2. Find affected product if there is something wrong with a supplier’s ingredient (harder test that potentially affects many days of production) A supplier has supplied you with an ingredient that contains a pathogen, or is contaminated with a toxic substance. Operational Prerequisite Programs ● approval of new or modified product formulations ● control of allergens for incoming materials ● control of cross-contamination of undeclared allergens ● accuracy of new or modified labels ● disoposal of obsolete 废弃的 materials ● control of: ○ food additives ○ nutrients (incl. vitamins, minerals, amino acids) ○ modified atmosphere packaging (incl. vacuum pack) ○ processing aids Priority Allergens ● peanuts ● tree nuts (named) ● sesame seeds ● milk ● sulphites ● egg ● fish, crustaceans and shellfish ● soy ● wheat ● additional priority allergens (effective August 2012) ○ mustard

Pathogen Survival Chemical C Contamination with Non-Food Chemicals Presence of Allergens Contamination with Toxins Physical P Hazardous Extraneous Material (HEM) Contamination Use hazaed descriptions and “due to” statements to describe food processing hazard Examples: 1. A tofu manufacturer inspects the soybeans that are received at the plant before using them to make tofu. Sometimes they find rocks and stones in the shipment that may be there due to poor harvesting practices at the farm Hazard: Physical Hazard; Hazardous Extraneous Material (rocks and stones) because of poor harvesting practices at the farm - The processor needs to inspect ingredients that have a history or problems; this is in addition to the inspection of the truck and condition of the shipment. - The processor must also have a policy of working with credible suppliers; it is not acceptable to purchase a substandard product because it is inexpensive. Hazard Because of Contamination due to ● poor harvesting practices at the farm ● contaminated packaging ● contamination during storage ● contamination during production or transportation ● poorly maintained premises Because of Temperature due to ● improper heat treatment ● time/ temperature abuse ● omitted 遗漏 heat treatment ● inadequate cooling Because of Incorrect Procedures due to ● residual cleaners or sanitizers ● faulty equipment setup ● damaged packaging ● equipment wear & tear ● unsanitary equipment ● improper employee hygiene and handling Because of Allergens due to ● incorrect label ● incorrect production sequence

● Is the Critical Limit adequate? 7. Establish Record Keeping Procedures (Step 12) ● Regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, records, documenting and monitoring of critical control points, critical limits, verification activities and handling of processing deviations. HACCP is only as good as the commitment of the personnel implementing and managing the program HACCP requires: ● The full commitment and involvement of management and the workforce. ● a multidisciplinary approach HACCP Decision Tree ● developed by Codex Alimentarius (1991) ● a systematic series of 4 questions ● designed to assess required CCP’s ● In HACCP Terminology: e.g. ○ Mycobacterium bovis identified as a potential biological hazard ○ Pasteurization as a critical control point ○ and critical limits were established to ensure reduction to acceptable levels Example of how to use Decision Tree: Pathogen survival because of incorrect pasteurization procedure 1. Can a Prerequisite Program be used to control this identified hazard? Not fully controlled by Personnel Training Program or Equipment program so continue with Decision tree. 2. Can the operator control the hazard by using a control measure? 71.6C for 16 seconds 3. Is hazard severe or is it possible for the hazard to get worse? incorrect pasteurization procedure may result in survival of pathogens 4. Will this process step eliminate or reduce the hazard? The Control Measure is to ensure the correct time and temperature of heat treatment 5. Will a subsequent process step eliminate or reduce the hazard? e.g. Pathogen growth because of incorrect formulation There is no furtherstep that will eliminate the hazard

RECALL Compare and contrast the types of product recovery A product recovery may be: - a recall - product withdrawal - stock recovery - correction. - recall: - the removal from sale of a product that violates the legislation and represents a health hazard to the consumer or user. - correction: - A car manufacturer does repair work on faulty breaks, or a few years ago Dell computers sent out a disk to all people who had purchased a computer as there was an error in the operating system for the computer. - stock recovery: - when the product hasn't left the control of the manufacturer. - For example, the QC department determines that all of yesterday's production is packaged underweight. It is not a health hazard but they don't want to sell underweight product to their consumers. The product is still in their warehouse so they just put it on hold. - product withdrawal: - when the product doesn't violate 违反 legislation 立法；法律 but might be out in the store . - For example, the product is approaching its code date. The company pulls it from the store and returns it to the factory.

