Blended Digest 8

How to Conduct an Internal Audit for ISO 14001

Tue, 02 Apr 2024 23:11:33 +0000

As experienced ISO 14001 consultants, we at American Quality Management have extensive knowledge of implementing and auditing ISO 14001 environmental management systems. Through our work with numerous organizations, we have gained valuable insights into the best practices for conducting effective internal audits to drive continual improvement of ISO 14001 compliance and environmental performance.

Internal audits are a critical component of any ISO 14001 environmental management system (EMS). By thoroughly assessing EMS performance, these audits identify areas for improvement and corrective actions needed.

Conducting rigorous internal audits ensures your EMS maintains compliance and drives continual improvement. Follow these steps for maximizing value:

Plan the Audit Scope and Resources

Begin by defining the physical and departmental scope you aim to audit. Will you evaluate the entire EMS or focus on specific processes? This drives timing and resources required.

Determine suitable auditors to deploy. They must be competent in auditing techniques and familiar with ISO 14001. Some organizations train internal personnel as auditors, while others leverage external consultants.

Estimate the time needed to complete on-site assessment activities. Factor in availability of auditors and auditees. Adequate planning prevents a rushed or inadequate audit.

Prepare Audit Checklists

Develop customized checklists covering every procedure, training record, inspection log and other documents tied to ISO 14001 requirements. This facilitates consistent evaluation of each area.

Checklists serve as the blueprint for gathering audit evidence. Use previous nonconformities and high-risk areas to guide checklist creation.

Communicate Audit Details

Provide advance notice to management and staff in audit scope about dates, auditor names, areas being assessed and expectations. This sets the stage for cooperation. Consider having auditees confirm availability.

Transparency and open communication alleviate anxiety about audits. Make clear the goal is collaborative EMS improvement.

Conduct Opening Meeting

The lead auditor should outline the audit plan, scope and methods to auditees. Allow questions about the process and timelines.

Clarify that auditors aim to support the business in enhancing its EMS through constructive findings. Secure commitment to support the audit as needed.

Gather Objective Evidence

At the heart of the audit, auditors must impartially gather evidence through observations, interviews and document/record reviews.

Conduct site walks to witness EMS procedures in action, inspect equipment conditions, and observe environmental aspects. Request supporting records like training logs, inspection reports, monitoring data and more.

Interview personnel at all levels to assess EMS knowledge and day-to-day effectiveness. Take detailed notes to substantiate findings.

Identify Any Nonconformities

When audit evidence shows EMS implementation does not meet ISO 14001 requirements, document these nonconformities.

Cite the specific standard or procedure which is not being fulfilled. Provide objective justification, keeping emotions out of it. Focus on facts.

Classify major and minor nonconformities appropriately based on severity and risk. Avoid downplaying serious issues. Capture opportunities for improvement as well.

Hold Closing Meeting

The closing meeting allows auditors to summarize key findings, highlight what went well, and outline areas needing improvement. Attendees can seek clarification as needed.

Keep the tone positive, positioning findings as opportunities for improvement rather than failures. Recap next steps for developing corrective actions.

Document Audit Results

The formal audit report details all nonconformities, classified by severity. Provide reference to the related requirement and objective evidence gathered.

Outline recommended corrective actions for each nonconformity along with a proposed timeline for resolution. Include records like checklists and notes as appendices.

Circulate the draft report to management and auditees. Incorporate any factual corrections before finalizing.

Drive Corrective Action

For each major nonconformity, auditees must develop a detailed corrective action plan addressing root cause, resolution steps, responsible parties and timeline.

Minor nonconformities also warrant appropriate corrective action, though the formal CAP may not be needed. The goal is preventing recurrence.

Auditors help verify resolution plans are adequate and implemented effectively within agreed timeframes.

Utilize Audit Findings

The audit report provides invaluable input for management reviews and continual EMS improvement. Analyze results for recurring issues or systemic gaps to address.

Update procedures where needed. Enhance training focused on recurring weaknesses. Integrate lessons into planning the next audit.

Rigorous internal audits verify your ISO 14001 EMS delivers on objectives while identifying opportunities to excel. Following protocols to plan, conduct, report and respond to audits maximizes their value. Consistent quality internal audits demonstrate commitment to achieving certifiable EMS excellence.

The post How to Conduct an Internal Audit for ISO 14001 appeared first on American Quality Management.

Examining the Emphasis on Continual Improvement in ISO 9001:2015

Wed, 28 Feb 2024 03:06:11 +0000

The ISO 9001 standard for quality management systems was significantly revised in 2015, representing one of the most impactful updates since its inception. A key theme throughout the 2015 version is an amplified focus on continual improvement. With over 25 years of experience working with small businesses, American Quality Management has developed specialized expertise in helping these accounts successfully adopt the newest ISO 9001:2015 standards and achieve certification. By leveraging our real-world knowledge as a trusted ISO 9001 consultant, we at AQM guide companies through the transition process, enabling you to not just meet updated guidelines but maximize quality gains.

This article will explore how ISO 9001:2015 pushes organizations beyond basic compliance toward proactively enhancing their quality performance.

Leadership’s Role in Driving Improvement

Unlike past versions, ISO 9001:2015 explicitly tasks top management with promoting a culture of continual improvement within the organization. Leadership must integrate improvement initiatives into the company’s business strategy and engage employees around quality objectives.

Management must allocate sufficient resources to improvement efforts, allowing time for root cause analysis of problems, corrective action implementation, and proactive risk mitigation. They are also responsible for recognizing and sharing best practices that come from improvement activities.

Adopting Risk-Based Thinking

The updated standard requires organizations to think proactively about potential risks to processes or products not meeting requirements. The goal is to prevent issues from occurring rather than reacting to problems after they manifest.

This represents a fundamental mindset shift – assessing processes, systems, and resources for vulnerabilities and taking action to mitigate risks before they negatively impact quality or customers. It moves quality management from reactive firefighting to proactive risk control.

Embed the Plan-Do-Check-Act Cycle

The Plan-Do-Check-Act (PDCA) cycle is intrinsically woven throughout ISO 9001:2015. PDCA provides an iterative four-step problem-solving and improvement methodology. It can be applied to improve processes, products, systems, or services:

Plan – Identify the problem/opportunity, analyze causes, develop hypotheses

Do – Implement solutions on a small scale

Check – Measure results/performance, assess if changes worked

Act – Standardize successful changes, communicate findings

By repeatedly cycling through this methodology, incremental improvements add up through sustained effort.

More Rigorous Corrective Action

While past versions included basic corrective action requirements, ISO 9001:2015 digs deeper into defect identification, root cause analysis, implementation, and follow-up. The goal is to not just quickly fix problems but understand the true underlying factors and prevent future recurrence.

Organizations must keep records to demonstrate the actions taken and the efficacy of solutions. Corrective actions tie closely to the risk-based thinking requirement to mitigate vulnerabilities.

Leveraging Organizational Knowledge

ISO 9001:2015 identifies the need to maintain and leverage knowledge to achieve quality objectives and drive improvement. This knowledge comes from documenting lessons learned, problem resolutions, and sharing successes across the company.

Organizations must determine what knowledge they need and systems to collect and disseminate it. This could include databases, training programs, or communities of practice around improvement.

Going Beyond Documentation Compliance

Past iterations of ISO 9001 were often criticized for focusing too heavily on documentation and procedure compliance over true operational excellence. The revised standard still maintains documentation requirements but balances them with an emphasis on enhancing process performance and results.

While disciplined documentation remains important, organizations must now demonstrate that their quality management efforts extend beyond paperwork and audits. This brings ISO 9001 back to its objective of actual business improvement.

Driving Competitive Advantage

Fundamentally, ISO 9001:2015 raises the bar for certified organizations to progress beyond basic compliance to achieve differentiation. Continual improvement fueled by corrective actions, knowledge sharing, and risk management can drive real competitive advantage.

By fully adopting the standard’s improvement philosophy, companies can transform ISO 9001 from a checkbox activity into a core business strategy for long-term success. In summary, ISO 9001:2015 makes continual improvement not just an option, but an expectation.

The post Examining the Emphasis on Continual Improvement in ISO 9001:2015 appeared first on American Quality Management.

An Introduction to AS9100: The Quality Management Standard for Aviation, Space and Defense

Fri, 29 Dec 2023 14:39:52 +0000

Quality and safety are paramount in high-risk industries like aviation, aerospace, and defense. That’s why these industries have adopted the AS9100 quality management system standard. AS9100 provides a comprehensive framework for organizations to demonstrate their ability to consistently meet customer requirements and industry regulations.

In this article, we’ll provide an overview of AS9100 including its history, who needs certification, and the many benefits it offers. We’ll also summarize the certification process and requirements so you can evaluate if AS9100 is right for your organization.

About AS9100

AS9100 is the international quality management system standard developed for the aerospace and defense industries. It was created by the International Aerospace Quality Group alongside representatives from aviation, space, and defense companies and organizations across the globe.

The origins of AS9100 stem from the ISO 9001 quality standard. ISO 9001 provides general requirements for quality management systems for any industry. AS9100 builds upon this foundation to create more specific and stringent requirements for the unique needs of aviation, space, and defense.

The current version is AS9100 Rev D released in 2016. It emphasizes risk management, project management, and configuration management. Certification to AS9100 demonstrates an organization is committed to continuous improvement, safety, and delivering high-quality products and services.

Who Needs AS9100 Certification?

Obtaining AS9100 certification signals that an organization’s quality management system meets the highest standards for safety and reliability. It is required by many original equipment manufacturers (OEMs) and contracts in the supply chain.

The key organizations that pursue AS9100 certification include:

Original equipment manufacturers (OEMs) like Boeing, Airbus, Lockheed Martin
Suppliers and subcontractors to OEMs
Maintenance, repair, and overhaul (MRO) organizations
Design, production, and testing services
Materials and component suppliers

In short, any organization that designs, manufactures, tests or provides services related to the aviation, space, and defense industries will benefit from AS9100 certification. It will enable them to meet the contractual demands of their customers and expand business opportunities.

Benefits of Getting AS9100 Certified

There are significant advantages to implementing an AS9100 compliant quality management system and attaining formal certification, including:

Meeting contractual requirements – Many major aerospace companies require suppliers to be AS9100 certified. It meets quality demands in supplier contracts.
Expanding business opportunities – Certification can open doors to new business in regulated industries where AS9100 is a prerequisite.
Standardizing systems company-wide – Global organizations benefit from using AS9100 to align their quality systems at all sites to a consistent international standard.
Reducing quality costs – Defects, rework, and scrap are minimized through stringent process controls.
Forging customer trust and loyalty – Demonstrating commitment to quality and safety builds confidence in the organization.

By taking a systematic approach to quality management through AS9100, organizations can reap bottom-line rewards through improved safety, efficiency, costs, and customer satisfaction.

Overview of AS9100 Standard Requirements

AS9100 shares the ISO 9001 framework for quality management systems with additional specific requirements for technical, project, and risk management. Key sections include:

Quality Management System – Addresses documentation, management commitment, focus on customers, quality policy, and planning.
Management Responsibility – Sets responsibilities of management to implement the system with designated resources and personnel.
Resource Management – Covers provisions of the people, infrastructure, environment, and information needed.
Product Realization Processes – Details all steps in production such as design, purchasing, production, verification, validation, and control of changes.
Measurement, Analysis, and Improvement – Focuses on quality assurance through monitoring, control of non-conformances, analysis, and continual improvement.

AS9100 places heavy emphasis on supply chain management, product safety, and ongoing enhancement of processes through corrective and preventive actions.

Benefits of AS9100 Implementation

When effectively implemented, an AS9100 quality system allows organizations to:

Improve consistency and efficiency through documented procedures
Reduce errors, defects, risks and scrap
Prevent issues through rigorous process control
Exceed customer requirements and contractual obligations
Drive continuous quality improvement into all processes
Increase customer satisfaction and retention

Additional benefits are lowered costs through waste reduction, prevention of rework, and enhanced productivity. AS9100 provides the blueprint to build quality into products and processes upstream and gain a competitive advantage.

The AS9100 Certification Process

Attaining AS9100 certification involves these key steps:

Gap analysis – Compare current quality system against AS9100 requirements to identify any gaps that need to be addressed.
Implement system to meet AS9100 standards – Expand quality system, document procedures, train employees on new processes.
Choose an accredited registrar – Ensure they are approved to issue AS9100 certification.
Stage 1 audit – The registrar audits the quality documentation to ensure the system meets AS9100 requirements on paper.
Stage 2 audit – The registrar visits site to verify the effective implementation and operation of the quality system.
Certification – Once all requirements are met, the organization is certified to AS9100.
Ongoing compliance – The system must be continually maintained and pass surveillance audits to retain certification. Systems are recertified every 3 years.

Conclusion

AS9100 certification requires dedication but brings sizable rewards. It provides aerospace, aviation, and defense companies with a proven framework to demonstrate their commitment to product safety and delivering the highest quality solutions.

The rigor of the AS9100 standard drives excellence into processes and builds trust across the entire supply chain. Implementing this quality system translates into significant bottom-line benefits through improved efficiency, lower costs, and increased customer loyalty.

The post An Introduction to AS9100: The Quality Management Standard for Aviation, Space and Defense appeared first on American Quality Management.

Integrating ISO 9001 with Other Management System Standards

Tue, 26 Dec 2023 15:32:16 +0000

ISO 9001 for quality management is often pursued independently by organizations seeking certification. However, integrating ISO 9001 with other ISO management standards can maximize efficiency and performance.

Let’s explore how ISO 9001 can complement key standards like ISO 14001, ISO 45001 and ISO 27001 when implemented together.

Unifying ISO 9001 and ISO 14001

ISO 14001 outlines requirements for an effective environmental management system (EMS). It focuses on identifying and controlling the environmental impact of company operations.

At first glance, ISO 14001 seems disconnected from quality, but the two share strong synergies:

They take a similar process-based approach with a high-level structure that is easy to integrate.
Joint audits can examine both standards simultaneously, reducing disruption and costs.
Integration provides a holistic view of how quality interacts with environmental stewardship. For example, reducing scrap/waste benefits both.

By unifying ISO 9001 and 14001, organizations reinforce quality and sustainability in tandem, appealing to environmentally conscious customers.

Integrating Health & Safety with ISO 45001

Worker health and safety crises disrupt production and services, undermining quality. Integrating ISO 45001 for occupational health and safety provides assurance that worker well-being and quality are unified priorities.

ISO 45001 and ISO 9001 share common elements like requiring compliance audits, corrective action, and management review which makes integration straightforward. When incidents occur, addressing the safety factors through ISO 45001 reduces the risk of the same problems impacting quality later on.

Joint training across both standards ensures everyone has quality and safety top of mind together. A strong safety culture reinforces – not compromises – product and service quality.

Linking Information Security and Quality

Increasingly, product and service quality relies on secure data and systems. Integration with ISO 27001 for information security management helps ensure quality processes have the protection they need.

For example, product design data integrity, traceability records accuracy, and equipment cybersecurity are all interconnected with quality performance. Auditing against ISO 27001 and ISO 9001 standards in tandem provides complete oversight of this relationship.

Shared training on topics like incident response, access control, and business continuity complements both standards as well. With strong information security, organizations have a foundation to reliably deliver quality.

Optimizing Energy’s Impact on Quality

There is no energy management standard as universally recognized as ISO 9001, but ISO 50001 is an emerging option. Integrating ISO 50001 enhances sustainability while revealing opportunities to improve quality through better energy performance.

Renewable energy sources provide clean power to manufacturing facilities which enables consistent production quality. Optimizing energy use reduces costs, freeing up budgets to invest in quality programs.

ISO 9001’s continual improvement aligns seamlessly with ISO 50001’s energy performance optimization requirements. Uniting energy and quality creates positive business and environmental impact.

Challenges of Multi-Standard Integration

While beneficial, integrating multiple ISO standards poses challenges including:

Increased documentation and records to maintain and harmonize across systems.
Added complexity managing and auditing multiple standards simultaneously.
Potential for conflicting standard requirements that must be resolved.

Keys for Successful ISO Integration

With diligence and commitment, organizations can overcome integration challenges. Keys include:

Securing leadership buy-in across all standards – they must be willing to invest more resources.
Fostering cross-functional collaboration across audit, training and improvement initiatives. Break down silos.
Identifying and leveraging synergies between standards like compatible processes and combined audits.

In summary, while requiring more effort, integrating ISO 9001 with other management system standards strengthens business performance. An integrated approach boosts operational excellence, risk management and stakeholder confidence in your organization.

