Food quality final

Process Control

A. In statistical control and capable of producing within control limits. B. In statistical control but not capable of producing within control limits. C. Out of control. Process control deals with frequency, lower and upper limit control and size (weight, length speed, etc.).

Disclosure for small manu.

Sales from 2.5 mil to 10 mil telephone or website for disclosure. For small or very small packages, Shortened statements for eletronic or digital, text message and phone number disclosures. Very small packages may use existing URL or Phone number.

Steps in creating control charts

1. Takes amples from the population and compute the appropriate sample statistic. 2. use the sample statistic to calculate control limits and draw the control chart 3. Plot sample results on the control chart and determine the state of the process ( in or out) 4. Investigate possible assignable causes and take any indicated actions 5. Continue sampling from the process and reset the control limits when necessary.

Retail quality audit objectives

1. To determine the quality of the company's product available to the consumer 2. To compare the results to the limits of the company's quality control spec. 3. Compare the quality of the company's product the the quality of competitive brands 4. Compare the quality of the company's product to that of the same productin previous years. 5. Compare the quality of the product, as manufactured by the company's different plants.

Bioengineered Foods

A food that contains detectable genetic material that has been modified through in Vitro recombinant deoxyribonucleic acid (rDNA) techniques. Food in which the modified genetic material is not detected are not bioengineered foods.

AQL and LTPD

Acceptable quality level- Poorest level of quality we are willing to accept Lot tolerance percent defective- Quality level we consider bad, consumer does not want to accept lots with more defects than LTPD

Water corrective action

Additional flexibility including the following: Allowing time for microbes to die off by using time intervals. Between last irrigation and harvest no more then 4 consecutive days. Allowing time for microbes to die off between harvest and end of storage or to be removed during marketing activities (washing). Treating the water (CA)

List of Bioengineered Foods

Alfalfa Apple (artic avoids oxidation and hard to bruise) Canola Corn Cotton (largest) Eggplant(BARI Bt Begun varieties) Papaya (ringspot virus) Pineapple(pink flesh) Potato Salmon (aquadvantage) Soybeans Squash Sugar beets

Natural Variations SPC

Also called common causes. Affect virtually all production processes Expected amount of variation. Output measures follow a probability distriction. For any distribution there is a measure of central tendency and dispersion. If the distribution of outputs falls within acceptable limits, the process is said to be "in control".

Assignable Variations SPC

Also called special causes of variation- Generally this is some change in the process. Variations that can be traced to a specific reason. The objective is to discover when assignable causes are present- Used to eliminate the bad causes, incorporate the good causes.

Objectives of Process Control

An effective program of process contorl aims to: Manufacture a product that consistently meets specifications. Ensure that only acceptable products are released from each step of the overall process. Favors improved Stability. Reduce variability in the processing steps in the final prodcut.

Disclosure options for small food manu.

Any of the four disclosures are available. Using the phone number or visit a url for more food info is acceptable.

Reasons for conducting Manufacturing Audits PC

Assuring that the proceudres reflect acutal practices. Uncovering inaccuracies so that they can be quickly corrected. Determining conssitency of a process (person to person day to day). Demonstrating a proactive approach to process improvement. Encouraging ongoing corrective action.

Maintaining Manufacturing Control

Best to divide processes into the unit operations invovled. Unit operations approach allows control of each factor that plays a role in each step.

Soil amendments- Raw manure

Currently FDA doesn't object to farmers complying with the NOP standard to raw manure. 120 day interval between the application of manure for crops in contact with soil. 90 day interval for between the application of manure for crops in contact with the soil. FDA considers the adoption of these standards prudent wile the risk assessment is conducted.

Untreated ground water

Considered a low risk. Min of 4 samples per source. Samples taken close to harvest. Collected over a period of 1 year. Used to calculate both the GM and STV. GM and STV used to determine if water source meets the required microbial standards. Annual survery min. 1 sample per source. Annual values used to update calculations of GM and STV. New samples plus 3 most recent from previous years creates 4 samples. Results of the 4 samples confirm the GM and STV are in AL. Used for processing, required testing of 4 samples per year for initial assessment. Farms must make a determination as to the use of this water based on results. If no detectable lvls are in annual sample 1 per year then it is adequate. If detection occurs, farm must return to 4 sample per growing season test cycle.

