The Sanitary Transportation of Human and Animal Food rule goes into effect June 6, 2016. Large businesses must comply by April 6, 2017; small businesses must comply by April 6, 2018. The rule governs the protection of food during transport, including the sanitation of transport vehicles and equipment, refrigeration of food for safety, and proper cleaning of bulk transport vehicles between loads. So you’ll need a game plan…but what should your game plan include?
Read the rule—every word of it—to understand the reasoning behind the decisions made in crafting it and to get a glimpse into how it will be regulated and enforced.
Review all of your processes, protocols, procedures, and contracts to ensure compliance with the rule, and outline responsibility for how you’ll manage the safe transportation of food.
Close any gaps in your current programs to ensure you’ll meet the regulations well in advance of the compliance date.
Kick the tires by conducting mock inspections. Find non-compliances and give yourself time to correct them, rather than wait for bad news during a real inspection.
Confirm the accuracy of all your documentation on a regular basis. Documentation can be the difference between success and failure when it comes to proving that you’re doing the right things.
Get all stakeholders on board to empower employees at all levels and drive culture change.
Establish a driver training program to ensure compliance with the Sanitary Transport rule. Image courtesy of Alchemy Systems (Click to enlarge)
Use Driver Training to Prepare
Drivers are the conductors of the food supply chain. They literally have loads of responsibilities, including maintaining the cold chain, meeting delivery requirements, practicing safe driving always, and meeting all Department of Transportation regulations and requirements. Whether transporting raw materials, packaging, work-in-progress, or finished goods, drivers are the people that keep food safe in transit. So how can you take advantage of your driver training program to ensure compliance with the Sanitary Transport rule?
A blended learning strategy, combining online and instructor-led training, has been shown to provide the best food safety training outcomes.
Use online lessons to introduce and reinforce knowledge of new FSMA regulations and food safety awareness topics. Digital lessons are economical, learner-paced, provide consistent messaging, and are accessible 24/7.
Use hands-on direct instruction for refreshers or for topics like proper vehicle inspections, reefer unit checks, cargo securement, etc.
Subject matter experts should conduct any instructor-led training using a skills check-off approach to document driver’s abilities and to ensure that drivers perform to standard.
Group and prioritize drivers for training based on their compliance history.
Use online lessons and safety messaging proactively to sustain driver compliance and performance.
Use online training at least quarterly, but use safety messaging monthly. Drivers, like all learners, need regular reminders in order to break old habits and form new ones. Communications programs can provide multi-touchpoints to reinforce new knowledge, shift behaviors, and help ensure compliance.
Put Your Game Plan Into Action
The Sanitary Transport Rule is a reality. Now is the time to put written procedures and protocols in place and make sure all stakeholders have a clear understanding of them. Determine precisely who has responsibility for compliance throughout the distribution channels. A blend of online and face-to-face training will ensure compliance, increase performance, and protect foods during transportation operations. The benefits far outweigh the cost.
WATCH VIDEO I: Apply Behaviorial Science Techniques to Food Safety Most people are influenced by the behavior that surrounds them, especially in a professional environment. In part III of a video series of his presentation at the 2015 Food Safety Consortium, Frank Yiannas, vice president of food safety at Walmart, discusses the key role that behavioral science plays in food safety culture and how companies can build a stronger culture by considering the principle of social norms.
Yiannas also touches on how learning through the mistakes of others can be an effective teaching tool.
“I think we have to teach food safety the wrong way sometimes to teach it the right way,” said Yiannas. “I think a lot of food safety professionals create curriculum and modules that are teaching it the right way…when the research is clear—teaching the wrong way can be pretty good.”
Across the board, increased employee awareness and training has become a big issue in food safety. The foodborne illness outbreaks that hit Chipotle Mexican Grill has put retail and restaurant establishments on high alert, yet this is just another example of the reactive culture in which we operate, according to Matt Schiering, vice president and general manager at Sani Professional.
“Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean,” says Matt Schiering of Sani Professional.Food Safety Tech recently hit the road with Schiering and John Caton, regional sales manager at Sani Professional, to experience first hand how one company is communicating its message to customers. Breaking with tradition has been an important part of promoting cleaner technology: The use of the rag and bucket as a means to clean both the front of the house (tables, chairs, counters, etc.) as well as the back of restaurants and retail establishments, while still fairly common, has outlived its effectiveness, and frankly, says Schiering, “screams unclean”. Caton and Schiering continued the conversation with their customers about how using disposable wipes for cleaning, sanitizing and disinfection helps prevent the spread of contamination, along with the cost savings associated with using such products. The company takes a multi-prong approach to promoting awareness among its current and potential clients, from deploying a sales force that directly interacts with quality assurance and food safety professionals in establishments to offering how advances in sustainable technology can help them stay ahead of the curve to driving consumer advocacy.
Food Safety Tech: How is Sani Professional raising the level awareness of the disadvantages of the traditional cleaning method (the rag and bucket method) in the retail environment?
Matt Schiering: There are a few ways to raise the level of awareness. The first and foremost is “feet on the street”. We’ve deliberately moved toward a direct-to-customer sales force, which gives us the opportunity to interface directly with QA, food safety and operations to show them a simpler, more efficient, more effective, and guest appealing way versus the traditional rag and bucket. The first win is one for the user (the employees of a given establishment), because associates have shown us time and time again that they do not like the mixing and measuring, and the errors that are often associated with that process. They don’t like the dirty rag itself—having to fish it out of the bowl and then present it or be seen with it in the front of the establishment. It’s a win for the operator (the manager), because with our system, there’s no longer any heightened heart rate when the health inspector shows up. One of the most common violations is the water in the buckets being out of spec or the rags themselves not being inside the bucket per regulation. And perhaps most importantly, it’s a win for the guest. Think about your own restaurant experiences. Guests don’t want to see or be confronted with a greyish brown rag [that is used to] wipe a table, then wipe a seat, then wipe an adjacent table. It just screams unclean.
As we talk about the evolution in perception, away from traditional methods, we believe that speaking directly to the consumer has to play a role. There has to be a degree of consumer-driven advocacy for a better way. – Matt Schiering
FST: Regarding employee training, how should retailers be more proactive in ensuring their employees are engaging in proper food safety practices and aren’t spreading foodborne illnesses?
Schiering: It varies by chain. Unfortunately, we live in a reactive culture—and that goes well beyond the restaurant industry.
Oftentimes a problem precedes a protocol or other means of addressing said problem. Chipotle is one example: They’ve taken an exhaustive look at restructuring their food safety protocols as a result of a myriad of foodborne illness-related issues that they suffered in the preceding months. The [retailers] who are doing it best are the ones who build it into their establishment in the first place where it’s not predicated by some sort of problem. That involves training materials, in-service lessons, and online training (i.e., ServSafe certifications). Waffle House, for example, has Waffle House University where food safety is a key component to that system.
We envision ourselves as part of that process. We take a microcosm—the notion of proper food handling, prevention of cross contamination related foodborne illness—and provide an innovative and easy-to-use solution, and all the training and collateral materials associated with the solution that explain the proper use. We also provide test kits so that if the health inspector wants an in-the-moment proof that our product is doing what the label says it does, [the retailer] can provide that at a moments notice. It becomes more of a service proposition than simply a product-driven solution.
Using disposable wipes for cleaning, sanitizing and disinfection can help prevent the spread of cross contamination and foodborne illness.
FST: Where do you see sustainable products fitting into the space?
Schiering: This also boils down to education, because the perception of disposables is that they’re wasteful, when in fact they needn’t be any more costly than existing solutions.
If you’re using a linen service, there’s a cost associated with renting towels, but there’s a higher cost associated with wasting towels. So if a towel ends up in a gym bag or in the trash because of overuse and/or abuse, there’s a significant upcharge for not returning that towel to the rental agency. That’s what we call the hidden cost or the dirty little secret of rag and bucket sanitizing. When you factor that in, and everyone [retailers] experiences that type of loss, and you look at the fact that sanitizing wipes kill pathogens trapped in the wipe as well as whatever it is coming into contact with at the surface, thereby enabling it to be used on multiple surfaces without causing cross contamination—the cost aligns very closely. And of course it’s a more value-added guest experience than a dirty rag being used from table to table, which is not preventing cross contamination.
