Archive for 2011

Nonconformities to Avoid with AS9100C Audits

Tuesday, July 5th, 2011

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   July 2011


This Month
* 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

 

Lunch and Learn
August 9, 2011
Phoenix, AZ

 

Information Security Management

Presented by Sustaining Edge Solutions, Inc.

 

Information and Registration

 

Quick Links…

Join Our Newsletter List!

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.  

 

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

 

 

 

Common Nonconformities to Avoid with AS9100C Audit

According to Robert Parsons, aerospace and defense business unit director at management system registrar, National Quality Assurance (NQA) after completing a number of audits to the AS9100C standard, the NQA, USA auditors have provided the following feedback on areas most often cited for nonconformances.

1. Failure to act on customer satisfaction 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-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, critical items, and key characteristics.

“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 company’s 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 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. Configuration 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 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, 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 continual-improvement 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. Ineffective 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 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. Ineffective corrective-action 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 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. Consequently, your auditor may come to your 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 British Assessment Bureau’s (BAB) independent 2011 Client Satisfaction Survey, 44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001, the quality management system standard from the International Organization for Standardization (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 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, we’re delighted to confirm that certified organizations are getting the reward they deserve from implementing a robust, recognized quality management system.”

Verbatim feedback from the survey backed up the figures, with some clients suggesting that ISO 9001 carried real weight. “We have won several government contracts which we couldn’t even have attempted without ISO 9001,” says Debbie Horlock from Screenfix Windscreens. It isn’t just the government that insists on certification either. “We are starting to win new accounts that we could not have approached in the past as they insisted on having ISO 9001,” says Christian Stoneham from Masters Exhibitions & Shows.

 

The ISO developer and publisher of more than 18,000 international standards, commissioned its own survey in 2009 showing that more than 40,000 ISO 9001 certificates were issued in the UK in that year. With 96 percent of BAB’s clients recommending the standard to other organizations, that figure 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 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 committee, ISO/TC 260, Human resource management, will develop standards for HR management, including guidelines, processes, policies, practices, services. It will promote reliable and transferable approaches to work force management in developed and emerging economies for the overall benefit for organizations and their employees. The standards will help organizations adapt to, and exploit demographic shifts that influence their access to workers.

Additive management

 

Additive manufacturing (AM) is an inherent part of the product development process. These additives are used to manufacture prototypes, tools, and production parts. In comparison to conventional methods where parts are molded into specified forms or cut from a massive block, AM is based on the principle that liquids, powders, and films are layered to build 3-D structures without the use of a mold. In the past, AM used in the development, modification, and use of mold-free production processes has been quite unsystematic. One of the main reasons is the unavailability of international standards. A new ISO technical committee, ISO/TC 261 Additive manufacturing will develop the much-needed standards for development and market penetration 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”

Additive manufacturing will develop the much-needed standards for development and market penetration of the industry. ISO now has created a new project committee, ISO/PC 262, Risk management, to promote this work by developing a document that offers further guidance for implementing these standards. The document will be applicable to all organizations of all sizes and will be written using plain expressions and terminology for ease of application. Currently some 30 countries are involved.

In the News

ISO 50001 Energy Management Standard

 

The ISO International Standard ISO 50001 on energy management systems is an eagerly awaited event because it is estimated the standard could have a positive impact on some 60 % of the world’s energy use. ISO 50001 will provide public and private sector organizations with management strategies to increase energy efficiency, reduce costs and improve energy performance.

ISO 50001 is intended to provide organizations with a recognized framework for integrating energy performance into their management practices. Multinational organizations will have access to a single, harmonized standard for implementation across the organization with a logical and consistent methodology for identifying and implementing improvements.

The standard is intended to accomplish the following, for example:

  • Assist organizations in making better use of their existing energy-consuming assets

  • Assist facilities in evaluating and prioritizing the implementation of new energy-efficient technologies
  • Allow integration with other organizational 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 Administration (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 dramatic change in strategy must be implemented.

For more information, visit the FDA Website for the Executive Summary and to download a PDF of the full report, “Pathway to Global Product Safety and Quality.”

 

Turtle Diagram – Process Evaluation Tool

The starting point for effective internal auditing is to understand your organization’s existing processes. By understanding the basics of any activity through a simple process model (input-process-output) you can start looking deeper into what is happening in your organization. Six Sigma practitioners have expanded the process model to get the supplier-input-process-output-customer (SIPOC) model.

 

The challenge is to determine if your current processes still add value to your organization 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 organization. Some say that the turtle diagram is a cross between the SIPOC and a cause-and-effect diagram. This is a good analogy because the turtle diagram looks at how the process satisfies 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 evaluation can be made as to whether the process is effective in meeting the customer’s requirements.

For more information on process evaluation tools, see our June 2006 newsletter – five years old but still valuable.

 

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 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. Don’t see a course, location, or date that fits your needs?

Contact Us

 

 

Phone: 888-572-9642 toll free

 

 

 

ISO 9001 Proven to Help Win New Business

Monday, June 13th, 2011

According to data from The British Assessment Bureau’s (BAB) independent 2011 Client Satisfaction Survey,  44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001, the quality management system standard from the International Organization for Standardization (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.

