This presentation was originally a webinar from St.Germain Collins to help guide Environmental, Health and Safety (EHS) professionals through unexpected inspections by OSHA, EPA and other regulatory agencies.
Objective evidence exists showing that:
a requirement has not been addressed
(intent)
practice differs from the defined system (implementation)
the practice is not effective
(effectiveness)
The document provides guidance on preparing for and managing an FDA inspection. It outlines steps to take before, during, and after the inspection including conducting a mock inspection, setting up an inspection team, and documenting any deficiencies found. It also provides dos and don'ts for interacting with inspectors such as being prepared, transparent, and avoiding arguments.
The document provides an overview of Good Manufacturing Practices (GMPs) for Alameda Chemical as they expand into FDA-regulated materials. GMPs ensure safety, purity and efficacy of pharmaceuticals through strict control measures and procedures. Key areas covered include organization and personnel responsibilities, facilities requirements, equipment cleaning and maintenance, production and packaging controls, laboratory testing, documentation practices, and contamination prevention. The goal is for ACS to develop and follow GMP procedures to ensure quality and integrity of FDA-regulated products.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
How can we prevent accidents caused by human error? This presentation deals with typical examples of severe accidents related to human errors, and shows methods to prevent them.
Practical approach to implement and comply to ISO 45001:2016 Occupational Health & Safety Standard.
This presentation will help organisations to effectively implement and keep the compliance to ISO 45001:2016 OHSA Standard
Objective evidence exists showing that:
a requirement has not been addressed
(intent)
practice differs from the defined system (implementation)
the practice is not effective
(effectiveness)
The document provides guidance on preparing for and managing an FDA inspection. It outlines steps to take before, during, and after the inspection including conducting a mock inspection, setting up an inspection team, and documenting any deficiencies found. It also provides dos and don'ts for interacting with inspectors such as being prepared, transparent, and avoiding arguments.
The document provides an overview of Good Manufacturing Practices (GMPs) for Alameda Chemical as they expand into FDA-regulated materials. GMPs ensure safety, purity and efficacy of pharmaceuticals through strict control measures and procedures. Key areas covered include organization and personnel responsibilities, facilities requirements, equipment cleaning and maintenance, production and packaging controls, laboratory testing, documentation practices, and contamination prevention. The goal is for ACS to develop and follow GMP procedures to ensure quality and integrity of FDA-regulated products.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
How can we prevent accidents caused by human error? This presentation deals with typical examples of severe accidents related to human errors, and shows methods to prevent them.
Practical approach to implement and comply to ISO 45001:2016 Occupational Health & Safety Standard.
This presentation will help organisations to effectively implement and keep the compliance to ISO 45001:2016 OHSA Standard
ISO 14001 - Environmental Management Systems, the first international standard for the world's environment helps thousands of organizations to improve their environment, sustainability and operational performance. This topic covers workshops and case studies to evaluate effectiveness of training. Each participant needs to solve this case study after undergoing the training. After successful completion of workshops and case study the ISO 14001:2015.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
The document discusses quality audits in the pharmaceutical industry. It defines a quality audit as an objective, systematic, independent and documented assessment of a company's quality system against given criteria. Audits are intended to provide unfiltered information to management, help minimize risk, and ensure the company remains in a state of control. The document emphasizes that audits should make quality systems compliant, effective and efficient. It provides tips for selecting qualified auditors, communicating results to management, and ensuring corrective actions are taken to continuously improve processes.
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
This document provides an overview of the internal audit process and ISO standards. It defines an audit as an evaluation used to determine validity, reliability, and assess internal controls. Internal auditing adds value by improving risk management, controls, and governance. The ISO defines quality as features and characteristics that satisfy customer needs. The document outlines the purpose, objectives, and framework for audits, including planning, performing, and reporting phases. It describes collecting evidence, analyzing findings, and issuing final reports, as well as post-audit evaluations for continuous improvement.
