June 22, 2017 - Kestrel Food Safety
How has your company interpreted and implemented the requirements of the Foreign Supplier Verification Program (FSVP)?
This year (2017), most U.S. companies that source food from foreign sources will be obligated to adopt and follow the Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) requirements. Under the FSVP, these new imperatives require companies to assess their foreign supply chain of food product and implement new programs to meet and achieve compliance. These programs must be implemented and ready for inspection under FDA FSMA enforcement by the compliance date. For many companies, that date was May 30, 2017.
Effective May 30, 2017, impacted companies are expected to follow the FSMA FSVP legal requirements or face a disruption in supply, business impacts, possible fines, and penalties. In short, this requires that companies ensure that receipt of foreign food includes the necessary information to be adequately inspected and verified.
Key areas to demonstrate FSVP compliance include the following:
- Determine the receipt information under FSVP to verify approval of each shipment of each product by lot identity.
- Confirm the existing information that may already be required for each shipment, including COA by product lot and FDA registration number (with expiration date).
- Document the actual site of manufacture of the foreign supplied product, including the location, contact information, operator, and Qualified Individual overseeing the Food Safety Plan.
- Require declarations with each shipment stating that the supplier is in good standing with FDA and their foreign government’s food safety regulations. Provide a list of all programs under FSMA (Food Safety Plan and Section 17 cGMPs) with each shipment under an authorized signature.
- Include any additional information that is required under the FSVP that adequately confirms compliance to the company’s program, product requirements, and FSMA.
- Establish and maintain receipt records on all information that can be accessed and inspected at the request of inspection authorities for at least two years.
At first glance, the FSVP requirements seem basic—foreign supplied food product is approved by meeting the FDA requirements and the requirements of U.S. companies receiving these products. It looks to be the same as existing supplier qualifications for U.S.-supplied food product.
However, the FSVP rule provides much information on “what” is required of companies but not “how” or how to validate and verify these programs. Many FSMA training programs, including the FDA-funded FSPCA, really do not provide a level of guidance for companies to develop and meet the anticipated inspection process, which could include shipments stopped at a foreign port or at the U.S. port of entry. Concurrently, established importers have programs to communicate import shipments based on the requirements prior to FSMA and the FSVP, but many have expressed confusion in determining the changes now required.
Leading up to the May 30th compliance date, many companies of all sizes and scale began to seek ways to best establish their programs to meet the full regulatory requirement. Much of the focus has been on establishing practices that informally address what is really required under the FSVP, while making a casual determination of compliance. Other companies have developed programs consistent with the procedural requirements of the FSVP rule, as published.
Some companies have taken the requirements to an extreme by determining new supplier requisite information for each shipment to prove compliance. This has resulted in generating a significant amount of information for each shipment by each product. This level of information is not what FSMA intended. Much of the required information for FSVP is already in the established supplier qualification program and must be maintained but is not required in its entirety with each shipment. In fact, there are issues with the approach of requiring all information with each foreign supply shipment, including:
- Sheer volume of information
- Time required to assemble the information
- Inability of inspectors to assess all the information for compliance
All of this leads to the confusing situation that exists in the market today concerning the FSMA FSVP, where compliant practices have not been developed and newly established requirements have not been tested by enforcement. As a result, reports indicate that many foreign suppliers of varying company size, scale and sophistication are not openly willing to respond without clear, simple instructions from their U.S customers.
Establishing Reasonable Plans
Ultimately, many of the FSVP practice requirements will be developed and refined through the regulatory inspection actions of the rule. That being said, industry cannot wait. Companies need to have reasonable plans established for all current shipments being made under the FSVP.
Companies should focus on the more fundamental aspects of the FSVP—those requirements that must be verified, recorded, and evident in the documents supporting all foreign shipments of food product under the rule. This information does not need to include the entire policy manual but select summary information.
An important consideration involves understanding how this law is expected to be inspected. Knowing this provides a basis to develop and implement an effective program. The premise is that the foreign shipments may not be stopped for inspection at the border level, but that inspections will more commonly occur at the receiving party location of the product shipment at delivery to their U.S. locations. Regulators will expect to inspect verified, recorded, and legal receipt of foreign supplied food product.
Areas to focus on to ensure compliance with the FSVP requirements include the following:
Receipt of RSVP Products. Focus on verification of the necessary information for receipt of FSVP products based on the law and the company’s defined program. This does not mean all program information but information that adequately meets the level required for compliance.