ISO 9001 is intended to help improve internal management processes, leading to greater efficiency. However, ‘improving internal processes’ was only the third most popular reason for seeking ISO 9001 certification, with 24 percent confirming this. However, the results of BAB Client Satisfaction Survey didn’t prove a surprise to BAB’s director of marketing, Robert Fenn. “Prospective clients have often mentioned that they require the [ISO 9001] standard to qualify for a particular tender,” says Fenn. “However, 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, we’re delighted to confirm that certified organizations are getting the reward they deserve from implementing a robust, recognized quality management system.”

Verbatim feedback from the survey backed up the figures, with some clients suggesting that ISO 9001 carried real weight. “We have won several government contracts which we couldn’t even have attempted without ISO 9001,” says Debbie Horlock from Screenfix Windscreens.  It isn’t just the government that insists on certification either. “We are starting to win new accounts that we could not have approached in the past as they insisted on having ISO 9001,” says Christian Stoneham from Masters Exhibitions & Shows.

Question: Has being registered helped your company improve the bottom line?  We know that a customer requirement is a major motivator for registration, but was going after more business a factor, and has it worked for your organization?

Let us know!


 

 

Which Method was First – or can I use Both?

Thursday, June 2nd, 2011

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   June 2011


This Month
* Which Method was First-or can I use Both?
* Quality Objectives
* Root Cause Analysis – Found It?
* In the News
* Training Courses

 

Lunch and Learn
June 16, 2011

 

Information Security Management

Presented by Sustaining Edge Solutions, Inc.

 

Information and Registration

 

 

Quick Links…

Join Our Newsletter List!

 

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

 

 

 

Which Method was First – or can I use Both?

 

We recently conducted a second Kaizen Event for a medical and dental service provider. During the project a team member asked “Is Kaizen the same as Lean, and is Six Sigma on its way out?” I remember leading my first Kaizen/Lean project 18 years ago and hearing “Is Kaizen replacing Total Quality Management?” Not much has changed over the quality improvement timeline. Many enterprises whether service or manufacturing are looking for simplified answers and methods to cost reduction, improved quality and enhanced customer satisfaction.

It is not about what’s been around the longest, or some new improvement method you heard about that “everyone is doing.” It is about what your organization is facing today, and what it could be facing tomorrow if you do nothing. Do you have customer dissatisfaction, product returns or service issues, high operating costs? Maybe trying to improve cycle time, service delivery or reduce process waste? These are the type of questions you need to ask to determine what to do, and how to focus your resources to improve profit. 

Lean and Six Sigma have become the most widely known methods for creating breakthrough and sustained improvement. Keep in mind that these methods have evolved from previous proven methods such as the plan-do-check-act (PDCA) cycle and Toyota’s process waste elimination system.

 

Lean Improvement Through Waste Elimination

A lean core principal is based on creating a “pull system” to produce faster, rather than the traditional “push systems” used by most organizations. The goal is to always pull from the customer demand, not push to the customer and suboptimize your capabilities. A method that started in manufacturing to reduce waste is now used to improve cycle time, and workflow in workplace and department performance, and reduce waste in hospitals, insurance companies, financial services, and nonprofit environments.

Value stream mapping is an important tool used in lean. It documents all the tasks (material and information flow) and process metrics (process time, cycle time, inherent costs, barriers) within a system including waste and non-value added activities. An example of a task level metric used in our lean events is called Complete and Accurate (%C&A). This equates to the time the downstream customer can perform the task without having to “CAC” the incoming work:

  • Correct information or material that was supplied
  • Add information that should have been supplied
  • Clarify information that should or could have been clear.

The output metric is measured by the immediate downstream customer and all subsequent downstream customers. This process makes visible the problems or waste so that they can be eliminated, thereby making the processes faster and cheaper to deliver. Creating “value” as seen by the eyes of the customer is the key component to lean. Providing value to the customer is why a supplier exists. Whatever does not provide value to the internal and external customer can be considered as process waste.

 

Six Sigma Improvement Through Voice Collection and Data Analysis

The fundamental objective of the Six Sigma methodology is the implementation of a measurement-based strategy that focuses on process improvement and variation reduction.

A Six Sigma system is based upon gaining customer, business, and organizational process knowledge “data” for utilizing information to drive performance improvement and measurement of core processes. Two primary methods known as “Voice Collection” and Define-Measure-Analyze-Improve-Control (DMAIC) are used to improve processes and products, and to help ensure that products and processes function well starting with the voice of the customer to the delivery of product and services.

Understanding what your customers consider “critical success factors” are absolutely necessary for determining the depth of your performance improvement system. This information further identifies a cause and effect relationship in regards to how your processes are performing, their capabilities, effective measurement, and the identification of necessary resources for your business to achieve performance excellence.


One of the most distinct differences in Six Sigma is the link to business finances. The DMAIC process is an improvement system for existing processes falling below specification and looking for incremental improvement.

Lean Six Sigma is quite simply the integration of lean and Six Sigma methodologies. Lean focuses on efficiency, and Six Sigma focuses on how effectiveness can lead to faster results than either method applied independently of the other. Any successful improvement deployment depends on a clear understanding of personnel roles, responsibilities, structures, and necessary training requirements for  employees.

Successful companies recognize that comprehensive process improvement is not achieved by a simple “fix it” to one-time problems, or band-aid approaches. Improved profits require a new way of doing business, and the smart companies use continuous improvement as a daily business function.

 

Quality Objectives

 

Are you having a difficult time identifying quality objectives for your organization? Think about your business.