Mandatory documents and records required by iso 14001:2015eimayem
The document outlines the mandatory documents and records required for ISO 14001:2015 environmental management system certification. It lists the scope of the EMS, environmental policy, risk assessment processes, criteria for evaluating environmental aspects, objectives and plans, operational procedures, emergency preparedness, training records, communication records, monitoring results, internal audit records, management review findings, and corrective action records. It also describes common non-mandatory documents like procedures for determining context, identifying environmental aspects and risks, competence and training, communication, document control, internal audits, management reviews, and corrective actions.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
The document provides guidance for internal auditors on ISO 9001:2015. It discusses planning an audit, conducting an opening and closing meeting, asking open-ended questions, documenting findings, and validating findings. The purpose of internal audits is to measure performance and determine conformance. Auditors should be prepared, conduct themselves professionally, and focus on continuous improvement opportunities.
Regulatory Enforcement and Inspections: An important part of regulatory gove...OECD Governance
The document discusses regulatory governance and enforcement in the UK. It provides context on the regulatory delivery unit within the Department for Business, Energy and Industrial Strategy and its goals of improving businesses' experience of regulation. A quote from a small business owner emphasizes that the attitude of inspectors can make a bigger difference to businesses than reducing some regulations. The document then outlines the history of regulatory reform in the UK from the 1940s to present. It discusses key themes in regulatory delivery such as ethical business regulation, risk-based approaches, regulatory futures reviews, and the Regulators' Code.
This document provides information on auditing and inspections. It defines key terms like audit, auditor, and auditee. Consistent auditing standards can provide benefits like effective GMP compliance assessments, reduced costs, and improved performance. Audits can be internal or external. The audit process involves planning, structuring, performing, reporting, and following up on findings. Inspections focus on current conditions, while audits review records to ensure all requirements were met. Qualified auditors with training and experience are important. Proper planning and cooperation are needed to avoid issues.
The document discusses root-cause analysis (RCA) and provides definitions, goals, cognitive biases to avoid, and tools to use when performing RCA. It defines root causes as specific underlying causes that can be reasonably identified and resolved. The goals of RCA are to identify what happened, how it occurred, why, and how to prevent reoccurrence. Tools mentioned for RCA include Five Whys, Current Reality Tree, Interrelationship Diagram, and Cause-and-Effect Diagram. The document emphasizes avoiding cognitive biases and adhering to a seven-step problem-solving process for objective, effective RCA.
This document outlines the key elements of a pharmaceutical quality management system (QMS). It discusses topics like training management, audit management, change management, quality risk management, complaint management, non-conformance management, document management, validation and qualification, corrective and preventive action management, and product recall. It also describes the importance of a QMS for ensuring uniform high quality in pharmaceutical production and compliance with industry standards. The benefits of a QMS include increased efficiency, reduced waste, improved quality and customer satisfaction.
Internal audits play a critical role in verifying and improving an organization's food safety management system. The document outlines the steps for conducting effective internal audits, including developing an audit program and schedule, performing audits using checklists and procedures as references, documenting any nonconformances found, and holding closing meetings to discuss audit findings. Key attributes for auditors include strong communication and interviewing skills to objectively evaluate processes, observe operations, and ensure auditees understand any nonconformances identified.
The document discusses Corrective and Preventative Action (CAPA) systems used to eliminate existing quality issues and prevent future problems. It defines key terms like nonconformity and describes the general CAPA process. Specific root cause analysis tools are also outlined, including 5 Whys, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. Each tool's purpose, methodology, advantages, and limitations are summarized. Finally, preventative action and risk management processes are covered.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
Presentation was presenting in part on January 21, 2011 for Exova's Environmental Seminar held in Calgary, Alberta. The presentation covers some important points and considerations for those conducting environmental sampling where the data could be used for litigious or litigation matters. Legal sampling is much more intense for procedures and documentation than regular sampling and those doing the work, need to be knowledgeable about those differences. The presentations illustrates the differences using case studies the author has been involved in.
