Jim Lee presents at ASA’s 2017 Annual Conference

ASA Conf 170710

Aviation Suppliers Association (ASA) is a not-for-profit association that represents over 600 worldwide member companies that lead critical logistics programs, purchasing efforts, and distribution of aircraft parts globally.

The 2017 ASA Annual Conference takes place July 9-11 in Reston, VA; and is one of the largest for the aviation distributor industry. The event draws aviation professionals worldwide with a range of business development and management, quality assurance, legal/regulatory and general industry topics. The itinerary includes general sessions, workshops, exhibitors, and networking events. SimpleQuE founder Jim Lee presented at the conference on Monday, July 10 about risk management requirements for distributors that are ISO and/or AS certified.

“This is our second year to present on 3 different topics.” said Lee. “We appreciate this opportunity to network with our clients and aircraft parts distributors. Last year we had three simpleQuE attendees at the conference, and this year two. By attending these conferences, we get a lot of information and value that we share with our consulting clients and other staff members.”

Aviation Suppliers Association promotes safety, regulatory compliance and ethical business practices among aviation parts suppliers throughout the aviation community. Over 300 companies have received accreditation to the ASA-100 Quality System Standard and FAA Advisory Circular 00-56 since 1996.  ASA Certification Body also certifies companies to ISO 9001, AS9120, AS9100, and AS9110.

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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.

Interaction of Process Maps – The Process Approach

Woman drawing flowchart, business process concept

By Jim Lee, President simpleQuE

Companies typically have some type of flow diagram showing their interaction of processes. This is the most common method to demonstrate compliance with the process requirements in ISO 9001:2015 clause 4.4 or ISO 9001:2008 clause 4.1.  The new standard emphasizes the need to determine inputs and outputs, along with the sequence and interaction of these processes.

For larger companies with multiple sites and headquarters, or parent companies whether domestic or international, a new complexity arises.  Registrars are targeting more detail on the linkages, interactions and inputs from sister sites and parent companies, even though those locations may be out of the certification scope.  For automotive (TS and IATF 16949) it is not permitted to exclude any related support function no matter where it is performed, remote or on-site.  The process map must clearly indicate these interactions.

For ISO 9001 and AS standards we are observing more emphasis by certification body auditors to scrutinize the interaction of process maps to ensure there is adequate clarity of the linkages and interactions, including headquarters that might be out of the certification scope. We are sharing this information as we see more creeping of scope from other standards, and the interpretations of related risks associated with process interactions between sister sites and headquarters.  It makes sense since they can be a source of past and current problems due to a quality system breakdown between these sites.

Clients are addressing this by showing the related bodies on their interaction of process maps, and using color coding or symbols with legends to show what is out of the certification scope and what is in. This is part of a company’s context.  Consider a situation where ABC Company has a Japanese parent company that is outside its certification scope, but interaction with the parent company can have a significant impact on its core processes in ABC’s interaction of process map.  Some companies treat these interactions through the purchasing process, and that is explained as part of their company’s context.

While process mapping is often the first step to process improvement, make sure you are also looking at the bigger picture to understand what influences process performance.  For more information about implementing or improving your quality management system, contact simpleQuE.

ISO 9001 Myths and Their Reality

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ISO 9001 is the world’s most used management system standard, existing for almost 30 years, it tends to fall into the gap where many people have heard about it, but not many fully understand what the standard involves. As a result, there are common myths about ISO 9001 that simpleQuE can help to clarify.

Is it complicated and difficult to implement?
In most cases, no. SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified, so we know what it takes to transition to the new standard. It is possible to simplify ISO implementation, transition, training and maintenance, by integrating simple solutions that fit into your company’s culture.  This can be done with a gap audit checklist to identify where you’re already in compliance and more effectively target only those areas that need work.

Isn’t ISO 9001 an outdated model?
While it is true that ISO 9001 has been around since 1987, it has evolved through several revisions to match the changing needs of business. Today there is instant access to information, higher expectations from customers, more complex supply chains and a globally competitive economy.  ISO 9001:2015 takes all of these factors into account.

Isn’t ISO 9001 a standard that only benefits big corporations?
This is not the case. ISO 9001 is intended to be a set of requirements that can be used by any company, of any size, in any industry. The requirements are written as a set of best practices needed to control all the processes of a business system – no matter what the company does. The standard is designed to be flexible; the focus is on improving quality and customer satisfaction, which every organization can benefit from including:

  • More efficient use of resources and improved financial performance,
  • Improved risk management and protection of people and the environment, and
  • Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.

