Introduction to Traceability in manufacturing
Posted on 31. Jan, 2010 by admin in Research
Introduction:
This series aims to:* Raise awareness of the relevance and importance of traceability* Highlight important aspects and associated subject matter* Help manufacturers and distributors who are proposing to implement or improve traceability systems to make sound investments in sub-systems that work together.
This series aims to
* Raise awareness of the relevance and importance of traceability
* Highlight important aspects and associated subject matter
* Help manufacturers and distributors who are proposing to implement or improve traceability systems to make sound investments in sub-systems that work together rather than making inappropriate investments in sub-systems that are unable to inter-operate
* Provide a resource to manufacturers that can be used as the basis for a checklist for traceability system implementation
An unsafe product scenario
To set the scene, consider the hypothetical scenario of a bottle of flavoured milk. The bottle has a batch number and expiry date printed on it. The label says that its ingredients comprise low fat milk, sucrose, cocoa powder, stabilisers, permitted flavourants and colourants. In the event that the manufacturer investigates a consumer complaint and becomes aware that this batch of flavoured milk is unsafe, the manufacturer should be able to precisely identify the source of each of its ingredients and the container.
The ingredients label on our bottle includes the term “permitted colourants”. What were the actual colourants used to manufacture the contents of this bottle of flavoured milk? There may have been more than one colourant used to achieve the required colour. The manufacturer needs to have this detail archived for fast and accurate retrieval. For simplicity, assume that only one colourant was used and the manufacturer of the flavoured milk identifies that this was contaminated. The manufacturer may have more than one supplier of this colourant. What was the lot number of the colourant? Who supplied the colourant used in this bottle of flavoured milk? Perhaps the colourant was not supplied by the primary producer but by an importer or distributor. If there is a problem with this colourant, can the importer rapidly identify his supplier of this colourant? Can his supplier (let us assume that this is the primary producer of the colourant) identify the suppliers of the ingredients that went into this lot of this colourant? These suppliers may be a mix of industrial producers and farms. If the substance is an agricultural product, we might want to ask to what pesticide treatments this particular crop was exposed.
There is another gotcha here. Having found that there is a problem with this particular lot of colourant, is each organisation in its supply chain able to identify where other parts of this lot went? Is it necessary to retest and/or recall other products?
This is a very simple example. We started with a bottle of flavoured milk and have only brushed the surface of tracing the provenance of a single ingredient. However, it helps to illustrate that traceability requires a continuity of accurate data capture and record keeping from primary producer through to retailer.
What is traceability?
Broadly speaking, traceability refers to the ability to trace a substance through all stages of the supply and manufacturing chains.
Formal definitions of traceability
The International Organization for Standardization (ISO) is a world-wide federation of national standards bodies that promotes the development of standardisation and international standards for a wide range of products. ISO 9000 guidelines are quality management system standards. The ISO 9000:2000 Guidelines define traceability as the “ability to trace the history, application or location of that which is under consideration.”
From a food perspective, European Union (EU) Regulation (EC) No 178/2002 defines traceability as “The ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution.”
Why implement traceability?
There are many factors that motivate the implementation of traceability systems. These include:
* Supply management improvements
* Regulation
* Voluntary adoption of standards
* Safety and quality
* Brand value
* Expanded market / market share
* Economic / Profitability
* Customer imposed requirement
Supply management improvements
The successful implementation of traceability systems helps to identify bottlenecks and inefficiencies in the supply chain. Resolution of these reduces distribution costs. Traceability and tracking yield productivity gains resulting from improved marking, data capture and data retrieval. Stock-turn ratios are improved as a result of faster order fulfilment and more consistent delivery lead times. Improved stock rotation results in reduced losses from past sell-by date and age degraded products.
Regulation
In certain industries and trading blocs traceability is mandated by regulation.
In most countries an appropriate governing body requires the use of suitable traceability systems in pharmaceutical and medical device manufacture and distribution. In South Africa the Medicines Control Council administers this. In the USA this task falls under the Food and Drug Administration (FDA).
South African Government Notice R908 of 2003/06/27 requires owners of food handling enterprises to have in place “a HACCP system fully implemented to the satisfaction of the relevant authorised health authority in relation to the foodstuffs under consideration…”.
The US National Advisory Committee on Microbiological Criteria for Foods (NACMCF) lists a set of prerequisites for HACCP (Hazard Analysis and Critical Control Point) implementation. One of these is that “All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.”
