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IMPACT Autumn 2014 We Offer a World of ISO Certification, Assessments and Training Presented by UL DQS Inc. A New Milestone in Steiner History Page 2 The Global Food Safety Initiaitve Wraps Up Standards for Food Packaging Page 6 Waste Management: A Source for Savings Page 11 Medical Devices: The Challenge of Product Lifecycle vs. Labeling Page 4 Itron - Continuous Improvement & World Class Benchmarking Guidelines Page 8 e annual ISO Survey of Management Systems Certifications provides a glimpse of global trends in the adoption of core management systems standards such as ISO 9001 and ISO 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations seek 3rd party accredited management systems certification to enable internal improvements as well as business growth. As such, the 2013 ISO survey indicates the continued benefit and growth of management systems with over 1.13 million ISO 9001 certifications and over 300K ISO 14001 certifications. ese basic standards provide the impetus for the strong growth in ISO 13485 (+15%), ISO 22000 (+15%), ISO/TS 16949 (+7%), as well as other sector specific standards. Overall, management systems standards increased by +4% in 2013 following the varying econom- ic strength in different parts of the world while continuing to provide the independent assurance for global trade. With certifications in 187 countries, the ISO standards and independent 3rd par- Continued on Page 3

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Page 1: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

IMPACTAutumn 2014

We Offer a World of ISO Certification, Assessments and Training

Presented by UL DQS Inc.

A New Milestone in Steiner History

Page 2

The Global Food Safety Initiaitve Wraps Up Standards for Food Packaging

Page 6

Waste Management: A Source for Savings

Page 11

Medical Devices: The Challenge of Product Lifecycle vs. Labeling

Page 4

Itron - Continuous Improvement & World Class Benchmarking Guidelines

Page 8

The annual ISO Survey of Management Systems Certifications provides a glimpse of global trends in the adoption of core management systems standards such as ISO 9001 and ISO 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations seek 3rd party accredited management systems certification to enable internal improvements as well as business growth. As such, the 2013 ISO survey

indicates the continued benefit and growth of management systems with over 1.13 million ISO 9001 certifications and over 300K ISO 14001 certifications. These basic standards provide the impetus for the strong growth in ISO 13485 (+15%), ISO 22000 (+15%), ISO/TS 16949 (+7%), as well as other sector specific standards.Overall, management systems standards increased by +4% in 2013 following the varying econom-ic strength in different parts of the world while continuing to provide the independent assurance for global trade. With certifications in 187 countries, the ISO standards and independent 3rd par-

Continued on Page 3

Page 2: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

On Thursday, August 28th, UL DQS presented Steiner Electric Company a plaque commemorating 20 years of ISO 9000 certification. This achieve-ment is significant for the organiza-tion and the industry as a whole since Steiner is 1 of only 6 Electrical Distrib-utors in the Chicagoland area to be ISO certified. Steiner Electric is a fourth generation, original family-owned and operated, business founded in Chicago, Illinois in 1916. Today, Steiner is within the top 30 largest electrical distributors in the country. For 98 years it has provided “uncompromising integrity through dedicated people, services and resources, to help their customers be the very best for their customers.” In 1994 the Steiner Leadership Team came to the realization that incorporat-ing processes, procedures and guide-lines such as the ones for ISO 9000, would not only help improve their in-ternal effectiveness, but also provide a competitive advantage in the market-place. The team researched and com-pared several organizations that could help Steiner achieve the necessary cer-tification and came to the decision that Underwriters Laboratories (UL) pro-vides the most stringent program and was the right fit for Steiner. Over the past 20 years, Steiner has cre-ated a very mature and well-defined

Quality Management System. This system is managed by the corporate office in Elk Grove Village and over-sees the management of five additional locations: St. Charles, Chicago, Tinley Park, Gurnee and Loves Park (Rock-ford area). Steiner also engages in face–to-face events throughout the year at each of its eight locations in order to gauge customer satisfaction and en-courage performance feedback to sup-port a model of continuous improve-ment. Each of these events provides a strong basis for Steiner’s belief in forg-ing relationships and partnerships with both suppliers and customers. Additionally, Steiner’s annual com-munity service includes the following activities:• Steiner / Kerman Education

FoundationScholarship - Found-ed in 2007, provides scholarships within the eight communities sup-ported by Steiner locations, plus a

program that provides an oppor-tunity for the children of Steiner employees to qualify for a schol-arship.

• Homeless Children’s HolidayParty – Yearly event since 1992 for over 300 homeless children. Steiner provides a turkey lunch with all the trimmings, entertain-ment and a personal gift from Santa for each child. Everything is 100% donated from within the Electrical Association of Chicago, plus cash donations to cover all the out-of-pocket expenses, including a special gift for each participating shelter that provided computers, mattresses and linens.

