summer 2013 - omnex · summer 2013 6 8 9 10 12 15 ... iso/ts 22002-1 for food manufacturing and/or...

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Getting Started on the Path to Food Safety Managementusing the GFSI standards for management system certification by Chad Kymal, Chief Technical Officer

Energy Management Systems Gaining SteamISO 50001 adoption rate is growing around the worldby David Watkins - Executive Vice President

The Global Food Safety Initia-tive (GFSI), launched in 2010, is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers world-wide. GFSI provides a platform for collaboration between some of the world’s leading food safety experts from retailer, manufac-turer and food service companies and service providers associ-

ated with t h e fo o d s u p p l y

chain, international organiza-tions, academia and government.

Large food retailers and manufac-turers such as Wal-Mart, Coca-Cola, Hormel, and McDonald’s

are now driving the GFSI through their supply chain. Other organi-zations such as Kraft Foods and

“large food retailers and manufacturers are now driving the GFSI through their supply chain”

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GM Revising Quality System Basics

EwIMS Gaining Traction in the Aerospace Sector

Aerospace Product Quality Manual Update

News From Omnex Around the World

Omnex 2013 North American Training

ISO 9001 and ISO 14001 Revisions Underway / Changes Coming to the AS9100 Third Party Audit Process

Chad Kymal

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David Watkins

Since its release in June 2011 organizations have been enthu-siastically embracing ISO 50001. Why?

The bottom line is that it saves on energy cost and is an overall net positive revenue generator. During the ISO 50001 launch event, Ken Hamilton, Director, Global Energy and Sustainabil-i ty Services, Hewlett Packard (USA), described ISO 50001 as a “very pragmatic standard which will help companies to integrate energy management with busi-ness practices. It will allow mul-tinational companies like Hewlett Packard to reduce energy costs

and increase the efficiency of energy use throughout global supply chains.”

Mr. Hami l ton quoted resu l ts from two pilot implementations which were part of the Superior Energy Per-f o r m a n c e p r o g r a m sponsored

COnTinuED On Pg 5

“Energy is a significant cost in itself and c a n a l s o i m p o s e environmental and

societal costs”

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Nestlé are in the process of becoming third-party certified. However other food companies are missing out on this opportunity. Why?

There are many significant opportunities to companies who become certified including the ability to sell to the larger brands. Achieving certification is a big step towards establish-ing credibility for the organization. The GFSI will provide the structure and systems for managing and maintaining Food Safety Man-agement systems.

In Omnex’s work with food organizations, many have not looked at the GFSI due to confusion regarding the variety of different recognized standards and an overall lack of understand-ing. This article will help organizations who are having difficulties getting started.

The GFSI Standards

The GFSI initiative was launched in 2000 after a number of food safety scares dropped consumer confidence to an all-time low. Current activities within GFSI include the definition of food safety require-ments along the entire food supply chain to cover scopes such as feed, distribution and packaging. The development of a capacity building program for small and/or less developed businesses is facilitating their access to local markets and a focus on food safety

auditors is bringing industry experts to common consensus on the skills, knowledge and attributes that a competent auditor should possess.

The daily management of GFSI is undertaken by The Consumer Goods Forum, the only indepen-dent global network for consumer goods retailers and manufacturers worldwide. It serves the CEOs and senior management of nearly 400 members, in over 150 countries.

The GFSI created a benchmark model to which any and all standards could compare themselves. Once they are considered equivalent, the standard can be used as a GFSI standard. A list of currently recognized GFSI schemes can be found on this page.

This article will briefly summarize three of the more popular standards — SQF, BRC and FSSC 22000.

SQF

Safe Quality Foods (SQF) is owned by the Food Mar-keting Institute (FMI) and is the most popular of the

many GFSI standards. One of the reasons could be that Walmart mandated GFSI standards in the U.S. and SQF is the only U.S.-based GFSI standard. Nev-ertheless it is an effective and popular food safety standard.

Processors seeking to achieve certification focus on Sections 4, 5 and 6 of the code. Section 4 defines the requirements for food safety fundamentals such as document controls and identification of preserved foods. Section 5 covers building and equipment design and construction. Section 6 covers written program requirements for activities such as training, pest control and allergen control.

SQF can be achieved in three levels:

• Level I, which is the most basic level, ensures that the organization has met the food safety fundamentals. This level does not require HACCP and is meant for a low risk operation.

• Level II includes all the requirements of Level I and the requirements of HACCP, which re-quires a scientific approach to managing food safety risk.

• Level III includes the integration of Quality along with Food and represents the highest level of certification. HACCPs for food safety and quality are integrated in Level III.

Getting Started on the Path to Food Safety ManagementCOnTinuED frOm PagE 1

Current Recognized GFSI Schemes

• Global Aquaculture Alliance Seafood Processing Standard

• Global G.A.P. (Good Agricultural Practice) Integrated Farm Assurance Scheme and Produce Safety Standard

• Food Safety System Certification (FSSC) 22000

• Global Red Meat Standard (GRMS)

• CanadaGAP (Canadian Horticultural Council’s On-Farm Food Safety Program)

• Safe Quality Food (SQF) 7th Edition Level 2

• British Retail Consortium (BRC) Global Standard for Food Safety Issue 6 and BRC/IOP Global Standard for Packaging and Packaging Materials Issue 4

• International Featured Standard (IFS) Food Version 6

note: Primus gfS is currently undergoing the benchmarking process

“Many have not looked at the gfsi due to confusion regarding the variety of different recognized standards”


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BRC

The BRC Global Food Standard was created in 1998 by the British Retail Consortium which is made up of Britain’s largest retailers. This is the second most popular scheme after SQF. The standards cover food, consumer products, packaging manufacture, and storage & distribution. BRC standards are organized around seven fundamentals:

• Senior Management Commitment and Con-tinual Improvement

• Food Safety Hazard Analysis and Critical Control Points Plan (HACCP)

• Food Safety and Quality Management System

• Site Standards

• Process Control

• Personnel

In addition to meeting the requirements of all seven fundamentals, processors must have documented risk assessments for 28 specific areas identified by the standard to achieve BRC certification.

