A Deeper Look
Operations and Quality Management System Architect
Leveraging my extensive, multi-faceted IT experience in a completely new environment.
Operations and Quality Management System Architect
Regulatory Compliance and Cybersecurity
QMS Enhancement and Audit Preparation
Performing a detailed review of existing QMS to identify enhancement opportunities and to specifically address an organizations needs based upon their compliance requirements. This can be as straight-forward as providing mapping from the QMS to specific requirements and as detailed as designing entirely new processes and associated documentation. Providing coaching and implementation guidance along with new and enhanced processes as well as preparing organizations to represent the processes successfully during compliance audits. Examples of regulatory standards dealt with include:
- ISO 9001
- ISO 27001
- ISO 20252
- FDA 21CFR11
- EcoVadis
- Pharmacovigilance
- European Union General Data Protection Regulation (GDPR) 2016/679
- UK Data Protection Act 2018
- Swiss Federal Act on Data Protection
Cybersecurity
Designing and implementing Cybersecurity policies and practices to safeguard company assets. This is primarily focused on IT infrastructure, but also includes security practices regarding the corporate communications and physical campus logistics. Examples to demonstrate the scope of what is included:
- Facility Security
- Device Management
- Device Maintenance and Patch Management
- Data Management
- Access Control
- System Governance and Oversight
- Custom Code Management
- Configuration Management
- Backup Management
- Secure Communications
Security Plans leverage industry best practice standards, whether or not the particular organization is seeking to establish or maintain certifications.
- Cybersecurity Maturity Model (CMMC 2.0)
- National Institute of Standards and Technology (NIST) Cybersecurity Framework
Operations and Quality Management System Architect
Client Support / Incident Response Process
Client Support Management System
Design, implement and manage the Process, Procedures and overall workflow for the handling of issues reported by clients.
Elements of this process include:
- Information Capture Standards
- Service Level Agreements and Prioritization
- Issue Properties Matrix (status, types, categorization)
- Overall workflow targets and milestones
Incident Response Process
This focuses upon a heightened response process specifically reserved for cybersecurity breaches. Requirements and level of scrutiny here is magnified commensurate to the significance of the threat posed by the breach. A formal Incident Response plan that includes periodic testing and review, is an important requirement of most certifications and is expected to be front and center in any reviews and audits. Incident Response Plans I've designed and implemented draw heavily on the SANS Institute's Incident Response Cycle, which includes:
- Preparation
- Identification
- Containment
- Eradication
- Recovery
- Lessons Learned
When a cybersecurity breach has been identified, a designated team of stakeholders convenes to assess the situation, design and implement an action plan.
Operations and Quality Management System Architect
Custom Coding and Automation
Data Collection and Reporting
Design, implement and enhance Custom Solutions for Process Oversight, Data Collection and Compilation and Sophisticated Reporting that spans the entire organizational spectrum of activities. Solutions are fully automated and self-sustaining. Solutions incorporate the following languages and tools:
- PowerShell Scripting and Automation
- MSSQL and MySQL
- HTML / CSS / JavaScript
- ConnectWise Automate
- ConnectWise Manage
- BrightGauge Reporting Engine
- Windows Scheduled Task Automation
- External Data Source Integration
Remote Monitoring and Management
A critical element to any Managed Services organization is the ability to remotely monitor and manage (RMM) IT assets. In order to most efficiently and effectively perform this, tools must be fine tuned with custom scripting and automation. I've designed and implemented numerous enhancements and custom processes to optimize the performance of RMM systems that cover:
- Device Security
- Device Updates and Patching
- Anti-virus
- Policy Enforcement
Operations and Quality Management System Architect
Business Continuity / Disaster Recovery
BCDR
The importance of Business Continuity and Disaster Recovery (BCDR) Planning and Preparation cannot be overstated. I've provided a range of BCDR services to clients from guidance and coaching to full design and implementation of plans to address unexpected disruptions to operations and productivity. Establishing a robust BCDR plan includes:
- Assessing Risks and Impact to all aspects of business operations
- Develop a comprehensive plan
- Establish clear roles and responsibilities
- Implement reliable and regularly tested Backup Strategy
- Define Recovery Point Objectives (RPO) and Recovery Time Objectives (RTO)
- Implement Redundancy and High Availability solutions
- Establish clear communication channels and align with Incident Response Process
- Implement continuous monitoring and testing, including multi-scenario exercises
- Provide sufficient training to ensure employees and stakeholders are fully aware of emergency procedures
- Routinely review and update the plan in order to ensure continual improvement
Regulatory Considerations
Various industries and organizations are subject to specific regulatory frameworks governing data protection, privacy, and security. Prominent regulations among these include:
- Health Insurance Portability and Accountability Act (HIPAA)
- Payment Card Industry Data Security Standard (PCI DSS)
- General Data Protection Regulation (GDPR)
Examples of requirements to comply with these regulations:
- Protection and confidentiality of stakeholder data (Healthcare, financial, personal etc.)