Does your organization run internal audits regularly? Prepare for a regulator to come knocking at your door by catching areas of non-compliance before the inspector can. Internal audits allow you to identify gaps in your existing EHS programs and improve processes before an official inspection, so you can be confident in your audit-readiness.
ISO 14001 - Environmental Management Systems, the first international standard for the world's environment helps thousands of organizations to improve their environment, sustainability and operational performance. This topic covers workshops and case studies to evaluate effectiveness of training. Each participant needs to solve this case study after undergoing the training. After successful completion of workshops and case study the ISO 14001:2015.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
The document discusses quality audits in the pharmaceutical industry. It defines a quality audit as an objective, systematic, independent and documented assessment of a company's quality system against given criteria. Audits are intended to provide unfiltered information to management, help minimize risk, and ensure the company remains in a state of control. The document emphasizes that audits should make quality systems compliant, effective and efficient. It provides tips for selecting qualified auditors, communicating results to management, and ensuring corrective actions are taken to continuously improve processes.
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
This document provides an overview of the internal audit process and ISO standards. It defines an audit as an evaluation used to determine validity, reliability, and assess internal controls. Internal auditing adds value by improving risk management, controls, and governance. The ISO defines quality as features and characteristics that satisfy customer needs. The document outlines the purpose, objectives, and framework for audits, including planning, performing, and reporting phases. It describes collecting evidence, analyzing findings, and issuing final reports, as well as post-audit evaluations for continuous improvement.
Mandatory documents and records required by iso 14001:2015eimayem
The document outlines the mandatory documents and records required for ISO 14001:2015 environmental management system certification. It lists the scope of the EMS, environmental policy, risk assessment processes, criteria for evaluating environmental aspects, objectives and plans, operational procedures, emergency preparedness, training records, communication records, monitoring results, internal audit records, management review findings, and corrective action records. It also describes common non-mandatory documents like procedures for determining context, identifying environmental aspects and risks, competence and training, communication, document control, internal audits, management reviews, and corrective actions.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
The document summarizes the key changes and structure of ISO/IEC 17025:2017 compared to the 2005 version. Major changes include an expanded scope to include sampling and a process-based approach. It adopts a new high level structure with common clauses across standards. Key requirements include impartiality, confidentiality, personnel competence, facilities, equipment calibration, metrological traceability, and management of externally provided products and services. The standard aims to ensure laboratories consistently operate at a high level of technical competence and quality.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
The document provides guidance for internal auditors on ISO 9001:2015. It discusses planning an audit, conducting an opening and closing meeting, asking open-ended questions, documenting findings, and validating findings. The purpose of internal audits is to measure performance and determine conformance. Auditors should be prepared, conduct themselves professionally, and focus on continuous improvement opportunities.
Regulatory Enforcement and Inspections: An important part of regulatory gove...OECD Governance
The document discusses regulatory governance and enforcement in the UK. It provides context on the regulatory delivery unit within the Department for Business, Energy and Industrial Strategy and its goals of improving businesses' experience of regulation. A quote from a small business owner emphasizes that the attitude of inspectors can make a bigger difference to businesses than reducing some regulations. The document then outlines the history of regulatory reform in the UK from the 1940s to present. It discusses key themes in regulatory delivery such as ethical business regulation, risk-based approaches, regulatory futures reviews, and the Regulators' Code.
This document provides information on auditing and inspections. It defines key terms like audit, auditor, and auditee. Consistent auditing standards can provide benefits like effective GMP compliance assessments, reduced costs, and improved performance. Audits can be internal or external. The audit process involves planning, structuring, performing, reporting, and following up on findings. Inspections focus on current conditions, while audits review records to ensure all requirements were met. Qualified auditors with training and experience are important. Proper planning and cooperation are needed to avoid issues.