FSSC 22000

FSSC 22000 was created by a nonprofit foundation located in the Netherlands. It is supported by the Confederation of FoodDrinkEurope.

FSSC 22000 addresses food manufacturing and pack-aging in its scope of certification and is actively looking to add more. FSSC 22000 is made up of ISO 22000 and requires Prerequisite Programs following either ISO/TS 22002-1 for Food Manufacturing and/or PAS 223 for Food Packaging. ISO 22000 is a food safety standard developed by the International Organiza-tion of Standardization based in Geneva. This is the same organization that develops both the ISO 9001 (QMS) and ISO 14001 (EMS) standards.

Following international ISO standards and audit requirements are one of the strengths of the FSSC 22000 standard. Many of the largest food manufac-turers have adopted ISO 22000 as their standard of choice. The easy integration of this standard with ISO 9001 and ISO 14001 and the international rules they follow is a big differentiation of this standard.

Following ISO 22000, FSSC 22000 is organized into five sections:

• 4.0 – Food Safety Management System

• 5.0 – Management Responsibility

• 6.0 – Resource Management

• 7.0 – Planning and Realization of Safe Product

• 8.0 – Validation, Verification and Improve-ment of the Food Safety Management System

The standard is very similar to ISO 9001 – Quality Management System Standard in all respects except

Getting Started on the Path to Food Safety ManagementCOnTinuED frOm PagE 2

What Are the Differences Between FSSC 22000 and Other GFSI Recognized Schemes?

• Independent, International Standards FSSC 22000 uses international, independent ISO standards and additional requirements. These standards are not owned by a specific stakeholder organization like most other GFSI recognized schemes. The standards are developed and maintained by Food Safety experts from around the world working together in an ISO committee. The experts are nominated by the members of ISO, the national standard-ization organizations. They come from all stakeholders from the food supply chain like retailers, manufacturers, food authorities etc.

• Management System Certification FSSC 22000 is a management system certification scheme. Schemes like IFS, BRC and SQF are process / product certification schemes. This means a significant difference in the audit approach. First, the audit duration of a FSSC audit is longer and the audits have more depth. FSSC is not an annual audit where a list of requirements is checked but has a three year cycle. It starts with an initial certification that includes a stage 1 and 2 audit. The stage 1 audit is review-ing if the food safety management system covers all requirements and has an in depth review if the HACCP plan is complete and robust. Approximately 6 weeks later the stage 2 audit is conducted. This covers the implementation and effectiveness of the system. It includes a review of the implementation of CCPs, OPRPs and PRPs. After a successful certification audit a certificate is issued with a validity of 3 years. Each year a surveillance audit is conducted reviewing if the system is continuously implemented, effective and up to date. After 3 years a re-certification audit is conducted where the whole system is reviewed again and when being successful the certificate will be extended. Another significant difference between a management system audit and a process / product audit is that manage-ment system audits focus also much stronger on management commitment, effectiveness, and continuous im-provement. This supports the organization in achieving better results and a higher level of conformity.”

source: Benefits and Strengths FSSC 22000. (Note 11-4390-FSSC).

Retrieved from http://www.fssc22000.com/en

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navigatorGetting Started on the Path to Food Safety ManagementCOnTinuED frOm PagE 3

for 7.0 – Product Realization. ISO 9001 requires pro-cesses for new product development while FSSC requires HACCP in this section. Integrating ISO 9001 and FSSC 22000 brings in the process focus of the ISO 9001 greatly enhancing and also simplifying the food safety implementation.

The Path to Certification

This has been a short overview of the two most popular GFSI standards, BRC and SQF, and an up-and-coming standard with some key benefits in FSSC 22000. At a basic level, all organizations implementing GFSI standards have to document how they meet the “shalls” or mandatory requirements in BRC, FSSC 22000, and SQF. While not all the standards require a food safety manual, they all of them require docu-mentation i.e., procedures and/or work instructions.

The next step is to implement the requirements. Once implemented, internal audits need to be conducted to ensure they are meeting all requirements. Fol-lowing this, a third-party audit will be undertaken to obtain certification. After this, periodical surveillance

audits will take place to ensure they are maintaining conformance with the standards.

For more information, Omnex is conducting a webinar titled “Food Safety Standards — Understanding Food Certification Standards Basics and an Implementa-tion Roadmap. A recording of this webinar will be made available if you unable to attend a live session. Another alternative is to enroll in Omnex open enroll-ment training on FSSC 22000 (see upcoming training schedule on page 12). Omnex can also conduct BRC, FSSC 22000, and/or SQF training and implemen-tation support, including integration with existing management systems, onsite at your location.

Chad Kymal is the founder and CTO of Omnex inc., a global, business management consulting organization with hundreds of consultants and several offices worldwide. Chad is an international trainer and consul-tant whose broad experience includes TQm, setup reduction, technology assessment and inventory analysis, statistical process

control, and quality function deployment. Over Chad’s successful career, he has served on the malcolm Baldrige Board of Examiners and has received numerous quality achievement awards, including the Quality Professional of the Year award by the american Society of Quality automotive Division in 2005. in his role as Chief Techni-cal Officer, Chad is instrumental in determin-ing the strategic direction of the consulting and training organizations, as well as the product strategy for the software company - Omnex Systems. Chad is a registered lead auditor who con-ducted the first worldwide witness audit for QS-9000. He helped develop QS-9000 and is one of the authors of the iSO/TS 16949 Semiconductor Supplement. Chad is HaCCP and SQf (gfSi) Certified.

In March 2013, Omnex was licensed by the Foundation for Food Safety Certification – headquartered in the Netherlands – to provide training in FSSC

22000, which contains a complete certification scheme for Food Safety Management Systems based on existing standards for certification (ISO 22000,

ISO/TS 22003 and technical specifications for sector PRPs) along with some extra requirements. FSSC 22000 is intended for the certification of food safety

systems of organizations in the food chain that process or manufacture animal products, perishable vegetal products, products with a long shelf life, and

other food ingredients like additives, vitamins, bio-cultures and food packaging material manufacturing.

