At last the new Produce Rule is out, issued on November 13, 2015. For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.
The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act. It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.
The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.
During the FDA Town Hall, an audience member asks about the Produce Rule and the work being done with Mexico. Watch the video
For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along. For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).
This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.
The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.
However, some key requirements of the new rule not noted in existing third-party standards include:
Water testing of untreated water, sample collection and survey creation for agricultural water.
Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.
This rule does not apply to:
Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
Produce for personal or on-the farm consumption
If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
A food grain such as wheat or oats
The rule provides also for exemptions:
Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.
Under certain conditions the FDA may withdraw a farm’s qualified exemption.
The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.
This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.
FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.
The compliance dates for the new rule are staggered and based on business size.
After much anticipation, FDA has finally published the FSMA final rules. If you’ve had time to dig into the details, you most likely noted the new initiative that requires companies to measure food safety culture. The industry is also seeing SQF, BRC and other GFSI audit schemes ramping up discussions around measuring food safety culture. However, FDA and GFSI audits aside, how do you create a culture for sustained compliance with this initiative? Follow these 10 tips to ensure your food safety culture is constant and in line with the new requirements
Set clear expectations for employees across the board. Photo credit: Dennis Burnett for Alchemy Systems
1: Create a solid foundation of programs, procedures and policies
Have a preset annual schedule for review and update of all programs, procedures and policies. Don’t let the schedule slide because there are competing priorities. A small pebble is all it takes to start ripple effect in the company, making it difficult to recover.
2: Set clear expectations, driven from the top down
Everyone should follow the rules and guidelines—from visitors to the CEO to the plant manager to the hourly employee. A “no exceptions” policy will drive a culture that is sustainable and drive a “this-is-just-how-we-do-things” mindset.
3: Use record keeping to ensure that food safety culture is well documented and data-driven
Collect the data that is measureable and non-subjective to help drive continuous improvement. If you collect it, you must do something with it. Good documentation is imperative to proving you did what you said you were going to do, especially in the event of an audit. Be stringent in training, and review all documentation before it hits the file cabinet to ensure it is accurate and appropriate.
4: Implement a robust continuous improvement process
Forward momentum through a continuous improvement process cannot be achieved unless management nurtures the program. If you are not continuously improving, you are falling behind.
5: Have a 360-degree approach to employee engagement with 24/7 awareness and communication
Top-down communication is critical to highlighting the priorities and needs of an organization and will not be effective unless an organized program is in place. Organizations that are not making the necessary pivots to communicate with the multiple generations within their workplace today will struggle to sustain change.
6: Foster an atmosphere of mutual respect
Treat people as you would like to be treated, turn the other cheek, etc. There may be lots of adages you quote, but which one best describes your facility and the relationships with management and peers on a daily basis?
7: Be sure employees have consumer awareness for the products they produce
Do your employees know who the end consumer is of the product that they are producing every day? Does your culture include a review of consumer complaints and customer complaints with your frontline workers? Listening in to a call center is a very powerful way to help employees understand what affects consumers and how their job is critical to avoiding a food safety or quality issue.
8: Create accountability across the board
Hold folks who do not support the culture in which you are striving to develop or maintain accountable, regardless of their position or stature.
9: Provide positive reinforcement. It’s the best motivator
Work to catch people doing things right and make a big fuss when you do. Positive reinforcement for a job well done is the most powerful motivator. It helps keep every team member on board with food safety commitments.
10: Celebrate often
We spend too much time at work not to celebrate all the good things that are accomplished. Whether it’s a cake and recognition for those that served in the armed forces on Veterans Day or a successful launch of a new product—celebrations are a great way to recognize and reinforce your employees’ hard work. Identifying and correcting mistakes should also be celebrated; they are fertile ground for making changes and provide great nutrients for continuous improvement.
Millions of aluminum and tin-plated steel cans enter the marketplace every day, yet despite the extensive efforts of manufacturing plant quality control systems, a small percentage of the cans may have defects that can result in loss of the can integrity and subsequent contamination of the food products. Quality control operations within manufacturing plants typically have limited analytical chemistry capabilities and must rely on the manufacturer’s laboratory or independent laboratories to help identify and characterize the defects and troubleshoot the operations to eliminate the root cause of the defects. This article will present some of the current technology utilized for evaluating metal can defects.
Metal cans made from aluminum for beer and beverage products have been in use for about 50 years, whereas tin-plated steel cans for food products, have been in use for more than 100 years. Throughout that time, many improvements have been made to the design of the cans, the materials used for the cans (metal and internal/external protective organic coatings), the manufacturing equipment, chemical process monitoring, and quality control methods/instrumentation. The can manufacturing plants and their material suppliers are responsible for product integrity prior to distribution of the cans to food and beverage manufacturing operations throughout the world. Incoming quality control and internal quality control are also quite extensive at those manufacturing locations. Many of the can defects that would result in potential consumer issues are quickly eliminated from the consumer pipeline as a result of the rigorous quality control procedures. Occasionally, defective cans find their way into the marketplace, resulting in consumer complaints that must be addressed by the manufacturers.
The cause of the defects must be determined quickly, even if it means shutting down production lines while waiting for answers and corrective actions. Anything that results in a major product recall will have a high priority for the manufacturers to determine the root cause and take corrective actions. Major manufacturers have extensive analytical laboratories with a vast array of instrumentation and technical expertise for troubleshooting the defects. Smaller manufacturers usually have to rely on a network of independent laboratories to assist with their troubleshooting analyses.
Instrumentation and Methodology
Most major can manufacturing plants produce several hundred thousand to several million cans per day, and any can defects detected during quality control inspections will obviously have major implications. Most aluminum and tin-plated steel cans have an organic protective coating applied on the interior surface. One of the major quality control tests is to determine the amount of metal exposure inside the cans. This is done through the use of Enamel Rater instrumentation in which a sampling of cans are filled with an electrolyte. An electrode is immersed into the liquid and external contact is made with the can’s bottom or side wall. When a voltage is applied to the system, the current generated is directly proportional to the amount of exposed metal; a very small amount of exposed metal is acceptable. By reversing the polarity of the system, exposed metal regions produce gas bubbles as a result of the electrochemical reactions. This allows the inspector to identify the location of the exposed metal. When too much metal exposure is encountered, the troubleshooting process begins immediately.