what is a food safety recall? - An effective method of retrieving 恢复；取回；补偿 products that may represent a health hazard to the consumer - An action taken by a manufacturer, distributor, or importer to protect the public health . - An action taken in conjunction 结合 with regulatory agencies , with wide exposure to public view - voluntary 自愿的 , 自发的 Identify the 3 classes of recall and give example of each type Recall classification Class I: - Reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death. - The most serious class of recalls where use of products may result in serious health repercussions and/or death. Class II: - Use of or exposure to violative product will cause temporary adverse health effects or where the probability of serious adverse health consequences is remote 遥远的 . - Use of product may result in temporary health repercussions or where severity of health repercussions is rare Class III: - A situation in which the use of or exposure to a violative product is not likely to cause any adverse health consequences. - Use of product not likely to cause severe health repercussions. Class I → Severity of Hazard Class II → Risk to population Class III → Action taken to control the situation Describe role of CFIA in recall action Responsibilities of Health Canada - Establishing policies and standards relating to the safety and nutritional quality of food sold in Canada - for assessing the effectiveness of the Agency’s activities related to food safety Responsibilities of CFIA: - Administer and enforce all Agriculture Canada legislation related to food inspection, agricultural inputs and animal and plant health - Enforce 实施，执行；强迫 provisions 规定；条款 of the Food and Drugs Act and Consumer Packaging and Labelling Act as they relate to food How will CFIA help during a recall? - They will provide scientific, technical and operational advice - They will not carry out the recall for you - risk assessment “ Both parties had different interpretations of when the Agency should request Health Canada to conduct a health hazard evaluation --- Food Safety Assessment Public Warning:

- done only for Class 1 or 2 recalls. - done only when other means 手段；方法 appear inadequate 不充分的，不适当的 . - done only when decided by CFIA. Outline information required by CFIA Traceability - Product name, size and brand - Product code - Quantity produced - Quantity in possession 拥有；财产；领地 - Quantity in distribution - Distribution area - Reason for recall Product Coding Requirements -Traceability - code / lot numbers are permanent and legible 清晰的；易读的 (Best Before Date) - establishes day, month and year food produced - interpretation 解释；翻译；演出 of the codes are available when required. Distribution records: - customer names, addresses, telephone numbers. - production records - total produced - current and distributed inventory records - traceability down to a particular code or lot number required. List members of recall team The recall team: - Responsible for advance preparation, making the decision to recall a product and conducting the recall - Have back-up person for each function - Recall members include: - Recall Coordinator - Technical staff - Production/ Supply chain - Distribution - Sales/ Marketing - Purchasing - Finance - Legal/ Public Relations - Consumer Services A written recall procedure: - identifies the recall coordinator(s). - spells out functions and responsibilities of personnel. - defines methods to identify, locate and control recalled product. - investigates other potential affected products. - monitors effectiveness of recall. Recall guidlines: - prepare and maintain a detailed written recall system - identify personnel (internal and external) involved in a recall - spell out functions and responsibilities of personnel - define channels and means of communication - use sufficient coding of products to permit positive lot identification