The Foundation for Food Safety Certification was founded in 2004. The Foundation developed FSSC 22000 certification scheme, which uses ISO 22000

and technical specifications for sector PRPs such as ISO/TS 22002 (food manufacturing) and PAS 223 (food packaging), for the assessment of food safety

systems.. This development is supported by FoodDrinkEurope and the scheme is recognized by the Global Food Safety Initiative (GFSI).

Omnex’s Chief Technical Officer, Chad Kymal, stated “Omnex is proud to be a licensee to

provide training in this important and growing food safety process. We look forward to a

long and mutually-beneficial relationship with the Foundation for Food Safety Certification.

Omnex is listed on the FSSC website as a licensed FSSC 22000 training provider. FSSC 22000

training, including Understanding and Documenting, Internal Auditor and Lead Auditor, is

offered as open enrollment in multiple locations (see training schedule on page 12) and

can also be conducting at your location.

Omnex Licensed to Provide FSSC 22000 Training


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by the U.S. Council for Energy Efficient Manu-facturing and the U.S. Department of Energy.

He specifically cited the experience of two plants . One, a p lant owned by a major company, Dow Chemical, reduced its use of energy by 17.9 % over two years. At the same time, ISO 50001 principles are also successfully implemented by small busi-nesses as shown by the experience of the second plant, CCP, of Houston, Texas which employs 36 people. In two years, it achieved energy savings of 14.9 %, worth US$ 250,000 a year with zero capital investment. The press release for this launch event can be viewed in its entirety at www.iso.org/sites/iso5001launch/index.html.

What is ISO 50001 and How Does it Work?

First and foremost, as with all ISO standards, ISO 50001 is a voluntary international standard which defines the requirements for an Energy Manage-ment System (EnMS) while providing guidance on its use. These requirements provide a framework

enabling an organization to:

• Develop a policy for more efficient use of energy

• Fix targets and objectives to meet the policy

• Use data to better understand and make decisions regarding energy use and con-sumption

• Measure the results

• Review the effectiveness of the policy

• Continually improve energy management

ISO 50001 is based on, and aligned with, the QMS/EMS approaches laid out in ISO 9001, ISO 14001, OHSAS 18001, and other such standards. This allows an organization to integrate the energy management system seamlessly with their existing quality, envi-ronmental and/or occupational health and safety management systems.

ISO 50001 follows the Plan-Do-Check-Act process model focusing on continual improvement as well as energy performance and the effectiveness of the EnMS.

• Plan: Conduct the energy review and es-tablish the baseline, energy performance indicators (EnPIs), objectives, targets and action plans necessary to deliver results in accordance with opportunities to improve energy performance and the organization’s energy policy.

• Do: Implement the energy management action plans.

• Check: Monitor and measure processes and the key characteristics of its opera-tions that determine energy performance against the energy policy and objectives and report the results.

• Act: Take actions to continually improve energy performance and the EnMS.

How Can I Benefit or “What’s In It For Me”?

Energy use is a (if not the) critical resource to or-ganizations regardless of size, activities, sector and geographical location. Energy is a significant cost in itself and can also impose environmental and

Energy Management Systems Gaining SteamCOnTinuED frOm PagE 1

Who Is Using ISO 50001? The global need to save energy has many companies across the world embracing this standard. In fact, the U.S. Department of Energy has recently published an “eGuide for ISO 50001” which can be found at https://ecenter.ee.doe.gov/EM/SPM/Pages/Home.aspx . As of April, 2013 over 1,500 companies have achieved ISO 50001 certification worldwide. A sampling of these companies includes:

• 3M

• Airport Stuttgart

• Al Sindian Paper

• Alcoa Europe

• ArcelorMittal

• Automobili Lamborghini

• Bangalore International Airport, Ltd.

• Bently Motors

• Bouygues Telecom

• Bridgestone Americas Tire Operations

• China Steel Corporation

• Coca-Cola Enterprises, Ltd.

• Cooper Tire & Rubber Company

• Daimler AG Mercedes-Benz

• Delhi International Airport, Ltd.

• Dubai Airport Freezone (DAFZA)

• Dura Automotive Systems

• Equinix Data Centres

• Fiat Auto Poland

• Fiat Powertrain Technologies

• Goodyear Dunlop Tires Germany

• Hitachi, Ltd.

• Hyundai Motors

• IBM

• LG Electronics

• London Data Exchange (LdeX)

• Mercedes AMG High Performance Powertrains, Ltd.

• Northern Rail

• Pfizer

• Pilkington Floatglas AB

• PSA Peugeot Citroën

• Saint-Gobain

• Samsung Electronics

• Tokyo Energy Service

• Yokohama Tire Manufacturing

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societal costs. By implementing an EnMS, organiza-tions can improve energy management in the here and now, reducing energy cost, consumption and waste. An effective EnMS can also serve as one of the keys to enterprise sustainability.

An EnMS is a means to control and reduce an orga-nization’s energy consumption in order to:

• Reduce costs – this is becoming increasingly important as energy costs rise.

• Reduce carbon/greenhouse gas emissions and the environmental damage they cause, as well as the cost-related implications of carbon taxes and the like. An organization may find that promoting such an image of sustainability is often good for the bottom line.

• Reduce risk – the more energy consumed, the greater the risk that energy price increas-es or supply shortages could seriously affect profitability, or even make it impossible for the organization to continue. Through struc-tured energy management the organization can reduce this risk by reducing its demand for energy and by controlling it so as to make it more predictable.

In addition, it’s quite likely that managers have some rather aggressive energy-consumption reduction targets to be met at some worrisome point in the near future. An understanding of effective energy management will hopefully be the long-term solu-tion that will enable the organization to meet these targets.

With an EnMS implemented, organizations may make better use of their existing energy consuming assets while more effectively evaluating and prioritizing the implementation of new energy-efficient technolo-gies. This should promote energy management best practices and reinforces good energy management behaviors throughout the supply chain.

