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Nonconformities to Avoid with AS9100C Audits

Sustaining Edge Solutions, Inc. Newsletter
Performance Improvement Solutions for Your Business July 2011

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ISO 14001 Environmental. and other topics of interest to our readers. please let us know. aerospace and defense business unit director at management system registrar. That information at a minimum is to include product conformity. and others. it requires that organizations develop and implement plans for customer- Quick Links… Our Website Our Services Management Systems Newsletters and Blog 2 of 14 16/01/2013 2:26 PM . Space and Defense Standard includes specific information that must be monitored and used for evaluating customer satisfaction data. Information and Registration According to Robert Parsons. ISO 13485 Medical Devices. on-time delivery. Inc. AS9100 Avia on. This includes process audi ng techniques and process improvement methods Six Sigma.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. The AS9100C Aviation. Space and Defense. the NQA. 2011 Phoenix.sustainingedge. In addition. Lean Enterprise. 1. customer complaints. AZ Common Nonconformities to Avoid with AS9100C Audit Information Security Management Presented by Sustaining Edge Solutions. ISO 27001 Informa on Security. Failure to act on customer sa sfac on data. ISO/TS 16949 Automo ve. Lunch and Learn August 9. USA auditors have provided the following feedback on areas most o en cited for nonconformances. Na onal Quality Assurance (NQA) a er comple ng a number of audits to the AS9100C standard. and corrective action * 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. If you have any ques ons regarding the content or have a topic of interest for a future newsle er.

and key characteris cs. Lack of understanding of the concepts of special requirements. it is important to understand the relationship between special requirements and critical items. Because they are cited in sections 7.2 of the standard. Often.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. there have been no actions taken to improve performance.2. and therefore it is important that they are understand and addressed within the company’s current aerospace QMS. 2. and consequently are frequently misunderstood and then misapplied. Resources for obtaining this information can include supplier rating report cards. this information is not being reviewed by the top management. supply-chain 3 of 14 16/01/2013 2:26 PM .com/nonconformities-to-avoid-with-as9100c-audits/ Join Our Newsletter List! satisfaction improvement that address deficiencies identified by evaluations. or the actions taken are ineffective. 7. the actions taken have not been evaluated for effectiveness. Risk management. a company cannot avoid them. 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. feedback from trip reports. and the application of risk when they are identified by either the customer or the organization. cri cal items.3.5. contracts. and assess the effectiveness of the results. In addition. 3. it has been found that risk management is not implemented across all processes.sustainingedge. and 8. survey data. 7. 7.1. “Special requirements” and “critical items” are terms new to the AS9100C standard. Specifically.

Configura on management. the nature and complexity of the product. it has been determined that internal auditors are not trained on process auditing.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. This requirement has been moved into the standard’s 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. In many instances. and that there is a general lack of risk-mitigation plans and evidence that they have been reviewed. internal audits are still not process-based but instead are scheduled and audited in response to elements of the standard.sustainingedge. Ineffec ve internal audit processes. and follow-up on continualimprovement management. involvement. Additionally. that there are little to no defined tools or methodologies to handle risk-based activities. 4. and production processes. Management responsibility and review. not on processes carried out by the company. and review and evidence that action has been taken on processes that are underperforming and considered ineffective. 5. NQA has observed numerous instances where performance is not meeting customers’ expectations but with little or no action by top management. which in short is the management of change. planning. and any contractual requirements. and audit programs do not 4 of 14 16/01/2013 2:26 PM . It is expected that there will be commitment. Top management should be aware of and involved in these initiatives. AS9100C is more specific than the outgoing AS9100B regarding configuration management. 6.

