1. Lack of labelling of inspection status in production and shipping
8.5.1d...  The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

2. Maintenance activities are past due.
8.5.1c... the use of suitable infrastructure and environment for the operation of processes

Specific equipment in QA lab did not have any identification of its calibration status.

Fixture for part acceptance would accept Out of Tolerance Parts

Specific equipment, had an expired calibration due date.

Red rabbit parts at the Xxxx was accepted when it should have not cycled and stopped the fixture.

1.

Answer: Artificial Intelligence (AI) can significantly enhance an ISO 9001 Quality Management System (QMS) by automating processes, improving data analysis, ensuring compliance, and driving continuous improvement. ISO 9001, a globally recognized standard for quality management, focuses on meeting customer requirements, maintaining consistent quality, and fostering a culture of improvement. AI’s capabilities in data processing, predictive analytics, and automation align perfectly with these goals, offering manufacturers, a competitive edge. Below is a detailed exploration of how AI can improve an ISO 9001 QMS, with practical applications and benefits.

1. Automating Documentation and Record-Keeping

ISO 9001 requires extensive documentation, including quality manuals, procedures, work instructions, and records of processes like audits and nonconformities. Manual documentation is time-consuming and prone to errors, which can lead to noncompliance during audits.

• AI Solution: AI-powered document management systems can automate the creation, organization, and updating of QMS documentation. Natural Language Processing (NLP) tools can generate templates for procedures or work instructions based on ISO 9001 requirements, ensuring consistency. AI can also tag and store records in a searchable database, making retrieval effortless during audits.
• Example: A Dallas manufacturer can use AI to automatically update its quality manual whenever a process changes, ensuring Clause 7.5 (Documented Information) is always met.
• Benefit: Reduces administrative workload, minimizes human error, and ensures audit-ready documentation, saving time and resources.

2. Enhancing Risk Management (Clause 6.1)

Documenting your ISO 9001 management system effectively is critical to ensure compliance with the standard and the ongoing success of your organization’s quality objectives. The ISO 9001:2015 standard provides flexibility in how documentation is managed but requires specific records and documented information for various processes. Management Solutions Group can help you develop the best documentation techniques and procedures.

Below is guidance on how to best document your management system, along with relevant clauses from the ISO 9001 standard.

1. Documented Information Requirements

Clause 7.5 - Documented Information: This clause outlines the general requirements for creating, updating, and controlling documented information. It specifies that the organization must ensure that documents are appropriately identified, stored, and controlled, with proper version control and protection to prevent unintended use.

Best Practices:

Identify Required Documents: Create documents that are necessary for the effectiveness of your QMS, such as quality policies, objectives, process maps, and procedures. These documents should be clear and concise to avoid unnecessary complexity.

Online training is a transformative tool for enhancing management systems across various industries. 

Go to https://ingentius.com and sign up for an online training class and use MSG35 coupon code for a 35% discount off of any course.

Here’s how it can make a significant impact:

1. Flexibility and Accessibility: Online training allows employees to access learning materials anytime, anywhere, making it easier for them to balance training with their regular duties. This flexibility ensures that all staff can participate, leading to more comprehensive implementation of management systems.

2. Cost-Effectiveness: Traditional training methods often incur high costs related to travel, accommodation, and venue rentals. Online training eliminates these expenses, making it a more economical choice. Savings can be redirected to other critical areas of the management system.

3. Consistent Training Quality: Online platforms provide standardized content, ensuring that all employees receive the same high-quality training. This consistency helps maintain uniformity in understanding and applying management system principles.

   Read more: How Online Training Can Improve Your Management System

Typical Quality Problems in the Automotive Industry

The automotive industry, known for its high standards and precision, faces various quality challenges that can impact vehicle performance, safety, and customer satisfaction. Identifying and addressing these quality problems is crucial for manufacturers to maintain their reputation and ensure customer trust.

MSG is known in the industry as the best ISO consultant and especially the in the automotive industry to help manage and support Quality Management Systems.  We provide IATF 16949 support services.  Get a quote.

Here are some common quality issues encountered in the automotive sector:

1. Manufacturing Defects

Manufacturing defects are often the result of errors in the production process. These can include issues such as:

• Welding Defects: Incomplete or weak welds can compromise the structural integrity of a vehicle.
• Paint Defects: Problems like uneven coating, peeling, and bubbling paint affect the vehicle's appearance and can lead to rust.
• Assembly Errors: Incorrectly assembled components can lead to functional problems and safety hazards. Examples include improperly installed airbags or faulty wiring.

