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Nonconformities to Avoid with AS9100C Audits

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business July 2011

This Month

Our newsle ers provide informa on on business management

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* Common Nonconformities to Avoid with AS9100C Audit * ISO 9001 Proven to Win New Business * ISO Expands Work in Five Areas * In the News * Turtle Diagram Process Evaluation Tool * Training Courses

systems ISO 9001, AS9100 Avia on, Space and Defense, ISO/TS 16949 Automo ve, ISO 27001 Informa on Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others. This includes process audi ng techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.
If you have any ques ons regarding the content or have a topic of interest for a future newsle er, please let us know.

Lunch and Learn August 9, 2011 Phoenix, AZ

Common Nonconformities to Avoid with AS9100C Audit

Information Security Management Presented by Sustaining Edge Solutions, Inc. Information and Registration

According to Robert Parsons, aerospace and defense business unit director at management system registrar, Na onal Quality Assurance (NQA) a er comple ng a number of audits to the AS9100C standard, the NQA, USA auditors have provided the following feedback on areas most o en cited for nonconformances.

1. Failure to act on customer sa sfac on data. The AS9100C Aviation, Space and Defense Standard includes specific information that must be monitored and used for evaluating customer satisfaction data. That information at a minimum is to include product conformity, on-time delivery, customer complaints, and corrective action requests. In addition, it requires that organizations develop and implement plans for customer-

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satisfaction improvement that address deficiencies identified by evaluations, and assess the effectiveness of the results. Resources for obtaining this information can include supplier rating report cards, survey data, feedback from trip reports. Often, this information is not being reviewed by the top management, there have been no actions taken to improve performance, the actions taken have not been evaluated for effectiveness, or the actions taken are ineffective. 2. Lack of understanding of the concepts of special requirements, cri cal items, and key characteris cs.
Special requirements and critical items are terms new to the AS9100C standard, and consequently are frequently misunderstood and then misapplied. Because they are cited in sections 7.1, 7.2, 7.3, 7.5, and 8.2 of the standard, a company cannot avoid them, and therefore it is important that they are understand and addressed within the companys current aerospace QMS. Specifically, it is important to understand the relationship between special requirements and critical items, and the application of risk when they are identified by either the customer or the organization. 3. Risk management. There is still confusion regarding when to apply risk-management techniques and how much evidence must be shown to the third-party auditor to demonstrate the effective implementation of risk management principles. In addition, it has been found that risk management is not implemented across all processes, contracts, supply-chain

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management, planning, and production processes, that there are little to no defined tools or methodologies to handle risk-based activities, and that there is a general lack of risk-mitigation plans and evidence that they have been reviewed. 4. Congura on management. AS9100C is more specific than the outgoing AS9100B regarding configuration management, which in short is the management of change. This requirement has been moved into the standards Planning of Product Realization section because it must be emphasized and determined during the planning process of product realization. Determining the level of configuration management should take into account the type of organization, the nature and complexity of the product, and any contractual requirements. 5. Management responsibility and review. NQA has observed numerous instances where performance is not meeting customers expectations but with little or no action by top management. It is expected that there will be commitment, involvement, and follow-up on continualimprovement initiatives, and review and evidence that action has been taken on processes that are underperforming and considered ineffective. Top management should be aware of and involved in these initiatives. 6. Ineec ve internal audit processes. In many instances, internal audits are still not process-based but instead are scheduled and audited in response to elements of the standard, not on processes carried out by the company. Additionally, it has been determined that internal auditors are not trained on process auditing, and audit programs do not

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include contractual or customer-specific requirements. Though process auditing was required and expected by the AS9100B standard, many companies have still not fully embraced this concept. The result is that a third-party auditor will conduct a process audit at a company that is not being audited internally using a process approach, and will come up with disastrous results. 7. Ineec ve correc ve-ac on process. Auditors are finding a lack of containment and immediate correction, insufficient root-cause analysis, failure to fully implement actions to address the root cause, failure to follow up to determine effectiveness of actions taken, and recurring nonconformities resulting from ineffective corrective action. Though this is not specific to new requirements of the AS9100C standard, it continues to be the No. 1 cause of unsuccessful audits. 8. Failure to incorporate customer requirements. In preparation for audits, NQA auditors will determine who the suppliers main customers are and will be reviewing customer requirements, evaluating the OASIS database for customer feedback, and structuring audits to evaluate the effectiveness of processes and their ability to meet customers requirements and expectations. There have been many instances where customer flow-down requirements are not being implemented internally, or flowed down to sub-tier suppliers. In addition, many companies are still unaware that their customers can and do use the IAQGs Online Aerospace Supplier Information System (OASIS) database as a vehicle to inform the certification body that the company is not meeting customers expectations. Consequently, your auditor may come to your

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facility armed with information regarding poor levels of customer satisfaction and will most certainly want to see your corrective action plan. Preparing for an upgrade to this new standard is challenging because there are a number of new requirements, terms, and concepts to understand and implement within your new QMS. Looking for help with your upgrade to the AS9100C Standard? Contact us for effective and proven results.

