Blog

14 Apr
8 Functions of Compliance–Building a Reliable Foundation

Virtually every regulatory program—environmental, health & safety, security, food safety—has compliance requirements that call for companies to fulfill a number of common compliance activities. Addressing all (or those specified in the applicable regulation) of the eight compliance functions outlined below can be instrumental in establishing or improving a company’s capability to comply.

  1. Inventory means taking stock of what you have. For compliance purposes, the inventory is quite extensive, including (but not limited to) the following:
    • Activities and operations (i.e., what you do – raw material handling, storage, production processes, fueling, maintenance, etc.)
    • Human resources (i.e., who does what)
    • Emissions
    • Wastes
    • Hazardous materials
    • Discharges (operational and stormwater-related)

The outcome of a compliance inventory is an operational and EHS profile of the company’s operations and sites. In essence, the inventory is the top filter that determines the applicability of regulatory requirements and guides compliance plans, programs, and activities.

  1. Authorizations, permits & certifications provide a “license to construct, install, or operate.” Most companies are subject to authorizations/permits at the federal, state, and local levels. Common examples include air permits, operating permits, Title V permits, safe work permits, tank certifications, construction authorization. In addition, there may be required fire and building codes and operator certifications. Once the required authorizations, permits, and/or certifications are in place, some regulatory requirements lead companies to the preparation and updating of plans as associated steps.
  2. Plans are required by a number of regulations. These plans typically outline compliance tasks, responsibilities, reporting requirements, schedule, and best management practices to comply with the related permits. Common compliance-related plans may include SPCC, SWPPP, SWMP, contingency, food safety management, and security plans.
  3. Training follows once you have your permits and plans in place. It is crucial to train employees to follow the plans so they can effectively execute their responsibilities and protect themselves and the community. Training should cover operations, safety, security, and environment.
  4. Practices in place involve doing what is required to follow the terms of the permits and related plans. These are the day-to-day actions (regulatory, best management practices, planned procedures, SOPs, and work instructions) that are essential for following the required process.
  5. Monitoring & inspections provide compliance checks to ensure that the site is operating within the required limits/parameters and that the company is achieving operational effectiveness and performance expectations. This step may include some physical monitoring, sampling, and testing (e.g., emissions, wastewater). There are also certain regulatory compliance requirements for the frequency and types of inspections that must be conducted (e.g., forklift, tanks, secondary containment, outfalls). Beyond regulatory requirements, many companies have internal monitoring/inspection requirements for things like housekeeping and process efficiency.
  6. Records provide documentation of what has been done related to compliance—current inventories, plans, training, inspections, and monitoring required for a given compliance program. Each program typically has recordkeeping, records maintenance, and retention requirements specified by type. Having a good records management system is essential for maintaining the vast number of documents required by regulations, particularly since some, like OSHA, have retention cycles for as long as 30 years.
  7. Reports are a product of the above compliance functions. Reports from ongoing implementation of compliance activities often are required to be filed with the regulatory agency on a regular basis (e.g., monthly, quarterly, semi-annually, annually), depending on the regulation. Reports also may be required when there is an incident, emergency, or spill.

Reliable Compliance Performance

Documenting procedures on how to execute these eight functions, along with management oversight and continual review and improvement, are what eventually get integrated into an overarching management system (e.g., environmental, health & safety, food safety, security, quality). This documentation helps create process standardization and, subsequently, consistent and reliable compliance performance.

In addition, completing and organizing/documenting these eight functions of compliance provides the following benefits:

  • Helps improve the company’s capability to comply on an ongoing basis
  • Enhances confidence in compliance practices by others, providing an indication of commitment, capability, and reliability
  • Creates a strong foundation to answer auditors’ questions (agencies, customers, certifying bodies, internal)
  • Establishes compliance practices for when an incident occurs
  • Helps companies know where to look for continuous improvement
  • Reduces surprises and unnecessary spending on reactive compliance-related activities
  • Informs management’s need to know
21 Aug
FDA Clarifies Sanitary Transportation Rule Waiver

On August 14, the U.S. Food and Drug Administration issued guidance to clarify that a waiver to the Food Safety Modernization Act (FSMA) Sanitary Transportation of Human and Animal Food final rule (Sanitary Transportation rule) covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.

19 Aug
Using Mobile Technology to Turn Data into Information

A decade ago, when handheld computers first became popular, storing appointments and contact information on a portable electronic device was a convenient way to avoid lugging around your appointment calendar. Mobile technology has come a long way in the last few years; today’s smartphones are capable of much more.

Many mobile devices are as powerful as a desktop computer. They have processors that handle internet access, photos, voice recordings, and database applications. They allow viewing of documents, reports, presentations, and video files. They integrate cellular technology, digital networks, email, scanners, a world of Bluetooth devices, and global positioning systems (GPS).

As mighty as they may be, mobile devices have not replaced laptop computers because of their limited keyboards, screen sizes, and computing power. But the line between laptops and smartphones has blurred substantially. Mobile technology offers ways to become more efficient and provides more value to company operations and management systems.