Figure 1. Stereomicroscope image of a crater defect with an iron oxide (rust) particle in the center. (Click to enlarge)
Visual examination of additional cans from the production line is done, followed by examination with a low-power microscope, typically a stereo microscope, in order to characterize metal exposure defects. Typical defects are craters and/or fisheyes, which are seen as circular dewetting (also known as pullback) of the coating from a solid contaminant on the metal (see Figure 1) or an incompatible liquid, such as machine oil mist (fisheye). Additionally, broken blisters in the coating, known as solvent pops, can occur in the curing oven for the coating, resulting in exposed metal. The metal exposure produces two main problems for the filled food product: Metal migration into the product and corrosion of the metal, which eventually results in perforation and product leakage. Manufacturing plants typically do not have the necessary analytical instrumentation available to identify the contaminants and must send selected samples to the laboratory for the analysis.
Another critical test that is conducted in the can manufacturing plants looks for adhesion characteristics of the internal coatings and external coatings (inks and over varnish). A typical adhesion test involves cutting open the sidewalls and immersing the cans into hot water for a period of time. Upon removal from the water, the cans are dried and a tool is used to scribe the coatings. A tape is applied over the scribe marks and rapidly pulled off. If any coating comes up with the tape, the troubleshooting process must begin. Often, over-cure and under-cure conditions can result in coating adhesion failure. The failure can also be caused by a contaminant on the surface of the metal. Loss of internal coating adhesion can result in flakes of the coating contaminating the product and also metal exposure issues. Adhesion failure analysis is typically conducted in the analytical laboratories.
Analytical laboratories are well equipped with a vast array of instrumentation used to identify and characterize various can defects, including:
Optical microscopes, both stereomicroscopes and compound microscopes, are used with a variety of lighting conditions and filters to observe/photograph the defects and in some cases perform microchemical tests to help characterize contaminants. They are also used to examine metal fractures and polished cross sections of metals looking for defects in the metal that may have caused the fractures.
Scanning electron microscope (SEM) equipped with the accessory for energy dispersive X-ray spectrometry (EDS) are used, in conjunction with the optical microscopes, to observe/photograph the defects in the SEM and then obtain the elemental composition of the defect material with the EDS system. This method is typically used for characterizing inorganic materials. Imaging can be done at much higher magnifications compared to the optical microscopes, which is particularly useful for analysis of fractures.
Infrared spectroscopy, commonly referred to as Fourier Transform Infrared (FTIR) spectroscopy, is used mainly to identify organic materials, such as, oils, inks, varnishes, cleaning chemical surfactants that are commonly found in the can manufacturing operations. Solvent extractions from adhesion failure metal surfaces and the mating back side of the coating are often done to look for very thin films of organic contamination.
Differential scanning calorimetry (DSC) instrumentation is often used to determine the degree of cure for protective coatings on cans exhibiting adhesion failure issues.
Other more specialized instrumentation that is more likely available in independent analytical laboratories includes:
X-ray photoelectron spectroscopy (XPS), also known as electron spectroscopy for chemical analysis (ESCA), is used to analyze the outermost molecular layers of materials. The technique is particularly useful for detecting minute quantities of contaminants, typically thin films involved in adhesion failures. Depth profiles can also be done on the metal to determine thickness of oxidation or the presence/absence of surface enhancement chemical treatments. High-resolution binding energy measurements on various elements can provide some chemical compound information as part of the characterization.
Secondary ion mass spectrometry (SIMS) is also an outer molecular layer type of analysis method. Depth profiling also be accomplished with this instrumentation, but one of the major advantages is the ability to detect boron and lithium which are found in some greases and other materials in the manufacturing facility. To help identify organic films that may have resulted in the adhesion failures, it is often crucial to know if boron or lithium is present, which helps identify a potential source.
X-ray diffraction (XRD) instrumentation is used to identify crystalline compounds, mainly inorganic materials but can also be used for certain organic materials. Inorganic materials, isolated from coating craters, are often identified with a combination of SEM/EDS and XRD analyses.
Three case studies are presented to show how analytical lab instruments can be used to identify and characterize metal can defects.Metal can defects can take on numerous forms, some of which have been discussed in this article. Extensive quality control activities in can manufacturing plants often prevent defective cans from entering the marketplace. Characterizing the cause of the defects often requires major troubleshooting activities within the production plants, supplemented by the analytical laboratories with a vast array of instrumentation and personnel expertise. Due to the huge quantities of metal cans produced each day, it is inevitable that some defective cans will make it to the marketplace, resulting in consumer complaints. High priorities must be assigned to consumer complaints to not only identify and characterize the defects, but also to determine how widespread the defective cans are within the marketplace. In this way, decisions can be made regarding product recalls.
Dark stains were observed on the outer surfaces of ends on tin-plated steel food cans when the cans came out of the retort sterilization system. During gentle scraping with a needle, it was determined that the stains were deposits on the surface of the clear organic protective coating. Portions of the deposits were mounted for analysis by SEM/EDS and revealed a composition mainly of iron oxide with elevated levels of calcium, chlorine and silicon. Other minor and trace elements included sodium, magnesium, aluminum, phosphorus, potassium, and zinc. It was concluded that the residues were water salts and iron corrosion products, which would be consistent with retort water residue. Apparently the retort water was not sufficiently rinsed from the cans upon exiting the retort system. These deposits, being rather loosely adhered to the surface of the coating, could easily wash off into the product when the steel ends are opened with a circumferential can opener.
Case 2
Drawn & Ironed (D&I) tin plated steel food cans are formed in high-speed machines using an emulsified lubricant in the tooling. The cans then go through a cleaning process and as a final step in the process, a water-soluble organic coating, known as a wash coat, is put on the outside of the cans by a flow curtain application method. Numerous consumer complaints were received in which the internal protective coating on the cans was losing adhesion and depositing into the product brine. Examination of the interior sidewalls of sample cans revealed film-like stains near the top of the cans where the adhesion failure was occurring. FTIR analysis of the stains identified them as the wash coat. In this case, some of the wash coat had migrated into the inside of the cans by capillary action during the can washing process. The internal protective coating that was applied later in the can manufacturing operation was not compatible with the wash coat. Several corrective actions had to be taken, which included some modifications to the wash coat flow curtain system and reformulations of the wash coat and internal coatings to make them more compatible for adhesion.