failure to fully implement actions to address the root cause. In addition. many companies have still not fully embraced this concept. insufficient root-cause analysis. Failure to incorporate customer requirements. many companies are still unaware that their customers can and do use the IAQG’s Online Aerospace Supplier Information System (OASIS) database as a vehicle to inform the certification body that the company is not meeting customers’ expectations. your auditor may come to your 5 of 14 16/01/2013 2:26 PM . evaluating the OASIS database for customer feedback. or flowed down to sub-tier suppliers. failure to follow up to determine effectiveness of actions taken. 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. 1 cause of unsuccessful audits. 8. Consequently. There have been many instances where customer flow-down requirements are not being implemented internally. In preparation for audits. NQA auditors will determine who the suppliers’ main customers are and will be reviewing customer requirements. 7. Auditors are finding a lack of containment and immediate correction.sustainingedge.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. Though this is not specific to new requirements of the AS9100C standard. it continues to be the No. Ineffec ve correc ve-ac on process. and structuring audits to evaluate the effectiveness of processes and their ability to meet customers’ requirements and expectations. and recurring nonconformities resulting from ineffective corrective include contractual or customer-specific requirements. Though process auditing was required and expected by the AS9100B standard. and will come up with disastrous results.

Preparing for an upgrade to this new standard is challenging because there are a number of new requirements. 57 percent said that a client requirement motivated them to obtain certification. “However. the quality management system standard from the Interna onal Organiza on for Standardiza on (ISO).” says facility armed with information regarding poor levels of customer satisfaction and will most certainly want to see your corrective action plan. and concepts to understand and implement within your new QMS. terms. “Prospective clients have often mentioned that they require the [ISO 9001] standard to qualify for a particular tender. When asked. the prospect of winning more work was the primary motivation for implementing the standard.sustainingedge. with 31 percent responding that winning more business was their incentive. which was carried out by specialist market research organization. what we didn’t know is how many of our clients had actually won work as a direct result of achieving certification With the latest results now in. ISO 9001 Proven to Win New Business According to data from The Bri sh Assessment Bureau’s (BAB) independent 2011 Client Sa sfac on Survey. The survey. Lake Market Research (LMR). showed that for many organizations. 44 percent of respondents said that they had won business as a result of becoming cer fied to ISO 9001. we’re delighted to confirm that certified organizations are getting the reward they deserve from implementing 6 of 14 16/01/2013 2:26 PM . Looking for help with your upgrade to the AS9100C Standard? Contact us for effective and proven results.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www.

sustainingedge. These are: (1) Project. and (5) Risk management. and portfolio management ISO had originally established a project committee to develop a single standard on project management (ISO/PC 236). with some clients sugges ng that ISO 9001 carried real weight. “We have won several government contracts which we couldn’t even have a empted without ISO 9001. It isn’t just the government that insists on cer fica on either. that figure looks set to increase.” Verba m feedback from the survey backed up the figures.000 ISO 9001 cer ficates were issued in the UK in that year. recognizing that the discipline of project management is much broader than what a single standard can encompass.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. recognized quality management system. program. commissioned its own survey in 2009 showing that more than 40. However. (2) Outsourcing. “We are star ng to win new accounts that we could not have approached in the past as they insisted on having ISO 9001. 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. it was decided that a new technical committee would be created to develop additional standards in this 7 of 14 16/01/2013 2:26 PM .” says Debbie Horlock from Screenfix Windscreens. (4) Additive manufacturing. Project. and portfolio management.000 interna onal standards. With 96 percent of BAB’s clients recommending the standard to other organiza ons. (3) Human resources management.” says Chris an Stoneham from Masters Exhibi ons & Shows. program. The ISO developer and publisher of more than a robust.