Shipment Information for Receiving Records. Establish lists of shipment information for all shipments, which includes all products being received under FSVP, as summary forms with current and validated information. Summary information that can be effectively inspected as part of and aligned with the shipping paperwork will provide the necessary information as part of an FSVP receiving record.
Compliance Actions. Establish procedures and work instructions to ensure that compliant practices are approved, verified, and meet the minimum requirements. This will include modifying some existing documents and forms that are specifically required under the FSVP. This level of approved summary information must reflect the documented policies and procedures developed in the company’s FSMA Food Safety Plan and FSVP.
Internal Programs. Maintain internal programs, with oversight verification conducted diligently. All required information must be accounted for and records must be completed and maintained with a high level of accuracy and integrity. Verification must include oversight and multi-level signed approval.
Submitted by: Bill Bremer
June 22, 2017 - Kestrel Management
What is ISO 45001?
ISO 45001 is a new international standard created by the International Organization for Standardization (ISO) that specifies requirements for an occupational, health & safety management system (OHSMS). It provides a framework for managing the prevention of death, work-related injury, and work illnesses. The ultimate goal of the standard is to help organizations proactively improve OHS performance and create a safe and healthy workplace.
Note that ISO 45001 provides guidance. It does not state specific criteria for OHS performance, nor is it prescriptive about the OHSMS design. It is a management tool for voluntary use by organizations to minimize OHS risks.
Why Is ISO 45001 necessary?
There are several reasons why the creation of an international standard to manage OHS performance is necessary:
- First and foremost, organizations are responsible for minimizing the risk of harm to all individuals that may be impacted by their activities. The standard aims to protect human lives by encouraging organizations to create a safer, healthier workplace.
- According to the International Labour Organization (ILO), there were 2.34 million deaths worldwide in 2013 as a result of worker activities. The greatest majority (2 million) are associated with health issues, as opposed to injuries. The economic burden associated with this number of occupational injuries and illnesses is significant. Organizations must manage all their risks—including OHS—to survive. Poor OHS management can result in loss of key employees, business interruption, claims, higher insurance premiums, regulatory action, reputational damage, loss of investors, and loss of business.
- Finally, increased globalization creates new OHS challenges. ISO 45001 is an international standard that promotes global conformity.
What are the key aspects of ISO 45001?
Many of the elements of ISO 45001 are the same or similar to those found in OSHAS 18001. However, there are additions and changes in ISO 45001 that differentiate the new standard.
ISO 45001 establishes new roles for the organization’s people. First, it emphasizes worker participation in the OHSMS. This includes ensuring that workers are competent and have the appropriate skills to safely perform their tasks. Second, the role of top management is different than in OHSAS 18001. Of note, a designated Management Representative is no longer required; however, those individuals in management roles are expected to take ownership and demonstrate commitment to OHS through leadership. Top management must demonstrate direct involvement and engagement with the OHSMS by:
- Ensuring the organization’s OHS policy and objectives are compatible with the overall strategic direction of the organization
- Integrating OHSMS processes and requirements into business processes
- Developing and promoting an OHS culture that supports the OHSMS
- Being accountable for the OHSMS’s effectiveness
In addition to people, ISO 45001 follows a risk-based approach that advocates prevention. This requires identifying activities that could harm those working on behalf of the organization. A large part of this involves understanding the “context” of the organization, another new element of ISO 45001. Organizations must be able to identify all external and internal factors that have the potential to impact OHS management objectives and results.
To address risks and opportunities, there are new clauses related to hazard identification, as well. As with other sections of the standard, hazard identification becomes a process rather than a procedure and, importantly, considers all individuals near the workplace who may be impacted by the organization’s activities. ISO 45001 further outlines a more defined hierarchy for organizations to determine appropriate controls.
How does ISO 45001 fit in with other ISO standards and management system approaches?
ISO 45001 follows the same high-level management system approach being applied to other ISO management system standards (e.g., ISO 14001 and ISO 9001)—Annex SL. Because of this, the ISO 45001 requirements should be consistent with the other standards to allow for relatively easy alignment and integration into the organization’s overall management processes.
In addition, ISO 45001 takes into account other OHS standards, including OHSAS 18001, ILO-OSH Guidelines, various national standards, and the ILO’s international labour standards and conventions.
What is Annex SL?