2. Material Defects

Quality problems can arise from the materials used in manufacturing. Common material defects include:

...just for fun... We don't recommend using a
Wiggly Man to promote your certification.
Promoting your certified management system, such as IATF 16949, or ISO 9001 to your customers can help build trust, enhance your brand reputation, and attract more business. Be sure to check with your registrar for guidance and if they have a badge or image to use.  Here are nine ways to communicate the value of your certification:

1. Website and Online Presence

• Dedicated Webpage: Create a dedicated section on your website explaining your certified management system, its benefits, and how it enhances your products or services.
• Blog Posts: Write articles or blog posts detailing the certification process, the standards you meet, and case studies demonstrating the benefits to your customers.
• Social Media: Share updates, infographics, and posts on platforms like LinkedIn, Twitter, and Facebook about your certification and its impact on quality and customer satisfaction.  If you are a B2B business, Twitter or Facebook may not be worth the while.

2. Marketing Materials

• Brochures and Flyers: Include information about your certification in your brochures, flyers, and other printed marketing materials.  Include the registrar approved image or badge.
• Email Campaigns: Send newsletters or dedicated emails to your customer base highlighting the certification and what it means for them.  Be consistent and add the certificate mention on ever campaign.

3. Sales and Customer Service

The integration of Artificial Intelligence (AI) into management systems may bring significant changes to the way organizations operate, make decisions, and interact with customers and employees. Here's are some ways AI might affect management systems:

1. Decision Making

• Data-Driven Insights: AI can process and analyze vast amounts of data far more quickly than humans, providing real-time insights that can inform strategic decisions. This capability can significantly enhance the decision-making process, allowing management to use data-driven insights rather than intuition or experience alone.
• Predictive Analytics: AI's ability to forecast future trends based on historical data can help strategic planning, risk management, and resource allocation.

2. Efficiency and Productivity

Climate change can impact a Quality Management System (QMS) in several ways, particularly as organizations increasingly recognize the need to adapt their practices to address environmental risks and ensure sustainable operations. Here are some of the key ways in which climate change can affect a QMS:

1. Supply Chain Disruptions: Climate change can lead to more frequent and severe weather events such as hurricanes, floods, or droughts, which can disrupt supply chains. A QMS must be robust enough to manage these risks by ensuring alternative suppliers, adjusting inventory levels, and planning for logistical contingencies.

2. Regulatory Compliance: As governments around the world introduce stricter environmental regulations to combat climate change, companies must adapt their QMS to remain compliant. This includes integrating environmental management into quality management processes, ensuring that products and practices meet new standards for emissions, waste management, and resource usage.

3. Product Design and Development: Climate change necessitates innovation in product design to reduce environmental impacts. A QMS should facilitate the integration of sustainable design principles, such as energy efficiency, recyclability, and reduced material usage, into product development processes.

4. Operational Adjustments: Changes in climate can affect the operational conditions. For example, increased temperatures can affect machinery performance and worker productivity. A QMS needs to incorporate adaptive operational practices such as modified maintenance schedules, enhanced cooling systems, and changes in work hours to mitigate these impacts.

   Read more: Generically, how to address Climate Change in your Quality Management System

Simplifying complex processes and procedures within an organization involves streamlining operations to enhance efficiency, reduce costs, and improve overall performance.

Management Solutions Group has years of experience auditing process and procedures from thousands of organization and have developed these strategies to achieve this:

1. Process Mapping: Create detailed maps of existing processes to visualize and understand every step. Identifying bottlenecks, redundancies, and unnecessary steps is easier with a clear visual representation.

2. Eliminate Redundancies: Remove duplicated efforts and unnecessary steps identified during process mapping. Focus on value-adding activities and eliminate or consolidate those that don't contribute directly to desired outcomes.

3. Standardize Procedures: Develop standardized procedures for common tasks and processes. This reduces variability, improves quality, and makes training new employees easier.

4. Leverage Technology: Automate repetitive and time-consuming tasks with software and technology solutions. Automation not only speeds up processes but also reduces the likelihood of human error.

5. Employee Training and Engagement: Involve employees in the simplification process. They are the ones working with these processes daily and can provide valuable insights into inefficiencies and potential improvements. Ensure they are well-trained on any new procedures or technologies implemented.

6. Continuous Improvement: Adopt a culture of continuous improvement, such as the Kaizen methodology. Encourage ongoing evaluation of processes and openness to change, allowing for iterative improvements over time.

7. Simplify Documentation: Review and simplify documentation, keeping it clear and concise. Excessive or overly complex documentation can be as big a hurdle as the procedures they aim to clarify.

