Archive for November, 2014

ISO 9001:2015 DIS Receives Approval Moves to FDIS

Monday, November 10th, 2014

The ISO 9001 Draft International Standard (DIS) was put to vote to ISO member nations and received nearly 90% approval, which is enough for it to progress to the next stage: Final Draft International Standard (FDIS) currently forecast for publication in March 2015.

The countries that voted against the DIS were the United States, along with Canada, Finland, Germany, Ireland, Israel, Japan, and South Africa. A majority rule is needed to push the draft onto its next stage. ISO body rules require that the negative comments be addressed prior to the FDIS (final draft international standard) publication, and the number of comments appears to have been many. Prior to the DIS approval, thousands of public comments were submitted regarding the DIS content, for example the Annex SL structure requirements and the “risk based thinking” including the lack of a structured risk based methodology such as ISO 3100 Risk Management Standard.

The ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward for voting. Once approved beyond the FDIS publication, the completed standard will then be published with a projected date of September 2015.

The main changes to the future ISO 9001 Standard include:

  • Emphasis on risk-based thinking and management involvement
  • Stronger emphasis on process monitoring, measurement effectiveness, and performance delivery
  • Increased systems value for the organization and customer
  • Increased flexibility on the use of documentation
  • More applicable to service organizations

We will keep all our readers posted on any further information received on this revision.  Contact us with any specific questions.

 

Strategy Deployment

Monday, November 3rd, 2014

 

Sustaining Edge Solutions, Inc.    November 2014 
This Month

Events
ISO 9001:2015 Revision and Update. Phoenix ASQ Chapter General Session. January 8, 2015. Walter Tighe, Presenter  
 
Lean and Six Sigma Conference March 2-3, 2015 Phoenix, AZ.  See you there!  

 

 

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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.

Strategy Deployment

With the new year approaching, effective organizations should be thinking of and planning their overall strategic goals. Integration of a well planned strategy, along with business plans aligned with its vision, mission, value proposition, and core competencies, enables an effective organization to achieve and sustain a cultural shift toward lasting improvement.

Strategy deployment, also referred to as policy deployment or hoshin kanri, is a strategic planning methodology in which everyone can participate in process management to “cascade down” strategic objectives through all levels of the organization. This method is designed to ensure that all personnel go about their work in a way that applies to the master plan of the organization consistently. Strategy deployment links the strategic goals of an organization with a cascade of increasingly specific programs and activities that support those goals.

Implementation Process

Strategy deployment requires an organization to review its key strategy for the coming year, set goals to support strategic direction, identify specific areas where Lean events and other tools can support those goals, establish a pattern of improvement events and processes for the coming year. This method is not a single document creating meeting, and requires a cyclic management strategy, with regular review of actions to address any deviations from the strategic plan.

A common understanding of the strengths, weaknesses, opportunities, and threats (SWOT) present in the external and internal environment of the company. Generally speaking, strengths and weaknesses are internally-focused, and opportunities and threats are externally-focused. The team, which can be divided into sub-teams, then identify actions and an implementation schedule to align the direction with the information revealed in the SWOT analysis.

Methodology

Strategy definition and development can follow a number of methods, however a simplified and effective method is teams document the organization’s midterm strategy, annual strategy, and tactical improvement projects using a strategy deployment matrix, or X-matrix, which is used to guide strategy design and record the results. An X-matrix presents a visual display of the planning team’s strategy design on one piece of paper, and it is a place to record decisions to articulate and execute an improvement strategy.

Deselection is another important step in strategy deployment. Deselection requires team members to evaluate the alignment of improvement projects against the strategic objectives in the X-matrix, and “remove ” deselected projects that are not aligned. This step helps ensure that the organizations improvement efforts are focused and not spread over too many priorities.

Successful organizations remain successful not through chance, but through proactive planning and key strategy action, setting goals to support strategic direction, execution and robust performance measurement.

Contact us for more information, and an example of the method reviewed. We deliver organizational performance assessments and strategy deployment assistance.

Manufacturing Management Standard

An expected standard to be published in 2014 – SAE International standard, AS6500, is designed to encourage suppliers and OEMs to put more focus on manufacturability during the early phases of a product’s life cycle. The objective: more reliable, affordable, and on-schedule systems.

 

Problems with cost overruns, missed deadlines, supplier quality issues, and negative Government Accountability Office (GAO) reports prompted the standard.

 “The standard will help achieve that by requiring certain activities to be accomplished and certain assessments of manufacturing maturity to be done early in the life cycle,” the sponsor of the standard, David Karr, told Aerospace Engineering. “It applies all the way through development and production-and even in the sustainment phase, so when major modifications to weapons systems are being done, it will also cover those major modifications.”

 

From a Quality Management System perspective, the industry is well covered by ISO 9000 and AS9100, Karr said. “But there was a gap in the manufacturing management area for which there were no government or commercial standards available.”