Will everything have to be monitored and measured?
Processes do have to be monitored and measured to ensure that they are performing as designed, however, the standard allows a company to consider the impact that a process has on product/service conformity and the effectiveness of the Quality Management System (QMS) when determining what to monitor or measure and the method to be adopted.  A good QMS will help with monitoring performance and driving improvement.

Is ISO 9001 is the sole responsibility of the quality manager or department?
This couldn’t be farther from the truth, since the requirements cover every aspect of the business – from planning through delivery and post-delivery of your product or service.

Doesn’t ISO 9001 cost a lot to implement?
The question of cost will depend on the size and complexity of the organization and the competency of the personnel. Basic implementation pricing should be competitive and reasonable, depending if the work is done internally or through an external consulting service. The overall outcome of these activities should be to reduce costs through improvements and increase revenues through satisfied customers. Your return on investment should be well above the costs. Note that ISO certification is a separate additional cost.

SimpleQue can customize consulting for your organization and provide simple solutions while clearing up any misconceptions about ISO 9001 and how it can benefit your organization. Contact us today to find out more information and how simpleQue can help!

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

Look Fors – Part 1: Context of the Organization

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

Clause 4 of Annex SL – Context of the Organization

This is the cornerstone of a management system and the business’ strategic direction.  An organization needs to identify internal and external issues that can impact its intended outcomes, as well as all interested parties and their requirements.  It needs to document its scope and set the boundaries of the management system to line up with business objectives.

The context doesn’t have to be documented, so 3rd party auditors (as well as internal auditors) will be asking questions of various management members, and looking for these as objective evidence that an organization understands its context and considers all the factors and stakeholders affecting the business.  The items listed below don’t have to exist, but if they do, you want to take credit for them in understanding the context.  Some items may not by themselves demonstrate an understanding of the context, but combined with multiple examples, can provide the evidence an auditor is looking for.

  • Business plan
  • Strategic plan
  • SWOT analysis (Strengths Weaknesses Opportunities Threats)
  • Vision and mission statement
  • Process mapping
  • External parties identified
  • Lesson learned
  • Surveys
  • Internal meeting minutes to determine company goal setting
  • Metrics to measure effectiveness of QMS
  • Process turtle diagrams
  • Process flow plans
  • Quality manual

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

  • Identify or understand their primary competitors
  • Mention civic responsibility
  • Consider future business trends
  • Identify all customer requirements
  • Identify local/state/national requirements
  • Identify required outputs needed for internal customers
  • Identify uncertainties like negative risks or positive opportunities
  • Determine the processes used to flow the business from quote to delivery
  • Identify outsources processes
  • Establish process goals

 

Coming in future articles – what auditors are looking for in regard to Leadership and Risk.

 

Congratulations Accutech Mold and Machine!

AMM’s Quality Team (from left): Ray Young, John Rogers, Eric Boyd, Butch Poynter, Jim Lee (simpleQuE President) and Kari Anderson
AMM’s Quality Team (from left): Ray Young, John Rogers, Eric Boyd, Butch Poynter, Jim Lee (simpleQuE President) and Kari Anderson

Not only is Accutech Mold and Machine (AMM) ISO 9001:2008 certified, but they also achieved their ISO/TS 16949:2008 certification from Eagle Registrations.  In January 2016, simpleQuE consultants, Larry Vance and Don Milinkovich began working with AMM to assess their existing processes and formulate an action plan that would address the gaps and fit their very tight timeline.  That was followed up by an internal audit and training to prepare for the expansion to the automotive standard.

Why was this so important to AMM’s founders, Kelly and Darrin Geiger? As AMM’s website states, “International Standards are the backbone of our society, ensuring the safety and quality of products and services, facilitating international trade and improving the environment in which we live in. Conformity to International Standards helps reassure our customers that Accutech Mold and Machine’s products, systems and organizations are safe, reliable and good for the environment.”

Founded in 1996, AMM specializes in plastic injection mold manufacturing. In 2004 the company expanded with an injection molding press to sample molds that were built. Today, AMM continues to build high quality plastic injection molds and also produces plastic injection molded components with 25 presses running 24 hours a day.

Vice President, Darrin Geiger, had this to say, “It was easy to work with simpleQuE and they provided an action plan which our team utilized, working hard to reach our certification goal in just six months.  The advantage to being ISO/TS 16949 certified is that it has opened new doors for us in the automotive industry, and our non TS clients are happy because they also benefit from these additional business processes.”