Jeff Honeyager

Risk Mitigation: Understanding Your Unknowns

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This discussion applies broadly to Quality but is also relevant to Environmental, Safety, Information Security, Laboratories, etc.  If you have questions, please contact us (Connect) or call: (706) 318-5717.

Known Unknowns in Quality involve aspects or factors recognized as sources of uncertainty or variability. Their specific impact typically remains unclear or unquantified. We at Diversified Management Systems have developed these tips for your quality processes:

  1. Measurement Accuracy: The precision of quality measurements can be uncertain due to factors like instrument calibration, environmental conditions, and technique variability. Methods like Gage R&R, Measurement Systems Analysis (MSA), and Measurement Uncertainty Analysis help in understanding these uncertainties.
  2. Process Variation: Known variability in manufacturing might not have a fully understood impact on quality. Factors such as machine settings or material properties could be analyzed using techniques like Failure Modes Effects Analysis (FMEA).
  3. Human Factors: The influence of human operators or inspectors on quality outcomes includes variables like skill level, fatigue, or training. FMEA and studies on visual inspection reliability highlight these uncertainties.
  4. Raw Material Variability: Variations in raw materials due to sourcing or storage conditions affect product quality. Continuous monitoring and FMEA help in managing these known unknowns.
  5. Long-Term Reliability: Predicting how products will perform over time under various conditions is challenging. Techniques like FMEA, along with Mean Time to Failure and Mean Time to Repair analyses, are employed to estimate potential issues.
  6. Supplier Performance: The reliability of suppliers in delivering consistent quality introduces uncertainties that can affect quality control. Understanding and mitigating these involves ongoing assessment and FMEA.

Addressing Known Unknowns in quality control requires:

  • Continuous Improvement: Through research, data analysis, and stakeholder collaboration.
  • Resource Allocation: To investigate and reduce uncertainties.

Historical Insights on Risk Management:

  • Diverse Team Input: Essential for comprehensive risk identification.
  • Feedback Loops: Incorporating real-world outcomes into risk models enhances future predictions.

Training: Includes general risk management and specific techniques like Failure Modes Effects Analysis (FMEA).

By focusing on these known unknowns, organizations can bolster their quality control frameworks, leading to improved product quality and reliability.</

If you need help, please contact us (Connect) or call: (706) 318-5717.

ISO 9001 Consultant in Spartanburg SC

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The primary aim of a Quality Management System is to ensure that your Spartanburg organization consistently provides products and services that meet customer and regulatory requirements. An internal audit is an essential part of the ISO 9001 QMS. Its purpose is to assess and ensure the QMS’s effectiveness and identify areas for improvement.

The following components are typically included in an Spartanburg ISO 9001 internal audit:

  1. Audit Planning: Define the scope, criteria, and objectives of the audit. This involves determining which processes or departments will be audited, the standards to which they’ll be compared, and what the objectives of the audit are.
  2. Review of Documentation: Before conducting the audit, auditors review the documented QMS to understand the procedures, processes, and policies the organization has in place.
  3. Opening Meeting: This is a brief meeting at the start of the audit where the audit team meets with the auditee (the person or team being audited) to explain the purpose, scope, and process of the audit.
  4. Process Auditing: The core activity where auditors will:
    • Observe activities and processes in action
    • Review records and evidence of process outcomes
    • Interview staff and stakeholders about how processes are conducted
    • Verify that the QMS processes are being followed and that they’re effective
  5. Recording Nonconformities: Any deviation from the established QMS or from ISO 9001 requirements is noted as a nonconformity. Nonconformities are categorized, typically as:
    • Minor nonconformity: A single observed lapse in the system
    • Major nonconformity: A systemic failure or an absence of a process or procedure
  6. Closing Meeting: At the end of the audit, the audit team meets again with the auditee to discuss the findings, any nonconformities, and potential recommendations.
  7. Audit Report: After the audit, the auditors will produce a report detailing:
    • The scope and objective of the audit
    • A summary of the audit findings
    • Details of any nonconformities, including evidence and classification
    • Recommendations for corrective actions or areas of improvement
  8. Follow-Up: Depending on the findings and the organization’s internal processes, there might be a follow-up audit or review to ensure that corrective actions were taken and are effective.
  9. Continuous Improvement: The whole idea behind the ISO 9001 QMS is continual improvement. Therefore, the insights gained from the internal audit should be used to refine and improve processes, address weaknesses, and better meet customer and regulatory requirements.