Speaking to the environmental piece: At the moment, we’re actually fairly well ahead of the industry. It varies chain to chain—some chains are doing a better job than others, because it’s part of their corporate culture. But by providing solutions that are leveraging either recyclable substrates or compostable substrates, we provide greater opportunity to reduce the environmental impact often associated with disposable products. If a retailer is working with a waste management partner that can handle industrial compostable products or non-solid state recyclables, we have solutions that are appropriate for those operations, so that we’re not just adding to landfills but rather essentially recycling and/or regenerating the products that are being used, and at no greater cost.
Most retailers haven’t gotten there yet. It speaks directly to corporate culture and corporate mission of the end user. We deliberately target customers who are a little bit ahead of the curve when it comes to “green technology or “green behavior”. And so when the rest of the industry catches up, we’re more than ready to serve them with products that meet those needs.
FST: Where do consumers fit into the picture, especially has industry moves away from traditional methods in food safety?
Schiering: About a decade ago, consumers started demanding that retailers like Walmart, Target, and local grocers provide a means of sanitizing shopping carts when they walk into their local retail establishments. There were myriad news reports about the germs and potential for contamination and illness arising from the often used and rarely cleaned implements—these vehicles for placing your groceries. We answered the call a decade ago, and at one time it was a significant piece of our business. It continues to be a marketplace we serve, albeit a much commoditized one. But the rise in that solution would not have taken place if not for consumers advocating for a better way.
We’re starting to create a presence on Facebook and other social media outlets to remind consumers that it’s up to them in many cases to ask for, if not demand a more effective, more pleasing way of ensuring their safety in dining establishments. Unfortunately, incidents like what we saw at the large Mexican food service retailer do ultimately play a part in that consumer advocacy, albeit a negative one, because we are a reactive society. But by presenting a positive message and sharing alternatives in the absence of citing examples or shaming retailers through the problem, we believe that will be one of the keys to changing perceptions at the retail level.
Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.
Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.
Food Safety Tech: How has FSMA changed the landscape of employee training?
Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.
Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.
FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?
Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.
Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.
Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.
The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.
FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?
Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.
The food industry is becoming increasingly fast-paced. Regulations are changing, the supply chain is becoming more transparent, and resources are harder to access. To meet the needs of an ever-changing industry, digital learning is becoming the go-to solution for training managers and frontline food handlers alike, as it can be done quickly and efficiently. Now that most people have smartphones and mobile devices, there are multiple ways to make learning accessible.
Image courtesy of Alchemy Systems
The “Mind of the Food Worker” study conducted by the Center for Research and Public Policy (CRPP) points out that food workers have developed a preference for digital training over traditional classroom or instructor-conducted training. There are many new approaches to learning, including web-based eLearning, kiosk, gamification/competition, social media, digital signage, and coordinated communication programs. Let’s take a closer look at each of these.
eLearning
eLearning is no longer about reading through a PowerPoint presentation or watching a pre-recorded video. The number of companies offering eLearning continues to increase, as do the topics, content and format of the content. In addition, eLearning carries the added benefit of being affordable. For many companies, saving on the cost of travel when an individual attends a workshop provides an attractive incentive.
The ability to learn at one’s own pace at the time and place of one’s choosing has special appeal for today’s learners. The availability of eLearning via mobile devices is meeting that desire. It can be seen everywhere—people glued to their mobile devices while waiting in line, taking a lunch break, or in the evenings on their own time. This is multitasking at its finest.
Kiosks
The ability to take a device to a quiet environment helps with concentration and efficiency in training. Kiosks can be set up in an area that is conducive to learning with no traffic, noise or other distractions and are popping up at workplaces more and more. Learners can come and go at their convenience. A learning lab set up in a manufacturing facility will pay for itself very quickly. Sending workers to the lab one at a time is much more cost effective than shutting down a line or area of the plant for group or classroom training.
Gamification
Gamification, the use of interactive tools in conjunction with learning, is a term being used more often in training industry vocabulary. For example, it can involve the addition of a word and a definition-matching exercise in conjunction with a training module to encourage learners to retain what they have just learned. It also makes the education process more fun—and it seems to be working.
Gone are the days of sitting through hours and hours of dry lectures or reading textbooks that simply do not resonate. This method has always been especially difficult for employees working in a food plant. Sitting in a warm darkened room listening to a droning presentation is an invitation to sleep. Gamification eliminates the droning, and requires attention and participation.