The document discusses root-cause analysis (RCA) and provides definitions, goals, cognitive biases to avoid, and tools to use when performing RCA. It defines root causes as specific underlying causes that can be reasonably identified and resolved. The goals of RCA are to identify what happened, how it occurred, why, and how to prevent reoccurrence. Tools mentioned for RCA include Five Whys, Current Reality Tree, Interrelationship Diagram, and Cause-and-Effect Diagram. The document emphasizes avoiding cognitive biases and adhering to a seven-step problem-solving process for objective, effective RCA.
This document outlines the key elements of a pharmaceutical quality management system (QMS). It discusses topics like training management, audit management, change management, quality risk management, complaint management, non-conformance management, document management, validation and qualification, corrective and preventive action management, and product recall. It also describes the importance of a QMS for ensuring uniform high quality in pharmaceutical production and compliance with industry standards. The benefits of a QMS include increased efficiency, reduced waste, improved quality and customer satisfaction.
Internal audits play a critical role in verifying and improving an organization's food safety management system. The document outlines the steps for conducting effective internal audits, including developing an audit program and schedule, performing audits using checklists and procedures as references, documenting any nonconformances found, and holding closing meetings to discuss audit findings. Key attributes for auditors include strong communication and interviewing skills to objectively evaluate processes, observe operations, and ensure auditees understand any nonconformances identified.
The document discusses Corrective and Preventative Action (CAPA) systems used to eliminate existing quality issues and prevent future problems. It defines key terms like nonconformity and describes the general CAPA process. Specific root cause analysis tools are also outlined, including 5 Whys, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. Each tool's purpose, methodology, advantages, and limitations are summarized. Finally, preventative action and risk management processes are covered.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
Presentation was presenting in part on January 21, 2011 for Exova's Environmental Seminar held in Calgary, Alberta. The presentation covers some important points and considerations for those conducting environmental sampling where the data could be used for litigious or litigation matters. Legal sampling is much more intense for procedures and documentation than regular sampling and those doing the work, need to be knowledgeable about those differences. The presentations illustrates the differences using case studies the author has been involved in.
Does your organization run internal audits regularly? Prepare for a regulator to come knocking at your door by catching areas of non-compliance before the inspector can. Internal audits allow you to identify gaps in your existing EHS programs and improve processes before an official inspection, so you can be confident in your audit-readiness.
Incident Investigation Safety Training 2015KyleMurry
The document provides guidance on conducting incident investigations. It discusses gathering facts at the incident scene through witness interviews and evidence collection. Key steps in the investigation process include responding immediately, fact-finding through structured interviews and analysis of equipment, personnel, environment and processes involved. The goal is to identify root causes to control and eliminate them, thereby preventing reoccurrence. Corrective actions should be documented and their effectiveness measured. Fraud indicators known as "red flags" should also be considered. Prompt reporting allows for immediate medical care and investigation to implement controls. The hierarchy of control model outlines approaches from elimination and substitution to administrative and personal protective equipment controls.
Half day open training event held in London, England on how to conduct the dismissal/termination of an employee as professionally and efficiently as possible, whilst minimising the pain and suffering involved.
Workplace Investigations (Series: Protecting Your Employee Assets: The Life C...Financial Poise
This webinar discusses best practices for conducting internal workplace investigations. It covers when investigations should be triggered, the scope of formal vs informal investigations, elements of an effective investigation, who should conduct the investigation and be interviewed, documentation methods, final report preparation, and special considerations regarding confidentiality, privacy, and rights of interviewees. The webinar aims to provide guidance on properly handling investigations to determine policy violations while avoiding legal exposure.
Deviation, OOS & complaint investigation and CAPADr. Amsavel A
This document discusses deviation, out-of-specification (OOS), and complaint investigations and corrective and preventive action (CAPA). It defines key terms like nonconformity, corrective action, and preventive action. It describes the requirements for investigations per 21 CFR regulations. Common investigation tools like root cause analysis, 5 whys, fishbone diagrams, and fault tree analysis are explained. The document stresses identifying the root cause, avoiding focus on individuals, and verifying the effectiveness of CAPA.