According to ISO 9000:2005, 3.2.5, a quality objective is something sought or aimed for, related to quality. ISO 9001:2008, 5.4.1, states your quality objectives must be measurable and consistent with the quality policy.

Clause 5.3 of ISO 9001:2008 says your quality policy is a framework for establishing quality objectives. It also says that the policy must include a commitment to 1) comply with requirements and 2) continually improve the effectiveness of the quality management system. Using the quality policy as a framework, you would have a quality objective to measure the degree to which requirements are being met, as well as, a quality objective that measures the results of the quality management system.

If your quality policy identifies other important areas, for example, product reliability, you would be expected to have another measurable target for product reliability. ISO 9001:2008, clause 8.2.1, says a required performance measure is for customer satisfaction.

Remember, goals are conditions to be achieved in the future. They should be defined consistent with your vision and mission. Goals are established to guide your decisions and actions. They don’t change as much as objectives. Your objectives must involve measurable results to achieve your goals.

Objectives are focused on critical issues and milestones. They describe the activities and targets to achieve your goals. They even identify the dates for completing the activities. They are measurable in terms of being achieved, or not. For example, a general goal might be to reduce waste. The related, specific objective might be to reduce rework from 10% to 5% by the end of 2011.

Depending on your industry, you might consider quality objectives such as:

  • Scrap Rate = Product Rejects / Products Produced
  • Return Rate = Products Returned / Products Shipped
  • Complaint Rate = Received Complaints /Total Customers
  • Design Stability = Change Requests / Product Releases
  • Service Quality = Defective Transactions / Total Transactions

Be careful how you set these objectives and how you communicate them. You might find people actually manipulating processes to achieve the desired results, especially if the numbers are used to evaluate employee performance. When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be optimized at the expense of overall system performance.

If a target is perceived as arbitrary, and set beyond the capability of the process, it may lead to employee frustration, reduced morale, and even lower performance. Individuals must feel they have some control over the outcome for an objective to actually promote improvement. The objectives should help monitor and control the processes, not the people.

 

Root Cause Analysis – Found It?

Have you found the root cause yet?”

We frequently ask or hear others ask that question. Root cause analysis (RCA) is an old subject and is familiar to many people. If your company is registered to a major global quality standard, you hear it very often and you most likely have contributed to a corrective action using it.

According to Gary Jing, the phrase “root cause” can be somewhat misleading. Many who use it are unaware of the concept’s larger context. Asked what root cause means, some typically respond with:

  • “It is what is really happening.”
  • “It is the one thing that causes everything else.”
  • “It’s the light switch. When you flip it, the lights go on.”

These explanations imply there is one specific thing that is the originator of the considered effects, and the origination is absolute, meaning unconditional and inevitable. This absolute origination is usually referred to as the root cause. The challenge to people is to know when and where to stop drilling down through the infinite layers of cause and effect and conclude they have reached a root cause. The clue resides in the typical business mind-set. It’s similar to selecting something that can yield a high return on investment (ROI), for example. That is how most businesses make decisions.

One key to unlock the root cause chest is called the span-of-control or sphere-of-influence principle.

 

Span of Control

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.

Sphere of Influence

Similarly, if a cause is outside the sphere of influence (persuasion only), it’s a good indication you can stop drilling because working beyond that generates no returns. That’s not to say you’ll always give up in this case. The focus then must be shifted to expanding the influence boundaries to enclose the cause currently outside of your influence. In my experience, the sphere of influence is frequently the dominating factor in root cause selection.

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.

 

In the News

 

AS9100 Event

AS9100C:  Are You Ready?

Last month we conducted a workshop in Scottsdale, AZ for companies interested in the AS9100C Aviation, Space and Defense Standard requirements. Interpretation of key requirements were learned by all and attendees were able to share ideas about their company approach and new customer requirements.  If interested in a copy of the material presented or assistance with this new standard  Contact Us.


Eight Annual Medical Device Quality Congress

This year the conference will feature more than 15 in-depth sessions headed up by leading quality experts, including sessions led by 10 officials from the Center for Devices and Radiological Health and five former Food and Drug Administration officials. FDA news has pinpointed the top five most important quality issues-risk management, design control, supplier quality, quality systems regulation (QSR) compliance, and postmarket surveillance-and built this year’s program around them.

For more information visit the Conference Website.

World Accreditation Day

More than 60 countries are participating in World Accreditation Day on June 9, 2011, a worldwide initiative jointly established by the International Accreditation Forum (IAF) and others. Accreditation has been used for more than 50 years as the definitive means of evaluating organizations and is now utilized by all the world’s major economies and many developing economies. Accreditation of conformity-assessment bodies provides businesses and regulators with confidence that products entering the market conform to specifications, meet national legal and regulatory requirements, and fulfill the need to protect public interests.

For more information visit World Accreditation Day.

 

 

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 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. Don’t see a course, location, or date that fits your needs?

Contact Us

 

 

Phone: 888-572-9642 toll free


A Corporate ‘Lattice,’ not Ladder

Tuesday, May 24th, 2011

We found this new article on Leadership Styles informative and extremely insightful, enjoy!

Barry Salzberg, CEO of Deloitte, has spent his entire 34-year career in one place, climbing the corporate ladder. From his first unsupportive manager at the New York-based professional services firm to the mentors who helped pull him up through the ranks, Salzberg learned to lead and be led, eventually becoming CEO of Deloitte LLP in the United States in 2007. He has a message for the next generation of leaders: The old leadership hierarchy no longer works.