• The American Cancer Society,Walk&Roll

• KoatsforKids• BoyScouts• LookingglassTheater

2

New milestone in Steiner History

Impact Autumn 2014

UL DQS Inc. President & CEO, Ganesh Rao, presents the management team at Steiner, in-cluding Richard Kerman, President & COO, Adam Kerman, and Rich Hamer, Sr. VP Supply Chain & CIO, with a plaque recognizing 20 years of certification to ISO 9001

• Family owned for nearly 100 years

• Registered with UL and UL DQS Inc. since 1994

QUICK STATS3

Page 3: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

Steiner is a successful, family-owned, business that truly understands and ac-tively supports the commitment to val-ues. Here are some examples of how Steiner applies that principle:Going above and beyond for its cus-tomers by supporting them.• Treating their partners, manufac-

turers and suppliers the way they would want to be treated.

• Adding value for their partners, manufacturers and suppliers to help them grow and prosper.

• Caring about employees, their career growth, and their devel-opment to ensure Steiner is the “place of most potential.”

• Demonstrating passion about the success of Steiner Electric and

ensuring growth and continuity of the business to the next gener-ation.

• Striving to make a positive differ-ence in the communities it serves.

Receiving the 20-year plaque for ISO 9000 certification was a very proud moment for the organization and most importantly, for Rick Kerman and his son, Adam Kerman, who represent the

third and fourth generation. This rec-ognition supports Steiner’s values and its continued focus and investment for the future.

Kellie LindquistDirector of MarketingSteiner Electric Company

3

Impact Autumn 2014

ty assessments are now part of busi-ness-to-business transactions in virtu-ally every economic sphere. You can access the executive summary and complete survey results at http://www.iso.org/iso/iso-survey The ISO 9001 standard was first estab-lished 27 years ago in 1987 to help or-ganizations ensure that customer and stakeholder needs are met under spe-cific requirements related to the prod-

uct or service. It is indeed a significant achievement for an organization to stay committed to sustaining a manage-ment system for over 2 decades. It is an honor that we have many such achiev-ers who have invested in their compa-nies and trusted UL DQS Inc. as their certification partner for over 20 years. Companies like IEWC, Steiner Electric Co., Plitek, and Sturtevant Richmont show that sustaining a well- designed management system over the long term can be an essential ingredient

for weathering the economic ups-and-downs and seeking new opportunities for growth. There are many other ex-amples of forward looking leadership and commitment people. Congratula-tions to those that have achieved the 20 year milestone! Thank you for placing your trust in UL DQS in this journey.

Ganesh RaoUL DQS Inc.President & CEO

Continued from Page 1

Page 4: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

The product life cycle starts with an idea. Transforming the idea into reality begins with a design and proceeds to a prototype with further development and refinement. Ultimately, the idea turns into a product release. Where does la-beling fit into this scheme: what is the importance of labeling; how does the target market affect labeling; and what are labeling requirements? All of these questions are important from the start of the product life cycle through the end of product life.

Importance of LabelingWhat is the importance of labeling? Missing information required for the label may signify adulterated product. These requirements do not apply to the adequacy of labeling content, except to make sure the content meets labeling specifications contained in the device master record (DMR). If the DMR specifies information for the label then all of the information needs to be on the label exactly as specified. Spec-ified, but missing, information from the label can lead to fines and potential loss of license in that market.

When thinking about labeling, one must be mindful that labeling is not just limited to primary packaging. La-beling requirements may affect many items: equipment, labels, control la-bels, package labels, and directions for use, and maintenance manuals. Also, labeling requirements may extend to the instructions, prompts, cautions, and so on, displayed on monitors and other electronic message panels.Target MarketImportant questions to consider in determining the needs for product la-beling include the following: what is the product; what is the device classi-fication; and will the product be sold as sterile? These questions lead to the fundamental question: What is the tar-get market – the US, Europe, Canada, the rest of the world?The target market significantly influenc-es labeling requirements. Wherever you intend to sell product, you must meet specific labeling requirements. Every market has its particular requirements.Labeling RequirementsSo what information needs to be on a label? It depends! There are multiple variables that can influence the infor-mation required. The primary influ-ence is the market where the product will be sold. It is generally accepted that a label will include the name of the device, name and address of the manufacturer, the control number (when appropriate), indication of what the package con-

tains, indication of the product being “Sterile” – if the device is to be sold in a sterile condition – expiration date, intended use, and directions for the use and storage of the product. Fur-thermore, market place requirements influence content on the label.For example, the EU requires the name of the authorized representative be on the label. The classification of the de-vice can also change labeling require-ments. Active implantable devices in particular markets (i.e., Europe) have specific labeling requirements that do not apply to other types of devices.Like many requirements within the medical device industry, labeling is changing as well. A new labeling con-sideration is the inclusion of a Unique Device Identification (UDI) mark. Most medical devices distributed in the United States carry a Unique De-vice Identifier, or UDI. This also ap-plies to certain combination products that contain devices.What comprises a UDI? Here is a hy-pothetical example.