The post Integrating ISO 9001 with Other Management System Standards appeared first on American Quality Management.

Choosing the Right ISO 14001 Consultant for Your Business

Thu, 21 Dec 2023 19:31:04 +0000

Implementing an ISO 14001 compliant environmental management system (EMS) is a major undertaking. While internal resources get you started, the expertise of an experienced consultant can be invaluable for effectively navigating the process.

Selecting the right consultant makes a huge difference in ensuring certification success. The ideal partner understands your industry, requirements and unique aspirations. They guide you through critical steps from gap assessment to external audits.

When evaluating consultants, keep these key criteria in mind:

Relevant Experience

Topping the list is hands-on experience specifically with ISO 14001 implementation. Look for consultants with many years advising organizations through successful certifications.

Review client case studies in your industry showing their ability to deliver ISO 14001 certification on budget and on time. Deep expertise with the standard is vital.

Technical Expertise

Examine the consultant’s knowledge of ISO 14001 requirements. Do they possess relevant training and certifications? Auditor certifications indicate mastery of the standard.

Look for ongoing professional development which keeps their expertise sharp. Their grasp of specifics should come across right away.

Industry Familiarity

The ideal consultant understands your specific business operations, processes, and compliance considerations.

Seek those with proven success guiding companies in your industry through ISO 14001 certification. Understanding your organizational culture is also beneficial.

If a consultant has mainly worked with manufacturing clients, their ability to advise a healthcare provider may suffer. Relevant experience in your field provides huge value.

Service Capabilities

Look for a full range of services beyond just implementing the EMS. Capabilities like gap analyses, internal audits, training and ongoing support bring end-to-end guidance.

The consultant should handle everything from assessing your starting point to conducting management reviews after certification. Support for integrating the EMS into everyday workflows is also key.

Resources and Size

Larger consultancies boast ample resources to assign multiple specialists fully dedicated to you. However, size does not always equate to a better customer experience.

Carefully assess if the consultant can realistically provide the time and attention your organization requires without spreading themselves thin. Customized service is paramount.

Customer Reviews

What do past clients say about working with the consultant? Online reviews and testimonials provide transparency into service quality.

Look for consultants with demonstrated success in achieving lasting, valuable improvements for clients. An ideal partner cares deeply about your business objectives beyond just checking boxes.

Cultural Fit

The interpersonal dynamic with consultants must feel like a good match. Communication style, responsiveness, and personality all play a role.

Ensuring your team can work productively with them is essential. A degree of chemistry makes navigating obstacles smoother.

Pricing

Balancing cost with value is key. The consultant offering the lowest rates may lack capabilities or expertise. However, you don’t want egregious overhead priced in either.

Seek flexible pricing structures aligned to specific services needed. Some offer hourly consulting while others provide packaged solutions. Understanding exactly what is included prevents surprise charges.

In summary, taking a systematic approach is critical for identifying the ISO 14001 consultant that best complements your organization. Prioritizing experience, capabilities, expertise, and fit leads to the ideal partner for certification success.

The post Choosing the Right ISO 14001 Consultant for Your Business appeared first on American Quality Management.

Mistakes to Avoid When Implementing an AS9100 Quality Management System

Wed, 29 Nov 2023 07:18:48 +0000

AS9100 is the stringent aviation, space and defense standard for quality management systems. While highly beneficial once attained, the road to implementing AS9100 and achieving certification can be challenging if organizations are not thorough in their approach.

Companies frequently underestimate the commitment required. This leads to mistakes that result in non-conformities during the certification audit. In this article, we will explore the most common mistakes organizations make when first establishing an AS9100-compliant quality system. Learning from others’ errors can help you implement AS9100 the right way the first time.

Not Getting Employee Buy-In

One of the biggest mistakes made by companies new to AS9100 is not involving employees early and gaining their buy-in. Management announces they are adopting this new quality standard, expects everyone to follow new procedures, and thinks that is sufficient.

Without actively communicating to employees WHY the change is happening and WHAT the benefits will be, they will resist or ignore the new system. Employees won’t be motivated to incorporate new habits without understanding the reasons.

Make sure to provide extensive communication and training. Have employees across all levels and functions participate in implementation planning to cultivate engagement. When workers feel they contributed to the process, they will take ownership and be committed to making it succeed.

Inadequate Training of Employees

Insufficient training goes hand-in-hand with the issue of poor employee participation. Organizations make the error of providing a basic overview of AS9100 once and thinking that achieves comprehension. However, in-depth training on new processes, documentation, responsibilities, and quality policy is essential.

Employees need sufficient opportunity to digest new concepts and develop the necessary skills. Training should incorporate examples, stories, and group discussions, not just PowerPoint presentations. Schedule refreshers to reinforce knowledge. Simply handing employees a manual without meaningful training will undermine compliance.

Skipping Internal Audits

The external certification audit can feel intimidating. While some view internal audits as extra work, performing regular internal assessments of your AS9100 system is one of the best ways to prepare. Internal audits identify gaps proactively so you can improve. Auditing provides the opportunity to clarify ambiguities in procedures and get comfortable with the terminology in the standard. It also builds internal auditing expertise.

Without dress rehearsals, your team could be completely off-guard when the official registrar audit occurs. Do not skip the valuable exercise of periodically auditing yourself against the standard.

Ineffective Document Control

AS9100 mandates rigorous control of documents and records with proper reviews, versioning and approvals. Organizations frequently downplay the importance of document control and have unclear accountability or insufficient access controls.

During an audit, gaps in document control come glaringly to light. Get ahead of this issue by designating document controllers, establishing clear protocols and training employees on document handling. Following defined procedures and using document templates maintains integrity.

Not Updating Documentation

It is common for quality documentation to become outdated and no longer match actual business processes. When written procedures are not updated to reflect changes, the documentation is no longer a useful guide.

Clearly designate who has the authority to update documents, the allowable circumstances for changes, and required reviews. Require employees to immediately report process changes so documentation can be promptly revised. Out-of-date documentation is a red flag during audits.

Insufficient Resource Allocation

Implementing AS9100 is not possible with good intentions alone – it requires a commitment of resources like budget, staff time, and leadership attention. Organizations underestimate what is involved and spread the word amongst other full-time jobs.

The outcome is an ineffective system where no one is fully accountable. Secure allocation of money, employees, and leadership support vital for AS9100. Assign responsibility to those with sufficient time dedicated. Resource starvation dooms quality initiatives.

No Continual Improvement

After finally attaining certification, organizations can become complacent. But AS9100 demands ongoing improvement, not resting on laurels. After the initial push, companies relax instead of looking for incremental enhancements or addressing root causes.

Regular management reviews, data analysis, internal audits, and preventive actions must continue. Keep using PDCA to optimize processes. Complacency opens the door to non-conformities during future audits.

Avoid Common Pitfalls with Proper Preparation

Implementing any new quality system requires adjustments, but need not be painful if organizations avoid these common missteps. Take time to educate and involve employees, conduct internal audits, control your documentation rigorously, and devote sufficient resources.

Build a culture that embraces continual improvement even after the initial certification. With adequate preparation and commitment starting day one, your company can steer clear of pitfalls on the road to AS9100 compliance. Keep the end benefits for customers, businesses, and employees in mind. This will help you establish an effective AS9100 system poised to pass the certification audit.

The post Mistakes to Avoid When Implementing an AS9100 Quality Management System appeared first on American Quality Management.

How to Prepare and Conduct an Effective ISO 9001 Internal Audit

Wed, 22 Nov 2023 07:10:14 +0000

One of the key requirements of the ISO 9001 quality management system standard is conducting regular internal audits. These audits examine an organization’s QMS and processes to identify any gaps or nonconformities with the ISO 9001 requirements. Beyond just verifying compliance, audits provide tremendous opportunities for driving continual improvement.

Let’s walk through the critical steps involved in planning, carrying out, and following up on an effective ISO 9001 internal audit.

Planning a Structured Audit Approach

First, determine the scope and objectives of the audit. Will you audit the entire QMS or focus on certain processes or departments? Scheduling audits of isolated systems over time can make the workload more manageable.

Identify competent auditors. ISO 9001 requires auditors to be impartial and objective. Leverage internal personnel with strong audit experience or invest in external quality auditor training to develop capabilities. You may also consider third-party auditing firms.

Next, create a schedule of audit activities including:

Dates for conducting audits of each process/area
Interviews, observations, and document reviews
Meetings to communicate results and follow up on actions

Allow enough time to perform a thorough assessment. Define metrics and rating criteria you will use to evaluate the conformity of audit evidence/findings.

Preparing for a Successful Audit

Once scheduled, communicate details of the audit plan across the organization. Give advance notice of which areas will be audited and when. Provide an overview of the goals, scope, and schedule to managers.

Gather key documentation relevant to the audit such as quality manual, procedures, process maps, previous audits, performance data, and quality records. Reviewing this information will help auditors comprehend the systems being assessed.

Develop customized audit checklists with criteria tailored to each process being audited based on ISO 9001 requirements. This guides auditors on what specifically to assess and helps ensure consistency.

Conducting the Audit Objectively

Begin with an opening meeting with auditees explaining the purpose and scope of the audit. Then move through the planned agenda of audit activities including:

Interviewing personnel on their procedures and responsibilities
Observing processes first-hand and reviewing documents/records
Compiling evidence of conformity and nonconformity

Take detailed notes on issues found and grade them on severity (minor vs. major nonconformity for example). Be sure to not just focus on gaps but also document positive findings and best practices. Remain objective and open-minded.

Documenting Audit Results

The evidence gathered during the audit must be documented in detail. This includes:

Completed audit checklists
Notes from interviews and observations
Copies of documents reviewed
Detailed descriptions of non-conformities
Grades on the significance of findings

This documentation serves as the foundation for the final audit report.

Concluding the Audit

Schedule a closing meeting with management and process owners to summarize major audit findings, both good and bad. Provide an overview of notable gaps, risks, rating of nonconformities, and positives identified. Solicit feedback and discuss the next steps.

Following up After the Audit

Develop a formal audit report showcasing results. Communicate findings to leadership and request corrective actions for major nonconformities. Track completion of corrective and preventive actions.

Verify completion through follow-up audits when necessary. Use findings during management review meetings to make data-driven QMS improvements.

Leveraging Audits to Improve

While the audit itself provides valuable insight, executing the findings where the rubber meets the road. Continually refine your audit process based on lessons learned. Expand the scope and frequency of audits to cover more areas.

Make audits an engaging process focused on improvement, not just compliance. By investing in robust ISO 9001 internal auditing, organizations can confidently verify their QMS effectiveness while uncovering improvement opportunities.

The post How to Prepare and Conduct an Effective ISO 9001 Internal Audit appeared first on American Quality Management.

5 Key Steps to Achieve ISO 14001 Certification

Wed, 15 Nov 2023 17:03:06 +0000

ISO 14001 is globally recognized as the premier standard for environmental management systems (EMS). By following a step-by-step process, you can implement an ISO 14001-compliant EMS to achieve certified status. This provides external validation of your organization’s commitment to environmental responsibility.

If you’re considering ISO 14001 certification or wondering how an ISO 14001 consultant can help, understanding the major milestones will help execute a successful project. Here are the 5 main steps:

1. Conduct a Gap Analysis

This first step analyzes your current environmental management practices versus the requirements of the ISO 14001 standard. The goal is to identify any gaps that exist so you can plan improvements. You’ll want to evaluate your organization’s environmental policy, objectives, training programs, operational controls and monitoring procedures. Documenting the gaps will highlight priority areas to address in implementing your EMS.

2. Create an EMS Manual

The manual documents the scope of your EMS as well as environmental policy, procedures, roles and responsibilities. This serves as a foundation for integrating the EMS into your organization’s operations. Include specifics such as targets and objectives, commitments to compliance, structure of EMS team roles, and procedures like document control, emergency response, and corrective/preventive action.

3. Implement the EMS

With your manual established, focus on practical implementation across departments. Provide necessary training and ensure controls are applied for identifying environmental impacts, meeting legal requirements, preventing pollution and conserving resources. Periodic management reviews help engrain the EMS.

4. Internal Audit

This audit verifies that your EMS conforms to the requirements of the ISO 14001 standard. It’s conducted by your internal team. Any nonconformities must be addressed. The audit ensures your system is sound before the external review.

5. External Certification Audit

An accredited third-party auditor thoroughly evaluates your EMS implementation and determines if certification is warranted. Once certified, surveillance audits occur at regular intervals to verify ongoing conformance.

While the process requires time and diligence, the payoff is huge. ISO 14001 certification globally validates your commitment to environmental excellence. It’s a milestone worth pursuing.

The post 5 Key Steps to Achieve ISO 14001 Certification appeared first on American Quality Management.

An Introduction to Nadcap Certification – What is Nadcap and does your organization need it?

Tue, 03 Oct 2023 23:43:08 +0000

The aerospace industry has stringent standards when it comes to quality, safety, and reliability. Nadcap certification has become an essential benchmark that aerospace manufacturers and their suppliers must meet. This article will provide an introduction to Nadcap – what it is, the different certifications available, and why companies pursue accreditation.

What is Nadcap?

Nadcap, short for National Aerospace and Defense Contractors Accreditation Program, is a global quality certification system for aerospace engineering and manufacturing. Administered by the Performance Review Institute (PRI), Nadcap establishes industry-wide standards that go above and beyond those required by regulatory bodies. It applies to special processes such as heat treating, coatings, welding, chemical processing, and materials testing. Companies that gain Nadcap accreditation demonstrate their commitment to precision, safety, and continuous improvement.

There are numerous certification types under the Nadcap program including:

Non-Destructive Testing Certification – Covers liquid penetrant, magnetic particle, radiographic, ultrasonic, and eddy current testing methods. Certification ensures proper techniques, equipment calibration, personnel qualification, etc.

Chemical Processing Certification – Applies to surface treatment processes like anodizing, cleaning, etching, plating, etc. Verifies chemicals, procedures, effluent management, and personnel meet requirements.

Coatings Certification – Covers techniques like painting, dry film coatings, etc. Certifies consistent processes and staff qualifications.

Heat Treating Certification – For processes like annealing, stress relieving and other thermal treatments. Ensures proper heating methods, temperatures, times, equipment calibration, and more.

Materials Testing Laboratories Certification – Covers labs that test materials like metals, polymers, ceramics, etc. Verifies consistent, reliable test procedures and results.

There are over 20 specialized Nadcap certifications available in total. Aerospace companies can pursue certification in any processes relevant to their operations and products.

Why Pursue Nadcap Certification?

There are many benefits for manufacturers and suppliers that gain Nadcap accreditation:

Meet Customer and Regulatory Requirements – Major aircraft OEMs now require Nadcap certification for their supply chains. Regulatory bodies like the FAA also recognize Nadcap to ensure safety and quality.
Qualify for New Business – Many contracts require Nadcap certification even to bid on work. Accreditation opens doors to new revenue opportunities.
Ensure Product Quality and Consistency – Certification requires rigorous process control and personnel training that lead to reliable, repeatable results.
Validate Processes and Capabilities – Nadcap audits verify that facilities, equipment, techniques, etc. meet demanding industry standards.
Access Global Network of Certified Suppliers – Thousands of aerospace companies worldwide are Nadcap accredited, simplifying sourcing.
Enhance Reputation and Competitive Advantage – Nadcap certification highlights a commitment to excellence that impresses customers.

The Nadcap accreditation process involves a thorough audit of the company’s procedures, staff qualifications, equipment calibration and maintenance, facilities, quality control methods, and more. While preparing for Nadcap certification takes time and resources, it pays dividends through higher quality, new business opportunities, and meeting the evolving demands of the aerospace industry. Many leading manufacturers and suppliers now consider Nadcap a baseline qualification to participate in the aerospace sector.

Is Nadcap Certification Right for Your Organization?

As aerospace manufacturing and sourcing becomes more globalized, Nadcap provides an invaluable standardized certification system. Companies that gain Nadcap accreditation position themselves as premium suppliers that exceed normal quality requirements. Though an investment, certification ultimately reduces risk, improves processes, and opens doors across the industry. With such clear benefits, Nadcap is rapidly becoming an essential certification for aerospace suppliers looking to grow and partner with major manufacturers.

To learn more about how Nadcap could be a fit for your organization, contact American Quality Management to speak with a professional and experienced Nadcap consultant.

The post An Introduction to Nadcap Certification – What is Nadcap and does your organization need it? appeared first on American Quality Management.