Case 3
Figure 1. Polarized light microscope image, with fully crossed polarizing filters, of the spherulites under the can coating. Click to enlarge
Consumer complaints were received concerning orange/brown stains in or under the internal protective coating of tin-plated steel food cans. Optical microscopy examination revealed that the stains were underneath the coating. Polarizing filters, added to the compound microscope, revealed more optical properties of the stains as shown in Figure 1. They appeared as clusters of spherulites with black crossing lines, known as isogyre lines, and seemed, at first, like typical starch grains. The coating was carefully sliced away with a razor blade in order to expose the spherulites. SEM/EDS analysis of the exposed spherulites revealed high iron, carbon and oxygen content. In order to obtain a better identification of the spherulites, a portion of the can wall was placed into a low-temperature ashing system that removed the organic coatings exposing the spherulites, which could then be isolated and mounted for analysis by XRD. The analysis revealed that the spherulites were iron carbonate. To further confirm the carbonate composition, additional spherulites were mounted on a glass microscope slide and covered with a thin glass coverslip. While observing with a stereo microscope, a drop of 1N HCl acid was placed at the side of the coverslip to wick under the coverslip to make contact with the spherulites. Upon contact with the acid, the spherulites dissolved while emitting large quantities of gaseous bubbles, which is indicative of carbon dioxide gas evolution when carbonates are dissolved in acid.
On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.
“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.
Under FSVP, an importer’s basic responsibilities are to:
Determine hazards reasonably likely to cause illness or injury
Evaluate the risk, using hazard analysis
Evaluate the foreign supplier’s performance
Perform supplier verification activities
Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.
Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.
If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.
Who Is an Importer?
The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.
All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.” The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.
Exemptions to FSVP
FSVP does not apply to the following foods:
Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
Juice (in compliance with juice HACCP in 21 CFR 120)
Food for research or evaluation
Alcoholic beverages
Meat, poultry, and egg products regulated by USDA
Food imported for personal consumption,
Food that is transshipped through the United States
Food that is imported for processing and later export
U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)
Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.
Modified Requirements
Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:
If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.
Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.
Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:
The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.
Modified requirements for very small importers:
Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.
Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):
The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:
Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.
At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.
One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.
News concerning the safety of food seems to be everywhere these days. On a daily basis there’s a story about a salmonella outbreak or a company initiating a product recall due to possible contamination. Why is this the case?
If you visit most food businesses, whether it’s a restaurant, grocery store, manufacturer or foodservice operator, chances are you’ll see the same thing: Employees using pen and paper checklists, forms and log books to manage their food safety operations.
The recent E. coli outbreak traced to Chipotle Mexican Grill infected more than 50 people and led the company to shut down several restaurants. The outbreak was also a PR disaster for the company and damaged its reputation as a reliable provider of safe meals. Chipotle lost out on potential revenue and probably spent a good amount of money on hiring outside food safety consultants to examine its safety standards.
Since starting the business, Chipotle has remained focused on a core mission: Make great-tasting food, and more recently, food that is not modified with GMOs. While its goal has not changed, running a food company is vastly different today than in the past.
Modern Food Safety Isn’t So Modern
For one thing, there is a lot more paper to manage in today’s world. Between time and temperature controls, HACCP and HARPC requirements, and a whole host of industry certifications and brand standards, food businesses implement several safety processes. Even with advancements in technology, food safety operations are often run manually and therefore are error-prone.
In the early 1990s, food companies could handle the volume of paperwork themselves. Today, they’re swamped. Visit a food business, and you’ll see the same thing everywhere: Stacks of documents that need to be typed up and sent to food agencies. As one quality assurance manager recently stated, “We can barely keep track of them all.”
Surrounded by stacks of paper in their office, quality assurance (QA) managers explain that much of the pileup is due to more rules and regulations related to food safety. Food companies must comply with a growing number of local, state and federal laws that regulate food safety. The focus of recent laws such as FSMA is toward prevention of foodborne illness, placing even more emphasis on internal audits and recordkeeping. In addition to these laws, food companies must compete with the wealth of information available to customers about how their food safety operations work. Especially in the realm of social media, as Taco Bell has learned, one photo of an employee playing with food can lead to a PR nightmare.
A Day in the Life of a QA Manager
Complying with food safety laws often falls on a company’s QA manager who supervises food safety. She walks through the facility several times a day with clipboard in hand, reviewing a list of safety and quality measures.
The QA manager will then manually key this data into a spreadsheet, create reports, and file the results with industry partners and government regulators. These seemingly routine and time-consuming compliance tasks matter. Failing to comply with the appropriate laws can lead to costly penalties, permitting delays, loss of business from industry partners (such as retailers with strict requirements), and even legal action.
The legal requirements are often complex, overlapping, and they change every couple of years. The laws are designed, of course, to ensure that food preparation and delivery is safe, thereby protecting consumers. But an expanding body of regulations and fear of litigation have increased the time, cost and stress that play into compliance.
Mobile tools can help companies improve food safety processes.
Improve Food Safety with Technology
So how can companies improve their food safety operations? By using food safety technology, particularly mobile software tools, to improve their processes. Since food safety operations are still manual, they tend to be hard to standardize and difficult to track—especially at larger companies where employees are working in multiple shifts across dozens of locations. Mobile food safety software offers several major benefits:
No More Pen and Paper. Replacing paper-and-pencil clipboards with digital tools saves time and money. Digital audits and task-lists can be logged and tracked, ensuring that staff are performing tasks in real-time. Digital entries are more accountable; managers can confirm when and where tasks where conducted and completed (including requiring photos to be taken). And digital clipboards can be loaded with reference materials like images and training videos, which helps staff learn best practices and prepare for real inspections by government agencies.
Quality and Safety Checklists. Instead of letting employees complete tasks ad hoc and make notes on clipboards and log books, companies can use quality and safety checklists to ensure that key tasks are standardized across the organization. For example, data can be collected to show that a company is always forgetting to label produce with an expiration date. Digital food safety and quality checklists that are loaded on smartphones or tablets makes it easier to ensure that all employees are following brand standards and best practices.
Automated Reports. Instead of sifting through binders filled with audit logs, food safety software captures and stores data in a structured format, making it easy to search and analyze. Why waste hours at the end of every week or month sifting through binders full of paper, when software lets you generate insights with the click of a button?
Real-Time, Centralized Management. Food companies often have multiple locations in which employees are conducting food safety operations in their own way. For companies that have multiple locations, mobile software being used by employees at each location can help corporate managers track performance by location, provide critical alerts, and give employees real-time feedback to help standardize food safety operations.
Here’s an example of a QA manager running a food safety audit using mobile software. During a random spot check, the manager shows up on the line with a smartphone in hand. As she walks around, she pulls up a food safety application and answers a series of pre-set multiple choices questions that cover key criteria, dictates comments into the device using the built-in voice recognition, and takes high-resolution color photos of several problematic issues. If a QA manager is unsure about food safety requirements, she can use her mobile device to quickly pull up a reference document (or even the official code citation) from state, FDA, USDA or other agencies.
