A management system is the organizing framework that enables companies to achieve and sustain their operational and business objectives through a process of continuous improvement. A management system is designed to identify and manage risks—safety, environmental, quality, business continuity, food safety (and many others)—through an organized set of policies, procedures, practices, and resources that guide the enterprise and its activities to maximize business value.

The management system addresses:

• What is done and why
• How it is done and by whom
• How well it is being done
• How it is maintained and reviewed
• How it can be improved

Creating an Effective and Valuable Management System

Each company’s management system reflects its unique culture, vision, and values. To be effective and valuable, the management system must be tailored and focused on how it can enhance the business performance of the organization. It must also be:

• Useful to people in the operations
• Intuitive—organized the way operations people think
• Flexible—making use of methods and tools as they are developed and documented
• Valuable from the outset—addressing the most critical risks and processes
• Linked to the business of the business (not “pasted on”), with ownership at the operational level
• A means to better align operational quality, safety, and environment with the business

Attributes of an effective management system are senior management expectations and guidance coupled with employee engagement. Importantly, a management system involves a continual cycle of planning, implementing, reviewing, and improving the way in which safety, quality, and environmental obligations and objectives are met. In its simplest form, this involves implementing the Plan, Do, Check, Act/Adjust (P-D-C-A) cycle for continuous improvement.

Auditing for Ongoing Compliance

The connection between management systems and compliance is vital in avoiding recurring compliance issues and in reducing variation in compliance performance. In fact, reliable and effective regulatory compliance is commonly an outcome of consistent and reliable implementation of a management system.

Conducting periodic audits is a practical way to test a management system’s implementation maturity and effectiveness. One of the many advantages of audits is that they help identify gaps so that corrective/preventive actions can be put into place and then sustained and improved through the management system.

Audits also help companies with continuous improvement initiatives; properly developed audit programs help measure results over time. To achieve best value, audits should emphasize finding patterns that can yield opportunities for learning and continual improvement, rather than “gotchas” for exceptions that are discovered.

Management System Standards

Several options are available for structuring management systems, whether they are certified by third-party registrars and auditors, self-certified, or used as internal guidance and for potential certification readiness.

The International Organization for Standardization (ISO) standards are some of the most commonly applied. The ISO standards for quality (ISO 9001), environment (ISO 14001), health & safety (OHSAS 18001), business continuity (ISO 22301), and food safety (FSSC 22000) have consistent elements, allowing organizations to more easily align their various management systems. Aligned management systems help companies to achieve improved and more reliable quality, environmental, and health & safety performance, while adding measurable business value.

Certification

Companies can become certified to each of the standards discussed above. Certification has a number of benefits, including the following:

• Meet customer or supply chain requirements
• Use outside drivers to maintain management system process discipline (e.g., periodic risk assessment, document management, compliance evaluation, internal audits, management review)
• Take advantage of third-party assessment and recommendations
• Improve standing with regulatory agencies (e.g., USEPA, OSHA, FDA, and state programs)
• Demonstrate the application of industry best practice in the event of incidents/accidents requiring defense of practices

However, if there is no market or other business driver, certification can lead to unnecessary additional cost and effort regarding management system development. Certification in itself does not mean improved performance—management system structure, operation, and management commitment determine that.

Business Value

There are a number of reasons to implement a management system. A properly designed and implemented management system brings value to organizations in a number of ways:

• Risk management
  • Identify risks
  • Set priorities for improvement, measurement, and reporting
  • Provide great opportunity to identify, share, and learn best practices, while recognizing operational differences
• Protection of people
  • Send people home the way they arrived at work
  • Protect the public and the environment
• Compliance assurance
  • Improve and sustain regulatory compliance
• Business value
  • Continually improve quality, environmental, and safety performance across the organization (employee, public, equipment, infrastructure)
  • Reduce incident costs and accrued liabilities
  • Protect assets
• Reliability
  • Assure processes, methods, and practices are in place, documented, and consistently applied
  • Reduce variability in processes and performance
• Employee engagement
  • Help employees to find and use current versions of all procedures and documents
  • Provide a ready reference for field management to structure location-specific procedures
  • Enable the effective transfer of standards, methods, and know-how in employee training, new job assignments, and promotions

When business is disrupted, the costs can be substantial. Unfortunately, every organization is at risk from potential operational disruptions—natural disasters, fire, sabotage, information technology (IT) viruses, data loss, acts of violence. Recent world events have further challenged organizations to prepare to manage previously unthinkable situations that may threaten the future of the business.