Untreated surface water

Considered high risk water. Initial survey uses a min. of 20 samples per source. Samples to be taken as close to harvest as is practical Samples to be collected over a period of 2-4 years. Survery findings are used to calculate both the GM and STV GM and STV used to determine the water quality Profile (WQP) used to determine if the water source meets the required microbial standards. After initial survery an annual survery of min of 5 samples per source is required. Annual values used to update calculations of GM and STV. 5 new samples plus 15 most recent from previous years creates a rolling dataset of 20 samples. Results of the 20 samples confirm the GM and STV are still in acceptable limits.

Control Charts

Constructed from historical data, the purpose of control charts is to help distinguish between natural variations and avariations due to assignable causes.

Process Control Programs

Controls of the quality of raw material, Manufacturing equipment, Processes and procedures, Personnel qualification, Associated supplies, Utilities, Environment.

PC documentation

Critical for the execution of process control program. Developed specifically for each process. Flow diagrams helpful for understanding process- Diagram should identify the operation to be performed, the sequence, facilities and processing equipment to be used and process conditions. Documentation should include- Instructions and procedures to be followed during prodcution. Procedures for process monitoring and inspection Characterisitics to be measured Procedures for measurement Procedures for sampling,identification of samples and analysis data obtained from the measurements.

Traceability Lot Code

Defined as a desciptor, often alphanumeric used to uniquely identify a traceability lot within the records of the firm that assigned the lot code.

Unit Operations of PC

Definition: Operation of a piece of equipment or equipment systme that accomplishes some specified function on the product being processed and typically labeled by the function it accomplishes. Examples: Batching, heating, cooling, blending, pasteurization, sterilzation, freezing, evaporation, dehydration, fermentation, extraction, distilling, seperation, packaging.

RQA product sampling/ Departments involved

Departments involved- Marketing and Sales, Processing operations, Product development, Sensory evaluation, Packaging, Quality Assurance. Product sampling- Any sampling characteristics that we appropriate, a list of competition brands that should be included for comparison, Cities where both company's and competitive products should be purchased, any other aspect that me be of interest (container size), Should proportionally reflect actual production (plant and container size)

Elements of PC

Employee training, Documentation and Processing.

Recordkeeping

Everyone subject to mandatory BE food disclosure is required to keep sufficient reconrds to establish compliance with the standard. Must keep customary or reasonable records that would be generated in the normal course of business- no new records or forms required. Regulated entities may determine which records to maintain, provided they are suffcient to demonstrate compliance. Records can be hard copy or electronic Can be stored at any business location Possible records- Invoices, bills of lading,inventory records, supply chain, country of origin, process verification, organic certifications, laboratory test results. Records must be maintained for 2 years after food is sold or distributed for retail sale. Some records like verifying a certain manu. process or testing may be held for longer. When requested by USDA records need to be produced within 5 business days, unless granted a extension. On-site access is necessary, USDA wull provide notice at least three business day in advance.

Agricultural water

Final rule establishes two sets of criteria for microbial contamination. Both based on the presense of generic e-coli Generic e-coli is an indicator/marker for the presnese of fecal contamination in water.

Mandatory Preventive control

Food facilities are required to: Implement a written hazard analysis and Risk-based Preventative Controls Plan (HARPC) Evaluation of hazards that could affect food safety. Specifying steps and controls that will minimize or prevent hazards. Specify how the facility will monity these controls and ensure their efficacy. Specify what actions will be take to correct problems.

Control Charts for Attributes

For variables that are categorical (acceptable/unacceptable, good/bad). Measurement is typically counting defectives Charts may measure- Percent defective (p-chart) Number of defects (c-chart)

Control charts for Variables

For variables that have continuous dimensions (weight, speed, length, strength). X-charts are to control the central tendency of the process. R-charts are to control the dispersion of the process These two charts must be used together.

