Quality Management Dos and Don’ts – Don’t be guilty of being in the red

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1. Meet Customer Requirements

Surprisingly there are companies that want ISO 9001 certification just to satisfy one customer requirement. The customer states that it will only do business with vendors that are certified as ISO 9001 – so to get (or keep) the business they need that certification. The problem with these companies is that they’re looking for a short-term payoff and an end to the journey with a certificate. They see nothing but that one benefit — we need a certificate for this customer — and ignore the long-term benefits a robust quality management system will provide, like:

  • Less firefighting;
  • Fewer repeat problems when you perform better root cause analysis and systemic corrective actions;
  • Increased performance because you’re monitoring trends against goals;
  • More efficient and effective business processes;
  • Less scrap, rework, rejects, warranty; and
  • Increase customer satisfaction leading to more business opportunities.

Some organizations don’t embrace the concept of quality linked with the business systems and tied into the strategic direction of the company, to drive continual improvement and continued customer satisfaction. In other words, they haven’t bought into the program or the true intent of the standard.  Focusing only on that one benefit — your immediate gain — without putting the customer in front will end up costing you much more in the long run.

2. Increase Revenue and Business from New Customers

Once you earn your ISO 9001 certification, you can advertise your quality certification and respond to Requests for Quotes (RFQ) from companies that make ISO 9001 certification a “must-have”.  ISO 9001 certification can open up new markets you were virtually unable to do business with before your certification.

Yet, companies are not advertising their ISO certification enough, costing them potential business. Transition or implementation of a new standard is the perfect time to share that the company has achieved this important recognition with your potential customers, current customers, and stakeholders. Consider a link to a copy of your ISO certificate right on your website.

3. Improve Company and Product Quality

quality management system standard is all about quality so, of course, one result of adopting a QMS should be an improved level of quality for the entire organization — every process, and every product. Organizations should use the ISO series of standards to develop a QMS that is integrated into the way they do business, and assist in achieving their strategic business objectives – adding value.

Unfortunately, some organizations may have missed the mark and created a bureaucratic set of procedures and records that don’t reflect the reality of the way the organization actually works and simply add unnecessary costs, without adding value. When the business system is the same as the quality system processes, the value of ISO and certification become more logical and value-added for the business.

4. Describe, Understand, and Communicate Your Company Processes

The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better manage and control your business processes. Quality objectives or your business process goals form the center of your system. Metrics are used to understand and communicate your system’s performance and trends relative to your quality objectives. The level of monitoring, measurement and improvement of each process will depend on the organization’s context, strategic intent and determined risks and opportunities.

Companies may identify too many processes. So it is important to understand the differences between a process, a procedure and an activity. We recommend less than 10 core processes, and fewer is commonly better.  Looking at your business from a 50,000 foot view to understand the high level business processes needed to deliver the products or services you provide your customers are the core processes ISO wants you to define.  Everything from sales, to new product development, to production planning, to production or providing a service, and finally delivery are the processes to identify for your business.  A flow diagram is most commonly used with the linkages and interactions between each.  Each of these core processes needs to have at least one objective that is measured to evaluate the effectiveness and efficiency of that process. Problems can also occur when companies don’t have set metrics on which to evaluate processes and manage the control of their business processes.

The International Organization for Standardization (ISO) has created a useful whitepaper to explain the Process ApproachContact simpleQuE to see how our consultants can assist your company with these problems or other areas of concern.

 

 

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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.

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The Benefits of Working with a Management System Consultancy

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Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!

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.

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.

LSI Combines Unique Lighting and Graphics Capabilities to Deliver Image-Enhancing Cost Saving Opportunities to Customers Nationwide

Photo from left to right:  Larry Vance, VP SimpleQuE; Yvette Kilburn, Corporate ISO Coordinator, LSI;  Shawn Toney, President of LSI Lighting;  Virgilio Acevedo, Corporate Director of Quality
Photo from left to right: Larry Vance, VP SimpleQuE; Yvette Kilburn, Corporate ISO Coordinator, LSI; Shawn Toney, President of LSI Lighting; Virgilio Acevedo, Corporate Director of Quality

Whether it’s from New York’s George Washington Bridge to multitudes of CVS retail locations or Burger King restaurants around the country, LSI Industries’ high-performance, energy-efficient lighting and image-enhancing graphics are optimizing customers’ brands, products and services.  For 40 years, LSI has been proudly serving the commercial, industrial, institutional and specification markets with a broad offering of architectural and professional-grade lighting fixtures utilizing a range of integrated controls and lighting technologies from LED to traditional HID and fluorescent.

LSI is committed to advancing solid-state LED technology to make affordable, high performance, energy-efficient lighting and custom graphic products that bring value to their customers. With a vast offering of innovative solutions for virtually any lighting or graphics application, LSI provides sophisticated lighting and energy management control solutions to help customers manage their energy performance. And in addition, offers a full range of design support, engineering, installation and project management services to customers.