Getting Started

One of the first steps to be taken when implement-ing an Energy Management System is to conduct an energy review and establish the baselines of the program. In particular, what are the goals of the program and where are the opportunities to improve? Once this task is completed, the EnMS can be integrated into an existing ISO 14001-based Environmental Management System as there is much synergy between the two standards. Omnex has determined that 18 clauses are easily integrated

between the two. Overall implementation and main-tenance costs of the EnMS can be reduced greatly with integration.

For more information, there is a recording of a webinar available on our website titled “Energy Man-agement – A Discussion of ISO 50001.” Omnex also offers a number of training courses on ISO 50001, a schedule of which can be seen on page 12. These training courses can also be conducted on-site at your location. More information on these and all other Omnex training offerings can be found on our website at www.omnex.com.

Dave Watkins is the Executive VP, Director of international Operations, and a senior consultant and trainer for Omnex. With a wide range of international experience across a variety of manufacturing and service industries, his activities are focused on enhancing the ability of organizations to create value for their customers and stock-holders by developing and integrating man-agement and operating systems in order to achieve and sustain customer satisfaction and a competitive advantage.

Energy Management Systems Gaining SteamCOnTinuED frOm PagE 5

GM has a global supplier requirement for implementation of their “Quality System Basics” (QSB) patterned after their internal manufacturing quality process. Omnex has learned that GM is preparing to roll out the latest QSB revision to the suppliers later this year.

Over the years, GM’s Supplier Quality function has developed and implemented a number of similar second party supplier audits. These include the Potential Supplier Assessment (PSA), Process Control Plan Audit (PCPA), 8D and others. The new QSB audit will combine these into one process and one report out system.

GM Supplier Quality Development Engineers (SQD) will now have the ability to update the GM Bid List based on the status of the supplier’s conformance with QSB requirements. Annual QSB audits are planned and the supplier’s QSB capability will be updated as applicable.

At press time, GM has agreed to add Omnex to the GM list of approved North American providers of their Quality Systems Basics (QSB) and QSB+ supplier training. QSB+ adds three new chapters and will be rolled out to suppliers shortly. Omnex has also agreed to work with GM to transition the content into adult learner technol-ogy going forward.

As more information becomes available, Omnex will conduct a webinar on the new GM QSB process. This information will be posted on our website at www.omnex.com . Or, contact us today at [email protected] and you will let you know as soon as the webinar and public training offerings are scheduled. As with all our offerings, we can also conduct training on-site at your location.

GM Revising Quality System Basics


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AQuA Pro is integrated with Discus Software to automatically generate the Bill of Characteristics for your Quality reports

AQuA Pro Integration with DISCUS Software for Quality Reporting

Integrates Customer Requirements to Design and Process Documents avoiding manual errors of re-typing Characteristic information.

Seamless integration of Design Drawings to Process and Shop-floor documents.

Enables you to quickly address legacy and new parts.

Ensures that you have all requirements in one place.

Allows a single business process to support different customer formats.

Design and Process Reuse

Improves Quality and reduces launch effort using AQuA Pro.

Bene�ts

DISCUS integrated with Aqua Pro, allows quick and accurate requirement extraction. This transfer of information from the drawings and other requirements allows pre-population in the Aqua Pro system, allowing for instant and reusable ballooned drawings and models. Your First Article Inspection Report (FAIR), DMFEAs, PFMEAs, Control Plans, etc….. can now be set up with the addition of DISCUS software to your Aqua Pro suite.

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PPAP Management (AQuA Pro®)

• Dynamic linkages of key documents:ෙෙ DFMEA / PFMEA ෙෙ DVP&Rෙෙ Process Flow Diagramෙෙ Check Sheets ෙෙ Control Planෙෙ Work Instructionsෙෙ Re-usable Design and Process segments

to build Design and Process documents

• Ready-to-use PSW documents

• Apply customer specific document formats to existing PPAP documents

• Generate reports

• Link PFMEA action plans to APQP time plans

Document Management (Document Pro®)

• Integrated Document Man-agement system

• Approval workflow definition

• Ability to use multiple document formats

• Document Control:ෙෙ Revision Controlෙෙ Distribution Control

ෙෙ Document Change Request

• Search and retrieve documents

Gage Management (MSA Pro®)

• Gage Management for single and multi-parameters

• Studies with Graphical Reports:ෙෙ Bias Studyෙෙ Calibration Studyෙෙ GRR: X-bar and ANOVA (Crossed and Nested)

ෙෙ Stability

• Gage traceability established to National Standards

• Compliant with MSA 4th Edition

APQP Time Plan Management (APQP/PPAP Manager®)

• Comprehensive and Customiz-able New Product Develop-ment time plan templates

• Create, manage and track APQP projects

A leading Aerospace Original Equipment Manu-facturer with multiple manufacturing and as-sembly locations in North America was search-ing for a long term integrated software solution for managing all documentation related to their APQP/PPAP processes across all their locations while also having the capability to be scaled up for future quality system requirements. They wanted a system that could be implemented for their new product development process for reusable parts and processes in order to minimize the work needed in the future.

After reviewing available options, the organization selected three Omnex software modules: Aqua Pro for authoring APQP/PPAP documentation, Doc Pro for managing and storing their documents and MSA Pro for authoring measurement system documenta-tion. Omnex designed a month-long custom imple-mentation plan to address the Customer’s require-ment through “as-is” process studies, APQP/PPAP methodology training and software implementation.

The implementation was a resounding success, as evidenced by some of the feedback that was received:

Making EwIMS® Work For You

Omnex can craft a similar solution for your specific software needs as well. Benefits in the EwIMS® soft-ware include:

• Customers can now save up to 60% of their time in new product introduction activities using the generic family documentation.

• Customers can manage hundreds of gage calibrations and GR&R studies with a click of a button.

• Customers can now have an evolving da-tabase of reusable information regarding its parts and process that will fuel its new product development process for years to come and allow them to create better parts with less lead time, less resources and less defects.