8. Prioritize Customer Experience: Consider the impact on the customer experience when simplifying processes. Removing steps that may seem redundant internally but add value to the customer can be counterproductive.

9. Feedback Loops: Establish mechanisms for regular feedback on process efficiency from both employees and customers. Use this feedback to make informed adjustments.

10. Leadership and Clear Goals: Ensure strong leadership and clear goals for the simplification initiative. Leadership should communicate the importance of simplification and provide clear objectives and metrics for success.

By following these strategies, organizations can significantly simplify complex processes and procedures, leading to improved efficiency, employee satisfaction, and customer service.

Get a quote and we'll simplify...

Click Image for a Larger ViewThe process flow for audit management, particularly in the context of ISO 19011 which aligns with the principles of the Plan-Do-Check-Act (PDCA) cycle, is designed to ensure that audits are conducted systematically, consistently, and are continuously improved.

Contact Management Solutions Group to help your organization develop a plan for high quality, effective audits. 

This cycle is a core part of ISO management systems and applies to the management of an audit program as well. Here’s how the PDCA cycle applies to audit management:

Plan

1. Define Objectives: Establish the objectives and scope of the audit program to ensure it supports the organization’s policies, objectives, and performance.
2. Determine Resources: Identify and allocate the necessary resources for the audit program, including personnel, tools, and time.
3. Schedule Audits: Plan the audit schedule based on the risk and importance of the processes to be audited.
4. Develop Audit Plan: Each individual audit should have a plan that outlines its scope, criteria, duration, and resources required.

Do

Hiring an ISO consultant, specifically MSG, can provide several advantages for a company seeking to implement ISO standards effectively. ISO (International Organization for Standardization) consultants are experienced professionals who specialize in helping organizations navigate the complexities of ISO certification and compliance. Here are some reasons why a company might consider hiring an ISO consultant:

1. Expertise in ISO Standards: ISO consultants have in-depth knowledge of the specific ISO standard(s) relevant to your industry and can provide guidance on how to interpret and apply those standards to your organization's processes and practices.

2. Customized Solutions: Consultants can tailor ISO implementation plans to meet your company's unique needs, size, and industry sector. They can help you develop a customized approach that aligns with your goals and resources.

3. Faster Implementation: ISO consultants have experience with the certification process and can streamline the implementation timeline. They can help you avoid common pitfalls and delays, making the certification process more efficient.

4. Compliance Assurance: ISO consultants can help ensure that your organization is compliant with ISO standards, reducing the risk of non-compliance issues that could lead to certification delays or potential legal and financial consequences.

5. Cost Savings: While hiring a consultant involves an initial investment, their expertise can help you identify cost-effective solutions for implementing ISO standards and achieving certification. Over time, this can result in cost savings and increased efficiency.

   Read more: Why should a company hire an ISO consultant?

Adapting your ISO management system during a supply chain disruption is essential to maintain business continuity and ensure that you can meet your ISO certification requirements. Here are steps you can take to effectively adapt your ISO management system:

1. Risk Assessment and Continuity Planning:

   • Conduct a thorough risk assessment to identify potential disruptions in your supply chain. Consider both internal and external factors that could impact your ability to meet ISO requirements.

2. Communication and Stakeholder Engagement:

   • Maintain open communication with your suppliers and customers. Inform them about any disruptions and work together to find solutions and mitigate risks.

3. Documentation Review:

   • Review your ISO documentation, including your Quality Management System (QMS) and relevant policies and procedures, to identify areas that may need updates due to supply chain disruptions.

4. Temporary Changes and Contingency Plans:

   • Develop and implement contingency plans for addressing supply chain disruptions. These plans should outline temporary changes to your processes, including any adjustments to product/service specifications, suppliers, or delivery schedules.

5. Change Management:

   • Follow your ISO change management process to document and authorize any temporary changes made to your QMS. Ensure that these changes do not compromise the overall integrity of your system.

6. Supplier Management:

   • Assess the performance and reliability of your suppliers, and identify alternative sources or backup suppliers if possible. Ensure that any changes in suppliers or materials are documented and comply with ISO standards.

An ISO certification can improve the Quality Management System in several ways:

1. Standardization: ISO certifications provide a set of internationally recognized standards that ensure consistency in processes and procedures. This standardization helps organizations streamline their operations and improve efficiency.

2. Customer Satisfaction: ISO certifications require organizations to focus on customer satisfaction and meet their needs and expectations. By implementing customer-centric processes, organizations can enhance customer satisfaction and loyalty.