4

Medical Devices: The Challenge of Product Lifecycle vs. Labeling

Impact Autumn 2014

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5

Impact Autumn 2014

The FDA requires that a UDI is com-prised of two parts:• An identifier of the specific model

and labeler (usually the manufac-turer) of the device

• As required based upon the class of device, a production

identifier that may po-tentially include lot/batch of manufacture, serial num-ber, and/or expiration date or date of manufacture.

For some devices – specifically those that remain in use for an extended pe-riod of time (such as implantables), are sterilized routinely, or may become separated from their original label – the rule requires the UDI information to be

directly marked/etched on the device. Additionally, combination products and convenience kits require a UDI. However, there are specific exceptions for both situations, so it is necessary to

refer to the final regulation document. Additionally, the FDA speci-

fies that a “new UDI will be required in the event that a change to a device re-sults in a new version or model, or if a new device package is created.

Another type of labeling, referred to as “special” la-

beling, includes over-label-ing, electronic IFUs

(EIFUs) and sterilization.

Over-la-b e l i n g is plac-ing a new la-

bel over an old label.

This is highly discouraged, but ac-

ceptable as long as the new label used meets GMP requirements for legibility, reprocess-ing, and change control.

Over-labeling is most commonly seen in situations where the label revision changed, or was a part of

kitting/distribution processes.

Regulations in many coun-tries allow for the provision of EIFUs in addition to and as an alternative to paper hard copies, with specific re-quirements. Most manufacturers have

either started or have considered pro-viding EIFUs instead of paper. IFUs, although there are greater risks asso-ciated with this method. Accordingly, the requirements to deliver EIFUs are slightly more burdensome than provid-ing hard copies.

The labeling of sterile devices requires special attention. Devices that are not sterile in their entirety (for example, sterility may be needed only for the lumen of certain devices) must be la-beled to properly inform users what is actually intended to be “sterile” in the package. For example, a possible limit-ing statement might be “Caution: Only the fluid path of the set is sterile and non-pyrogenic. Do not use in a sterile or aseptic area without proper precau-tions.”

Some devices intend that the user ster-ilize them before use. In this situation, the labeling should provide adequate information to describe at least one suitable method of sterilization and any precautions or safeguards that the user should follow. In the case of single-use sterile devices, some manufacturers in-clude labeling to advise against re-ster-ilization and reuse. Some devices are simply not designed or constructed for re-cleaning and may not withstand re-cleaning or re-sterilization proce-dures.

For additional information on labeling requirements, refer to the specific mar-ket where the device will be sold.

Richard Burgess, UL DQS Inc.Medical Device Program Manager

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6

Impact Autumn 2014

As food manufacturers become ever more global with manufacturing in many countries and distribution net-works crossing borders to meet the de-mand of the global market place, food is no longer just a local issue – it now has global implications and concerns. While early efforts focused on the safe-ty of food alone, now organizations recognize that food safety must also in-corporate its packaging within the same framework.This global effort – The Global Food Safety Initiative (GFSI) – is the devel-oping mechanism to create a uniform industry approach. GFSI will establish protocols and standards that companies can follow in manufacturing and pack-aging processes for global acceptance. Michael Pearsall, Director of Food Safety Business Development at UL-DQS, Inc. pointed out at the Society of Plastics Engineers (SPE) Annual Blow Molding Conference last year: “This certification is important to your business because your food and bever-age customers will be very reluctant to purchase products from you unless you have a GFSI certification.”

The main goal of GFSI is to set accept-able standards in food manufacturing and packaging that – when applied – will ensure product safety, quality and legal requirements while encouraging continual improvement of business manufacturing practices. In an approach similar to ISO certifica-tion, the GFSI will establish standards and accredited certification bodies. Those organizations will work with companies to set in place practices and controls aligned with GFSI guidelines. A company can achieve GFSI certifica-tion once it meets such standards.The Consumer Goods Forum (CGF), located in Paris, governs this initiative; CGF benchmarks and approves stan-dards for inclusion in the certification requirements. The industry’s belief in the need for such a system comes from the support of industry leaders, such as Coca Cola, Pepsi, WalMart, Kroger, Unilever, Danone, Kraft, and Nestlé. The GFSI builds its methodology on the basis of existing food safety protocols previously initiated by various coun-tries. Some of these standards now re-

ceive recognition from countries other than the ones that developed them.FourExistingStandardsCompanies seeking certification can choose to adopt one of these four exist-ing standards:• British Retail Consortium-IoP