EwIMS® Gaining Traction in the Aerospace SectorA Leading Aerospace OEM Chooses ewims® for apqp/ppap softwareZack Peckham, Software Training, implementation and Support

“The software was easy to install, easy to manage and takes up a very small

network footprint” - IT Department

“Omnex’s knowledge of APQP in combination with its software that was

designed and built on the same ideals and principles makes for an extremely

effective and beneficial solution” - Manager

“What used to take months to do regarding authoring PFMEA’S and

Control Plans now can be accomplished in weeks with a higher rate of accuracy”

- End User

“I wish I would have had this solution two decades ago, I could have retired

years ago” - End User


navigatorAS9101D Auditing for Process Performance Combining Conformance and Effectiveness to Meet Customer Satisfactionby Chad Kymal

Do you manage your company’s AS9100 audit

program or are you an Aerospace internal auditor

making the transition to the latest revisions of the

AS9100/AS9110/AS9120/AS9101 standards? Or

perhaps you’re currently a QMS auditor interested

in entering the field of Aerospace auditing? Regard-

less of your background, there are many changes to

the AS9100 series of standards of which you must

be made aware. First and foremost is the transi-

tion to the use of the process approach within the

Aerospace industry.

Auditing for effectiveness has always been an ex-

pectation of AS9101, but the reality is that most

auditors focused in the past on process conformance

and clause-based requirements without taking into

account the process results. AS9101D has been

revised to address performance in a manner never

approached before and will challenge auditors to

shift their auditing techniques to evaluate effective-

ness of the system while placing a focus on customer

satisfaction.

Chad Kymal’s latest book, published by ASQ, is focused

on internal auditing and guiding those profession-

als responsible for conducting implementation and

setting up robust quality management systems that

will withstand external audits against the AS9101D

requirements. The book covers the history of the

aerospace quality requirements, key changes to the

AS9100C/AS9110/AS9120 standards, understanding

audit trails, the readiness review and onsite audit,

and corrective action and closeout activities.

Mr. Kymal has recently finalized an agreement to

complete two additional books for ASQ – one titled

“Implementing Integrated Management Systems” to

be completed by the end of this year and the other

titled “Auditing Integrated Management Systems”

to be completed in the first quarter of 2014.

Available now from ASQhttp://asq.org/qualitypress

Contact Omnex at (734) 761-4940to place your order now!

The International Aerospace Quality Group (IAQG) Aerospace Advanced Product Quality Planning (AAPQP) Guidance project is nearing completion by the drafting team. At this time, the team is plan-ning to forward their deliverables to the IAQG for approval in August. Once approved, it will become part of the IAQG Supply Chain Management Hand-book (SCMH).

See http://www.sae.org/iaqg/handbook/scmh-termsofuse.htm.

APQP has its origin in the Quality by Design (QbD) concept first promoted by Quality pioneer Joseph Juran. A guidance manual for advanced quality planning was first developed by the Automotive industry for use by their production suppliers in the early 1990s. It provided a roadmap for supplier

new product development to support the auto-makers’ process. In the Automotive industry, the culmination of a successful APQP process is a suc-cessful production part approval by the customer. This process is known as PPAP, and is a separate automaker requirements document.

The Aerospace AAPQP project includes PPAP as one element of the AAPQP process. PPAP differs from the Aerospace First Article Inspection (FAI) process in that PPAP is approval of the production process while FAI is approval of the initial production part(s). FAI has also been incorporated as one element of the Aerospace APQP process. It is needed for this sector because production parts from the beginning of production are sold to customers. Automotive PPAP approval is required prior to production part

shipment.

Another key addition to this guidance is the inte-gration of suppliers, which is not addressed in the Automotive APQP version. Many primes in the Aerospace sector are becoming more “systems integrators” thus they depend on suppliers more so than similar organizations in other sectors. This early collaboration with suppliers should result in fewer “pass through” issues from the supply chain. These are issues caused by organizations further down the supply chain and not detected by direct suppliers to the primes.

Watch for more information on this project in future issues of the Navigator. Omnex also offers training for APQP and PPAP for interested organizations.

Aerospace Product Quality Guidance Manual Update

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Omnex North America

Omnex has been represented by Dan Reid, Director of Consulting, at two major quality conferences this past year. In January 2013, Dan attended the 21st Annual International Conference on ISO 9000 & QMS held in San Diego and conducted two presentations – “Audit Trails for Process Auditing” and “Keys for Rapid Supplier Development.” Dan also attended the annual ASQ World Conference on Quality and Improvement held in May 2013 in Indianapolis, where he conducted a presentation titled “Keys for Rapid Supplier Development.”

Omnex is a subject matter expert in the IAQG APQP and PPAP committees. New guidance stan-dards are currently being drafted. More infor-mation on these new standards can be found on page 9. Omnex has sent representatives to a number of conferences including the IAQG APQP Project Team Conference and a number of Aerospace AQP F2F meetings. Omnex is also planning to attend both the AAQG Standards Committee Meeting and the IAQG Committee and Supplier Meetings, both of which will be held later this year.

Omnex APQP training is quickly becoming stan-dard practice within the Aerospace industry. Omnex offers 10 days of APQP and PPAP/FAI training for APQP and FMEA facilitators. We have trained over 500 Aerospace professionals in the past two years with this program.

Due to customer demand, Omnex is working with most of the Aerospace ballooning software providers to link the characteristics in the CAD design directly to AQuA Pro software in EwIMS. Omnex’s EwIMS software, and particularly the APQP and APQP/PPAP Manager modules, has seen great demand within the Aerospace in-dustry. Many large Aerospace organizations are currently conducting pilots and/or have adopted them as an internal standard. Details showing

how the software links with one such partner, DISCUS Software, can be found on page 7.

Omnex has worked with major food organiza-tions this past year to implement an Integrat-ed Management System integrating GFSI, ISO 14001, OHSAS 18001 and ISO 9001. An inte-grated GFSI and ISO 9001 system was imple-mented at Barakat in Dubai. We also conducted Lead Auditor training for two registrars including NSF, who is the world’s leading Food registrar.

Omnex has completed a major supplier improve-ment program for Volvo in Asia spanning India, China, and Southeast Asia. This program started with an audit of 115 suppliers, with an improve-ment program being conducted for the bottom third. In a matter of 10 months, all suppliers have shown major improvements in multiple areas important to the customer including logistics, quality, metrics, problem solving and Lean.