Another DOD philosophy that has contributed to the current state of affairs is a greater tolerance for risk as it relates to manufacturing maturity-“especially compared to how the commercial industry does things,” Karr said. “Commercial industry spends a lot of time, effort and money making sure their manufacturing processes are stable and capable and mature before they go into production. Unfortunately, we don’t mirror some of the commercial industry’s practices when it comes to maturing our production processes.”

for measuring your manufacturing maturity and level of risk. It’s a tool that the standard imposes that’s widely recognized and has a common language that everyone understands. The standard addresses the use of that tool very early on in the life cycle so that early on we understand where our manufacturing risks are and we can start addressing them.”

Risk tools identified are Producibility Analysis, Process FMEA, and Key Characteristics are among other tools.

 

Comment: Note that this standard is also addressing Risk and specific risk management tools and methods.  For example, AS9100 certified companies are using these risk tools to meet risk requirements. Keep in mind that “Risk” is mentioned 18 times in the current ISO 9001:2015 Draft International Standard.   

 

We will inform all our readers when AS6500 is published. 

Six Pillars of Supplier Assessments

Defined supplier criteria and effective measures are essential when it comes to selecting and assessing your supplier base and its current quality system. The Automotive Industry Action Group (AIAG) made up of global automotive manufacturers, think ISO/TS 16949 Automotive QMS Standard, have identified a general checklist of questions when assessing system quality.

 

These questions fall into six categories: facilities, profile information, logistics, manufacturing, quality, and technology. 

Here are some questions that can come up in a supplier assessment:

Facilities

  • Does the supplier have a formal capacity plan and analysis methodology that is used and maintained?

  • List the employee turnover rate for the past two years

  • Does the supplier have a formal capacity plan and analysis methodology that is used and maintained?

Profile Information

  • What products or services does the facility manufacture?

  • Is there any pending litigation against the supplier/facility?

  • What is the supplier’s on-time delivery percentage for production and service parts for the past two years?

Logistics

  • What are the different modes of transportation used to ship product?

  • Does the supplier have internal packaging design capabilities?

Manufacturing

  • Is there evidence of appropriate and adequate operator training?

  • Is the work place properly organized, e.g., 5S, lean, ergonomic?

  • Does the supplier select resources based on education, training, experience, and/or requirements?

Quality

  • Does the supplier ensure early sub-tier supplier involvement?

  • Does the supplier conduct equipment validation and perform run at rate in preparation for production?

  • Does the supplier have an end-of-life management process, e.g., controlled ramp-down, to protect customer quality and schedules?

Technology

  • Is there is evidence of regular design and development reviews with customers?

  • Are technical reviews completed to address all open issues?

  • Are formal documented design reviews by the appropriate functions conducted at appropriate stages of design per a design plan?

What we like about this list is that it provides measurement categories that drives improved supplier performance. This list may be to extensive for some organizations, but think beyond the supplier criteria basics of on-time-delivery, price, and if we received a purchased nonconforming issue.  

A full checklist of questions under supplier management process guidelines can be purchased through the AIAG Website.

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In the News
ISO Standards Still A Worldwide Priority

The annual ISO Survey, published in September 2014 is now entering its third decade, and continues to provide a pragmatic picture of certifications to ISO’s management system standards across the globe. On trend from previous years, the latest edition demonstrates reliable performance for all seven ISO management systems standards covered in the survey.

Getting certified to ISO management systems is still very much a priority. This conclusion comes courtesy of the latest ISO Survey of Certifications which records a grand total of 1, 541, 983 certificates issued worldwide at December 2013 – a 4 % increase over last year.

On trend from last year, three sectors exhibit steady growth, in particular information security management (ISO/IEC 27001) and food management (ISO 22001), respectively boasting a healthy 14 % and 15 % increase in certification, while the medical devices sector (ISO 13485) similarly shows a 15 % increment. Strikingly, the U.S. tops the certification charts for medical devices, a field otherwise dominated by Europe which claims a substantial 60 % share of the market.

To read the ISO Survey Executive Summary Overview (PDF) and to download the survey results (Excel) visit the ISO Website.

New Changes to Baldrige Award Eligibility

 

The Baldrige Performance Excellence Program, the component of the National Institute of Standards and Technology (NIST) has announced three changes in the eligibility requirements for the 2015 award. These improvements will expand opportunities for high-performing organizations to apply for the nation’s highest honor recognizing organizational performance excellence and innovation.

The 2015 changes to Baldrige Award eligibility requirements are based on customer and stakeholder input. They:

  • Allow an organization showing a high level of maturity and superior performance metrics to apply for a waiver of the standard requirement of first achieving a top-level award sanctioned by the Alliance for Performance Excellence (a body made up of the 30-plus state, local, regional and sector-specific Baldrige-based programs serving nearly all 50 states);

  • Make prior Baldrige Award recipients qualified to reapply after 5 years no matter what new or revised eligibility requirements are established; and

  • Base the eligibility of an organizational subunit (such as an individual business unit within a larger manufacturing company) solely on its ability to respond to the Baldrige Criteria for Performance Excellence rather than its size or the percentage of external customers its serves.

For more information about the requirements and the Baldrige Award visit the NIST Website.

 

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What makes exceptional companies?  Vision, Planning and Strategy Deployment.  The new year is approaching – What are you doing different? Avoiding past mistakes and taking the time to plan your next moves can make the difference between an exceptional year, and a mediocre year for you and your organization.

Sincerely,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
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