This document provides guidance on how to avoid fines from regulatory inspections. It discusses trends in regulatory activity, top violations for OSHA, EPA, and DOT, and why those violations occur. It emphasizes having a strong safety culture to prevent violations, with examples like management walkarounds, inspections, and training. When an inspection occurs, it recommends greeting the inspector, an opening conference to determine the scope, accompanying the inspector, taking notes, and a closing conference to identify any findings. Maintaining communication and responding to reports is also advised. The document stresses being prepared to decrease the likelihood of potential fines.
Managing serious incidents and fatal accidents, Exeter - June 2016Browne Jacobson LLP
This seminar aims to give practical advice to those being investigated and prosecuted for regulatory offences. We also look at the new powers of the Magistrates and the sentencing guidelines for regulatory offences to assist you in assessing your approach to any prosecution.
https://www.brownejacobson.com/sectors-and-services/services/regulatory
Crisis Management and Protecting Your ReputationTiffanyMiller57
This presentation by Partner Julie Davis of James E. Arnold & Associates, LPA outlines crisis management and protecting your reputation. The presentation was originally shared at The Ohio Society of CPAs 2017 Columbus Accounting Show.
http://arnlaw.com
My business processes are deviant! What should I do about it?Marlon Dumas
This document discusses techniques for identifying and addressing deviant business processes. It defines deviance as processes that violate compliance rules, service level objectives, or cost targets. The document recommends a two-pronged approach of deviance mining and predictive monitoring. Deviance mining involves analyzing process event logs to discover patterns that distinguish normal and deviant cases, in order to explain the causes of deviance. Predictive monitoring uses the patterns to predict future deviance and generate alerts. Several case studies are described where organizations successfully applied these techniques to problems like late deliveries, faulty products, and software issues. The key takeaway is that organizations should quantify, analyze, monitor, and predict deviance to preempt problems in their business processes.
1) Conducting internal audits and preparing for regulatory inspections can help minimize violations and penalties. It is important to form an inspection preparedness committee and have relevant documentation organized.
2) During an inspection, the committee will coordinate schedules and daily debriefings. Facility program managers will provide documents and answer questions. Escorts will introduce inspectors and monitor interviews.
3) It is important to communicate openly yet tactfully during inspections. Inspectors should be accompanied, questions should be answered directly without speculation, and potential issues should be addressed promptly.
I Know What You Did Last Summer: Workplace Investigations (Series: Protecting...Financial Poise
This webinar discusses best practices for conducting internal workplace investigations. It covers when investigations should be triggered, the elements of an effective investigation, how to structure the investigation process, interview techniques, and special considerations regarding confidentiality, privacy, and rights of employees. The webinar emphasizes the importance of promptly investigating potential policy violations or complaints in order to preserve evidence and comply with legal obligations. It provides guidance on identifying appropriate investigators, gathering documentation, interviewing witnesses, and creating a final report with findings and recommendations.
The document outlines a 7-step process for achieving comprehensive compliance. The steps include: 1) Identifying applicable regulations, 2) Selecting requirements that apply, 3) Implementing compliance processes with subject matter experts, 4) Documenting compliance actions, 5) Monitoring for regulatory changes, 6) Verifying compliance through audits and management reviews, and 7) Taking action on non-compliances and opportunities for improvement. Tools like Excel, specialized software, and tracking systems are recommended to help effectively implement the compliance management system. The goal is to move from reactive to proactive compliance in order to reduce risks and stay ahead of changing rules and standards.
Caveon Webinar Series - Conducting Test Security Investigations in School Di...Caveon Test Security
In the coming weeks, schools all over the country will be administering standardized exams to millions of students. And inevitably, test security incidents will arise, many of which may directly impact test score validity. Is your team prepared to answer the following tough questions?
