Tag Archives: data

Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

Food Safety Testing Must Live Up to Higher Expectations

By Maria Fontanazza
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Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.

Key trends:

  • Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
  • Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
  • The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.

Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?

Tim Curran, CEO of Sample6, pathogen detection
Tim Curran, CEO of Sample6

Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].

Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.

Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.

“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.

These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.

Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.

Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.

Michael Koeris, Ph.D., founder and vice president of operations, Sample6, pathogen detection
Michael Koeris, Ph.D., founder and vice president of operations

Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.

FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?

Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.

Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.

Jim Godsey, vice president of research & development, Sample6, pathogen detection
Jim Godsey, vice president of research & development

There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.

FST: How do you expect the final FSMA rules and implementation process will impact industry?

Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.

FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.

Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.

Is Your Document Control System Effective?

By Food Safety Tech Staff
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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.