Current State of Quality View

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Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding content, or have a subject of interest for a future newsletter, please let us know!

Current State of Quality View



With the advancements industries have made over the last 20 years, defining the quality needs of the near future – even five years out – requires a data-driven understanding on what is  working and what isn’t working.

A study initiated by the Automotive Industry Action Group (AIAG) was conducted to illuminate specific areas of focus for a near-future, industry-wide, quality-focused initiative. The goal was to  survey OEMs and suppliers to provide focus, which included the responses of the 22 AIAG board member companies, and distribution of the survey to companies within in their supply chains as well. This included an additional 23 leading automotive companies who were also interviewed.

It’s important to note here that the automotive supply chain follows ISO/TS 16949 Automotive Quality Management System Standard, one of the standards our company delivers. However, this study’s findings are relevant to many industries providing key improvement findings.  The ISO/TS Standard is also undergoing a current revision which is projected to be published in the spring of 2016.

The term “Quality 2020” was coined for this effort, with the goal to provide a reasonable timeframe to put improvements in place by 2017 and measure results by 2020. The results of the comprehensive study highlighted in a white paper (See AIAG Website  for downloadable copy) provide a summary of the key findings, and some insightful interpretation.

The top 5 issues as ranked by all respondents:

1. Problem Solving

2. Customer Specific Requirements

3. Quality Management System

4. Product Development

5. Loss of Experience

Problem Solving

OEMs and suppliers identify the same four reasons that they believe the industry’s problem-solving capabilities are inadequate, although they rank them in a different order of importance:

Root cause analysis is lacking, management/organizational culture, and feeling rushed are emphasized roughly the same. Particularly intriguing is that almost two-thirds of respondents feel their organizations are, at best, moderately capable at problem solving.

Point: Lacking Root Cause Analysis – Find it and fix it mentality still prevails. We continue to drive the train of fire-fighting versus problem prevention. Another problem is that very few companies enforce a structured problem solving/root cause methodology, equating to management culture issues, and rushed to correction, and corrective action results.

Customer -Specific Requirements (CSR)

OEMs and suppliers overwhelmingly agree that automakers would benefit from having one consolidated set of aligned OEM CSR requirements; however, they also agreed that significant effort would be required to change QMS standards or requirements.

Despite the expected challenge, a near-unanimous agreement on the benefits of a single set of requirements indicates an opportunity for collaboration in addressing this impediment to optimum quality.

Point: Standardization is good. The complexity of CSRs for Tier 1 suppliers can be difficult, and the challenge for Tier 2 through lower level tier suppliers can be very confusing.

Based on this study, AIAG personnel are confident that many of the current CSR redundancies can be incorporated into the basic quality standard or diverted to the OEMs and Tier 1s Terms & Conditions.

Quality Management System

Respondents agree that standardization is the #1 area impacted by complex and redundant QMS requirements, which also affects operational efficiencies, relationships, and ability to respond to quality-related events.

On a per-site average, respondents invest 116 workdays annually to comply with QMS requirements. More remarkable is that they forecast at least a 40 percent reduction in this investment if complexity and redundancy are reduced even to a minimum.

The top three actions that have the most potential for improving QMS are reducing TS requirements to only those elements with direct impact on product quality and reliability; determining audit schedules based on performance; and combining TS and VDA requirements.

Point: Respondents also are closely aligned on their top three concerns if no changes are made to QMS: The need to maintain multiple systems to satisfy multiple standards (relevant to all certified companies), a continued increase in the number of OEM and Tier 1 specific requirements, and continued incidents of poor correlation between certification status and actual performance.


Product Development

Survey respondents agree that assuring product compliance is the top reason why product development is important. OEMs also feel this issue is important to innovation and to sustained quality performance, while suppliers place greater emphasis on impact to profitability and operations.

OEM and supplier respondents overwhelmingly believe they are capable in product development, and they agree on the top five product development improvement opportunities: design in quality, design for manufacturability, lean product development, system DFMEA, and design for Six Sigma.

Point: Effort and actions produced up-front, at the beginning of the design of quality and design of manufacturing funnel are critical to identifying and solving problems, including preventing increased problems in the manufacturing and validation cycles.


Loss of Experience

Survey respondents indicate that a lack of skilled workers, compensation that does not meet requirements, and little incentive for young people to select careers in automotive are long-term concerns that may impact automotive quality.

OEMs and suppliers are particularly concerned about the large number of retirements in the next five to eight years (due to retiring Baby Boomers), which will result in a loss of know-how, teachers, and mentors. Furthermore, over one-third of OEM respondents describe themselves as somewhat capable or having no capability in preserving and transferring knowledge.


Point: We’re sure you can agree, that the overall consensus within the U.S. manufacturing industry is the same. Knowledge management for the long term is highly lacking, and our current educational system is not preparing or providing incentives, including funds to train and to replace our manufacturing working base.

The top three concerns for survey respondents regarding the industry’s near-future loss of experience include the ability to avoid repeating past mistakes; the ability to implement operational efficiencies; and the ability to develop new talent.

