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.
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IATF Transition Update from IAOB

Cherie Reiche of the International Automotive Oversight Board (IAOB) shared the following IATF 16949 transition update at several registrar conferences.  As of April 30th 2017:

  • 68,332 sites are ISO/TS 16949 or IATF 16949 certified worldwide
  • 181 audits were completed to IATF 16949 (0.3% upgraded)
    • To date the total NCs issued = 975 (avg 5.4 findings per audit)
      • Major NCs = 133 (16% of the findings are major)
      • Minor NCs = 842

A summary of the highest incidence of NCs (major/minor) by section is represented in the chart below.  It’s interesting to note that Customer Specific Requirements and Quality Management System Audit had the largest number of major NCs, while most minor NCs were written on Contingency and Control Plans.

2017-08-15-2

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

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.

Risk Management for Aerospace and Defense Industries

Aerospace transport and people. Two pilots dressed in uniform flying jet airliner on sunny day sitting inside aircraft cockpit surrounded by equipment. Selective focus on captain's hand on power lever

In a business environment failure and negative consequences are the last things anyone wants to encounter.  But the reality is that risk is always present and comes from multiple sources, whether from inside the organization or from external elements. Due to the complexity of aviation, space, and defense processes, products, and services, and the severity of the potential consequences of failures, a formal process to manage operational risks is required.

The exercise of risk management is how a company proactively applies quality standards to keep a lid on risk as much as possible from creating negative ramifications in the supply chain or to production or scheduling, etc. While to some it can seem like bureaucracy or unnecessary controls, risk management pays for itself many times over with the cost avoidance it helps secure. All it takes is one bad event to see why risk management is so important, that’s assuming the company survives that event.

The elements of risk management are clear and straightforward as well. It’s an ongoing, cyclical process of identifying risks, assessing them, proactively reducing their probability of occurring by control, and mitigating those that are allowable. But just following the process alone doesn’t explain why a business should have a risk management process in the first place.

In AS9100 the operational risk management process is supported by specific requirements throughout clause 8, to drive an enhanced focus on:

  • understanding risk impacts on operational processes; and
  • making decisions on operational processes and actions to manage (e.g., prevent, mitigate, control) potential undesired effects.

Within aviation, aerospace, and defense, risk is expressed as a combination of severity and likelihood of having a potential negative impact to processes, products, services, customer, or end users. In AS9100, operational risk management must include how the company defines their risk assessment criteria (e.g., likelihood, consequences, risk acceptance), and ultimately acceptance of risks remaining after implementation of any mitigating actions. Something as simple as the example below may be the simplest way to quantify risks. More detail could be utilized with scoring.

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The standard requires an aerospace quality management system that takes into account the identification of various risks related to organizational circumstances in regard to its needs, business objectives, product range, applied processes and the size of the organization.  Given the fact that risk can trigger catastrophic results when unmanaged, every aerospace process must have the ability to reduce the occurrences and impacts of unacceptable risks, if not eliminate them entirely. And a risk management process is the only consistent way to assess risks and quantify when they are acceptable risks or when action is required.

Benefits to companies that incorporate risk management through ISO and AS quality standards include:

  • An increased probability of meeting schedules, budgets and production objectives
  • The means of making management proactive instead of reactive to risk issues
  • An increased awareness across the organization to recognize and mitigate risk
  • Reduced warranty and field complaints
  • Reduced supply chain risks
  • An increased ability to successfully plan, manage and implement changes (whether customer, supplier or self-initiated)
  • An increased ability to comply with laws, regulations, and customer requirements
  • An enhanced capability to track financial expenditures to poor results, and
  • Improved relations with stakeholders who see the results of quality and risk management in place

AS9100 Change Announced

Big news for AS certified clients from the International Aerospace Quality Group (IAQG), which is overseeing the writing and release of the new 2016 AS standards.  There is a significant change regarding the implementation and upgrade timing for companies required to transition to the new AS standards.

AS9100

 

After June 15, 2017 all AS audits must be to AS9100:2016, AS9110:2016 and AS9120:2016.  There will be no more audits to the current AS standards after that time.  Certified companies must upgrade on their regularly scheduled annual audit after June 15, 2017.  For example, if a company just had an annual audit June 20, 2016, then they must upgrade to the new standard during their June 20, 2017 audit.  Delaying transition until the June 2018 audit would not be an option.  The final transition audit deadline for the AS9100D series is June 15, 2018.

 

Planes, Change and Automobiles

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Tight Transition Timelines

Important updates regarding the Aerospace and Automotive industries were shared with SimpleQuE representatives attending the Smithers Quality Assessment’s annual conference on July 14th.  Speakers from the International Automotive Oversight Bureau (IAOB) and International Aerospace Quality Group (IAQG) provided insight into the upcoming changes to the ISO/TS 16949 and AS9100 standards.  All are targeted for release in the last 4 months of this year, with certification bodies ready to audit to the new standards in the first quarter of 2017 for AS and possibly later for TS.  Transition timelines are going to be exceedingly tight.  Here are a few key takeaways:

ISO/TS 16949:2016

  • The IAOB recommends TS certified companies upgrade to ISO 9001:2015 now, prior to upgrading to TS. The benefit will be less audit days when upgrading to 16949:2016
  • The IATF is still working on how it can have more time beyond the September 15, 2018 expiration, before ISO/TS 16949:2009 expires and the 16949:2016 standard has to be implemented.
  • The IAOB was very careful not to say the new TS standard is based around ISO 9001:2015, but said it does follow the 10 clauses from Annex SL. They were also careful not to call the new standard ISO/TS 16949:2016.
  • There are only 4,353 active TS certificates in the US, down from a high of almost 6,000 prior to the recession.
  • OEM’s are raising the bar with the new TS standard and performance is key for the automotive supply chain.  (See our previous post – Shifting into High Gear for what we learned about the Rome, Italy meeting with TS stakeholders earlier this year.  Many things are still changing from that meeting, so expect differences with the final release.)

AS9100:2016

  • AS is accelerating requirements to upgrade. After June 15, 2017 no certification body can perform audits to the current AS standards.  After 6/15/17 all scheduled surveillance and recertification audits must be to the new 2016 standard.
  • This prevents companies from waiting until the last minute to upgrade because there are a limited number of AS certification body auditors and it would not be possible to get everyone upgraded near the deadline.
  • There is concern regarding the extremely tight timelines. Companies have a shorter amount of time to retrain internal auditors, conduct audits, do a new management review, and get upgraded at the next scheduled audit after 6/15/17.  Watch for simpleQuE’s aerospace training on the new standard.
  • Here are two scenarios of the new timing requirements communicated by SQA:
    • If your last registrar audit was June 1, 2016 then you could delay upgrading to your June 2018 annual audit.
    • If your last registrar audit was June 21, 2016 then you must upgrade during your June 2017 annual audit, and have no choice to delay until 2018.

Keep up with simpleQuE’s blog posts and training courses for the latest information affecting the quality world.