Food Sampling & Analysis - III

Statutory and Regulatory Requirements

The central requirement of any regulations or codes which concern sampling, is that they include details of the steps to be taken to ensure that any sample procured is a “fair sample” that accurately reflects the constituents of the bulk material being sampled. The procedure by which a product or substance is sampled for enforcement purposes is of prime importance and must satisfy any statutory requirements. This is to ensure that the sample will constitute valid evidence in any subsequent court proceedings. Thus it is mandatory to follow all the statutory and regulatory requirements set by the specific food regulatory authority of the country concerned. There are various limitations and regulations are published for the public awareness of such matters which must be followed whenever you are taking samples for the propose of analysis to understand the safety or quality of the food concerned.  

The basic principles that must be addressed in sampling are as follows:

1. The sample should represent the food as sold to the consumer and each part of a divided sample should be truly representative of the original
2. Where divided, all parts of the sample must individually be representative of the food and of each other
3. The sampling process must not alter the sample in any way that might affect the analysis
4. Storage and transportation of the sample must not alter it in any significant way – whether through contamination, loss, deterioration or other means.
5. What follows is further practical guidance on food sampling to ensure that the results can be used to enforce the law in a sound manner.

 Reasons for Analyzing Foods

Foods are analyzed by scientists working in all of the major sectors of the food industry including food manufacturers, ingredient suppliers, analytical service laboratories, government laboratories, and University research laboratories.

In addition, food manufacturers and producers would need to satisfy themselves that any sample taken for analysis is sufficiently representative of the food for the analytical result to be meaningful. This is true whether the data are to be used as the basis of labeling declarations, assurance of compliance with legislative or other standards such as ISO 22000, monitoring of production as part of HACCP (Hazard Analysis and Critical Control Points), or for routine quality control.

Regulations and Guidelines

Codex Committee on Methods of Analysis and Sampling

The Codex Committee on Methods of Analysis and Sampling (CCMAS) defines criteria for Codex methods of analysis and sampling and coordinates the work of Codex with other international groups working in methods of analysis and sampling and quality assurance systems for laboratories.

CCMAS specifies reference methods of analysis and sampling for Codex Standards and considers and endorses methods of analysis and sampling proposed by Codex Committees, except those related to pesticide residues and veterinary drugs in food, the assessment of microbiological quality and safety in food and food additives. It also considers issues submitted to it by the Codex Alimentarius Commission and defines procedures, protocols and guidelines for quality assurance systems and assessment of proficiency for food laboratories.

Existing Codex Standards

Standards relating to methods of analysis and sampling that have been endorsed and adopted into the international food code include:

1. Recommended Methods of Analysis and Sampling
2. Methods of Analysis and Sampling for Fruit Juices and Related Products
3. Guidelines on Performance Criteria and Validation of Methods for Detection,Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods

Government Regulations and Recommendations

Any of the government regulations and recommendations are designed to maintain the general quality of the food supply, to ensure the food industry provides consumers with foods that are wholesome and safe, to inform consumers about the nutritional composition of foods so that they can make knowledgeable choices about their diet, to enable fair competition amongst food companies, and to eliminate economic fraud. There are a number of Government Departments Responsible for regulating the composition and quality of foods, i.e., in US, the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), the National Marine Fisheries Service (NMFS) and the Environmental Protection Agency (EPA). Each of these government agencies is responsible for regulating particular sectors of the food industry and publishes documents that contain detailed information about the regulations and recommendations pertaining to the foods produced within those sectors. It is common for most of the governments around the world.  These documents can be purchased from the government or obtained on-line from the appropriate website.

Permit Guidelines

A permit is required whenever a food facility is open for business. Any time food sampling occurs, it must be done in a permitted food facility such as a food establishment, mobile food preparation unit, mobile food facility or temporary food facility. Any food preparation of the samples must be done in a permitted food facility that has been permitted to allow the type of food preparation proposed. For example, a food establishment, which is permitted to sell prepackaged food only, may not offer samples that require food preparation.

Sampling may occur from a mobile food facility only if the foods being sampled are allowed to be sold from a mobile food facility and the food meets the requisite packaging requirements. It is better to contact the local enforcement agency for specific information on the types of foods that may be sampled from a mobile food facility. Sampling from a mobile food preparation unit or temporary food facility may occur if the samples are prepared and kept within the structural confines of the facility or are properly prepackaged, held at appropriate temperatures and are supervised. The enforcement agency may issue a permit to the retail food sample employee or company as necessary to assure that the food is prepared in a pure, safe and unadulterated manner.

Structural Guidelines

A large amount of food sampling is done by people who are not employed by the retail food establishment. Instead, they are employees of a company that is contracted by the manufacturer of the product or food establishment to conduct sampling at various retail outlets. Since these employees are not employees of the food establishment, a written agreement must be provided between the food establishment and the sampling company. The written agreement must indicate that the employees of the sampling company will have available for their use the sanitary facilities of the food establishment to properly wash, rinse and sanitize the equipment they are using, wash their hands as needed and generally clean up the area where the sampling took place. The agreement must be kept by the food sampling employee to be provided to the enforcement agency upon request. The local enforcement agency may require a separate utensil washing/prep area if there is a significant amount of sampling by non-food establishment workers within the food establishment.

