Summary of Significant Changes to AS9100C

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Performance Improvement Solutions for Your Business Needs March 2009
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Greetings!

Welcome to Sustaining Edge Solutions E- Newsletter

Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.

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Summary of Significant Changes to AS9100C
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Our last issue informed our readers about the revised Aerospace QMS Standard, AS9100C:2009. We have been asked to identify the major changes to the standard.

7.1.1 Project Management New requirement for planning and managing product realization in a structured and controlled way.

7.1.2 Risk Management New requirement of implementation of a risk management process applicable to the projects & products; responsibility, criteria, mitigation & acceptance.

7.1.3 Configuration Management Moved from clause 4.3 to clause 7.1 and added details on the different activities to be covered.

7.1.4 Control of Work Transfer Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on having a process for planning and control of transfer activities.

Product quality and on-time delivery performance. Added requirement to measure “product conformity” and “on-time delivery” and take appropriate actions if planned results are not achieved. The intent is to provide a linkage between the QMS and organization performance.

Process to address control of Special Requirements, Critical Items and Key Characteristics. Key characteristic requirements remain unaltered but a new concept is added to identify special requirements from the Customer or internal sources that require additional controls (e.g. risk management) that translates into Critical Items that may flow to Key characteristics for variation control.

Formal monitoring of Customer satisfaction data. Added the requirement to monitor data and to develop improvement plans that address deficiencies. The intent is to promote continuous improvement of the product and Customer satisfaction.

Requirements from regulatory authorities. A general requirement has been introduced in 4.1 to address all the applicable statutory and regulatory QMS requirements in the organization’s QMS instead of keeping detailed requirements in chapters.

First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed. Production process verification “FAI” is the requirement to validate the production process’s documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it is part of product realization and is not intended to be a follow-on activity.

Difference between Key Characteristics, Special Requirements and Critical Items. Special Requirements are those requirements that have high risks to being achieved, which require their inclusion in the risk management process. Critical Items, including key characteristics, are those items that have significant effect on product realization and use of the product, which require specific actions to assure they are adequately managed.

AS9100C is consistent with ISO 9001:2008 and the length of time to transition is 30 months. Companies will be encouraged to upgrade on their scheduled audit cycle.

Purchase AS9100C at the SAE International Website.

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FMEA: Risk Identification and Control
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Identifying and reducing risk should be viewed as a critical process in your organization. Whether it’s a new idea, design, process, or a potential solution, the risk of failure always exists. Failure cannot be eliminated, but if potential failures are identified and analyzed early mitigating actions can be taken to minimize the impact if the failure occurs. The Failure Mode and Effects Analysis (FMEA) process provides the framework within which this can occur.

Purpose of FMEA. FMEA is an analytical methodology used throughout the product and process development cycle to ensure that potential problems have been identified, considered and addressed. Its most visible results are the documentation of the collective knowledge of cross- functional teams and the action items which mitigate the potential risk.

Key Elements of an FMEA. A FMEA can be prepared to examine the design of a single part, an assembly, the entire system or the processes used to produce them. The following required elements are common for all:

Appropriate Scope. The first step is to establish the depth and level of the analysis. This is accomplished by first identifying and scoping the area of the product or process design, by some form of boundary, block, or flowchart. The complexity of the scope will determine if a single FMEA or multiple (system level and component) FMEAs are required.

Early Start. No value exists in doing an FMEA after the design is completed or the manufacturing process has been developed. The greatest benefit is received by doing it as early as possible. Partial FMEAs can be done at the conception of design to identify key requirements and risks early in the design development cycle, and updated as the design progresses.

Knowledgeable Team. The FMEA is the collaborative effort of a team. Individual team members can affect the scope, direction, or quality of the analysis. The best FMEAs are obtained when teams include subject-matter experts associated with the design or process under review.

Structured Analysis. Simple techniques such as brainstorming can be used to evaluate risk associated with a single event, but evaluating multiple events and their possible interactions requires the structured approach offered by a FMEA. Use of FMEA assures that: (1) All potential failures are identified. (2) Effects (impact to the customer) are identified. (3) Risk assessment (severity, causes, design prevention and controls, occurrence) is made for each failure mode.