EU Regulation (EC) 2065/2001 concerns the compulsory labelling of fish and requires traceability to catch area, vessel identification, capture method and more. Similar regulations are in place in many countries to address sustainability of natural resources, food safety and the humane treatment of living creatures.
In member countries of the EU Regulation (EC) No 178/2002 mandates traceability in the production, processing and distribution of food and animal feed products from primary production to final consumer. When it was promulgated, this requirement logically appeared to extend to manufacturers outside the EU who export such products for consumption in the EU. Subsequently, Regulation (EC) No 852/2004 confirmed that “Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to Community rules.”
In December 2004 the FDA issued its final rules on maintaining food traceability records under the Public Health Security and Bioterrorism Preparedness Act of 2002. In terms of this all companies that manufacture and transport food products must maintain records that identify the immediate previous source and subsequent recipient of the food they distribute. The regulations apply to entities that “manufacture, process, pack, transport, distribute, receive, hold, or import food”, although farms and restaurants are excluded. The FDA can request shipment records when it “has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.” Entities must make records available within 24 hours of official request, or face civil action in federal court. Failure to maintain the necessary documentation can result in criminal charges.
The Bioterrorism Act requires those entities that pack, process and export food to the USA comply with certain requirements. These relate principally to registration with the US government, a process of prior notice of exports to the USA, and a requirement to maintain records to enable traceability of food supplied.
Voluntary adoption of standards
Frequently organisations or whole industries in a region will elect to adopt an established set of non-mandatory standards in order to help them achieve their manufacturing and profitability objectives and to benefit from the synergies of this approach.
European Article Numbering (EAN) standards and Supply Chain management solutions firmly entrench traceability principles along with tracking, tracing, marking and data exchange standards.
The SA Guide to GMP (Good Manufacturing Practice for Medicines in South Africa) is another example of a standard or guideline that requires traceability. An extract from section 1.3.2 reads: “The basic requirements and objectives of Good Manufacturing Practice are as follows:
(i) records of production, control and distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form
(k) system is available to recall any batch of product from sale or supply”
Safety and quality
Traceability systems result in reduced costs associated with recall and litigation and improved response times to product quality problems. The cost of recall can be limited to specific batches or to product manufactured by specific operators or at particular manufacturing stations. Without suitable systems in place there may be significant costs involved in bringing in outside auditors to work through manufacturing documentation to try and establish an audit trail so that contaminated lots can be identified.
Organisations are coming to view traceability systems as an essential part of their risk management toolbox.
A brand is an immensely valuable asset. For brands like Coca-Cola or Perrier brand values are measured in billions of dollars. Both of these brands have suffered damage in Europe as a result of product recalls. When problems that require a product recall occur, brand value will suffer least where systems facilitate rapid withdrawal by the manufacturer and supply chain before such product reaches the final consumer.
A Product that meets internationally recognised compliance guidelines establishes higher recognition from customers and suppliers, thus building brand value.
Brand value is an “after incident” victim. A brand suffers damage when an unsafe product comes into the market.
Perrier only started to return to break-even in 2003, after the 1990 recall of 280 million bottles of water in which trace amounts of the carcinogen, benzene, were found. That single incident cost Perrier almost US$200 million, marred its image and opened up the niche market that it had dominated to a large number of new arrivals.The ability to identify and pull contaminated product in a targeted way means that harm to brand value can be limited and consumers can continue to purchase the brand with confidence.
In the 2003 Pick ‘n Pay incident, turnover was actually enhanced through competent recall and well-managed consumer communication. A survey conducted at the time by Research Surveys found that “65% of respondents who were aware of the food scare feel that Pick ‘n Pay have handled the incident to the best of their ability. Twenty four percent felt that it was handled fairly well, but that it could have been handled better, and only12% of those polled felt the retailer had not handled the incident very well.“
Expanded market / market share
Business are achieving increase turnover and premium pricing as a result of changed consumer perception concerning intangible or hard-to-identify product and brand characteristics that rely on traceability for their credibility. Dolphin-friendly tuna fishing, organic foods, non-genetically modified foods, vitamin-enriched foods and beverages, pharmaceuticals not tested on animals and fair-trade products are just some examples. Without credible traceability systems and audits these differentiators would have limited influence on consumer preferences.
Many buyers and consumers prefer products that have been manufactured under well-defined, controlled and recorded conditions. With appropriate manufacturing records in place, quality becomes another selling tool.
If manufacturers are unable to meet new regulations then their markets diminish. Conversely new markets open up if suitable control systems are in place.