Standards

Government agencies have specified a number of voluntary and mandatory standards concerning the composition, quality, inspection, and labeling of specific food products.

Mandatory Standards

Standards of Identity – These regulations specify the type and amounts of ingredients that certain foods must contain if they are to be called by a particular name on the food label. For some foods there is a maximum or minimum concentration of a certain component that they must contain, e.g.,  peanut butter must be less than 55% fat, ice-cream must be greater than 10% milk fat, cheddar cheese must be greater than 50% milk fat and less than 39% moisture.

Standards of Quality – Standards of quality have been defined for certain foods (e.g., canned fruits and vegetables) to set minimum requirements on the color, tenderness, mass and freedom from defects. e.g., Standards of Fill-of-Container; These standards state how full a container must be to avoid consumer deception, as well as specifying how the degree of fill is measured.

Voluntary Standards

Standards of Grade – A number of foods, including meat, dairy products and eggs, are graded according to their quality, e.g. from standard to excellent. For example meats can be graded as prime, choice, select, standard etc according to their origin, tenderness, juiciness, flavor and appearance. There are clear definitions associated with these descriptors that products must conform to before they can be given the appropriate label. Specification of the grade of a food product on the label is voluntary, but many food manufacturers opt to do this because superior grade products can be sold for a higher price. The government has laboratories that food producers send their products too to be tested to receive the appropriate certification. This service is requested and paid for by the food producer.

On the other hand, there are number of standards such as ISO 22000, FSSC 22000, BRC, ISO 9001, IFS, etc., which are requesting confirmation and validation of the implemented standard where you have to carry out initial raw material quality and microbial testing as well as for the end products sampling. These tests are carried out to ensure that the implemented standard is operating up to date and no hazards are transferred to end products.

Food Sampling & Analysis - II

Food Sampling Methods 

With a single grain of rice, an Asian housewife tests if all the rice in the pot has boiled; from a cup of tea, a tea-taster determines the quality of the brand of tea; and a sample of moon rocks provides scientists with information on the origin of the moon. This process of testing some data based on a small sample is called sampling. “Sampling is the process by which inference is made to the whole by examining a part”. In general terms, Food Sampling is a scientific method used to confirm the safety and wholesomeness of food. As such it is a useful support tool for officers inspecting food businesses and to food law enforcement generally.

Samples are basically submitted for two different types of tests: - 

Microbiological examination to determine both the general level of microbes and the presence of specific pathogens (e.g. Salmonella, E.coli O157)

Analysis for non-microbiological contamination (e.g. glass pieces in manufactured beverages)

In addition to sampling food, other techniques are available that assist in determining food safety, e.g. swab testing of equipment and work surfaces.   

Sampling Priorities

The focus of food sampling activity mostly based on:

The investigation of food contamination and food poisoning incidents 

Complaints concerning the sale or supply of contaminated foodstuffs 

National and European (EU) coordinated sampling programmes 

Locally manufactured products; local events and initiatives 

Local high risk premises (EU approved or licensed food producers) 

However, there has to be sufficient flexibility to allow for emergency responses or where other particular issues of concern arise. 

Methods of Sampling

It can be seen that there is a dichotomy - probability and non probability sampling methods. Two major principles underlie all sample design: the desire to avoid bias in the selection procedure and to achieve the maximum precision for a given outlay of resources. Sampling bias arises when selection is consciously or unconsciously influenced by human choice, the sampling frame inadequately covers the target population or some sections of the population cannot be found or refuse to co-operate.

Random, or probability sampling, gives each member of the target population a known and equal probability of selection. Systematic sampling is a modification of random sampling. To arrive at a systematic sample we simply calculate the desired sampling fraction and take every nth case. Stratification increases precision without increasing sample size. There is no departure from the principles of randomness. It merely denotes that before any selection takes place, the population is divided into a number of strata, then a random sample is taken within each stratum. It is only possible to stratify if the distribution of the population with respect to a particular factor is known, and if it is also known to which stratum each member of the population belongs. Random stratified sampling is more precise and more convenient than simple random sampling.

Random Sampling

Random, or probability sampling, gives each member of the target population a known and equal probability of selection. 
The two basic procedures are:
The lottery method, e.g. picking numbers out of a hat or bag
The use of a table of random numbers

Systematic Sampling

Systematic sampling is a modification of random sampling. To arrive at a systematic sample we simply calculate the desired sampling fraction, e.g. if there are 100 distributors of a particular product in which we are interested and our budget allows us to sample say 20 of them then we divide 100 by 20 and get the sampling fraction 5. Thereafter we go through our sampling frame selecting every 5th distributor. In the purest sense this does not give rise to a true random sample since some systematic arrangement is used in listing and not every distributor has a chance of being selected once the sampling fraction is calculated. However, all but the most pedantic of practitioners would treat a systematic sample as though it were a true random sample, because there is no conscious control of precisely which distributors are selected.

