Best Practices for Regulatory Change Management
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This document provides an overview of Nimonik's comprehensive compliance solution. It discusses Nimonik's approach to compliance management, which involves identifying all relevant compliance obligations, tracking required actions, and conducting audits. The document outlines different levels of compliance maturity and describes Nimonik's system architecture and key elements like obligations, actions, audits, categories, custom fields, and tags. It also explains Nimonik's implementation process and different workflow types for sharing compliance information across facilities.
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Best Practices for Regulatory Change Management
- 1. Comprehensive Compliance Best Practices for Regulatory Change Management
- 2. About Us Founded in 2008 with offices in Montréal, Calgary and Shanghai. Nimonik services over 500 customers around the world, with a focus on mid-size international companies.
- 3. About Us Nimonik is not an EHS management software or just a content provider or simply an audit tool. Nimonik is an integrated compliance solution for regulations, standards and internal requirements.
- 4. Why compliance matters How to get there 1 2 Categories, Custom Fields & Tags 4 Workflow Types 5 Agenda Compliance Obligations Structure 3
- 5. Minimal Management Supervisor led Systems are in place and training is mandated. Most of the issues are pushed by supervisors and reports identify problematic areas. General staff do not feel a strong responsibility for compliance. Integrated Team based compliance All members of the organization believe that compliance to standards and regulations is good business. Strong comprehension by all of policies and procedures. Easy access to data and software that empower teams. Reactive Focus on putting out fires Organization reacts to EHS, Quality and Compliance issues as they arise. People and teams respond only when there is an immediate problem. Inconsistent Piecemeal approach Some processes and systems are in place. Most facilities or business units are independent and do not share best practices or systems. Compliance Maturity Proactive Forward thinking Meet with stakeholders and regulators. Conduct continuous improvement of compliance program. Why compliance matters
- 6. Most organisations do not know ALL of their obligations, leading to “surprises”... A typical Facility has 3,000 Compliance Obligations and 200 new ones per year. Why compliance matters
- 7. The Four Pillars of Compliance Prevention Risk profile Historicals Monitoring Detection Early detection Self-reporting Internal Audits Response Fast response Data analysis Action plans Correction Actions Corrective Effectiveness IMPACT Why compliance matters IMPACT IMPACT IMPACT
- 8. A Comprehensive Compliance program captures all of your Obligations across your areas of compliance: Quality, environmental, safety, HR, OHS, product... ...and Sources: Regulatory, standards, contracts, permits, stakeholders, customers,... ...and enables timely management of Actions and Audits. Why compliance matters
- 9. Actions External actions when regulations & standards change. Internal actions issued by your team to come into compliance. Audits Inspect your facilities based on your Obligations. Verify for action completion and effectiveness of those actions. Why compliance matters Obligations External obligations from regulations & standards Internal obligations from your files, permits and procedures.
- 10. Why compliance matters How to get there 1 2 Categories, Custom Fields & Tags 4 Workflow Types 5 Agenda Compliance Obligations Structure 3
- 11. Traditional Compliance Approaches How to get there Shared Compliance Obligations ● Inconsistency ● Loss of institutional knowledge ● Time consuming In-house Shared Compliance Obligations ● Compliance gaps ● Variability in work ● Expensive Consultants Shared Compliance Obligations ● Compliance gaps ● Variability in work ● Expensive Consultants Shared Compliance Obligations ● Integration is complex and can take years ● Expensive to build & maintain Enterprise software
- 12. Clause Level 250,000 identified obligations Obligations in internal documents Web & Mobile Audits Convert obligations and actions into audits Inspect & collect evidence Document Level 500,000 external documents + Internal documents Nimonik Solution Architecture Action Management Actions when obligations change Actions you create Audits Obligations Actions How to get there
- 13. Continuous Comprehensive Compliance: Nimonik Implementation Select obligations & personalize the system Map to responsible teams Establish your process Monitor for changes Follow-up on compliance findings Identify Obligations with Questionnaire Audit compliance on a regular basis Continuous Improvement Plan Do Check Act How to get there
- 14. Elements for Success: Nimonik Implementation Management Understands proactive compliance is an investment Project Lead Can prioritize implementation and has the necessary support Team Recognizes the benefit of a compliance system and has time for training Comprehensive Compliance with Nimonik How to get there
- 15. Why compliance matters How to get there 1 2 Categories, Custom Fields & Tags 4 Workflow Types 5 Agenda NimonikApp Structure 3
- 16. Identify your physical operations and outline Obligations, Actions and Audits for each location. Control access by business unit, region or facility Facilities NimonikApp Structure
- 17. Lists of documents that are associated to a Facility or to multiple Facilities Compliance Obligations NimonikApp Structure