LSI’s major markets include commercial / industrial lighting, entertainment venues, petroleum / convenience stores and multi-site retail facilities (including automobile dealerships, restaurants and national retail accounts). Headquartered in Cincinnati, Ohio, LSI has facilities both there and in seven other states.

Guided by Larry Vance, Jim Bannan and a team of simpleQuE consultants, LSI achieved ISO 9001:2015 certification through Eagle RegistrationsCongratulations LSI Lighting!

The Quality Connection

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As a consulting company, simpleQuE specializes in quality and environmental management systems and we are frequently asked what services we provide and how we are different from a certification body. This article explains the objectives, roles and responsibilities of the organization, consulting company and certification body to provide a better understanding of the connection between all three.

Organization (Manufacturing or Service Company)

Seeks to achieve one or more of the following objectives:

  • Implement and develop a new quality (QMS) and/or environmental management system (EMS)
  • Upgrade certification or expand to a new standard
  • Improve and/or simplify an existing QMS or EMS registration
  • Obtain certification

Consulting Company (simpleQuE)

Assists organizations with implementation, improvement or transition by:

  • Providing customized consulting, training and internal auditing services and solutions
  • Assessing existing processes through a gap analysis and developing an action plan
  • Offering internal and supplier audits
  • Training for internal auditors and management including implementation and full standard reviews

Helps organization partner with Certification Body:

  • Assuring a common language for auditing and interpretation of the standard so it corresponds with the expectations of the Certification Body and requirements of the standard

Certification Body (Registrar)

Issues certifications: Provides organizations a resource for management system certification by evaluating policies and procedures to verify implementation and effectiveness against the specific requirements of the standard.  Assessment consists of a series of audits:

  • Document review (sometimes combined with Stage 1)
  • Initial certification audit – Stage 1
    • Confirm that organization is ready (or not) for a full Certification Audit. Typically 30-60 days prior to the Stage 2 Certification Audit.
    • Verifies required documentation exists, certain requirements have been met such as a full internal audit completed, a management review completed, and risks considered.
    • Verifies processes have been established and is appropriate for the scope of certification, and that appropriate monitoring and measuring of processes are in place with appropriate objectives.
    • Plans the Certification Audit based on information and data gathered
  • Certification audit – Stage 2
    • A full QMS or EMS audit. Confirms that the management system fully conforms to the requirements of the standard.
    • Certification is issued upon successful completion of Stage 2 assessment and closure of any findings.
  • Surveillance audit
    • Certification is maintained through a series of annual surveillance audits (sometimes semi-annual). Every third year a full recertification audit is performed and a new certificate issued.

In summary, good communication between all partners is important to ensure all requirements and objectives are met in a simple straightforward way to comply with the standard. At simpleQuE we partner with the client and Certification Body to make quality excellence “simple”.

ISO 9001 Certification Changing the Standards for Higher Education

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More than 1 million organizations and companies worldwide understand the benefits of being ISO 9001 certified. Educational institutions are beginning to recognize the importance of established standards and are seeking certification, as well. As we enter the new school year, a these schools have taken the initiative and will start the year as ISO 9001 certified: Oakwood University, Greater Altoona Career and Technology Center,  DRS International School, and Wenatchee School District #246. Continue reading “ISO 9001 Certification Changing the Standards for Higher Education”

News Update from the International Automotive Task Force (IATF)

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In October 2016 IATF 16949:2016 will be published by IATF and it will replace the current ISO/TS 16949, defining the requirements of a quality management system for organizations in the automotive industry. It will be aligned with ISO 9001:2015 and its structure and requirements. IATF 16949:2016 will be implemented as a supplement to, and in conjunction with, ISO 9001:2015.  www.iatfglobaloversight.org

IATF has also released a new transition strategy document for automotive suppliers and certification bodies to help with the transition.  It includes information about timing and transition audit requirements. After October 1, 2017 no audits (initial, surveillance, recertification or transfer) will be conducted to ISO/TS 16949:2009. IATF Transition Strategy ISO/TS 16949 › IATF 16949

It is also important to note that IATF/IAOB will recognize TS certified companies that have upgraded to ISO 9001:2015 prior to IATF 16949 and allow reduced audit days when the company does eventually upgrade to the new IATF 16949 standard.  Companies should coordinate with their registrar to determine the optimal audit approach and cost benefit.  (Separate audits may be not be cost effective, but it will depend on each company’s situation.)

SimpleQuE consultants and instructors are ready to assist companies now with implementation, transitioning and training for ISO 9001:2015 and TS 16949:2009.  Consulting and training for IATF 16949 will be available after its release in October.  Contact simpleQuE