Stratified Samples

Stratification increases precision without increasing sample size. Stratification does not imply any departure from the principles of randomness it merely denotes that before any selection takes place, the population is divided into a number of strata, then random samples taken within each stratum. It is only possible to do this if the distribution of the population with respect to a particular factor is known, and if it is also known to which stratum each member of the population belongs. Examples of characteristics which could be used in marketing to stratify a population include: income, age, sex, race, geographical region, possession of a particular commodity.

Stratification can occur after selection of individuals, e.g. if one wanted to stratify a sample of individuals in a town by age, one could easily get figures of the age distribution, but if there is no general population list showing the age distribution, prior stratification would not be possible. What might have to be done in this case at the analysis stage is to correct proportional representation. Weighting can easily destroy the assumptions one is able to make when interpreting data gathered from a random sample and so stratification prior to selection is advisable. Random stratified sampling is more precise and more convenient than simple random sampling.

When stratified sampling designs are to be employed, there are 3 key questions which have to be immediately addressed:

The bases of stratification, i.e. what characteristics should be used to subdivide the universe/population into strata?

The number of strata, i.e. how many strata should be constructed and what stratum boundaries should be used?

Sample sizes within strata, i.e. how many observations should be taken in each stratum?

Bases of Stratification

Intuitively, it seems clear that the best basis would be the frequency distribution of the principal variable being studied. For example, in a study of coffee consumption we may believe that behavioural patterns will vary according to whether a particular respondent drinks a lot of coffee, only a moderate amount of coffee or drinks coffee very occasionally. Thus we may consider that to stratify according to "heavy users", "moderate users" and "light users" would provide an optimum stratification.

In general, it is desirable to make up strata in such a way that the sampling units within strata are as similar as possible. In this way a relatively limited sample within each stratum will provide a generally precise estimate of the mean of that stratum. Similarly it is important to maximize differences in stratum means for the key survey variables of interest. This is desirable since stratification has the effect of removing differences between stratum means from the sampling error.

Number of Strata

The next question is that of the number of strata and the construction of stratum boundaries. As regards number of strata, as many as possible should be used. If each stratum could be made as homogeneous as possible, its mean could be estimated with high reliability and, in turn, the population mean could be estimated with high precision. However, some practical problems limit the desirability of a large number of strata:

No stratification scheme will completely "explain" the variability among a set of observations. Past a certain point, the "residual" or "unexplained" variation will dominate, and little improvement will be effected by creating more strata.

Depending on the costs of stratification, a point may be reached quickly where creation of additional strata is economically unproductive.

If a single overall estimate is to be made (e.g. the average per capita consumption of coffee) we would normally use no more than about 6 strata. If estimates are required for population subgroups (e.g. by region and/or age group), then more strata may be justified.

Quota Sampling

Quota sampling is a method of stratified sampling in which the selection within strata is non-random. Therefore, it is not possible to estimate sampling errors. A quota interview on average costs only half or a third as much as a random interview, the labour of random selection is avoided, and so are the headaches off non-contact and call-backs, and if fieldwork has to be quick, perhaps to reduce memory errors, quota sampling may be the only possibility. Quota sampling is independent of the existence of sampling frames.

Cluster Sampling

The process of sampling complete groups or units is called cluster sampling, situations where there is any sub-sampling within the clusters chosen at the first stage are covered by the term multistage sampling. For example, suppose that a survey is to be done in a large town and that the unit of inquiry (i.e. the unit from which data are to be gathered) is the individual household.

A large number of small clusters is better, all other things being equal, than a small number of large clusters. Whether single stage cluster sampling proves to be as statistically efficient as a simple random sampling depends upon the degree of homogeneity within clusters. If respondents within clusters are homogeneous with respect to such things as income, socio-economic class etc., they do not fully represent the population and will, therefore, provide larger standard errors. On the other hand, the lower cost of cluster sampling often outweighs the disadvantages of statistical inefficiency. In short, cluster sampling tends to offer greater reliability for a given cost rather than greater reliability for a given sample size.

Multistage Sampling

The population is regarded as being composed of a number of first stage or primary sampling units (PSU's) each of them being made up of a number of second stage units in each selected PSU and so the procedure continues down to the final sampling unit, with the sampling ideally being random at each stage. The necessity of multistage sampling is easily established. PSU's for national surveys are often administrative districts, urban districts or parliamentary constituencies. Within the selected PSU one may go direct to the final sampling units, such as individuals, households or addresses, in which case we have a two-stage sample. It would be more usual to introduce intermediate sampling stages, i.e. administrative districts are sub-divided into wards, then polling districts.

Area Sampling

Area sampling is basically multistage sampling in which maps, rather than lists or registers, serve as the sampling frame. This is the main method of sampling in developing countries where adequate population lists are rare. The area to be covered is divided into a number of smaller sub-areas from which a sample is selected at random within these areas; either a complete enumeration is taken or a further sub-sample.