Securing Company Assets

This goes beyond the mere Emergency Response Plan or disaster recovery activities that have been previously implemented. Organizations must now engage in a more comprehensive process to secure their companies’ assets (e.g., people, technology, products, and services). Today’s threats require implementation of an ongoing, interactive process that assures the continuation of the organization’s core business activities and data center(s) before, during, and, most importantly, after a major crisis event.

Creating a Resilient Organization

Business continuity planning helps ensure that companies have the resources and information needed to maintain service, reliability, and resiliency under adverse conditions. While companies can’t plan for everything, they can take steps to understand and effectively manage events that might compromise their products/services, supply chain, quality, security, and future as an organization.

A Business Continuity Plan ensures that all involved parties understand who makes decisions, how the decisions are implemented, and what the roles and responsibilities of participants are when an incident occurs. Through business continuity planning, companies are able to:

• IDENTIFY the human, property, and operational impacts of potential business threats
• EVALUATE the potential severity of associated risks
• ESTIMATE the likelihood of business threats occurring
• CREATE timelines for restoration and strategies that proactively mitigate the most pressing business threats, take advantage of opportunities that lie ahead, and provide for a more resilient and sustainable future

Systematic Approach

A sound Business Continuity Program relies on a systematic approach to identify and critically evaluate risks/opportunities, as outlined below. This approach broadens the scope of issues beyond mere emergency response and allows companies to budget for and secure the necessary resources to support critical business activities before, during, and after a major crisis event. Ultimately, following this process helps companies to stay in business through a time of crisis.

Sustaining Business for the Long Term

Sustainability is about staying in business for the long term, and today, business continuity is key to sustaining business over time. That is because a well-developed and implemented Business Continuity Plan:

• Keeps employees and the community safe when an incident occurs
• Protects the organization’s important assets (e.g., people, technology, products, services)
• Reduces disruption to critical functions in order to limit financial impacts due to loss of product/service
• Reduces adverse publicity, loss of credibility, and loss of customers
• Reduces legal liability and regulatory exposure
• Reduces the risk of losing critical business data (e.g., historical, operational, customer, regulatory compliance)
• Provides for an orderly and timely recovery by allowing critical decisions to be made in a non-crisis mode
• Helps companies mitigate risks and focus on the future

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Guiding Standards

ISO 22301: Societal Security – Business Continuity Management Systems is specifically designed to help organizations protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise. Like other ISO standards, ISO 22301 applies the Plan-Do-Check-Act/Adjust model to developing, implementing, and continually improving a Business Continuity Management System. Following this internationally recognized standard allows organizations to leverage their existing management systems and ensure consistency with any other ISO management system standards that may already be in place (e.g., ISO 14001 – environment, ISO 9001 – quality, ISO 45001 – safety, ISO 22000 – food safety).

The American Society for Industrial Security (ASIS) Business Continuity Management System Standard, National Fire Protection Association (NFPA) 1600: Standard on Disaster/Emergency Management and Business Continuity Programs, and Office of the Comptroller of the Currency (OCC) federal banking requirements for business continuity provide further industry-specific guidance on business continuity management.

Today’s business managers face greater complexities than ever when it comes to making business decisions. For every business decision, there are a number of factors that impact the associated risks. Fortunately, the use of statistics, predictive analytics, and data mining has become increasingly useful in taking the “gut feel” out of making important and often complex business decisions.

Data-Driven Decisions

Most people are familiar with common descriptive statistical techniques, like measures of central tendency (e.g., mean, median, mode) or variability (e.g., interquartile range, standard deviation). More advanced data mining and predictive analytical techniques are increasingly being used to explore and investigate past performance to gain insight for future business decision making.

Data mining draws on large amounts of data to identify patterns, which are often classified as opportunities or risks. Predictive analytics encompasses a variety of statistical techniques that are used to analyze historical data to predict the most probable future events. A few examples of these include the following:

• Discriminant Analysis – a machine learning model where a computer program “learns” a pre-existing data set that includes attributes and outcomes for each individual, and then predicts probable outcomes for individuals in the new data set based on attributes.
• Linear Regression – creates an equation so that one variable can be predicted based on the known values of other variables.
• Logistic Regression – a machine learning model where a computer program “learns” a pre-existing data set that includes attributes and a binary (“yes/no”) outcome for each individual, then predicts “yes/no” outcome for each individual in a new data set, along with a probability associated with the decision.
• Decision trees – machine learning model where a computer program “learns” a pre-existing data set that includes attributes and outcomes (not necessarily binary) for each individual, then predicts outcomes for each individual in a new data set, along with confidence in the decision; also identifies the attributes that are most helpful for making predictions (i.e., those that are best able to discriminate between outcomes).
• Neural networks – similar to decision tree, but more effective if finding the connections between attributes is a concern.