- maintain product distribution records as necessary - keep records for a time that exceeds shelf life and expected use of product Communicating: - have a prepared communications plan. - designated spokesperson only speaks to media. - don’t try to hide anything or deceive media. - cooperate with regulatory authorities. - time to sort out 挑选出；分类 blame at a later date. food allergens - An Allergen is a component of food that can cause an adverse reaction in sensitive individuals. - An adverse reaction can be serious and sometimes fatal - The most common cause of adverse reactions is: undeclared ingredients - e.g. Peanuts, Tree nuts (named), Sesame seeds, Milk, Egg, Fish, crustaceans and shellfish (named), Soy, Wheat (gluten sources), Sulphite, Mustard How does undeclared ingredient get into a food product? - Carry-over of product through incomplete cleaning of food contact surfaces and utensils, sometimes because of poor equipment design - Inappropriate use of rework containing allergenic ingredients - Ingredient changes , substitutions or additions not reflected on the label - Incorrect labels put onto products - Incorrect or incomplete list of ingredients - Unknown ingredients in raw materials - Misrepresentation of common names to describe products/ingredients - Labelling exemptions 免除 under the Food and Drug Regulations operational prerequisite 先决条件 program Control of new or modified product formulations - Control and identification of allergens for incoming ingredients - Control of finished product labels - Control of manufacturing activities - formulation control, use of rework and disposal of obsolete materials. - Activities used at the facility to control cross-contamination of undeclared allergens in the food products. Methods to control allergen cross contamination - production scheduling - traffic patterns of employees - the traffic flow and handling of ingredients containing allergens during receiving, storage, processing and packaging; - dedicated or segregated storage of ingredients containing allergens; - the identification and sanitation of bulk containers housing allergens or ingredients containing allergens; dedicated utensils, equipment and areas used to handle allergens; - the handling and storage of rework product(s) - cleaning of equipment/food contact surfaces/areas during operations if dedicated lines/equipment/areas for allergens are not available Allergen control program → operational prerequisite program - G.1 Allergens, Nutrients, Food Additives and Processing Aids - G.1.1 Allergen Control Program - G.1.2 Food Additives and Nutrients - G.1.3 Food Processing Aids Describe action steps of the recall plan Emergency Responce steps - Emergency Identification - Risk assessment - Done by CFIA (when guidlines exist)

- HEE (health hazard evaluation) requested from HC (when no guidline exist) - Classification of Recall (Class I, II, III) - Emergency Management: - public anouncement - recall of the product - effectiveness check - post-emergency review Cost of a product recall - insurance coverage may cover all expenses in the case of the manufacturer or for 3rd party liabilities 责 任债务 - $ replace - refund - repair - communication - shipping - hiring extra personnel - overtime to curent employees - warehouse/ storage space - investigation costs - logistics costs - disposal costs - lost profits - damaged brand reputation

Discuss reasons for performing a mock recall as part of the recall prerequiste program ● In the unfortunate event of a recall, an organization must react immediately by following the best practices of recall management ; ● it must have an established plan so that there is no question about the course of action and who must be involved in each step. ● Conducting a mock recall is one way to ensure that all processes are still effective ● ● Mock Recalls: ○ 2 per year is good practice ○ Supplier Problem ○ Problem at Facility List the 7 Prerequisite Programs -premise -transportation, receiving, and storage -equipment -sanitation -personnel -recall -operational prerequisite program Describe the elements in each Prerequisite Program Describe how Prerequisite Programs are used to cont rol identified hazards Compare and contrast Prerequisite Programs and Good Manufacturing Practices Define Hazard List three types of hazards in food production Use hazard descriptions and “due to” statements to describe food processing hazards State the 7 principles of HACCP and explain their r ole as the 12 steps of implementation Prepare Basic Product Information (Complete Forms 1 -4) Transfer input materials and process steps to Form s 5,6 and 7 (Hazard Analysis) Complete Forms 5,6,7 Justify Hazard Analysis Justify Critical Control Point determination Develop Critical Limit for a CCP Demonstrate how an d appropriate hazard analysis can reduce the risk o f a food safety hazard Support the CCP (critical control point) selection in a food process Establish Monitoring, Deviation and Verification pr ocedures for each CCP

Establish record keeping for HACCP Plan Justify the HACCP Plan (CFIA form #10) for a food p rocess Prepare a Standard Operating Procedure Compare and contrast the types of Product Recovery Identify the 3 classes of Recall and give example o f each type Describe role of CFIA in recall action Outline information required by CFIA List members of Recall team Describe action steps of the Recall plan Discuss reasons for performing a mock recall as part of the Recall Prerequisite Program