The Association for Psychological Science has confirmed that competition engages learners, drives retention, and leads to higher test scores. Got a boring topic for training? Get your game on! A great example of gamified learning that is readily available is Merriam-Webster’s Word of the Day. Sign up for free and receive a daily email with a new word, along with its pronunciation, definition(s), use and history. The email also links to several great games that provide word calisthenics for the brain.
Social Media
Leveraging social media helps to expand and continuously improve training programs. This mode of technology will ensure that every employee in a company has timely, consistent answers to questions. Using private company social media provides a safe environment for posting questions and answers while complementing a training program and filling any knowledge gaps. The CRPP study points out that 80% of workers regularly use public social media platforms such as Facebook and LinkedIn.
Companies can take full advantage of this familiarity with social media by providing an internal forum that encourages open discussion and group learning. This approach enables the workforce to engage in an interactive learning path that is continually up to date. Internal social media also encourages networking, which fosters a sense of camaraderie between individuals, along with company loyalty. One major food company that has used this approach has seen employee questions flourish from 3,000 entries in the first year to more than 15,000 the following year. What an incredible way to keep the workforce updated minute by minute with appropriate, relevant answers to their inquiries.
Today the Center for Research and Public Policy (CRPP) released a survey that highlights several key findings related to how frontline food workers operate and approach their jobs. Commissioned by Alchemy Systems, the annual “Mind of the Food Worker” survey revealed enthusiasm on the part of these employees to continue to grow and move up the ranks within their organizations while also underscoring what has become an increasing problem across all U.S. industries—the fact that employees still show up to work when they’re ill.
Food & workplace safety. All graphics courtesy of Alchemy Systems
“Leadership doesn’t believe that people go to work when they’re sick,” Holly Mockus, product manager at Alchemy, told Food Safety Tech. “If people are sick, they should stay home. Not only are we talking about [infecting] people who you’re working with, but we’re also talking about foodborne illnesses that can be transmitted into food.” Employees go into work when they’re sick for a variety of reasons: They don’t want to let their fellow coworkers down (46% provided this response in the survey); they feel peer pressure as a result of staff shortage; or they feel they simply don’t have a choice due to attendance policies and can’t afford to lose pay (more than 45% of respondents gave this answer). “As an industry we have to take a look at the policies and procedures, along with the way that we’re staffing, and see what we can do to alleviate this [issue]”, says Mockus.
Good News on the Frontlines
Worker confidence reflects a paradigm shift in the food industry.
When confronted with a food safety or product issue, 93% of respondents said they had the confidence to stop working. “The industry has made the paradigm shift that we’ve all been striving so hard to achieve over the last several years,” says Mockus. “The fact that [food workers] understand their role, food safety and workplace safety, and are willing to take responsibility to ensure they stop something that is going awry—that was a very positive thing to come out of the survey.”
The other area of optimism on the frontlines concerns the enthusiasm of workers in improving performance—67% of respondents expressed an interest in being involved in the development of training. This response indicates a movement towards more proactive employees who want to be part of the solution and make a difference. The key takeaway here is for corporate leadership to leverage the institutional knowledge that these in-house frontline workers have to further improve the business and how it operates.
“The food industry needs to take a step back and stop thinking about their workers as hourly workers and instead as an asset to the business,” says Tara Guthrie, communications at Alchemy. “Right now they’re not traditionally viewed as human capital in a corporate world, but they could be a big asset and have a big impact on the bottom line.”
How Employees Learn: A Shift in Mindset
Businesses need to change how they collaborate with and train employees.
Millennials and the reliance on technology have changed how employees learn and operate in the workplace. Within the leadership survey results, nearly 33% of respondents are making changes to adjust to how millennial employees learn. “Traditional management style doesn’t always work well with millennials,” says Mockus. This particular generation is also more in tune with using technology to communicate—even when they are sitting across from each other. Mockus indicates that leadership needs to clearly communicate to millennials the importance of understanding their role within their organizations, especially from a day-to-day operation level, as well as present information in a manner that captures their attention, allows them to retain the information, and enables them to put it into practice every day. This strategy should also extend to other generations of frontline workers. “I think all of us have become accustomed to having immediate information that is encapsulated and contained within a few words,” says Mockus. “We are so used to scanning information and moving on. We have to keep in mind that the way in which people are learning, retaining information and using it is changing. Companies that work toward accommodating those millennials will also be doing a good service for the rest of the adults in the workforce.”
