On behalf of our team, Kestrel Management would like to invite you to attend the 6th Annual Food Safety Consortium Conference & Expo on Nov. 13-15 in Schaumburg, IL.
The Consortium is a premiere event for food safety education and networking—and we want to offer you the chance to visit us at the event (booth #119) for a discounted rate (see offer below).
You can accomplish more in two or three days at the Food Safety Consortium than you might otherwise achieve in weeks! Here are five ways the Food Safety Consortium will allow you to enhance your business:
- Get expert advice on specific challenges faced by your business.
- Listen to insights from thought leaders & innovators.
- Stay up-to-date with emerging or changing trends.
- Upgrade your skills, knowledge and on-the-job effectiveness.
- Gain new ideas and insights to grow your business.
Come see Kestrel at booth #119. When you register, use our discount code Cubs and receive a 20% discount off registration.
BY: Stacey Pisani
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The AirWorks 2018 Conference is focused on the growing commercial drone industry and how developers, partners, and operators can work to reshape the global economy with drones. This year, Kestrel Management will be teaming with Union Pacific Railroad to talk about our experience and lessons learned from managing industrial-scale drone programs.
October 30 – November 1, 2018
Kestrel Presentation: Bringing Your Drone Program to Scale: Lessons Learned from Going Big
Thursday, November 1 at 11:00 a.m.
Rachel Mulholland, Kestrel Management Consultant, Industrial UAS Programs
Edward Adelman, Union Pacific Railroad, General Director of Safety
This presentation will discuss the risks and opportunities associated with building an industrial drone program and share some of the lessons learned from our experience. We’ll discuss common questions, including the following:
- What does it take to build an industrial drone program?
- How can UAS technology fit into your current business model?
- What challenges can occur with fleets of certified remote pilots and unmanned vehicles?
- How do you ensure you operate in compliance with FAA regulations?
- What are some common pitfalls to avoid and best practices to incorporate into your program?
Why You Should Attend
If you currently have a drone program or are looking to implement one, this event is for you!
- Attend sessions focused on the industry track most relevant to your business: construction, energy, agriculture, public safety, infrastructure
- Network with companies that are on the forefront of enterprise drone adoption
- Get a preview of the latest drone technologies
- Receive hands-on training from experienced industry leaders and instructors
When looking at FSMA, it’s important to look at what we should be doing in industry under FSMA’s prevention scheme. FDA seeks for companies to assess risk and implement preventive controls on a broad basis. Thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or an importer, is key for any food company when planning for the future.
From Reactive to Proactive
With the FSMA rules, FDA has moved from reactive to proactive. Preventive strategies are the essence of FSMA. Proactively creating or updating a food defense and safety plan is the first step to ensure compliance.
The four “A’s” of food defense, as outlined below, provide a methodology for building a proactive and comprehensive food defense program.
Step 1: Assess
Assess the risks throughout the supply chain, including to the origin of raw materials. Conduct a vulnerability assessment of weaknesses and critical control points to identify where someone could attempt product adulteration. The focus must be both inside and outside of company walls and extend to the source of materials and services within the supply chain for producers and distributors of food to the public.
Step 2: Access
Who has access to critical control points and food material risk areas? Pay close attention to the four key activity types that FDA has identified as particularly vulnerable to adulteration:
- Mixing and grinding activities that involve a high volume of food with a high potential for uniform mixing of a contaminant
- Ingredient handling with open access to the product stream
- Bulk liquid receiving and loading
- Liquid storage and handling, which is typically located in remote, isolated areas
Restrict access to these areas from suppliers, contractors, visitors, and most employees—limiting access to critical employees only. This provides a higher level of protection, and supports video and/or physical monitoring.
Step 3: Alerts
Alerts of intentional and unintentional food adulteration must be sent to the appropriate individuals, according to the documented food safety and defense program. Response time is critical. Every passing minute is a minute when more health risks could develop, leading to a greater chance of negative impacts on public safety and the related businesses.
Step 4: Audit
Auditing operational and regulatory compliance helps to ensure and maintain best food defense practices and provide documentation of compliance to regulators. FSMA promotes the safety of the U.S. food supply by focusing on prevention, rather than reactive response. Prevention is only as effective as the actual compliance processes put in place. Regular and random auditing, including remote video monitoring, provides evidence confirming that the appropriate preventive measures are taken and effective.
Taking a proactive approach to food defense that follows these four “A’s” will help meet a key requirement by ensuring that the organization is working to avoid the risks associated with food adulteration and contamination.
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.
Supply chain management is becoming more and more relevant to small and entrepreneurial food businesses, particularly related to FSMA requirements that are required to be fully implemented by this September. To meet these requirements, it is important for small businesses to understand:
- Applicable FSMA requirements
- How to develop a supplier approval program
- What challenges companies may encounter and tips to overcome them
- How to find an appropriate starting point to develop a supply chain management program
Read Kestrel Senior Consultant Melody Ge‘s latest article in Food Safety Tech, written to help small and entrepreneurial companies understand the basics of food supply chain management to start formulating their own programs.
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.
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).
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
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.
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:
- Vision & Values
- Goals, Policies & Initiatives
- Organization & Structure
- Employee Engagement, Behaviors & Communications
- Resource Allocation & Performance Management
- Systems, Standards & Processes
- Metrics & Reporting
- Continually Learning Organization
- 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:
- Action item closure. Address repeat findings. Identify patterns and seek root cause analysis and sustainable corrections.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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”.
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.
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:
- Establishes a common documented framework to achieve more consistent implementation of compliance policies and processes—addressing the eight core functions of compliance:
- Permits and authorizations
- Practices in place
- Monitoring and inspection
- 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.
- 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.
- 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.
- Empowers facilities to take responsibility for processes and compliance performance without waiting to be told “what” and “how”.
- Enables better collaboration and communication across a distributed company with many locations.
- Enables the selection and implementation of a robust information system capable of tracking and reporting on common activities and performance metrics across the company.
- 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.
- Creates consistent processes and procedures that support personnel changes (e.g., transfers, promotions, retirements) and training of new personnel without causing disruption or gaps.
- Allows for more consistent oversight and governance, yielding higher predictability and reliability.