- 18. The compliance obligations table contains the following fields (columns): ● Category ● Document ● Track ● Status ● Published Date ● Modified Date ● Obligations ● Assessment Status ● Responsible Party ● Notes ● Assessment History ● Internal Actions ● Custom Fields Compliance Obligations Table NimonikApp Structure
- 19. Why compliance matters How to get there 1 2 Categories, Custom Fields & Tags 4 Workflow Types 5 Agenda Compliance Obligations Structure 3
- 20. ● Help group the documents in CO registers ● Can be used to filter the information ● Are editable and can vary from one CO to another Categories Categories, Custom Fields, & Tags
- 21. ● Add additional context and information ● Editable types ‘Custom Fields’ (Text, Date, User, Multiple Choice, & Risk) ● Use custom fields to link Compliance Obligations to Controls Custom Fields Categories, Custom Fields, & Tags
- 22. ● Tags help tie the elements in your account together - by business unit, by product line or by anything that you wish to report by ● Tags can be created and edited by account administrators ● They can be associated to facilities, audits, internal actions and (soon) obligations ● They can be used to filter reports Tags Categories, Custom Fields, & Tags
- 23. Why compliance matters How to get there 1 2 Categories, Custom Fields & Tags 4 Workflow Types 5 Agenda Compliance Obligations Structure 3
- 24. A PARENT Facility/CO receives ALL New & Updated Documents/Clauses, and then link the New Documents to the CHILD Facility/CO. Each facility receives ALL New & Updated Documents/Clauses in their Compliance Obligations (COs) separately. Unique Compliance Obligations Shared Compliance Obligations All facilities use the SAME COs, which receive ALL New & Updated Documents/Clauses. Connected Compliance Obligations Shared Compliance Obligations Facility 1 Facility 2 COs 1 COs 2 COs 1 COs 2 Facility 1 Facility 2 COs 1 COs 2 Facility 1 Parent COs 1 Facility 2 Facility 3 Child COs 1 Child COs 1 Workflow Types
- 25. Each facility receives ALL New & Updated Documents/Clauses in their Compliance Obligations (COs) separately. Unique Compliance Obligations Start ALL COs in ALL Facilities receive ‘External Actions’ published by Nimonik New & Updated Documents/Clauses Responsible Party of each CO reviews the ‘External Actions’ and closes non-relevant actions Responsible Party set the ‘Assessment Status’ to ‘Review’ Are the ‘External Actions’ relevant to the Facility’s operations? Responsible Party reviews the remaining ‘External Actions’ NO YES Change the ‘Assessment Status’ to ‘Applicable’ Change the ‘Assessment Status’ to ‘Non-Applicable’ Un-track the document if no further monitoring is required Update ‘Assessment Status’ to ‘Complying’ Once the ‘Internal Actions’ are completed, record closure notes and close the action Assign ‘Internal Actions’ & due date to the Responsible Party End Does the New & Updated Documents/Clauses require ‘Internal Actions’ to achieve compliance? Determine the ‘Internal Actions’ required YES NO Workflow Types
- 26. All facilities use the SAME COs, which receive ALL New & Updated Documents/Clauses. Shared Compliance Obligations Start The COs shared by ALL Facilities receive ‘External Actions’ published by Nimonik New & Updated Documents/Clauses The Responsible Party of the shared COs reviews the ‘External Actions’ and closes non-relevant actions The Responsible Party of the COs set the ‘Assessment Status’ to ‘Review’ Are the ‘External Actions’ relevant to the Facilities’ operations? The Responsible Party of EACH Facility reviews the remaining ‘External Actions’ NO YES In a ‘Custom Field’ note which Facilities these documents apply to Add a ‘Note’ (Or use a ‘Custom Field’) to indicate the Facility that has completed the review Update ‘Assessment Status’ to ‘Complying’ Once the ‘Internal Actions’ are completed, record closure notes and close the action End Does the New & Updated Documents/Clauses require ‘Internal Actions’ to achieve compliance? The Responsible Party of EACH Facility determines the ‘Internal Actions’ required YES IF the ‘External Actions’ are NOT relevant to any Facility, the Responsible Party of the shared COs can change the ‘Assessment Status’ to ‘Non-Applicable’ Assign ‘Internal Actions’ & due date to the Responsible Party The Responsible Party of the shared COs closes the remaining ‘External Actions’ Change the ‘Assessment Status’ to ‘Applicable’ NO Workflow Types
- 27. Connect the New Documents to the applicable CHILD COs Connected Compliance Obligations Start The PARENT register receives ALL ‘External Actions’ published by Nimonik New & Updated Documents/Clauses Responsible Party reviews the ‘External Actions’ and closes non-relevant actions Responsible Party reviews the New Documents in the PARENT CO Change the ‘Assessment Status’ to ‘Non-Applicable’ Are the New Documents applicable to the CHILD Facilities/CO? NO YES Change the ‘Assessment Status’ to ‘Applicable’ Un-track the document if no further monitoring is required Update ‘Assessment Status’ to ‘Complying’ Once the ‘Internal Actions’ are completed, record closure notes and close the action Assign ‘Internal Actions’ & due date to the Responsible Party End Does the Updated Documents/Clauses require ‘Internal Actions’ to achieve compliance? A PARENT Facility/CO receives ALL New & Updated Documents/Clauses, and then link the New Documents to the CHILD Facility/CO. The CHILD COs will receive the same updates to Documents/Clauses as the PARENT CO Determine the ‘Internal Actions’ required YES NO Workflow Types
- 28. Nimonik offices Solution Partners Montréal HQ Shanghai Nimonik.com - info@nimonik.com - 1-888-608-7511 - +86 021 51720468 Thank you! Calgary