The survey found some key findings related to communication gaps that impact the workforce.
The survey polled more than 1200 food employees working within production, processing, and distribution—from farms and ranches to slaughterhouses and food processing plants to commercial bakeries, retailers and distributors. It was conducted earlier this summer, and employees were located in the United States and Canada. One of the goals of the survey is to give the industry active takeaways to further drive safety in the food supply. “We are trying to understand the food workers because they’re such an important part of the whole supply chain,” says Mockus. “They are the most important ingredient in every product that is produced.”
Next month’s Food Safety Consortium conference will address issues related to employee training, Food Safety Culture, compliance and much more. Register here. The event takes place November 17-20 in Schaumburg, IL.
After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.
The Retail Program Standards include:
Promoting the adoption of science-based guidelines from the FDA Food Code
Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
Implementing risk-based inspection programs
Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination
The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.
Restaurants can face major risks related to pest activity, which is why a proper Integrated Pest Management (IPM) program must be in place. However, restaurant owners are not the only ones who should play a part in the IPM program; employees should participate as well.
Often times, live pests are sighted in restaurants, which can result in immediate consequences to a restaurant owner’s bottom line. Therefore, restaurant employees should be trained on how to prevent and react to pest sightings in their establishment.
The following tips will help restaurateurs get their employees on board with pest management:
Contact a pest management professional for a complimentary on-site employee training that will teach employees the importance of pest management and how it could affect the diners’ experience.
Diners have zero tolerance for pests. Ensure employees know the protocol for pest sightings, which should include:
Catching the pest for identification
Recording when, where and how many pests were seen
Assisting your pest management professional to determine the method of treatment.
The most productive way to keep all employees involved in pest management is to add one or two pest control responsibilities to their daily routine. These responsibilities should align with employees’ roles and can be as simple as regularly emptying trash cans and re-lining them, or clearing and sweeping food debris.
In common employee areas, post educational materials such as sanitation checklists and pest identification sheets that provide information on common pests and potential health threats.
Establish an open line of communication that encourages all employees to report pests immediately. Remember that employees can bring pests into the restaurant on their belongings from home, so it’s important that they know pest sighting reports are encouraged to prevent pest activity in areas such as break rooms, the kitchen or the dining area. Fostering an open line of communication will help restaurateurs get ahead of any pest issues and related health and safety threats.
This article describes eight traits to look for in a good Document Control System, and the overlying benefits that can be reaped from using Document Control to drive compliance in your processes.
Document Control is one of the most common applications in compliance today. It allows an organization to manage the creation, approval, distribution and archiving of all controlled documents and processes. It is an integral part of Quality, Environmental Health and Safety (EHS), or Compliance Management systems. This is because in order to effectively maintain consistency in processes, job descriptions, work instructions, and more, an organization needs to ensure that records are controlled. It also keeps tasks on track and ensures that they are accomplished on time. This article describes eight traits to look for in a good Document Control System, and the overlying benefits that can be reaped from using Document Control to drive compliance in your processes.
Eight characteristics of an effective Document Control System
1. Workflows for All Document Types: No two document types are alike. There are differences within each that should be taken into consideration. For example, a job description cannot be treated the same as a work instruction or procedure. Each of these types of documents may have separate approvers, managers, and workflows and should be handled in a unique manner. A good Document Control System can automate and manage documents efficiently. A great Document Control System can facilitate dedicated workflows for all document types, each complete with their own routing options.
2. Ability to Configure Metadata: When in the Document Control form, one of the critical aspects is the ability to segment that data and describe the type of document. This is accomplished through metadata, which is essentially a high level description of each document. It assigns a department that the document is associated with, describes priority level, ISO elements, and records specific information. Metadata also helps to categorize and report on data. It helps to search and filter so it can be found in the system and categorized. The key for an organization is to find a system that will allow it to configure metadata based on document type, in a flexible manner. This will allow them to change fields, add categories, keywords, and more. This configurability within Document Control forms is critical to adapt the Document Control System to meet unique business needs.
