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

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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.

Associate Spotlight – Kimberly Roan

We are excited to introduce one of our newest team members, Kimberly Roan, a simpleQuE consultant.  Kimberly brings not only years of experience, but a great curiosity and drive to find the best solutions for our customers.  Here’s more on Kimberly:

What is your position and what do you do for simpleQuE?
I am a consultant for simpleQuE and I consult with clients, perform internal audits, and teach on site training on automotive QMS topics.

What do you like most about working for simpleQuE?
This is an opportunity to make a difference.  Every day I get to help clients identify issues and improve processes.  Sustained process improvements lead to greater customer satisfaction and improved effectiveness and efficiency in the organizations we work for.

What is your favorite QMS standard and why?
My favorite QMS standard is ISO 9001:2015.  This standard builds the foundation of an effective QMS and is the cornerstone for a series of important industry QMS standards.

What attracted you to simpleQuE?
Top managers who understand QMS development and believe in simple, sustainable, and value added quality management solutions.

What expertise do you bring to simpleQuE’s clients?
I spent 17 years in automotive and was always involved in auditing both first and second party and spent many years participating in 3rd party audits and acting as the management rep. If I could draw you a picture, I would show you a pyramid that includes a 17 year work experience – base, and approximately 8 year formal education – middle, and a 3 year certified auditor – crown. The large sections of the pyramid underpin everything I knew to make me an effective auditor. With this balanced experience I can provide clients with answers from a company management perspective, an internal auditor perspective and a third party auditor perspective. Every day I use the whole pyramid but the biggest part of it will always be my work experience.

What was your first job?
My first automotive job was part time administrative assistant for an engineering team at Saturn.  My first job ever was doing office work for a neighbor in direct sales at the age of 12 to 13.

Have met…
John Glenn, in an elevator at a Marriott hotel.  We talked about Harley Davidsons and how he wouldn’t get one now because he promised his wife he was done with high risk activities.

Where did you go to college?
Baker College of Flint for my Mechanical Engineering degree and The Chicago School of Professional Psychology for a Masters in Psychology with an emphasis in organizational leadership.

What is your hometown?
Cadillac, MI

Would love…
To visit the hometowns of my great grandparents in Germany.

My hidden talent is…
Slow racing my VT1100

What is your favorite sports team?
Let’s go Red Wings!!!

What advice would you give to a new college graduate entering the technology industry?
Learn something new every day and do something good with what you learn as often as you can.

Explain how simpleQuE is different from their competition.

SimpleQuE is different because they focus on simple solutions to meeting complex QMS requirements.  The company supports a value added approach to meeting requirements.

Where do you see simpleQuE the next five years?
SimpleQuE will grow to become the leading QMS consulting firm and they will continue to support the success of their clients.

How would other people describe you in three words?
Independent, tenacious, and helpful.

Not ready for IATF Certification? MAQMSR May Be an Option

worker with protective mask welding metal. in Industrial automotive part. in car production factory.

For automotive suppliers who are having a difficult time meeting the requirements of the new IATF 16949 quality standard, Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) may be an option you want to consider in conjunction with ISO 9001 certification.  With initial audit results coming in from certification bodies, it is evident that companies are failing to comply and in some cases IATF certification can’t be achieved.

IAOB released the top IATF 16949 findings based on 3,172 audits conducted as of August 2017 – the top 5 non-conformances overall were written against:

  • 5.1.5 Total productive maintenance
  • 5.1.1 Control plan
  • 1.2.3 Contingency plans
  • 5.1 Control of production and service provision
  • 2.3 Internal auditor competency

As an option for suppliers, the Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) was released in September 2017 as a possible intermediate step for a supplier’s Quality Management System (QMS) under the authorization of IATF 16949, Section 8.4.2.3.c and Sanctioned Interpretation, SI #8.

Conformance to MAQMSR helps a lower tiered supplier transition to IATF 16949 by allowing many of the key Automotive Requirements to be met while developing the remainder of the QMS. The ultimate goal of the supplier development process is to achieve 3rd party registration to IATF 16949.  It is important to note that the customer determines the path and steps, so approval must first be obtained before proceeding.  The suggested steps of supplier development referencing 8.4.2.3 are as follows:

  1. Certification to ISO 9001 through 3rd party audits
  2. Certification to ISO 9001 + compliance to MAQMSR through 2nd party audits* (suppliers who did not achieve upgrade transition may consider this)
  3. Certification to ISO 9001 + compliance to IATF 16949 through 2nd party audits*
  4. Then finally certification to IATF 16949 through third party audits

MAQMSR aligns the Automotive QMS Requirements with the corresponding IATF 16949:2016 section(s); however, it is not certifiable or a third party auditable standard, though the guideline may be referenced during a second party audit *(by customer or with a qualified 2nd party like simpleQuE).

