Forensic Science is the application of scientific principles and technological practices to the purposes of justice in the study and resolution of criminal, civil, and regulation issues. In 1993, the Board of Directors of the American Academy of Forensic Sciences (AAFS) partitioned Forensic Science into 11 categories and Food Science and Food Safety are not among them - even though food is ingested into the body, and the fields of food science and food safety have not been recognized. But that is expected since food science and food safety forensics are among the emerging fields of related forensic sciences.
Forensics is generally understood as the method of using science to solve crimes.Food Science ForensicsTMis the methodology of using food science principles and processes to solve crimes, or to verify and document adulteration food poisoning for both humans and pets. It is nonspecific to food micro-organism poisoning. It represents a disciplined methodology for identifying the food poisoning case and contributing factors, and identifies a sequential "tracking and tracing" investigative steps, technologies, and detection tools. An example in recent history is the detection and tracking of arsenic in rice products from the field of origin.
The primary threats to consumers in food safety cases are life and overall healthy well being, as well as adulteration, mislabeling, lack of regulatory oversight (like pharmaceutical compounding), and economic fraud on a grand international basis. However, the use of a structured methodology used in the forensic fields today with the application of sound food science and safety principles can quickly and accurately identify the core problem - and provide a full audit trail of evidence.
It maps the manufacturing process It measures the manufacturing process performance It verifies compliance (process verification) Process verification represents a quality system that follows standard operating procedures, best management practices, and HACCP principles. Process verification is typically more detailed and more interdependent than traceability. Under process verification plans, animals must be raised according to USDA-approved specifications and guidelines.
- Product Tracing and Traceability
"Traceability" is a concept developed in industrial engineering and was originally seen as a tool to ensure the quality of production and products (Wall 1994). Economic literature from supply-chain management defines traceability as the information system necessary to provide the history of a product or a process from origin to point of final sale (Wilson and Clarke 1998, Jack, Pardoe, and Ritchie 1998, Timon and O'Reilly 1998).
Traceability (or product tracing) systems differentiate products for a number of reasons. Food traceability systems allow supply chain actors and regulatory authorities to identify the source of a food safety or quality problem and initiate procedures to remedy it. While traceability in the food sector has focused increasingly on food safety (Smyth and Phillips 2002), agrifood and nonfood sectors such as forestry and textiles (particularly cotton) have instituted traceability requirements for product identification, differentiation, and historical monitoring. Specific standards for food traceability have been mandated internationally; by law in the European Union (EU), Japan, and more recently the United States; and by private firms andassociations.
In the context of agricultural policy, traceability refers to full traceability along the supply chain, with the identification of products and historical monitoring, and not just the separation of products under specific criteria at one or more stages of the chain. The Codex Alimentarius Commission2 (CAC 2006) defines traceability as: the ability to follow the movement of a food through specified stage(s) of production, processing and distribution. . . . The traceability/product tracing tool should be able to identify at any specified stage of the food chain (from production to distribution) from where the food came (one step back) and to where the food went (one step forward), as appropriate to the objectives of the food inspection and certification system. Click here for more information.
Product genealogy is the tracking of a product's assembly through the manufacturing process. It supports the ability to do the following:
Track information about components assembled into a finished food product Verify that all required ingredients are assembled at the start of the product assembly operation Place ingredients on hold to prevent quality issues Load and replenish ingredients during the production process Determine supplier information for failed components Produce reports detailing which ingredients were assembled into a given SKU or Product # Genealogy provides control of ingredient consumption, WIP accuracy, improved ingredient traceability, and compliance with customer requirements regarding change control and shipping. It provides visibility into the current status and location of the food product, the activities that have been logged for the product, and all manufacturing personnel who have worked on the product. It solves the issue of tracking processes, resources, tools, and materials used during the manufacturing of a product. It also provides visibility and traceability into the complete product life cycle, from inception to finished product storage and distribution.
Using data collection processes, the system creates a comprehensive history of every ingredient used for the manufacture of a product and the events during the production process - and provides data for analysis. It allows you to trace component issues quickly, efficiently, and precisely to their points of use in all products. For example, if a product fails, it can be traced back to where the product was made, how it was made, and with what components it was made, even down to the vendor of each ingredient. When diagnosing which ingredient or process failed, you can find all events and equipment settings where a similar process setting was used, thus enabling the identification of the defective process setting or ingredient during upstream food product manufacturing - and locate the failure point more quickly.
Food product profiling is used to assign perishable characteristics or qualities of food products which are instrumental in the forensics process.
- Food Industry Application Areas
A few strategic food product areas that can really use Food Safety ForensicsTM methodology application include: Fresh Fruit, Fresh Vegetables, Raw Meat and Poultry, Organic and Natural Foods, Restaurants, and Grocery Delis.