Food Sampling & Analysis - I

Food Sampling and Analysis for End Product Testing 

Introduction

Food sampling is a process used to check that a food is safe and it does not contain harmful contaminants, or it contains only permitted additives at acceptable levels, or it contains the right levels of key ingredients and its label declarations are correct, or to know the levels of nutrients present. Food analysis is carried out by exposing the food product to a chemical analysis. Analysis may be undertaken by or on behalf of a manufacturer regarding their own product, or for official food law enforcement or control purposes, or for research or public information. To undertake any analysis, unless the whole amount of food to be considered is very small so that the food can be used for testing in its entirety, it is usually necessary for a portion of it to be taken (e.g. a small quantity from a full production batch, or a portion of what is on sale in a shop) – this process is known as food sampling.

In most cases, food to be analyzed are having two levels of sampling – the first being selection of a portion from the whole, which is then submitted to a laboratory for testing and the second being the laboratory’s taking of the individual amounts necessary for individual tests that may be applied. It is the former that is ‘food sampling’: the latter is analytical laboratory ‘sub-sampling’, often relying upon initial homogenization of the entire submitted sample. Where it is intended that the results of any analysis to relate to the food as a whole it is crucially important that the sample is representative of that whole – and the results of any analysis can only be meaningful if the sampling is undertaken effectively. This is true whether the ‘whole’ is a manufacturer’s entire production batch, or where it is a single item but too large to all be used for the test. Factors relevant in considering the representativeness of a sample include the homogeneity of the food, the relative sizes of the sample to be taken and the whole, the potential degree of variation of the parameter(s) in question through the whole, and the significance and intended use of the analytical result.

Food analysis is the discipline dealing with the development, application and study of analytical procedures for characterizing the properties of foods and their constituents. These analytical procedures are used to provide information about a wide variety of different characteristics of foods, including their composition, structure, physicochemical properties and sensory attributes. This information is critical to rational understanding of the factors that determine the properties of foods, as well as the ability to economically produce foods that are consistently safe, nutritious and desirable and for consumers to make informed choices about their diet. The objective is to review the basic principles of the analytical procedures commonly used to analyze foods and to discuss their application to specific food components, e.g. lipids, proteins, water, carbohydrates and minerals.

Sampling

The adequacy and condition of the sample or specimen received for examination are of primary importance. If samples are improperly collected and mishandled or are not representative of the sampled lot, the laboratory results will be meaningless. Because interpretations about a large consignment of food are based on a relatively small sample of the lot, established sampling procedures must be applied uniformly. A representative sample is essential when pathogens or toxins are sparsely distributed within the food or when disposal of a food shipment depends on the demonstrated bacterial content in relation to a legal standard. The number of units that comprise a representative sample from a designated lot of a food product must be statistically significant. The composition and nature of each lot affects the homogeneity and uniformity of the total sample mass. The proper statistical sampling procedure, according to whether the food is solid, semisolid, viscous, or liquid, must be determined by the collector at the time of sampling by considering the product is being sampled.

Whenever possible, submit samples to the laboratory in the original unopened containers. If products are in bulk or in containers too large for submission to the laboratory, transfer representative portions to sterile containers under aseptic conditions. There can be no compromise in the use of sterile sampling equipment and the use of aseptic technique. Sterilize one-piece stainless steel spoons, forceps, spatulas, and scissors in an autoclave or dry-heat oven. Use of a propane torch or dipping the instrument in alcohol and igniting is dangerous and may be inadequate for sterilizing equipment. Use containers that are clean, dry, leak-proof, wide-mouthed, sterile, and of a size suitable for samples of the product. Containers such as plastic jars or metal cans that are leak-proof may be hermetically sealed. Whenever possible, avoid glass containers, which may break and contaminate the food product. For dry materials, use sterile metal boxes, cans, bags, or packets with suitable closures. Sterile plastic bags (for dry, unfrozen materials only) or plastic bottles are useful containers for line samples. Take care not to overfill bags or permit puncture by wire closure. Identify each sample unit (defined later) with a properly marked strip of masking tape. Do not use a felt pen on plastic because the ink might penetrate the container. Whenever possible, obtain at least 100 g for each sample unit. Submit open and closed controls of sterile containers with the sample.

Deliver samples to the laboratory promptly with the original storage conditions maintained as nearly as possible. When collecting liquid samples, take an additional sample as a temperature control. Check the temperature of the control sample at the time of collection and on receipt at the laboratory. Make a record for all samples of the times and dates of collection and of arrival at the laboratory. Dry or canned foods that are not perishable and are collected at ambient temperatures need not be refrigerated. Transport frozen or refrigerated products in approved insulated containers of rigid construction so that they will arrive at the laboratory unchanged. Collect frozen samples in pre-chilled containers. Place containers in a freezer long enough to chill them thoroughly. Keep frozen samples solidly frozen at all times. Cool refrigerated samples, except shellfish and shell stock, in ice at 0-4°C and transport them in a sample chest with suitable refrigerant capable of maintaining the sample at 0-4°C until arrival at the laboratory. Do not freeze refrigerated products. Unless otherwise specified, refrigerated samples should not be analyzed more than 36 h after collection. Special conditions apply to the collection and storage of shucked, unfrozen shellfish and shell stock. Pack samples of shucked shellfish immediately in crushed ice (no temperature specified) until analyzed; keep shell stock above freezing but below 10C. Examine refrigerated shellfish and shell stock within 6 h of collection but in no case more than 24 h after collection.