SimpleQuE consultants have been assisting companies to understand their options and make the change to drop IATF 16949 and prepare for ISO 9001:2015 certification.  Upon receiving  customer approval to use 2nd party audits to be compliant with MAQMSR, our consultants can provide guidance for that process and perform the audits.  For more information on MAQMSR, contact us.

Questions for Auditing Utilizing a Process Approach

Whether facing a surveillance audit from a certification body or preparing for an internal 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)?

8)  Are these methods effective? – refer to outputs

9)  Are the resources adequate? Which are they?

10) Are records available and appropriately maintained?

11) What are the inputs to this process?

12) Are these inputs documented and reviewed by competent persons?

13) Is a description of the processes available and documented?

14) Are these descriptions controlled? – Verify the effectiveness of the organization’s

documented information control procedure.

15) Who are the “customers” (internal and external) of the processes?

What are the requirements of these customers?

17) What are the characteristics of the intended results of the process?

18) What are the characteristics of the unintended results of the process?

19) Are correction and corrective action applied as appropriate?

20) What are the criteria for monitoring, measurement and analysis?

21) How are these criteria incorporated into the planning of the processes?

22) Are the business performance issues taken into proper account?

23) What methods are used for data gathering?

24) What records are kept and how these are maintained?

25) What are the communication channels?

26) How is external and internal information about the process provided?

What are the outputs of the process? – Identify outputs.

28) Do these outputs provide evidence of effective implementation of the process?

29) How is process performance monitored?

30) Are appropriate controls defined?

31) What measurements are applied?

32) How is the gathered information analyzed?

33) How are the results of the analysis taken into account?

34) How is feedback obtained?

35) What data is collected?

36) 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 quality internal auditing possible.

Links to Sample Manufacturing Process Audit Checklists:

IATF 16949 Checklist

AS9100 Checklist

ISO 9001 Checklist

Top 5 Reasons Not to Miss a Single Issue of Our Newsletter

At simpleQuE it’s not just our name that represents quality excellence, it’s our unique combination of consultants, knowledge and expertise.  We believe in serving our clients before, during and after the certification process. This value added service consists of an ongoing education process on the quality standards through our website, newsletters social media, and blog. Each month, we provide updates on the latest news from the ISO, AIAG, ASA, IAOB and IATF standards community, and what we’re is seeing in the industry.

In a year that will be filled with companies scrambling to upgrade their certifications, we feel it’s even more important to stay informed.  That is why we encourage anyone who is currently not receiving our monthly newsletter to sign up today.  And if you’re still on the fence, here are our top five reasons:

  1. Obtain the latest quality standard news and updates from simpleQuE.
  2. Learn useful tips, tools and best practices for transitioning and maintaining an effective quality management system.
  3. Preview the latest simpleQuE blogs and infographics.
  4. Receive data and reports from industry leaders and registrars on current certification standards and how they will impact you.
  5. Check out the latest companies who have earned their QMS and EMS certifications as we proudly recognize our clients’ success!

Ready to get started? Just sign up for our newsletter below.

Pilgrim Harp is AS9120:2016 and ISO 9001:2015 Certified!

Pilgrim Harp 1

Pilgrim Harp, located in Avon, Ohio, provides the global and domestic sourcing of components and assemblies, handling every aspect of the sourcing process from beginning to end and ensuring the highest quality levels at all times.  Pilgrim Harp and its manufacturing partners all maintain TS, ISO and/or AS certifications.

As a manufacturing outsourcing company for the healthcare/medical, heavy industrial and aerospace industries Pilgrim Harp is a source for a wide range of products.  For aerospace, their aircraft interior products include: airplane seat legs, seat spreaders, seat backs, seat frames, seat arms, seat arm assemblies, seat tray tables, seat tracks and more.  For this customer base, Pilgrim Harp leadership recognized the need for AS9120B certification – which pertains to Quality Management System (QMS) requirements for Aviation, Space and Defense distributors. This standard includes ISO 9001:2015 QMS requirements.

SimpleQuE consultants, Jen Briese and Jim Lee began working with Pilgrim Harp in 2016 to assess where there were gaps between their current system and the new requirements.  They then worked out a customized action plan and timetable to make implementation simple and sustainable.  End result – certification was achieved in June 2017 with no findings from Eagle Certification Group!  Congratulations to the team at Pilgrim Harp!

The Benefits of Working with a Management System Consultancy

BusinessMeeting

Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!