As mentioned above, Annex SL is the structure for all new and revised ISO standards. It defines the framework for a generic management system—and is then customized for each discipline. This standard structure allows for easier integration between management systems and improved efficiencies. The major clauses for all ISO management system standards are identical under Annex SL and fall into the Play-Do-Check-Act (PDCA) cycle. Organizations who have already implemented ISO 9001:2015 or ISO 14001:2015 will be familiar with the Annex SL structure.
The table below outlines the main clauses in Annex SL, as well as the OHSMS-specific clauses. Highlighted areas indicate those sections that are significant changes/additions to the existing OHSAS 18001 standard.
What does this mean for OHSAS 18001?
As outlined in the table above, ISO 45001 does not conflict with OHSAS 18001. In fact, it expands and enhances the existing standard to improve integration of the OHSMS into the overall business. Once it is finalized, ISO 45001 is intended to replace OHSAS 18001. Much like other management system standards, current users of OHSAS 18001 will need to update their systems according to the requirements of the new standard within a three-year transition period.
When will it be finalized?
The current expected publication date is February 2018. Drafts will be available through local ISO members once they reach the public enquiry (DIS) stage and Final Draft (FDIS) stage.
Once it’s published, who should use ISO 45001?
The short answer is everyone. ISO 45001 is designed to be a flexible management system that can be implemented by any organization, no matter the size, type, or industry. As long as the organization has people who may be affected by its activities, an OHSMS has value in ensuring worker health and safety and fulfilling legal requirements.
Why should I do this? Why are management systems like ISO 45001 beneficial?
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 through an organized set of policies, procedures, practices, and resources that guide the enterprise and its activities to maximize business value. There are a number of reasons to implement a management system (see this article: http://kestrelmanagement.com/business-benefits-mgmt-sys/).
What do I do next?
- Get informed! Start reading up on ISO 45001. While the final standard may not yet be published, current versions can provide a good indication of what is to come.
- Identify gaps in your existing OHSMS that will need to be addressed to meet any new requirements. If you don’t have an existing OHSMS, review the requirements and determine what pieces you may already have in place.
- Develop an implementation plan. There is a three-year transition period once the new ISO 45001 standard is published (anticipated February 2018). Plan according to this timeline.
- Provide training. It is vital to ensure that workers and management are engaged in the OHSMS and that they are competent in any new skills/responsibilities that may be required.
- Put your plan into action. Update/develop your OHSMS to meet the ISO 45001 requirements and provide verification of its effectiveness to ensure certification.
June 22, 2017 - Kestrel Management
This is the fifth in a series of five articles on developing and maintaining a world-class compliance assurance program.
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 on a daily basis.
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
To achieve a compliance assurance program on par with world-class organizations, there are a number of best practices that companies should employ:
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).
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.
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.
Take action on issues and problems. Capture, log, and categorize noncompliance issues, process nonconformances, 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.
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.
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.
Maintaining Ongoing World-Class Compliance Assurance Program
The compliance assurance program must be a living, breathing program. As risks change, the program must be refreshed, refined, and redeployed. A Management System framework can help ensure operational sustainability. A Management System drives the auditing process and helps companies say what they will do, do what they say and, importantly, verify it.
Together, there is real value at the intersection of a compliance assurance program and Management Systems. Management Systems define the internal controls that are in place to reduce risks, prevent losses, and sustain and improve performance over time through the Plan-Do-Check-Act (PDCA) cycle of continual improvement.
Testing and Monitoring
Testing, monitoring, and measuring are crucial elements of this cycle. Without them, it is difficult to understand what is working and what needs improvement. Robust testing and monitoring programs can serve as early warning systems for identifying potential compliance risks before they become enforcement issues.
Compliance should be tested and monitored throughout each level of the organization. A strong testing program will evaluate the results of the compliance risk assessment and assign compliance risks to the business units and processes where they are most likely to occur, creating clear lines of responsibility and accountability. Key risks and the related controls should be tested periodically using statistically valid sampling methodologies, and monitoring activities should be performed on an ongoing basis. Doing so produces trend data that provides the rationale needed for making changes to underlying business processes, as well as emerging risks.
Ongoing compliance excellence relies on top management, operations managers, EHS personnel, and individual employees throughout the organization working together to build and sustain an organizational culture that places compliance on par with business performance. Senior management must focus on the overall culture of the company in terms of taking the necessary steps to reduce risk and make prevention part of daily operations. While it may be impossible to eliminate all risk exposure, a solid risk framework, assessment methodology, and compliance assurance program can help to prioritize risks for active management, sustained compliance, and positive business impacts.