“Gone is the day of the old command-and-control environment, the climb-the-ladder model in which the employee kept quiet and didn’t say too much, certainly not much beyond what was asked and tasked,” Salzberg told his audience at a recent Wharton Leadership Lecture. “Gone, too, is the densely layered organizational hierarchy [and] dinosaur-like structures that are too slow and lumbering for today’s environment.”

To thrive in an ever-changing world, companies must actively commit to cultivating younger leaders throughout the organization, and encouraging older leaders to pass on what they know. “Leadership now needs to be the norm, not the exception,” he noted. “No longer is leadership about a few exceptional leaders at the top of the organization. Rather, the future is about exceptional teams and the leaders within those teams who can out-maneuver, out-manage and out-innovate their competition.”

Up the ‘lattice’

That is why leadership needs to be flat, Salzberg noted. In a global world, leaders are required at all levels of the organization, not just at the top. In fact, Deloitte has “kicked away the ladder,” he said. “In my organization, we talk now about the lattice, not the ladder.” With a lattice structure, people can move not just up and down but also sideways. If employees need to ease up on the intensity of work to take care of a child or an aging parent, the lattice structure allows them to do that without destroying their career. “The corporate lattice metaphor signals a shift in mindset. It’s better reflective of today’s employees, who want variety and flexibility, and reject a one-size-fits-all approach.”

Another leadership relic, according to Salzberg: the idea of a “ruling elite in the clouds of some bureaucratic Mount Olympus.” In the past, it would have been unthinkable for the average employee to have direct contact with the CEO, he pointed out. Today, CEOs regularly host employee town halls, in which people are encouraged to ask and say anything. “Our people have to see that if they disagree [with their boss], nothing will happen, that there are no [negative] consequences to promotion or compensation.”

No ostriches, no elephants

Leaders today must also be transparent, especially in our socially networked world, said Salzberg. “In today’s social media environment, it’s fascinating to see how in 10 seconds what you say is spread throughout the organization. There are few hiding places.”

The experience helped him develop what he calls his “no ostriches, no elephants” principle. “No burying your head in the sand if there’s a problem, and no ignoring the elephant in the room,” he said. “Much better to name and tame an issue, no matter how difficult it is, than to ignore it or pretend it isn’t there. Making sure the truth is told and discussed with all is the foundation of leadership. Without that, you can’t build trust.”

To read the entire article, see Knowledge@Wharton website.

Question: Has the current social media business environment lifted teamwork to a newer dynamic area of stability, or can total transparency harm team organizational effectiveness? Respond! :)

Free Tutorial on New ISO/IEC 17021

Thursday, May 5th, 2011

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 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   May 2011

 


This Month
* Free Tutorial on ISO/IEC 17021
* Hackers Putting Your Business in Danger?
* Missing Ingredients
* In the News
* Training Courses

 

  
  
  
  
  
  
  
 
Lunch and Learn  
May 19, 2011   
  
 

 

Information Security Management 

Presented by Sustaining Edge Solutions, Inc. 

 

Information and Registration 

 

 

  
 
Quick Links…
  
  

Join Our Newsletter List!

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

 


Free online Tutorial on New ISO/IEC 17021  

 

Last month in our April issue, we discussed the ISO/IEC 17021:2011 Conformity Assessment  and how the new edition adds new requirements developed in response to market feedback on the use of the first edition. The new requirements provided in ISO/IEC 17021:2011 relate to the competence of the auditors who carry out certification and to the way in which they are managed and deployed. Certification bodies that use the new edition will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner.

This issue we want to inform our readers that a free tutorial is available on the iso.org website on the improved second edition of ISO/IEC 17021 published on 1 February 2011. 

The purpose of ISO/IEC 17021:2011 is to increase the value of management system certification to public and private sector organizations worldwide. The online tutorial on the standard has been made available by the ISO Committee on conformity assessment, (ISO/CASCO). It was developed by Randy Dougherty and Alister Dalrymple, the two leaders of the working group responsible for the standard.

 

The tutorial explains the differences to the first edition, published in 2006, and the new requirements. The explanations are displayed in the speakers note of each slide. The tutorial (available in English only), consists of three PowerPoint presentations, including notes.  The first is an Overview (27 slides), the second is the Audit Process (62 slides), and the third is Auditor Competence (19 slides).

 

View all the downloadable presentations here on the iso website    

 


Are Hackers Putting Your Business in Danger? 
 

With all organizations susceptible to cyber-attacks, a new International Standard on business continuity management processes has a huge potential to improve security measures taken against hacking, denial of service and malware attacks.

 

ISO/IEC 27031:2011: Information technology – Security techniques – Guidelines for information and communication technology readiness for business continuity, gives advice that will be useful for all types of security-conscious organizations, regardless of their size, complexity and risks.

 

Information and communication technologies (ICT) have become an integral part of the critical infrastructure in all sectors, whether public, private or voluntary. The proliferation of networking services, and the capabilities of systems and applications, has also meant that organizations are ever more reliant on safe and secure ICT infrastructures. Failure of these systems will impact the continuity of business operations.  

 

 The critical functions that require business continuity are usually dependent upon ICT. This dependence means that ICT disruptions can constitute strategic risks to organizational reputation.