When performing an ISO 9001 internal audit, it’s important to have competent auditors who understand the standard, the organization’s internal processes, and the principles of auditing. Often, organizations will train their own staff to conduct these audits or hire external consultants to ensure objectivity and expertise.

Manufacturing Outlook for Spartanburg SC

Spartanburg, SC, has a positive manufacturing outlook, driven by ongoing investments in automotive, aerospace, and advanced manufacturing sectors. BMW’s extensive operations and expansions continue to support economic growth, attracting suppliers and creating a robust automotive supply chain. The region also benefits from its proximity to the Inland Port, facilitating efficient logistics and trade. Growth in aerospace and green technology manufacturing is anticipated, aligning with national trends in sustainable manufacturing. Workforce development initiatives with local institutions are aimed at addressing skill gaps, ensuring a qualified labor pool. Spartanburg is well-positioned for continued manufacturing expansion and economic resilience.

 

How can an ISO 27001 ISMS help prevent a cyber attack?

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An ISO 27001 Information Security Management System (ISMS) can significantly help prevent cyber attacks by providing a structured framework for managing and protecting sensitive information. Diversified Management Systems can help you navigate your ISMS.

Here are some ways an ISO 27001 ISMS contributes to cyber attack prevention:

  1. Risk Management: ISO 27001 requires organizations to systematically identify, assess, and manage information security risks. DMS can help you identify vulnerabilities and implementing controls to address them, organizations can proactively minimize the risk of a cyber attack.
  2. Access Control: An ISMS enforces strict access control policies, ensuring that only authorized personnel have access to sensitive information. This reduces the risk of unauthorized access, which is a common avenue for cyber attacks.
  3. Regular Security Audits: The standard mandates regular audits and reviews of security practices. We can provide ISO 27001 audits. Diversified Management System help organizations identify gaps in their security posture, ensuring they remain resilient against new and evolving cyber threats.
  4. Incident Management and Response: ISO 27001 requires organizations to have a formal process for identifying, reporting, and responding to security incidents. A prepared incident response plan enables quick, efficient action in the event of an attempted cyber attack, minimizing potential damage.
  5. Employee Training and Awareness: The standard emphasizes the importance of employee security awareness and training. Educated employees are less likely to fall for phishing attacks or other social engineering tactics that can lead to cyber breaches.  DMS can also develop custom training solutions.
  6. Secure Configuration and Patch Management: An ISMS ensures that all systems are securely configured and regularly updated to protect against vulnerabilities. Timely patching and secure configurations make it harder for attackers to exploit system weaknesses.
  7. Monitoring and Logging: ISO 27001 promotes monitoring and logging of network activities, enabling organizations to detect and respond to suspicious behavior. This helps identify potential threats early before they can escalate into a full-blown cyber attack.
  8. Third-Party Risk Management: The standard includes guidance on managing risks associated with third-party vendors. This reduces the chances of a cyber attack through vulnerable third-party systems connected to the organization’s network.
  9. Encryption and Data Protection: ISO 27001 promotes the use of encryption and other data protection measures, making it more challenging for attackers to access or exploit sensitive data even if they breach other defenses.
  10. Compliance and Continuous Improvement: ISO 27001 requires ongoing improvement of security practices and compliance with legal and regulatory requirements. This ensures the organization’s defenses adapt to changing threats and technologies, keeping it prepared against evolving cyber threats.

By implementing and maintaining an ISO 27001 ISMS, organizations can establish a robust defense framework that minimizes the likelihood of a successful cyber attack and prepares them to respond effectively if one occurs.  Contact us to learn more.

IATF 16949 Internal Auditor Near Charlottesville VA

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An IATF 16949 internal auditor is responsible for assessing and ensuring that an organization’s quality management system (QMS) complies with the IATF 16949 standard, which is specific to the automotive industry.

The main duties of an IATF 16949 internal auditor from Diversified Management Systems include for your Charlottesville VA business:

  1. Planning Audits: Developing audit plans and schedules to systematically evaluate the QMS processes.
    2. Conducting Audits: Performing internal audits by examining processes, documents, and practices to ensure compliance with IATF 16949 requirements.
    3. Identifying Nonconformities: Identifying areas where the QMS does not meet the standard’s requirements and documenting these nonconformities.
    4. Evaluating Effectiveness: Assessing the effectiveness of corrective actions taken to address nonconformities.
    5. Reporting: Preparing detailed audit reports that outline findings, including nonconformities and opportunities for improvement.
    6. Providing Recommendations: Offering recommendations for corrective actions and improvements to enhance the QMS.
    7. Follow-Up: Verifying the implementation and effectiveness of corrective actions to ensure continuous compliance.
    8. Training and Support: Educating and supporting staff on IATF 16949 requirements and best practices.