Acceptance Sampling

Form of quality testing used for incoming materials or finished goods.: Take samples at random from a lot (shipment) of items Inspect each of the items in the sample. Decide whether to reject the whole lot based on the inspection results. Only screens lots; does not drive quality improvement efforts.

Worker training health and hygiene

GAP principles for training, health and hygiene are contained in final rule. Proper hand washing. Sick and ill or injured personnel Training of farm personnel on health and hygiene and its impact on farm food safety. Workers and supervisors are required to have a combination of training, education and experience.

Recall Plan

If hazards analysis identifies a hazard requiring a preventative control the facility must have: Written recall plan that describes the procedures to preform a recall of a product. Recall plan: Procedures for notifying consignees. Procedures for notifying the public if necessary. Procedures to conduct effectiveness checks. Procedures to appropriately dispose of recalled products.

Food Supply control improvements

Improvement to preventtion measures. Changes to inspection and compliance standards FDA response to contaminanats and violations Expanded FDA authority on imported goods.

Labeling Disclosure Options

Information Panel adjacent to the manufacturer/distributor information. Principal display panel. If there is insuffcient space on either the info. panel or the principal display panel, then disclosure may be made on any other panel likely to be seen by a consumer under ordinary shopping conditions.

Product pick-up and testing (Analytical testing)

Instructions are given to personnel for- Cities to pick up in, Types of prodcuts and brands requested, stores to be visisted , number of sample codes per store per city, number of containers per sample per city, number of containers per size per sample and per city. Auditor should keep records of instructions and document samples collected. As samples arrive at testing location, each should have a receipt log listing: Sample number, city of origin, product lot codes, number of samples received from each location, date of receipt, condition of the cases containing the samples, condition of the samples. Testing- Package quality- Primary, Secondary and Tertiary packaging examined. Sensory evaluation- Necessary to compare to a reference product (product with optimum quality characteristics) One reference sample for five to six audit samples Trained panelists rate samples on numerical scale. Analytical testing- Instumental testing performed to compare to tolerable limits- Weight, Height, length, texture, water activity, pH, color, vacuum packaging, Degree Brix (sugar content determines alc percent), salt percent

Samples (Charts) (A-E)

It is used to measure the process, we take the samples and analyze the sample statistics following these steps. A. Samples of the product, say five boxes of cereal taken off the filling machine line, vary from each other in weight. B. After enough samples are taken from a stable process they form a pattern called a distribution. C. There are many types of distribution, including the normal (bell-shaped) distrubtuion, but distributions do differ in terms of central tendency (mean), standard deviation or variance, and shape. D. If only natural causes of variation are present, the output of a porcess forms a distribution that is atable over time and is predictable. E. If assignable causes are present, the process output is not stable over time and is not predicable.

Food Traceability

Records of critical tracking events are required. CTE'S include: Harvesting, Cooling, Initial packing Fist land-based receiver (person taking position of a food for the first time on land or directly from a fishing vessel). Shipping, Receiving, transformation.

Control limits

Look at slide shows for charts.

Central Limit Theorem

Regardless of the distribution of the population, the distrubition of sample means drawn from the population will tend to follow a normal curve. 1. The mean of the sampling distribution (x) will be the same as the population mean (u) x=u 2. The standard deviation of the sampling distribtution (Ox) will equal the population standard deviation (o) divided by the square root of the sample size (n). Ox= o/square root n.

Population and Sampling distributions

Mean of sample means= x. Three population distribtutions- Beta, Normal, Uniform.

Mandatory produce safety standards

Minimum standards for the safe production and harvesting of fruits and vegetables. Standards consider naturally occuring ones as well as ones introduced intentionally or unintentionally. Applies to water, soil, hygiene, packaging, temperature controls and animals in growing area.

Automated Inspection

Modern technology allow virtually 100 percent inspection at minimal costs. Not suitable for all situations.

Detectability

Modified genetic material is not detectable if: Records verify the foods is made from a non-bioengineered food Records verify that the food has been refined using a process validated to render the modified gentic material undetectable. Testing records for the specific food confirm the absence of detectable modified genetic material.