ISO 22000: Traceability in Food Supply Chains/ Costs and Benefits of Traceability - VII

ISO 22000 & Food Traceability 
Part VII

Benefits of Traceability

Much of the current motivation in the food industry for implementing tracking and tracing systems is in response to current or anticipated regulation. If the only objective is to meet regulatory requirements traceability costs can appear to be a significant burden. However, traceability can also provide significant benefits that extend far beyond simply meeting regulatory requirements unlike other investments in process improvement. The key to achieving those benefits is first to identify them and then to develop a plan to achieve them. This means taking a different approach to traceability; from the planning stage right through to execution. Accurately assessing benefits is challenging because they tend to be harder to identify and individual benefits vary among different markets, products and processes. However, it is evident that, taking the high level systematic approach can help managers on potential new profit or cost saving opportunities.

After examining areas of potential value for traceability, it is observed that benefits fell into four key categories areas:

1. Regulatory Compliance;
2. Market and Customer Related;
3. Recall Risk and Scope Reduction;
4. Efficiency and Quality Improvement;

The process of assessing benefits begins with an area of mandatory regulation, where most managers are most familiar with. It then drills up searching for other market incentives, impacts on recalls and finally opportunities for improvements in efficiency and quality. The key to truly understanding the whole business case is to identify and enumerate the benefits at every level and compare the complete package of benefits to the cost of implementing the system. The different categories of benefits are discussed in more detail in the following sections.

Compliance of Regulatory Requirements

Many organizations agreed that, the significant motivator for adopting traceability is meeting regulations. Regulations or anticipated regulations are being spurred by factors ranging from Bovine Spongiform Encephalopathy (BSE) and Avian Influenza to the new bio-security regulations for food importation into the United States and new E.U. requirements for traceability. These regulatory requirements have predictably sensitized most food organizations to the need for more responsive and robust food traceability systems and processes. The predominant sentiment seems to be eventually traceability may be mandatory and it will simply cost the business and customers more money. When regulations are imposed, traceability becomes a market entry requirement; without it a firm cannot ship product into the regulated market. Managers can compare the value of being in regulated markets with alternative markets and measure the difference in revenue and contribution to gross margin or profits. If there are few unregulated market alternatives then traceability may be essential to the survival of the business. However, even in such cases, it is important to continue the business case analysis through the next levels of value assessment, since they identify benefits which will cover the costs of implementing traceability.

Addressing Customer & Market Needs

Even in markets without traceability regulations, traceability can still be a customer requirement. Customer requirements and the motivations behind those requirements can vary significantly. Retail organizations like Wal-Mart are imposing Radio Frequency Identification (RFID) systems on their suppliers in the search for process efficiencies and ultimately reduced cost. Other customers and markets require traceability as an assurance of product attributes, particularly for attributes which are not visible, often referred to as credence attributes. Credence attributes fall into two broad categories: content and process.

Non-visible content attributes are tracked because the products appear to be the same as others on the market, but their composition is different and the difference is important for customers.

Process attributes are tracked because products are produced using different processes and the process matters to selected customers. Organic food products are an excellent example where using traceability helps track process attributes. The premium value for organic products lies in the process by which they are produced. Traceability is needed to assure buyer and consumers that the products are actually produced under organic processes. Animal welfare and fair trade coffee are other examples of process attributes.

Genetically modified (GM) crops are examples of products differentiated on both content and process basis. Non-GM products can attract a premium if exported into selected markets. Traceability assures consumers that the products do not contain any GM crops. In the future, functional food products and GM crops that provide health benefits will be traced so that their full value may be realized. The benefit assessment for content or process attributes will include looking at current or future product sales volumes and margins and comparing them to the values for other market alternatives not requiring traceability.

Considering the benefits of traceability; i.e., one produce company which was able to claim a significantly higher price for its product because it could accurately and consistently identify the quadrant of land from which its product was harvested. The particular quadrant of land (due to environmental factors) and seed genetics produced a highly desirable group of attributes which lessened the need for blending at the processor level. The company used its ability to identify the product to attract export customers. This enabled the company to not only open itself to new markets, thus expanding its revenue potential, but to claim a higher price (margin) for its product. The interesting aspect in this one case was that traceability was initially designed so that the product would not run the risk of being rejected by regulatory requirements in the receiving country. The company turned a regulatory compliance issue into a market benefit, significantly raising the value it had assigned to traceability. It creatively used the ability to trace its product back to a specific plot of land as a competitive advantage to become identified as a high quality supplier.

Recall & Risk Management

Governments impose traceability on companies as a risk management tool to protect public health or animal health. However, traceability also acts as an effective means of reducing the risk exposure of firms. The most obvious benefit comes from the ability to accurately identify problem lots, their location and source, important factors during a recall situation. An effective traceability system can reduce the potential scope of a food recall, the volume of product which must be withdrawn in order to be sure to capture compromised product. In an examination of the food industry full traceability can cut the scope of the recall substantially, and can observe instances where the scope of recall could be lowered as much as ninety percent. Increasing recall speed and reducing product risks should decrease risk to consumers. This can ultimately decrease liability claims by consumers, a fact that can eventually be reflected in lower liability costs and lower insurance premiums.