An Overview of ISO 13485 – What It Is and Why It Matters

Sat, 30 Sep 2023 20:20:22 +0000

For companies in the medical device industry, quality management is not just a priority – it’s an imperative. When products directly affect human health and safety, having rigorous systems in place to ensure effectiveness, reliability, and compliance is crucial. This is where ISO 13485 comes in – the internationally recognized standard specific to medical device quality management. But what exactly is ISO 13485, and why does certification matter so much for medical device organizations? This article will provide an overview of the standard and discuss key reasons it’s become ubiquitous across the sector.

ISO 13485: The Medical Device Quality Management System Standard

Published by the International Standards Organization (ISO), ISO 13485 is a framework outlining comprehensive quality management system requirements for medical device manufacturers. It encompasses guidelines for regulatory, safety, and performance-related processes. The primary objective of ISO 13485 is to facilitate the design, development, production, and distribution of safe, effective medical devices that consistently meet customer needs and regulatory requirements.

The standard specifies quality system expectations covering various areas:

Quality Management System Requirements: Instructions for documentation, document control, management responsibility, resource management, product realization, and measurement analysis.
Supporting Processes: Risk management, corrective/preventive actions, product design control, purchasing controls, production process controls, traceability, and customer feedback handling.

By providing a clear structure and universal language around quality, ISO 13485 promotes consistency and efficiency across global supply chains. It offers a blueprint for continually monitoring and improving processes and product quality.

Why ISO 13485 Certification Matters for Medical Device Companies

While voluntary for some regions, certification to ISO 13485 has practically become mandatory for medical device companies worldwide. Here are some of the key reasons the standard has become ubiquitous:

Regulatory Compliance

ISO 13485 exceeds the FDA’s Quality System Regulation requirements which U.S. manufacturers must meet. Consequently, certification demonstrates adherence to the FDA’s Current Good Manufacturing Practices for quality system expectations.

In the European Union, certification will soon be required under the new Medical Device Regulation (MDR) replacing the existing Medical Device Directive (MDD). ISO 13485 is also recognized by Health Canada, Japan’s Ministry of Health, Labor and Welfare, Australia’s Therapeutic Goods Administration, and more. Obtaining certification streamlines global regulatory approvals.

Access to Global Markets

Many countries now necessitate ISO 13485 compliance for medical device market access. It is increasingly a requirement for procurement contracts and tenders issued by governments and health systems worldwide. Certification opens doors to attractive sales opportunities abroad.

Supply Chain Assurance

With ISO 13485, medical device organizations must demonstrate oversight of third-party suppliers through selection criteria, contractual controls, and routine performance evaluations. This reduces downstream issues while promoting transparency and traceability across the supply chain.

Operational Efficiency

Standardized ISO 13485 processes generate greater consistency, improving cost control and resource utilization. Routine audits help identify issues to address through continual improvement. Certified companies also benefit from easier integration of new personnel.

Reduced Risk

Proactive quality management mandated by ISO 13485 reduces product failures, customer complaints, and non-conformities. Risk management requirements identify potential weaknesses early when easier to rectify. This prevents costly recalls and liability concerns.

Customer Confidence

Third-party ISO 13485 certification delivers external validation that a company is committed to quality and safety. This level of scrutiny offers assurance to purchasers that medical devices will consistently meet performance claims and regulatory requirements.

Conclusion

As the foremost medical device quality management system standard, ISO 13485 aims to safeguard patient health while facilitating global compliance and driving supply chain excellence. Obtaining ISO 13485 certification has transitioned from a box-ticking exercise into an essential pathway for accessing markets and demonstrating dedication to product quality and safety. With numerous business benefits, medical device companies can leverage ISO 13485 not just for compliance, but to build trust and gain a true competitive edge.

Is your organization looking for help in becoming certified? Reach out to us and speak to an ISO 13458 consultant today and learn more.

The post An Overview of ISO 13485 – What It Is and Why It Matters appeared first on American Quality Management.

Preparing Your Company for ISO 9001 Certification

Fri, 29 Sep 2023 22:48:11 +0000

ISO 9001 is the internationally recognized standard for quality management systems (QMS). It outlines requirements for ongoing quality control and process improvement in companies. Becoming ISO 9001 certified demonstrates to customers and stakeholders that your organization is committed to quality.

The certification process can seem daunting, but breaking it down into manageable steps will set your company up for success. In this article, we’ll walk through the key stages involved in preparing for ISO 9001 certification.

Perform a Gap Analysis

The first step is conducting a gap analysis, which compares your current QMS against the requirements set out by ISO 9001. Go through each section of the standard and honestly assess areas where your company meets the standards and where there are gaps that need to be addressed.

Look closely at clauses related to documentation, monitoring and measurement, management commitment, internal auditing, and continual improvement. The gap analysis creates a roadmap for your improvement efforts. You can’t address gaps until you’ve identified them.

For smaller companies, you may be able to conduct the gap analysis internally. Larger companies often hire a consultant who is an ISO expert to perform the assessment.

Train Employees on ISO 9001

Education is critical so employees at all levels understand ISO 9001 and its impact on their role. Provide training on the core principles of the standard, requirements, and definitions of common terms. Explain why you are seeking certification and how it will benefit the company.

Focus especially on educating management. The commitment and participation of leadership drives the implementation process forward. Managers must actively support and resource ISO 9001 efforts.

Clearly delineate responsibilities related to procedures and address any knowledge gaps with supplementary training. For example, those writing procedures need training on documentation requirements.

Document Processes and Procedures

ISO 9001 emphasizes the need to document your QMS processes and outline the interactions between them. Start by mapping out key processes within the scope of your QMS. Common examples include order processing, production planning, customer service, purchasing, and equipment maintenance.

For each process, establish a procedure detailing the actions performed, responsibilities, and oversight to meet ISO 9001’s requirements. The procedures should aim to improve quality, efficiency, and effectiveness. Leverage process mapping and lean tools like value stream mapping as you document.

Review Existing Documentation

Dig into your organization’s existing documents like work instructions, forms, job descriptions, and flowcharts. Identify any that need to be updated to meet ISO 9001 standards. Eliminate any obsolete or redundant documents.

Examine where you lack documentation and develop additional procedures, plans, forms, etc. to fill those gaps. For example, if you don’t have a document control or internal audit procedure, draft it. Ensure the documentation format aligns with ISO guidelines.

Conduct Internal Audits and Management Review

Internal audits verify your QMS is ready for certification by assessing its conformance to ISO 9001. Either designated internal auditors or external quality consultants can perform them. Audit all areas covered by the QMS, noting any non-conformities or areas for improvement.

Management should review the system as well, prior to the certification audit. Evaluate internal audit results, customer feedback, process performance, and progress on quality objectives. This determines if any final adjustments should be made before the certification body conducts its audit.

Select a Certifying Body

Research several accredited certifying bodies that perform ISO 9001 assessments in your industry and location. Compare costs, audit timelines, and certification processes. Some specialize in certain fields like manufacturing, healthcare, or technology.

Select one that aligns with your company culture and needs. Larger organizations may need auditors with experience reviewing more complex, multi-site QMS. Schedule your stage 1 and stage 2 audits once you’ve confirmed readiness through your preparations.

Achieving ISO 9001 certification takes time and dedicated effort, but following this structured approach sets your organization up for a smooth assessment. View preparation as an opportunity to thoroughly evaluate and optimize your processes. The hard work you put in before the audit translates to greater efficiency, improved quality, and demonstration of your commitment to customers.

The post Preparing Your Company for ISO 9001 Certification appeared first on American Quality Management.

Achieving AS9100 Certification: The Step-by-Step Process

Fri, 22 Sep 2023 22:56:00 +0000

For companies in aerospace, aviation, and defense, implementing the AS9100 quality management standard culminates in the significant milestone of formal certification. This rigorous certification process verifies your organization has a fully compliant system that meets all requirements in the standard. Obtaining independent, third-party AS9100 registration brings major benefits like meeting customer requirements, opening new business opportunities, and driving continual improvement. In this article, we will walk through the key steps involved in attaining certification.

Conduct a Thorough Gap Analysis

The first major step is performing an in-depth gap analysis comparing your existing quality management system against the details in the AS9100 standard. This analysis uncovers any deficiencies where your current processes, documentation, or implementation do not yet meet AS9100 requirements. Closely evaluate each clause and subsection of the standard to pinpoint potential non-conformities. If your organization is not currently certified to ISO 9001, gaps may include lack of:

A documented quality policy and objectives
Work instructions for production processes
Change management and configuration management procedures
Required quality records and forms

Identify any shortcomings in responsibility, accountability, training, infrastructure, or resources needed to fulfill AS9100. The gap analysis report becomes an action plan for the work ahead to upgrade your quality system. Working alongside an experienced AS9100 consultant through this process can help ensure all the gaps are identified and your organization will have a plan in place for the steps to come.

Implement an AS9100 Quality Management System

With gap analysis complete, you can now tackle the necessary enhancements to implement a system aligned with AS9100 requirements. This involves:

Creating an AS9100-compliant quality manual, procedures, work instructions, and forms. Use the standard as a model.
Integrating new documented processes into everyday operations.
Training all employees on their roles and responsibilities within the quality system.
Assigning accountability to specific personnel for key processes.
Providing necessary resources like staffing, tools, and budget.
Updating infrastructure if needed to comply with standards.

This stage takes dedication to integrate AS9100 into the full organization. But the work pays dividends when well-executed processes become second nature to staff.

Choose an Accredited Registrar

A critical prerequisite is selecting an auditing firm accredited specifically for AS9100 to conduct your certification. General ISO registrars cannot issue official AS9100 certification. Verify the scope of accreditations held by the registrar. Also, assess the audit approach used by the firm:

Do they emphasize coaching and partnership or just rigid assessment?
What qualifications and aviation/aerospace experience do their auditors have?
Can they share other clients as references?

Choose a registrar that fits your organization’s culture and needs.

Undergo the Stage 1 Audit

The registrar first performs a Stage 1 audit on-site. This involves auditing your AS9100 quality documentation for completeness, compliance with the standard, and alignment with actual business processes. Any gaps or non-conformities are identified and must be addressed before Stage 2. Ensure any deficiencies noted get corrected and necessary changes made for a smooth Stage 2 experience.

Undergo the Stage 2 Audit

In the Stage 2 audit, the registrar sends auditors to your facilities to verify the effective implementation of your AS9100 quality management system. Auditors inspect processes, interview employees at various levels, examine records, and trace specific work examples end-to-end through your system. Any remaining non-conformities or weaknesses get documented. Your organization must take corrective action and prove the issues have been resolved before certification can proceed.

Receive Formal Certification

Once all AS9100 requirements are adequately met without outstanding non-conformities, your organization is recommended for certification by the audit team. The registrar then makes the certification official by issuing the AS9100 certificate. Certification is valid for three years as long as ongoing compliance is maintained. Now the real work begins of living up to your certified status!

Maintain Ongoing Compliance

At least annually, your registrar will perform surveillance audits on-site to verify your organization still conforms 100% to AS9100. Any non-conformities that arise must be immediately addressed. Surprises identified during surveillance audits could put your certification at risk if not corrected quickly. These ongoing assessments ensure you never become complacent in following or improving quality processes. Within three years, your system must undergo a full recertification audit to renew AS9100 registration.

Achieving Certification Opens Doors

Gaining AS9100 certification takes dedication over many months, but success delivers rewards for years to come. With a compliant quality system validated by accredited auditors, organizations in aerospace, aviation, and defense unlock access to new business, meet customer requirements, and reach new heights of safety, quality, and performance.

The post Achieving AS9100 Certification: The Step-by-Step Process appeared first on American Quality Management.

Nadcap And The Future Of Aerospace And Defense Regulations: What To Expect And How To Stay Ahead

Mon, 18 Sep 2023 18:44:46 +0000

The aerospace and defense industry is on the brink of a revolution, with NADCAP poised to make seismic shifts in how regulations are set and enforced. The changes that NADCAP has proposed for the future have been monumental; so much so that it almost feels like we’re stepping into uncharted territory. As such, keeping up-to-date with these developments can seem like an insurmountable challenge – but fear not! This article will provide readers with insights into what to expect from the new rules, as well as tips for staying ahead of the game. With its comprehensive approach to knowledge about the current state of affairs in this highly regulated industry, this article promises to be a veritable goldmine for anyone looking to stay informed and remain competitive.

Overview Of Nadcap

The aerospace and defense industry is ever-changing, with the introduction of new regulations that shape the future. One such regulation is NADCAP (National Aerospace and Defense Contractors Accreditation Program), a globally recognized accreditation program that requires organizations to meet quality standards throughout their operations. This article will provide an overview of NADCAP and its implications for the aerospace and defense industries as well as discuss how stakeholders can stay ahead in this rapidly changing landscape.

NADCAP was established by the Performance Review Institute (PRI) in 1991 as a method of assessing suppliers who produce parts or services used in commercial aircraft, military aircraft, space vehicles, missiles, engines, ground systems, materials, and processes. The goal of NADCAP is to ensure high levels of safety and reliability through rigorous auditing programs based on international consensus standards from various sectors including chemical processing, non-destructive testing/examination, heat treating, welding, and more. To achieve compliance with these standards companies must demonstrate excellent performance in terms of product quality management system design capability evaluation process control etc. Additionally, PRI works closely with government agencies like NASA FAA Department Of Defense, etc. to develop specialized requirements for certain products or services related to those agencies’ needs.

The implementation of NADCAP has had significant impacts on the global aerospace and defense industries; it provides assurance that components being utilized are safe reliable consistent conforming to specifications while also driving innovation through continual improvement activities within the supplier base which ultimately helps reduce costs across value chain. Furthermore, many countries have adopted similar programs modeled after NADCAP due to their success thus far creating larger markets for compliant suppliers worldwide. Even though there may be additional challenges associated with staying ahead in this quickly evolving sector stakeholders can use tools such as benchmarking data analysis training seminars networking events risk assessments etc., so they remain informed about current trends regulations best practices technological advancements opportunities available, etc.

For all participants involved understanding NADCAP’s importance having proper resources and support structure place remains a vital component in maintaining a competitive edge in the marketplace position strong foothold long-term sustainability organization growth continuing commitment to providing the highest quality goods and services to customers alike regardless of regulatory environment changes come with time

The Impact Of Nadcap On Aerospace And Defense Regulations

NADCAP, or the National Aerospace and Defense Contractors Accreditation Program, is a global program designed to provide ongoing regulatory oversight for aerospace and defense industries. Its impact on industry regulations has been significant since its inception in 1989. This article examines the effects of NADCAP on current aerospace and defense regulations, with a focus on what organizations can expect moving forward.

First, it is important to understand how NADCAP affects existing standards. The program works by creating an accreditation process that regulates suppliers used by industry members. Organizations are required to meet specific criteria to become approved NADCAP vendors; if they do not comply with these guidelines, their products cannot be sold or used in production processes within the aerospace or defense sector. As such, this provides assurance that materials being used for manufacturing operations have met stringent quality control requirements. In addition, NADCAP also audits suppliers regularly to ensure continued compliance with established standards. By doing so, companies can rest assured that their parts will meet all applicable safety and performance requirements throughout their lifespan.

Moving forward, there will likely be some changes in terms of how NADCAP operates as well as which standards need to be maintained. For example, new technologies such as 3D printing may require additional measures of accuracy when approving vendors due to the complexity involved in producing those components accurately and safely at scale. It is also possible that other areas related to cybersecurity could come under closer scrutiny given recent developments in cyber threats posed by malicious actors both domestically and abroad. As such, staying up-to-date on any changes made by the organization regarding certification procedures is essential for remaining compliant with relevant regulations while continuing business operations without interruption.

Organizations should take proactive steps now to prepare for future updates from NADCAP in order to remain competitive and safe in rapidly changing markets. Regularly reviewing vendor certifications and auditing internal processes against current standards can help identify potential risks early on before they become major issues down the line—ultimately saving time and money later on when dealing with unexpected complications associated with noncompliance penalties or product recalls due to inadequate quality checks prior to release into circulation.

How Nadcap Impacts The Quality Assurance Process

A new era of quality assurance has arrived, as the National Aerospace and Defense Contractors Accreditation Program (NADCAP) impacts aerospace and defense regulations. Like a beacon cutting through the night sky, NADCAP provides an illuminated path for manufacturers to follow in order to meet stringent standards in their industry. But what does this mean for those looking to stay ahead? How can they ensure compliance with these ever-changing rules? An understanding of how NADCAP affects the quality assurance process is essential.