After running a digital audit with food safety software, the QA manager can immediately print or e-mail a report that shows all of the items out of compliance, creating actionable intelligence for her team. The QA manager can then share this with line workers during their weekly team meeting, which help to train staff on best practices in food safety.
The data the QA manager collected through her mobile device is immediately stored in the cloud. From there it can be easily accessed by a colleague (i.e., her manager at corporate headquarters) at any time. Over time, the data from each of these spot checks is stored in a central database that a manager can analyze, looking for trends in performance, issues that keep arising, or locations that may need extra training and attention. Mobile software makes it easier to generate insights that can drive major improvements in an organization’s safety and performance.
By using software to help manage food safety audits, logs and line checks, businesses can save time and money on compliance, train staff on best practices, and most importantly, keep customers safe and satisfied.
Today, food safety technology, especially mobile software, should be a critical part of any modern food company’s operations. Mobile audit and task-management software allows QA managers to streamline and standardize quality and safety operations across large teams and multiple locations, helping save valuable time and money. Whether you’re a mobile food vendor or a large-scale food processor, modern software tools can help food businesses of all sizes effectively manage time-consuming tasks around food safety and compliance, from digitizing audit logs for analysis to created automated filings for supply chain partners.
When a business decides to invest in technology, the primary driver is usually to save money over the long term. As with most automated systems, inventory management tools can reduce costs by saving time and resources used to manage inventory.
But the benefits that automated inventory tracking can provide through traceability (of lots, batches, and even individual items) go beyond the financial. These systems can also be used in every aspect of your food safety program from helping with compliance, to improving your quality controls.
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In a nutshell, having an automated system that allows full visibility into the supply chain—that is, one that identifies in real time where items are being used and where they are sent, while retaining a historical record of that flow through the chain—makes it much simpler and faster to implement procedures to ensure the safety of the food you produce.
All about Accuracy and Speed
Speed and accuracy make a huge difference when it comes to dealing with potentially contaminated food. Being faster and more accurate than a manual inventory method is the most immediate benefit that an automated system brings to your food safety program.
The most compelling reason for having accurate and readily accessible track-and-trace data is to handle food recalls and to comply with requests for documentation from government agencies such as the FDA. In cases where consumer health is at risk, that information needs to be delivered quickly to prevent further harm, and it must be accurate to enable investigators to move in the right direction. Responding to requests for detailed documentation within a 24-hour timeframe can be nearly impossible if you are not using an automated system.
Even when the situation doesn’t involve a federal investigation, once a situation in which possible contamination or mislabeling arises, the faster you have accurate and detailed data, the faster your internal processes can move forward.
If the issue is identified through your quality control process, you will be more likely to be able to prevent contaminated product from reaching the retail outlet and thus getting into the hands of the consumer. Having traceability built into your inventory management systems provides immediate knowledge about whether a product using ingredients from the same batch have entered the distribution chain, and if so, where they are going. This greatly improves the likelihood of limiting the cost and scope of a recall.
Depending on the specific technology you employ, an automated system can provide immediate access to the track and trace information for specific ingredients at least one step backward and one step forward, as required by the Bioterrorism Act of 2002. A supply chain that integrates the most sophisticated technology, such as DNA tracking, can trace an item all the way from the farm or border to the individual consumer or restaurant kitchen.
This traceability means that if an ingredient was already contaminated before it entered your production line, the inventory tracking system can identify all products using that ingredient from the contaminated lot and thus will help you define the scope of the problem. This automation can go a step further by identifying where the ingredient lot originated, and thus help trace the ingredient at least one step backward to the vendor. If the vendor (whether a distribution company or a direct supplier) has traceability in an automated system, or if you are using a system hosted by a distribution partner, tracing the source farther back than one step is possible.
Such information can help you respond more quickly to FDA requests for product information and support the agency’s efforts in product traceability.
Protect Your Reputation
Just as using tracing technology can help identify potential contamination sources quickly, it can also be used to eliminate sources more quickly and accurately, thereby speeding up investigations into food contamination incidents. The faster a company can be eliminated from an investigation, the less time is taken away from normal production. In addition, quick exclusion can protect a company’s reputation from harm.
Additional Benefits
Through their ability to store specific data that can be used to identify potential risks, automated track and trace systems contribute to many preventive food safety measures as well as to the following corrective responses:
For perishable products, automated traceability can identify how long specific perishables have been in supply chain. This allows you to avoid using ingredients close to spoilage and to remove overdue products from the distribution chain.
During mock recalls, automated tracking systems reduce the time spent away from regular production and allow you consistent information throughout the organization, eliminating wasted effort due to miscommunications.
Automated systems reduce the time needed for notifications both internally and externally in the case of an incident affecting food quality or safety. This leads to faster line clearance and faster isolation of the possibly contaminated product.
With more effective accounting for possibly affected batches, you can better identify where to apply cleanup measures in the production chain.
In short, automated tracking can improve implementation of preventive controls to stop the contaminated product from reaching the marketplace, and in cases in which corrective actions are required, the automated system can help you respond more quickly and can reduce the scope of risk.
Not just Foodstuffs
Although raw ingredients and food products obviously require traceability, they aren’t the only traceable inventory that can impact food safety. Automated lot tracking can enhance food safety efforts related to all inventory items used in food processing/manufacturing:
Packaging. A sub-standard packaging lot can allow incursion of harmful substances or the growth of harmful bacteria. Leakers can contaminate an entire batch of meat or poultry product. Automated lot tracking can help you rapidly isolate the bad lot and know which production lines have already used the sub-standard materials.
Labeling. If an inferior adhesive has been applied to a batch of labels, you can identify which product lots to pull from the distribution chain. You can do the same if your quality controls find a batch of inaccurate labels.
Protective equipment and clothing. Gloves, masks and other protective gear must function properly to ensure the safety of your workers and also to prevent contamination from being introduced on the production line. An inferior batch of protective gloves that tear during use, for example, could violate your food safety practices. Identifying the bad batch quickly and removing it from the operations area immediately can save potential contamination.
Cleaning solutions. Even a batch of cleaning solution can be sub-par. If tests show that cleaning has not eliminated the targeted bacteria, for example, you can more quickly take measures to determine whether the root cause of the problem was a procedural issue or a quality issue with the batch of cleaner.
Beyond the Production Line
The benefits of automated tracking systems to your food safety program extend beyond the production line. They can also enhance decision-making, vendor management and communications functions.