Read the other articles in this series:
- Part 1: Enterprise and Compliance Risk Management
- Part 2: Management Systems and their Importance to Compliance Assurance
- Part 3: Compliance Risks and Compliance Program Assessment
- Part 4: Audit Program Best Practices
Submitted by: Tom Kunes
June 8, 2017 - Kestrel Food Safety
On behalf of the Food Processing Suppliers Association (FPSA), Kestrel Management is pleased to be offering a 2-day Hazard Analysis and Critical Control Point (HACCP) certification training course at the 2017 PROCESS EXPO in Chicago.
The 2-day HACCP course will cover the current Food Safety Modernization Act (FSMA) compliance requirements, with focus on the Preventive Controls Rule and how this aligns with the existing industry HACCP requirements. Training will assist food industry professionals in understanding the requirements for hazard analysis, preventive controls required for Qualified Individuals, and the FSMA requirements impacting their responsibilities and their companies. Course content is based directly on the FSMA regulations and cGMPs under FDA CFR Section 117.
For the incredibly low price of $699 ($799 after July 19), course enrollees can get the benefit of this valuable industry certification AND enjoy admission to PROCESS EXPO, including access to the innovative show floor, additional educational programming, and networking opportunities with colleagues from across the country and around the world.
*Participants will be certified to HACCP and as Qualified Individuals.
This course will be led by Kestrel Management’s Roberto Bellavia, Food Safety Lead and Senior Consultant, and Frank Ferko, Senior Consultant.
Kestrel Management’s Food Safety division helps companies achieve compliance with regulatory and food safety certification requirements, including GFSI and FSMA. Led by senior consultants averaging over 25 years of experience, team members are certified in FSSC 22000, BRC, IFS, and HACCP training/development, and share expertise that integrates quality, environment, safety, and security.
June 1, 2017 - Kestrel Management
Join Kestrel at the 30th annual EHS Seminar next week to hear A.W. Armstrong present on Using a Data-Driven Method of Accident Analysis: A Case Study of the Human Performance Reliability (HPR) Process.
June 5-8, 2017
Moody Gardens Convention Center
Kestrel Presentation: Thursday June 8 at 8:30 a.m.
Kestrel Booth: #611
The Role of Human Error in Occupational Incidents
The concept of human error and its contribution to accidents and incidents has received considerable research attention in recent years. When an accident/incident occurs, investigation and analysis of the human error that led to the incident often reveals vulnerabilities in an organization’s management system.
This recent emphasis on human error has resulted in an expansion of knowledge related to human error and the most common factors contributing to incidents. Kestrel’s Human Performance Reliability (HPR) process helps to classify human error—with the additional step of associating the control(s) that failed to prevent the incident from occurring. This process allows organizations to identify how and where to focus resources to drive safety performance improvements.
In this presentation, A.W. describes Kestrel’s method for identifying the most frequent human errors and most problematic controls, and presents a case study wherein HPR was applied to a large petroleum refining company.
Catch Up with Kestrel
In addition to the presentation on June 8, Kestrel’s experts will also be available in the exhibit hall (booth #611) to discuss HPR, as well as our holistic approach to the management of process safety.
We welcome the opportunity to meet with you, learn more about your needs, and discuss how Kestrel helps our clients:
- Improve occupational and process safety performance
- Manage EHS and quality risks
- Achieve regulatory compliance assurance
See you at booth #611 in Galveston!
Submitted by: A.W. Armstrong
April 21, 2017 - Kestrel Food Safety
Each year, Kestrel looks forward to the Food Safety Summit as one of the premier events in the food industry for networking with other food professionals, hearing about industry trends, and learning practical information to bring back to our food industry clients.
Kestrel is proud to provide our ongoing support for the manufacture, processing, and distribution of safe food, and to be taking an active role in the Summit again this year!
Food Safety Summit Expo & Conference
May 8-11, 2017
Donald Stephens Convention Center
Connect with Kestrel
Stop by to visit with Kestrel representatives at our booth (#708). We are happy to also welcome special guests from Grainger to our booth, who will be on-hand to discuss their solutions. We look forward to talking further about your food safety needs and how Kestrel might be of assistance.
