Regulatory compliance is not an easy challenge. No matter the industry or the scale or complexity of business operations, companies throughout the world have to manage an ever increasing number of laws and rulings. This is especially true in the United States where an average of 2,500 to 4,500 new rules are passed each year. Some receiving the most attention lately include the Food Safety Modernization Act (FSMA), the Pesticide Container and Containment rule and the Unique Device Identification rule.
While complying with regulatory requirements is a necessity, it is also burdensome and costly. In fact, a National Association of Manufacturers report estimates that federal regulations cost an average of $10,000 per employee per year in 2012. Eighty-eight percent of those surveyed say that federal regulations are a top challenge for their firm.
While this cost can be reduced by automating the compliance process, most manufacturers have been slow to do so. According to the Aberdeen Group’s “Compliance and Traceability in Regulated Industries: Benchmark Report”, only eight percent of the manufacturers surveyed have eliminated pen and paper or manual spreadsheet processes from their compliance and programs. Additional findings include:
- Of the manufacturers still relying on manual processes to manage compliance and traceability programs, 93 percent were unable to achieve best-in-class status,
- 73 percent of best-in-class regulated manufacturers have integrated their compliance and traceability solutions with other enterprise applications, and
- Best-in-class companies are five times as likely to measure performance in real time than other manufacturers.
Compliance with government regulations requires detailed and accurate records. Manual processes can lead to inaccuracies and time delays that ultimately defeat the purpose of maintaining critical information. An asset tracking system can minimize reporting costs by providing a convenient and efficient way to gather and monitor relevant information.
With TrackAbout asset tracking software, employees collect data using smartphones, tablets or rugged handheld scanners that read barcode labels or RFID tags. The data can be retrieved quickly at an inspector’s request and helps avoid fines, facility closings or other costly penalties.
Lot tracking is key to achieving compliance for many businesses. Lot tracking enables product traceability by keeping track of which customers received specific shipments of items (with specific lot numbers) and when the items were received. The purpose is to quickly identify items from a lot where one item is found to be defective and speed up the recovery of the remaining items. TrackAbout provides several ways to track lot numbers. And the data can be searched in minutes, allowing companies to:
- Judge the scope of a recall,
- Identify which items pose a risk to consumers, and
- Stop the product at any point in the supply chain.
Inspections and Maintenance
For companies that manage regulated equipment, ensuring that required inspections occur and that proper maintenance is performed can be a cumbersome process. It’s impossible to tell if inspections or preventative maintenance is due just by looking at a piece of equipment. And it takes a lot of time to search through paper records or spreadsheets to check every asset.
TrackAbout reports provide a list of assets that are due for a scheduled inspection, test or service so they can be removed from the active pool until the necessary maintenance is performed. It timestamps actions to record when the procedures were performed and captures approvals through electronic signatures. Because the software guides employees through the required sequence of procedures, it ensures collection of accurate, essential data.
Compliance often relies on detailed and accurate records of production and maintenance processes, quality analyses, safety inspections, delivery procedures and similar activities. TrackAbout automates workflows so employees are certain to follow required procedures and data is validated to guarantee accuracy. Validation patterns can be established for fields that require manual text entry and limits can be set for numeric data. Each saved record is time-stamped and electronic signatures capture approvals. All of these help to collect mission-critical data and to provide the required information to regulators at a moment’s notice.
TrackAbout in Action
Colonial Chemical Solutions, a chemical repackaging and distribution company, uses TrackAbout to ease their compliance burden. According to John Larkin, the company’s warehouse manager, “All the critical information about our totes is captured so much faster by TrackAbout. I’m more focused on business operations now because I don’t have to spend time managing paperwork.” Read more about how Colonial uses TrackAbout to achieve regulatory compliance.