A whole chain traceability system can reduce the time required to withdraw recalled product. In the case of a potentially hazardous product, this will ultimately reduce a firm’s exposure to liability claims by recalling product before it is sold to the public and possibly consumed. Traceability can affect recall frequency in two ways. First, accurately identifying only recall product and reducing the scope of individual recalls will reduce the number of locations and organizations experiencing the recall. For an example; where a recall included six retail locations under current levels of traceability when, in fact, the affected product actually only went to a single location. Under enhanced traceability the other retail locations would not have experienced that particular recall. Second, by maintaining accurate information on products it is possible to move older products more effectively through the chain and thereby reducing the risk of bacterial contamination. The benefit of improved risk management can be assessed by first considering the improvement in recall costs through reductions in frequency, scope and severity, and then considering the impacts on liability claim costs and potential reductions in insurance premiums.

Process Improvements – Efficiency and Quality

An enhanced traceability system is another tool that managers use to increase the efficiency and effectiveness of business processes, and thus improve the quality and cost of their products. Today, organizations appeared to have difficulty contemplating improvements in efficiency and quality by adding traceability, mainly mentally separate traceability from other supply chain related activities and do not view it as an integral component of their management systems. Few consider that being able to track and locate products accurately can reduce out of date product losses, identify problem processes or suppliers and improve logistics and warehouse operations. This is curious when one reflects on the value traceability brings to such diverse industries as pharmaceuticals, automotive, aerospace and electronics. The first step in identifying efficiency gains is to break business processes into a small number (ten or fewer) of key ones that can be analyzed in more detail. Once the key processes are identified you can ask the following questions.

1.      Do I have full control of the product lot and its identity through this process and am I able to maintain identity throughout the process?

2.      Could the tracking information be used to:

Adjust processes on a real-time basis to improve yield or quality?

Identify product approaching its due date so that it can be used or sold quickly?

Optimize inventory management to reduce overall inventory requirements?

Compare supplier performance, packaging or shipping alternatives and identify improvement opportunities?

Increase quality or efficiency in some other manner?

3.      How much would potential improvements contribute to the bottom line?

For example, one processor was able to identify potential yield improvements using the information from a traceability system to make process adjustments on a real-time basis. In order to accomplish this, a significant investment in new process equipment and changes to internal processes were required. In this case, the investment had an estimated payback of less than one year because of the increase in product yield and the ability to trace the variation in yield on an individual unit basis. Being able to trace to this level of specificity would also allow the processor to trace yield back to different suppliers which, in turn, would allow them to preferentially buy from producers with higher yielding product. The process yield improvements were significant enough to warrant the investment.

Qualitative Benefit Assessment

To complete the assessment of the real value of traceability, it is necessary to consider

benefits which are not easily measured in monetary terms. Working through the benefit hierarchy is possible to estimate real values for many, but not all, factors. Others may be important to the firm yet it may be extremely difficult for managers to put accurate estimates on the real value of those benefits to the firm. For example, traceability may affect the reputation of the firm, providing a market advantage, and the perceived risk reduction may be extremely important to the firm. Such benefits are often termed intangibles, but improved reputation and reduced risks are very tangible benefits for the organizations affected. They are tangible, just not easily measured. You can refer to such benefits as qualitative benefits. One way to assess the importance of such benefits is to ask managers to answer the following questions and apply a five point (Likkert) weighting scale.

How important is this benefit to the organization?

How much will implementing traceability affect this benefit?

Traceability Costs

There are two issues related to costs - what they are and who bears them. There are several key categories of costs. Costs may be incurred during implementation or on an ongoing basis. Costs incurred at one level may be passed on to different levels or may benefit other levels. For example, label costs may be borne at the producer and processor level but the investment will benefit all other levels using them.

An example cost of a system may be:

Hardware – computer and tracking

Hardware and other capital expenses

Software

Consultancy services – Integration and support  

Education and training

Other professional costs

Ongoing maintenance support

Label supplies

Policy development, compliance and auditing

Other costs

Traceability costs can vary widely depending on the nature of the firm and its products, its role in the supply chain in which it operates, its main activities and current track and trace technologies and capabilities.

ISO 22000: Traceability in Food Supply Chains /An Overview of GS1 Traceability Standard - VI

ISO 22000 & Food Traceability

Part VI

An Overview of GS1 Traceability Standard

GS1 is a neutral, not-for-profit organization dedicated to the design and implementation of global standards, technologies and solutions to improve the efficiency of supply and demand chains by adding useful information to any exchange of goods or services. It was formed from the joining together of EAN International and UCC, the Uniform Code Council, and is today the most widely used supply chain standards system in the world. GS1 has more than 30 years experience and is present in over 145 countries. More than a million companies representing all points in the supply and demand chain and executing over five billion transactions every day drive the organization’s activities. It operates in more than 20 sectors, including fast-moving consumer goods, healthcare, transport and logistics, and defense. GS1 works with small and mid-sized firms, as well as many of the world's largest corporations. GS1's integrated system of standards is the foundation for accurate identification and communication of information regarding products, assets, services and locations.