(BRC-IoP)• Safe Quality Food (SQF)• Food Safety System Certification

(FSSC22000), and • International Featured Standards

(IFS).Most all protocols use the HACCP practices (Hazard Analysis and Criti-cal Control Points) that direct efforts to detect hazards to food safety in man-ufacturing and establishes controls to prevent hazards rather than relying on testing the end product. This is a pro-cess control approach. What follows is a summary of the four food safety standards.TheBRC-IoP standard, originating in the UK, developed from the collabo-ration of packaging and product safety experts. BRC-IoP is rigorous and de-

The Global Food Safety Initiaitve Wraps Up Standards for Food PackagingOptions include four standards to ensure product safety, quality and legality

Page 7: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

tailed, yet easy to understand. Follow-ing HACCP, the standard is “hazard and risk management-based.” It incorpo-rates food safety management systems and internationally accepted best man-ufacturing practice. The standard offers a clear step-by-step path towards certi-fication and a comprehensive support package to get a company started. The straightforward certification process means that companies can easily identi-fy costs at the beginning of the process. The SQFCode, originating in Austra-lia, is unique in that it has three levels of certification. The SQF 2000 Code re-quires a supplier to review its SQF sys-tem at least annually and make chang-es where appropriate. Moving through the three levels of certification also encourages continuous improve-ment of a supplier’s management of product safety and quality. The standard acknowledges that some suppliers have already made considerable investment in developing extensive product safety and quality management systems; achieving SQF Level 3 certification would formalize these management systems.FSSC2200, the Food Safety Manage-ment System, owned by the Foundation for Food Safety Certification, a world-wide concern based in The Nether-lands, extends the certification scope of FSSC 2200 to include Packaging Ma-terial Manufacturing, according to the recent publication of PAS 223 (Public Available Specification): “Prerequisite Programs and Design Requirements for Food Safety in the Manufacture and Provision of Food Packaging.” A steer-ing group consisting of leading global packaging and food manufacturing companies developed PAS 223.PAS 223 outlines the requirements for establishing, implementing, and main-taining prerequisite programs (PRPs) as well as design requirements to assist in controlling food safety hazards in the manufacture of food packaging. Be-

cause members of the working group include representatives from leading food manufactures (Coca Cola, Uni-lever, Danone, Kraft, and Nestlé) and international packaging material man-ufactures (TetraPak, Rexam, Amcor, O-I, and Berry Plastics), the Board of the Foundation for Food Safety Certifi-cation has strong confidence that there will be a need for certification.IFSPACsecure, created by IFS Man-agement GmbH (owner of the GFSI benchmarked IFS Food Standard) and the Packaging Associa-

tion Canada (PAC) provides packaging manufacturers with the ability to certify primary and secondary packaging ma-terials for the food industry. A technical working group comprised of some of North America’s largest global packag-ing and food manufacturers developed the standard. Management of the stan-dard comes from a joint effort of the PAC through its technical expertise in the packaging industry and from IFS and its global network of food safety and quality standards infrastructure. HowtoGetStartedThese four standards comprise the GFSI portfolio for the global thermo-

plastics industry involved in the man-ufacturing of food related products. A company can choose either standard depending on its specific needs. The four standards differ in method of im-plementation and some require special-ized training, while others may require minimal or no training.If a company lacks the knowledge or personnel to prepare for certification to its chosen GFSI Standard, it is ben-eficial to involve a consultant or a con-sulting group to assist it. Preparing the organization for certification requires establishing the proper documentation, performing training, and driving the necessary culture changes to adapt, or replace, past business practices.

When the company is ready for cer-tification, an authorized body must

conduct the audit; there are many to choose from. Pearsall adds, “One key criterion is to find a firm that is willing to establish a solid relationship with your organization. This is accom-plished by answering questions

such as the reasons why a re-quirement is in the standard.” It’s

important to note that a certification body is not allowed to consult with a

company seeking certification during an audit. GFSI audits are systems audits and in-volve every aspect of a business that involves product safety, quality and le-gal requirements. These standards are an excellent way of reducing risk and thereby liabilities as companies expand farther and farther into the global mar-ket. Also, GFSI Standards serve as a teaching tool to improve company or-ganization. In conclusion, Pearsall points out, “Gone are the days of the one day Good Manufacturing Practices or quality au-dits. Packaging safety has been incorpo-rated into the GFSI certification audits and the plastic packaging manufactur-ers will be all the better for it.”