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Efficiency vs Efficacy of your ISO 9001 Management System

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Efficiency and efficacy in an ISO 9001 Quality Management System (QMS) are both critical concepts, but they refer to different aspects of performance and improvement. We help you create, implement and monitor your Quality Management System.  Contact Diversified Management Systems to help attain and maintain your QMS.

Here’s a breakdown of the two concepts with their corresponding clauses from ISO 9001:

  1. Efficiency of the QMS

Efficiency relates to how well the organization uses its resources (time, labor, materials) to achieve its goals with minimal waste. An efficient QMS optimizes processes to achieve the desired outputs with the least input.

Relevant ISO 9001 Clauses:

Clause 7.1 – Resources: This clause addresses resource management and emphasizes the need for efficient use of personnel, infrastructure, and the work environment to achieve product or service quality.

Clause 8.5.1 – Control of Production and Service Provision: It requires organizations to ensure that processes are carried out efficiently by controlling the use of resources and reducing variability and waste in operations.

Clause 9.1 – Monitoring, Measurement, Analysis, and Evaluation: Efficiency is measured by monitoring and analyzing the performance of processes, such as tracking productivity and resource utilization.

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How to manage your ISO 9001 Management System During an Economic Downturn

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Managing your ISO 9001 Quality Management System (QMS) effectively during an economic downturn requires a focus on maintaining quality, optimizing resources, and ensuring business continuity. Contact Diversified Management Systems to walk you through potential tough times.

Strategies to help maintain compliance through challenging times:

  1. Focus on Risk Management (Clause 6.1)

Use risk-based thinking to assess the potential impact of the economic downturn on your business processes, supply chain, and customer demands.

Identify key risks related to financial stability, reduced demand, or supply chain disruptions, and implement mitigation plans to protect your quality management processes.

  1. Optimize Resource Allocation (Clause 7.1)

Assess resource usage to ensure critical areas are adequately supported while identifying where costs can be reduced without compromising quality.

Use lean principles to optimize processes, reduce waste, and improve efficiency across your operations.

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ISO Amended to address Climate Change

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ISO Standards have been Amended to cover climate change

This February, the International Organization for Standardization (ISO) released amendments to several ISO standards.

  • ISO 9001
  • ISO 14001
  • ISO 45001

The amendments cover climate change. Section 4.1 of these three standards, the amendment requires the organization to determine whether climate change is a relevant issue impacting their management system.  Also, a note has been added to section 4.2 stating that relevant interested parties may require requirements about climate change. Here are some FAQs:

Why these requirements were added?

Consistent with the London Declaration on Climate Change, ISO amended these standards to clarify the need for organizations to consider the impact. The amendment calls out this specific topic as having a potential impact.

What does this mean if you are already certified?

If organizations have considered environmental impacts, nothing is needed.  If it is needed, they must consider whether climate change impacts their management system. There are a number of ways to address this.

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ISO 27001 Requirements

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The main requirements are found in clauses 4 through 10. Below are a summary of each:

Clause 4 – Context of the organization

Implementing an Information Security Management System successfully requires an understanding the context of the organization. External, internal issues, and interested parties, need to be identified and addressed. Typical requirements include:

  • regulatory issues
  • competition
  • cultural
  • political
  • strategic direction
  • internal capabilities

Given the context, the organization must define the scope of ISMS.

Clause 5 – Leadership

The requirements of ISO 27001 for leadership are many and various. The commitment of upper management is mandatory and essential. The ISMS objectives must be developed in concert with the strategic direction and objectives of the organization. Management must provide the necessary resources, as well as support personnel in their responsibilities with the ISMS.

In addition, upper management must establish a top-level policy for information security. These policy statements need to be documented and communicated within the organization and to all interested parties.

Roles and responsibilities need to be assigned, to meet the requirements of the ISO 27001 standard and to report on the performance of the ISMS.

Clause 6 – Planning

Risks and opportunities should be accounted for during planning. A risk assessment for an ISMS provides a foundation on which to build. Objectives from the risk assessment must be aligned with the company`s overall objectives, and need to be adopted within the company. The objectives provide the security goals to work toward. From the risk assessment and the security objectives, a risk treatment plan is derived using the controls in Annex A.