Traceability is the ability to identify the past or current location of an item, as well as to know an item's history. The most well known use of traceability is locating defective or unsafe foods, pharmaceuticals or other products, in order to remove them promptly from shelves. In some cases, being able to quickly and easily recall an item (or a group of items) can save lives. Speedy recall also greatly reduces the potential negative economic impact, and preserves consumers’ trust in the quality of their favorite brands and their confidence in the systems that are designed to protect their safety. There is however more to traceability than just recall. For example, traceability systems can validate the presence or absence of attributes important to consumers, such as organic farming methods, kosher foods, non-allergenic cosmetics, or sugar-free products. Traceability has become a tool in fighting product counterfeiting and protecting brands. Recently, it has also become a regulatory requirement in some countries in the fight against bioterrorism.

Safety, security and traceability are currently at the forefront of both government regulations and industry concerns around the world. As a result, numerous irreconcilable track and trace solutions have been proposed to the national, regional and global supply chain participants. The cost of diverse government regulations, proprietary service offerings and incompatible commercial solutions to the consumers, companies and the global supply chain called for defining traceability as a business process, which is supported by voluntary business standards that are accepted around the world. To further develop the capability to assist consumers, businesses and governments worldwide, GS1 has defined traceability as a business process and produced a global Traceability Standard, which links it to enabling technologies and relevant GS1 System tools.

Attributes of GS1

GS1 has succeeded in producing a global business agreement on generic requirements and a common way to describe the traceability process, while taking into account differences imposed by diverse legislative and business requirements and diverging expectations in terms of enabling technologies. While businesses recognize the value of traceability, they do not want multiple, potentially conflicting, traceability systems, and they do not want to increase costs unnecessarily. Businesses also recognize that an individual company is only one partner in the supply chain, and that a chain is only as strong as its weakest link. So they want a system that could easily be adopted by just about everyone in the supply chain.

The GS1 Traceability Standard addresses these business needs in the following ways:

1. It is based on existing business practices, and there is no need to purchase, create or integrate new systems.
2. The standard uses a common language, the GS1 System of identification and bar coding, as well as GS1 EANCOM® and GS1 XML messaging.
3. Therefore, broad-based in that GS1 Standards are used in over 150 countries around the world by a large majority of supply chain partners (there are over 1 million GS1 user companies).
4. It takes a global approach, addressing the supply chain as a whole rather than any particular individual partner.
5. Standard is thorough, covering the fundamentals of traceability – identification, data capture and management, links management, and communication.
6. Standard focuses on the interfaces of physical flow of materials and products, establishing an open, global relationship between independent partners.
7. It is flexible, recognizing that circumstances vary within and between sectors, and thus providing for tailored applications.

In addition you must keep in mind that it is not a standard for internal traceability, although it does show the inputs and outputs that must be linked by an internal traceability system which is also not a law or regulation, although it is designed to help business comply with existing and expected laws or regulations. On the other hand, it is not a replacement for a service provider for e.g. training or implementation support, although it does identify the types of information and core specifications that a service provider needs to consider in designing a system to manage traceability. The standard is not a replacement for safety or quality programmes, which complements them when a problem arises i.e., food safety programs such as the CIES Global Food Safety Initiative and quality programmes such as EUREPGAP.

Implementing a traceability system within a supply chain requires all parties involved to systematically link the physical flow of materials and products with the flow of information about them. This requires a holistic view of the supply chain, which is best attained by deploying a common business language. While businesses recognize the value of traceability, they do not want multiple, potentially conflicting traceability systems, and they do not want to increase costs unnecessarily. Businesses also recognize that an individual company is only one partner in the supply chain, and that a chain is only as strong as its weakest link. In short, businesses want a traceability system that can easily be adopted by just about everyone in the supply chain. The GS1 Traceability Standard meets this criterion. It defines business rules and minimum requirements to be followed when designing and implementing a traceability system. GS1 standards (such as GS1 Bar Codes, GS1 EPC, GS1 e Com business messaging, and more) enable the easy implementation of this GS1 Traceability Standard.

GS1 Traceability Tools

The introduction of GS1 standards can improve the efficiency of recording and exchanging information between supply chain participants. When used in conjunction with databases containing accurate and timely records, GS1 standards provide all supply chain participants with the technical capability to see the origin of a product, both in their own locations and across the entire supply chain. At the simplest level, item numbering is what the name suggests – a system for identifying items by giving each one a unique number (e.g. a bottle will have a different number to a case). Numbering can be applied at every stage of production and distribution. It is used to identify products and services. While the most visible aspect of item numbering is the bar code, it is only a machine-readable representation of a number. It is the number, which is the most important element in the GS1 System, because the number identifies the item to which it is assigned.