 

The standarddescribes the concepts and principles of ICT readiness. It provides a framework of methods and processes to identify and specify all aspects, such as performance criteria, design, and implementation for improving an organization’s ICT readiness. It also enables an organization to measure performance parameters that correlate to its ICT readiness for business continuity programme (IRBC) in a consistent and recognized manner.  

 

ISO/IEC 27031:2011 covers all events and incidents (including security related) that could have an impact on ICT infrastructure and systems. It includes and extends the practices of information security incident handling and management and ICT readiness planning and services.

 

Purchase the ISO/IEC 27031:2011:Information technology – Security techniques at the ISO Store.   

 


Missing Ingredients  
  

Improvement initiatives may help your organization improve, but are they really giving you a competitive advantage? Probably not, according to Michael Bremer, co-author of “Escape the Improvement Trap: Five Ingredients Missing in Most Improvement Recipes”.

 

That’s because the competition is likely implementing the same improvement methods and the end result is most companies are merely average. His book identifies five characteristics that the most effective companies display, yet are missing or underused in most improvement programs:

1. Customer Value

 You need not only a clearly articulated value proposition to grow your desired business, but also the correct value proposition. That well-conceived proposition should drive improvement initiatives. 

2. People Engagement

 The most effective organizations create environments that actively encourage everyone to do their best work, develop critical thinking skills, and collaboratively innovate.
 

3. Key Metrics

 

A few very meaningful metrics are more important than having a lot of metrics that provide overwhelming amounts of data that are not useful.   

 

 

4. Process Thinking

 

Effective organizations manage and improve business performance along cross-functional process lines rather than by individual business functions.  

 

5. Executive Mindset

 

Leaders must understand and manage the four ingredients listed above, as well as, how they are being used to make a difference in the marketplace.  

 


In the News  
 

International Forum on DFMA

 

Boothroyd Dewhurst Inc. will host the 26th annual International Forum on Design for Manufacture and Assembly (DFMA) to be held June 13-15, 2011, at the Crowne Plaza Hotel in Providence, Rhode Island. This year’s theme is “Manufacture Success: Meeting the Challenge of Growth in Product Development and Manufacturing.”

For more information visit the DFMA Event Website.  

 

Machine Vision Market Soared 54% in 2010  

Sales of machine vision components and systems in North America soared 54 percent in 2010 to nearly $1.8 billion, according to new figures released by the Automated Imaging Association (AIA), the world’s largest machine vision trade group.

The substantial market growth in 2010 demonstrates the importance of machine vision technology to companies in manufacturing and nonmanufacturing sectors,” says AIA president Jeff Burnstein. “We saw strong evidence of this at the recent Automate 2011 Show and Conference, which was our largest in a decade. Exhibitors reported strong interest in machine vision solutions, and conference sessions focusing on vision were packed.”


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 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. Don’t see a course, location, or date that fits your needs?

Contact Us   

  

 

Phone: 888-572-9642 toll free

AS9101D: Are You Ready?

Monday, April 18th, 2011

If your company is certified to AS9100B, you should already know that the transition to AS9100C Aviation, Space, and Defense Standard starts July 1, 2011. If your surveillance or re-certification audit is going to take place after this date, you must have completed the transition to the new requirements, and have the correct documentation and objective evidence to demonstrate effectiveness.

AS9101D Audit Requirements for Aviation, Space, and Defense is the new, completely rewritten standard that defines the requirements for Certification Bodies (CBs) to audit your system. This standard creates common auditing methods and document formats (seven appendices) that the CB auditor will use, and can be used by your organization in support of your internal audits, and external audits at your suppliers.

Key differences to the audit requirements and CB audit process include:

• Expanded scope of what and when a Major nonconformity will be written. Major nonconformity situation example, “a nonconformity where the effect is judged to be detrimental to the integrity of the product.”

• A new nonconformity report (NCR) used by the auditor. Example, when nonconformity found requires immediate containment action meaning –“fix now” to contain the nonconforming condition, it will be done. Immediate containment and correction can be reviewed by the audit team during the audit.

• Each audited “Product Realization Process – level of effectiveness” will be recorded on the Process Effectiveness Assessment Report (PEAR). The PEAR identifies 4 effectiveness levels. If the auditor classifies the effectiveness level as a “1 or 2” it will result in a nonconformity being issued.

• No more soft grading or scoring. If the auditor found evidence of non-fulfillment of a requirement, the auditor determines the nonconformity classification (major/minor). The “observations and opportunities for improvement” grade no longer exists for borderline correction actions.

• Audit results will be posted on the Online Aerospace Supplier Information System (OASIS) for approved parties to view (i.e., your customers)! This transparency alone only emphasis the need to seriously examine your current documented system and its conformity and effectiveness.

With the development of the AS9100C and AS9101D standards, you can count on performance-based, process-oriented audit methods and techniques facing your company future. It is now May, and the clock is ticking. Life was good when the auditor would ask for “thus and so” and you could show “thus and so” and get a check mark. Those days are changing fast!

Question:  Has your Certification Body (CB) informed your organization of the new requirements and their future audit process?  We have found it’s a CB communication mixed bag!  Let us know, and do you think the new CB audit process and AS9100C expanded requirements will make a difference in supplier quality? Respond!! :)

Why is My CB Auditor Driving a Cadillac?

Monday, April 4th, 2011

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                   April 2011


This Month
* Why is My CB Auditor Driving a Cadillac?
* AS9100C – July 1, 2011
* ISO/IEC 17021:2011-”Conformity Assessment”
* In the News
* A3 – One Page Report
* Training Courses

Lunch and Learn
May 19, 2011

Information Security Management

Presented by Sustaining Edge Solutions, Inc.