Submitted by: Bill Bremer
April 18, 2017 - Kestrel Food Safety
The Food Safety Modernization Act (FSMA) includes new requirements for food site inspections. Beyond that, the Act increases the frequency of established inspections. For example, FSMA mandates that high-risk facilities must be inspected within five years of enactment and no less than every three years following the initial inspection. The Act also requires inspection of at least 600 foreign facilities initially and double that number every year for the next five years. Routine inspections from FDA and other enforcement agencies will continue based on schedules to be communicated.
With FSMA rules moving to the compliance stage, food companies must prepare to best respond to the requirements and, correspondingly, to additional inspections beyond GFSI or as part of customer requirements.
Inspectors will focus heavily on new requirements and the “letter of the law”. Therefore, a well-established inspection program and response that is implemented and tested will help to achieve the most favorable outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources. It is critical to have established roles, planning, and testing as part of any inspection readiness program.
As reported, the FDA is underfunded to conduct the scheduled inspection of food operations under FSMA. While many inspections will be administered by the FDA, which will continue to expand internal resources, some local agencies are already under contract for conducting inspections that will be much more detailed than visits from them in the past.
These local regulatory agencies, including state health departments, are providing the “boots on the ground” to conduct inspections for direct compliance under FSMA or as a means of communicating more serious issues to the FDA. Based on recent experience, more critical issues are being raised to the FDA level for final action.
Roles and Responsibilities
Regardless of a company’s experience with FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals. Additionally, organizations under the FSMA Preventive Control Rule must have multiple Food Safety Plan Qualified Individuals, Qualified Auditors, competent sanitation management, and competent plant operators. Ultimately, all food company employees must be prepared for their roles in an FDA compliance inspection.
As preparation for FDA inspections, companies must establish a program to best address an inspection. The focus must be on compliance to FDA, FSMA, and internal requirements—with the inspection providing this for the company in question. The biggest concern is gaps in compliance or known non-compliances; however, with FSMA there is no tolerance or excuse for ignorance.
A response procedure should be well-orchestrated to meet and respond to the representative of the FDA or the agency visiting the site for an FDA inspection. Along with the immediate response to any inspection (including those planned and those unplanned), food companies should consider the following:
- Completely develop a FSMA Food Safety Plan to ensure that it is aligned with a possible audit and includes reference to all supporting programs, cCMPs, resource qualifications, and records. The plan must be developed under the oversight, validation and verification of a preventive controls Qualified Individual, as trained, qualified and designated.
- Have the most appropriate organizational structure (i.e., with Qualified Individuals, Qualified Auditor, sanitation leads and food plant operators) to meet FSMA resources and minimize the organizational impacts.
- Regularly review the FSMA Food Safety Plan as part of a general and management review process, including the internal audit by the Qualified Auditor, to ensure the up-to-date compliance of the Plan.
- Review all records to maintain verification requirements for FSMA, as required by Section 117. Ensure that all records are compete, validated, and verified.
- Conduct mock regulatory inspections to ensure readiness and understanding of the responsibilities of each employee based on their roles in the process. This should include following the program and confirming all actions, roles and responsibilities. All improvements from this process should be updated into programs and implemented for possible inspection purposes.
- Ensure compliance with all other regulatory requirements, including FSMA Sanitary Transportation, Foreign Supplier Verification, site registration, and any other related regulatory requirements.
- Confirm compliance with Management of Change (MOC) to ensure that all building, equipment and process changes are reflected in current Food Safety Plans and Section 117 cGMPs. This must include product-level specifications, including packaging, ingredients and processing.
- Document and update review and mock drills of regulatory inspection programs with any non-conformances addressed as quickly as possible. Consider the process for verifying the inspector’s credentials, opening the session, and ensuring that all required personnel or backups are onsite in the case of an inspection. In cases where all cannot be present or for outside contacts, ensure availability of ownership, corporate compliance management, and designated legal counsel.
Compliance to both FSMA and GFSI requirements means fully conforming with the other. A non-conformance to the GFSI food safety system represents a potential FSMA violation; correspondingly, lack of conformance to FSMA can be a non-conformance to GFSI certification. Criminal violations for non-compliance to FSMA begin with misdemeanor charges starting at $250,000 and up to one year in jail. With these consequences on the line, the importance of FDA inspections must be taken very seriously.
Submitted by: Bill Bremer
April 18, 2017 - Kestrel Management
This is the fourth in a series of five articles on developing and maintaining a world-class compliance assurance program.