The GS1 numbering system provides for global uniqueness and overcomes problems of confusion, duplication and misinterpretation, because all users of the GS1 System follow the same coding rules. A GS1 number can be recognized not only by local trading partner companies, but by companies operating overseas as well. Each GS1 number is unique worldwide, so there is no possibility of confusion. The GS1 numbering system also provides the ability for items to also carry, within the numbering convention, extra or attribute information pertaining to the item. GS1 standards carry data, which allow supply chain participants to track and trace products. The application of these standards requires manufacturers, importers/exporters, carriers, distributors and retailers to keep records of serial numbers of logistics units (SSCC), identification numbers of trade items (GTIN) and their attribute information (Application Identifiers), and location numbers of their origin (GLN).

Global Location Number (GLN)

A GLN is a numeric code that identifies any legal (e.g. company, division), functional (e.g. accounts dept) or physical entity (e.g. plot of land) within a business or organization. Each location is allocated a unique number. The use of a GLN is a pre-requisite for efficient Electronic Data Interchange (EDI).

Global Trade Item Number (GTIN)

The GTIN is a number used for the unique identification of trade items worldwide. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, ordered or invoiced for trade between participants at any point in any supply chain.

Serial Shipping Container Code (SSCC)

The SSCC (Serial Shipping Container Code) is a number, which is used for the unique identification of logistic units. A logistic unit is an item of any composition established for transport and/or storage, which need to be managed throughout the supply chain. The SSCC provides an unambiguous identification for logistic units (e.g. a flexi tank or a container). All parties in the supply chain can use it as a reference number to the relevant information held in electronic or human readable files.

Application Identifier (AI)

Attribute information is any variable information required over and above the trade unit or logistics unit identification, such as a batch number, production date or customer purchase order. In the GS1 System, this information is expressed by means of GS1 Application Identifiers (AI). Attribute information is bar coded in the GS1-128 bar code symbol.

Bar Codes and RFID

GS1 bar codes allow automatic data capture of GS1 numbers, which is a key business solution in an efficient supply chain. The GS1 numbering and bar coding system allows fast accurate and timely data input into computer systems, automating the flow of information into business processes. It also enables improved data capture and transfer of information, while reducing costs. Recent GS1 standardization developments in the field of RFID are internationally known as the EPC global Network.

Data Alignment

Some companies already have effective internal traceability systems in place. For them, the next step is to achieve full supply chain traceability. The main requirements for handling product withdrawals and recalls across the supply chain are having reliable data, the possibility to exchange the data and properly mapped business processes. A good internal traceability system is a prerequisite to a chain traceability system. The investments in an internal traceability system will not be wasted in moving towards chain traceability. All good supply chain traceability software should be able to integrate seamlessly to any internal system. The application of GS1 standards is a prerequisite for the alignment of traceability systems.

The reason for using GS1 standards is to overcome the barriers to commerce that national, industry and company specific standards create when they are used in place of international multi-industry standards. Trading, tracking and tracing goods become more expensive because of the need to fulfill different identification and communication requirements of each importing country or company. The key to designing cost-effective and efficient traceability systems is to satisfy different customer and legal requirements by applying one global standard.

Companies that implement collaborative best practices and GS1 standards need to encourage their partners to do the same. Before any GS1 bar code label can be scanned, there has to be an exchange of master data between the trading partners. This data defines the specific trade item, such as its GTIN; the logistic unit, such as its SSCC; and the trading partner details, such as its GLN. Because this information is retrieved from the receiver’s files, it is crucial that the receiver is able to maintain the necessary GS1 data standards in its database. As the full product data is built from both the sender and receiver’s information, it is vital that the data is aligned. Therefore, it is very important that data alignment occurs prior to any physical transaction between the sender and receiver.

The Difference

Considering the number of traceability initiatives, whether regional, national or international (Codex, ISO), it is reasonable to ask what point of difference the GS1 Traceability Standard provides. Quite simply, this Standard delivers the “nuts and bolts” that these other initiatives require or recommend. For example, the two major economies, the European Union and the United States, have within the last few years passed regulations requiring specific information be collected to trace food products “one step up, one step back” within a supply chain. These regulations do not, however, specify how this should be done, leaving it to industry to find the most efficient and effective methods for their situations.

On an international scale, the Codex Alimentarius Commission is developing Guidelines for traceability of foods in international trade and has drafted a number of useful and important principles. While the ISO 9001:2008 Quality System Management Standard is applicable to all products not just foods, its approach is systematic - the criteria and limits for each product characteristic, how they are measured, actions to be taken if they are not met, auditing, training of personnel, etc. – but does not specify the criteria or the information to be collected. It is important to point out that the GS1 Traceability Standard does use the ISO definition of traceability. Having a proven global standard-based traceability process can demonstrate that an organization has met requirements of corporate responsibility.

Reference

http://www.gs1au.org/assets/documents/info/brochures/gs1_broch_traceability_faq.pdf

http://www.gs1.org/docs/traceability/GS1_tracebility_what_you_need_to_know.pdf

http://www.gs1.org/docs/gsmp/traceability/GS1_Global_Traceability_Standard_i1.pdf

http://www.gs1hk.org/files/publications/industry_solutions/food/gs1_wine_traceability.pdf

http://www.gs1.org/docs/gsmp/traceability/GS1_Global_Traceability_Standard_i1.pdf