Congratulations to MPC, Inc and Knight Ergonomics!

Recognizing quality and the teams of two simpleQuE clients who share news of their successful certification.
MPC, Inc. (Walworth, WI + 7 sites) – IATF 16949:2016 Certified
From left:  Sommer Gramly – Quality Engineer, Alexis VanVleet – Quality Systems Coordinator, April Keller – APQP Engineer, Jay Graveen – Corporate Quality Manager, Steve Leathers – Plant Manager Bldg #2, Not pictured:  Tracy Apfel – Internal Audit Administrator
Knight Ergonomics & Assembly Systems, Inc. (Brecksville, OH) – ISO 9001:2015 Certified
Team Knight Ergonomics
Sign Up For Our Newsletter

Supplier Quality Audits – Do You Really Know Your Supplier?

Binders with papers are waiting to be processed by bookkeepers back in blur. Accounting planning budget, audit, insurance and business concept.

Supplier quality audits – a way to examine and really know your suppliers.  Many factors contribute to making a company successful, from both internal and external perspectives. While you can certainly ensure the success of your internal operations, your external operations – such as your suppliers, external providers, and outsourced processes – can sometimes be a riskier situation.

In order to continue operating an efficient quality management system, it is vital that your relationship with your suppliers and external providers is strong and reliable. And in order to maintain that relationship, it is just as important to sometimes perform a supply chain audit to determine what is working and what areas need improvement. Especially when risks or problems drive the need for supplier audits of their quality systems.  

A supplier audit from simpleQuE can go above and beyond other auditing processes, and certainly beyond ISO and good manufacturing practices. When it comes to your relationship with suppliers, our audits can provide a number of services:

  • Problematic supplier assessments
  • Sourcing evaluations
  • Ongoing supply chain strategy assessments and audits
  • Corporate quality audits
  • Assistance in the monitoring and closeout of corrective actions
  • Improving your company’s measures of effectiveness
  • Training

Our supplier quality audits and corrective actions will drive supplier development, and allow you to resolve both supplier quality and internal issues more effectively. 

With supplier quality experts from Fortune 100 companies, simpleQuE has the auditing expertise and certified resources to offer true value to your business. Whether you need help with problematic supplier assessments, sourcing evaluations, ongoing supply chain strategy assessments and audits, automotive 2nd party audits (including MAQMSR – Minimum Automotive Quality Management System Requirements), or corporate quality audits – simpleQuE can deliver.  Contact us to discuss a customized strategy.

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.

The Countdown Begins

Hour glass on calendar concept for time slipping away for important appointment date, schedule and deadline

By Jim Lee, President of simpleQuE

With the deadline for ISO 9001:2015, ISO 14001:2015, AS9100:2016 and IATF 16949:2016 approaching on September 14, 2018, companies have been slow to transition.  The statistics are sobering, although not unexpected.  The new ISO standards have been in effect for 2 years but only 6-20% have made the leap. (The number varies among registrars and the ANAB.) The final draft for the AS 9100 series followed a year later, but with the same deadline, and only 3% have upgraded.  Even fewer IATF companies have transitioned – and all have only 1 year left to get the upgrade completed.

What should you be doing if you’re one of these companies that has pushed out the inevitable?

  • Know that your next scheduled annual audits are the dates when you must transition to the new standards. If your next audit is a recertification and upgrade, you will need to perform the audit at least 2 months prior to your certificate expiring to give you enough time to address any potential nonconformances.
  • Review the new standard and do a gap analysis to see where there are differences in your quality (and/or environmental) management system and the changes to the standard. Generic basic checklists are available from your certification body, or detailed gap checklists with tips and explanations can be purchased from simpleQuE.  Learn more about simpleQuE’s Gap Checklist for: ISO 9001:2015, ISO 14001:2015, or IATF 16949:2016.  Note that IAQG offers a free AS9100D Gap Assessment Workbook.
  • Establish an action plan that will have you ready for your audits. Assign responsibilities and due dates to ensure you’re ready on time.
  • Train your internal auditors and perform a full system audit to make sure your system is on track and in compliance. You must have evidence of a full internal audit and subsequent management review prior to upgrading with your certification body.  If you can’t get your audits done in time you’ll need to outsource them.  (SimpleQuE can conduct an internal audit to the new standard after the implementation effort to prepare you for the external audit.)
  • Don’t expect to wing it and do nothing in preparation for these changed standards, or you will fail your next audit and lose your certification. Worst case if you aren’t ready in time, you may have to let your certification lapse and then become recertified at a later time when you’re ready.  No one wants to hear that, but it is a reality for some who haven’t started.
  • If you still aren’t sure how to proceed, work with a consulting firm (like simpleQuE) with certified experts who can provide consulting, training and customized plan to guide you through the transition.

Quality + Certification = Success!

SimpleQuE congratulates the following companies on their successful certification and commitment to quality.

image002

SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.

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.

ISO Certification Instills Trust

Trusted partner mark imprinted on a paper texture. Concept background for illustration of trust in partnership and business services.

Obtaining an ISO certification is so important to businesses that many will specify the distinction next to their business name, and some customers and industries mandate it through the supply chain.  A client or potential business partner may ask why having an ISO certification is important.  Simply stated, an ISO certification means the client can trust a business and have confidence that  It has the processes in place that are independently audited, to improve the likelihood that products and services will meet or exceed customer expectations.

What is an ISO Standard?

ISO standards define and structure a company’s management systems. These standards apply to all industries and require businesses seeking certification to define how their systems meet the standards’ rigorous requirements. Meeting the standards assures customers that all vendor company activities – design, manufacturing, production, purchasing, quality control, packaging, handling, storage, shipping, and customer service – are appropriately managed and controlled.

Certification Builds Confidence

When a business certifies to an international standard, they are representing a trusted symbol of quality, safety, and compatibility. These standards are developed through a process that is balanced, open, and transparent and help elicit trust among the groups and businesses that have placed value in the certification process.

Building Trust with simpleQuE

There are several paths to obtaining ISO certification. A company can create its own documents and systems, then prepare for and manage their audit internally, or they can work with a specialist to provide consulting, auditing and training services to expedite the certification process.  It is important to note that actual ISO certification is the result of an audit conducted by an external registrar or certification body and not the International Standards Organization who develops the standards.

SimpleQuE’s consultants are experts in their respective fields and are ready to provide unique solutions that fit your specific needs. For more information on choosing an ISO consultant, visit simpleQuE’s YouTube channel.