7

Impact Autumn 2014

Page 8: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

Corporation OverviewItron, Inc. (ITRI) is a global technol-ogy company. We build solutions that help utilities measure, manage, and analyze energy and water. Our broad product portfolio in-cludes electric-ity, gas, water, and thermal en-ergy measure-ment and control technology; communications systems; software; and professional services. With thousands of employees sup-porting nearly 8,000 utilities in more than 100 countries, Itron empowers utilities to responsibly and efficiently manage energy and water resources. Itron-Waseca is one of the 23 Itron fac-tories around the world.Facility OverviewItron-Waseca is an 110,000 sq. ft. Manufacturing and R&D facility in Waseca, MN. The non-union plant is a 3-shift, 7-day/week operation. Wase-ca currently employs 304 people. (Direct Operation Employees: 121, Operations Support Staff: 82, Product

Development: 47, Management: 23, Supply Chain: 19, Customer Relations: 12). The Waseca facility designs and builds automated meter reading devic-es for gas, water, and electric meters. Advanced and innovative, Itron’s com-munication modules attach to new or existing meters to equip them for data collection. Itron-Waseca produces 358 unique endpoints or kits that are avail-able for meters from all leading meter manufacturers. These benefit suppliers by delivering accurate usage and tam-per data for enhanced customer service and improved operations.

Waseca – Certifications with UL DQS Inc.

ISO-9001:2008 Quality System, ISO-14001 & OHSAS 18001, along with ATEX certification. Our quality sys-tem is our baseline for all the contin-uous improvement programs we have in place.Waseca’s Improvement Journey

In 2010, the management team in Wase-ca recognized the need for an overall system to help support the various lean manufacturing initiatives that were being conducted. This system would demonstrate leadership’s commitment and help prevent backsliding. As a result, the Operations Management System (OMS) Steering Committee was formed and continues to meet on a weekly basis. The Steering Committee is made up of key managers from the Operations, Quality, Reliability, Pur-chasing, Human Resources, and Lo-gistics Departments. The OMS Com-mittee has used the Tools, Systems & Principles (TSP) Map tool of the Shin-go Model for Operational Excellence to develop a strategic plan for Industrial Excellence.

8

Itron - Continuous Improvement & World Class Benchmarking Guidelines

Impact Autumn 2014

• 8,000 employees support nearly 8,000 customers in more than 120 countries

• Provides 1,500 manufacturing jobs in the U.S.

• Invested $1.3 million into the local communities in 2013

QUICK STATS3

Page 9: IMPACT Autumn 2014 - We cover a world of certification · 8/22/2018  · 1400, as well as industry sector standards such as ISO 13485, ISO/TS 16949, ISO 22000 etc. Industry organizations

We began Shingo prize training with the help of Utah State University and great-ly benefited from using the Shingo Mod-el for Operational Excellence to provide strategic direction for our Lean Manu-facturing implementation. For the past four years, Itron has used the Shingo Model for Operational Excellence as a roadmap for continuous improvement for our Manufacturing and Business Operation, thereby giving Itron a com-petitive advantage. The Shingo Mod-el has allowed us to connect our Lean Business Principles, Systems, and Tools to our Core Values as a company allow-ing us to transform our culture and pre-vent Lean Manufacturing from being a mere “flavor-of-the-month” training initiative. The foundation of our work over the past four years has been our TSP Map (Tools/Systems/Principles). This allowed us to evaluate and bench-mark ourselves in the key foundational elements and helped create a strategy of achieving excellence in each supporting system of our Lean Enterprise. The TSP allows us to see the relation-ship between our Key Behaviors and our Key Systems and Tools associated with each system. Successful imple-mentation of these Systems and Tools, aligned with our Business Principles and Core Values, has led and will con-tinue to lead us to excellent business results. Some of our best practice con-tinuous improvement ideas include the following:• IdeaGenerationBoard(employ-

ee suggestion system) - One of our best practices is our Idea Gen-eration Board System. This con-tinuous improvement system was developed by a group of produc-tion team leaders and supervisors to find a way to collect and com-plete as many improvement ideas as possible to ensure that the cor-rect resources were working on the solutions in a timely manner. The IGB System has generated over

1,000 ideas in the past 2 years with over 500 ideas being implemented with an estimated cost savings of $250,000.

• Key Behaviors - Itron’s Reward and Recognition System is based on rewarding key behaviors that are aligned with our core values and basic principles to maximize

9

Impact Autumn 2014

GOAL 2011 2012 Q2 - 2013 Q3 - 2013 Q4 - 2013

SN = Strong Negative 100% 0% 40% 65% 75% 80%

X = Not Existent 0% 50% 112,263 81,462 (27.4%) 64,011 (43%) 66,049 (42%) 57635 (49%)

W = Weak 20% 100% 25% 75% 100% 100% 100%

W+ = Weak plus 50%

SP = Strong Positive 80% 50% 55 ppm 16 ppm (71%) 14 ppm (75%) 14 ppm (75%) 12 ppm (78%)

50% 1360 ppm 175 ppm (87%) 344 ppm (75%) 89 ppm (94%) 107 ppm (92%)