Pharmaceutical Industry Benchmarking for Food Industry
1. Serialization in General
The basic idea behind serialization is very easy to understand, but very difficult to implement in the manufacturing process. It requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. The vast majority of prescription drugs received by patients are safe. However, given the number of potential players in the supply chain and the differences in regulations and laws worldwide covering each of them, opportunities do exist for dangerous counterfeit and adulterated drugs to be introduced into the consumer's supply. Serialization involves many functions - software, coding, material handling, inspection, integration and data collection and management - but few standards.
In an effort to combat this risk of counterfeit and adulterated drugs, national regulators have pursued the need for serialization. A complete serialization program represents the complete history of a given product's chain of custody from the manufacturer to the point of dispensing. Much of the early work around implementing solutions has focused on support of serialization using electronic solutions, both in terms of applications for managing serialization data, printing of human readable markings and sensory technologies for verifying this marking. While there are many advantages in early implementation of a serialization program there is still much confusion as to how laws and regulations will evolve in the future. Pharmaceutical manufacturers are investing in ways to uniquely serialize each unit and to register the parent child relationships of units into larger containers, cases or cartons and even up to pallets. The information required in a serialization program is strongly dependent on the many different laws and standards. Typical information could include some or all of the following:
The complete supply chain ownership information from the manufacturer all the way down to the pharmacy from which the prescription drug was handed out to the patient Detailed information for each person who certified delivery and receipt of the prescription drug including company, name and address The name of the prescription drug, its quantity, its dosage form and strength The date of each transaction in its distribution The sales invoice number(s) for each transaction The number of containers for each transaction The expiration dates and the lot/batch number(s) Complete shipping information A certification that the information is true and accurate, click here for more information 2. Serialization Challenges
Some of the challenges of serialization include:
Complexity Customization (no out-of-the-box or one-size fits all solution) Need for a collaborative approach Control of process to ensure a unique code is applied and data is aggregated accurately Code/substrate contrast Potential impact on line efficiency Secure rejection of faults Provision of decommissioning numbers Need for extensive testing Handling and storage of large volumes of data Access to data by supply chain partners Integration with enterprise system - at all levels Validation 21 CFR Part 11 compliance (Electronic Records; Electronic Signatures - Scope and Application) - click here for more information 3. SNI/Standardization Number Identification Identifier (FDA Pharma Standard)
On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) was signed into law, and instructed the Secretary to develop an SNI to be applied to a prescription drug at the point of manufacturing and repackaging at the package, or pallet-level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug. An SNI applied at the point of repackaging is to be linked to the SNI applied at the point of manufacturing and, to the extent practicable; the SNI should be harmonized with international consensus standards for such an identifier. (See Section 505D (b) (2)). Click here for more information.
The SNI for most prescription drug packages should be a serialized National Drug Code(sNDC). The sNDC is composed of the National Drug Code(NDC)(as set forth in 21 CFR Part 207) that corresponds to the specific drug product (including the particular package configuration) combined with a unique serial number, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric (numbers) or alphanumeric (include letters and/or numbers) and should have no more than 20 characters (letters and/or numbers). An example is shown below with a 10-character NDC.
Food Safety ForensicsTM Supply Chain Software Solutions
1.Role of ERP (Enterprise Resource Planning)
Lot control is a standard ERP (Enterprise Resource Planning) feature, in terms of assigning a lot number to a raw material or finished product, entering a lot number during receiving or order selection, and generating a variety of reports or queries based upon lot-related parameters. Lot traceability is a crucial ERP function that is responsible for tracking and tracing the lineage of all raw materials and finished products, including their characteristics and lot numbers.
Due to the batch-run quantities produced in process manufacturing, a process-oriented ERP application should be capable of tracking and tracing an ingredient even if it is only present in miniscule amounts, such as a spice in a finished product; this is especially critical for meat processors.
In many ERP applications, lot traceability is limited to an inventory snapshot, meaning information on a product is available for its current state. Full lot traceability requires the merging of inventory records, which can take days to manually compile with many ERP solutions. Although some of these ERP applications can merge or link this information, these reports can still take almost a day to complete.
Leading process-oriented ERP applications are optimized for full lot traceability. With "end-to-end" or bi- directional lot tracing, these ERP applications can quickly track raw materials from receiving into production, track finished goods from supplier receipt to customer invoice, and identify the raw materials and resources that produced the finished products. As customers and regulatory agencies continue to pressure food processors to deliver 100% accurate lot traceability within shorter and shorter periods of time, bi-directional lot tracing enables food processors to respond to product recalls in a matter of minutes, rather than hours or days.
This capability allows meat processors to pass customer mock recalls and certification audits. In the event of an actual product recall, the ability to remove suspect products from the shelves quickly minimizes consumer risk, as well as contains the scope of recalls. Click here for more information.
2. Role of Factory Floor Systems
Factory Floor systems are often called SCADA or Supervisory Control and Data Acquisition. Supervisory Control and Data Acquisition (SCADA) refers to industrial control systems (ICS) that are employed to control and keep track of equipment or a plant in industries like water and waste control, telecommunications, energy, transport, and oil and gas refining. SCADA is a computer system used to gather and analyze real-time data. This data is processed by the computer and is presented on a regular basis. SCADA also saves and make logs for every event into a log file that is saved on a hard drive or is sent to a printer. SCADA gives warnings by sounding alarms if situations develop into hazardous scenarios.