Together, this information can help decision makers to predict the outcome(s) of a decision before it is made—and make smarter decisions based on data instead of gut feelings. The following case studies demonstrate the value that statistics provide when it comes to making important business decisions.

Case Study: Wildfire Risk Index

For a large transportation organization, wildfires have historically presented a unique challenge. The company has worked diligently over the past several years to control its fire risk through research and a number of assessments. To help further minimize the wildfire risk, the company turned to past data and is working with Kestrel to develop a comprehensive Wildfire Risk Index to:

1. Quantify the operational risks of wildfires (i.e., identify environmental conditions, determine areas of concern)
2. Make informed business decisions to help minimize identified risks

Creating the Index requires a significant amount of data from both internal and external resources, including traffic, weather, geography, internal fire incidents, and others. This information is used in several components contained within two main models that create the Wildfire Risk Index. These model components are relatively simple when used on their own. The complexity arises when combining the various models and their components into a single Wildfire Risk Index that reasonably reflects relative risks, while considering all variables.

The ultimate output of the Wildfire Risk Index is a single number that quantifies the relative risk of wildfire by location and by month. This information will help the company to:

1. Identify the areas of greatest risk.
2. Focus resources on those areas.
3. Make more informed decisions regarding operations—like when to plan hot work and when and where to perform vegetation control—to help prevent future incidents.

Case Study: Incident Data

For a large petroleum refining organization, safety and environmental incidents present a significant risk to operations. In order to reduce incident frequency, the company has implemented a robust safety management system, which includes frequent audits and inspections. Despite the company’s best efforts, however, incidents have continued to occur.

To further improve safety and environmental performance, Kestrel is working with the company to conduct detailed reviews of previous incidents using Kestrel’s proprietary Human Performance Reliability (HPR) approach. This approach identifies and classifies the human factors contributing to incidents, as well as the controls associated with those human factors (engineered, administrative, and/or PPE). Once the reviews are finished, the results are statistically analyzed to generate a prioritized list of human factors to be addressed. Kestrel’s Human Factors Integration Tool (HFIT™) software then generates a list of existing controls associated with the top human factors, as well as a list of missing controls that could be created and implemented.

The ultimate output of the incident review process is to help the company identify the human factors contributing to incidents, create or improve associated controls, manage operational risks, and protect the health and safety of workers and the surrounding environment.

Versatility

These examples demonstrate how predictive analytics can be used to support decision making. The versatility of predictive analytics, combined with the variety of statistical techniques available, can be applied to help companies analyze a wide variety of problems and gain insight for future business decision making.

On Monday, September 17, 2018, the Office of the United States Trade Representative (USTR) released a list of approximately $200 billion worth of Chinese imports, including hundreds of chemicals, that will be subject to additional tariffs. The additional tariffs will be effective starting September 24, 2018, and initially will be in the amount of 10 percent. Starting January 1, 2019, the level of the additional tariffs will increase to 25 percent.

In the final list, the administration also removed nearly 300 items, but the Administration did not provide a specific list of products excluded. Included among the products removed from the proposed list are certain consumer electronics products, such as smart watches and Bluetooth devices; certain chemical inputs for manufactured goods, textiles and agriculture; certain health and safety products such as bicycle helmets, and child safety furniture such as car seats and playpens.

Individual companies may want to review the list to determine the status of Harmonized Tariff Schedule (HTS) codes of interest.

View the final tariff list here.

Read the USTR press release.

Maturity assessments are designed to tell an organization where it stands in a defined area and, correspondingly, what it needs to do in the future to improve its systems and processes to meet the organization’s needs and expectations. Maturity assessments expose the strengths and weaknesses within an organization (or a program), and provide a roadmap for ongoing improvements.

Holistic Assessments

A thorough program maturity assessment involves building on a standard gap analysis to conduct a holistic evaluation of the existing program, including data review, interviews with key staff, and functional/field observations and validation.

Based on Kestrel’s experience, evaluating program maturity is best done by measuring the program’s structure and design, as well as the program’s implementation consistency across the organization. For the most part, a program’s design remains relatively unchanging, unless internal modifications are made to the system. Because of this static nature, a “snapshot” provides a reasonable assessment of the design maturity. While the design helps to inform operational effectiveness, the implementation/operational maturity model assesses how completely and consistently the program is functioning throughout the organization (i.e., how the program is designed to work vs. how it is working in practice).