Information and Registration

Quick Links…

Join Our Newsletter List!

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Why is My CB Auditor Driving a Cadillac?

All organizations that are registered to management systems standards such as ISO 9001 or AS9100 have a Certification Body (CB), also known as a Registrar.  The CB is responsible for certifying the company and conducts onsite audits on a semi annual or annual basis.   Many of these CB auditors travel from other states to conduct surveillance or recertification audits.  Client contractual agreements made (usually covering a three-year period) state that  the auditor will use the most “cost effective” methods for travel.

If you’re a quality systems professional with at least twenty years of experience, you remember the past stories about auditors receiving that special treatment, high dollar dinners, special gifts and fancy hotels. I can picture many of you reminiscing right now, remembering those days of gratuitous behavior.  I certainly do. 

Many organizations are also aware that the majority of these auditors are working for the CB’s as a contract auditor- not a full time employee. The majority of CB’s do ensure that their auditors follow specific rules about spending, and they do a good job reviewing receipts and ensuring they comply with specific rules.

However, every so often we still hear about that one bad apple. A client of ours recently had an out-of-state auditor from a global CB arrive in a rental Cadillac (luxury car, average daily rate $110-$160). The auditor was from the East Coast (no prejudice, I was born there) flying to the West. The company he was auditing was a number of miles away from a major city or hotel service. He inquired prior to arriving where the “nicest hotel” could be found. Unknowing to our client, the auditor also stayed at a high price hotel and we can only imagine what the food bill amounted to. Remember, all auditor travel costs are charged to and paid for by the client.

We do know that this occurrence nowadays is a rarity, but be aware that it’s totally acceptable to question any charges that you feel go beyond the conventional.

As a management systems consulting and training firm, we deliver for our clients services necessary for them to reach a level of successful certification. Consulting firms that provide these services are familiar with many CB’s and do provide their clients information about them.

Under the auspice of continuous improvement, we have queried our clients over the years about their CB experiences with regards to expectations and services provided. Problems range from administrative – leaving messages with no return call – to prescriptive auditors – issuing non-conformances for items not required or even identified within the Standard. For example, management review requires signatures of attendees.

Examples of further comments received include:

  • Customer service person does not know how to reach the auditor when client calls.
  • Customer service person is not trained in the basic understanding of the subject standard inquiry or application process.
  • Client e-mails documentation for review to auditor with Gmail account and the e-mail is returned because file is too large.
  • Client receives advanced audit schedule and auditor does not follow-up with a call to confirm audit arrival, or if any questions; one week or even the day prior to the audit.
  • Auditor receives numerous calls from other clients while auditing and makes the client management team wait to begin the closing meeting while conversing with another client.

According to Quality Digest Magazine, the most important registrar customer satisfaction items are:

  1. Was the audit fair?
  2. Was the registrar very responsive?
  3. Was the auditor professional?
  4. Was the auditor technically qualified?
  5. Was the auditor objective?
  6. Did the auditor understand how to apply ISO Standard to your business?
  7. Was the auditor a good communicator?
  8. Was the auditor realistic about applying ISO Standard to your company?
  9. Did the registrar return calls in a timely manner?

According to the Quality Digest Magazine report, most companies are satisfied with their registrar.  However, taking the time and making the effort to select a registrar, and interviewing the auditor is worth the investment as you will reap the benefits for years to come.

AS9100C Aviation, Space and Defense - July 1, 2011

Are you an AS9100B certified company?  The DEADLINE FOR TRANSITIONING to AS9100C begins July 1, 2011.

If your surveillance or re-certification audit is going to take place after July 1, 2011, You MUST have completed the TRANSITION of your Documented Quality Management System or you will find yourself answering a plethora of corrective action requests from your Certification Body.

This new standard is not just for aerospace (i.e. aviation and space). It is also includes “land and sea based defense applications” standard. By moving to AS9100C, suppliers will find it easier to compete in the international marketplace in all three categories: aviation, space and defense.

Key New Definitions Include:

  • Risk: “An undesirable situation or circumstance that has both the likelihood of occurring and a potentially negative outcome.”
  • Special requirements: “Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process.”
  • Critical item: “Those items having significant effect on product realization and the use of products that require specific actions to ensure they are managed.” 

New Requirements Include:

  • Customer Focus/Satisfaction: Measuring product conformity and on-time delivery performance and planning for appropriate actions when planned results are not achieved (clauses 5.2/8.2.1)
  • Project Management: Planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk (Clause 7.1.1)
  • Risk Management: Implementing a risk management process covering: responsibility, criteria, mitigation and acceptance (Clause 7.1.2) 

Looking for assistance? Contact us for all your gap assessment, documentation development, and training requirement needs. Don’t wait, timing your company’s upgrade to AS9100C requires careful planning and execution.

For complete details on all the changes to the standard, download

IAQG 9100:2009 Revision Overview (Revision 3) by the IAQG 9100 Team, May 14, 2010. PDF (630k)

ISO/IEC 17021:2011 – “Conformity Assessment”

Requirements for bodies providing audit and certification of management systems, is intended to increase trust in certificates attesting conformity to management system standards (MSS) such as ISO 9001 (quality management), ISO 14001 (environmental management) and ISO 22000 (food safety management).