• What will you do if you find yourself in a position of having to respond to an incident or breach in your state or district?
• What process will you follow?
• What is your incident escalation plan?
• How will you communicate with internal and external stakeholders?
• Most importantly, how will you discover the truth of what did or did not occur, and its impact on test scores?
Join Caveon’s test security experts for an important, hour-long webinar to help you understand the steps to take when challenging situations arise. We will share:
• Recent experiences other districts have had with possible cheating, and what they have done to resolve their concerns
• Information and tools for you to arm yourself before an issue arises, and to help you be better equipped to deal effectively and efficiently
• Essential tips you need to know when invoking a Security Incident Response Plan, and further conducting a security investigation
I Know What You Did Last Summer: Workplace InvestigationsFinancial Poise
Now, more than ever, employers must be prepared to promptly and effectively respond to complaints of workplace harassment and/or discrimination. Often, that requires knowing when and how to conduct an internal investigation. Given the significance of the issues often at stake and the potential for a negative outcome (attorneys’ fees, high dollar settlement, negative PR), learning on the fly is not a viable option when undertaking an investigation. This program covers a host of questions, including what sort of issues should be investigated, who should conduct the investigation, what steps should you take and in what order, who should be interviewed, what sort of documents should be created and how do you close out the investigation? It also explores the investigation process and provides guidance from a seasoned investigator as to how to handle the many issues that you will often confront during the course of an investigation.
Part of the webinar series: PROTECTING YOUR EMPLOYEE ASSETS: THE LIFE CYCLE OF THE EMPLOYMENT RELATIONSHIP 2022
See more at https://www.financialpoise.com/webinars/
The document provides information from presentations given at a National Grants Management Association conference on April 22, 2015. It discusses topics like common issues found in investigations of grant fraud by the National Science Foundation Office of Inspector General and the Department of Transportation Office of Inspector General, such as misuse of funds, false claims, and disadvantaged business enterprise fraud. It also offers lessons for grant recipients and grantors to avoid grant management problems and the potential civil or criminal penalties that can result from investigations.
Comprehensive Compliance for Environmental, Safety, Quality Requirements in C...Nimonik
Nimonik has 7 step process to ensure thorough and comprehensive regulatory compliance for environmental, occupational health and safety and quality requirements for your organization. By following these steps, you will reduce your operational risk and optimize your processes to become a proactive compliance company. This presentation also covers compliance risks such as accidents and penalties, challenges that organizations face along with a case study of Lac Megantic Oil Train Car disaster in July 2013 that killed 47 people and spilled 6 million litres of oil.
Similar to Regulatory Inspection Preparedness Training (20)
Trichogramma spp. is an efficient egg parasitoids that potentially assist to manage the insect-pests from the field condition by parasiting the host eggs. To mass culture this egg parasitoids effectively, we need to culture another stored grain pest- Rice Meal Moth (Corcyra Cephalonica). After rearing this pest, the eggs of Corcyra will carry the potential Trichogramma spp., which is an Hymenopteran Wasp. The detailed Methodologies of rearing both Corcyra Cephalonica and Trichogramma spp. have described on this ppt.
Monitor indicators of genetic diversity from space using Earth Observation dataSpatial Genetics
Genetic diversity within and among populations is essential for species persistence. While targets and indicators for genetic diversity are captured in the Kunming-Montreal Global Biodiversity Framework, assessing genetic diversity across many species at national and regional scales remains challenging. Parties to the Convention on Biological Diversity (CBD) need accessible tools for reliable and efficient monitoring at relevant scales. Here, we describe how Earth Observation satellites (EO) make essential contributions to enable, accelerate, and improve genetic diversity monitoring and preservation. Specifically, we introduce a workflow integrating EO into existing genetic diversity monitoring strategies and present a set of examples where EO data is or can be integrated to improve assessment, monitoring, and conservation. We describe how available EO data can be integrated in innovative ways to support calculation of the genetic diversity indicators of the GBF monitoring framework and to inform management and monitoring decisions, especially in areas with limited research infrastructure or access. We also describe novel, integrative approaches to improve the indicators that can be implemented with the coming generation of EO data, and new capabilities that will provide unprecedented detail to characterize the changes to Earth’s surface and their implications for biodiversity, on a global scale.