More than half of respondents expect a high level of risk to the industry if no actions are taken to close the gap between the current rate at which the industry is losing experienced workers versus its ability to attract and replace these workers with new talent.


New Standard Improves Certification Process

An effective management system is an essential business ingredient and having it certified to a recognized standard can bring a number of benefits. Now, the certification process is even better with a new standard for auditors and certification bodies who certify to ISO’s management system standards.


The just-published ISO/IEC 17021-1:2015 replaces the second edition of ISO/IEC 17021:2011.

ISO/IEC 17021-1:2015, Conformity assessment – Requirements for bodies providing audit and certification of management systems, Part 1: Requirements, relates to the competence of certification bodies themselves and their auditors. It applies to the auditing and certification of all types of management systems in order to increase their value to public- and private-sector organizations worldwide.

Certification bodies that use the new ISO/IEC 17021-1 will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner. It will also help create confidence among regulators, consumers, suppliers and other stakeholders that certificates granted by one certification body are effectively equivalent to that offered by another.

What’s new? 

But how does the new ISO/IEC 17021-1:2015 differ from its predecessor (ISO/IEC 17021:2011)? In concrete terms, ISO/IEC 17021-1:2015 has been updated to focus more on how certification services are delivered by a certification body, and as such, the improvements are intended to:

  • Bolster the effectiveness of operational and organization control by certification bodies of remote offices, regardless of their organizational structure,

  • Enhance an additional risk management approach,

  • Define audit time and audit duration, and then focus requirements for justification on audit duration, which is the time from the opening to the closing meeting.

ISO and the IAF have agreed on a two-year transition period from the date of publication of ISO/IEC 17021-1:2015 for certification bodies to bring their operations and processes in line with the requirements of the new standard.

A joint ISO-IAF Informative Document giving detailed information is available here.

How Annex SL Will Change ISO Standards

The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of multiple management systems.

Integrated management systems generally refers to integrated processes that result in one management system to implement ISO 9001, ISO 14001, OHSAS 18001 (the new ISO number will be ISO 45001) or food safety standards such as FSSC 22000.

Annex SL addresses the requirements for the future of management system standards (MSS). It consists of 9 clauses and 3 appendices. This annex has been developed primarily with ISO technical committees who develop management system standards; however the impact of Appendix 2 of Annex SL will be felt by all users of management system standards in the future.

Appendix 2 is in three parts:

* high level structure,

* identical core text,

* common terms and core definitions.

Future management system standards will need to have these elements. In addition, there will be less confusion and inconsistency because common terms will all have the same definition and there will be common requirements across all the management system standards, for example the requirement to establish, implement, maintain and continually improve the management system.


High level structure

The major clause numbers and titles of all management system standards will be identical They are:

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement.

All ISO MSS should be consistent and compatible – they will have the same look and feel. At this time, it is questionable whether ISO 13485 Medical Devices Standard will utilize Annex SL. Many of us are hoping that this could be the beginning of the end of the conflicts, duplication, confusion and misunderstanding arising from subtly different requirements across the various MSS.

Auditors now face the challenge of focusing their own and their clients’ thinking on viewing organizations management systems holistically.

We will continue in our next newsletter with more information on the transitioning of MSS and specific requirements.


In the News

2015’s Best & Worst Cities to Work for a Small Business 

Small businesses collectively make up 99.7 percent of all U.S. employer firms, employ nearly 49 percent of the private workforce, pay about 42 percent of the private payroll, and created 63 percent of all new jobs added during the past 20 years, according to the U.S. Small Business Administration.

WalletHub analyzed the small business environment within the 100 most populated U.S. metro areas to assess their friendliness toward employees and job seekers. They used 11 key metrics, ranging from net small business job growth to industry variety to earnings for small business employees.

Visit the WalletHub website for further study information.


Aerospace Suppliers Ramping Up To Meet Surging Orders

The aerospace supply industry is still in the early days of a long-term boom in orders, say industry participants at a recent suppliers summit hosted by GE Capital at GE Aviation’s headquarters in Cincinnati, OH.

The large majority of participants, who were split about evenly in serving wide-body and narrow-body commercial aircraft platforms said they plan to increase their workforce over the next 12 months (84%), expect to win new long-term supply agreements in the next three years (91%), and expect aircraft deliveries to continue to grow at least through 2016 (76%).

When asked about their manufacturing future, 87% said they will be investing in new manufacturing equipment over the next 3 years. Regarding incorporating additive manufacturing, 27 percent are already doing it, 10 percent expect it to happen within the next year and 37 percent expect it in the next one to five years.

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In June we attended National Quality Assurance (NQA), a leading Global Certification Body Teaming Conference for three days in St. Lois, Missouri.  A great learning and knowledge experience with consultants and third party auditors!  The conference was packed with new information on many management system standards and the transition of future standards being revised.  In our August Newsletter we will be sharing this information with our readers.
Stay Tuned!   

Best regards,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642



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