Certificates to these and other management system standards are widely used in global markets to establish confidence between business partners and between organizations and their customers, to qualify suppliers in supply chains, and as a requirement to tender for procurement contracts.

The new edition adds new requirements developed in response to market feedback on the use of the first edition. The new requirements provided in ISO/IEC 17021:2011 relate to the competence of the auditors who carry out certification and to the way in which they are managed and deployed. Certification bodies that use the new edition will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner.

ISO/IEC 17021 is also being published in an unofficial marked-up edition highlighting the new and deleted text. The new edition is to be reviewed one year after it has been in use to decide whether any first-edition requirements need modifying to align them further with the new requirements.

ISO and the International Accreditation Forum (IAF)-the association of national accreditation bodies that declare the competence of certification bodies-have agreed on a two-year transition period from the date of publication of ISO/IEC 17021:2011 for certification bodies to bring their operations and processes in line with the requirements of the new edition.

For more information visit ISO News .  ISO/IEC17021:2011 can be purchased at the ISO Store.

In the News

ASQ Creates Healthcare IT Tool

A significant step has been taken in ASQ’s efforts to help implement positive change as health information technology (HIT) moves toward “meaningful use.”  ASQ developed a web-based assessment tool to assist healthcare providers in creating systematic improvements in their care and practice.

With this tool, healthcare providers can assess their current level of HIT maturity as a baseline.  They can then obtain process guidance for evolving their HIT, and measure and report on their progress over time.  The tool supports all categories of providers, from small EP practices to large, multi-location health care systems.

For more information visit ASQ Media Room.

Automotive Webinars from Siemens

Product life-cycle management (PLM) is the process of managing the entire life cycle of a product, from its conception, through design and manufacture, to service and disposal. Siemens PLM Software shares strategies for improving PLM at your company through the following webcasts (no cost, registration required).

April 7:  The Automotive Industry: Making Better Product Development Decisions.

April 21:  Quality in Today’s Automotive Supply Chain. Featuring Presentations by Ford and J.D. Power.   

A3 – One Page Report

What is it:

A3 is a one page structured problem solving tool that forces the problem to be focused on just a one page report, usually a A3 size paper sheet although any size paper can be used. Using this method helps to focus in on the problem and forces one to be concise making the reports easy to read, easy to follow and an ideal format to present results to management.

Why use it: Most problems that arise in organizations are addressed in superficial ways.  Meaning, we work around the problem to accomplish our immediate objective, but do not address the root causes of the problem so as to prevent its recurrence. By not addressing the root cause, we encounter the same problem or same type of problem again and again.

Where to use it: For problems that require in-depth root cause analysis. The A3 Process helps people engage in collaborative, in-depth problem-solving. It drives problem-solvers to address the root causes of problems which surface in day-to-day work routines.

How to use it: A3s are simple to use. An A3 is composed of a sequence of boxes arrayed in a template. Inside the boxes the A3′s “author” attempts, in the following order, to: (1) establish the business context and importance of a specific problem or issue; (2) describe the current conditions of the problem; (3) identify the desired outcome; (4) analyze the situation to establish causality; (5) propose countermeasures; (6) prescribe an action plan for getting it done; and (7) map out the follow-up process

Example of an A3 Report - Customer Complaints.

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 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. Don’t see a course, location, or date that fits your needs?

Contact Us

Phone: 888-572-9642 toll free

This email was sent to wtighe@sustainingedge.com by wtighe@sustainingedge.com |

Sustaining Edge Solutions, Inc. | 8055 N. High Branch Drive | Tucson | AZ | 85743

ISO 27001 ISMS – Annex A Controls

Thursday, March 17th, 2011

ISO 27001 is an international standard which defines the requirements for an Information Security Management System (ISMS). The standard is designed to ensure the selection of adequate and proportionate security controls. The standard is particularly suitable where the protection of information is critical, such as in the finance, health, public and information technology sectors.

The confidentiality, integrity, and availability of vital corporate and customer information are essential to maintain competitive edge, profitability, legal compliance and commercial image.

Annex A of ISO 27001 is probably the most mentioned annex of any management standard. Why is there so much talk about it? Let’s take a look at the security controls and examples.

If you have read Annex A, you have seen that 133 security controls are listed there.  Annex A contains the following clauses:

  • A.5 Security policy
  • A.6 Organization of information security
  • A.7 Asset management
  • A.8 Human resources security
  • A.9 Physical and environmental security
  • A.10 Communications and operations management
  • A.11 Access control
  • A.12 Information systems acquisition, development and maintenance
  • A.13 Information security incident management
  • A.14 Business continuity management
  • A.15 Compliance

These 133 controls which can be seen from the names of the clauses, are not focused solely on IT – they also cover for example physical security, legal protection, human resources management, and organizational issues. You could consider Annex A as a form of a catalogue of security measures to be used during your treatment process – once you identify unacceptable risks in risk assessment, Annex A will help you choose the right control(s) to decrease those risks. And ensure you don’t forget any important control.

Annex A is where ISO 27001 and ISO 27002 come together – the controls in ISO 27002 are named the same as in Annex A of ISO 27001, but the difference is in the level of detail – ISO 27001 gives only a short definition of a control, while ISO 27002 gives detailed guidelines on how to implement the control.