Travis Hills of MN Promotes Practices That Help Farms and Ecosystems Thrive, ...Travis Hills MN
Travis Hills of MN implements cutting-edge technology to enhance water efficiency by recycling clean water for irrigation. He advocates for responsible water management practices, reducing freshwater dependency in agricultural settings. Travis' initiatives support sustainable farming practices and ecosystem health, aligning with environmental sustainability goals.
GFW Office Hours: How to Use Planet Imagery on Global Forest Watch_June 11, 2024Global Forest Watch
Earlier this year, we hosted a webinar on Deforestation Exposed: Using High Resolution Satellite Imagery to Investigate Forest Clearing.
If you missed this webinar or have any questions about Norway’s International Climate & Forests Initiative (NICFI) Satellite Data Program and Planet’s high-resolution mosaics, please join our expert-led office hours for an overview of how to use Planet’s satellite imagery on GFW, including how to access and analyze the data.
2. Regulatory Inspection
Preparedness Topics
• Anatomy of a Regulatory Inspection
• Inspection Protocol
• Effective Communication
• Attitudes and Behaviors
StGermainCollins.com 2
3. Regulatory Inspections –
What Prompts Them?
• Inspection quotas
• Agency initiatives – media or industry specific
• Regulatory classifications
• Complaints
• Non-compliance issues – failure to submit
reports, permit exceedances, etc.
• Permit renewals or new permits
• Random – “luck of the draw”
StGermainCollins.com 3
4. Anatomy of an Inspection
Finding Your Way
Through the Maze
StGermainCollins.com 4
5. What Happens First?
• The Agency(s) will conduct research prior
to the inspection
– Company website
– Press releases
– Publications
– State and local file reviews
– Prior non-compliance/enforcement actions
– Drive by
StGermainCollins.com 5
6. What Is the Process?
Opening
Conference
Facility
Inspection
Records
review
Daily
Debriefings
Closing
Conference
Follow Up
Report
Potential
Enforcement
Notice or
Request for
Information
(RFI)
StGermainCollins.com 6
7. Which Regulatory
Requirements Will They Look At?
• Multi-Media Inspection
– RCRA: Hazardous waste management
– Clean Air Act: Air emissions permits, records
and reports, Risk Management Plans
– Clean Water Act: Wastewater, storm water
and Oil SPCC
– EPCRA: Tier II reports, Form R reports
– OSHA: Safety programs
StGermainCollins.com 7
10. Inspections: Logistics and Planning
• Internal Notification
– Contact list and phone numbers
• Contact EHS Consultant/Engineer
• Set up the Opening Conference
• Work out the logistics with the inspectors
– how long onsite, what they will be looking at,
document review, etc.
• Enlist support to “sweep” the facilities and
implement corrective actions
• Daily communication
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11. Preparing for an Inspection…
…Be Ready!
• Inspection protocol & internal training
• Work out communications and logistics
• Facility escort kits
– Site plans, phone / camera, notepad, list of waste
accumulation/storage areas, telephone list, etc.