Design Maturity

A design maturity model helps to evaluate strategies and policies, practices and procedures, organization and people, information for decision making, and systems and data according to the following levels of maturity:

• Level 1: Initial (crisis management) – Lack of alignment within the organization; undefined policies, goals, and objectives; poorly defined roles; lack of effective training; erratic program or project performance; lack of standardization in tools.
• Level 2: Repeatable (reactive management) – Limited alignment within the organization; lagging policies and plans; seldom known business impacts of actions; inconsistent company operations across functions; culture not focused on process; ineffective risk management; few useful program or project management and controls tools.
• Level 3: Defined (project management) – Moderate alignment across the organization; consistent plans and policies; formal change management system; somewhat defined and documented processes; moderate role clarity; proactive management for individual projects; standardized status reporting; data integrity may still be questionable.
• Level 4: Managed (program management) – Alignment across organization; consistent plans and policies; goals and objectives are known at all levels; process-oriented culture; formal processes with adequate documentation; strategies and forecasts inform processes; well-understood roles; metrics and controls applied to most processes; audits used for process improvements; good data integrity; programs, processes, and performance reviewed regularly.
• Level 5: Optimized (managing excellence) – Alignment from top to bottom of organization; business forecasts and plans guide activity; company culture is evident across the organization; risk management is structured and proactive; process-centered structure; focus on continuous improvement, training, coaching, mentoring; audits for continual improvement; emphasis on “best-in-class” methods.

A gap analysis can help compare the actual program components against best practice standards, as defined by the organization. At this point, assessment questions and criteria should be specifically tuned to assess the degree to which:

• Hazards and risks are identified, sized, and assessed
• Existing controls are adequate and effective
• Plans are in place to address risks not adequately covered by existing controls
• Plans and controls are resourced and implemented
• Controls are documented and operationalized across applicable functions and work units
• Personnel know and understand the controls and expectations and are engaged in their design and improvement
• Controls are being monitored with appropriate metrics and compliance assurance
• Deficiencies are being addressed by corrective/preventive action
• Processes, controls, and performance are being reviewed by management for continual improvement
• Changed conditions are continually recognized and new risks identified and addressed

Implementation/Operational Maturity

The logical next step in the maturity assessment involves shifting focus from the program’s design to a maturity model that measures how well the program is operationalized, as well as the consistency of implementation across the entire organization. This is a measurement of how effectively the design (program static component) has enabled the desired, consistent practice (program dynamic component) within and across the company.

Under this model, the stage of maturity (i.e., initial, implementation in process, fully functional) is assessed in the following areas:

• Adequacy and effectiveness: demonstration of established processes and procedures with clarity of roles and responsibilities for managing key functions, addressing significant risks, and achieving performance requirements across operations
• Consistency: demonstration that established processes and procedures are fully applied and used across all applicable parts of the organization to achieve performance requirements
• Sustainability: demonstration of an established and ongoing method of review of performance indicators, processes, procedures, and practices in-place for the purpose of identifying and implementing measures to achieve continuing improvement of performance

This approach relies heavily on operational validation and seeking objective evidence of implementation maturity by performing functional and field observations and interviews across a representative sample of operations, including contractors.

Cultural Component

Performance within an organization is the combined result of culture, operational systems/controls, and human performance. Culture involves leadership, shared beliefs, expectations, attitudes, and policy about the desired behavior within a specific company. To some degree, culture alone can drive performance. However, without operational systems and controls, the effects of culture are limited and ultimately will not be sustained. Similarly, operational systems/controls (e.g., management processes, systems, and procedures) can improve performance, but these effects also are limited without the reinforcement of a strong culture. A robust culture with employee engagement, an effective management system, and appropriate and consistent human performance are equally critical.

A culture assessment incorporates an assessment of culture and program implementation status by performing interviews and surveys up, down, and across a representative sample of the company’s operations. Observations of company operations (field/facility/functional) should be done to verify and validate.

