simpleQuE Spotlight – Karen Spencer

Allow us to introduce one of our accomplished consultants, Karen Spencer. She has been with simpleQuE for nearly 2 years and continues to be an asset to the company. Read on to discover Karen’s interests, achievements, and goals.

What is your position and what do you do for simpleQuE?
I am a consultant, auditor and trainer for simpleQuE, as well as a lead auditor in ISO 9001, AS9100, ISO 14001 and OHSAS 18001. I am also an ASQ Certified Quality Auditor.

What attracted you to simpleQuE.
My husband has worked with them for many years. After going through the intense interview process I decided that I wanted to pursue a career with them. I like that they are on Facebook and LinkedIn.

What is your favorite part of the day?
I am a morning person. I love that first cup of coffee in the morning and take that time to review my plan for the day.

What was your first job?
My very first job was when I was sixteen and worked at a factory doing inspection after school.  

Have you met someone famous or interesting to you?
I love art so when I had the opportunity to meet Peter Max I jumped at the opportunity.

Where did you go to college?
I graduated with honors from Cardinal Stritch University in Milwaukee, WI

Where is your hometown?
Belvidere Il

What is one thing you’d love to do or have?
I am living life to the fullest and enjoying visiting many places with my job and on vacation. My husband and I work hard and we pick places to travel and plan for it. We just did a cruise to Alaska this year and it was truly a beautiful place. Everyone should see a glacier.

What is your hidden talent?
I love to rehab houses. I like to take an ugly house and make it beautiful. My husband and I have flipped about 8 houses. We bought our existing house to flip but we fell in love with it and we are still here.

What is your favorite sports team?
Chicago Bulls and of course the Cubbies

Client satisfaction is pinnacle to your background. What are your client-focused approaches to simpleQuE?
When I am teaching a class I adjust my approach to the weakest person in the class. We may have to work on a workshop longer than expected but when I am done the students know what they are doing. When I am auditing or consulting I take the approach that everything will not work for everyone. I adjust to what the client needs to have in pace to be successful. I also want to make sure that it is value added for the client.

What advice would you give to a new college graduate entering the technology industry?
Try to be an intern at a company that you want to work at. Give it your all and don’t give up. It will be a tough road but you can do it.

Explain how simpleQuE is different from their competition.
SimpleQuE is amazing and they want all of the employees/consultants to succeed. They had an symposium for all of the team. It was really nice to meet the team face to face.

How would other people describe you in three words?
Helpful, kind, and considerate.

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Questions for Auditing Utilizing a Process Approach

Whether facing a surveillance audit from a certification body or preparing for an internal quality audit – knowing what you face and being prepared puts you a step ahead.  Review this checklist which covers the majority of the QMS requirements.

  1. Who or what are the:
    • Processes
    • Process Owner
    • Personnel Interviewed
    • Documentation Reviewed
    • Records Sighted
  2. What are the resources needed for the process?
  3. Are these resources appropriate?
  4. Are authorities and responsibilities for required resources defined, documented and known throughout the organization?
  5. Are these persons competent?
  6. Are competency criteria defined? What are these criteria? How is competency evaluated, approved and monitored, and by which method(s)?
  7. Are these methods effective? – refer to outputs
  8. Are the resources adequate? Which are they?
  9. Are records available and appropriately maintained?
  10. What are the inputs to this process?
  11. Are these inputs documented and reviewed by competent persons?
  12. Is a description of the processes available and documented?
  13. Are these descriptions controlled? – Verify the effectiveness of the organization’s documented information control procedure.
  14. Who are the “customers” (internal and external) of the processes? What are the requirements of these customers?
  15. What are the characteristics of the intended results of the process?
  16. What are the characteristics of the unintended results of the process?
  17. Are correction and corrective action applied as appropriate?
  18. What are the criteria for monitoring, measurement and analysis?
  19. How are these criteria incorporated into the planning of the processes?
  20. Are the business performance issues taken into proper account?
  21. What methods are used for data gathering?
  22. What records are kept and how these are maintained?
  23. What are the communication channels?
  24. How is external and internal information about the process provided? What are the outputs of the process? – Identify outputs.
  25. Do these outputs provide evidence of effective implementation of the process?
  26. How is process performance monitored?
  27. Are appropriate controls defined?
  28. What measurements are applied?
  29. How is the gathered information analyzed?
  30. How are the results of the analysis taken into account?  
  31. How is feedback obtained?
  32. What data is collected?
  33. Is the issue of improvement of the processes properly addressed? How? What are the results?