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.
There are a number of third-party auditing standards that offer guidelines for ensuring accurate, complete, and reliable EHS audits, including:
- The Board of Environmental, Health, and Safety Auditing Certifications (BEAC) Standards, 2008
- ISO 19011 Auditing Guidelines, 2002
- Auditing Roundtable Standards, 1993
- USEPA Auditing Policy, 1986, 2000
- Institute of Internal Auditors Standards, 1997
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”.
Most common options for compliance audit team design include the following:
- Facility-based EHS Team
- Advantages – awareness of operations and specific facility EHS regulated activities
- Disadvantages – lack independence and objective outside perspective; may have some responsibilities for activities audited; likely to have limited regulatory expertise needed; likelihood of significant inconsistencies and variability from facility to facility
- Best use – routine and frequent inspections and monitoring, including progress checks on completion of corrective actions arising from other audits; desirable to have staff from other facilities participate on audit team; auditors should not audit their own departments or operations; may conduct and submit to corporate annual facility compliance self-assessments and assurance statements by facility management
- Independent Inside EHS Team
- Typically, from corporate headquarters (may include facility EHS representatives from other facilities)
- Advantages – improved independence from operations; likely to provide regulatory know-how and multi-facility perspective; consistency in audit methods and content likely across facilities
- Disadvantages – can be subject to limited independence and internal business pressures; may have limited perspective on best industry practices from outside organization; may not have up-to-date regulatory requirements awareness
- Best use – dedicated corporate EHS lead auditor(s) supported by subject matter experts on audit team; EHS personnel from other facility(s) participate on team for cross-facility learning; audit protocols maintained to be current; audits conducted annually at higher risk facilities; team review of facility self-assessments at lower risk facilities
- Third-Party Independent Audit Team
- Advantages – organizational independence; outside perspective and experience with compliance practices of other companies; auditor credentials and up-to-date awareness of audit methods and regulatory requirements; ability to bring specialized know-how, as needed; must meet client expectations for deliverable quality and timeliness
- Disadvantages – may not have organizational standing to ensure necessary cooperation and openness of auditees
- Best Use – periodic audit of the company’s audit program and process (5-year cycle); periodic compliance audits of selected facilities (3-year cycle), including auditing the completion of corrective actions initiated as a result of internal audits by corporate team; audits of company’s management system as part of compliance audits; done under attorney-client privilege
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).
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 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 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.
In our fifth and final article in this series, we talk about compliance program best practices and what it takes to maintain an ongoing world-class compliance assurance program.
Read the other articles in this series:
- Part 1: Enterprise and Compliance Risk Management
- Part 2: Management Systems and their Importance to Compliance Assurance
- Part 3: Compliance Risks and Compliance Program Assessment
- Part 5: Maintaining a Compliance Assurance Program
Submitted by: Tom Kunes
April 18, 2017 - Kestrel Management
Organizations in the chemical manufacturing and energy industry face the daily challenge to safely manage the processing, storage, and transportation of hazardous materials. To enable this, a great deal of focus and effort is put into compliance, strong management systems, well-maintained equipment, and organizational capability.
A key component of organizational capability is the competence of employees. This is critical to an organization’s success—and very relevant for process safety. In fact, process safety competence is both a regulatory requirement and a business improvement driver. But what does competence mean when it comes to the management of process safety?
Process safety competence is an area that is sometimes misunderstood as simply providing training to employees. However, it is much more. Organizations need to understand the definition of competence and ensure employees have the basic competence required to fulfill their job function successfully.
Competence is often defined as “an individual having the right level of training and experience to enable the successful execution of defined job responsibilities”. By this definition, competence is a step beyond basic job training—one that necessitates understanding and the ability to successfully apply what is learned.
To fulfill this intent, especially for those working around the management of process safety, it is critical that employers have a structured and sustainable approach to ensure process safety competence. This may include a clear process safety competence assurance program. Not only will this assist with regulatory compliance, it is a critical element in the prevention of a process safety incident.
Steps to Ensure Competence
To successfully create an organizational culture that values and emphasizes process safety competence assurance, there are some basic steps that need to be followed, including those outlined below:
- Understand and define positions within the organization that impact or influence process safety.
- Define desired competence levels and requirements for each of these positions.
- Develop an organizational competence matrix for process safety that documents the positions and requirements.
