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Quality + Certification = Success!

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

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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.

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News Regarding Revision of the ASA-100 Standard

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Aviation Suppliers Association (ASA) promotes safety, regulatory compliance and ethical business practices among aviation parts suppliers throughout the aviation community. Jim Lee is a presenter and attending the ASA Annual Conference and shares news about important changes to the standard.

The ASA-100 standard is going through a revision that will require all accredited companies to add to their quality manuals.  The standard and checklist will be released October 1, 2017 and all audits afterJanuary 1, 2018 must be completed to the new 4.1 version.

  • One of the changes requires that quality manuals or specific procedures contain requirements for drop shipments direct from a supplier to a customer, bypassing the distributor who sold the part.
  • Another change follows ISO and requires that suspect and non-conforming material be addressed in a procedure. Material is to be segregated. If non-conforming material is shipped, the customer must be notified timely.
  • All changes to the quality manual must be submitted to ASA by 1/1/2018.

Over 300 companies have received accreditation to the ASA-100 Quality System Standard and FAA Advisory Circular 00-56 since 1996.


Jim Lee presents at ASA’s 2017 Annual Conference

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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.


Powder Processing & Technology Transitions to ISO 9001:2015

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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.


The History of AS9100

Once again, the IAQGs AS9100 standard has undergone a new revision. The latest version of this standard adds requirements for product safety, counterfeit parts, formal processes for operational risks, awareness, and ethics and human factors. Read more about the journey this pivotal standard has taken over the years.
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Don’t forget, June 15, 2018 is the final transition audit deadline for the new AS9100 standard. Learn more by viewing our transition timeline.


IATF 16949:2016 Transition Q & A from IAOB

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Cherie Reiche, program manager for International Automotive Oversight Bureau (IAOB) recently presented at Eagle Certification Group’s June Boot Camp to discuss progress of the IATF 16949 transition and the unique intent behind some of the new requirements.   While no FAQs or SIs have yet been published for IATF 16949:2016, Cherie shared some of the common questions that IAOB and IATF members have received for interpretation and clarification from Certification Body automotive auditors.

Must both ISO 9001:2015 and IATF 16949:2016 be used when conducting audits?
Answer:  Yes, as it states in the IATF 16949 Foreword – Automotive QMS Standard, IATF 16949 is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015.

Will the IATF be granting waivers for those organizations who cannot meet the transition plan timing?
Answer:  No, there are no plans to approve/grant waivers.  If the organization does not complete their transition audit in a timely manner (including allowing time for Non Conformance management and CB certification decision), then the organization will lose their certification.  ISO/TS 16949 certificates are not valid past their expiry or September 14, 2018.

Is IATF 16949, Section 4.4.1.2 related to product safety during manufacturing or final customer product safety concerns?
Answer:  4.4.1.2 was created to address final customer safety concerns (braking systems, airbags, fuel systems, etc.).  If the product (or process) is a safety item on the final product, then the organization has to identify the statutory and regulatory product safety requirements that must be met, along with items a) through m) in 4.4.1.2.  This is one of IATF 16949’s required documented processes, so inputs/outputs, metrics, etc. are required.

Can an organization demonstrate competence only through degrees and certifications for their employees?
Answer:  No, there are multiple ways for an organization to identify training needs and achieving the necessary competence for their personnel.  It is up to the organization to define (and document) training needs, including awareness, and competency requirements for all personnel performing activities that impact conformity to product and process requirements.

What about competency for internal auditors and second party auditors?  Do they all have to take an IATF-sanctioned lead auditor training course?
Answer:  No.  Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent.  The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.  Organizations are still allowed to have key personnel trained and certified as lead auditors, and then use those key personnel to train-the-trainer to disseminate the information throughout the organization.

If an organization is not design responsible for the software used in their product, does 8.3.2.3 (embedded software) apply?
Answer:  Section 8.3.2.3 refers to internally developed embedded software, not “functional test” software to see if a widget works (or not) during production.  For those organizations that are design responsible for the software used in their product, they must use a software development assessment methodology to assess their own software development process.  Annex B contains suggested Software Process Assessments such as CMMI or SPICE.

What is the goal of 8.4.2.3?  Do all organizations supplying automotive product have to be IATF 16949 certified?
Answer:  The ultimate objective is to have IATF 16949 certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.  At a minimum, the expectation is for organizations to be certified to ISO 9001:2015, unless otherwise authorized by the organization’s customers.  Items a) through e) are a cadence which is applicable to the entire automotive supply base.

How are 8.3.2.3 and 8.4.2.3.1 different?
Answer:  8.3.2.3 refers to the organization itself and their internally developed embedded software. 8.4.2.3.1 refers to the organization’s suppliers of automotive product related software.  The organization needs to ensure that their suppliers of automotive product related software implement and maintain a process for software quality assurance for their products.

SimpleQuE will be sharing more information from IAOB and other Eagle Boot Camp sessions in future posts and on social media.  Follow us on Facebook, LinkedIn and Twitter for the latest quality and certification news.


World Accreditation Day 2017

HILVERSUM, NETHERLANDS - FEBRUARY 06, 2014: Social media are trending and both business as consumer are using it for information sharing and networking.This year, the theme is “delivering confidence in construction and the built environment.” Construction companies and distributors are impacted by advances in manufacturing technologies, construction techniques, and rapid urbanization. Risk mitigation in construction is critical as structural failures, natural disasters, and material quality are all factors to be considered. Accreditation standards allow for companies to prepare for and assess how to mitigate all potential risks in the built environment.

As a result, accreditation is essential to providing assurance that construction projects are safe, secure, and sustainable. Accreditation does this through systems that help increase efficiency, manage risk, and determine compliance with regulations. Some of the management standards that pertain to construction as well as to a wide variety of industries are: ISO 9001 – for quality management systems; ISO 14001 – for environmental management and; OHSAS 18001 – for occupational health and safety.

In coordination with World Accreditation Day, events, media coverage, and workshops will occur in more than 100 countries globally to bring attention to the impact of accreditation. Ultimately, accreditation can be thought of as a common language used to examine and discuss issues related to environmental, safety and quality management.

SimpleQuE 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.

 

#WAD2017


SimpleQuE shares an important AS9100:2016 transition timeline reminder from IAQG

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“The IAQG Other Party Management Team (OPMT) would like to remind all certificated organizations that there are two key target dates within the “International Aerospace Quality Group (IAQG) Other Party Management Team (OPMT) Supplemental Rule 003 – Rules for 9100/9110/9120:2016 and 9101:2016 Transition” document that were established in order to ensure that a certified organization transition occurs prior to the 15 September 2018 end date.

The first key target has now passed. In accordance with SR003; “10.a By March 1, 2017 AQMS certified organizations shall communicate with their CB to establish an intended date for 9100/9110/9120:2016 AQMS standard transition readiness.”  We greatly appreciate the efforts that certificated organizations have taken to meet this requirement and would like to remind those that have not yet made transition plans; there is an elevated risk of not meeting the 2018 end date if you have not established and communicated the aforementioned date to your CB.

The second key target date in SR003 is 15 June 2017. In accordance with SR003; 9.g No initial, surveillance or recertification audits shall be started to the previous versions of the AQMS standards after June 15, 2017.” We must ensure that transition has a start date or Certification Bodies may face auditor resource issues in 2018 as the transition end date approaches.”

SimpleQuE is an ISO 9001:2015 certified company that provides ISO, AS and IATF consulting services from quality experts to assist organizations in successfully meeting transition targets. Contact us for more information.  IAQG also provides AS9100 D transition support materials.


Interaction of Process Maps – The Process Approach

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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.