 

Source:  Eagle Certification Group – 2017 Annual Bootcamp/Conference

SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest internal quality auditing possible.

Links to Checklists:

IATF 16949 Sample Manufacturing Process Audit Checklist – FREE

AS9100 Sample Manufacturing Process Audit Checklist – FREE

ISO 9001 Sample Manufacturing Process Audit Checklist – FREE

ISO 9001 Resources and Tools to Prepare for Certification

Many companies aren’t sure where to start when it comes to implementing ISO 9001 or a new quality management system, so ISO 9001 resources and tools are useful.  SimpleQuE has been around since 2005 and over the years, we’ve developed some tools for organizations to utilize to “make quality excellence simple”.  After all, that’s what our name stands for. So see if one or more of the options below is just what you need to be on the right path.

Understanding what you need – A short video providing guidelines for choosing an ISO 9001 consultant.

Customized consulting services – ISO 9001 Gap assessment is one of the many tools we use to support and improve an organization’s overall processes.  A thorough ISO 9001 Gap Analysis identifies what needs to be implemented or changed based on the extent to which a company already complies with their current systems. The gap assessment results in an action plan that functions as a road map for each task that needs to be accomplished and is a great project management tool, as it assesses their own timing expectations based on the resources available. Additionally, using our gap analysis as a pre-assessment tool or readiness audit rather than a certification body’s allows our ISO 9001 consultants to coach and consult when problems are found.

Download our free ISO 9001 Sample Manufacturing Process Audit Checklist – This example is used to examine a company’s key manufacturing process and prepare for the highest quality internal auditing possible.

Customized on-site training – From ISO 9001 Implementation and Requirements Training to ISO 9001 Internal Audit Training, simpleQuE courses are designed to meet the specific needs of an organization.  The course – ISO 9001 Internal Auditor with the Process Audit Approach fulfills the requirements for competent, knowledgeable, and well trained internal auditors, including hands-on practice auditing.

Whether you have a mature system and an experienced quality team or are new to the quality arena, simpleQuE has the resources and expertise to help you achieve your objectives and ISO 9001 standard certification.  Contact us to learn more.

What is ISO 9001 Certification and Why is it so Important?

The ISO 9001 standard exists to provide organizations with the opportunity to develop baseline quality management systems, improve processes and meet the needs of customers. Achieving ISO 9001 certification is an important step for manufacturers and service providers, as it emphasizes performance while proving a dedication to quality and customers.

As ISO 9001 certification has been adopted across a wide range of industries, the standards have been altered to fit specific industry requirements. From the automotive and aerospace industries to telecommunications companies, laboratory settings, medical device manufacturers and more, each industry has adopted its own set of standards that all derive from the basic principles of the ISO 9000 series.

What are the Benefits of ISO 9001 Certification?
There are a variety of advantages to having ISO 9001 certification. It creates a more efficient, effective operation for a company, if implemented properly, and also improves employee awareness and motivation, and increases customer satisfaction. Here are some additional reasons to get ISO 9001 certified:

  • Client Requirements – More and more customers are demanding that their vendors be certified. If your business doesn’t meet this criteria you could be losing out on sales.
  • Increased Revenue – Studies show that ISO 9001 certified organizations are paid 7% more on average, have better sales growth and an improved ROA. (source: iso.org)
  • Reduce Waste – By establishing the rigor of an ISO 9001 Quality Management System, you can reduce inefficiency and make the most of your business’ time and resources.
  • Brand Image – Maintaining quality in your organization minimizes the chance of a slip up or error that could hurt your reputation.
  • Manage Risk – ISO 9001:2015 is all about managing risk. By adopting these standards you will learn how to best identify and mitigate threats to your business model.