A culture assessment should evaluate key attributes of successful programs, including:

1. Leadership
2. Vision & Values
3. Goals, Policies & Initiatives
4. Organization & Structure
5. Employee Engagement, Behaviors & Communications
6. Resource Allocation & Performance Management
7. Systems, Standards & Processes
8. Metrics & Reporting
9. Continually Learning Organization
10. Audits & Assurance

Assessment and Evaluation

Data from document review, interviews, surveys, and field observations are then aggregated, analyzed, and evaluated. Identifying program gaps and issues enables a comparison of what must be improved or developed/added to what already exists. This information is often organized into the following categories:

• Policy and strategy refinements
• Process and procedure improvements
• Organizational and resource requirements
• Information for decision making
• Systems and data requirements
• Culture enhancement and development

From this information, it becomes possible to identify recommendations for program improvements. These recommendations should be integrated into a strategic action plan that outlines the long-term program vision, proposed activities, project sequencing, and milestones. The highest priority actions should be identified and planned to establish a foundation for continual improvement, and allow for a more proactive means of managing risks and program performance.

Audits provide an essential tool for improving and verifying compliance performance. As discussed in Part 1, there are a number of audit program elements and best practices that can help ensure a comprehensive audit program. Here are 12 more tips to put to use:

1. Action item closure. Address repeat findings. Identify patterns and seek root cause analysis and sustainable corrections.
2. Training. Training should be done throughout the entire organization, across all levels:
   • Auditors are trained on both technical matters and program procedures.
   • Management is trained on the overall program design, purpose, business impacts of findings, responsibilities, corrections, and improvements.
   • Line operations are trained on compliance procedures and company policy/systems.
3. Communications. Communications with management should be done routinely to discuss status, needs, performance, program improvements, and business impacts. Communications should be done in business language—with business impacts defined in terms of risks, costs, savings, avoided costs/capital expenditures, benefits. Those accountable for performance need to be provided information as close to “real time” as possible, and the Board of Directors should be informed routinely.
4. Leadership philosophy. Senior management should exhibit top-down expectations for program excellence. EHSMS quality excellence goes hand-in-hand with operational and service quality excellence. Learning and continual improvement should be emphasized.
5. Roles & responsibilities. Clear roles, responsibilities, and accountabilities need to be established. This includes top management understanding and embracing their roles/responsibilities. Owners of findings/fixes also must be clearly identified.
6. Funding for corrective actions. Funding should be allocated to projects based on significance of risk exposure (i.e., systemic/preventive actions receive high priority). The process should incentivize proactive planning and expeditious resolution of significant problem areas and penalize recurrence or back-sliding on performance and lack of timely fixes.
7. Performance measurement system. Audit goals and objectives should be nested with the company business goals, key performance objectives, and values. A balanced scorecard can display leading and lagging indicators. Metrics should be quantitative, indicative (not all-inclusive), and tied to their ability to influence. Performance measurements should be communicated and widely understood. Information from auditing (e.g., findings, patterns, trends, comparisons) and the status of corrective actions often are reported on compliance dashboards for management review.
8. Degree of business integration. There should be a strong link between programs, procedures, and methods used in a quality management program—EHS activities should operate in patterns similar to core operations rather than as ancillary add-on duties. In addition, EHS should be involved in business planning and MOC. An EHSMS should be well-developed and designed for full business integration, and the audit program should feed critical information into the EHSMS.
9. Accountability. Accountability and compensation must be clearly linked at a meaningful level. Use various award/recognition programs to offer incentives to line operations personnel for excellent EHS performance. Make disincentives and disciplinary consequences clear to discourage non-compliant activities.
10. Deployment plan & schedule. Best practice combines the use of pilot facility audits, baseline audits (to design programs), tiered audits, and a continuous improvement model. Facility profiles are developed for all top priority facilities, including operational and EHS characteristics and regulatory and other requirements.
11. Relation of audit program to EHSMS design & improvement objectives. The audit program should be fully interrelated with the EHSMS and feed critical information on systemic needs into the EHSMS design and review process. It addresses the “Evaluation of Compliance” element under EHSMS international standards (e.g., ISO 14001 and OHSAS 18001). Audit baseline helps identify common causes, systemic issues, and needed programs. The EHSMS addresses root causes and defines/improves preventive systems and helps integrate EHS with core operations. Audits further evaluate and confirm performance of EHSMS and guide continuous improvement.
12. Relation to best practices. Inventory best practices and share/transfer them as part of audit program results. Use best-in-class facilities as models and “problem sites” for improvement planning and training.  The figure below illustrates an audit program that goes beyond the traditional “find it, fix it, find it, fix it” repetitive cycle to one that yields real understanding of root causes and patterns. In this model, if the issues can be categorized and are of wide scale, the design of solutions can lead to company-wide corrective and preventive measures. This same method can be used to capture and transfer best practices across the organization. They are sustained through the continual review and improvement cycle of an EHSMS and are verified by future audits.

