Tag Archives: electronic records

Michelle Lombardo Smith, The Wenger Group
FST Soapbox

Top of the Pecking Order: How We Transformed Our Processes

By Michelle Lombardo Smith
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Michelle Lombardo Smith, The Wenger Group

A 75-year-old feed manufacturer making more than 2,000 feed formulas is bound to have a lot of business complexities. Add to that several years of rapid growth combined with outdated, manual processes. Several years ago, this was the situation we faced at our family-owned feed manufacturer and egg/poultry provider in the mid-Atlantic region.

We needed a way to simplify and streamline key processes, such as activities involved with safety and compliance. After evaluating several enterprise content management systems in 2015, we eventually selected Laserfiche to digitize records, implement electronic forms and automate manual workflows. While we completed an initial Laserfiche software install in 2016, we were still tasked with the process of building out solutions the company wanted to use in house, and we therefore continue to work closely with the company today.

Meeting Regulations With Data Sheets

Our initial project focused on digitizing our collection of safety data sheets, standardized documents that contain occupational safety and health data. Prior to implementing this software, we relied on paper manuals across different locations. Managing the creation of new data sheets and ensuring old ones were removed became quite the task. This project couldn’t have come at a better time, as the Occupational Health and Safety Administration (OSHA) had recently mandated changes to the data sheets.

By digitizing data sheets and storing them in a central repository, the documents were made more accessible and searchable for mill managers, and compliant to the new mandated standard. Additionally, data sheets were easily retrieved for any first responders seeking to understand what chemicals were in a facility in the event of a fire. It now takes just minutes to search for and retrieve documents, helping the organization stay in compliance with state reporting. Having the ability to create and add new sheets immediately is a tremendous benefits as well. These new capabilities allow us to help keep employees safer than ever before.

Shortened Delivery Processes

The next process that needed to be targeted was deliveries. Delivery tickets at the feed mills were billed based on production weight in the company’s enterprise resource planning software, and delivery weight was entered manually when the physical tickets were returned to the office, which could sometimes be days after the product was shipped. When the shipped weight showed a different amount than the production weight, the finance team had to issue the customer a credit leading to more inefficiency and a wrinkle in customer confidence.

Laserfiche allowed the company to develop delivery tickets to be scanned at the mill. Tickets are now available in 24 hours, and the processing time for invoicing has gone from six hours to just three. Warranty costs have decreased while customer confidence has increased.

Mobile App to the Rescue

Finally, with the mobile app the organization was able to decrease the complexity for one of its farming divisions, Dutchland Farms, all while staying in legal compliance. This specific division contracts egg production and pullet growing. The FDA published its Veterinary Feed Directive (VFD) regulations in 2015, a regulation that directly applied to Dutchland’s this team of growers and producer. The directive added to the list of antibiotics that required a veterinarian’s prescription to administer. In addition, flock owners now had to have a flock health plan and an established relationship with a veterinarian. We initially had a manual process to write and store the plans, but that process was digitized and automated with Laserfiche in 2017. Service technicians can now get electronic forms signed at the farm and be immediately transmitted to the company’s consulting veterinary practician, who lives out of the country. As a result, we were able to significantly reduce the time from farm signature to vet approval/signature of the Flock Health Plans, and saved on a huge amount of paper copies and mail costs.

What’s next? These days, we’re searching for a new ERP system, a multi-year journey that will include scanning capabilities and an expanded role for Laserfiche. Meanwhile, all the products developed are still a work in progress even as the software expands to teams like quality assurance and human resources.

FDA Access to Records Under FSMA

By Michael Biros
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What are the latest updates with FSMA and how has FDA’s access to records changed? Dr. David Acheson of The Acheson Group gives us the latest.

When it comes to latest updates regarding FSMA, the comment period on the proposed sanitary transportation rule has been extended to July 30, 2014.

What does FSMA change in terms of FDA access to records?

Before FSMA, FDA needed reasonable proof that a food would be adulterated and a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) in order to access records.

Now, FDA needs reasonable probability that the use or exposure to a food, or any other articles of food that FDA believes is likely to be affected in a similar manner, would cause serious adverse health consequences. What FDA considers to be a reasonable probability will be determined on a case-by-case basis. These changes significantly expand the scope of what FDA can look at and lowers the threshold for records access.

Does FDA need to issue a formal request?

Formerly, FDA needed to invoke the Bioterrorism Act in order to gain access to records. This was a cumbersome process that required strict criteria to be met.

Currently under FSMA, FDA must provide written notice of what they are asking for. This documentation will be delivered by a credentialed FDA official.

Generally, access to records must be given as quickly as possible within 24 hours of the request. The records do not need to be in any particular format. Electronic records are still considered on-site records so long as they can be accessed from within the facility.

What can FDA ask for?

FDA has produced guidance documents that lists what they can ask for. FDA can request access to manufacturing records, ingredients receipt records, product distribution records, product inventory records, test records, recall records, reportable food records, customer distribution lists, and complaint/adverse event records.

There are some exceptions. FDA cannot request personnel records, financial records, recipes, some records from farms, and some records from restaurants.

How will FDA maintain the confidentiality of any protected information in records it obtains?

While some of these records may be accessible through the Freedom of Information Act (FOIA), FDA is responsible to protect and redact commercial confidential information in accordance with their own requirements. However, some of this sensitive information can be shared with other federal, state, local, and foreign authorities.

For more information, click here to see archived FSMA Fridays webinars, organized by SafetyChain Software