Improved Documentation for Compliance and Maintenance

A compliance-driven software system has three key benefits: data integrity, mobility, and reporting capability.

• By Kathleen Merrick
• Nov 01, 2003

IT'S every facility manager's worst nightmare: plant failures, workers injured on the job, or a pending lawsuit over facility safety. Do you have an organized and accurate documentation process to prove you have taken the appropriate preventive measures for safety compliance and equipment maintenance?

It is becoming extremely difficult to maintain accurate records and meet increasingly stringent compliance regulations. However, technical innovations have made the documentation process easier. Software systems can be implemented to reduce liability and fulfill the challenge of compliance verification. Using advanced automated technologies, the majority of compliance-driven processes and procedures can be achieved by replacing the old paper-and-pen documentation method with specialized software, hand-held computers, and bar codes, saving facilities critical productivity time, liability, and money.

In conjunction with collecting the preventive inspection information with a hand-held device, the data can be uploaded manually or wirelessly from the device to a database software application. For example, the software installed onto a hand-held device, such as a Palm, prompts inspectors to ensure a building's fire extinguishers (or any equipment or process) have been maintained at specific intervals. Using the device, employees record that the extinguishers were checked at the inspection site and at the required times. The software then time and date stamps each inspection, providing indisputable proof the check took place. The data can then be uploaded or remotely sent to the software database for storage.

Once data is recorded to the database, the application assists in centralizing and storing the information needed to prove your facility is in compliance. At the same time, the system assists employees in maintaining that compliance by providing detailed history pertaining to regulations, equipment conditions and locations, components, procedures, and processes. All of the data can be quickly retrieved and assessed directly from a PC database or automatically viewed on a hand-held computer while in the field.

By using an automated inspection software program, documents, files, and Web links providing in-depth information regarding equipment and processes can literally be at your fingertips--anywhere, any time. What's more, facility procedures and processes can be electronically delegated and scheduled to assigned technicians in the field.

A compliance-driven software system has three key benefits:

• Data Integrity
• Mobility
• Reporting Capability

Does Data Have Integrity?
Because of the importance of meeting or exceeding regulation standards, the integrity of your data is critical. What is data integrity? Data integrity is a procedure that ensures your information cannot be manipulated, modified, or deleted without leaving a trail. If information can be manipulated without leaving a trace, the credibility of the data diminishes.

In some cases, not having a feature such as an electronic signature capture or a time-and-date stamp to protect the integrity of your information would defeat the purpose of using an automated system. The credibility of data is important, if not vital. This information is used to assert that your company performed the inspections and procedures according to regulatory requirements. If the data is manipulated or falsified, the data integrity would be considered compromised and would never hold up if disputed or presented in a court of law. On the other hand, intact and uncompromised data dramatically improves the credibility of your inspections and has been admitted as court evidence in the past.

Some regulatory authorities such as the Food and Drug Administration (FDA) require an audit trail of all modifications to individual records, whether you are performing the inspections using a manual or an automated procedure. The FDA has recently recognized that keeping up with the increased number of regulations manually has become a tremendous burden on companies. With these concerns in mind, the FDA and the Parenteral Drug Association (PDA) co-sponsored an initiative to implement the technical provisions of regulations 21 CFR Part 11 regarding electronic records and electronic signatures. New guidelines describe archiving procedures, record integrity and audit trails, time-and-date stamps, electronic signatures, and electronic recordkeeping in clinical studies.

By outlining these guidelines, software companies now can modify their software applications to meet these standards. If you need to meet 21 CFR Part 11 guidelines, ensure your inspection system can provide the required, uncompromised documentation trail.

Mobility and Safety Merge
Having the ability to access inspection, regulation, and equipment information on a mobile device while out in the field or on the floor of a facility is an enormous benefit to many technicians. As opposed to carrying a clipboard, manuals, or documents to view information about each piece of equipment being inspected or maintained, that data can be stored electronically on a mobile device and viewed at the touch of a button. A simple tap or a scan of a bar code attached to a piece of equipment (assuming your device has a built-in integrated scanner) can retrieve detailed manufacturers' information about the item, in addition to the machine's inspection, regulation, and equipment history.