When it comes to potential contamination, decision making needs to be both timely and based on the best information available. Automated systems can provide you with accurate information quickly to help you answer these and other key questions, so that the decision on what actions to take can be based on good information:
How widespread is the potential contamination?
Where is the product in the production and distribution chains?
Have we already exposed consumers?
These systems can put the answers to these questions in front of the appropriate decision makers early in the process. The technology can be configured to allow access to the data via a browser, so if those who make the final decisions are located elsewhere, they can see in real time the same information that you are seeing in the plant. This makes communication about potential contamination more effective and clear, since everyone can see the same thing at the same time, and it can eliminate the potential for miscommunication up the chain of command.
By identifying where bad lots entered your supply chain, automated track-and-trace can enhance supplier accountability. You can accurately see if you have vendors with recurring issues in the quality of the supplies they are providing.
Automated Inventory Tracking Technologies
An automated inventory tracking system depends on three components:
A physical component, such as a label or tag, which contains detailed information identifying the specific lot or item.
A database, where each discrete data item is stored.
A reporting interface that allows people to access and use the identification information. This is the programming code that performs searches, retrieves the data, and formats the information in a formatted report, which is then presented on the screen, saved to a file, or sent to a printer.
The most common physical components used by automated inventory tracking systems rely on barcode or RFID technology, or a combination of both. The choice of which technology to use to integrate into the inventory management database layer of the system depends on a number of factors, but both have been proven extremely accurate (some sources say up to 99%). What is more important than the choice of tracking tools is the quality of the data encoded in them.
The latest in tracking technology uses an engineered DNA marker, in the form of an edible spray. When applied to produce, this DNA marker can track the individual item (i.e., an apple, head of lettuce or onion), along the entire food supply chain, identifying where it was farmed, the date it was picked, and where it was processed.
Whatever form of technology you employ, ensuring that your data is complete and accurate and can be integrated into both your supply and distribution chain is critical to realizing the benefits of that system in supporting your food safety efforts.
The WDS Food Safety Team also contributed to this article.
No one can contest the power of social media these days. As of August 2015, there were 2.2. billion users of social networks globally, with Facebook still by far the largest social network platform, at nearly 1.5 billion active users. Even if you aren’t on Twitter or Instagram, you have most likely heard or read about topics on them through other media. The influence of social networks to reach so many people makes them perhaps the most powerful communications tool available.
When it comes to a food safety crisis—whether a product recall or a report that a consumer has found a foreign object in prepared food product—you have to assume that messages about it will show up on Facebook, Twitter, Instagram, and even YouTube. From there, it is likely to end up on TV through newscasts as well. If your company maintains silence on social media, the public is likely to assume that you have something to hide, that your company is out of touch with public concerns, or that you just don’t care.
For these reasons, it is important that your food safety program be integrated with a social media crisis communications plan. That does not mean that your food safety team has to create the plan or manage the communications. These responsibilities should fall to your designated communications and public relations personnel. But it does mean that when a food safety issue with potentially harmful effects on public health arises, your food safety team should be aware of the plan and coordinate with the public relations team in the overall response.
The Positive Side of Social Media in a Crisis
The most obvious benefits of using social networks for crisis communications are speed and the large number of people you can reach. In a situation with potential to impact a large number of people, getting accurate information out to the public quickly is important to lower the risk to public health.
Other benefits may not be as obvious. By presenting a consistent and accurate message to a broad audience, your communications can help prevent or counter misinformation. A well-crafted social media post should be clear and concise, and thus is less likely to be misunderstood. That clarity and concision may help to avoid your message being reported as a “sound bite” out of context. And your message is more likely to be transmitted and repeated accurately, as social media users can share it in full.
Studies have shown that frequent communications from a firm can increase consumers’ intentions to comply with a recall effort and, when well handled, actually enhance consumer perception of a company. Thus, a social media crisis communications plan can contribute to action on the part of consumers and to maintain your company’s reputation.
The Downside of Social Media in a Crisis
As with any communications platform, social network communications do have a downside. The social nature of the platforms means that anyone with an account can post a response, and the potential for inaccuracies and outright hostility is very real. How to respond appropriately, and when not to respond at all, takes training and experience. That is the reason that crisis communications need to be handled carefully by the communications experts in your organization.
However, even if you are not the one posting the communications, having an understanding of the plan will help you as you carry out your responsibilities as part of the coordinated response to a food safety incident.
The Basics of a Social Media Crisis Plan
Although each social media crisis communications plan should be tailored for the individual company, the following some common elements of a good plan:
Clear assignment of roles and responsibilities. Who should post/comment/tweet on behalf of the company? All others should avoid commenting about the situation, even if using their own accounts, to prevent confusion and promote consistency.
Identification of the primary social media channel to use during the crisis (and of secondary channels). For example, will you post all relevant information to the corporate website, on Twitter, or on the corporate Facebook page? Picking one channel helps control the messages and makes it possible to funnel users of other social networks to one central source.
Message templates. One template should be for an initial message, indicating that your company is aware of the situation and will be issuing an official statement shortly. Twitter is a good channel to use for this message, but it is also appropriate for your corporate Facebook page. It is also a good idea to include the platform you will be using as your primary channel for communications. For example, the initial message for a company intending to use Facebook as the primary social media communications channel could be “@Company is aware of the [brief description of the situation] and will be issuing an official response soon. For continuing updates, please visit our Facebook page [url].”
Internal contact information (including for after-hours). You should know whom to alert and how to contact them regardless of the time, and under what circumstances you should contact them. This is key information to include in your food safety plan.
Clear procedures and responsibility for cancelling scheduled social media posts. During a crisis, the company needs to prove that situation is their top priority. Pre-scheduled messages about products can send the wrong message.
Guidelines on the frequency and content of messages. For example, measures the company is undertaking and actions consumers can take to avoid the contaminated item(s) should be posted. However, prematurely stating that preliminary measures will completely address the problem should be avoided; otherwise, if you have to increase the scope of corrective measures, your company could lose consumer trust.
Message approval procedures. Identify any specific type of message that requires approval by senior management. However, be mindful that a lengthy approval process for all messages will defeat the purpose for communicating through social media. (That’s one reason why templates are an important part of the plan, as they can be vetted and approved ahead of time).
Message review procedures. On the other hand, all messages should be reviewed before being posted to verify technical accuracy and to ensure clarity and appropriateness. During a crisis situation, you must adhere to the highest standards of professionalism.