3. Risk Management: ISO certifications emphasize the identification and mitigation of risks. By implementing risk management processes, organizations can minimize the likelihood of errors, defects, and accidents, leading to improved product or service quality.

Note: the following specifically refers to Quality, but could just as well focus on Environmental, Safety, Information security, Laboratories etc…

Known unknowns in quality refer to the aspects or factors that are recognized as potential sources of uncertainty or variability in the quality process, but their precise impact or nature is not fully understood or quantified. These known unknowns are acknowledged and recognized as areas where further investigation, analysis, or research is required to gain a deeper understanding. Here are a few examples of known unknowns in quality processes:

1. Measurement Accuracy: While various measurement techniques and instruments are used in quality, there may be uncertainties associated with the accuracy and reliability of these measurements. Factors such as instrument calibration, environmental conditions, and measurement techniques can introduce unknown variations that require further study. Two typical methods to study and estimate this are Gage R&R / Measurement Systems Analysis (MSA) and Measurement Uncertainty Analysis

2. Process Variation: In manufacturing or production processes, there are often known sources of variability, but the extent to which they impact the quality outcome may be uncertain. For example, the influence of machine settings, material properties, or environmental factors on product quality may not be fully understood, necessitating further investigation. A good method for this is Failure Modes Effects analysis (FMEA)

Recessions can pose significant challenges for businesses across all industries, as they often lead to reduced consumer spending, shrinking profit margins, and increased competition. During these difficult times, maintaining and even enhancing the quality of products and services becomes crucial to survive and thrive. Below are a few effective strategies for managing quality during a recession.

Focus on Core Competencies and Outsource

In times of financial uncertainty, it is important to concentrate resources on core competencies. Identify the key strengths that set your business apart and allocate your limited resources accordingly. By focusing on what you do best, you can maintain a higher level of quality and ensure efficient use of available resources. Consider outsourcing non-core activities to reputable partners who can deliver consistent quality, allowing your organization to concentrate on its core value proposition.  Consider contacting Management Solutions Group and find out how to reduce costs while improving your QMS.

I am often asked about training by the management systems staff that I regularly work with.  The question is typically: “I now feel competent with the ISO standards that I am working with, so what training should I pursue next?”  I almost universally answer with Project Management for these reasons:

• Management Systems staff have significant Project requirements since most of the management system activities are expected to be driven by them, but are completed by people that do not report to them, Including, but not limited to:
  • Completing internal audits
  • Preparing and conducting management reviews
  • Measuring effectiveness and efficiency of processes through metrics and KPIs
  • Completing continuous improvement projects
  • Completing a host of required tasks related to the management system over the course of a year (e.g. environmental and safety reporting…)

So being a competent project manager can help to accomplish these responsibilities more efficiently and effectively, reduce stress, and help to hold the process owners accountable.  It can make the difference between struggling and career success. 

With this in Mind, Management Solutions Group, Inc. had created a training workshop focused on Management Systems staff.  This course would be helpful for anyone with Quality, Environmental, Laboratory, IT, or safety management systems responsibility – including any who support these systems with technical tasks.

The ISO Standards have attempted to be normalized across the specific management systems. ISO 9001, IATF 16949, 14001, 45001, 27001 et.al. have similar structures.  Because they span a number of standards they are called High Level Structures.  They were created and used as guidelines during the creation of the latest and future versions. For example the structure or areas covered in the standard (i.e. clauses) are:

The clauses of the High Level Structures were formed based on the Plan-Do-Check-Act (PDCA) improvement cycle.


The modern ISO management system standards are based on this common structure - High Level Structure. These include:

• Quality management: ISO 9001
• Environmental protection: ISO 14001
• Security and health at work: ISO 45001
• Energy management: ISO 50001
• Information security: ISO 27001
• Compliance management: ISO 37301
• Business continuity management: ISO 22301

These are some of the more recent Nonconformances found in IATF 16949 Quality Management Systems including both internal and registrar audits:

• Product and Layered Process Audits are not being performed to the documented schedule
• Contingency Plans do not address all requirements (Including Sanctioned Interpretations) and / or are not tested / simulated
• Key performance indicator metrics are not meeting goals, and have no documented countermeasures
• Customer Specific requirements are not implemented (The specific requirements could be from revised customer specifics or implementation could have lapsed)
• Off site warehousing has been added, but internal documentation has not been updated, material / part identification does not meet requirements (Including nonconforming product)
• Changes to Outsourced Processes not included in the required quality management system documentation, Approved Supplier Lists, or records of required certifications and supplier development

This applies to all standards (ISO 9001, ISO 14001, ISO 45001, ISO 17025, IATF 16949, AS9100, ISO 13485, ISO 27001…)

• Has your Management System become a One person show?
• Does Management struggle during audits when asked questions about the management system?
• Do you feel that the support for activities is not there as intended in the standard?