June 2013 GOAL 2011 2012 Q2 - 2013 Q3 - 2013 Q4 - 2013

2 3 0 0 2

457 7 11 16

90,796 115,354 64,011 66,049 57,635

808 698 496 293 382

44 37 27 23

98% 94% 100% 100% 100%

9% 12% 6.1% 3.80% 2.6%

113% 167% 110% 110%

3.2% 2.9% 2.30% 3.4%

8 0 0 0

Water Final Assm

Gas Final Assm

SMD

CE.1 CE.2 CE.3 CPI.4 CPI.5 CPI.6 CPI.7 CPI.8 CPI.9 CPI.10 CPI.11 CPI.12 CPI.13 CPI.14 EA.15 EA.16 EA.17 EA.18 EA.19 R.20 R.21 R.22 R.23

Educ. Training Coaching

Empower Involve Everyone

Assure Safe Envir. Pull/ Demand of Product

Flow of Product/ Service

Flow of Resources, Mat.,

Info.Stabilize/ Standard Visual Mgmt. Directly

ObservingIdentify Eliminate Waste Sense of Urgency Problem Solving Quality at the Source Integrate Improv.

IdeasCreate Constancy of

PurposeStrategy Deployment Long term focus -

PlanningTransparently Sharing

InformationStand. Daily Mgmt. Create Value for

CustomerMeasures that Matter Align Behavior w/ Perf. Cause & Effect

Educ. - External Team Structure SustainabilityBuild Rate Schedule

Value Stream Mapping

Supplier Kanban

Standard Work Andon SystemEMS/QMS

AuditKaizen

SPC notification and escalation

PDCA PRAIdea Generation

Board

Plant Improvement

Plan

Plant Improvement Plan

Quarterly Strategy meetings

Communication Coaching QMS Plant wide metricsPerformance Management

DCAV

Intern Development Coaching EMSScheduling

SystemCellular Design

Value Stream Mapping

Visual Management ?

5S 5SCell information

boards (Rotocube)Reward &

RecognitionDOE CIT Training

ESD/ SSI Safety Teams

Vision Statement Goal Setting QMS/MPSPlant Improvement

PlanQRQC Kaizen Communication

Plant Improvement Plan

Coaching

ISO 360 Performance Management Communication Super Market Day by Hour MRP Training

Cell information boards (Rotocube)

Gemba Walks Steering

CommitteeValue Stream Mapping Red Alert FMEA

Process Enforcement

Kaizen WorkshopsMission

StatementKPI

Site Financial Report

Plant wide metrics DCAV VOC KPI TSP MappingPerformance Management

Lean TrainingIdea Generation

BoardISO 14001

Resource Planning

MRPResource Planning

Coaching QRQC Boards Coaching Recycling Program Tiger Teams DFX Red Box LLCGuiding

PrinciplesCommunication

meetingCommunication

Industrial Excellence Assessment

CommunicationProduct Life

CyclePlant Improvement

PlanReal Time SPC Communication

Safety Training Communication OHSAS 18001 Line BalancingSupplier Kanban

Train Delivery System

DOC Control Plant wide metrics DCAV Training QRQC Coaching PFMEA Product Life CycleIndustrial Excellence Standard

Product Support Team

IMPACT room Gemba Walk KBI TSP Mapping

OJTReward &

RecognitionErgonomics

Process Standard Work

One Piece FlowProject Priority

MatrixReal Time SPC QRQC DCAV DCAV QRQC

Poka -Yoke Error Proofing

TPM Waseca ValuesSite Financial

ReportStandard Work

New Hire Orientation

QRQC Zero Waste to landfillTrain Delivery

SystemPlant

Improvement Plan5S DCAV Autonomation IMPACT Ideal Behaviors Resource Planning TSP Mapping

Coaching Job Safety Analysis 5W2H DFX QRQC IMPACT KPI/KBI

Supplier Quality Day Leader Std workQuarterly Strategy

meetings

Team Leader Training

Out of Box - Gas line (Defined as a return that is < 90 Days Old)

Out of Box - Water line (Defined as a return that is < 90 Days Old)

IDEAL BEHAVIORS THAT AMPLIFY THE ORGANIZATION'S VALUES (KBI)

BEHAVIOR DRIVENIDEAL PERFORMANCE (KPI)

PERFORMANCE DRIVEN

Build Customer Value OMS goals

Quality

W+

W+ W+

SP SP

w w

W+ W+

W+

W+ W+W+

W+

L = Leader

S = Support Staff

A = Associates

W+

W+

W+

SP

w

W+

LEAD

ERSH

IP F

OCU

S

Employee Empowerment

Community Involvement

Striving for Excellence

Leaders create an expectation of excellence on a continuous basis. They are seen in the workplace routinely, actively listening and removing road blocks in areas to achieve flow and the creation of a quality product.

L

Commitment to Diversity & Teamwork

L

Leaders establish customer focused requirements & objectives and promote the development of specific key performance metrics that drive the right behavior.