Procedures for coordination with regulatory agencies. In the case of a recall, the FDA, CDC and USDA post information on their consumer food safety site at FoodSafety.gov. It is critical that the information provided to these agencies is consistent with messages posted on your social network channel(s).
Coordinating Response and Communications
So what should a food safety professional do regarding a social media crisis plan? Here are some first steps to help with a coordinated response:
Review your food safety procedures to see if procedures for crisis communications are included.
If not, check with your corporate office to find out if there is already a social media crisis plan. Ask to see it, and then update your food safety procedures to include relevant steps to keep the designated contact information updated. If yes, be sure the information in your response plan is current.
Make sure everyone is familiar with the plan and of specific roles and responsibilities. Ensure that employees are trained on what they should expect, and what they should and should not do, regarding social regarding social media during a crisis. Employees should understand that if they post information related to the crisis using their own social media accounts, it can lead to confusion and undermine efforts to protect the public health, as well as affect the company’s credibility.
During a crisis, provide timely and accurate updates to the communications team as appropriate. Be sure to check the designated channels to remain aware of what the company is communicating publicly.
Can Social Listening Lead to Better Crisis Response?
Several major companies in the food industry have found that social listening—the monitoring of social networks for mention of their company and its products—can help them identify a potential problem early. If a consumer post describes finding a foreign object in a can of soda, for example, the manufacturer can quickly reach out to that person through social media to request that the individual contact the customer service department to provide details. That way, an investigation can get underway to determine the accuracy and extent of the potential issue, and the customer can have their situation addressed more quickly and appropriately.
Monitoring the company Facebook page, Twitter ID and hashtags for product names can be a component of proactive measures for averting a larger problem. Better that you find out that someone posted that they found a rat tail in their soup than for you to be blind-sided by a report about it in traditional media.
Public health agencies in New York City and Chicago are also studying the use of social media to identify potential outbreaks of foodborne illnesses in their jurisdictions. They are working to determine if searching restaurant reviews posted on Yelp can help them identify foodborne health issues that have a common source. Results suggest that online restaurant reviews might help to identify unreported outbreaks of foodborne illness and restaurants with deficiencies in food handling.
Don’t Wait Until a Crisis
It is better not to have to learn about the power of social media once a crisis has arisen. Having an understanding of social media’s role in communications and of how your company can use it effectively can help improve your crisis communications efforts.
If you want the public to trust what you say on social media during a food safety crisis, one of the best strategies is to build a reputation as a trustworthy source of food safety information before a crisis occurs. Consider a social campaign around food safety topics, such as how to prepare food products safely, the difference between a sell-by date, a best by date, and an expiration date, and other topics that tell the consumers that you are attuned to their concerns around food safety. If you are considered a trustworthy source of food safety information, your communications during a food safety crisis are more likely to be believed. As a result, you are more likely to be able to protect both public health and your reputation should a crisis arise.
In a future article, we will discuss specific ways to integrate a social media crisis communications plan into your food safety incident response plan.
The WDS Food Safety Team also contributed to this article.
SQF certification is an ongoing process; once you have attained it, you have effectively committed to a continuous improvement program for your business. Conducting regular, thorough and transparent management reviews will play a key role in ensuring that you continue to achieve your SQF goals.
The first and most important thing to understand about management reviews is that they don’t have to be a cost to your organization. In fact, when conducted correctly, these reviews should become the cornerstone of your continuous improvement program, assisting you in measuring company performance against documented objectives.
Once you’ve committed to a management review, it’s important to be aware of the fact that these reviews take significant preparation. The senior management team will be responsible for reviewing the SQF system, preparing for and documenting the review procedure in its entirety. As outlined in clause 2.1.2.4 of the SQF system, there are four key elements against which company performance must be reviewed:
The SQF policy manual
Internal and external audit findings
Corrective actions (investigation and resolution)
Customer complaints (investigation and resolution)
Click to enlarge this document on how to conduct a Management Review Procedure
The management team is required to make adequate resources available for food safety and quality objectives and to support the development, implementation and maintenance and ongoing improvement of the SQF system (clause 2.1.2.3). This team must also establish processes to improve the effectiveness of the SQF system in order to demonstrate continuous improvement (clause 2.1.2.9).
Keeping Good Records
One cannot overstate the importance of thorough and effective documentation of the review, so remember the mantra: If you don’t write it down, it didn’t happen.
Every aspect of your review must be clearly and thoroughly documented. These records are important documents in the SQF audit process and also as benchmarks against which company performance and subsequent reviews can be measured.
Management Review Process
The management review process comprises four key stages:
Identifying objectives
Collecting and analyzing data
Management review meeting
Disseminating results
1. Identifying Objectives
Identifying objectives should be your first step. You cannot start collating data before you know what you’ll be measuring it against. Objectives are essentially short statements that outline what you want your company to achieve in specific business areas. They should encompass a whole-of-company approach in that they should contribute to overarching company goals rather than delivering a one-sided or fragmented approach to continuous improvement. It is important to note that objectives are neither mission statements nor warm and fuzzy statements.
As a general rule of thumb, objectives should be:
Measurable. They should outline specific quantities and quotas for what you are trying to achieve.
Business-specific. Objectives should be relevant to the future of your business and to the individual business improvement process. Don’t worry about what your competitors are doing.
Relevant. Make sure the objectives will have a significant and lasting impact on your business once they are achieved. This might mean choosing complex objectives versus taking the easy way out.
Linked to a key performance indicator. Every objective should contribute to the company’s KPIs and be part of its broader strategic goals..
Clearly defined. Be clear about what you are trying to achieve and how you plan to achieve it.
Documented. Write your objectives down! The review process, future audits and your ongoing improvement efforts will be measured against them, so it is important to accurately capture the details.
Communicated across the breadth of the organization. Don’t make the mistake of keeping them in a filing cabinet somewhere. Put them in the lunchroom, put them in induction packs, hand them out during annual updates—share them with your team so that everybody understands the goals.
2. Collecting and Analyzing Data
Data collection is one of the most time consuming components of the management review process, so have a clear game plan ready before starting. Ask the following questions:
a. What information must be extracted from company records?
Determining the sort of data you need depends largely on your management review objectives. Your data should deliver insights on company performance and provide an evidence base for changes you make to your business processes. As a food company, your SQF systems should monitor and collect data on a wide range of business activities, including:
Swab and microbiological results from cleaning processes
Microbiological results from water supply and product testing, or raw material testing
Insurance and credit claims
Chemical product results
Mock recall tests
Product traceability tests
Think about the data sources that respond directly to the objectives you developed for your review. You should be leveraging the systems you already have to collate information, with a view to feeding the information back into work practices to create a loop of continuous improvement.
b. What format is the data in and how can you make it accessible?