First and foremost, NADCAP creates consistency throughout the aerospace and defense industries by establishing benchmarks that all suppliers must adhere to during production. This ensures that regardless of who is manufacturing parts, safety remains at the forefront. Additionally, it strengthens communication between buyers and suppliers since both parties are aware of exactly what needs to be done when producing components or materials. Subsequently, this reduces costs associated with miscommunications or misinterpretations while also increasing operational efficiency.

Furthermore, NADCAP requires accredited companies to undergo annual audits which further promote accountability within their respective fields. Through these rigorous inspections, organizations have no choice but to remain up-to-date on any changes or updates concerning regulations set forth by governing bodies such as AS9100D/EN 9100:2018 Quality Management System certification requirements from the International Standards Organization (ISO). By holding themselves accountable in this way, companies demonstrate commitment towards meeting industry standards while simultaneously enhancing customer satisfaction rates—an invaluable asset in today’s competitive marketplaces.

In sum, NADCAP offers many advantages regarding quality assurance processes across multiple sectors including aviation and defense. From setting consistent expectations among its members to providing avenues for greater accountability and customer satisfaction levels, there’s no doubt that complying with NADCAP protocols is critical for staying ahead in today’s dynamic regulatory environment.

What Organizations Must Comply With Nadcap Regulations

The use of NADCAP regulations is an ever-changing landscape for organizations involved in aerospace and defense. To stay ahead, it is essential to understand what compliance entails and how the rules may evolve over time. As the saying goes, ‘forewarned is forearmed’.

Organizations that work with materials or processes used in aerospace and defense must comply with NADCAP standards set by PRI (Performance Review Institute). These standards are designed to ensure consistent quality assurance practices across all industries within this sector. Compliance requires a series of audits conducted by PRI auditors to verify that procedures meet specified criteria. This can include everything from assessing supplier management systems to testing chemical composition on parts. In addition, regular reports must be filed detailing any changes made since the last audit, as well as any nonconformances discovered during the process.

Achieving and maintaining NADCAP certification has become increasingly important due to increased competition among suppliers for contracts with major buyers such as Airbus, Boeing, and Lockheed Martin. It demonstrates that an organization meets quality requirements at every step of production—from raw material sourcing through final inspection—and ensures that products remain safe and reliable despite fluctuations in demand or changing technologies. Organizations should also consider investing in additional training courses for their employees so they can better understand industry trends and stay up-to-date on current regulations. Doing so will help them anticipate potential issues before they arise and maintain compliant operations throughout the year.

The Benefits Of Meeting Nadcap Requirements

Recent studies have found that over 90% of the aerospace and defense industry has voluntarily adopted NADCAP standards in their operations. This high rate highlights just how beneficial meeting NADCAP requirements can be to organizations in this sector. By adhering to these stringent guidelines, companies are able to reap a variety of advantages that help ensure they remain competitive within the market.

One such advantage is quality assurance. Meeting NADCAP regulations requires companies to use processes and procedures that guarantee consistency across all manufacturing stages. Additionally, through its rigorous audit process, NADCAP ensures the highest levels of safety for customers by ensuring products meet established performance criteria. As a result, any organization that meets NADCAP regulations will be able to provide superior goods or services with greater confidence as well as demonstrate their commitment to customer satisfaction.

Furthermore, compliance with NADCAP also brings significant financial rewards for businesses investing in this area. Companies who are willing to implement systems necessary to pass an audit can save money on materials and labor costs associated with inefficient production methods or costly rework due to poor quality control mechanisms in place prior to accreditation. In addition, having NADCAP certification allows businesses access to new markets since many countries require suppliers to have this standard before entering certain sectors. Ultimately, achieving compliance with these regulations helps organizations not only reduce expenses but also increase profits through improved efficiency and cost savings opportunities presented by increased sales opportunities around the world.

The adoption of NADCAP standards provides numerous benefits for those involved in aerospace and defense industries including improved product quality assurance, enhanced customer service experiences, and better financial outcomes due to lower costs and wider global reach potentials. For organizations looking towards continued success far into the future, understanding the importance of meeting Nadcap requirements should form an integral part of any strategic planning process going forward.

Challenges In Achieving Nadcap Compliance

As the old adage goes, “Rome was not built in a day.” Achieving NADCAP compliance is no different; often it requires a considerable effort to meet all of its requirements. In this context, meeting and maintaining these standards can prove to be daunting for many organizations within the aerospace and defense sector.

NADCAP has stringent criteria that must be met with regard to materials and processes used in order to ensure quality products are delivered on time. Companies must also regularly assess their internal systems and procedures while also staying up-to-date with changes or new interpretations as they occur. This could include additional training or certifications being required from personnel, which adds an extra layer of complexity. Organizations may need to invest time and resources into researching applicable regulations and updating protocols accordingly in order to remain compliant.

In addition, there is significant pressure placed upon companies to maintain high levels of efficiency and cost control during production processes – something that may be difficult if adjustments need to take place due to changing standards. Furthermore, failure by any organization within the supply chain could result in delayed delivery times or even penalties imposed by Nadcap auditors which can have serious financial implications for businesses involved in the process.

Therefore, it is essential that aerospace and defense companies stay up-to-date with NADCAP regulations so they can continue providing safe and reliable services throughout the industry. To achieve this goal, organizations should pay close attention to governmental policies related to manufacturing practices while also making sure their own facilities adhere strictly to such rules at all times.

Role Of The Supplier In Achieving Nadcap Compliance

Navigating the turbid waters of NADCAP compliance requires a clear-headed and collaborative approach from both the supplier and the customer. Like two heads of a hydra, each partner must work in tandem to maintain strict regulations while keeping an eye on future advancements in aerospace and defense technology. This article will explore the role of the supplier in achieving NADCAP compliance, highlighting challenges, strategies for success, and insight into staying ahead.

The first step on this journey is understanding the scope of regulation that suppliers face when adhering to standards set forth by NADCAP. Ensuring full compliance with these protocols can be daunting as they vary based on industry sector or product type; regardless, every supplier is expected to meet certain criteria related to their specific area(s) of expertise. As a result, it’s important for companies to stay abreast of changes made by NADCAP so they remain compliant and up-to-date with all relevant requirements.

In addition to monitoring regulatory updates, suppliers should also evaluate their own processes periodically to ensure any adjustments are reflected accordingly within their organization. Developing comprehensive internal training programs that emphasize proper documentation practices is one way for suppliers to demonstrate commitment to quality assurance measures imposed by external auditors like those employed at NADCAP-certified facilities. Further, proactive steps include investing resources into improving production efficiency through better process mapping and data analytics capabilities – investments that can pay off over time in terms of cost savings, higher throughput rates, improved quality control outcomes, and greater customer satisfaction ratings.

To remain competitive in today’s ever-evolving aerospace landscape it’s essential for suppliers to recognize the significance of meeting or exceeding current expectations while also looking ahead at potential opportunities presented by new technologies on the horizon. To do this effectively means building strategic partnerships between buyers and sellers who share common goals regarding safety, performance excellence, and long-term sustainability across multiple industries within aviation manufacturing supply chains worldwide.

Understanding The Nadcap Audit Process

The NADCAP audit process is an essential part of ensuring the quality and reliability of aerospace and defense products. According to data from Quality Magazine, over 80% of aerospace suppliers are now participating in the NADCAP program. This requirement has been adopted by many manufacturers worldwide, as it ensures that their products meet all necessary industry standards while also reducing costs associated with product failure. Understanding how this audit process works can help businesses stay ahead of new regulations and remain compliant.

This comprehensive audit covers a variety of topics related to manufacturing processes, including chemical processing, materials testing, non-destructive testing, calibration services, and heat treating. The goal is to assess the supplier’s compliance with industry standards for these areas. For example, auditors will review documents such as lab test reports or inspection records to verify that they adhere to established guidelines. In addition, suppliers must demonstrate proficiency in using approved methods and procedures when conducting tests or inspections on components or parts destined for use in aerospace applications.

To ensure successful completion of their audits, suppliers need to be aware of what is expected during each phase: • Preparation: Before the actual audit begins, suppliers should prepare documentation related to their processes and equipment used in production operations. • Audit Process: During the onsite visit, auditors evaluate the facilities against criteria outlined in applicable specifications set forth by customers and/or regulatory agencies (i.e., FAA). • Post Audit: After completing the audit process, any corrective actions required by the auditor must be implemented within a timely manner so that future re-audits can occur without issue.

By taking proactive steps toward understanding the requirements for NADCAP compliance before beginning the audit process, companies can save time and money while avoiding costly mistakes along the way. Additionally, having a clear plan for meeting customer expectations can not only give organizations peace of mind but also enable them to stay one step ahead when it comes to complying with changing regulations in aerospace and defense industries across the globe

Common Audit Findings And Corrective Actions

The NADCAP audit process is an essential component of the aerospace and defense industry, but it is often misunderstood. As its importance continues to grow in the future, it will be essential for those working within these industries to understand common findings and corrective actions that may come up during a typical audit. Irony can be found here – while understanding these aspects might seem intimidating at first glance, with the right preparation they can become just another part of everyday operations.

Audits typically focus on several key areas: compliance with technical specifications; adherence to quality management processes; assurance of qualification testing; and conformance to customer requirements. Additionally, other topics such as safety protocols or environmental issues could also be covered depending on individual circumstances. Within each area, there are specific criteria that must be met in order for companies to demonstrate their commitment to excellence. If any deficiencies are identified by auditors during this process, corrective action plans should quickly follow in order to address them before further problems arise.

Properly preparing for a NADCAP audit requires cooperation between multiple departments within a company, including engineering, production control, purchasing/supplier management, and quality assurance. Doing so enables teams to stay ahead of potential failures and reduce the risk of non-conformances being detected during audits. It’s important that everyone remains focused on finding solutions rather than assigning blame when discrepancies do occur – only then will organizations have what it takes to successfully pass their next inspection without issue.

Organizations that take proactive steps toward understanding the expectations set forth by NADCAP audits stand a greater chance of achieving success sooner rather than later. Through proper planning and effective cross-departmental collaboration organizations can ensure they remain compliant with current regulations and avoid costly delays

The Importance Of Compliance: How Iso 13485 Can Benefit Your Medical Device Business

Mon, 18 Sep 2023 18:21:45 +0000

Compliance is the engine that drives modern medical device businesses. Without it, companies risk compromising quality products and services, leading to costly delays and liabilities. Achieving compliance requires a thorough understanding of regulatory requirements such as ISO 13485 – but how can organizations leverage this knowledge to benefit their business? It’s like navigating an uncharted ocean: there are dangers lurking beneath the surface but with preparation and planning, you can chart a course for success. This article will explore the importance of compliance and how ISO 13485 certification can help your medical device business reach new heights of efficiency and profitability.

ISO 13485 is an internationally recognized standard that sets out detailed specifications for processes related to design, production, installation, sales, and service in the medical devices industry. Adherence to these guidelines helps ensure product safety and reliability while reducing costs due to improved process control. By meeting or exceeding the requirements stipulated by this standard, organizations demonstrate commitment to quality management systems (QMS) that protect consumers from potential harm associated with defective products.

The implementation of ISO 13485 provides many benefits beyond just compliance; it facilitates better communication between stakeholders, streamlines operations resulting in increased efficiency and cost savings, encourages innovation through continual improvement initiatives, and reinforces customer trust through consistent delivery of safe and reliable products. In short, investing in ISO 13485 certification can be hugely beneficial for any organization operating within the Medical Devices industry – allowing them to remain competitive in today’s ever-changing marketplace.

What Is ISO 13485?

ISO 13485 is an internationally recognized quality management system standard that is specifically tailored to medical devices. Developed by the International Organization for Standardization (ISO), it defines requirements for a comprehensive Quality Management System (QMS) and helps organizations demonstrate their ability to provide safe and effective products.

The scope of ISO 13485 covers all aspects of product realization, from design and development through production, installation, servicing, storage and distribution. It also includes post-delivery activities such as customer service and corrective action procedures. The standard seeks to ensure compliance with applicable regulations throughout these processes.

Organizations certified under ISO 13485 can benefit in many ways: they are better positioned to manage risks associated with regulatory noncompliance; they have improved operational efficiencies due to rigorous internal controls; they can improve their reputation among customers and other stakeholders; and they may even increase market share by becoming eligible for certain contracts or tenders which require certification. Overall, adhering to this international standard provides assurance that medical device businesses are producing reliable products while meeting stringent safety standards – a critical component of overall business success.

The Benefits Of Implementing ISO 13485

The benefits of implementing ISO 13485 are nothing short of remarkable. Not only does this international standard ensure that medical device businesses adhere to the highest levels of compliance, but it also offers a unique opportunity for organizations to distinguish themselves from their competition and demonstrate their commitment to quality assurance. By leveraging the power of ISO 13485, companies can benefit in ways both tangible and intangible – creating an environment with long-term sustainability and growth potential.

To begin with, establishing a quality management system (QMS) based on ISO 13485 provides medical device businesses with more than just regulatory compliance; it allows them to create a set of guidelines that will help promote continuous improvement throughout all aspects of operations. Moreover, having a QMS certified by an accredited body ensures customers have trust in the product they’re buying. This gives organizations an edge over those who do not take such steps towards compliance and shows buyers that the company is taking its responsibility seriously when it comes to providing safe products and services.

Furthermore, having a well-defined QMS helps streamline processes within the organization while allowing staff members to better understand what is expected from them at any given moment. It also encourages communication between departments and promotes collaboration among teams -all essential components for creating an efficient work environment. Additionally, these systems provide transparency into each step taken during production or service delivery and make available data about how successful certain activities were upon completion. Combined together, these features allow companies to maximize efficiency within their operations while reducing financial risks associated with non-compliance.

It is clear that implementing ISO 13485 provides numerous advantages for medical device businesses seeking success in today’s marketplace. From ensuring high standards of compliance through promoting ongoing improvements across multiple areas, this international standard has become increasingly important as healthcare technology continues to evolve rapidly around the world. Companies must recognize this fact if they wish to remain competitive and profitable over time in order to build sustainable growth paths forward.

Quality Management System Requirements

The world of medical device business is complex and highly regulated. To ensure quality assurance, the ISO 13485 standard was developed to provide a framework for compliance. Quality management system requirements are an essential part of this framework that must be met in order for organizations to gain certification.

It can seem like a daunting task to fulfill these quality management system (QMS) requirements; however, with careful planning it is possible. Being compliant means adhering to certain processes such as risk analysis, design control procedures, validation activities, corrective action plans, and other aspects associated with product lifecycle management. Having effective QMS protocols in place helps businesses meet regulatory standards while also providing consistency throughout their operations..

Careful implementation of ISO 13485 will help medical device companies demonstrate commitment to customer satisfaction by ensuring products meet the highest levels of safety and efficacy. This ultimately leads to greater confidence from customers, suppliers, and regulators alike which then translates into increased loyalty and better reputation overall. Implementing quality management systems allows organisations to efficiently monitor performance across all areas of the business leading to improved operational efficiency, cost savings and enhanced consumer experience – all critical components necessary for success in today’s competitive market.

Risk Management In Medical Devices

Risk management in medical devices is an important factor for any business that manufactures and sells them. This risk must be managed properly to ensure the safety of those using the device, as well as staying compliant with regulations such as ISO 13485. To do so, companies need to take a holistic approach which involves four key steps: identifying risks, assessing their probability and severity, developing mitigation strategies, and monitoring outcomes.

First, it is necessary to identify all potential sources of harm associated with a medical device. The process should involve researching industry standards and expectations on design controls, verification processes, and validation tests. Additional research can include studying customer feedback from previous products or market surveys about consumer perceptions. By examining these data points, manufacturers are better equipped to map out areas where risks may arise during production or use of the product.

Having identified possible hazards associated with the medical device, it is time to assess both their likelihood of occurring and the magnitude of damage they could cause if present. Here businesses should consider various scenarios when evaluating each source of risk; one example would be how would different temperatures affect usage. Having established an understanding of what risks exist, executives then need to develop plans for mitigating them through additional safeguards like improved testing procedures or new software algorithms. These measures will help reduce damages incurred by users should something go wrong while also helping protect against legal liabilities.

Finally, once effective preventative actions have been taken it is critical that organizations maintain oversight over their performance regularly to ensure they remain effective at controlling danger levels posed by their products. This monitoring activity can consist of surveying customers after purchase or conducting internal audits on manufacturing facilities every few months depending on needs encountered during development phases earlier in the process cycle. When done correctly these reviews provide valuable insights into whether improvements are needed or whether existing protocols are working adequately in keeping people safe from harm caused by malfunctioning equipment.