Omnex has concluded a global contract with Magna International to provide quality training for a specified curriculum globally in English, Spanish, Indian, Chinese, and multiple European languages.

Omnex India

Omnex recently concluded training for various customers including Daimler India Commercial Vehicles in DFMEA, PFMEA, Core Tools, Global 8D, Six Sigma, and Geometric Dimensioning and Tolerance.

SKODA Automotive India has contracted Omnex to implement a unique Dealer Management system (SDMS) with SKODA-specific require-ments for all SOKDA dealers across India. Phase 1 of SDMS implementation started in January at all 51 SOKDA dealers. Omnex deployed a team of 15 people for the SKODA project at 16 loca-tions across India.

Omnex congratulates our client, Visteon Climate System Ltd. for winning the Shingo Silver Me-dallion. Visteon has been an Omnex client for Lean VSM implementation since 2011. Con-gratulations also go to our ISO 14001 client, Woodward India Pvt. Ltd., for achieving ISO 14001 certification.

Omnex India has been appointed as an autho-rized reseller of AIAG publications, which include the ISO/TS 16949 standard, the Core Tools “blue books” (APQP, FMEA, SPC, PPAP and MSA) and the Effective Problem Solving guide. For more in-formation, please contact [email protected].

Omnex India has signed a contract with SKF Bearings to qualify Omnex to provide training for employees on GPS and GD&T. Omnex has completed training at SKF India plants and also completed workshops at SKF Jakarta, Indonesia.

For the fifth consecutive year, Tata Auto Com-ponents Systems Learning Centre contracted Omnex as their training partner including em-ployee development programs. Last year Omnex completed more than 1,000 man-days of training with the Tata Learning Centre.

The Omnex office in Bangalore has completed Six Sigma Yellow Belt for over sixty officials of Tata Marcopolo.

Other recent Omnex agreements include:• Poclain Hydraulics Pondicherry for supplier

development and new product development • Tata Motors Engineering Division for AIAG’s

Effective Problem Solving Techniques• INA Bearing for Quality and Business Manage-

ment System improvements• ZF Steering for SQE employee development• JCB, Fariabad, for Core Tools training work-

shops• Spm Autocomp, Pune, for Core Tools training

workshops


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Omnex Middle East

Omnex recently completed an ISO 22000 Food Safety with ISO 9001:2008 implementation at Barakat Quality Plus. The second phase of this project for integration methods started in June, 2013.

Omnex conducted workshops at Snamprogetti Saudi Arabia Co. Ltd. / Saudi Arabia Saipem Co. Ltd. which led to HR / Human Capital improve-ment for Saipem employees. Over 100 employ-ees have currently completed such training.

Omnex Singapore

Omnex signed a pact with Dutch Lady Malaysia for training, consulting and implementation of Lean Six Sigma projects.

In addition to 100 days of consulting for the Omnex Automotive Tier 1 base in Thailand last quarter, Omnex also completed training work-shops in Singapore and Jakarta.

Omnex China

Omnex implemented a two-day PFMEA training workshop for the wholly owned subsidiary of Japan’s biggest medical device and pharmaceuti-cal manufacturer. The manufacturer was ranked the 14th most innovative enterprise and 1st in the medical device industry in the July, 2011 issue of Forbes Magazine.

Before the training, the instructor trainees were asked to consider how FMEA can be improved specifically for the medical industry and how to operate as per the requirements of ISO 14971. In the beginning, attendees raised issues such as how to complete a PFMEA without a DFMEA being conducted, and the relationship between the risk analysis form, detailed flow chart and special characteristics in the PFMEA and how they convert to each other effectively. By the end of the training, not only were these ques-

tions answered in detail, but the attendees also expressed a greater understanding of FMEA.

Omnex has recently kicked off a DFSS Phase III for a safety equipment manufacturer es-tablished in Pittsburgh, PA (U.S.) that recently launched its R&D center in Suzhou. Since the establishment of this R&D center in China, the manufacturer has maintained cooperation with Omnex in training and coaching. The training for DFSS is Level I in Phase III and is attended by staff from different departments, to be fol-lowed by Level II training and coaching. After the completion of each phase, Omnex offers tele-coaching for better understanding and assimilation to apply what has been learned during the training to daily work. Omnex is a long-term service provider for this company.

Omnex has implemented training on Lean production for one of the world’s biggest and leading manufacturers for medical devices, phar-maceuticals, surgical instruments and peripheral

products with several subsidies in many countries around the world. This manufacturer provides professional and thorough hemodialysis and hemopurification therapy related products and solutions, and supplies for clinicians and phar-macists for a variety of reliable medicine and consumables. The main purpose of this training is to sell the Lean concepts to the staff. During the workshop, actual issues the manufacturer faces were written on a whiteboard and each were solved.

Omnex Human Capital Enrichment Division

This year, Omnex has started a new division, Omnex Human Capital Enrichment (HCE) for employee skill enhancement. The goal is to help organizations improvement employee morale, soft skills and techniques that will make them more successful in their jobs. The HCE division is headed by Mr. Siva Subramanian (Siva), a profes-sional with over 30 years of experience in orga-nizational performance management through capacity building of the Human Capital. Siva has helped many organizations in India, the Middle East and Southeast Asia realize their potential and improve employee performance.

Omnex’s HCE division completed many train-ing workshops since its inception in January, 2013. Some of the clients that have been helped include Maruti Suzuki India Ltd., ALP Nishikawa, Denso Haryana, Saipem and Saudi Arabian John Deere.

mr. fuge Qin, Omnex senior consultant, con-ducting Lean training.

PfmEa training in the medical industry.

DfSS kick-off at r&D center in Suzhou.