Like most food companies, your company is likely to be home to a mix of paper-based and electronic data. Different data types throw up different challenges when it comes to data acquisition. Paper forms are easy for staff to use and easy for management to collect, but they require double handling in order to translate relevant data into a format that can be analyzed with any degree of depth. Electronic data collection is more useful when it comes to number crunching, but you need access to specific expertise when it comes to data extraction if you want your data to work effectively for you. Newer, more sophisticated data management systems will help automate data collection activities and will also ensure that your database systems can communicate with each other to share relevant information.
Data access is another issue to think about early in the process. Who is responsible for all the different data sets that must be accessed for the review? Is he or she the right person to manage that data? Will he or she be available at the time you need to access the data before the review?
c. Who will analyze the data, and do you have the requisite skills in-house?
Another important element of the pre-planning process is the question of who will analyze the data once it has been extracted from your systems. Does your staff have the skills and time required to conduct effective statistical analysis? Do you have suitable software systems to support the analysis process? If so, you’ll need to allocate each data analysis task to a staff member, making roles, responsibilities and timelines for the analysis process clear. In addition, ensure that all managers have access to (and an understanding of) the previously identified management review objectives so they can target their analysis appropriately.
If you don’t have the requisite data management skills in-house, you need to think through potential solutions during the pre-planning stage, whether it involves providing training for staff or bringing in outside expertise.
Prior to the data analysis process, you should also be looking at your raw data and reviewing data outliers (that is, data that lies above or below the mode)—these can sometimes provide interesting insights about your processes and procedures. It’s important to have an experienced quality assurance team on board before you start assessing your outliers; your QA team should already understand the variables within your processes and procedures, and will therefore be able to identify whether the outliers are one-off data spikes or trends requiring further investigation.
3. Management Review Meeting
a. Meeting preparation
Meticulous preparation is key to a successful management review meeting. Ensuring all meeting attendees are on board with the agenda and meeting outcomes is a good way to get started. First, develop a written agenda and timeline for the review. Think about the timing of your meeting in conjunction with your unannounced SQF audit. Set the date of the meeting with enough time to ensure close off of the corrective actions issued as a result of the meeting. Yes, if you’re doing it properly, you should have corrective actions issued.
Next, you’ll need to get all participating staff members up to speed with the review process. Pull together the requirements of the review, the relevant SQF clauses, customer requirements and company objectives, and put them into a document that can be circulated well in advance of the meeting. Identify the individual managers who will be involved with the review—that is, the managers whose business areas will make a contribution to, or be impacted by, the review process itself. Ask participating managers to prepare the data that is relevant to their key performance areas and to the management review objectives you’ve identified, as this will be distributed at the meeting.
b. At the meeting
Good record keeping is particularly important during the management review meeting itself. Poor documentation can undermine the review and its subsequent outcomes, not to mention the SQF auditing process. As such, it’s important to capture the details of the discussion that occurs at the meeting—you need more than just a few scribbled notes. Nominate a scribe whose sole responsibility is to take notes at the meeting. Ensure they capture (at a minimum) the following:
Meeting date and time
Meeting attendees and no-shows
Discussion of each agenda topic
Key items
Outcomes
Conclusions
Action points
Objectives. Were they met? If not, why not? Do they need to be modified for next year? If so, why, and to what?
Action points, role responsibilities and verification of actions being undertaken
Conclusions
The scribe should also be responsible for compiling all supporting documentation from the meeting for audit purposes and for review prior to future management review meetings.
4. Disseminating Results
Once the review process is completed, any processes and procedures identified as requiring modification must be updated. This is also the time to follow up on action items—your meeting documentation should clearly show who is responsible for each item and their respective tasks. Engage with the staff members responsible for each item at regular intervals to chart their progress, and follow up again at subsequent management meetings to ensure that all actions have been completed.
Communicating review outcomes is very important. Charting a specific course requires an understanding of, and commitment to, that course by everyone involved in the navigation process—and you need your team to understand where you’re going so that they can help you get there. This means communicating all the outcomes, both good and bad, to all relevant personnel, and taking the time to thank and congratulate staff who were instrumental in achieving positive results.
The last step of the review process is to share your success—don’t let your hard work go unnoticed! Communicate the value of the review both to your team and your superiors, and demonstrate the link between the review itself and the achievement of individual, team and company KPIs.
Conclusion
A completed management review will deliver significant benefit to your company in the form of documented, measurable and communicated objectives that are reviewed on an annual basis. Additional benefits include:
Increased business value
Enhanced safety (for staff) and quality of product (for clients)
A more targeted approach to business strategy
Reduced financial risk and increased profitability
In order to ensure that a food testing laboratory maintains a quality management system that effectively manages all aspects of laboratory operations that affect quality, there are numerous records, reports and data that must be recorded, documented and managed.
Gathering, organizing and controlling all the data that is generated, managed and stored by food testing laboratories can be challenging to say the least. As the ISO Standards and regulatory requirements for food testing laboratories evolve, so does the need for improved quality data management systems. Historical systems that were very efficient and effective 10 years ago, may no longer meet the demanding requirements for ISO 17025 certification. One way to meet the challenge is to turn to automated solutions that eliminate many of the mundane tasks that utilize valuable resources.
There are many reasons for laboratories to seek this certification, including to enhance reputation, gain a competitive advantage, reduce operational costs, and meet regulatory compliance goals. A major advantage for food testing laboratories to obtain ISO 17025 Certification is that is tells prospective clients that the laboratory has a strong commitment to quality, and they hold the certification to prove it. This certification not only boosts a laboratory’s reputation, but it also demonstrates an organization’s commitment to quality, operational efficiency and management practices. Proof of ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Many ISO Certified laboratories will only buy products (raw materials, supplies and software) and services from other ISO-certified firms so that they do not need to do additional work in qualifying the vendor or the products.
There are many areas in which a LIMS supports and promotes ISO 17025 compliance. Laboratories are required to manage and maintain SOPs (standard operating procedures) that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, managing all test methods, and managing all documents pertaining to quality. In addition, all contact with clients and their testing instructions should be recorded and kept with the job/project documentation for access by the staff performing the tests/calibrations. With a computerized LIMS, laboratory staff can scan in all paper forms that arrive with the samples (special instructions, chain of custody (CoC), or any other documentation). This can be linked to the work order and is easy assessable by anyone who has the appropriate permissions. The LIMS provides extensive options for tracking and maintaining all correspondence, the ability to attach electronic files, scanned documents, create locked PDFs of final reports, COAs (Certificate of Analysis), and CoCs.