Understanding Your Regulatory Environment

The regulatory environment of medical devices is complex and has a direct impact on the success or failure of any business operating in this market. For businesses to remain competitive, it is essential that they understand the applicable regulations and standards for their industry. ISO 13485 is an important standard that can help medical device companies ensure compliance with current laws and regulations.

ISO 13485 provides comprehensive requirements addressing all aspects of quality management systems related to medical device manufacture, including design, production, installation, and servicing. It also outlines expectations for document control, risk management processes, and traceability of products throughout their lifecycle. Companies that comply with ISO 13485 demonstrate their commitment to providing safe, effective medical devices while minimizing potential risks associated with them.

Adopting ISO 13485 as part of your medical device business operations offers many benefits; from increased customer confidence and improved product safety to enhanced operational efficiency leading to cost savings and reduced time-to-market for new products. Furthermore, by ensuring compliance with existing regulations through regular audits and reviews you can reduce the risk of costly fines or other penalties due to noncompliance issues. As such, understanding the importance of proper regulation within your industry should be a priority in order to maximize your company’s success going forward.

Design And Development Of Medical Devices

When it comes to designing and developing medical devices, following a regulatory compliance framework such as ISO 13485 is essential for businesses that manufacture these products. This standard helps ensure the safety and efficacy of products by establishing requirements for quality management systems throughout the manufacturing process.

The design and development process begins with an understanding of customer needs and expectations. This includes researching current trends, market demand, and other criteria necessary in order to develop a product that meets or exceeds those requirements. The next step involves creating a design plan based on this research, which should include risk assessment activities like hazard analysis and verification/validation testing procedures. Finally, the design must be implemented properly in order to meet all relevant regulations.

ISO 13485 provides guidance on how companies can approach each stage of the design and development process in accordance with applicable laws and standards. By adhering to its principles, businesses can create medical devices that are safe and effective while also meeting their customers’ expectations regarding quality control measures. Ultimately, following this standard has many benefits that help organizations achieve greater success in terms of customer satisfaction, cost savings, and competitive advantage, among others.

Production And Service Provision

Producing and providing medical devices is a complex yet integral part of the entire business process. This means that it is essential to be aware of compliance regulations, such as ISO 13485, in order to ensure a successful operation. To illustrate this point further, consider the following:

Firstly, if production and service provision are not managed effectively according to ISO 13485 standards, then your business may encounter costly delays due to regulatory issues or even worse – non-compliance penalties. Moreover, there can be significant financial losses associated with these complications; therefore, adhering to industry guidelines becomes an important factor for success.

To make sure the quality of produced goods meets customer requirements and any applicable legal regulations, certain steps need to be taken during production and throughout the life cycle of each device. These include: • Ensuring product traceability • Regularly monitoring processes • Performing risk analyses on products In turn, these will help you achieve greater control over your operations while also ensuring safety standards are met at all times. As such, if implemented correctly, ISO 13485 should play an imperative role in maintaining efficient production and service provision cycles within your medical device business. It provides a framework for improving operational performance by addressing potential risks earlier in the development process rather than later down the line when costs tend to rise exponentially.

Control Of Nonconforming Products

Control of nonconforming products is a critical component for organizations seeking to comply with ISO 13485, the international standard for medical device quality management systems. It ensures that organizations are able to identify and eliminate any defects in their processes or products before they enter the market. This helps ensure that customers receive safe, effective, and high-quality devices that meet their needs.

The control of nonconforming products involves several stages. First, it requires identifying any failed tests and/or design issues through rigorous testing and inspection procedures. Second, it includes analyzing root causes to determine why the product did not meet requirements and implementing corrective actions accordingly. Finally, after identifying and resolving any potential problems, companies must establish preventive measures to mitigate similar occurrences from occurring again in the future.

Organizations can only benefit from following these steps as part of their compliance program under ISO 13485:2016; such practices guarantee customer satisfaction by providing them with reliable devices that meet safety and performance standards while also protecting manufacturers from legal liabilities due to defective products entering the marketplace. Companies should therefore take care to ensure proper control over their nonconforming products so that they can continue offering superior services to their clients.

Traceability And Identification

Traceability and identification are two essential elements of compliance management that must be addressed in order to achieve ISO 13485 certification. In a medical device business, these concepts ensure that any nonconforming products can be easily traced back to their sources and identified as such, thus preventing them from entering the market or being delivered to customers.

This traceability is achieved through various processes such as tracking incoming materials by lot numbers and serializing finished goods for easy identification. Furthermore, product labeling should include information about its classification (Class I, IIa/b, III), which allows for a quick assessment of how it needs to be handled during manufacturing and delivery operations. That said, there are further steps needed in order to maintain full control over the production process – such as establishing an effective corrective action program – but those start with proper traceability and identification.

The implementation of appropriate procedures can help businesses meet all regulatory requirements related to safety while also improving overall performance levels due to their increased visibility into supply chain activities. As a result, companies will have greater confidence when launching new products into the market because they know they’ve taken all necessary measures to prevent issues caused by incorrect parts or components. Ultimately, this leads to delivering higher quality devices at lower costs while meeting customer satisfaction goals.

Internal Auditing And Management Reviews

Internal auditing and management reviews are an essential part of any medical device business’s compliance program. They provide structure and guidance, ensuring that the company is adhering to applicable laws and regulations. Through internal audits and management reviews, companies can get a better understanding of their organization’s performance in terms of safety, quality, cost-effectiveness, customer service, and other important metrics.

The importance of regular internal auditing and management reviews cannot be understated when it comes to meeting ISO 13485 requirements. It helps organizations identify gaps between actual processes and what should occur according to established standards. This allows them to make necessary changes or improvements quickly so they don’t fall out of compliance with the standard. Here are three key benefits offered by regularly conducting these activities:

Improved process efficiency – Regularly reviewing processes helps ensure that resources are used efficiently while still producing high-quality results for customers. • Enhanced risk management – Identifying areas where risks may exist enables businesses to take proactive steps toward mitigating those risks before they become issues that could lead to noncompliance or financial losses. • Increased accountability – Proper documentation from internal audit reports provides evidence of responsible behavior in case questions arise about decisions made by employees or managers within the organization.

By leveraging the power of internal auditing and management reviews, medical device businesses can gain greater confidence knowing that their operations are compliant with ISO 13485 standards as well as all relevant laws and regulations governing their industry. These activities also help streamline workflows, support sound decision-making practices, foster organizational transparency, improve customer satisfaction levels, and drive business growth initiatives forward — ultimately helping organizations stay competitive in today’s marketplace.

Training And Competence

When it comes to compliance, training and competence are essential. A recent study revealed that almost 70% of medical device companies lack the skills required to effectively meet their regulatory requirements. It is therefore no surprise that effective training and competency assessment has become a key factor in ensuring compliance with ISO 13485 – the international standard for quality management systems specific to medical devices.

Training provides employees with the knowledge they need regarding standards and regulations, as well as best practices when it comes to producing safe devices. This can help reduce risks associated with non-compliance, while also increasing employee productivity. Additionally, regular assessments allow businesses to identify areas where further improvement is needed and provide targeted training on these topics if necessary.

Therefore, comprehensive training programs combined with periodic evaluation of personnel competencies form an important part of any successful compliance strategy. By implementing these measures, organizations can ensure that all staff members have the tools they need to remain compliant in today’s highly regulated environment. Consequently, it provides a firm foundation for long-term success and protection from potential fines or other negative outcomes due to non-compliance issues.

Control Of Production And Service Validation

The control of production and service validation is a critical element in medical device businesses that must be carefully managed. It forms part of the larger requirement for compliance with ISO 13485, an international standard developed to ensure quality management systems are effective when manufacturing medical devices. With this in mind, it’s essential to understand how su

ISO 14001 & Climate Change: Addressing The Impact Of Your Business Operations

Mon, 18 Sep 2023 18:12:56 +0000

Even though climate change has become an increasingly pressing concern for businesses, it is not the only environmental issue that companies must address. ISO 14001 provides a framework of standards to help organizations identify and manage their environmental impacts in a responsible manner. Coincidentally, this standard emerged at almost the same time as concerns about global warming began to gain traction in mainstream media.

ISO 14001 was first published by the International Organization for Standardization (ISO) in 1996 as part of its series of Environmental Management Systems (EMS). The most recent version of ISO 14001—the 2015 edition—provides guidance on how to develop, implement, maintain, and improve an EMS. It also outlines specific requirements related to topics such as leadership commitment, life cycle thinking, and risk assessment – all of which are key components of any successful sustainability strategy.

Although some may view compliance with ISO 14001 as simply meeting minimum legal standards, when implemented correctly it can be much more than just ticking boxes. Companies that adhere to the standard demonstrate their commitment to reducing their environmental impact while providing tangible benefits like improved energy efficiency, increased resource recovery and reduced waste management costs. This makes implementing ISO 14001 an essential tool for addressing the impact of business operations on climate change.

Benefits Of Adopting ISO 14001

The implementation of ISO 14001 offers numerous advantages to businesses, particularly those with operations that produce a considerable amount of greenhouse gas emissions. Adopting this international standard can be beneficial for companies in terms of enhancing their environmental performance, reducing costs, and increasing stakeholder engagement.

One of the key benefits of implementing ISO 14001 is its ability to help organizations identify potential environmental impacts associated with their activities or products and services. This enables them to take proactive steps to reduce any negative effects on climate change while promoting best practices within the industry. Additionally, by incorporating this system into existing operational processes, it gives businesses an opportunity to optimize resources and save money through improved energy efficiency. Furthermore, customers’ confidence in a company will increase as they are able to see the efforts being taken towards protecting the environment and mitigating climate change risks.

Moreover, having an effective Environmental Management System (EMS) based on ISO 14001 helps companies engage positively with stakeholders such as investors, employees, and local communities. It also opens up opportunities for new business relationships due to increased trustworthiness from other parties involved in similar initiatives. All these factors make adopting ISO 14001 a vital step for organizations wishing to create a positive impact on both the environment and their reputation within the marketplace.

Environmental Impacts Of Business Operations

The modern world is an ecosystem of interconnected parts, where the environmental impact of business operations has become increasingly palpable. In this context, it is essential for organizations to be conscious about their activities and strive towards mitigating the effects of climate change through a range of measures. ISO 14001 is one such measure that provides a comprehensive framework for organizations to address the negative impacts of their operations on the environment. Like a jigsaw puzzle, its pieces fit together perfectly to enable businesses with efficient ways to minimize their ecological footprint.

To begin with, adopting ISO 14001 helps companies identify potential risks they may face due to their activities as well as develop strategies to mitigate these risks in order to reduce any environmental damage. A key component of this process includes conducting regular audits and setting up measurable goals that are linked directly to the organization’s overall objectives and plans for sustainability. As part of this exercise, organizations also involve stakeholders (e.g., employees, suppliers) who can then take ownership and help them stay committed in fulfilling all requirements under the standard.

In addition, when businesses opt-in for ISO 14001 certification, they can avail various other benefits like improved operational efficiency by reducing waste or resources used during production processes; higher customer satisfaction since customers tend to prefer those products that meet certain standards; better brand reputation among competitors; financial savings from reduced liabilities; etc. All these advantages ultimately contribute significantly towards achieving long-term sustainability within an organization while simultaneously supporting climate action initiatives across industries worldwide.

Despite being highly beneficial in curbing emissions generated due to business operations, there are still some challenges associated with implementation of ISO 14001 such as high costs related to training personnel and meeting specific criteria set forth by certifying bodies; lack of clear guidelines regarding legal obligations applicable in different countries/regions; difficulty tracking progress made over time without access to reliable data sources; inadequate resources allocated for continual improvement programs post-certification etc.. However, if managed properly, these issues can be mitigated thereby enabling companies make significant strides in helping protect our planet from further degradation due to human activity – thus providing everyone with a brighter future ahead!

Understanding Climate Change

Climate change is an ever-growing threat to the environment and our planet’s future. It is a challenge that, if left unchecked, could lead to devastating consequences for all species on Earth. To understand this phenomenon, one must first grasp its underlying causes and effects.

The primary cause of climate change can be attributed to human activities such as burning fossil fuels or deforestation for agricultural purposes. These activities release large quantities of carbon dioxide into the atmosphere, creating a ‘greenhouse effect’ that traps heat from the sun and warms up the Earth’s surface temperature. This warming then triggers further changes in weather patterns across the globe – extreme temperatures, rising sea levels, floods, droughts, melting icecaps and more – with serious implications for human health, economic growth prospects and food security among other areas.

To address these challenges posed by climate change effectively requires us to take action at both individual and organizational levels. Businesses have a responsibility to reduce their emissions by implementing sustainable practices throughout their operations – from energy efficiency measures like switching off lights when not in use, to investing in renewable sources of energy like solar panels or wind turbines. Moreover, they should commit themselves to developing strategies that actively seek out solutions that will help mitigate the impact of climate change going forward.

In short, it is clear that understanding climate change is key to combatting its effects successfully. Only through taking tangible steps towards making our businesses more environmentally responsible can we protect ourselves against potential disaster down the line – protecting both people and planet alike.

The Role Of ISO 14001 In Addressing Climate Change

As the effects of climate change become increasingly evident, businesses must take steps to mitigate their contributions. ISO 14001 is an internationally recognized standard for environmental management that can help organizations reduce their impact on the environment and address climate change. This article will explore the role of ISO 14001 in addressing climate change and how it can be used to ensure sustainable operations.

The increasing severity of extreme weather events serves as a reminder of the urgent need to respond to climate change. Businesses play a vital role in this process; reducing emissions, minimizing waste production, maximizing energy efficiency, and improving resource utilization are all necessary components of any effective response strategy. By implementing ISO 14001, companies can develop comprehensive plans for managing these elements in order to reduce their impacts on the environment.

ISO 14001 provides guidance on establishing environmental objectives and targets based on legal requirements, stakeholder expectations, and organizational values while also promoting continual improvement through regular audits and reviews. These processes allow organizations to track their performance relative to goals set out by the standard and make changes where needed. Additionally, certification helps demonstrate commitment towards sustainability initiatives which may open up new opportunities both internally within the organisation and externally with customers or other stakeholders.

Through its focus on continuous improvement, risk assessment, and goal setting, ISO 14001 offers an invaluable tool for companies looking to reduce their contribution towards global warming while at the same time demonstrating leadership in terms of corporate responsibility. With greater implementation comes greater potential for improved resource efficiency across industries – one step closer to achieving a more sustainable future for everyone.

Identifying Potential Environmental Risks

Research on climate change has revealed that businesses are responsible for nearly 70% of global greenhouse gas emissions. This statistic underlines the importance for organizations to take an active role in addressing environmental risks. ISO 14001 is a widely used international standard, providing guidance and tools for companies to identify potential environmental risks associated with their operations and develop strategies to address those risks.

In order to ensure compliance with the requirements of ISO 14001, organizations must first undertake careful assessments of their current processes and practices. It is important to consider not only direct impacts such as energy consumption or air pollution, but also indirect ones such as transportation services, waste management, and other activities related to supply chains. Assessments should involve examining existing systems and identifying areas where changes could be made, then developing plans in collaboration with stakeholders including employees, customers, and suppliers.

Organizations can use various methods when evaluating potential environmental risks in line with ISO 14001 standards. These include internal audits by staff members or external consultants; studying historical data about performance within certain areas; conducting surveys of employee behavior; assessing legal regulations governing any aspects relevant to the business; consulting external experts who may have additional insight into specific topics; using software tools designed specifically for risk analysis; utilizing public databases containing information from research studies or other sources; or creating customised models based on company-specific scenarios. All these methods help identify potential problems which can then be addressed through appropriate measures.

The Process Of Certification Under ISO 14001

Gaining certification under ISO 14001 is an important part of mitigating negative environmental impacts from business operations. It involves a rigorous process that requires commitment and dedication to ensure successful implementation of the standards set by the International Organization for Standardization (ISO). This article will analyze in detail the steps necessary to become certified, as well as how it can benefit organizations working towards climate change mitigation.

The first step in becoming ISO 14001 certified is conducting an internal audit. This entails taking stock of current practices and procedures with regard to environmental management, identifying any areas where improvements could be made, and creating and executing an action plan that meets the requirements defined by ISO’s Environmental Management System (EMS). Additionally, the organization must demonstrate its ability to meet applicable legal requirements related to environmental protection and have documented evidence outlining its compliance with them.

The second step necessitates putting together all relevant documents such as procedures, processes, records of activities or results, etc., into one document known as an EMS Manual. The manual should include information on objectives, roles, and responsibilities within the company related to environment management, reporting mechanisms for monitoring performance indicators, emergency response plans if there are any potential risks associated with activities conducted by the organization, and more.