Most importantly, as your company grows, becoming certified is vital to fostering continued success in the future.

SimpleQuE – ISO 9001 Certification Experts

SimpleQuE (an ISO 9001 certified company) assists organizations with implementation, improvement or transition of the standards by providing customized ISO 9000 consulting, training and internal auditing services and solutions. Contact us for more information or to hire an ISO 9001 consultant.

What is the Return On Investment of a Quality Management System?

3D illustration of a magnifying glass over a golden positive chart symbol. Concept of investing opportunities and excellent investment.

Your company could have many motivations behind implementing a quality management system (QMS) such as ISO 9001. But in the end, making the decision to invest in a QMS always comes down to potential for profit, and an organization’s quality performance absolutely affects the bottom line. That’s why it’s essential to understand the return on investment for a quality management system.

First, the term “quality” extends far beyond an organization’s products or services. Every process and system in an organization, whether a manufacturing, distribution or service industry, can meet quality objectives and expectations. And once an organization applies the quality concept to its entire management system and all of its processes, then the effect on bottom line will really be noticeable.

Here are a few benefits of a certified quality management system that make a financial impact.

  1. Quality management systems can help reduce manual processes, which means there’s less of an opportunity for human error. In the end, this translates to greater employee productivity.
  2. Your leadership team will have access to real-time reporting, which means they can make better, more informed decisions. Getting that real-time data means less downtime overall.
  3. Improving the processes and increasing efficiency means production can go more effectively. The end result is higher production yield.
  4. A QMS provides consistent quality control, leading to fewer product defects and/or service complaints. And ultimately, this means you’ll see fewer complaints, returns, reworks and escapes.
  5. Being more compliant with ISO 9001 (or any of the other QMS standards) means more satisfied customers, and you’ll see more sales, new sales and referral sales.

Quality does have a cause-and-effect relationship with finance – consider the simple economic equation of income minus expense equals profit. Therefore, either increasing income and/or decreasing expense increases your profit.

Investing in “good” quality systems can increase income in many different ways, including attracting more customers, encouraging repeat business and giving your organization a competitive advantage. Meanwhile, it can also lower your expenses by lowering production costs by streamlining processes, lowering inspection cost, and lowering working capital through reduced inventory. So even when factoring in the cost of implementing and maintaining a QMS, the numbers show that you’ll come out ahead by investing in quality.

Congratulations!

These ISO 9001:2015 certified companies recognize the value of implementing and maintaining a Quality Management System. Congratulations from our team at simpleQuE to your team, we’re pleased with your success and to have provided consulting services along the way!

Batesville Products, Inc. – ISO 9001:2015

From Left:  Trevor Bovard, Plant Manager and Matt Scholl, Purchasing Agent

BHC (Brulin Holding Company) – ISO 9001:2015

BHC Office Staff

BHC (Brulin Holding Company) – ISO 9001:2015

BHC Plant Staff

Silfex – ISO 9001:2015

Quality Team

The Advantages of Outsourcing Internal Quality Audits

Business concept. Business people discussing the charts and graphs showing the results of their successful teamwork.

If your organization is certified to ISO 9001 or a standard that is aligned with it, like AS9100 or IATF 16949, and you perform internal quality audits, then you should know this:

This means that Certification Bodies are scrutinizing internal auditors and their competency, especially when it involves IATF.  That’s why many companies are choosing to outsource their internal audits to a 2nd party like simpleQuE whose auditors are qualified, certified, competent and are experts on the standards and customer specific requirements. In addition, many are current or former 3rd party auditors and bring valuable insight because of that knowledge gained from auditing for certification bodies.