Electronic/ digital disclosure

Must include "scan here for more info" or similar language that reflects a change in tech. "scan anywhere on package for more info (information)". When accessed, the link must go to a info page that is the first to appear, include the BE disclosure in text or symbol form. Must not collect info about the consumer or their device. Must also have a phone number for more info. Must provide a BE food disclosure regardless of time of day May be a recorded message. When texting, text a word to a number for a BE info. Number must be a number including a short code that sends an immediate response to the consumer's mobile device.

Water for post harvest

No detectable levels of generic e-coli are allowed for certain uses of agricultural water. These include: Water used for washing hands during and after harvest. Used on food contact surfaces. Makes direct contact with produce. Used to make ice. Used for sprout irrigation.

Public water

No requirements to test agricultural water that is supplied by public water systems. Documentation is required to verify public water standards.

Disclosure Accessibility (On package text)

On package text Symbol Electronic or digital disclosure Text message "Bioengineered Food" "Contains a bioengineered food ingredient" or "Contains bioengineered food ingredients"

Food sold in bullk

Retailers are responsible for disclosure. Disclosure can be made using any of the four standard options. Disclosure must be placed on signage or other materials on or near the bulk food items.

Retail quality audit procedure

Part of the QA program (RQA) Preliminary planning review meeting (QA auditor should hold a meeting with interested department heads prior to audit) Protocol- Audit objectives, Sampling plan, Analytical tests to be preformed, sensory characterisitics to be analyzed, time schedules.

Education and Training of PC

Personnel capability to accurately implement process control is key. Trained on: Assigned process control activities- Principles and practices, engineering, statistical, analytical, instrumental or related procedures. Training plan should be formal and documentation kept for training records.

GMP

Previously non-binding provisions are now binding. Education and training for employees is now mandatory. Management is required to ensure that employees who manufacture process pack or hold food are qualified. Combination of education training and or experience Similar requirements to preventive controls Allergen cross-contract is now explicit in the reg.

produce exemptions

Produce that is used for personal consumption. Farms with an average annual value of produce sold during previous three year period of 25,000 or less. Produce that recieves commercial processing that reduces the presence of micro-organisms of public health significance. Farm sales less than 500,000 per year during previous 3 years. Farm still must need to meet requirements of documentation and labeling.

Producer and consumer risk

Producer risk (a)- Probability of rejecting a good lot. Probability of rejecting a lot when the fraction defective is at or above the AQL Consumer risk- Probability of accepting a bad lot. Probability of accepting a lot when fraction defective is below the LTPD

Retail Product quality audit

Product samples are collected at the point of purchase. It allows for evaluation of market conditions for product through consumers eyes Assists in identifying possible improvement opportunites in both quality and profitability Definition: Process of inspecting a sample that has previously been inspected and accepted by normal inspection methods, to determine the degree of compliance to established requirements and its quality performance at the retail level.

Supply chain requirements

Program is flexible and the rule mandates that a facility have a risk based supply chain program. Manufacturing processing facilities who rely on a customer to control hazards, do not need to have a supply-chain program for that hazard. Covered food facilities are respnsible for ensuring that these foods are reveived only from approved suppliers.

Steps in Planning PC

Select process to audit. Decide who will conduct the audit (with experience). Decide frequency. Record audit schedule (should be random and throughout an entire shift). Conduct audit. Document problems. Informed allaffected. Monitor corrective action results.

Operating Characteristic Curve

Shows how well a sampling plan discriminates between good and bad lots (shipments). Shows the relationship between the probability of accepting a lot and its quality level.

FSMA (Food Safety Modernization Act) Background

Signed into law in Jan. 4th 2011. Amends the federal food,drug and cosmetic act in respect to the safety of the food supply. FDA mandated to require comprehensive science based preventative controls in all food supply including human, animal and pet.

Disclosures for small packages

Small package (less than 40 sq. inch.) using a shortened version of required on package statments "Scan for info" "Text for info" or "Call for info". Very small (less than 12 sq inch.) If the label includes a preexisting uniform resource locator for a website to a telephone number that a consumer can use to get more food info. then the url or number may be used for the required disclosure.