Finally, when all required documentation has been compiled and reviewed internally by qualified personnel – who need not necessarily be external auditors – they may then submit their application for assessment against ISO’s criteria. Benefits derived from obtaining this type of certification include: * Improved sustainability through better use of resources; * Reduced costs due to improved efficiency; * Increased credibility among stakeholders; * Enhanced reputation amongst customers; * Stronger market position versus competitors who lack similar certifications.

In summary, following these steps outlined above allows businesses to successfully obtain certification under ISO 14001 while also providing tangible benefits that contribute positively towards mitigating climate change impacts caused by business operations.

Developing An Environmental Management System

Developing an environmental management system is like a journey. It involves mapping out the necessary steps to ensure that your business operations have minimal impact on climate change and ultimately leading to certification under ISO 14001. Achieving this requires a company-wide commitment from senior leaders, as well as input from external consultants who can guide you through the process.

The first step in developing an effective environmental management system is to identify which aspects of your business are likely to be contributing to climate change. This could include activities such as energy consumption, waste production, water use, and transportation emissions. Once these areas have been identified, it is important to set goals for improvement and establish key performance indicators (KPIs) that will allow you to measure progress against them over time.

In order to meet these KPIs, it is essential that appropriate systems and procedures are put in place across all departments within the organization. These should address topics such as resource efficiency, pollution prevention, employee training, and stakeholder engagement. To make sure they are implemented effectively, regular audits should be carried out by internal or external auditors with relevant expertise. By taking all of these steps together, businesses can create an efficient environmental management system capable of making real progress towards reducing their contribution to climate change – something required for companies aiming for certification under ISO 14001.

Monitoring & Evaluating Performance

Impressively, monitoring and evaluating performance is an essential step in developing an environmental management system (EMS) to address the impact of business operations on climate change. As a formative exercise that can sharpen organizational objectives and strategies, it allows businesses to better understand their influence in this area while also considering potential opportunities for improvement. Notably, with meticulous attention to detail and effective communication channels, organizations are able to accurately assess their progress toward reaching sustainability goals.

To begin with, measuring performance should be done regularly as part of EMS implementation. This could include the use of indicators such as energy consumption, waste reduction, or water usage which would help track progress against predetermined targets over time. Moreover, these measurements should be conducted across all levels of the organization to ensure compliance with applicable regulations and standards – including ISO 14001:2015. Additionally, managers must consider external factors like customer feedback when assessing results. By doing so they will gain valuable insights into how their operations affect stakeholders directly impacted by them.

Ultimately then, monitoring and evaluation functions as both a corrective tool and a strategy-building device allowing companies to identify areas where interventions may be necessary for improving outcomes related to climate change mitigation efforts. Consequently, through continual refinement of its processes, any organization can increase efficiency while simultaneously reducing its carbon footprint – thereby contributing towards creating a more sustainable future for everyone involved.

Implementing Green Initiatives

Implementing green initiatives is a critical part of addressing the impact of business operations on climate change. There are many ways to reduce greenhouse gas emissions and other environmental impacts, from adopting renewable energy sources to implementing efficient processes for waste management. Companies should identify areas in which they can make an effort to be more sustainable, and then develop strategies that include both short-term and long-term goals.

One key strategy for achieving these goals is reducing energy consumption through improved efficiency. This includes making investments in equipment upgrades, utilizing smart technology to monitor usage and improve efficiency, or even changing operational practices such as turning off lights when leaving a room. Additionally, companies may consider switching to renewables like solar or wind power if economically feasible.

Another important element of green initiatives is encouraging employees to contribute ideas and participate actively in sustainability efforts. Integrating eco-friendly principles into everyday corporate culture helps ensure that all team members understand the importance of their role in protecting the environment. Employees also benefit from being exposed to new knowledge about climate change and having opportunities for growth within the company by taking ownership of environmental projects. Therefore, businesses must prioritize employee engagement as well as investing in technological advancements if they want their green initiatives to be successful in mitigating their carbon footprint and contributing towards fighting climate change.

Engaging Employees In Environmental Protection

Engaging employees in environmental protection is an essential step for organizations to sustainably address the impacts of their operations on climate change. By taking a holistic approach, companies can make meaningful progress toward protecting the environment and mitigating its negative consequences. With this in mind, it behooves business leaders to recognize that employee engagement is integral to achieving success.

Inspiring people to take action needs to occur at both individual and collective levels; as such, employers should strive to create a workplace culture that encourages employees’ active involvement in green initiatives. Consequently, below are five key elements that businesses must consider when engaging staff in environmental protection:

Establish clear objectives – Set realistic goals with measurable outcomes so everyone can track their progress; • Provide education & training – Ensure all personnel understand how they can contribute by providing resources such as tutorials and workshops; • Celebrate successes – Make sure achievements are publicly acknowledged through rewards or recognition programs; • Model behavior – Leaders need to demonstrate commitment by acting as role models and setting high standards; • Listen & respond – Involve staff members in decision-making processes by creating feedback channels where their voices can be heard.

At its core, successful employee engagement is rooted in effective communication between management and workers. Therefore, managers must prioritize fostering relationships based on trust while actively promoting sustainability efforts within the organization. When done correctly, this will result in an engaged workforce that shares common values and works together collaboratively towards shared goals related to climate change mitigation.

Working With Suppliers & Other Stakeholders

Responsible environmental management is like a jigsaw puzzle, with each piece playing an integral role in the finished picture. When it comes to addressing climate change and its impacts on business operations, w

St. Joseph’s School Commends American Quality Management for Its Generosity to the Lakota Children

Mon, 12 Oct 2020 22:22:07 +0000

Supply Chain Optimization in the Age of COVID

Mon, 12 Oct 2020 18:26:43 +0000

The COVID-19 pandemic has forced companies worldwide to scale back production and transportation, temporarily close, or shut down permanently. These disruptions have severely impacted global supply chain optimization.

Supply chain optimization is key to operating at optimal performance, and the health crisis has created new challenges for businesses across all industries to maintain their highest rate of productivity.

If companies want to survive throughout the pandemic and successfully emerge from it, they must focus on protecting and improving their supply chain efficiency. To do so, business leaders need to:

Understand the ways the disease has impacted their supply chains
How they can adapt to these changes
Learn the steps to take to protect themselves
Plan for the future of supply chain optimization post-COVID-19

Diving Deeper: How COVID-19 Affects Supply Chain Optimization

Reduced Workforce

Over 235 countries have recorded Coronavirus cases, with more than 35 million people infected, and over one million deaths as of early October 2020, according to the Johns Hopkins University Center for Systems Science and Engineering. In the U.S., there have been 7.4 million cases and 210,000 deaths from the disease.

Following government guidelines, companies have taken steps to ensure their employees’ safety, such as requiring face coverings, social distancing, remote work, and limiting the number of employees on each shift. Many employees have also refused to return to work out of fear for their health.

All these factors have created a reduced workforce, leading to less product manufacturing and slower delivery times.

For example, consider the farming industry. Many farms rely on migrant workers as their workforce. Shortly after the pandemic hit, the U.S. announced immigration and travel bans, which included seasonal migrant workers.

Over the spring and summer, countless farms faced a shortage of labor to pick produce. The situation left farmers with excess fruit and vegetables rotting in unharvested fields. That meant less produce reached consumers, and what did reach them came at an inflated price.

Supply and Demand

While reduced production has reduced supply, demand shortages have ravaged other industries. The travel and leisure industries have suffered the hardest. Since the pandemic started, fewer people are buying airline tickets or booking hotel rooms, and many hot tourist destinations are in lockdown.

Airline travel was essentially grounded at the start of the pandemic. Customers were simply too fearful to fly. As a result, many airline companies have reduced their daily flights, removed routes, and scaled back plans to purchase new planes.

With more planes left on the ground, fewer planes need regularly scheduled maintenance and updated parts. Companies that manufacturer those parts will either build up a surplus or limit production capacity.

Companies that build airplanes are in the same boat. The slowdown or cancellation of airplane production has caused a ripple effect for airplane part production companies.

For example, Boeing temporarily stopped producing its 787 Dreamliner planes at facilities in South Carolina and Seattle due to COVID-19 restrictions. The Chicago-based company applied for federal relief to cover losses and to boost its supply chain.

These examples are just a small window into the havoc COVID-19 has wreaked on supply chains worldwide—like dominos, supply and demand changes affect every link in the chain. The pandemic has forced companies to place emphasis on planning short-term and long-term contingency plans. Only those who find innovative ways to mitigate supply chain disruptions will be standing when the economy stabilizes, and that requires supply chain optimization.

How Companies are Adjusting

Six months into the pandemic, companies are learning to steer through supply chain problems by developing new policies. Many business leaders find themselves:

Staying away from single-source dealers
Ordering extra inventory
Reviewing their contracts with suppliers
Developing mapping to maximize efficiency

Bidding Farewell to Single-Source Dealers

In an attempt to get the best deal, many companies narrow down the field of suppliers to one company. While this may drive the price of the product down, it can leave those same companies without a Plan B.

If a company’s single-source supplier can’t deliver a product, then the company is left to scramble to find another supplier. The pandemic has highlighted just how dangerous counting on Plan A can be, as many suppliers have either shut down or been unable to manufacture their products.

Smart logistics managers are now lining up contingency plans for their supply lines with a hybrid approach where they order products from two or more suppliers. While it may increase costs, the move provides insurance that the company will receive its products and continue to meet customer demands.

Ordering Extra Inventory

Many companies rely on just-in-time manufacturing to reduce supply chain waste. With this system, suppliers deliver materials according to a pre-arranged schedule. This approach works efficiently because manufacturers can order the exact amount of product necessary without any excess.

However, we never know when the next crisis will hit. Right now, the world is dealing with a pandemic. The next international calamity could be a natural disaster in a geographical location that is a critical link in the supply chain, a war, or who knows what else.

To plan for the worst, companies have begun to stock up on inventory to reduce the chance of a shortage of materials if an unplanned event impacts their primary supplier. Just-in-time ordering hasn’t been abandoned, rather cautiously reserved for less-vital supply chain elements.

Reviewing Contracts with Suppliers

The pandemic has raised some red flags on the current contracts suppliers and manufacturers have agreed to, as well as on future contracts. Due to fewer flights, closed ports, and fewer trucks on the road, product delivery has been delayed.

Companies are closely monitoring their existing contracts with suppliers to determine what obligations each party is liable for. When existing contracts are set to expire, companies are considering the ramifications of the pandemic and future global emergencies that could arise.

Developing Mapping of a Supply Chain to Maximize Efficiency

When it comes to supply chains, companies have different tiers of suppliers. The Tier 1 level is primary suppliers, while Tier 2 is secondary suppliers.

For a company to manage an international crisis, it must keep track of all its suppliers – and not just the Tier 1 level. The disruption of one supplier can halt or delay the entire supply chain. Companies that have visibility across all levels can survive a supply chain catastrophe, mostly unscathed.

General Motors is a perfect example of this approach. When the tsunami of 2011 impacted Japan, GM invested in mapping tools. These supply chain tools helped GM to discover which suppliers were close to the event.

In turn, GM figured out what steps were necessary to avert a major disruption to its supply chain.

As the coronavirus first originated in Wuhan, China, companies with updated mapping tools knew whether they had suppliers in the area. If they did, they were able to reach out to suppliers in other areas or countries to order their products.

How Companies are Safeguarding Their Supply Chains

Almost every industry is currently focused on taking preemptive measures to diminish the threat of COVID-19 on their supply chains when it comes to personnel—and rightly so. Here are a few examples of the steps that may counter future delays:

Focus on showing employees how they can avoid catching the coronavirus. Business leaders must remind the workforce to wear a face covering, remain six feet apart from co-workers, and frequently wash their hands.
Develop a screening process. Companies are requiring employees to answer a series of questions to determine their risk and possible exposure to COVID-19.
Take temperatures daily to test for a fever with a touchless thermometer. The Centers for Disease Control considers someone with a temperature of 100.4 degrees or greater to have a fever.
Plan for a daily reduction in the workforce. According to the CDC, employees who have a confirmed COVID-19 diagnosis or contact with someone who does must quarantine for at least 14 days. Businesses must prepare for employees to remain out of work with contingency plans to cover for anyone unable to return to work for an extended period.

Measures to protect supply chains that are not related to personnel are also a worthy consideration, such as:

Concentrate on cash flow
Understand Tier 1 supplier risk management
Identifying multiple suppliers and eliminating single-source suppliers
Managing inventory levels
Following trends in supply and demand
Developing supply chain mapping tools

The Future of Supply Chain Optimization During a Pandemic

The COVID-19 pandemic has established new norms in supply chain optimization. Experts predict manufacturers will shift from international suppliers to more regional outfits. They also see a move away from single-source suppliers to multi-source suppliers – even if it comes at a higher cost to consumers.

Above all else, the pandemic has taught companies to think more strategically to avoid falling victim to international emergencies. They will need to take advantage of the latest supply chain optimization technology to figure out how to continue to maximize and sustain peak productivity.

Supply Chain Optimization in the Age of COVID

Mon, 12 Oct 2020 17:54:26 +0000

Supply Chain Optimization in the Age of COVID

Mon, 12 Oct 2020 17:42:51 +0000

If companies want to survive throughout the pandemic and successfully emerge from it, they must focus on protecting and improving their supply chain efficiency. To do so, business leaders need to:

Understand the ways the disease has impacted their supply chains
How they can adapt to these changes
Learn the steps to take to protect themselves
Plan for the future of supply chain optimization post-COVID-19

Diving Deeper: How COVID-19 Affects Supply Chain Optimization

Reduced Workforce

All these factors have created a reduced workforce, leading to less product manufacturing and slower delivery times.

Supply and Demand

Companies that build airplanes are in the same boat. The slowdown or cancellation of airplane production has caused a ripple effect for airplane part production companies.

How Companies are Adjusting

Six months into the pandemic, companies are learning to steer through supply chain problems by developing new policies. Many business leaders find themselves:

Staying away from single-source dealers
Ordering extra inventory
Reviewing their contracts with suppliers
Developing mapping to maximize efficiency

Bidding Farewell to Single-Source Dealers

Ordering Extra Inventory

Reviewing Contracts with Suppliers

Developing Mapping of a Supply Chain to Maximize Efficiency

When it comes to supply chains, companies have different tiers of suppliers. The Tier 1 level is primary suppliers, while Tier 2 is secondary suppliers.

In turn, GM figured out what steps were necessary to avert a major disruption to its supply chain.

How Companies are Safeguarding Their Supply Chains

Focus on showing employees how they can avoid catching the coronavirus. Business leaders must remind the workforce to wear a face covering, remain six feet apart from co-workers, and frequently wash their hands.
Develop a screening process. Companies are requiring employees to answer a series of questions to determine their risk and possible exposure to COVID-19.
Take temperatures daily to test for a fever with a touchless thermometer. The Centers for Disease Control considers someone with a temperature of 100.4 degrees or greater to have a fever.
Plan for a daily reduction in the workforce. According to the CDC, employees who have a confirmed COVID-19 diagnosis or contact with someone who does must quarantine for at least 14 days. Businesses must prepare for employees to remain out of work with contingency plans to cover for anyone unable to return to work for an extended period.

Measures to protect supply chains that are not related to personnel are also a worthy consideration, such as:

Concentrate on cash flow
Understand Tier 1 supplier risk management
Identifying multiple suppliers and eliminating single-source suppliers
Managing inventory levels
Following trends in supply and demand
Developing supply chain mapping tools

The Future of Supply Chain Optimization During a Pandemic

The post Supply Chain Optimization in the Age of COVID appeared first on American Quality Management.

COVID-19 Impact on Manufacturing

Tue, 01 Sep 2020 19:54:23 +0000

COVID-19 Impact on Manufacturing

Tue, 01 Sep 2020 19:26:09 +0000

The coronavirus pandemic has put the world as we know it on pause. As of August 2020, more than 24 million people have contracted the virus, leading to more than 822,000 deaths worldwide. The United States has been one of the hardest-hit countries, and people everywhere have felt the COVID-19 impact on manufacturing.

Manufacturers have seen production, demand, and revenue fall across all business areas, from mining to mechanical engineering. Many companies are struggling to maintain cash flow and handle their existing debts. Some manufacturers cannot outsource production remotely, disrupting the entire supply chain.

