Category: simpleQuE

What You Need To Know About ISO 45001

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Worldwide over 6300 people die each day from work-related accidents or diseases – nearly 2.3million every year.  ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, to provide a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world. ISO 45001 is targeted to be published in the first quarter of 2018 and will replace OHSAS 18001. Current users of OHSAS 18001 will need to update their systems according to the requirements of the new international health and safety standard within a three year transition period that will commence after ISO 45001 is published.

 

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Recognizing our Nation’s Manufacturers

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Industrial robot with conveyor in manufacture factory,Smart factory industry 4.0 concept.

During National Manufacturing Month, simpleQuE recognizes the important role that manufacturers have in our economy and everyday lives.  We work with a wide range of manufacturing clients who produce components and parts of every kind for a variety of industries. Those products include:  tires, wheels, brake systems, fitness equipment, electronics, motors, batteries, lighting, assemblies, harnesses, springs, air compressors, acoustical insulation, specialty chemicals, coatings, firearms and ammunition, gears, powertrains, meters and pumps, steel and other metals, gauges and valves, compressors, electrical connectors, machines and tooling, rubber molded and extruded parts, plastic molded parts, steel, metal stampings, printing ink, and clay products. (Just to name a few.)

Many are Tier I and Tier II suppliers to the automotive and aerospace industries, and as with all of our clients, they take pride in the design, development and manufacture of their products and recognize the importance of establishing and maintaining a quality management system to provide the highest level of customer satisfaction.

Industries/Market Sectors Served

  • Automotive/Truck/Commercial Vehicles
  • Aerospace, aircraft parts, space, defense
  • Chemical
  • Steel
  • Construction
  • Consumer Products
  • Electronics/Electrical, including semiconductor
  • General Manufacturing (machining, molding, stamping, assembly)
  • Medical
  • Mining
  • Oil and Gas
  • Telecommunications
  • Train/Locomotive

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

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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.

The Countdown Begins

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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!

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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.

The History of AS9100

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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.
SQ_Infographic_AS9100

 

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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Welding robots movement in a car factory

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.  IATF 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.

Look Fors – Part 2: Leadership

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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.