Good Discussion and Dissection. The FMEA form should not drive the FMEA discussion. A “good” discussion gets down to the “mechanism” of failure or the physics of how a design or system works. If your FMEA meeting is just filling out the form, it’s a waste of time.

Risk Mitigation. Identifying and assessing risks is not enough. Actions such as redesign, elimination or reduction of the causes, or provision for early detection must be taken to mitigate their impact upon the customer. The key is to assign someone on the team to either resolve the issue or follow-up with the team members needed to resolve the issue(s).

Proper Documentation. Finally, the collaborative efforts of the team – the structured analysis, the “good” discussion and the risk mitigation – need to be captured so that the same issues are not duplicated in the future and improvements can be made. Enough detail must be documented so that the FMEA can be picked up in a year and fully understood. The FMEA should not be archived until all action items have been completed and all risks identified by the team have been resolved.

The FMEA process can be a powerful tool to reduce process, product, and design issues.

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How to Motivate Your Team
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When you turn on the TV, the headlines are all about the doom and gloom economy. Could the bad news get any worse? You bet it could. Your company could be one of those businesses in trouble. And that could mean reductions in force. You can bet that your staff are wondering what it all means to them. What do you do? Hunker down, turn into a hermit and wish it away? Absolutely not. Now is the time for you to be a true leader in your organization.

When a business is in trouble, the tendency for most leaders is to keep everything quiet. They’re afraid of a mass exodus of employees if word gets out. And that’s a valid concern because once employees get the whiff of a rumor that a company is in trouble many of them will jump ship. So that means your top priority right now is to communicate as much as you can about how your business is doing and what actions are being taken to move the company ahead among all this bad news.

You simply must crank up the volume of your communication efforts to keep your team members motivated and productive. Team members want to hear from you. If you don’t keep them informed, they’ll make things up to fill the void. You’ll be able to tell whether you are communicating enough by listening to the noise level at your company. Is the rumor mill really loud or just a soft murmur? The louder the rumor mill, the more you need to communicate to quiet it down.

You also need to take a proactive individual approach with key players in your company to help them stay motivated and working at peak performance. The way to motivate good employees to stay through tough times is to understand how each team member perceives their “fit” in the organization and how their role plays out in terms of company goals.

This does two things for your company. It helps you secure commitment from the employee to stay and communicates to them that they are important. It all begins with a one-on-one discussion. Take a look at what each employee values and see what you can do to provide motivation to accommodate those values.

Find out how your employees feel by asking them:

  • What do you find most challenging about your work?
  • What aspect of your work provides the most satisfaction?
  • What are the biggest obstacles to completing your work?
  • What resources would make your work easier?

The answers to these questions can help you nail down just the right motivational tactic to keep each team member on the right track and will keep your business moving ahead no matter what’s happening in the world.

Written by Denise O’Berry

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ISO Family of Standards Free Paper
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ISO has just published an attractive new paper edition of its popular brochure of advice for managers, Selection and use of the ISO 9000 family of standards.

ISO Secretary-General Rob Steele comments: “With an estimated one million users worldwide, ISO 9001 tends to overshadow the rest of the ISO 9000 family and that means lost opportunities because integrated use of these standards can multiply the benefits for organizations and their customers. This new edition of the Selection and use brochure will give managers ideas on how to achieve such benefits.”

The brochure includes concise examples of the integrated use of ISO 9000 family standards in the following manufacturing or service organizations:

  • A metal parts fabricating company
  • An electrical appliance manufacturer
  • A chemical processing company
  • A computer software developer
  • A franchise organization.

It provides an overview of the standards in the ISO 9000 family and demonstrates how, collectively, they form a basis for continual improvement and business excellence.

View and download the new paper edition of the brochure of advice for managers.

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Best Practices Articles and News
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In these turbulent times its important to identify strategies and read about best practices in whatever industry you may be engaged.

We have found that “Industry Week’s Connecting Manufacturing Leaders” contains great articles in various topics for improving and sustaining your business.

If you are aware of a viable news source that would help manufacturers and service industry companies, please let us know. We are all in these trying times together.

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Training Courses
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To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.

Understanding & Implementing ISO9001:2008
ISO 9001:2008 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding & Implementing AS9100B:2004
AS9100B: 2004 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO/TS16949:2002
ISO/TS16949:2002 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO14001:2004
ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Contact Us

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