Here are more reasons to outsource internal audits from our very own team of auditors (who have seen it all):

Why audits should not be done internally:

  • Without proper training and experience, internal auditors don’t fulfil the competency requirements
  • Lack of time to perform the audits and write reports
  • Reports with limited or no findings or objective evidence
  • No demonstration of the process approach or risk based thinking
  • Timeliness of management in responding to findings/report
  • Internal turnover resulting in too much variation in reporting/focus and overall quality of audits

Advantages to outsourcing internal audits

  • Fresh set of eyes from outside the organization that are objective and unbiased
  • Reduces company’s investment in continual training on changing requirements
  • Professional and timely reports
  • More cost and time effective, freeing up internal resources
  • Management gives greater attention to an outside expert, especially when there are sensitive issues that an inside auditor may be hesitant to address
  • Better internal response and acceptance of findings and opportunities for improvement
  • More content, findings, comments, opportunities for improvement and observations for added value
  • Our auditors have:
    • In depth knowledge of the standard’s requirements,
    • Experience in the field and can share best practices,
    • An understanding of the process approach and risk based thinking
    • The ability to provide consulting while auditing
    • Compliance to ISO 19011 on auditing management systems

All solid reasons for turning your audits over to the experts.  Contact us at 740-305-0868 or [email protected] for more information about internal quality auditing.

Lauren Manufacturing Achieves Quality and Environmental Management System Certifications

Congratulations!  Lauren Manufacturing (New Philadelphia, Ohio), a Lauren International company, received ISO 9001:2015 and ISO 14001:2015 (environmental) certifications from Eagle Certification Group.  Since 1965 the company has grown from a seal and gasket manufacturer to a sophisticated business supply partner for leading OEMs, engineers and builders and to industries around the globe including automotive, agriculture, window and door, HVAC, renewable energy, lighting and more.  With facilities in Ohio and Michigan, total quality management is the foundation of their entire organization. To ensure quality materials are used for every customer application, they mix and test their own materials on site. They also design and build process equipment in-house to ensure products are manufactured to exact specifications.  Lauren’s adherence to lean manufacturing principles prevents defects and maximizes value for their customers from product design to delivery.

In addition, the company is committed to environmental management requirements and complies with regulations by local, state and federal agencies.  With EMS risks and opportunities identified, Lauren’s leadership planned objectives to address them. Each objective has a responsible person or team assigned with action item plans for achieving the EMS intended results.  These objectives and targets were communicated across the organization and are monitored and evaluated for status/progress updates to ensure continual improvement of the EMS and enhance environmental performance.

To assist with the transition to the new ISO 14001 and ISO 9001 standards, simpleQuE consultants began working with Lauren in early 2017, providing a gap analysis and support in preparation for their external audit in November 2017.  Originally, the company which is currently ISO/TS 16949 (automotive) certified, had thought they would also transition to the new IATF 16949 standard.  However, due to the complexities and numerous requirements of the new standard, it was determined that Lauren Manufacturing could meet their automotive customer’s requirements with MAQMSR and CQI-19 audits and compliance.  SimpleQuE consultants continue to work with Lauren to meet those objectives and to ensure that their reputation is built upon trust, service, innovation and quality.

Impact Label – Making a Lasting Impact

Image of Impact Label Corp

Congratulations to Impact Label Corporation for achieving ISO 9001:2015 certification! Impact Label leaves a lasting impact with their custom labels, panels, overlays and tags for industrial and consumer applications. The company has been a West Michigan product identification provider since 1964. Customer driven and quality focused, Impact Label is continually striving for zero defects by encouraging team members to use scientific problem solving methods and empowering them to stop the production process when necessary in order to build quality the first time, ensuring consistent results.

ISO certification was a way to further ensure their quality objectives were met.  Working with simpleQuE consultant, Karen Spencer, who performed a gap analysis of the quality management system, the Impact Label team worked their way through the action plan to be sure they were ready for their certification audit with DQS, Inc.  Good work and congratulations!