Soil- Stabilized compost

Stabilized compost properly prepared using scientificially valid composting proactive can be applied. Compost must be applied in a manner that minimizes the potential for contact with covered produce after application.

Water testing

Testing frequency based on the type of water source. Untreated surface water or ground water. FDA requires an initial water survey based on the risk factors associated with the type of water

Process capability

The natural variation of a process should be small enough to produce products that meet the stands required. A process in statistical control does not necessariy meet the design specifications Process capability is a measure of the relationship between the natural variation of the process and the design specifications.

Managerial issues and control charts

Three major management decisions: Select points in the processes that need SPC(statical process control) Determine the appropriate charting technique Set clear policies and procedures.

Exemptions

Threshold: Allows each ingredients to contain up to 5 percent of a BE substance as long as it is inadvertent or technically unavoidable. Animals feed Food certified under national Organic Program

Types of Genetic modification methods

Traditional crop modification: Selective breeding: Oldest form of breeding. Purposefully holding back seeds of the largest and most productive plants and re planting the next growing season (this excludes all others from the breeding process). Allows for the desired properties of the plants to assert themselves overtime. Cross breeding: Choosing plant parents with particular characteristics and breeding together to produce offspring with more desirable attributes. Genetic engineering: Copying a gene with a desired trait in one organism and puttting it into another. Genome editing: Genome editing is a new method that gives scientists more precise and targeted ways to develop new crop varieties. It makes it easier and quicker to make changes that were previously done through traditional breeding.

In class notes

Transglutanminase- Enzyme that chemically binds meat together. FMIA- Federal meat inspection act PPIA- poultry prodcut inspection act EPIA- Egg prodcut inspection act If meat is number 1 or 2 on inquiry then it is not subject to standard Meat is number 3 or below it is subject to standard for bioengineered labeling Principal display panel- front of package Country of origin for recordkeeping (sugar or chocolate or wood need certification if being shipped into Mexico)

Voluntary Disclosure under the standard (Dervied from bioengineering)

Two types of voluntary disclosure: 1.Entities that are exempt 2. Foods that do not contain detectable modified genetic material but are derived from bioengineering Entities that are exempt: May voluntarily disclose using any of the available options. May include very small manu. restaurants, bars and food trucks. Foods that do not contain detectable modified genetic material but are derived from BE.- Only applies to highly refined ingredients in which BE is no longer detectable (corn syrup, soybean oil). Is not allowed for any other foods or ingredients ( animal feed BE food, soups where first ingredient is meat, incidental additives). Has to say "derived from bioengineering" or "ingredients derived from a bioengineering source"

R- Chart

Types of variables control chart Shows amples ranges over time Difference between smallest and largest values in sample Monitors process variability Independent from process mean.

Chart limits

Upper control limit=x+zox Lower control limit=x-zox x=means of the sample means or a target value set for the proces. z=number of normal standard deviations ox=standard deviation ofthe sample means= o/ square root of n. o=population standard deviation n= sample size X-chart control limits- UCL= x+a2R LCL= x-a2R r= average range of the samples A2=control chart factor x= mean of the sample means R-Charts: UCL-D4R LCL- D3R R= average range of the samples D3 and D4= control chart factors

Statistical Process Control

Variability is inherent in every process- Natural or common causes, special or assignable causes. Provides a statistical signal when assignable causes are present. Detect and eliminate assignable causes of variation.

Types of Data

Variables: Characteristics that can take any real value. May be in whole or in fractional numbers Continuous random variables. Attributes: Defect-related characterisitics Classify products as either good or bad or count defects. Categorical or discrete random variables.

water for produce

Water that is directly applied to growing produce (sprouts). Criteria are based on two values: Geometirc mean and the statistical threshold value. GM of sample is 126 or less CFU of Generic e-coli per 100 ml of water STV is 410 or less cfu per 100 ml of water. GM- It is the average. Represents the central tendency and quality of the water source STV- Reflects the amount of variability in water quality at each source. Takes into account adverse conditions. To simplify; it is level at which 90 percent of smaples taken are below the value.