Processes can be made available on the hand-held device to help walk technicians through inspections or maintenance repairs. Even regulation information can be referenced; if an incident or violation is found, the occurrence can be recorded on the spot. The inspection results can be captured electronically on the device, leaving no room for error, and then uploaded to the PC application for analysis.

Technicians performing inspections on production-type machines, which require procedures such as lockout/tagout, can ideally benefit from using a mobile device such as a Palm or Pocket PC. Lockout/tagout refers to the complete energy isolation of equipment during maintenance or service work. OSHA regulations 29 CFR 1910.147 and 1926.416 require the use of locks or tags as warning devices to ensure personnel are not injured from accidental machine start-ups. Examples of such machinery or equipment include, but are not limited to, high-voltage power supplies, milling machines, boilers, electron microscopes, elevators, fan systems, and lasers.

When inspecting or maintaining these types of machines, it is necessary to identify, shut off, and lock access to energy sources located on the machine. Technicians can carry the information related to the machine on their mobile devices, which can assist in identifying the inspection procedures, the machine's components, and the diagram or layout of the mechanism. Knowing the procedures on how to work securely with this machine prior to working on it can be critical to the safety of employees. Viewing a diagram or schematic of the machine and what needs to be secured would also assist in verifying all components are taken care of. For example, if an operator were to turn on a machine while the maintenance technician happened to be working on a hazardous area of the machine such as a chopping blade or electrical wiring, serious harm or death of either employee could occur.

Mobile device accessories or integrated modules, such as portable printers, digital imaging modules, and wireless connectivity, are useful. Technicians can use portable printers in conjunction with mobile devices to print labels for identifying components, create warning signs to prevent accidents, or print and program bar codes that are adhered to equipment and scanned for identification purposes.

In addition, hand-helds have the capability to record images digitally. Digital snapshots of the entire machine, equipment, or of an incident or a component failure can be useful for repairing, maintaining, and inspecting an item. These images can be collected on the portable device, viewed on the spot, and uploaded to the PC database for analysis.

With radio frequency or cellular wireless technologies, technicians in the field can receive or send the necessary information and images without having to return to their offices. The ability to send and receive data while out in the field gives technicians an enhanced advantage when responding to emergencies or urgent repairs.

True Reporting
When choosing an automated software solution, you may want to pay particular attention to the reporting tool that is offered with the application. You want to have the ability to categorize specific collected data and compile a report that will help your organization meet compliance regulations and help maintain your facility, ultimately saving you valuable productivity time, liability, and expense. Not only can you ensure your compliance level is high, you can realize any maintenance trend that may cost your company more money by having not detected problems early on.

You can generate reports and statistics on elements, such as equipment inspections, incidents, violations, maintenance, costs. and time. Graphs and charts can decipher trends or critical areas that need attention. These indicators will assist you in managing your facility effectively and ensure you can prove compliance.

Service companies have highly requested Web reporting to better serve their clients and to remain a step ahead of their competition. Web reporting allows employees to view detailed reports about their facility inspections, maintenance activities, and the type of support provided by a service company. A Web interface can provide secure access to reports or application data without the complicated set-up that is usually associated with remote connectivity.

Keeping up with ever-changing regulations can be an overwhelming task. Software companies have been striving to meet the needs of their facility clients and have created automated tools to assist with processes and compliance management. An inspection-based software system can help to ensure both scheduled and unscheduled safety inspections are met, as well as any incident or equipment failure that technicians may encounter is recorded. An effective and improved inspection process means a higher rate of compliance, which in return provides less likelihood of incidents, violations, and subsequent fines.

This article originally appeared in the November 2003 issue of Occupational Health & Safety.