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navigatorNORTH AMERICANTRAINING COURSE

SCHEDULE2013Aerospace and Defense

Understanding and Documenting AS9100 (RABQSA-QM) (RABQSA-certified Training Provider)

ann arbor, mi September 30 - October 1

san Jose, caOctober 7-8

huntsville, alSeptember 23-24

mississauga, ontarioSeptember 30 - October 1

AS9100 Internal Auditor Training (RABQSA-QM and RABQSA-AU) (RABQSA-certified Training Provider)

ann arbor, miSeptember 30-October 4



mississauga, ontarioSeptember 30-October 2

AS9100 Lead Auditor Training (RABQSA-QM, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)

ann arbor, miSeptember 30-October 4



mississauga, ontarioSeptember 30-October 4

Automotive and/or Semiconductor Industry

Understanding and Documenting ISO/TS 16949:2009 (RABQSA-QM) (RABQSA-certified Training Provider)

ann arbor, miAugust 19-20September 23-24October 21-22November 11-12December 9-10

san Jose, caSeptember 23-24

mississauga, ontarioAugust 19-20September 23-24October 21-22November 11-12December 9-10

ISO/TS 16949:2009 Internal Auditor Training (RABQSA-QM and RABQSA-AU) (RABQSA-certified Training Provider)

ann arbor, miAugust 19-21September 23-25October 21-23November 11-13


mississauga, ontarioAugust 19-21September 23-25October 21-23November 11-13

Customer-Specific Requirements and Core Tools-Effect on Process Approach to Auditing

ann arbor, miAugust 22

September 26October 24November 14December 12

mississauga, ontarioAugust 22September 26October 24November 14December 12

ISO/TS 16949:2009 Lead Auditor Training (RABQSA-QM, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)



mississauga, ontarioAugust 19-23September 23-27October 21-25November 11-15December 9-13

Conducting Process Audits to VDA 6.3

ann arbor, miAugust 5-7October 7-9

mississauga, ontarioAugust 5-7October 7-9

Automotive Core Tools

(Five one day modules; can attend for whole week or can take by individual modules)

ann arbor, mi

Module 1: APQP and DFMEASeptember 16

December 2Module 2: PFMEA and Control Plans

September 17December 3

Module 3: PPAPSeptember 18December 4

Module 4: SPCSeptember 19December 5

Module 5: MSASeptember 20December 6

mississauga, ontario

Module 1: APQP and DFMEASeptember 16December 2

Module 2: PFMEA and Control PlansSeptember 17December 3

Module 3: PPAPSeptember 18December 4

Module 4: SPCSeptember 19December 5

Module 5: MSASeptember 20December 6

Energy Management

Understanding and Documenting ISO 50001:2011

ann arbor, miSeptember 23-24November 18-19

mississauga, ontarioSeptember 23-24November 18-19

Omnex is an RABQSA-certified Training Provider for the Understanding and

Documenting, Internal Auditor and Lead Auditor courses as noted


navigatorNORTH AMERICANTRAINING COURSE

SCHEDULE2013ISO 50001:2011 Internal Auditor Training



ISO 5001:2011 Lead Auditor Training



Environmental Management

Understanding and Documenting ISO 14001:2004 (RABQSA-EM) (RABQSA-certified Training Provider)



ISO 14001:2004 Internal Auditor Training (RABQSA-EM and RABQSA-AU) (RABQSA-certified Training Provider)



ISO 14001:2004 Lead Auditor Training (RABQSA-EM, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)



Food SafetyUnderstanding and Documenting FSSC 22000 (RABQSA-FS) (RABQSA-certified Training Provider) (FSSC 22000 Licensed Training Organization)

ann arbor, miNovember 18-19

mississauga, ontarioNovember 18-19

FSSC 22000 Internal Auditor Training (RABQSA-FS and RABQSA-AU) (RABQSA-certified Training Provider) (FSSC 22000 Licensed Training Organization)



FSSC 22000 Lead Auditor Training (RABQSA-FS, RABQSA-AU,and RABQSA-TL) (RABQSA-certified Training Provider) (FSSC 22000 Licensed Training Organization)

ann arbor, miNovember 18 -22


HACCP Certification (RABQSA-HP) (RABQSA-certified Training Provider)

ann arbor, miAugust 26-27

mississauga, ontarioAugust 26-27

Functional Safety Management Systems

ISO 26262 Executive Overview

ann arbor, miAugust 12October 7December 2

san Jose, caNovember 4

mississauga, ontarioAugust 12October 7December 2

Understanding ISO 26262 Functional Safety Management Systems

ann arbor, miAugust 12-16October 7-11December 2-6

san Jose, caNovember 4-8

mississauga, ontario August 12-16October 7-11December 2-6

Auditing to ISO 26262


san Jose, caNovember 4-8

mississauga, ontario September 16-20November 4-8

Medical DevicesUnderstanding and Documenting ISO 13485:2003 (RABQSA-MD) (RABQSA-certified Training Provider)




mississauga, ontario September 30-October 1

ISO 13485:2003 Internal Auditor Training (RABQSA-MD and RABQSA-AU) (RABQSA-certified Training Provider)





ISO 13485:2003 Lead Auditor Training (RABQSA-MD, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)





ISO 13485 Risk Management Using FMEA

ann arbor, miAugust 5-9November 11-15

mississauga, ontario August 5-9November 11-15

Occupational Health and Safety Management

Understanding and Documenting OHSAS 18001:2007 (RABQSA-OH) (RABQSA-certified Training Provider)



OHSAS 18001:2007 Internal Auditor Training (RABQSA-OH and RABQSA-AU) (RABQSA-certified Training Provider)


13


navigatormississauga, ontario

September 9-11November 4-6

OHSAS 18001:2007 Lead Auditor Training (RABQSA-OH, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)



Quality Management Systems

Understanding and Documenting ISO 9001:2008 (RABQSA-QM) (RABQSA-certified Training Provider)


san Jose, caOctober 7-8huntsville, alSeptember 23-24

mississauga, ontario August 19-20September 23-24October 21-22

November 11-12December 9-10

ISO 9001:2008 Internal Auditor Training (RABQSA-QM and RABQSA-AU) (RABQSA-certified Training Provider)




mississauga, ontario August 19-21September 23-25October 21-23November 11-13December 9-11