ISO 9001 Proven to Win New Business

According to data from The Bri sh Assessment Bureaus (BAB) independent 2011 Client Sa sfac on Survey, 44 percent of respondents said that they had won business as a result of becoming cer ed to ISO 9001, the quality management system standard from the Interna onal Organiza on for Standardiza on (ISO).
The survey, which was carried out by specialist market research organization, Lake Market Research (LMR), showed that for many organizations, the prospect of winning more work was the primary motivation for implementing the standard. When asked, 57 percent said that a client requirement motivated them to obtain certification, with 31 percent responding that winning more business was their incentive. Prospective clients have often mentioned that they require the [ISO 9001] standard to qualify for a particular tender, says Fenn. However, what we didnt know is how many of our clients had actually won work as a direct result of achieving certification With the latest results now in, were delighted to confirm that certified organizations are getting the reward they deserve from implementing

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a robust, recognized quality management system.

Verba m feedback from the survey backed up the gures, with some clients sugges ng that ISO 9001 carried real weight. We have won several government contracts which we couldnt even have a empted without ISO 9001, says Debbie Horlock from Screenx Windscreens. It isnt just the government that insists on cer ca on either. We are star ng to win new accounts that we could not have approached in the past as they insisted on having ISO 9001, says Chris an Stoneham from Masters Exhibi ons & Shows. The ISO developer and publisher of more than 18,000 interna onal standards, commissioned its own survey in 2009 showing that more than 40,000 ISO 9001 cer cates were issued in the UK in that year. With 96 percent of BABs clients recommending the standard to other organiza ons, that gure looks set to increase.

ISO Expands Work in Five Areas

The International Organization for Standardization (ISO) continues to diversify its scope with the recent addition and expansion of five work areas for standards development. These are: (1) Project, program, and portfolio management, (2) Outsourcing, (3) Human resources management, (4) Additive manufacturing, and (5) Risk management. Project, program, and portfolio management ISO had originally established a project committee to develop a single standard on project management (ISO/PC 236). However, recognizing that the discipline of project management is much broader than what a single standard can encompass, it was decided that a new technical committee would be created to develop additional standards in this

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area. The new ISO/TC 258-Project, program, and portfolio management, will address aspects that are not covered in the standard currently in development. The first meeting took place in June 2011 in Washington. Currently, 34 countries are involved. Outsourcing A new project committee ISO/PC 259, Outsourcingwill develop a standard to provide overarching guidance and terminology, enabling practitioners to harmonize principles, procedures, and vocabulary in existing and future standards. It will also improve understanding of all parties involved in outsourcing by providing a common set of practices for managing the outsourcing life cycle. It will promote interoperability and coherence, contribute to removing technical barriers to trade, and reduce transaction costs for outsourcing. The committee took place in June 2011, in Sofia, Bulgaria. Currently, 14 countries are involved.

Human resource management

A new ISO commi ee, ISO/TC 260, Human resource management, will develop standards for HR management, including guidelines, processes, policies, prac ces, services. It will promote reliable and transferable approaches to work force management in developed and emerging economies for the overall benet for organiza ons and their employees. The standards will help organiza ons adapt to, and exploit demographic shi s that inuence their access to workers. Addi ve management

Addi ve manufacturing (AM) is an inherent part of the product development process. These addi ves are used to manufacture prototypes, tools, and produc on parts. In comparison to conven onal methods where parts are molded into specied forms or cut from a massive block, AM is based on the principle that liquids, powders, and lms are layered to build 3-D structures without the use

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of a mold. In the past, AM used in the development, modica on, and use of mold-free produc on processes has been quite unsystema c. One of the main reasons is the unavailability of interna onal standards. A new ISO technical commi ee, ISO/TC 261 Addi ve manufacturing will develop the much-needed standards for development and market penetra on of the industry. Risk management In 2009, a comprehensive risk management toolbox was developed by an ISO working group. Toolbox elements included: ISO 31000-Risk management-Principles and guidelines ISO Guide 73-Risk management vocabulary ISO/IEC 31010-Risk management-Risk assessment techniques Addi ve manufacturing will develop the much-needed standards for development and market penetra on of the industry. ISO now has created a new project commi ee, ISO/PC 262, Risk management, to promote this work by developing a document that oers further guidance for implemen ng these standards. The document will be applicable to all organiza ons of all sizes and will be wri en using plain expressions and terminology for ease of applica on. Currently some 30 countries are involved.