- Maintaining secure networks
- Data Minimization
- Lawful Processing
- Data Breach Notification
Operations and Quality Management System Architect
User Management
User Lifecycle Management
Designing and implementing a process that establishes a comprehensive approach to managing user (company employee, associate, stakeholder) access to corporate assets and establishes secure guardrails around their activities. Elements and milestones of this process include:
- User Eligibility (candidate screening) and Approval
- Secure Onboarding including electronic assets and physical devices
- Credential Management that ensures uniquely identifiable users, password property enforcement and multi-factor authentication
- Permission Management that ensures only approved access and functionality is available to users. Role-based authorization that includes least-access principles.
- Communication Management to prevent potential intrusions and breaches
- Termination and Transfer Management that handles all required account modifications upon changes in account status
- Extensive analytics and real-time tooling to identify and suppress any potential threats.
Operations and Quality Management System Architect
Risk Assessment
Risk Assessment Planning
Working with clients to establish a thorough Risk Assessment Plan that optimizes business outcomes and meets any relevant regulatory requirements. This can range from providing guidance and coaching, to fully designing, documenting and helping clients implement a plan from scratch. The end goal being a process for analysis of risks that is revisited on a regular cadence, that identifies targets and creates action plans resulting in an overall continual improvement cycle.
Risk Assessment Process
The purpose of an IT risk assessment is to identify, analyze, and evaluate potential threats and vulnerabilities to an organization's information systems, data, and technology infrastructure. By doing so, we can determine the likelihood and potential impact of these risks, enabling them to prioritize resources and implement effective controls to mitigate them. The key objectives of the risk assessment process are:
- Risk Identification – Thoroughly assess an organization’s IT landscape to identify potential risks, including external threats, internal vulnerabilities, and compliance gaps
- Impact Assessment – Evaluate the potential impact of identified risks on critical business functions, assets, reputation, and compliance obligations. This step helps in prioritizing risk mitigation efforts
- Quantify Likelihood – Determine the likelihood of each identified risk materializing. This analysis aids in understanding the probability of occurrence and enables an organization to focus on high-risk areas
- Prioritize Risks – based on their potential impact and likelihood, ensuring a risk-based approach to resource allocation and risk mitigation efforts
- Develop Mitigation Strategies – Effective strategies and controls minimize or eliminate identified risks. This involves designing preventive, detective, and corrective measures that align with the organization’s risk appetite
- Monitor and Review – Establish a robust monitoring and review mechanism to ensure the ongoing effectiveness of implemented controls, promptly address emerging risks, and adapt to changes in the threat landscape
Ultimately, Risk Assessment can be very beneficial, but also very resource intensive. Clients should take this seriously, but also approach it strategically to maintain an equitable balance between risk appetite and scale.
Operations and Quality Management System Architect
Whistleblower Policy and Procedure
Whistleblower Policy
Often neglected in situations where it is not explicitly required to meet compliance standards, a well-formed and communicated Whistleblower Policy serves to provide an additional layer of risk mitigation by creating an environment of trust that encourages stakeholders, including employees, contractors, customers, suppliers, and shareholders, to report any observed or suspected information security breaches, vulnerabilities, or other concerns. This results in even more comprehensive oversight as provided by all members of the team. By establishing a clear and transparent process for reporting, we aim to:
- Safeguard corporate assets, informational and beyond
- Foster a culture of security and integrity
- Enhance stakeholder trust
- Provide Confidentiality and Non-Retaliation Guarantees