Clause 7 – Support

The key areas for support include:

    • Resources,
    • competence of employees,
    • awareness,
    • communication
    • documentation

Information needs to be documented, created, and updated, as well as controlled. A series of documentation, including a communications plan, must be maintained in order to support the success of the ISMS.

Clause 8 – Operation

Processes used to implement information security are wheels to the ISMS. These processes must be planned, implemented, and controlled. The risk assessment and objectives have to be put into action.

Clause 9 – Performance evaluation

The requirements of the ISO 27001 standard necesitiate monitoring, measurement, analysis, and evaluation of the Information Security Management System. Key performance indicators must be created and monitored. Internal audits are conducted on a regular and scheduled basis to check the success of the implementation. Upper management needs to review the organization`s ISMS and ISO 27001 KPIs frequently at first, then on a scheduled basis.

Clause 10 – Improvement

After evaluation improvement follows. During an audit nonconformities are documented. They then need to be addressed through an action plan resulting their elimination. A process for continual improvement should be documented and implemented. The traditional PDCA (Plan-Do-Check-Act) cycle is recommended. It provides a solid structure and fulfills the requirements of ISO 27001.

Annex A Information security controls reference

This Annex provides a list of 93 controls that can be implemented to decrease risks and comply with security requirements from interested parties. The selected controls that are implemented must be designated in the Statement of Applicability.

 

ISO Internal Auditor In Hattiesburg Mississippi

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Diversified provides a full range of ISO consulting services in Hattiesburg MS.

More and more businesses are choosing Hattiesburg. If you are considering moving your business to Hattiesburg, it may be the smartest decision your company makes. Our City boasts a stable economy supported on all sides by business, education, government, and the military. If you are looking to grow, expand or just become more efficient use these services from Diversified Management Systems:

  • Internal Audits
  • 3rd Party Audits
  • IATF 16949 Core Tools
  • ISO 27001 Gap Analysis and Auditing
  • Strategic Planning
  • ISO 9001 quality system standards
  • IATF 16949 Core Tools
  • OHSAS 18001 and ISO 45001
  • ISO 27001 Gap Analysis and Auditing
  • In Person Training Engagements
  • CMMI (Capability Maturity Model Integrated)
  • ISO 13485 medical device design and manufacturing
  • Business Profitability Improvement
  • ISO 14001 environmental management system

DEVELOPMENT REVIEW PROCESS

A pre-application meeting is required for all new development, redevelopment or expansions for commercial or multi-family residential zoned properties within the City of Hattiesburg.

A Pre-Application meeting with the Planning staff is required prior to submitting a Site Plan Application.  At the meeting, the applicant will describe and present their project in the conceptual design stage.

The goals of this meeting are to emphasize the applicable development regulations for:

  • Site Plan Review
  • Clearing and Grading
  • Building in a Historic District
  • Building in a Flood Zone
  • Subdivision of Land
  • Use Permit on Review
  • Zoning Change
  • Planned Unit Development
  • Planned Residential Development
  • Variance
  • Address and discuss potential problems and solutions to technical and design review issues.
  • Discuss the roles of the Site Plan Review Committee, the Planning Commission and the City Council.
  • Apply the City’s Comprehensive Plan 2008-2028.

ISO Internal Auditor Near Gainesville Florida

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Diversified provides a full range of ISO consulting services in Gainesville FL.

More and more businesses are choosing Gainesville. If you are considering moving your business to Gainesville, it may be the smartest decision your company makes. Our City boasts a stable economy supported on all sides by business, education, government, and the military. If you are looking to grow, expand or just become more efficient use these services from Diversified Management Systems:

    • 3rd Party Audits
    • Internal Audits
    • ISO 14001 environmental management system
  • ISO 27001 Gap Analysis and Auditing
  • Strategic Planning
  • ISO 9001 quality system standards
  • CMMI (Capability Maturity Model Integrated)
  • ISO 13485 medical device design and manufacturing
  • Business Profitability Improvement
  • IATF 16949 Core Tools
  • IATF 16949 Core Tools
  • OHSAS 18001 and ISO 45001
  • ISO 27001 Gap Analysis and Auditing
  • In Person Training Engagements

Small and Service-Disabled Veteran Business Program

Local small businesses support the City of Gainesville’s overall economic development and the city is committed to their success, growth and development. To help these businesses be more successful, the city has adopted the Small and Service-Disabled Veteran Business Program. The program provides significant opportunities for qualified local small businesses to participate on a nondiscriminatory basis in all aspects of the city’s contracting and procurement programs as well as providing other needed business services.

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