Read the part 1 audit program best practices. 

Audits provide an essential tool for improving and verifying compliance performance. Audits may be used to capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices. An audit is typically part of a broader compliance assurance program and can cover some or all of the company’s legal obligations, policies, programs, and objectives.

Companies come in a variety of sizes with a range of different needs, so auditing standards remain fairly flexible. There are, however, a number of audit program elements and best practices that can help ensure a comprehensive audit program:

1. Goals. Establishing goals enables recognition of broader issues and can lead to long-term preventive programs. This process allows the organization to get at the causes and focus on important systemic issues. It pushes and guides toward continuous improvement. Goal-setting further addresses the responsibilities and obligations of the Board of Directors for audit and oversight and elicits support from stakeholders.
2. Scope. The scope of the audit should be limited initially (e.g., compliance and risk) to what is manageable and to what can be done very well, thereby producing performance improvement and a wider understanding and acceptance of objectives. As the program is developed and matures (e.g., Management Systems, company policy, operational integration), it can be expanded and, eventually, shift over time toward systems in place, prevention, efficiency, and best practices.
3. Committed resources. Sufficient resources must be provided for staffing and training and then applied, as needed, to encourage a robust auditing program. Resources also should be applied to EHSMS design and continuous improvement. It is important to track the costs/benefits to compare the impacts and results of program improvements.
4. Operational focus. All facilities need to be covered at the appropriate level, with emphasis based on potential EHS and business risks. The operational units/practices with the greatest risk should receive the greatest attention (e.g., the 80/20 Rule). Vendors/contractors and related operations that pose risks must be included as part of the program. For smaller, less complex and/or lower risk facilities, lower intensity focus can be justified. For example, relying more heavily on self-assessment and reporting of compliance and less on independent audits may provide better return on investment of assessment resources.
5. Audit team. A significant portion of the audit program should be conducted by knowledgeable auditors (independent insiders, third parties, or a combination thereof) with clear independence from the operations being audited and from the direct chain of command. For organizational learning and to leverage compliance standards across facilities, it is good practice to vary at least one audit team member for each audit. Companies often enlist personnel from different facilities and with different expertise to audit other facilities. Periodic third-party audits further bring outside perspective and reduce tendencies toward “home-blindness”.
6. Audit frequency. There are several levels of audit frequency, depending on the type of audit:
   • Frequent: Operational (e.g., inspections, housekeeping, maintenance) – done as part of routine EHSMS day-to-day operational responsibilities
   • Periodic: Compliance, systems, actions/projects – conducted annually/semi-annually
   • As needed: For issue follow-up
   • Infrequent: Comprehensive, independent – conducted every three to four years

7. Differentiation methods. Differentiating identifies and distinguishes issues of greatest importance in terms of risk reduction and business performance improvement. The process for differentiating should be as clear and simple as possible; a system of priority rating and ranking is widely understood and agreed. The rating system can address severity levels, as well as probability levels, in addition to complexity/difficulty and length of time required for corrective actions.
8. Legal protection. Attorney privilege for audit processes and reports is advisable where risk/liability are deemed significant, especially for third-party independent audits. To the extent possible, make the audit process and reports become management tools that guide continuous improvement. Organizations should follow due diligence elements of the USEPA audit policy.
9. Procedures. Describe and document the audit process for consistent, efficient, effective, and reliable application. The best way to do this is to involve both auditors and those being audited in the procedure design. Audit procedures should be tailored to the specific facility/operation being audited. Documented procedures should be used to train both auditors and those accountable for operations being audited. Procedures can be launched using a pilot facility approach to allow for initial testing and fine-tuning. Keep procedures current and continually improve them based on practical application. Audits include document and record review (corporate and facility), interviews, and observations.
10. Protocols & tools. Develop specific and targeted protocols that are tailored to operational characteristics and based on applicable regulations and requirements for the facility. Use “widely accepted or standard practice” as go-by tools to aid in developing protocols (e.g., ASTM site assessment standards; ISO 14010 audit guidance; audit protocols based on EPA, OSHA, MSHA, Canadian regulatory requirements; GEMI self-assessment tools; proprietary audit protocol/tools). As protocols are updated, the ability to evaluate continuous improvement trends must be maintained (i.e., trend analysis).
11. Information management & analysis. Procedures should be well-defined, clear, and consistent to enable the organization to analyze trends, identify systemic causes, and pinpoint recurring problem areas. Analysis should prompt communication of issues and differentiation among findings based on significance. Audit reports should be issued in a predictable and timely manner. It is desirable to orient the audit program toward organizational learning and continual improvement, rather than a “gotcha” philosophy. “Open book” approaches help learning by letting facility managers know in advance what the audit protocols are and how the audits will be conducted.
12. Verification & corrective action. Corrective actions require corporate review, top management-level attention and management accountability for timely completion. A robust root cause analysis helps to ensure not just correction/containment of the existing issue, but also preventive action to assure controls are in place to prevent the event from recurring. For example, if a drum is labeled incorrectly, the corrective action is to relabel that drum. A robust plan should also look for other drums than might be labeled incorrectly and to add and communicate an effective preventive action (e.g., training or posting signs showing a correctly labeled drum).