Sample Handling and Acceptance
Laboratories are required to have a procedure that defines all processes that a sample is subjected to while in the possession of the laboratory. Some of these procedures will relate to sample preservation, holding time requirements, and the type of container in which the sample is collected or stored. Other information that must be tracked includes sample identification and receipt procedures, along with acceptance or rejection criteria at log-in. Sample log-in begins and defines the entire analysis and disposal process, therefore it is important that all sample storage, tracking and shipping receipts as well as sample transmittal forms (CoC) are stored, managed and maintained throughout the sample’s analysis to final disposal. To summarize, the laboratory should have written procedures around the following related to sample preservation:
Preservation
Sample identification
Sample acceptance conditions
Holding timesShipping informationStorage
Results and Reporting
Disposal
The LIMS must allow capture and tracking of data throughout the sample’s active lifetime. In addition, laboratories are also required to document, manage and maintain essential information associated with the analytical analysis, such as incubator and refrigerator temperature charts, and instrument run files/logs. Also important is capturing data from any log books, which would include the unique sample identifier, and the date and time of the analysis, along with if the holding time is 72 hours or less or when time critical steps are included in the analysis, such as sample preparations, extractions, or incubations. Capturing the temperature data can be automated such that the data can be directly imported into the LIMS. If there is an issue with the temperature falling outside of a range, an email can automatically be spawned or a message sent to a cell phone to alert the responsible party. Automation saves time and money, and can prevent many potential problems via the LIMS ability to import and act on real-time data.
If any instrumentation is used in the analysis, the following information must also be recorded in the instrument identification (to ensure that it is in calibration, and all maintenance and calibration records are current), operating conditions/parameters, analysis type, any calculations, and analyst identification. In addition to analyst identification, laboratories must also keep track of analyst training as it relates to their laboratory functions. For example, if an analyst has not been trained on a particular method or if their certification has expired, the LIMS will not allow them to enter any result into the LIMS for the method(s) that they have not been trained/certified to perform. The LIMS can also send automated alerts when the training is about to expire. Figure 1 shows a screen in the LIMS that manages training completed, scheduled, tests scores, and expiration dates of the training, along with the ability to attach any training certificates, exams, or any other relevant documentation. Laboratory managers can also leverage the LIMS to pull reports that compare analyst work quality via an audit report. If they determine that one analyst has a significant amount of samples that require auditing, they can then investigate if there is a possible training issue. Having immediate access to data allows managers to more rapidly identify and mitigate potential problems.
LIMS manages a variety of aspects in training, including when it has been completed, scheduled, tests scores, and expiration dates. (Click to enlarge)
Another major area that a LIMS can provide significant benefit is around data integrity. There are four main elements of data integrity:
Documentation in the quality management system that defines the data integrity procedure, which is approved (signed/dated) by senior management.
Data integrity training for the entire laboratory. Ensures that the database is secure and locked and operates under referential integrity.
Detailed, regular monitoring of data integrity. Includes reviewing the audit trail reports and analyzing logs for any suspicious behavior on the system.
Signed data integrity documentation for all laboratory employees indicating that they have read and understand the processes and procedures that have been defined.
The LIMS will enhance the ability to track and manage data integrity training (along with all training). The LIMS will provide a definition of the training, the date, time, and topic (description); instructor(s); timeframe in which the training is relevant, reminders on when it needs to be repeated; along with certifications, quiz scores, copies of quizzes, and more. With many tasks, the LIMS can provide managers with automated reports that are sent out at regular time intervals, schedule training for specific staff, provide them with automatic notification, schedule data integrity audits, and to facilitate FDA’s CFR 21 part 11 compliance (electronic signatures). The LIMS can also be configured to automatically have reports signed and delivered via fax or email, or to a web server. The LIMS manages permissions and privileges to all staff members that require access to specific data and have the ability to access that data, along with providing a secure document control mechanism.
Laboratories are also required to maintain SOPs that accurately reflect all phases of current laboratory operations such as assessing data integrity test methods, corrective actions and handling customer complaints. Most commercial LIMS provide the ability to link SOPs to the analytical methods such that analysts can pull down the SOP as they are doing the procedure to help ensure that no steps are omitted. Having the SOPs online ensures that everyone is using the same version of the locked SOPs, which are readily available and secure.
Administrative Records, Demonstration of Capability
Laboratories are required to manage and maintain the following information on an analyst working in the laboratory: Personal qualifications and experience and training records (degree certificates, CV’s), along with records of demonstration of capability for each analyst and a list of names (along with initials and signatures) for all staff that hold the responsibility to sign or initial any laboratory record. Most commercial LIMS will easily and securely track and manage all the required personnel records. Individuals responsible for signing off on laboratory records can be configured in the LIMS to not only document the assignment of responsibility but also to enforce it.
Reference Standards and Materials
Because the references and standards that laboratories use in their analytical measurements affect the correctness of the result, laboratories must have a system and procedures to manage and track the calibration of their reference standards. Documentation that calibration standards were calibrated by a body that can prove traceability must be provided. Although most standards are purchased from companies that specialize in the creation of reference standards, there are some standards that laboratories create internally that can also be traced and tracked in the LIMS. Most commercial LIMS will also allow for the creation, receipt, tracking, and management of all supplies in an inventory module, such that they document the reference material identification, lot numbers, expiration date, supplier, and vendor, and link the standard to all tests to which it was linked.
The ISO 17025 Standard identifies the high technical competence and management system requirements that guarantee your test results and calibrations are consistently accurate. The LIMS securely manages and maintains all the data that supports the Quality Management System.
Key advantages of food testing laboratories that have achieved ISO 17025 Certification with a computerized LIMS that securely and accurately stores all the pertinent data and information:
Proof of ISO 17025 Certification eliminates the need for supplier audits, because the quality, capability and expertise of the laboratory have been demonstrated by the certification.
Knowledge that there has been an evaluation of the staff, methods, instrumentation and equipment, calibration records and reporting to ensure test results are valid.
Verification of operational efficiency by external auditors that have validated the quality, capability and expertise of the laboratory.
Defines robust quality controls for the selection and authentication of methods, analyzing statistics, controlling and securing data.
Clearly defines each employee’s roles, responsibilities and accountability.
Confidence that the regulatory and safety requirements are effectively managed and met in a cost efficient-manner.
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