In the News ISO 50001 Energy Management Standard

The ISO Interna onal Standard ISO 50001 on energy management systems is an eagerly awaited event because it is es mated the standard could have a posi ve impact on some 60 % of the worlds energy use. ISO 50001 will provide public and private sector

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organiza ons with management strategies to increase energy eciency, reduce costs and improve energy performance. ISO 50001 is intended to provide organiza ons with a recognized framework for integra ng energy performance into their management prac ces. Mul na onal organiza ons will have access to a single, harmonized standard for implementa on across the organiza on with a logical and consistent methodology for iden fying and implemen ng improvements. The standard is intended to accomplish the following, for example: Assist organiza ons in making be er use of their exis ng energy-consuming assets Assist facili es in evalua ng and priori zing the implementa on of new energy-ecient technologies Allow integra on with other organiza onal management systems such as environmental, and health and safety. The standard is available now on the ISO Website.

FDA Unveils Global Strategy for Quality of Imported Products The U.S. Food and Drug Administra on (FDA) unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the Pathway to Global Product Safety and Quality. The FDA report calls for the agency to transform the way it conducts business and to act globally to promote and protect the health of U.S. consumers. There has been a perfect storm-more products, more manufacturers, more countries, and more access. A drama c change in strategy must be implemented.

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For more informa on, visit the FDA Website for the Execu ve Summary and to download a PDF of the full report, Pathway to Global Product Safety and Quality.

Turtle Diagram Process Evaluation Tool

The star ng point for eec ve internal audi ng is to understand your organiza ons exis ng processes. By understanding the basics of any ac vity through a simple process model (input-process-output) you can start looking deeper into what is happening in your organiza on. Six Sigma prac oners have expanded the process model to get the supplier-input-process-output-customer (SIPOC) model.
The challenge is to determine if your current processes s ll add value to your organiza on and its customers. To achieve this, we now must move to what is called the turtle diagram for individual processes. Internal auditors can create and review these diagrams for every major process in an organiza on. Some say that the turtle diagram is a cross between the SIPOC and a cause-and-eect diagram. This is a good analogy because the turtle diagram looks at how the process sa ses the customer (typically an internal customer at this stage). By looking at what is really happening versus what procedures say is supposed to be happening, an evalua on can be made as to whether the process is eec ve in mee ng the customers requirements.
For more information on process evaluation tools, see our June 2006 newsletter five years old but still valuable.

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Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for these courses and customized training to fit your specific needs. We offer group discounts. View all our Courses View Our Web Based E-Training Courses ISO 9001 Quality Management Understanding and Implementing ISO9001:2008 ISO 9001:2008 Process Based Internal Auditor Documenting Your Management System AS9100 Aviation, Space and Defense Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense AS9100C:2009 Process Based Internal Auditor Documenting Your Management System ISO/TS 16949 Automotive Understanding and Implementing ISO/TS16949:2009 Automotive ISO/TS16949:2009 Process Based Internal Auditor Documenting Your Management System ISO 14001 Environmental Understanding and Implementing ISO14001:2004

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Environmental ISO14001:2004 Process Based Internal Auditor Lean Enterprise and CI 5S Five Pillars of a Lean Workplace Organization Continuous Process Improvement Lean Six Sigma 8 Disciplines (8D) of Problem Solving ISO 13485 Medical Devices Understanding and Implementing ISO 13485:2003 Medical Devices ISO 13485 Process Based Internal Auditor ISO 27001 Information Security Understanding and Implementing ISO 27001:2005 Information Security ISO 27001 Process Based Internal Auditor All courses can be delivered at your company. Dont see a course, location, or date that fits your needs? Contact Us

Email: wtighe@sustainingedge.com Phone: 888-572-9642 toll free Website: http://www.sustainingedge.com

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