It will promote interoperability and coherence. Currently. It will also improve understanding of all parties involved in outsourcing by providing a common set of practices for managing the outsourcing life cycle. and exploit demographic shi s that influence their access to workers.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. powders. ISO/TC 260. It will promote reliable and transferable approaches to work force management in developed and emerging economies for the overall benefit for organiza ons and their employees. Addi ve management Addi ve manufacturing (AM) is an inherent part of the product development process. The first meeting took place in June 2011 in Washington. processes. 14 countries are involved. services. Currently. will develop standards for HR management. Outsourcingwill develop a standard to provide overarching guidance and terminology.sustainingedge. policies. and reduce transaction costs for outsourcing. and vocabulary in existing and future standards. The standards will help organiza ons adapt to. Outsourcing A new project committee ISO/PC 259. and films are layered to build 3-D structures without the use 8 of 14 16/01/2013 2:26 PM .” will address aspects that are not covered in the standard currently in development. procedures. These addi ves are used to manufacture prototypes. in Sofia. Bulgaria. The new ISO/TC 258-”Project. The committee took place in June 2011. Human resource management. contribute to removing technical barriers to trade. enabling practitioners to harmonize area. In comparison to conven onal methods where parts are molded into specified forms or cut from a massive block. including guidelines. AM is based on the principle that liquids. program. 34 countries are involved. and portfolio management. tools. and produc on parts. Human resource management A new ISO commi ee. prac ces.

A new ISO technical commi ee. Currently some 30 countries are involved. 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. AM used in the development. Risk management. to promote this work by developing a document that offers further guidance for implemen ng these standards. ISO/PC 262. In the past. 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. ISO/TC 261 Addi ve manufacturing will develop the much-needed standards for development and market penetra on of the industry.sustainingedge. a comprehensive risk management toolbox was developed by an ISO working group. 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 world’s energy use. One of the main reasons is the unavailability of interna onal standards. modifica on.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. and use of mold-free produc on processes has been quite unsystema c. ISO 50001 will provide public and private sector 9 of 14 16/01/2013 2:26 PM . ISO now has created a new project commi ee. Risk management In of a mold.

harmonized standard for implementa on across the organiza on with a logical and consistent methodology for iden fying and implemen ng improvements. 10 of 14 16/01/2013 2:26 PM . Mul na onal organiza ons will have access to a single. There has been a perfect storm-more products.” 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. The standard is available now on the ISO Website. consumers.S.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www. more countries.sustainingedge. A drama c change in strategy must be implemented. ISO 50001 is intended to provide organiza ons with a recognized framework for integra ng energy performance into their management prac ces. The standard is intended to accomplish the following. and more access. and health and safety. more manufacturers. reduce costs and improve energy performance. 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. 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-efficient technologies Allow integra on with other organiza onal management systems such as organiza ons with management strategies to increase energy efficiency. FDA Unveils Global Strategy for Quality of Imported Products The U.S.

sustainingedge. For more information on process evaluation tools.” Turtle Diagram – Process Evaluation Tool The star ng point for effec ve internal audi ng is to understand your organiza on’s exis ng processes. By looking at what is really happening versus what procedures say is supposed to be happening. 11 of 14 16/01/2013 2:26 PM . “Pathway to Global Product Safety and Quality. we now must move to what is called the turtle diagram for individual processes. an evalua on can be made as to whether the process is effec ve in mee ng the customer’s requirements. To achieve this. Internal auditors can create and review these diagrams for every major process in an organiza on. see our June 2006 newsletter – five years old but still valuable. 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. This is a good analogy because the turtle diagram looks at how the process sa sfies the customer (typically an internal customer at this stage). visit the FDA Website for the Execu ve Summary and to download a PDF of the full report. The challenge is to determine if your current processes s ll add value to your organiza on and its customers.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge For more informa on. Six Sigma prac oners have expanded the process model to get the supplier-input-process-output-customer (SIPOC) model. Some say that the turtle diagram is a cross between the SIPOC and a cause-and-effect diagram.

Space and Defense Understanding and Implementing AS9100C (9110 &9120) Aviation.sustainingedge. 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. and on-line registration click on the course title below. We offer group discounts. schedule. 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 12 of 14 16/01/2013 2:26 PM . We deliver onsite training for these courses and customized training to fit your specific Training Courses To see the course description.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge http://www.

Don’t see a 13 of 14 16/01/2013 2:26 PM . or date that fits your needs? Contact Us Email: Phone: 888-572-9642 toll free Website: http://www.sustainingedge. location.Nonconformities to Avoid with AS9100C Audits | Sustaining Edge 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.

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