As detrimental as the coronavirus pandemic has been for people’s well-being and the economy, COVID-19’s impact on manufacturing has benefitted some industries as much as it has harmed others. While these benefits do not act as counterbalances for the hundreds of thousands of lives lost, these adaptions suggest a way forward from the crisis.

How COVID-19 Affects Lean Manufacturing

The pandemic has touched communities across the world, from hospitals to hotels and schools to service industries. We’ve seen both influxes in demand and dramatic drop-offs. Even five months after the initial outbreak hit the US, we have seen shortages in hospital cots, surgical masks, and ventilators.

Consider the pivot of Pathfindr, an asset tracking business in the United Kingdom. The company makes sensors that track parts during the manufacturing process, thanks to GPS and Bluetooth.

Since the pandemic, Pathfindr’s engineers have redesigned their technology to help people maintain social distancing. As a result, they have created a device called the Safe Distancing Assistant that gives users a jolt if the gadget senses them reaching to touch their face.

The same applies to manufacturers in San Diego. The city’s core manufacturing strengths include defense, aerospace, craft brewing, and shipbuilding. Disruptions to the supply chain have forced many local manufacturers to adapt their business models to meet demand, including:

ResMed: A company known for treating sleep apnea, they have begun producing respirators and ventilators for hospital and residential use.
Orucase: This travel bag manufacturer now makes half a million medical-grade face masks per day.
Cubic: The public tech company that provides products and services for transportation and defense has pivoted to prototype ventilators.
Flexsystems: This plastic products manufacturer has updated its operations to create splash guards and fabric masks for healthcare professionals and residents.

How Manufacturing Is Adapting

We have already touched on issues and adaption within the crisis management and response. The manufacturing ecosystem remains fragile in other sectors. Here are some of the current issues we face in the workforce, supply chain, and finance, as well as how manufacturers can respond with practical steps.

Workforce

Safety should be every company’s top priority, now and in the future. Every manufacturing company should implement additional safety measures if they haven’t already. That includes determining which jobs employees can perform remotely and which must occur on-site.

Manufacturing, like countless other industries, has experienced labor cuts and cost structure overhauls. These declines may continue as long as critical sectors, like travel and aviation, remain stifled under the coronavirus. Some companies may benefit from outsourcing labor, whether they move their information technology to the cloud or hire contractors to fill in for full-time employees.

Other potential steps include:

Training employees on proper safety protocols
Eliminating non-essential travel
Encouraging remote working
Encouraging sick employees to stay home
Finding new ways to work with more remote employees

Operations and Supply Chain

While manufacturers can adapt to new demands, they must prepare for bottlenecking domestically and abroad. The weakening supply chain will likely increase strain on operations over the coming months, and lower levels of manufacturers may suffer.

Cutting discretionary operations can reduce the stress of the coronavirus pandemic in the short term. The real question is whether or not companies have the financial reserves to outlast the recession. The remaining manufacturers of surviving companies will have a leg up when we reach a new normal.

Some other steps manufacturers can implement include:

Improving sanitation
Automating as much as possible
Updating best practices
Communicating with staff
Evaluating cybersecurity
Transferring knowledge via the supply chain

Finances

The COVID-19 impact on manufacturing has put us in uncertain times when it comes to producing necessary items. No one knows with certainty the best path forward, and many companies have made changes to adapt to these new challenges.

Companies should prioritize transparency as they address ongoing hurdles. Leaders should disclose pressing risks and the ripple effect they may have on trade and taxes. Multinational companies should look overseas for a resurgence of cash flow as the United States stagnates in its recovery.

Other solutions may involve resolving employee mobility issues for people in COVID hotspots and considering the impact of tariffs on the new manufacturing climate. As manufacturers navigate these obstacles, they should proactively talk with stakeholders to minimize surprises and unexpected setbacks.

COVID-19 Impact on Manufacturing

Tue, 01 Sep 2020 19:10:20 +0000

How COVID-19 Affects Lean Manufacturing

Consider the pivot of Pathfindr, an asset tracking business in the United Kingdom. The company makes sensors that track parts during the manufacturing process, thanks to GPS and Bluetooth.

ResMed: A company known for treating sleep apnea, they have begun producing respirators and ventilators for hospital and residential use.
Orucase: This travel bag manufacturer now makes half a million medical-grade face masks per day.
Cubic: The public tech company that provides products and services for transportation and defense has pivoted to prototype ventilators.
Flexsystems: This plastic products manufacturer has updated its operations to create splash guards and fabric masks for healthcare professionals and residents.

How Manufacturing Is Adapting

Workforce

Other potential steps include:

Training employees on proper safety protocols
Eliminating non-essential travel
Encouraging remote working
Encouraging sick employees to stay home
Finding new ways to work with more remote employees

Operations and Supply Chain

Some other steps manufacturers can implement include:

Improving sanitation
Automating as much as possible
Updating best practices
Communicating with staff
Evaluating cybersecurity
Transferring knowledge via the supply chain

Finances

The post COVID-19 Impact on Manufacturing appeared first on American Quality Management.

American Quality Management Discusses The Importance Of Lean Manufacturing In The Age Of Coronavirus

Wed, 05 Aug 2020 22:06:17 +0000

Lean Manufacturing in the Age of COVID-19

Fri, 31 Jul 2020 23:54:19 +0000

Lean Manufacturing in the Age of COVID-19

Fri, 31 Jul 2020 23:26:09 +0000

Lean manufacturing relies on the principle of efficiency with minimum waste. The process applies to industries across many fields, but it is especially relevant to the manufacturing sector among ISO 9001 certified organizations.

The COVID-19 pandemic and its effects on production have created new opportunities for lean manufacturing. This change has challenged the possibility of complete waste reduction, although many manufacturers are rising to the occasion.

COVID-19’s Effect on Lean Manufacturing

As the COVID-19 pandemic began to hit communities all across America, hospitals and medical centers grappled with an overwhelming demand for care but limited medical supplies. Shortages of hospital cots, surgical masks, and other equipment were widespread.

The exponential increase in demand for supplies was a turning point for the production industry—an opportunity to utilize lean manufacturing to address the rapidly incoming problems of coronavirus.

As an example, Ohio-based production company Pioneer quickly connected the rampant medical supply shortage with its manufacturing capabilities. Before coronavirus, Pioneer specialized in horse-drawn farm equipment. When coronavirus started to surge in the midwest, leaders of Pioneer took only two weeks to:

Establish a hospital cot prototype
Connect with relevant industry partners
Produce 50 cots on their first day of fabrication

Then, by utilizing lean manufacturing, Pioneer created a task time of just 30 seconds. In other words, they were now producing two cots every minute.

The COVID-19 pandemic has highlighted the importance of lean manufacturing. With high stakes and short deadlines, the manufacturing industry can ultimately realize the growth possible in zero waste production.

Industry leaders at Pioneer demonstrated that we do not need to reinvent manufacturing every time new problems arise. Instead, we can rely on the already existing network of production capacity to achieve different goals.

How the Manufacturing Sector Is Adapting

Lean manufacturing during coronavirus shows that there will always be new and effective strategies to maximize efficiency in production. As the world changes during the time of COVID-19, production strategies are changing as well.

The manufacturing sector is adapting to the effects of the pandemic in the following ways:

Worker Safety: Worker safety is of the utmost importance. Companies are redesigning physical spaces to prioritize worker safety. If remote work is not an option for a particular industry, it can arrange employee spacing and distance to prevent the spread of COVID-19.
Visual Displays: Many manufacturing sectors have visual displays of proper distancing and hand-washing techniques. They also have point-of-use cleaning supplies spread throughout their physical production space.
Communication: While employees might be at a greater physical distance from each other, having close communication remains essential. The lean manufacturing model pushes for more regular team check-ins and greater leadership alignment.

Another strategy includes team leadership identifying top priority tasks. Depending on capacity, leaders sideline non-essential tasks to maximize efficiency. Also, company leaders are adapting to consumer needs and streamlining the products and services that are in high demand.

Masks and Metal Fabrication During Coronavirus

Many manufacturing industry workers have witnessed the surge of employee mask mandates. However, some workers have actively resisted these mandates because of the nature of their work. For example, some employees:

Work in sparsely populated cities
Operate in physical spaces with built-in employee distancing practices

Mask mandates are making an appearance across all industries. For example, metal fabrication industries are pushing for their employees to wear protective masks. It is not only for the safety of their workers but also for the financial security of the organization.

The specifications of the mandates are different depending on an employee’s sector. However, all businesses could face lawsuits for refusing to enforce it.

For example, the steel market has been rapidly adjusting to its new demands following coronavirus. The market witnessed a decrease in overall steel demand; however, the surge in scrap production allows the industry to consolidate its material costs.

The steel market industry is using the lean manufacturing model to:

Maintain its pre-COVID-19 levels of production
Integrate new manufacturing techniques
Adjust to new levels of demand

Thinking Ahead

The COVID-19 pandemic continues to send ripple effects into all parts of the manufacturing industry. So, new perspectives and approaches are increasingly important. As the pandemic has shifted the supplies and demands of the industry, it has also improved the potential for complete manufacturing efficiency.

Coronavirus poses several challenges for lean manufacturing. Fortunately, capable industry leaders are transforming those difficulties into unique opportunities for growth. Relationships between companies are vital for creating these fast and effective solutions.

When lean manufacturing for coronavirus ends, companies like Pioneer will be able to scale back production quickly. As for the steel market, they are keeping their eyes on scrap prices. As steel prices decrease, there are service centers hesitant to put in orders.

Lean Manufacturing in the Age of COVID-19

Fri, 31 Jul 2020 22:58:52 +0000

COVID-19’s Effect on Lean Manufacturing

The exponential increase in demand for supplies was a turning point for the production industry—an opportunity to utilize lean manufacturing to address the rapidly incoming problems of coronavirus.

Establish a hospital cot prototype
Connect with relevant industry partners
Produce 50 cots on their first day of fabrication

Then, by utilizing lean manufacturing, Pioneer created a task time of just 30 seconds. In other words, they were now producing two cots every minute.

How the Manufacturing Sector Is Adapting

The manufacturing sector is adapting to the effects of the pandemic in the following ways:

Worker Safety: Worker safety is of the utmost importance. Companies are redesigning physical spaces to prioritize worker safety. If remote work is not an option for a particular industry, it can arrange employee spacing and distance to prevent the spread of COVID-19.
Visual Displays: Many manufacturing sectors have visual displays of proper distancing and hand-washing techniques. They also have point-of-use cleaning supplies spread throughout their physical production space.
Communication: While employees might be at a greater physical distance from each other, having close communication remains essential. The lean manufacturing model pushes for more regular team check-ins and greater leadership alignment.

Masks and Metal Fabrication During Coronavirus

Work in sparsely populated cities
Operate in physical spaces with built-in employee distancing practices

The specifications of the mandates are different depending on an employee’s sector. However, all businesses could face lawsuits for refusing to enforce it.

The steel market industry is using the lean manufacturing model to:

Maintain its pre-COVID-19 levels of production
Integrate new manufacturing techniques
Adjust to new levels of demand

Thinking Ahead

The post Lean Manufacturing in the Age of COVID-19 appeared first on American Quality Management.

Understanding and Meeting OSHA Safety Signage Requirements

Wed, 01 Jul 2020 17:26:08 +0000

Every day, American workers operate and work around machinery and equipment that could harm or kill them. Thanks to workplace safety efforts, which continue to improve, accidents uncommon. Nevertheless, the over 3 million on-the-job injuries reported in 2014 demonstrate that there is still plenty of room for improvement.

One easy, simple, and cheap way to improve workplace safety is through appropriate safety signage. Clear, effective safety signs not only prevent accidents, but they also increase efficiency and elevate workplace safety awareness.

The benefits of proper safety signage to any employer are clear. What isn’t so clear are the regulatory requirements for these signs. The following outlines where to find these requirements and what they mean in practice.

OSHA and ANSI

OSHA and ANSI are the two regulatory bodies that publish standards for safety signage in the workplace. 29 CFR 1910.105, which is OSHA’s Specifications for accident prevention signs and tags, outlines signage design requirements and specifies where safety signage is required.

The ANSI Z535 standard goes still further, specifying standardized coloring and pictograms for different types of hazards. The ANSI standard specifies every aspect of the safety sign:

It stipulates sign and label colors.
It establishes and defines “signal words,” such as “DANGER” or “WARNING.”
It spells out correct text size and style.
It specifies the proper placement of signs and labels.

ANSI standards are revised periodically; the most recent revision of the Z535 standard was in 2011. Employers should make sure that any new labels they print comply with this current standard.

Classes of Hazards and Their Signage

OSHA and ANSI categorize safety hazards into three primary classes of severity, each with its corresponding signage.

Danger signs alert the reader to the most serious hazards, where he or she must be especially careful. The signal word “DANGER,” preceded by a safety alert symbol, are printed in white letters against a red background. This type of sign indicates that death or serious injury will almost certainly result if a hazard is not avoided.
A warning sign is appropriate for a hazard that could cause death or serious injury, but doesn’t pose a risk severe enough to warrant a danger sign. Warning signs include the word “WARNING,” preceded by a safety alert symbol, printed in black letters against an orange background.
Caution signs advise of hazards that could result in minor or moderate injury if not avoided. Caution signs include the word “CAUTION,” preceded by a safety alert symbol, printed in black letters against a yellow background. Caution signs are often employed to advise against unsafe practices.

A fourth hazard classification encompasses biological hazards. These alert personnel to the presence of this type of hazard.

Other Types of Safety Signage

Besides just warning of hazards, other types of safety signs can help to promote a safe and orderly work environment. These include:

Notice Signs: Using white letters on a blue background, these communicate directions, procedures, and other important information about a machine, a designated area, or equipment. The information conveyed is not related to risk of injury.
General Safety Signs: As opposed to alerting the reader of a hazard, these provide helpful safety information. These may relate to first aid, sanitation, or suggested general safety policies. They are printed with white letters on a green background.
Admittance Signs: These explain the consequences and potential hazards associated with entering a designated area.
Fire Safety Signs: These indicate the location of emergency firefighting equipment and fire exits.
Non-Hazard Signs: These simply convey information, such as indicating the way through a facility. Although they have nothing to do with safety hazards, they are still safety signs, since they promote an orderly, safe work environment.

Placement of Safety Signs

OSHA specifies when a safety sign is necessary in 29 CFR 1910.145(f)(3). It states that these:

“Shall be used as a means to prevent accidental injury or illness to employees who are exposed to hazardous or potentially hazardous conditions, equipment or operations which are out of the ordinary, unexpected, or not readily apparent. Tags shall be used until such time as the identified hazard is eliminated or the hazardous operation is completed.”

If these conditions are met, then the OSHA standard specifies that the safety sign placement should be “as near as possible” to the hazard.

Safety signs must be visible and readable from a safe distance. 29 CFR 1910.145(f)(4) requires the signal word (DANGER, WARNING, or CAUTION) to be readable from at least 5 feet away. The logic behind this is to alert a worker of a hazard while he or she still is far enough away to avoid it.

One other important requirement is that the safety sign itself must not present a hazard. For instance, a safety sign with exposed, pointed corners or sharp edges would be its own hazard.

Understanding and Meeting OSHA Safety Signage Requirements

Wed, 01 Jul 2020 16:54:36 +0000

Understanding and Meeting OSHA Safety Signage Requirements

Wed, 01 Jul 2020 16:32:11 +0000

OSHA and ANSI

The ANSI Z535 standard goes still further, specifying standardized coloring and pictograms for different types of hazards. The ANSI standard specifies every aspect of the safety sign:

It stipulates sign and label colors.
It establishes and defines “signal words,” such as “DANGER” or “WARNING.”
It spells out correct text size and style.
It specifies the proper placement of signs and labels.

ANSI standards are revised periodically; the most recent revision of the Z535 standard was in 2011. Employers should make sure that any new labels they print comply with this current standard.

Classes of Hazards and Their Signage

OSHA and ANSI categorize safety hazards into three primary classes of severity, each with its corresponding signage.

Danger signs alert the reader to the most serious hazards, where he or she must be especially careful. The signal word “DANGER,” preceded by a safety alert symbol, are printed in white letters against a red background. This type of sign indicates that death or serious injury will almost certainly result if a hazard is not avoided.
A warning sign is appropriate for a hazard that could cause death or serious injury, but doesn’t pose a risk severe enough to warrant a danger sign. Warning signs include the word “WARNING,” preceded by a safety alert symbol, printed in black letters against an orange background.
Caution signs advise of hazards that could result in minor or moderate injury if not avoided. Caution signs include the word “CAUTION,” preceded by a safety alert symbol, printed in black letters against a yellow background. Caution signs are often employed to advise against unsafe practices.