- Assess position holders’ (i.e., employees’) process safety competence against the requirements outlined on the organizational matrix.
- Identify gaps in competence for each individual and develop individual closure plans.
- Work with employees to address identified competence gaps and verify that they have been closed.
When filling a position that has process safety requirements, the identified candidate(s) should undergo an assessment against the defined process safety requirements for the position to ensure they are competent. It is important to ensure the new employee has the required competence before they are appointed or hired. Successful candidates may have some minor gaps that can quickly be rectified, but putting candidates into jobs that impact or influence process safety as “development” or a “learning opportunity” is a large risk to the organization and unfair to the individual. It is also a practice organizations should stop if they are truly committed to process safety.
Maintaining the Commitment to Competence
To further enhance the ongoing process safety competence of an organization, each position that impacts or influences process safety must maintain the required process safety competencies identified on the competence matrix. The commitment must be sustained to be successful; it should not be a one-time effort.
Organizations can do this by:
- Reviewing competence requirements and adjusting the matrix as new requirements are identified;
- Conducting regular assessments to verify employee competence; and
- Providing opportunities for training and experiential learning that ensure process safety competence remains a top priority.
Submitted by: Ewan Ross
April 18, 2017 - Kestrel Management • dynaQ
All types of business and operational processes demand a variety of audits and inspections to evaluate compliance with standards—ranging from government regulations, to industry codes, to system standards (i.e., ISO), to internal corporate requirements.
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.
By combining effective auditing program design, standardized procedures, trained/knowledgeable auditors, and computerized systems and tools, companies are better able to capture and analyze audit data, and then use that information to improve business performance. Having auditing software of some sort can greatly streamline productivity and enhance quality, especially in industries with many compliance obligations.
The following tips can help ensure that companies are getting the most out of their auditing process:
- Have a computerized system. Any system is better than nothing; functional is more important than perfect. The key is to commit to a choice and move forward with it. Companies are beginning to recognize the pitfalls of “smart people” audits (i.e., an audit conducted by an expert + notebook with no protocols or systems). While expertise is valuable, this approach makes it difficult to compare facilities and results, is not replicable, and provides no assurance that everything has been reviewed. A defined system and protocol helps to avoid these pitfalls.
- Invest time before the audit. The most important time in the audit process is before the audit begins. Do not wait until the day before to prepare. There is value in knowing the scope of the audit, understanding expectations, and developing question sets/protocol. This is also the time to ensure that the system collects the data desired to produce the final report.
- Capture data. Data is tangible. You can count, sort, compare, and organize data so it can be used on the back end. Data allows the company to produce reports, analytics, and standard metrics/key performance indicators.
- Don’t forget about information. Information is important, too. Information provides descriptions, directions, photos, etc. to support the data and paint a complete picture.
- Be timely. Reports must be timely to correct findings and demonstrate a sense of urgency. Reports serve as a permanent record and begin the process of remediation. The sooner they are produced, the sooner corrective actions begin.
- Note immediate fixes. During the audit, there may be small things uncovered that can be fixed immediately. These items need to be recorded even if they are fixed during the audit. Unrecorded items “never happened”. Correspondingly, it is important to build a culture where individuals are not punished for findings, as this can result in underreporting.
- Understand the audience. Who will be reading the final report? What do they need to know? What is their level of understanding? Not all data presentation is useful. In fact, poorly presented data can be confusing and cause inaction. It is important to identify key data, reports desired, and the ways in which outputs can be automated to generate meaningful information.
- Compare to previous audits. The only way to get an accurate comparison is if audits have a common scope and a common checklist/protocol. Using a computerized system can ensure that these factors remain consistent. Comparisons reinforce and support a company’s efforts to maintain and improve compliance over time.
- Manage regulatory updates. It is important to maintain a connection to past audits and the associated compliance requirements at the time of the audit. Regulations might change and that needs to be tracked. Checklists, however, may remain the same. Companies should have a process for tracking regulatory updates and making sure that the system is updated appropriately.
- Maintain data frequency. For data, frequency is key. Consider what smaller scope, higher frequency audits look like. These can allow the company to gather more data, involve more people, and improve the overall quality and reliability of reports.
A well-designed and well-executed auditing program—with analysis of audit data—provides an essential tool for improving and verifying business performance. Audits capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices. And using a technology tool or system to manage the audit makes that information even more useful.
Submitted by: Evan Fitzgerald