Managers actively monitor and evaluate performance metrics, targets, and goals. They take the initiative to remove road blocks that inhibit the flow of the product and focus on the process, not the person. S

Associates take the initiative to identify quality issues or defects immediately. They engage collectively with the right support resources to ensure that problems don’t reoccur. A

Leaders align resources and remove barriers to create diverse, effective teams to accomplish organizational objectives. Leaders create an environment that promotes a constructive relationship and unity between all employees (L, S, A).

W+

A

W+ W+ A

Leaders encourage and actively participate in community service. They provide appropriate resources and time for all employees to engaging in serving their own communities.Leaders identify environmental objectives and targets to ensure a safe community free of pollution. L

A

SP

W+ W+

S

Associates can identify how the work they do impacts the quality and the customer. Associates are actively engaged in seeking ideas that improve their work area. A

Managers coach problem solving and encourage decision making in their area. They listen and actively seek ideas, providing quick and meaningful feedback.

SP, W, X, SN

RESULTSENTERPRISE ALIGNEMENT

Warranty Result (PPM)

Days supply on hand

On time shipments

Cost of Non Quality

Productivity

Absenteeism

Safety

Managers lead by example, actively participating in community service and encouraging all employees to regularly participate in their own community.Managers actively seek ways to recycle and minimize the use of chemicals and hazardous material.

Leaders create an environment that encourages self-confidence and self-esteem. They provide resources and actively encourage ideas from all employees. Leaders encourage guided decision making at all levels.

L

W+

SP

SP

SP

W+

W+

W+

SP

SP SP

Motivation

ASSO

CIAT

E FO

CUS

CULTURAL ENABLERS CONTINUOUS PROCESS IMPROVEMENT

SYSTEM CATEGORIES (23)

Complete Systems and processes have been reviewed and are in use.

Revision: 02/12/2014 JAG

W+ W+

W+ W+

SP

W+ W+

Complete

Completion Estimate

Half complete

These systems can enable us to move significantly ahead in accomplishing our strategic goals/objective.

Keep on Radar this Year

Secondary Focus

Primary focus

These systems support our Primary Focus and Reinforce the Cultural Climate that leaders want to create.

We don't want to lose sight of these systems but the impact is minimal at this time. Required for Industrial Excellence standard.

W+

1/4 complete

KBI Guide

OMS IMPLEMENTATION MAP

Implement Operations Management System using the Shingo Model in Waseca by 12/31/14

Reduce defects by 50% for all product lines by 12/31/14 in PPM (% improvement) Jim G.

Achieve Zero Waste to Landfill for Waseca by 12/31/13 (Paul A.)

Reduce out of box failures by 50% for each product line by 12/31/13 (Steve D.)

IDEAL PERFORMANCE (Financial KPI)

Supplier Quality Incidents (Cum)

Out of Box incidents

Total Process Rejects (PPM)

Managers create an environment that fosters problem solving, where suggestions are encouraged and success quickly recognized. Managers are seen in the workplace daily with a committed passion to assure process integrity.

S

Associates ensure no defects are passed on. There is a sense that identifying waste is just part of their job.

L

Managers create an environment that fosters teamwork. They utilize appropriate cross-functional teams to focus on improvements that involve various value streams. Managers involve outside eyes from other departments to help challenge the status quo.

S

Associates engage in teamwork on a daily basis to solve problems and identify waste/opportunities. They collectively work with peers and management to meet organizational goals.

Supply Chain

Cost Performance

S

Associates regularly take the initiative to make a better community by participating in diverse community service. Associates actively seek ways to recycle and minimize the use of chemicals and hazardous material.SP

3/4 complete

Our Vision, Mission, and Beliefs

Our Vision The way we manage energy and water will shape this century. Itron’s innovative solutions enable our customers to build a sustainable future for their business, their customers and the environment.

Our Mission We provide critical knowledge to empower the world’s utilities to responsibly manage energy and water.

Our Beliefs At Itron, we believe that our innovative solutions provide the critical knowledge to help build a sustainable future for us all. Shaping the way the world manages energy and water is the value that we provide to our shareholders, employees and the communities in which we work and live. Our shared values guide us, inspire us and drive us to succeed every day. As individuals we live them. As a company, we measure our success by them. Build Customer Value - We listen to customers, understand their challenges and strategies, and ensure that Itron is viewed as fundamental to their success. Instill Excellence - We are unrelenting and uncompromising in our pursuit of quality and reliability in our products, systems and services. Invest in Our Communities - We invest in products, programs and organizations that focus on sustainable resources and community development— to the benefit our customers, employees and the environment. Embrace Diversity and Teamwork - We embrace employees from different geographies, cultures, backgrounds and with different points of view. We contribute as diverse individuals and win as a unified team by sharing knowledge and opinions.

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customer satisfaction. If we con-sistently reward the right key be-haviors that support the principles of quality and teamwork, we will continue to drive results and cus-tomer satisfaction in a positive di-rection.