Powder Processing & Technology Transitions to ISO 9001:2015

Powder Processing Tech PPT 6-2017

Powder Processing & Technology, LLC  has maintained ISO 9001 certification since 1998 and just transitioned to the latest version – ISO 9001:2015.  PPT’s professionals have assisted the top materials technology companies around the world for over 30 years. The company performs process development and contract manufacturing on a wide range of powders, and has a fully equipped pilot plant as well as multiple production areas specializing in spray drying, calcining and firing

PPT uses the formulas and processing parameters provided by their customers and/or develops the formulations and processing parameters of the products produced for customers.  Therefore precise process control is necessary to meet high quality standards. For that reason in 2012, PPT brought in simpleQuE to conduct its quarterly internal audits.  Kenneth Bartelt, President, said,  “PPT is a small technology company which places significant weight on its quality management system and which needs to ensure its valuable and limited technical resources are focused on customer requirements and our ability to deliver results.”

“We consider the quality system to be part of the fabric of our management system and simpleQuE has added a critical component to that system,” added Ken.  “I think that simpleQuE has a practical approach to quality management that is effective and efficient.”  In the case of PPT, the commitment to maintaining quality standards is evident and practiced from the highest level of management to their plant workers.

SimpleQuE matched PPT to auditor/consultant, Don Milinkovich, whose 34 years in the chemical manufacturing business made him the right fit.  “Don is an experienced and personable consultant who has delivered meaningful audits and provided relevant expertise. Our audits have been at the right level of detail and have made a significant contribution to the business. The performance from simpleQuE has been such that the registrar’s representative and auditor has been very complimentary of the service they have performed,” stated Ken regarding the benefits of working with an experienced auditor.  Don also worked with the PPT team to prepare them for a smooth transition to the new standard.

These internal audits have reinforced the objectives of PPT to maintain high levels of service and customer satisfaction while utilizing the principles of ISO 9001 to incorporate continual improvement into their business practices.

Look Fors – Part 2: Leadership

Stock quotes price charts and a magnifying glass with stock price in detail.

Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015? 

What are 3rd party auditors looking for?  This is the second of a three part series by Jim Lee, President of simpleQuE

Clause 5 of ISO 9001:2015 – Leadership

Leadership is the focus of this clause, which means top management now has greater accountability, responsibility and involvement in the organization’s management system. The standard wants to see that leadership demonstrates leadership and support for the quality management system (QMS). They need to integrate the QMS into the organization’s business strategic direction, to ensure the management system achieves its intended outcomes and allocate the necessary resources. Top management is also responsible for communicating the importance of the QMS and enhancing employee awareness and involvement.

With this clause there is a requirement that top management will be present and leading the implementation and monitoring of the QMS.  Processes within the QMS must have process owners. In addition, leadership shall demonstrate leadership and commitment with respect to customer focus and the continual improvement aspect of the business.  3rd party auditors will be scheduling time with the management and leadership team asking questions and looking for the items below as objective evidence.

  • Established and communicated quality policy, objectives, strategic direction, and performance
  • Organizational chart, job descriptions and other evidence that responsibilities and authorities are defined and communicated
  • Metrics evaluated in the Management Review and the overall effectiveness of the key business processes
  • Actions being taken when goals are not met, and when trends for performance are going the wrong way. They want to see management is looking at the data and taking actions when necessary.
  • Promotion of risk based thinking and evidence of risk management processes with action items when risks are too high. This might include contingency plans, safety stocks, inventory levels, supplier selection and qualification process, etc. as a very few of the many possible ways to demonstrate this.
  • Involvement in audit activity and reviewing the outcomes and assessing the risks and actions that might be necessary for the QMS
  • Customer satisfaction and perception
  • Identification of contract terms and conditions and customer requirements, including any laws that must be met. How are these evaluated, understood, communicated and implemented in the departments that need to know and comply?
  • Evidence of continued improvement , which denotes that performance is monitored and tracked with trends
  • The company’s context changes over time, and the needs of stakeholders too. Management needs to be aware of the changing context and issues affecting the business to adjust the strategic direction.

Not that all of the elements listed above will be needed, but organizations may risk failure if they do not:

  • Identify process owners
  • Use metrics to monitor performance of the QMS
  • Include performance metrics in the Management Review
  • Develop action plans when performance goals are not met
  • Develop customer communication processes
  • Respond to customer complaints
  • Consider results of customer feedback/surveys and take appropriate actions
  • Identify internal customer requirements
  • Make improvement part of the quality policy
  • Align roles and responsibilities with processes
  • Contingency and emergency roles and responsibilities not defined
  • Have appropriate training and awareness of the ISO 9001:2015 requirements

Coming soon – Part 3 and what auditors are looking for in regard to Risk.  Also, read more about Context of the Organization in Part 1.

Source:  NQA’s Teaming Conference – August 2017