Why does this occur?

There can be many reasons that this occurs, and sometimes it is partially the fault of the management rep. If you are taking care of the auditors and audits all by yourself, updating documents for processes where you are not the owner, and creating records necessary to pass audits, this may indicate that you have taken too much control.
(I can personally relate to this!)

While the Management Representative for the Management System will most likely need to support all processes with knowledge of the standard, they need to let (And encourage) the Process owner dictate the processes. They also need to be less concerned when there are nonconformances identified in audits due to issues with different processes having issues – this just allows for the re-evaluation and improvement to occur. (This can be difficult to those of us that like to be in control to achieve)

Other times it can come from management system staff struggling to present information in the language best understood by upper management (This is where accounting training can help)

Things to try:

Good place to start would be with a thorough internal audit by a competent and independent auditor (This could be a resource like Management Solutions Group). This audit would include interviewing process owners and more in-depth assessment of the system and the implementation. This information would arm the organization with the knowledge of the best areas to focus on first.

As part of the cannabis legalization process, most states are requiring testing labs become accredited to the ISO 17025 standard as part of their licensing.

We have noticed an increase in Cannabis Testing labs needing assistance.  There are many issues to consider when developing management systems to meet the ISO 17025 requirements. For example, Michigan requires a laboratory achieve accreditation within 12 months after the date the laboratory license is issued.

We have worked with many small labs.  From that experience MSG has developed a process to quickly prepare a laboratory for accreditation with lower costs. For us, this is a fairly standard project for which we have developed a very efficient process.

This is important for the cannabis product users since most users want to ensure that they are purchasing products with accurate listings for THC content, and that the products meet requirements for Herbicides and other potentially harmful chemicals. A quick internet search will show that historically there has been significant discrepancy in the reported THC contents of many products, and a real concern for other chemicals that can be concentrated as part of the processing.

If your organization is like most these days, you are having trouble finding enough staff to complete your work in an effective and efficient manner. One significant task that you can find highly competent staff to assist you with is your internal audits. Whether you are operating a quality, environmental or safety management system we have the ability to support you in an efficient manner. Once complete you will:

• Have a very thorough internal audit completed by highly competent staff
• Know the areas to focus on for action
• Have confidence that your surveillance audits will go smoothly
• Need less internal resource needs for completing the internal audit and corrective actions
• Receive input on any issues found that will also provide outside eyes on ideas to solve these issues

Many organizations that complete their own internal audits struggle to find the right team members, obtain training (Particularly for staff changes), allocate the necessary time for the audits, struggle to maintain internal auditor focus while work piles up on the auditor’s desk, and do not always obtain audit results that are really reflective of the actual system effectiveness and efficiency.

Our workshops are hands on learning events that focus on your processes and designs. These onsite or virtual sessions can be focused on training newer staff or staff transitioning from the 4th edition AIAG FMEA methods. All of our training staff have worked with the previous 4th edition AIAG FMEA Manual and understand the challenges of the new FMEA approach, and the resources and knowledge required. We have 2 specific training options for organizations

For Practitioners:

These classes will help organizations and staff understand the new format of the FMEA forms and how to utilize the new format to implement the 7 Step Process along with the 5T’s needed to effectively create FMEA’s that will:

• Provide prioritized actions to reduce for potential risk
• Provide opportunities for preventive actions and continual improvement
• Effectively document cause & effects of failures
• Document preventive and detection risk
• Increase the usefulness of the resulting FMEA’s for continual improvement
• Ensure that your staff are creating the new FMEA's inthe most efficient way possible

We also offer options to start a draft of a current 4th Edition FMEA in the new format prior to the training to help workshop participants view the results of the process

For Auditors:

This training is specifically for auditors (3rd Party and Internal) with a focus on an overview of the FMEA process, the new FMEA requirements (Design and Process), and how to audit this as part of the management system and process audit.

(Determination of Legal and Other Requirements):

Management Solutions Group has team members competent in the regulatory requirements for safety & environment and as such can assist an organization with their required Evaluation of Compliance with Legal requirements that apply to the organization and advise on how to take these into account with the Management System. Those organizations with ISO 14001 Environmental Management Systems will be familiar with this process. For others, we will review the regulations and your processes determine the applicable requirements. These would then be managed through operational controls. If you have questions, we would be happy to discuss the requirements and your options.

Take a 45001 Course on Ingentius.com.