Find & Fix

Traditional processes tend to produce traditional results. One cannot expect technological innovation without technological integration. Integration allows companies to stretch and empower every limited resource. The key is identifying those traditional processes that will realize benefit (mostly likely cost or time savings) from technological integration.

Take the business practice of internal auditing for example. The most traditional practice for internal auditing an aspect of a company (e.g., general safe practices, OSHA compliance, OHSAS 18001) is a “find it & fix it” cycle, where the internal inspector goes into a facility and inspects operations as they exist. The inspector typically walks a facility with a notepad and pencil, taking notes of field observations that are not in compliance with the defined protocol.

Following the audit, the inspector creates a report and shares the findings with a responsible party. Sometimes the process of creating a report and communicating findings can take weeks or even months. The cycle is repeated when the inspector comes back to check the site at a later time.

The “find & fix” inspection cycle works—but only to a point.

Same Old Methods: Same Old Problems

The difficult part comes next. What happens to that inspection form or accident investigation report after it is completed? It is likely reviewed by a few people, perhaps transcribed into electronic form by a data entry clerk (where data entry errors may enter the equation), and filed away for legal and compliance reasons, rarely (if ever) to be seen again.

Filing data away in a drawer is better than nothing—it at least shows some documentation of findings— but what happens when the inspector is asked to compile annual data from the findings? And how are trends and patterns evaluated to best allocate resources for improvement initiatives? The paper method of recordkeeping makes compiling field data into a report an enormous task consuming resources and money.

Electronic Data Capture and Reporting

When the inspector captures all field data electronically, the task of generating a report to analyze trends becomes much easier. Mobile technology allows the inspector to capture data electronically—in the field, at the point of discovery—and can eliminate the problems associated with manual data entry and manipulation.

And when data is collected, uploaded, and stored in a database, accessing and reporting on the data becomes as easy as simply requesting the desired information—from questions like, “How many deficient issues were there at the warehouse last year?” to “How many overdue action items does Bruce have in repackaging?”

Reports generated can include photos and reference information, along with field comments. These reports support the inspector’s findings and eliminate many questions about whether a situation is accurately described and/or in violation of the defined protocol. With this information, reports also become a valuable learning tool for employees in the field.

Once uploaded, data are stored in a database for later reference. Assessments continue to be added as inspections are performed and a large bank of data is amassed. That data in electronic format, unlike hand-written notes that are filed away, can be easily arranged for future analysis. Reports can be generated using a large menu of criteria that address specific business needs, such as running statistics on a site over a period time or reviewing instances of a particular violation.

Not only is reporting easier, it can serve more needs:

  • Certain reports provide a means of internal communication, enabling transparency and creating clear accountability.
  • Automated notifications provide real-time improvements.
  • Follow-up actions can be assigned and sent to those who need them.
  • Reports on action status can be sent as reminders to each assignee.
  • Follow-up reports can show photo evidence from the point of discovery, cite the relevant regulatory reference, and encourage continued improvement.
  • Positive observations can be used to provide positive feedback to those employees who have met or exceeded expectations.
  • Mining data in different ways can help to identify root causes and end harmful trends so that real improvement can occur.

Value of Good Software

Even with all of the power and functionality that mobile devices offer, they are of limited value without good software. Software applications use the mobile device’s power, synchronize with web and network applications, and use new programming languages.

A number of management efficiencies are realized when auditing/inspection software offers:

  • Consistency: Pre-defined answers allow users to answer consistently to like situations, lessening the potential for inconsistent interpretation of the responses from one inspector to the next.
  • Standardization: Providing a centrally located database with standard criteria helps ensure that all facilities are on the same page.
  • Consensus: On priority rating of inspection findings.
  • Tracking: The ability to assign and check status of fixes and corrective/preventive actions helps ensure compliance.
  • Analysis: Results can be analyzed for relative importance, statistics, comparisons, patterns, trends, and, ultimately, to identify root causes.

Looking Forward

Our world continues to demand faster response times, constant internet connectivity, and immediate access to information. Technology manufacturers have responded, as we continue to see the emergence of hybrid devices that incorporate laptop computer capability with cellular technology.

The growth of mobile devices has accelerated to the point where they can be a huge asset to company operations:

  • Provide electronic data collection
  • Integrate data from different types of media
  • Offer data management to organize reference materials, inspection protocols, and field data
  • Immediately generate reports
  • Easily assign and track follow-up actions
  • Educate employees and eliminate confusion
  • Query and organize data for analysis to discover trends and identify root causes

Ultimately, the goal is to continually improve the company’s overall performance—health & safety, environmental, quality, overall business. Fortunately, technology can enhance traditional business practices, such as the “find & fix it” inspection cycle, to create greater efficiencies and enhanced business value. Integrating technology with current business practices not only allows for continual improvement, it helps create the next level of competitive advantage.

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