Read the part 2 audit program best practices. 

A management system is the framework that enables companies to achieve their operational and business objectives through a process of continuous improvement. In its simplest form, a management system implements the Plan, Do, Check, Act/Adjust cycle. Several choices are available for management systems (ISO is commonly applied), whether they are certified by third-party registrars and auditors, self-certified, or used as internal guidance and for potential certification readiness.

Business Benefits of a Well-Documented Management System

The connection between management systems and compliance is vital in avoiding recurring compliance issues and in reducing variation in compliance performance. In fact, reliable and effective regulatory compliance is commonly an outcome of consistent and reliable implementation of a management system.

Beyond that, there are a number of business reasons for implementing a well-documented management system (environmental, safety, quality, food safety, other) and associated support methods and tools:

1. Establishes a common documented framework to achieve more consistent implementation of compliance policies and processes—addressing the eight core functions of compliance:
   • Inventories
   • Permits and authorizations
   • Plans
   • Training
   • Practices in place
   • Monitoring and inspection
   • Records
   • Reporting

2. Provides clear methods and processes to identify and prioritize risks, set and monitor goals, communicate those risks to employees and management, and allocate the resources to mitigate them.
3. Shifts from a command-and-control, centrally driven function to one that depends heavily on teamwork and implementation of a common system, taking into consideration the necessary local differences and building better know-how at the facility level.
4. Establishes a common language for periodic calls and meetings among managers, facility managers, and executives, which yields better goal-setting, priority ranking, and allocation of resources to the areas with greatest risk or the greatest opportunity to add business value.
5. Empowers facilities to take responsibility for processes and compliance performance without waiting to be told “what” and “how”.
6. Enables better collaboration and communication across a distributed company with many locations.
7. Enables the selection and implementation of a robust information system capable of tracking and reporting on common activities and performance metrics across the company.
8. Employs a design and implementation process that builds company know-how, captures/retains institutional knowledge, and enables ongoing improvement without having to continually reinvent the wheel.
9. Creates consistent processes and procedures that support personnel changes (e.g., transfers, promotions, retirements) and training of new personnel without causing disruption or gaps.
10. Allows for more consistent oversight and governance, yielding higher predictability and reliability.

A well-designed and well-executed compliance assurance program provides an essential tool for improving and verifying business performance and limiting compliance risks. Ultimately, however, a compliance program’s effectiveness comes down to whether it is merely a “paper program” or whether it is being integrated into the organization and used in practice daily.

The following can show evidence of a living, breathing program:

• Comprehensiveness of the program
• Dedicated staff and resources
• Employee knowledge and engagement
• Management commitment and employee perception
• Internal operational inspections, “walk-abouts” by management
• Independent insider, plus third-party audits
• Program tailoring to greatest risks
• Consistency and timeliness of exception (noncompliance/nonconformance) disclosures
• Tracking of timely and adequate corrective/preventive action completion
• Progress and performance monitoring

Best Practices

To achieve a compliance assurance program on par with world-class organizations, there are a number of best practices that companies should employ:

1. Know the requirements. This means maintaining an inventory of regulatory compliance requirements for each compliance program, as well as of state/local/contractual binding agreements applying to operations. It is vital that the organization keep abreast of current/upcoming requirements (federal, state, local).
2. Plan and develop the processes to comply. Identify and assess compliance risks, and then set objectives and targets for performance improvement based on top priorities. From here, it becomes possible to then define program improvement initiatives, assign and document responsibilities for compliance (who must do what and when), develop procedures and tools, and then allocate resources to get it done.
3. Assure compliance in operations. The organization needs to establish routine checks and inspections within departments to evaluate conformance with sub-process procedures. Process audits should be designed and implemented to cut across operations and sub-processes in order to evaluate conformance with company policies and procedures. Regulatory compliance audits should further be conducted to address program requirements (e.g., environmental, safety, mine safety, security). Audit performance must be measured and reported, and then expectations set for operating managers to take responsibility for compliance.
4. Take action on issues and problems. Capture, log, and categorize noncompliance issues, process non-conformances, and near misses. Implement a corrective/preventive action process based on importance of issues. Be disciplined in timely completion, close-out, and documentation of all corrective/preventive actions.
5. Employ management of change (MOC) process. Robust MOC processes help ensure that changes affecting compliance (to facility, operations, personnel, infrastructure, materials, etc.) are reviewed for their impacts on compliance. Compliance should be assured before the changes are made. Failure to do so is one of the most common root causes of noncompliance.
6. Ensure management involvement and leadership. Set the tone at the top. The Board of Directors and senior executives must set policy, culture, values, expectations, and goals. It is just as important that these individuals are the ones to communicate across the organization, to demonstrate their commitment and leadership, to define an appropriate incentive/disincentive system, and to provide ongoing organizational feedback.

The new ISO 9001:2015 standard for Quality Management Systems (QMS) was issued in late 2015—which means the three-year transition period to become certified to the new version is now in full swing. Change can certainly present challenges; however, the ISO 9001:2015 update is designed to simplify the requirements, focus more on business needs, and make the ISO standards more user-friendly.

That being said, organizations will need to make adjustments to their QMS to meet the new requirements. The major impacts that organizations need to consider for ISO 9001:2015 certification include the following:

• Increased management responsibility
• Organizational identification of risks and opportunities
• Impacts of process implementation vs. guidance procedures
• Overhaul of internal audit requirements

Management Responsibility

The increase in management responsibility requires an organization’s objectives and targets to be:

• Business-driven
• More explicit in content
• Reviewed and monitored on a regular basis

Importantly, the QMS must be connected to the business strategy. This involves management taking ownership for the QMS and creating a vision and strategy for the organization, its employees, and customers to follow and interact with in a mutually beneficial manner. The idea is that this will foster a sustainable business plan.

Identification of Risks and Opportunities

The organization must identify and quantify the risks and opportunities presented by each new business endeavor or market driver they seek to enter. This will help management understand the full operational requirements and potential related consequences that must be addressed prior to moving the organization in a new direction.

The process of identifying risks and opportunities involves reviewing and evaluating employee skill sets, equipment capabilities, facility requirements, logistics requirements, environmental and safety risks, and others. In addition, quality control requirements must be reviewed in terms of possible training and equipment needs, and then verified as either adequate or in need of required changes prior to startup.

Process Implementation

The single largest change to the QMS is arguably the notion of written procedures guiding the organization vs. the use of a process approach to enhance the organization’s ability to exhibit systematic control over any/all changes to the products and/or services it provides. This change represents a shift in the approach regarding business operations.

Under a process approach, the management team must:

• Define inputs and outputs of each process
• Determine the correct performance indicator(s) to assure compliance and customer specifications have been met
• Assign appropriate responsibility for these steps

To comply with ISO 9001:2015, the organization must be able to stop a process and rectify the issues of concern prior to a nonconforming product and/or service being given to a customer. As such, employees are empowered to complete a root cause analysis and then notify management of possible change(s) required.

Internal Audit

Corresponding to the process orientation discussed above, the internal audit program will also need to be revamped to go from auditing a single clause to auditing an entire process. This may require additional auditor training for internal auditors, as well as an overall better understanding of the processes the organization follows in its daily business.

The following tips can all help modify the internal audit process to work under the ISO 9001:2015 standard.

1. Audit one complete process at a time. This will allow auditors to better assess the process itself, identify possible areas for review and improvement, and verify adequacy of current controls in place.
2. Develop flow charts that outline every step in the process(es) and the associated procedures, work instructions, and forms required to assure compliance of each identified step.
3. Look for areas throughout the audit where the product and/or service hand-off between departments and equipment cells may be unclear or confusing, leading to a potential nonconformance to the customer.

Big Steps toward Continuous Improvement

While any one of the changes discussed above would represent a significant improvement over the 2008 version of ISO 9001, taken together and implemented properly, the 2015 updates are set up to help organizations take large step towards continuous improvement.

Under ISO 9001:2015, day-to-day operations should:

• Be more functional and harmonious
• Allow for improvements in product and/or service hand-offs between departments
• Improve the consistency of delivering to the customer exactly what is requested
• Reward the organization with improvements to internal functions and lower costs over time