Economic
All the above factors have a significant impact on an organisation’s turnover and profitability.
Customer imposed requirement
Manufacturers, distributors, retailers and consumers are requiring their suppliers to have verifiable traceability systems in place for many of the reasons listed.
Where does traceability fit in my process?
It is clear from the definitions of traceability that this is an end-to-end process. Whether you are an importer, a manufacturer, a distributor or a logistics operation, your traceability starts with materials receiving (Who is this coming from? What is it? What lot number? What expiry date? What sample metrics?), continues through manufacture / aggregation / bulk break (In which plant or manufacturing area was it manufactured? Which lots of which components went into which manufactured lots? What are the sample metrics of the manufactured item? What is its expiry date?) and is a necessary part of materials despatch (To whom was each lot of the manufactured item sent? When? On what waybill / delivery note / invoice?).
What are the implications of my implementing traceability?
In order to implement traceability successfully within an enterprise you need to capture the necessary information at source in an accurate, efficient and reliable manner. Traceability needs to embrace “real world” / “on event” capture of information as opposed to pre-emptive / post-event transaction capturing. It does not involve trying to capture information on what we planned to use, nor on what we should have used, but on what we actually used.
This may mean agreement on suitable labelling, marking or identification specifications (bar coding, RFID…) and lot numbering systems between your business and your suppliers. Or it may mean the application of your own internal lot numbering methodology and re-labelling at material receiving.
It may also mean the introduction of bar code readers or RFID readers and marking systems within your manufacturing processes in order to record component usage and the use of bar code printers or RFID writers to mark manufactured and semi-manufactured product.
With such procedures in place you will need systems to archive and retrieve the captured information.
What are the implications of my failing to implement traceability?
According to the Center for Science in the Public Interest (CSPI), in the period 1990 to 2003, multi-ingredient foods, where the contaminated ingredient was not identified, were linked to 601 food-poisoning outbreaks and 18,006 illnesses. There is growing consumer concern and reaction to this failure to identify contaminated ingredients.
The wide-scale introduction of regulations enforcing the use of traceability systems and increasing consumer awareness mean that manufacturers who do not embrace traceability can expect:
* Non-compliance notices in the public domain
* Fines
* Diminishing market shares
* Closure
* Litigation
In forthcoming articles…
Forthcoming articles will address points to consider when planning a traceability project, such as:
* Lot and batch numbering
* Marking
* Equipment and software selection
and process-specific suggestions relating to:
* Materials receiving, sampling and inspection
* Manufacturing
* Dispatch
* Stocktake
and more.
References
BusinessWeek. The Global Brand Scoreboard. 2 August 2004.
Center for Science in the Public Interest. Outbreak alert! 4 April 2004.
EAN International. Traceability Management tools for agriculture, food and beverage products. February 2004.
European Parliament and the Council of the European Union Regulation (EC) No 2065/2001 of 22 October 2001.
European Parliament and the Council of the European Union Regulation (EC) No 178/2002 of 28 January 2002.
European Parliament and the Council of the European Union Regulation (EC) No 852/2004 of 29 April 2004.
ISO (2000). ISO 9000:2000. Quality Management Standards.
Research Surveys: How will the poison scare affect shoppers?
RSA Department of Health Government Notice R.908 of 27 June 2003.
RSA Medicines Control Council. Good Manufacturing Practice for Medicines in Douth Africa. January 2004.
US Food and Drug Administration Fact Sheet on FDA’s New Food Bioterrorism Regulation: Establishment and Maintenance of Records. December 2004.
US National Advisory Committee on Microbiological Criteria for Foods. Hazard Analysis and Critical Control Point Principles and Application Guidelines adopted August 14, 1997.
About the authors
Andrew Ashton has qualifications in electrical engineering, mechanical engineering and commerce. He has worked in and been providing automation solutions to the food, beverage and pharmaceutical industries for the past 27 years. He enjoys the challenge of helping clients to integrate their business management systems with front-end applications that facilitate traceability.
Marc Ashton has organised conferences focusing on food factory floor operations and systems and is a regular contributor to business-to-business publications in the food, pharmaceutical, logistics and IT arenas. Marc makes a point of keeping abreast of trends in the food and pharmaceutical industries both locally and internationally.
Both are directors of ProLoCon (Pty) Ltd, a company that manufactures software for formulation management, industrial dispensing, shop floor capture of traceability data and logistics.
Traceability in Manufacturing and Distribution
The first in a series of articles covering the important and topical subject of traceability.