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Beyond Just Testing
Contract labs can take on more critical tasks such as ongoing management of supply chain issues
by Arthur Rumpf
As food manufacturers and retailers grapple with an ever-growing list of food safety and quality compliance demands, they are looking for ways to better utilize their contract laboratories to help manage these additional compliance requirements.
While the traditional role of contract laboratories in the food industry has been to assist companies in providing routine and non-routine food testing services that could not otherwise be done in-house, core competency is not the only issue that drives companies to outsource.
Another issue is cost effectiveness. For example, a company may only use an expensive piece of test equipment once a month, while contract laboratories, which use this equipment every day, are more knowledgeable about the equipment and can use it more efficiently.
Another reason a company might outsource a product is to have an independent third party do the testing. An unbiased party conducting product testing can help ensure that the product going to market is reliable and safe.
Capacity is another issue that drives companies to outsource. Although many companies would like testing and related services to go through their in-house facilities, they may not have the head count to do so. It is often more cost effective to outsource the services to a contract laboratory instead of hiring additional staff.
In some cases, required testing services involve handling dangerous materials such as microbiological pathogens, hazardous chemicals, and radioactive substances—materials an organization does not want to have in its production facilities. The company may want to avoid any chance of product cross contamination and may also want to steer clear of the employee safety and disposal issues associated with using these materials at their facilities.
The initial decision to use a contract laboratory is often the result of a crisis situation or tight project deadline. Companies don’t generally think about the range of services beyond these immediate needs. As the role of the contract laboratory continues to evolve in the food industry, companies should consider what role a contract laboratory and its experts could play in improving the company’s overall food safety and quality management system and in helping it run more efficiently. This will allow better allocation of limited resources and better preparation in the event of a food safety crisis.
The food industry is under continuous pressure to ramp up food safety and quality management systems in difficult economic times. Challenges include:
- Regulators: Federal and local regulatory agencies are applying more stringent oversight to all sectors of the food supply chain. The FDA Food Safety Modernization Act, signed into law by President Obama on Jan. 4, aims to ensure the safety of the U.S. food supply by shifting the focus of federal regulators from response to prevention of contamination. Within this legislation, the U.S. Food and Drug Administration (FDA) was charged with developing systems of accreditation for laboratory testing and auditing service providers with a background goal of expanding capacity and enabling additional resources from accredited firms to support the requirements of the legislation.
- Consumers: Increasing consumer sophistication about food composition, nutritional content, and safety issues means that the industry cannot afford to compromise on product quality, process controls, or cleanliness of facilities. In recent years, food safety and food quality problems have become more frequent in most countries. Problems such as melamine adulteration in foods and animal feed, Salmonella contamination, and mycotoxins and dioxins in animal feed and animal products have led to consumer mistrust of foods in general, putting political attention on increasing food safety.
- Competition: Today’s consumers face a growing array of choices vying for their limited budgets. Private label brands are becoming more common, not only as an accepted alternative but often as one preferred to national brands. One bad experience may be the last chance an organization has for a share of a consumer’s business.
- Supply Chain: With a diverse and complex supply chain, it can be a challenge to ensure consistency of product quality. Non-conforming products from suppliers can result in substantial costs in the food industry. In response to a number of food safety scares, a group of international retailers created the Global Food Safety Initiative (GFSI) in May 2000. GFSI, now representing more than 70% of food retail revenue worldwide, is committed to benchmarking food safety management schemes in order to enhance food safety and restore consumer confidence. Equally importantly, GFSI promotes common acceptance of GFSI-recognized standards by retailers worldwide in order to improve the cost efficiency of food safety audits for food suppliers.
Many major retailers now require GFSI-compliant auditing schemes of their suppliers. With the focus on prevention, and the recognition that effective food safety and quality management systems are essential for success, numerous auditing schemes against benchmarking standards like those under GFSI continue to be developed and improved within the food industry.
At the heart of these regulatory, public, and private-sector efforts are some core elements of a food safety and quality management system. Establishing and maintaining a compliant system in the food industry has become increasingly complicated, especially for small- to medium-sized growers, distributors, manufacturers, and retailers who may not have the resources to fully address all the changing demands.
The initial decision to use a contract laboratory is often the result of a crisis situation or tight project deadline. Companies don’t generally think about the range of services beyond these immediate needs.
To manage the expanding and increasingly complex demands on establishing, maintaining, and improving their food safety and quality management systems, organizations are looking to contract laboratories, not just to play a supporting role through testing services, but to take over some of their core management system elements as a more cost-effective way of doing business. In particular, many small- to medium-sized suppliers do not have the quality assurance staffing or capabilities to meet the newer and constantly changing standard requirements being mandated for compliance by their customers and regulatory authorities.