ISO 9001:2008 Lead Auditor Training (RABQSA-QM, RABQSA-AU, and RABQSA-TL) (RABQSA-certified Training Provider)




mississauga, ontario August 19-23September 23-27October 21-25November 11-15December 9-13

Testing and Calibration Labs

Understanding and Documenting ISO/IEC 17025:2005

ann arbor, miOctober 28-29


mississauga, ontario October 28-29

ISO/IEC 17025:2005 Internal Auditor Training

ann arbor, miOctober 28-30


mississauga, ontario October 28-30

ISO/IEC 17025:2005 Lead Auditor Training

ann arbor, miOctober 28-November 1


mississauga, ontario October 28-November 1

Integrated Management Systems

Understanding and Documenting Integrated Management Systems (ISO 9001 and/or ISO/TS 16949, ISO 14001 and OHSAS 18001)


mississauga, ontario November 11-12

Integrated Management Systems Internal Auditor Training (ISO 9001 and/or ISO/TS 16949, ISO 14001 and OHSAS 18001)

ann arbor, miNovember 11- 13

mississauga, ontario November 11- 13

Integrated Management Systems Lead Auditor Training (ISO 9001 and/or ISO/TS 16949, ISO 14001 and OHSAS 18001)


mississauga, ontario November 11-15


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The International Organization for Standardization (ISO) has begun its regular five year review of its ISO 9000 and ISO 14000 series and has elected to make revisions. Work has begun in the international Technical Committee Work Groups and a 2015 release of revised Quality Management System (QMS) and Environmental Management System (EMS) Standards is targeted.

ISO 9001 was first released in 1987. Minor edits were released in 1994 and 2008. The year 2000 revision was a significant revision including requirements for use of a process approach, customer-focus, fact-based decision making and mutually beneficial supplier re-lationships. Much in the world has changed since the 2000 revision so the next revision promises to be another significant revision.

Last year ISO conducted a global user survey to gather user data as a prerequisite for deciding on a revision. Over 60% of respondents indicated that a revision to ISO9001 would be ok, compared to less than 30% who thought ISO 9001 was ok “as is”. Over 65% said that the following topics were needed in ISO 9001 going forward: Voice of the Customer, Risk Management, Knowledge Management, Metrics, Strategic Planning, Innovation and Systemic Problem Solving, among others. Other key findings from the survey are that ISO 9001 must change to be relevant to organizations today and in the future. It must integrate with other management system standards, e.g. environmental, occupational health and safety and ensure efficiency and effectiveness of audits going forward. This includes

solving current concerns with third party certification, e.g. credibility of certificates.

In a separate, but related initiative, ISO has developed a set of requirements that all new management system standards must meet. This includes use of a common structure (outline) as well as mandatory text for many of the common clauses in use today, e.g. management review, internal audit. It also excludes some of the requirements that are currently required by all, man-agement representative, records, preventive action.

The initial ISO 9001:2015 Concept Draft (CD) was re-cently released and utilizes this new mandatory struc-ture and text. The new clause structure increases the total number of clauses to ten. Still subject to change, the new clause structure is currently:

1. Scope2. Normative References3. Terms and Definitions4. Context of the Organization (including under-

standing the organization and its context, needs, requirements, scope and management systems)

5. Leadership (including management commit-ment, policy, roles, responsibilities and au-thority)

6. Planning (including actions taken to address risk7. Support (including resources, competence,

awareness, communications, documented information

8. Operations (including planning and control)9. Performance Evaluation (including monitoring,

measuring, internal audit, management review)10. Improvement (including nonconformity, correc-

tive action and continual improvement)

This high level structure and text requirements has not been well received by some sectors using ISO 9001 as a base for their sector requirements. These sectors include aerospace and automotive, the latter of which has appealed to and been granted a waiver from ISO to be able to continue using the 2008 version after release of a subsequent version. Normally there is a withdrawal of obsolete versions of standards by ISO.

Subsequent to the required five year review of ISO standards, the ISO 14001 standard is also being revised and it too will be subject to the mandatory clause structure above.

Given all this, the next version of ISO 9001 will likely represent a major change but see some variation with some sectors staying with the 2008 version.

Omnex is a global leader in training organizations in the integration of management systems, effective and efficient auditing and Risk Management. Omnex’s Dan Reid is participating in the ISO 9001 and ISO 14001 revision process as a member of the U.S. Technical Committees responsible for these management system series. Dan will conduct a webinar on the ISO 9001 revisions in August and the ISO 14001 revisions in September. There will be no charge for either of these webinars and a recording will be made available if you cannot attend the live event. Watch the Omnex website for more information or contact us for more information on how to register for these webinars.

ISO 9001 and ISO 14001 Revisions Underway

In late summer or early fall of this year, IAQG will be releasing version E of AS9101. There are changes that will affect the audit process – most notably, the elimination of the requirement for the completion of the Objective Evidence Record (OER). While the elimination of the OER seems like a reduction in the requirement for recording objective evidence, the added emphasis on the updated Process Effective-ness Assessment Report (PEAR) and the QMS Matrix should result in a more thorough description of the objective evidence the auditor reviews.

In the past, there have been audit reports that did not meet the needs of all stakeholders. Audit evidence was

so poor that audits seemed to be more subjective than objective. The proper recording of objective evidence assures stakeholders that the audit was objective and provides confidence in the process. Objective evidence should provide enough detail to create a clear link from the audit report to a specific issue.

There is a clear directive to auditors that they must be more descriptive in recording objective evidence. The PEAR will continue to be used for clause 7 of the standard and the QMS Matrix is to be used for all other clauses. To assist auditors in the proper evaluation of effectiveness, the Process Evaluation Matrix (PEM) has been created. A PEM must be completed for

each PEAR. The PEM is a 3x3 matrix that focuses on process realization and process results to determine the level of effectiveness for a process.

It should be noted that AS9101E has not yet been finalized and some changes could still occur. Due to this, the information in the PEM and the updated PEAR could change before being officially published. It is important that organizations currently certified to AS9100C, Certification Bodies, Aerospace Auditors, and Aerospace training organizations thoroughly review the new document when it is released.

Changes Coming to the AS9100 Third Party Audit Process

15

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