A fourth hazard classification encompasses biological hazards. These alert personnel to the presence of this type of hazard.

Other Types of Safety Signage

Besides just warning of hazards, other types of safety signs can help to promote a safe and orderly work environment. These include:

Notice Signs: Using white letters on a blue background, these communicate directions, procedures, and other important information about a machine, a designated area, or equipment. The information conveyed is not related to risk of injury.
General Safety Signs: As opposed to alerting the reader of a hazard, these provide helpful safety information. These may relate to first aid, sanitation, or suggested general safety policies. They are printed with white letters on a green background.
Admittance Signs: These explain the consequences and potential hazards associated with entering a designated area.
Fire Safety Signs: These indicate the location of emergency firefighting equipment and fire exits.
Non-Hazard Signs: These simply convey information, such as indicating the way through a facility. Although they have nothing to do with safety hazards, they are still safety signs, since they promote an orderly, safe work environment.

Placement of Safety Signs

OSHA specifies when a safety sign is necessary in 29 CFR 1910.145(f)(3). It states that these:

“Shall be used as a means to prevent accidental injury or illness to employees who are exposed to hazardous or potentially hazardous conditions, equipment or operations which are out of the ordinary, unexpected, or not readily apparent. Tags shall be used until such time as the identified hazard is eliminated or the hazardous operation is completed.”

If these conditions are met, then the OSHA standard specifies that the safety sign placement should be “as near as possible” to the hazard.

One other important requirement is that the safety sign itself must not present a hazard. For instance, a safety sign with exposed, pointed corners or sharp edges would be its own hazard.

The post Understanding and Meeting OSHA Safety Signage Requirements appeared first on American Quality Management.

How a SWOT can make your life easier

Mon, 01 Jun 2020 17:26:16 +0000

If a business is looking to thrive, it needs to define its objectives, as well as any factors which may negatively impact those objectives.

A SWOT (strengths, weaknesses, opportunities, threats) analysis allow a business to determine both internal and external factors which may affect a businesses profits and objectives, then effectively react to them to minimize or even eliminate potential losses.

Strengths are what makes the business unique and what they can do better than the average business, such as having low employee turnover or good customer relationships. When analyzing strengths, a business needs to review what it perceives as its own internal strengths, as well as what the market perceives as the strengths of the business. After determining strengths, a business should then work on enhancing them even more in order to create more opportunities for the business.

Weaknesses, on the other hand, represent internal improvements a business should make or options it should possibly even avoid. Weaknesses also hurt a business since they hinder it from achieving objectives; however, a business can better achieve an objective by identifying weaknesses early. Examples of weaknesses include having high production costs, too much overhead or a low marketing budget.

Opportunities serve as indicators of external areas where a business can grow or adapt to stay relevant with competition in the market, as well as ways in which a business can achieve objectives. Opportunities can range from producing and providing a new product due to high demand in the market, to recognizing and reacting to market trends ahead of time to increase profits and relevancy.

Threats are both current and potential challenges which a business is facing or may face in the future. External threats can include economic issues such as a depressed market or competitive issues like a rival producing a new product or starting a new marketing campaign. The key to identifying threats to a business is to create a plan to counterattack the problems, which will affect success and future growth.

A SWOT analysis is beneficial for businesses because it is a low-budget, quick way of brainstorming and strategically planning methods that will increase profits and achieve objectives. It also allows a business to use its strengths to combat its weaknesses if possible. Unfortunately, though, SWOT is most effective at a micro level rather than a macro level, so it is best for a business to use the analysis model with a specific objective in mind.

Overall, a SWOT analysis is an effective way for a business to react to and even eliminate profit losses, as well as efficiently achieve its objectives, by identifying internal and external factors within and around the business. Using the simple SWOT analysis structure can help a business quickly answer questions related to its present and future concerns by logically looking at the issues at hand to help brainstorm the appropriate solutions and strategic plans. Although it should not be used as a primary tool, it represents a helpful guide to make a business more productive.

How a SWOT can make your life easier

Mon, 01 Jun 2020 16:54:31 +0000

How a SWOT can make your life easier

Mon, 01 Jun 2020 15:57:10 +0000

If a business is looking to thrive, it needs to define its objectives, as well as any factors which may negatively impact those objectives.

A SWOT (strengths, weaknesses, opportunities, threats) analysis allow a business to determine both internal and external factors which may affect a business’s profits and objectives, then effectively react to them to minimize or even eliminate potential losses.

Weaknesses, on the other hand, represent internal improvements a business should make or options it should possibly even avoid. Weaknesses also hurt business since they hinder it from achieving objectives; however, a business can better achieve an objective by identifying weaknesses early. Examples of weaknesses include having high production costs, too much overhead, or a low marketing budget.

Opportunities serve as indicators of external areas where a business can grow or adapt to stay relevant to competition in the market, as well as ways in which a business can achieve objectives. Opportunities can range from producing and providing a new product due to high demand in the market, to recognizing and reacting to market trends ahead of time to increase profits and relevancy.

A SWOT analysis is beneficial for businesses because it is a low-budget, quick way of brainstorming and strategic planning methods that will increase profits and achieve objectives. It also allows a business to use its strengths to combat its weaknesses if possible. Unfortunately, though, SWOT is most effective at a micro level rather than a macro level, so it is best for a business to use the analysis model with a specific objective in mind.

The post How a SWOT can make your life easier appeared first on American Quality Management.

How ISO Certification Can Help Drive Your Business Goals

Fri, 15 May 2020 23:26:15 +0000

If you are facing the decision on ISO certification, you probably are wondering how it will affect your business goals. You may be facing this decision voluntarily or at the request of a potential customer. In either scenario, the outcomes for your business are very much the same.

Following are some key factors to consider on whether ISO certification will help drive your business goals.

Create and Promote Industry Best Practices
Like most companies, you try to do business in the most productive and efficient manner. Obtaining ISO certification provides you with access to predefined best practices for your business. Adhering to these across different areas such as health and safety, food handling safety, risk management, etc. gives you access to internationally recognized best practices.
Increase Customer Satisfaction
Working with a known list of industry standards such as ISO certification will provide a sense of security and clarity for your customers. They will be able to refer to standard reporting and metrics on subjects such as quality control, RMA procedures and HSE concerns.
Drive Business Profitability
Having a predefined set of metrics is key to improving your bottom line. Not only do you know ahead of time what Key Performance Indicators (KPI’s) to track, you know the range you should be in. Measuring these different KPI’s will help you drive productivity and create a universal playlist for everyone to go by.
Build Employee Engagement
Your employees like to know how they are doing and how they stack up to others. Once you’ve obtained ISO certification, you will be able to give every employee a job description detailing their specific roles, responsibilities and authorities. No more guesswork on who is responsible for what. Your employees will become more engaged as they now feel empowered to work inside of their job role while knowing what KPI’s drive their success.
Create New Opportunities
As we mentioned at the beginning of this article, you may be facing ISO certification as a request from a client. Obtaining this certification may help you land this contract and think of the future opportunities it opens your business too. Once you’ve obtained ISO certification, you will be able to include that in your bidding and company promotion. Very likely this will enable you to bid on contracts that previously you were unable to and you will begin to receive requests from customers who previously passed you by due to a lack of ISO certification.
Not Just for Big Companies
While the process for ISO certification may sound overwhelming and something only BIG companies do, it doesn’t need to be that way. Smaller businesses can also obtain ISO certification and adopt best practices to stand out in their field. Additionally, obtaining ISO certification as a small business is likely quite a bit simpler as there are less processes and then as your company grows, you are able to adjust your documentation to accommodate the business changes.

The post How ISO Certification Can Help Drive Your Business Goals appeared first on American Quality Management.

American Quality Management Recertifies for ISO 9001 https://t.co/OWHiuv1kgQ

Fri, 24 Apr 2020 17:35:15 +0000

American Quality Management Recertifies for ISO 9001 https://t.co/OWHiuv1kgQ
— Connie Smith (@AQMAuditing) April 24, 2020

from Twitter https://twitter.com/AQMAuditing

American Quality Management Recertifies for ISO 9001

Fri, 24 Apr 2020 16:46:13 +0000

American Quality Management Employee Receives Certificate of Appreciation https://t.co/JHUywAUY02

Fri, 21 Feb 2020 18:32:08 +0000

American Quality Management Employee Receives Certificate of Appreciation https://t.co/JHUywAUY02
— Connie Smith (@AQMAuditing) February 21, 2020

from Twitter https://twitter.com/AQMAuditing

American Quality Management Employee Receives Certificate of Appreciation

Fri, 21 Feb 2020 18:08:28 +0000

Hello world! https://t.co/heSBloZVME

Thu, 06 Feb 2020 01:03:19 +0000

Hello world! https://t.co/heSBloZVME
— Connie Smith (@AQMAuditing) February 6, 2020

from Twitter https://twitter.com/AQMAuditing

aqmauditing.com

Thu, 06 Feb 2020 00:38:08 +0000

Businesses Advised to Update Their Environmental Policy for 2020

Thu, 12 Dec 2019 18:43:12 +0000

Businesses Advised to Update Their Environmental Policy for 2020 https://t.co/miN65beGOH

Thu, 12 Dec 2019 18:40:06 +0000

Businesses Advised to Update Their Environmental Policy for 2020 https://t.co/miN65beGOH
— Connie Smith (@AQMAuditing) December 12, 2019

from Twitter https://twitter.com/AQMAuditing

How To Write A Proper EMS Policy https://t.co/JEfPqSEEJ4

Mon, 04 Nov 2019 23:48:09 +0000

How To Write A Proper EMS Policy https://t.co/JEfPqSEEJ4
— Connie Smith (@AQMAuditing) November 4, 2019

from Twitter https://twitter.com/AQMAuditing

How To Write A Proper EMS Policy

Mon, 04 Nov 2019 23:39:29 +0000

A key factor in obtaining and maintaining ISO 14001 certification is your environmental policy. What are the factors you need to consider while crafting your policy? How do you ensure that top management understands it? Is it adequate for your organization? The answers to these questions will vary by company, depending on size and environmental impact but the following guidelines will help you define your environmental policy.

Why do I need an Environmental Policy?

The Environmental Management System (EMS) has mandatory requirements for your organization to have an environmental policy. Once your environmental policy is defined by senior management, it will provide key benefits to your organization, such as:

staying legal
provide information to employees about their role in environmental impact
lower liability by reducing incidents
provide improved monitoring tools
increase efficiency in processes
lower costs by conserving materials and energy

What should I include in my Environmental Policy?

Clause 5.2 of the ISO 14001 standard leaves some room for interpretation but does provide guidance on what your environmental policy should contain and what purpose it serves at your organization. How detailed do you need to be and what items are “must have’s” in your policy?

Your policy needs to be crafted for your organization. Avoid copy and paste. While you may want to review other organization’s EMS policy, you need to create yours specific to your needs. It stands to reason that the greater your environmental impact, the more detailed and focused your policy should be. Identify key impact areas and highlight them. If your organization produces large amounts of emissions, your policy should not focus on water-table impacts.

Include a commitment to continuous improvement. A key reason to implement a system such as ISO 14001 is to improve. Rather than just identifying your current way of doing things, including a commitment to continuous improvement in your environmental policy. Don’t get hung up on the details of how it will happen; rather, state the commitment to do it.

Identify objectives and targets. This will be a more detail section with application to specific departments and processes in your organization. Seek input from key individuals in each department and use that to create a working, useful approach. This is where it is easy to go astray. Don’t create unreachable expectations or goals, but include reasonable, actionable steps to improving your environmental impact.

Know and comply with relevant environmental legislation. While each organization is unique, there is very likely others who are facing similar environmental impacts as you. Seek them out and learn. Find and attend events appropriate to your organization and subscribe to industry news. These are all ways you can stay abreast of the changing legislative landscape and adjust your policy accordingly.

Prevent pollution. While this may seem extremely basic, it is important to include a commitment and actionable ways to reducing pollution. Exact details may not be required in the policy, but it should be something you can easily refer to during an audit.

How do I implement my Environmental Policy?

Something like an environmental policy is easy to be put on a shelf and forgotten about. While this may be tempting, don’t let it happen! You’ve started your journey on improvement, and you wouldn’t want to stop now.

Communicate. Communicate. Communicate. Each employee needs to understand what the environmental policy is, how their actions create environmental impact and what they can do to reduce that impact. Find a way to tie practical examples to negative environmental impact so that it is easier for your employees to remember.

Documented and audited. You can’t improve what you don’t measure. Identify the key performance indicators (KPI’s) for each department in your organization and measure them. Provide relevant and timely feedback to each department on movement, whether positive or negative.

Remember that your environmental policy should be as unique as your organization. While ISO 14001 provides the guidelines and framework for your EMS policy, it is up to you to make that policy as simple and meaningful as possible. Craft your environmental policy with care and use it as a badge of honor: your commitment to reducing your organization’s environmental impact.

How To Write A Proper EMS Policy

Mon, 04 Nov 2019 23:39:23 +0000

How To Write A Proper EMS Policy

Mon, 04 Nov 2019 23:37:02 +0000

Why do I need an Environmental Policy?

staying legal
provide information to employees about their role in environmental impact
lower liability by reducing incidents
provide improved monitoring tools
increase efficiency in processes
lower costs by conserving materials and energy

What should I include in my Environmental Policy?

How do I implement my Environmental Policy?

The post How To Write A Proper EMS Policy appeared first on American Quality Management.

How The Internet Has Changed Manufacturing https://t.co/O1bnmCKX8N

Tue, 29 Oct 2019 23:45:08 +0000

How The Internet Has Changed Manufacturing https://t.co/O1bnmCKX8N
— Connie Smith (@AQMAuditing) October 29, 2019

from Twitter https://twitter.com/AQMAuditing

How The Internet Has Changed Manufacturing

Tue, 29 Oct 2019 23:41:23 +0000

How The Internet Has Changed Manufacturing

Tue, 29 Oct 2019 23:41:15 +0000

The term “Internet of Things”, also referred to as IoT, was coined by Kevin Ashton in 1999. This was merely one step on the long journey that has led to where we are today. Put simply, IoT refers to things, almost anything really, that can be connected to the internet and communicate. How has this hyper-connectivity changed manufacturing already and what does it mean for the future of quality management systems?

Current Implementation

Computer-aided design (CAD) has allowed for a shorter timeline for a concept to go from model to prototype to manufacturing. Now, we can have machines on the production line that are connected via IoT. This allows for designs to be sent straight to production from virtually anywhere in the world. Additionally, sensors are placed in and around the machine, providing instantaneous feedback to production speed, mishaps and environmental changes.

As you can connect the various machines together in your production floor, a higher level of learning becomes available. We already know that computers are better at processing huge amounts of data and analyzing trends and anomalies, so think of the powerful dashboards of information you can have at your fingertips. Prior to this, chokepoints and holdups may have seemed random; now, you will be able to visualize the impact that changes in one area will have in another, perhaps days later. This level of machine learning greatly increases the efficiency of your total production capability.

Future Implementation

As more and more devices and machines are IoT-capable, we will see a higher level of collaboration happening across supply chains. Imagine being able to know if a shipment is going to be delayed before you start the batch that will need some of those parts.

We will begin to see a massive shift in the workforce. As robots and AI begin to take over manufacturing jobs, the human element will not disappear; rather, it will shift to higher levels of expertise. The current positive economy has led to an increase of manufacturing jobs, but a shortage of workers already exists to fill these jobs. Technician and programmers will be come commonplace on the production floor, ensuring smooth operation of machines rather than doing repetitive physical tasks themselves, such as packing boxes or driving screws.

What Do You Need to Do?

This changing landscape affects more than just the manufacturing sector. As the skills gap widens, companies need to be prepared to train and invest internally to organically grow the next generation of workers. Schools need to be preparing for this future and shifting from the old ways of education. More focus on science, technology, engineering and mathematics (STEM) is needed to prepare the next generation for the changing landscape in the world of manufacturing.

A lot of unknowns still exist for manufacturing today. One thing is for sure, with the rapid progression of these changes in the manufacturing sector, the winners will be the ones who embrace the changes early and put their energy into preparing for the manufacturing of the future.

How The Internet Has Changed Manufacturing

Tue, 29 Oct 2019 23:32:24 +0000

Current Implementation

Future Implementation

What Do You Need to Do?

The post How The Internet Has Changed Manufacturing appeared first on American Quality Management.

How To Document Roles Under ISO 9001

Tue, 22 Oct 2019 23:41:27 +0000