• DCAV - Problem Solving Culture project which is also displayed in the factory as (Detection-Commu-nication-Analysis-Verification)DCAV PrinciplesDetection• Make problems visible, and

welcome opportunities to im-prove.

Communication• Quick, transparent commu-

nication of problems enables fast resolutions.

Analysis• Using simple tools, find the

root cause of problems based on logical analysis.

Verification• Build upon new knowledge

gained from products, pro-cesses, services and activities.

Control Plan training for operators and increased usage on the manu-facturing floor.• Development of a Six-Sigma

system to address the larger Idea Generation Board projects.

• QRQC – European Automo-tive suppliers developed this tool based on Toyota problem solving techniques. Any problems that the teams or technicians cannot re-solve or fix long term are escalated to the Product Quick ResponseQuality Control (QRQC) daily meeting. The supervisors present

defect information to the Product Support Team, and the Operations Manager assigns a project to one individual to gather more data and identify root cause and corrective action for the problem.

Itron’s Industrial Excellence (I2E) programIn 2013 we incorporated a new system for our Lean journey. Itron Industrial Excellence is a ContinuousImprove-ment process, enabling each site to move towards Excellence, whatever its starting point, and taking into account Itron Industrial Excellence Network bestpractices. ROADMAP1. We have gathered all best practices from our teams into one unique roadmap. This roadmap is split into three phases: • the basics; • advanced monitoring; • Excellence. 2. ASSESSMENT EVALUATION• A simple assessment has been de-

veloped to determine the status of each facility and determine the steps for improvement.

These two tools, the roadmap and the assessment evaluation—allow each factory to build their own journey to-

wards excellence. Waseca Achievements 2011-2013• 34% improvement in First Pass

Yield• 60% reduction in Product Scrap• 35% improvement in Revenue/

Employee• 24% reduction in Energy/Unit• 6% improvement in On-time De-

livery• 16% increase in amount recycled• Achieved Zero-Waste-to-Landfill• 41% reduction in Near Misses• 47% reduction in Reportable Inci-

dentsAwards • 2009 “GOLD” Supplier Quali-

ty Rating from San Diego Gas & Electric

• 2010 Assembly Magazine Plant of the Year – Honorable Mention

• 2010 Outstanding Delivery Perfor-mance from Southwest Gas

• 2014 AME – Plant of the Year fi-nalist

• 2014 Shingo Prize finalistJim GertsenItron - Waseca Quality Assurance Manager

10

Impact Autumn 2014

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11

Impact Autumn 2014

Waste management is an area where simple chang-es to process steps and behavior can generate significant savings while improving environmen-tal performance. I want to share a story with you about how one of our clients gained this under-standing.In McAllen, Texas on January 2014, I visited Paramount Bedding to conduct a sec-ond ISO9001:2008 assessment, au-diting 8.3 non-conforming materials. When I asked my client what they did with their waste, i.e., wood skids, banding, cardboard, fabric, foam, and bedsprings. Their response: We throw it in the dumpster, and it goes to the landfill. My initial thought was “Why pay money to dispose of waste when you could recycle it at no direct cost?”During lunch I had time to reflect on this issue. It bothered me that our cli-ent hadn’t yet made the connection that

managing waste can help them to save money while reducing their impact on the environment. So I communicat-ed my concerns to our client, and we discussed the benefits of an Environ-mental Management System (EMS) program and the role of UL-DQS as well as our commitment to our clients’ improvements and the environment. The results of this conversation are both satisfying and impressive. Below, are email excerpts from Paramount Bed-ding to me that describe what happened. February 12, 2014Hi Peter!I wanted to let you know that I talked to Alfredo and Lupe today and they wanted me to tell you they are now re-cycling plastic AND they found some-one to take all of the fabric scraps. Wow! That wouldn’t be happening if you hadn’t brought it up at the January 31st audit!Thank you so much.Kind regards,Debbie

February 27, 2014

Good Afternoon,So after two weeks of Re-cycling we are removing a lot of waste from the landfill. We used to fill two 8-yard containers to the top, per week cost-ing $232.12 a month. I changed the container size and now we will re-ceive one 2-yard contain-

er weekly, which costs only $73.37 a month. So we will only be sending 2 yards of waste to the landfill compared to the 16 yards per week. And, it will cost $158.75 less a month. Now we will only send 104 yards of waste com-pared to 832 yards per year. I believe if I did my math right we recycle about 93.7% of our waste.Thank you,LupeBy making simple changes to process steps and behavior, Paramount Bed-ding now recycles most of its waste – saving money and improving the en-vironment. UL-DQS commits itself to creating value for our customers by as-sisting them to become environmental stewards.

Peter Delbert

UL DQS, Inc. Lead Auditor

Waste Management: A Source for Savings

• Made in the USA

• 2 facilities with 47 employees

• ISO 9001 certified since 1998

• Participate in the DR3 Mattress Recycling program

QUICK STATS3