SCADA systems were initially employed in the 1960s. They include both software and hardware components. The hardware collects and enters data into a computer with SCADA software. Click here for more information.
3. Role of Supply Chain Management
An integrated supply chain performance management system is comprised of both Demand Planning and Supply Planning software modules. Although these are the main software systems, other systems that are commonly integrated and required for thorough Food Safety ForensicsTM are Transportation Management Systems (TMS), Inventory Management Systems (IMS), Warehouse Management Systems (WMS),distribution route management systems (RMS), and others.
4. Role of PLM Electronic Document Management Systems
PLM (Product Lifecycle Management) represents the process of managing the entire lifecycle of a product from ideation, product innovation, product development, manufacturing, and product commercialization. PLM software integrates people, data, processes and business systems and provides a product information backbone for companies and their extended enterprise.
The following diagram illustrates integrated business information dependencies within a food and beverage company managed by PLM. PLM functions as an electronic data and document management hub for information that is typically not managed by the enterprise.
Figure 1: Integrated PLM Functionality in Food Processing
PLM functionality can include all of the following:
1. Document Management and Data Mining
2. Ingredient Tracking and Tracing
3. Specification Management & Version Control
4. Certification Process Workflow & Document Management
5. Synchronization with Marketing Calendar
6. Connectivity to Nutritional Database
7. Connectivity to statistical process control QA data
8. Integration with customer PLM or databases
9. New Product Development & Commercialization Workflow Management
Role of RFID Tags (New Technology)
RFID technology offers promising capabilities for traceability throughout the developing and the developed world, and is seen as an alternative to older barcode systems. Passive RFID tags use an initial signal from an RFID reader to scavenge power and store data on an event at a specific point in time. Passive RFID tags do not use a power source and are less expensive than active RFID tags. Grain-sized RFID tags or transponders incorporated as particles or attached as labels to food products can identify the food item and become connected to the Internet as uniquely identified nodes.
The advantage of electronic traceability systems based on RFID is their staggering capacity to store data on product attributes. Barcodes permit only limited data storage. Unlike barcode systems, which are read-only, RFID systems possess read/write capability. Barcodes require the item and the scanner to be in the direct line of sight, and items must be physically moved to collect data on the product, whereas data are automatically collected via RFID without line of sight (Cronin 2008; Nambiar 2009; Sarma 2004; Stokes 2010).
Role of Barcodes (Old Technology)
Conventional methods of traceability through a chain of custody involve the use of barcodes and labels. Barcodes are commonly and recognizably used for inventory control management and global logistics of people and goods, such as air travel tickets or parcel shipping and delivery. Barcodes represent data to uniquely identify a product. Barcodes can be scanned by an electronic reader to identify and interpret key data elements stored in the barcode. The data can be used to trace the product forward and backward through the supply chain.
Barcode solutions require a printing component to print barcodes on labels or products and a scanning technology to read barcoded information. Barcode labels may also contain some information below the barcode to allow for human verification and cross-checking of data. Storage of data elements on a barcode depend on the type of barcode technology used. The GTIN uses a 14-digit barcode with information about companies, products, and product attributes worldwide, which can be read upstream and downstream through a supply chain. Click here for more information.
Summary
The purpose of this document was to define the emerging fields of Food Science ForensicsTM and Food Safety ForensicsTM. A second purpose was the explanation of the structured methodology for identifying, collecting, analyzing, and reporting data tracking and tracing throughout the entire food and beverage supply chain around the world. The current leadership in this field is the pharmaceutical industry. But, as the methodologies mature in the Pharma industry, the food industry can benchmark its future practices to established Pharma consumer safety processes. The overriding conclusion is that food processors need to pursue a food safety tracking audit throughout the entire supply chain, and use the many electronic software systems integrated throughout the supply chain.
This article discusses issues of general interest and does not give any specific legal or business advice pertaining to any specific circumstances. Before acting upon any of its information, you should obtain appropriate advice from a lawyer or other qualified professional.
This article may not be duplicated, altered, distributed, saved, incorporated into another document or website, or otherwise modified without the permission of TASA.
References
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Jack, Pardoe, and Ritchie, 1998
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Smyth and Philips, 1998
Timon, D., and S. O'Reilly. 1998. "An Evaluation of Traceability Systems along the Irish Beef Chain." In Long-Term Prospects for the Beef Industry, edited by C. Viau. Paris: Institut National de la Recherche Agronomique (INRA). Pp. 219-25. Unnevehr, L. J. 2000. "Food Safety Issues for Fresh Food Product Exports from LDCs." Agricultural Economics 23:231-40.
Wilson, N., and W. Clarke. 1998. "Food Safety and Traceability in the Agricultural Supply Chain: Using the Internet to Deliver Traceability." Supply Chain Management 3:127-33.