Many companies use testing laboratories to help them develop internal food safety and quality management systems, but who will complete and maintain all the required activities of the system on an ongoing basis?
Following are some of the core management system compliance requirements in the food industry in which contract laboratories can play an important role. Because contract laboratories should have ISO 17025 accreditation, which has many comparable core requirements, it can be a logical extension for them to help manage similar requirements for clients and their supply chains. In offering these services, contract laboratories often utilize secure web-based portal systems or IT systems that interface directly with those of the client:
- Purchasing management: Food safety and quality management system compliance standards usually require a company to control purchasing processes to ensure that all externally sourced materials and services that have an effect on food safety and quality conform to requirements. A contract laboratory can help an organization manage many areas, including developing specifications, approving suppliers against these specifications, and monitoring ongoing compliance of purchased ingredients and materials to help assure that they remain in control.
- Non-conformance management (NCM): Contract laboratories can help companies identify non-conforming (out-of-spec) products by inspecting incoming materials, investigating customer complaints, or reviewing internal process measures. NCM provides for containment action generation and assigns disposition status. Management of non-conforming materials, customer complaints, and audit findings are a logical extension of work performed through a contract laboratory.
- Corrective and preventive action (CAPA): This is a system of structured, documented actions taken to address existing product or quality problems and prevent their recurrence. Contract laboratories can manage an organization’s CAPA system requirements to record and investigate product, process, or supplier non-conformance problems; perform root-cause analysis and impact analysis; and track progress of events through to resolution. The CAPA system developed typically includes notification and escalation features and dashboard analytics to track CAPA status and cost metrics.
- Complaint management: Contract laboratories can be particularly adept at handling complaints against suppliers and distributors, as well as supporting corrective action and dispute resolution procedures (including charge-back provisions). Complaint management typically includes reports to monitor complaint volume by vendor and product, along with charge-back amounts and disposition.
- Crisis management: Ideally, an organization should have agreements in place before a crisis happens to help with technical guidance and sample testing capacity to address the situation.
- Audit management: One area in which contract laboratories can add great value is in creating and managing the periodic scheduled or event-driven audit requirements of a company, whether initiated by customers, internal teams, or regulatory agencies. Audit management should include reviewing pass/fail results based on qualitative and quantitative criteria, reporting final results, and recommending follow-up actions. It is important to note that any contract laboratory you consider hiring for the management of audits for accreditation purposes must ensure that its certification bodies—those performing accreditation auditing services—are established as separate legal entities. These auditors must be independent of any direct testing and consulting services that you use in order to ensure impartiality and avoid any perceived or actual conflict of interest.
- Training management: Contract laboratories can be highly skilled at scheduling required training and education sessions for employees and maintaining training history records. Look for a contract laboratory that has expertise and training materials available to support employee training in test methods, quality control techniques, current good manufacturing practices, hazard analysis and critical control points, and regulatory requirements.
- Measuring and monitoring equipment management: Any contract laboratory qualified to perform calibration services should be able to manage this function. Services should include scheduling inspection and preventative maintenance of equipment and devices and providing notifications and alerts on pending preventative maintenance schedules.
- Document management: Contract laboratories can serve as a central repository of some or all of the quality documents that need to be accessed by employees, customers, and suppliers, as well as other applications. Document management controls the creation, maintenance, and retrieval of documents relating to standard operating procedures, instructions, product specifications, recipes and handling procedures, and regulatory materials. This would include access control, document sharing, editing, updating, and version control features.
- Regulatory management: A contract testing laboratory can help ensure that an organization is being kept up to date with the latest relevant information, including proposed regulations, new regulations, and active recalls. A related area would be reviewing packaging materials and formulations for compliance with regulatory requirements.
Find the Right Partner
If your company is looking to manage its food safety and quality systems more efficiently, a full-service contract laboratory could provide the expertise and services you need. Keep in mind that most food compliance standards require that companies that choose to outsource any process that might affect food quality must still have control over such processes and that control of any outsourced processes is identified, documented, and monitored within the food quality management system. Make sure this is part of any contractual agreement you forge with an outside laboratory.
Take the time to explore how your company can improve the efficiency of its quality management systems through the use of a contract laboratory. A strong partnership with the right contract laboratory can yield highly beneficial results: safer and higher quality products, improved brand reputation, and more cost-effective solutions to staying in compliance and staying ahead of the competition.
Arthur Rumpf is a senior technical consultant at Specialized Technology Resources (STR) in Canton, Mass., a leading global provider of quality assurance testing and supply chain support services for the food industry. He can be reached at arthur.rumpf@STRQuality.com.