• Communication and cooperation
• Implement corrective actions
immediately
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12. St.Germain Collins
Here’s How It Goes…
1. Agency inspector arrives at front desk
(rarely are you given advance
warning)
2. Receptionist activates the call list
3. EHS or Facilities organizes and
facilitates the Opening Conference
4. Participants are selected and will
include others responsible for EHS
compliance
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13. …and then…
5. The Opening Conference is conducted
6. Individuals are selected to escort the
agency officials through the facility
7. One person is assigned to gather
documents and records requested by the
agency officials
8. Daily debriefings are held
9. The Closing Conference takes place at
the end of inspection
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14. St.Germain Collins
In the Meantime…
• Once notified that an agency
inspection will be taking place:
– Alert everyone within your area of
responsibility
– Review hazardous waste generation and
storage areas:
• Ensure labels are in place and properly filled
out, containers are closed, and inspection
records are up-to-date and available
– Take corrective actions as necessary
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15. St.Germain Collins
Opening Conference
• Company statement regarding commitment to
environmental health and safety and
compliance with applicable regulations
• The agency identifies regulatory areas for
inspection (multi or single media) and schedule
– Determine reason for the inspection
• Logistics are worked out – agency escorts,
schedule for lunch, debriefing, etc.
• Set up safety training for agency inspectors
– prior to facility inspection
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16. St.Germain Collins
General Guidelines
for the Inspection
• Accompany each inspector at all times
• Cooperate, but do not offer information not
requested
• Document review of requested files only;
should take place in a neutral area – not in
someone’s office
• Duplicate all records copied
• Take good notes, photographs, split samples
• Monitor employee interviews
• Conduct an exit interview for each area to
identify any issues
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17. St.Germain Collins
Escort Guidelines
• Restate unclear answers from the
interviewee to the regulatory inspector
• Stay by the inspectors side
• Take notes during and shortly after the
interview:
• Of issues that the inspector notes during the
inspection
• Of questions that could not be answered
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18. St.Germain Collins
Taking Care of Business
• Fixing potential violations
– As issues are found
– Prior to agency inspector entry
– Before agency inspector finishes for the day
• Behind the scenes during the inspection
– Know agency inspector locations during the
day
– Keep in close communication with escorts
– Field questions as they arise
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19. St.Germain Collins
Most Important!!
• If an inspector notes a
problem, correct it
immediately if
possible, before they
leave the facility, or
outline plans for fixing
the problem
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21. St.Germain Collins
The Inspection – Effective
Communication
• Key to Success
• Four major levels:
– Written (taking good
notes)
– Verbal (saying the
right things)
– Visual (keeping your
eye on the inspector)
– Listening (paying
attention)
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22. St.Germain Collins
Effective Communication
• During daily debriefings
– With agency inspectors
• Find out what the issues are
• Get an idea of tomorrow’s agenda
• Go over what’s been fixed
– With personnel
• Corrective actions taken
• Issues of concern
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23. St.Germain Collins
Attitude & Behavior
• Goal: Stay in Control
• Be courteous and respectful
• Be positive, professional and confident
• Be honest
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24. St.Germain Collins
Guidelines for Interacting
With Agency Inspectors
• Do understand the question - ask for
clarification or repeat it back to them
• Don’t volunteer additional, unnecessary
information
• Do keep answers simple and direct
– If you don’t know the answer or need
assistance, write it down - tell them you
will get the answer for them
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25. St.Germain Collins
More Guidelines…
• Don’t attempt to deal with hypothetical
situations
• Do “Fix” simple deficiencies along the way
• Don’t offer an opinion or agree/disagree
with the inspectors
• Don’t sign anything
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26. St.Germain Collins
Closing Conference
• Consider having highest
level representative and
possibly an attorney present
• Present documentation of
corrective actions taken
during the inspection
• Have answers to questions
that couldn’t be answered
during the inspection
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27. St.Germain Collins
Before they leave…
• Ask for copies of their
notes / pictures
• Ask what is the next
step in the process
• Ask if there is
anything that needs to
be corrected
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28. St.Germain Collins
What happens next?
• The agency will prepare a written report
and/or request for additional information
(RFI)
• Timeframe will vary – it may be up to a
year or more before you receive it
• Be sure to address and document all
deficiencies and corrective actions
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29. Any Questions?
Sandra J. Perry, Director of EHS Services
St.Germain Collins
846 Main Street
Westbrook, Maine 04092
(207) 591-7000 x43
sandyp@stgermaincollins.com
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