3. Integration with MS Office Documents: The majority of organizations use Microsoft Office to manage most of their documents and files such as Word, Excel, and PowerPoint are still the standard for creating documents within businesses today. Therefore, the ability for a Document Control System to work well with MS Office is an important distinction. This way, an organization can preserve the metadata and sync both components. If a change is made in the Document Control form, it is reflected in the Word file, and vice versa. This integration links the two components together, so that one is never inconsistent with the other.
4. Intelligent Business Rules for Review and Approval: The power of an automated Document Control System lies in its ability to route documents along the workflow. Documents can’t just be checked in or out, there needs to be a process of approval and review as well as document sign off —it has to go through different phases of workflow. This makes flexible routing options a necessity in a Document Control System. A good Document Control System enables organizations to route documents to the next phase in the workflow, but also has intelligent business rules associated.
5. Integration with Employee Training: A critical component to any Document Control System is that if a new document is created or an existing document is changed, people need to be trained. This is a vital reason for having Document Control process. During revision or creation of a document, the user should be able to specify the type of training associated with it. A bonus is the ability to automatically integrate training. Some companies include a “waiting release” phase. This means that before the document is released, it is out in a holding pattern—this is when training happens. The benefit is that employees can train on the document before it is released to world, so that when the document is released employees are already trained and knowledgeable on it. Some systems automatically have a Training System built into Document Control, which allows them to integrate Training with Document Control and to test their knowledge on that document. Ultimately, when there are changes made to any document, employees need to be apprised of new procedures and specifications and trained on any new revisions that are released. This process should be automated—manual tracking and training processes leave room for error. A Document Control System integrated with the Training application helps to easily define who needs training on each document. It also automatically updates training records for each employee, allows for self training, and automatically updates each employee status upon training completion.
6. Change Request and Revision Control: Document Control is a continual process. Once documents are created and approved, there will most likely be changes made in the future. Change control and revision control in itself should be a workflow to ensure controlled access of all documents and changes to documents. A good Document Control System will have its own change request workflow that includes revision review and approval. It will also hold the original document until the new document is changed—once the new document is approved, it will take the old document’s place. Sometimes an organization will have changes that affect multiple documents. In this case, the system should be able to make a global change. This allows an organization to make multiple document changes within the same workflow and will show all documents to be changed, all affected areas, and where it will be changed. This is important because when making changes to a document, other documents may be involved or affected. A good Document Control System includes a multi-document change request that will save time and resources for the company.
7. Reporting: When an organization has a lot of documents and data going into the system, it needs visibility to look at that data in a meaningful way. Using metadata can help by filtering documents by phase, keyword, and more. Having a system to filter data this data is key. Good Document Control has reporting engines built into, or tied to it. This allows the system to quickly and effectively look at data on aggregate level, and run ad hoc reports, scheduled reports, and template reports on the health of the Document Control System. People want to be apprised of where overdue documents so they can take steps to fix them. Reporting provides this visibility.
8. Intuitive Filtering and Data Security: Within any system, the ability to ensure secure data and documents is critical. An organization wants to make sure that appropriate levels can access, approve, review and make necessary revisions to the document. A good Document Control System will have the security in place that will allow the organization to filter each document to appropriate security levels. In multisite, centralized systems, filtering and securing data often becomes a concern. An effective Document Control System lets an organization limit data visibility to only what is necessary to the user. Depending on the access level of the user, the visibility of documents will change. This ensures that an organization can operate in their Document Control System safely and securely.
Summary
The Document Control System is major information hub for the Quality system and sets the foundation for doing business in a compliance context. It sets the policies, the practices and the enforceable regulations that drive the company’s Quality and EHS initiatives. A good Document Control System will intelligently automate the review and approval process. It will link documents and records so that information is easily transferred, and will foster a platform for intelligent business rules and change management. It allows the integration of Document Control with the Change Management System to simplify change requests and allow single revisions; with Employee Training to efficiently train employees on new documents; and with Deviations to ensure that employees are aware of any planned deviations and these are tracked to completion. The eight traits of an effective Document Control System, combined with the overreaching benefits of the quality system, provide a holistic system for managing documents and extending to the other crucial areas of the enterprise. The QMS is the guide to making sure this is done as easily and effectively as possible.
The above article has been adapted from a white paper by EtQ, Inc.
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