Obstacles

If by now you are thinking that Annex A is a perfect implementation tool for your information security project, don’t get confused – it also has some things that don’t always make good sense. For instance, some controls define almost the same issues, sometimes causing confusion – like A.9.2.6 (Secure disposal or re-use of equipment) and A.10.7.2 (Disposal of media).  Annex A mentions policies and procedures, however it does not require those to be documented. It might seem strange, but only where the word “documented” appears, does the standard require written policies and/or procedures.

Mandatory relationship with ISO 27001

The mandatory clauses 4 to 8 contain the management part of the standard – they prescribe the PDCA cycle (Plan-Do-Check-Act phases), including risk assessment and treatment, documentation control, records control, provision of resources, internal audit, management review, corrective and preventive actions.  The risk assessment & treatment process is the main connection between clauses 4 to 8 and the controls from Annex A – it will help you decide whether individual controls from Annex A are necessary for decreasing risks or not. It means clauses 4 to 8 and Annex A cannot exist one without the other.

The focus on risks and the flexibility to apply security controls according to what your organization considers as appropriate are the real benefits of the an ISO 27001 ISMS – you must be careful to take full advantage of them.

Question: How did/will your organization identify it’s appropriate controls, too many, too little, was it successful,  and what lessons have you learned?

Thanks for reply!

Design of Documentation

Tuesday, March 1st, 2011
Sustaining Edge Solutions, Inc. Newsletter )
Performance Improvement Solutions for Your Business Needs March 2011
In this issue

  • Design of Documentation
  • Creating Customer Value
  • Manufacturing Technology Consumption Up 85% in 2010
  • In The News
  • Training Courses
  • Greetings!

    Welcome to Sustaining Edge Solutions Performance Improvement Newsletter.

    Our newsletters provide information on Business Management Systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others. This includes process auditing techniques and process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

    Have a topic of interest for a 2011 future newsletter? Please let us know.

    Newsletter Sign-up


    Design of Documentation
    Audit

    A critical question that many organizations face when starting a documented operational management system or improving a current one is “How much documentation is required?”

    If you’re a quality improvement veteran, you remember the ISO 9001, 1987 and 1994 versions required a number of ‘documented procedures’ as part of the standard’s 20 requirements. Such an approach did lead to an organization putting effort into creating documentation which doesn’t add much value. This was reduced with the ISO 9001:2000 revision, specifying just 6 documented procedures, although implementers are given the latitude to define more as they see fit.

    We find today in many cases that lessons learned from past year’s experiences is driving a “less is more” when it comes to management systems documentation. If we cannot rely on the ISO standard telling us where and how much documentation to write, what can we base our decision on?

    Do we base it on:

  • our friends documentation given to us to copy from another organization?
  • a canned template software program “ISO kits” found on the Internet?
  • a 2 page Quality Manual (or is that 4 pages) external firms are presenting to you?
  • The answer is in the risk associated with needing to control your business processes. What is the risk of a certain system or process not being controlled? Many factors come into play: personnel experience, competencies, turnover, task complexity, customer and regulatory requirements are just some to be considered.

    The Standard also asks that the organization document to ensure the planning, operation and control of the Management System processes is effective. An embedded guidance note further states that the extent of documentation is going to depend on:

    • the size of organization and type of activities
    • the complexity of processes and their interactions, and
    • the competence of personnel.

    No two management systems are quite the same. Documentation will look different; exclusions are taken for requirements that don’t apply. The number and diversity of procedures, work instructions, and forms, will always vary. The standard’s structure should be a guide for the kinds of documents the organization should consider including within their system. We have seen too many cases where the requirements themselves are only used for guidance (example: verbatim standard language for policies) rather than a sequenced and integrated documentation focus for improving our company competitiveness and profitability.

    Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required. Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

    Interested in extended risk management information and/or developing a custom approach to your documented operational and quality management system?
    Contact us
    .

    Creating Customer Value
    Cust Sat

    It appears from our vantage point and the experts that the manufacturing segment is coming back. Many of us are thinking of what is the best way to shape our company’s economic recovery into the most profitable form possible. The answer is to deliver more than your share of customer value. Keep in mind your competition won’t be standing idle while you innovate and grow during the improving economy. To stay ahead of your competition, you should keep a laser focus on what sets your company apart within your industry.

    You could have a number of marketable differences from your competition. Spending more on R&D? Acquiring capital equipment beyond your current capacities? Is what you’re doing focused on internal needs, or are you implementing your customers ideas?

    1. Conduct face-to-face interviews. Of all the ways to learn about customer needs-telephone, e-mail survey, Internet, nothing comes close in effectiveness to face-to-face customer interviews. Many of us use customer surveys to determine satisfaction levels. We use a Likert Scale method (1-5) based on questions we have determined are important. The reality, though, is that most questions asked are actually customer-reactive, not market-customer proactive interviews. Get out and visit your customers and find out what’s important to them.

    2. Develop a Voice of the Customer mentality. Voice of the Customer studies typically consist of both qualitative and quantitative steps. They are generally conducted at the start or finish of a new product, process, or service design in order to better understand the customer’s wants and needs. That e-mail survey with the 3-5% average return, is it handing you a report of “what the customer wants?” This is a flawed model. Train your people to be VOC experts.

    Best of all, you’ll develop a reputation among customers as “that supplier who really does listen to us.”

    3. Become a quantitative organization. After you conduct good qualitative customer interviews, you can target specific customer ideas you could work on. Which ideas do you target in your product design? Which ideas do you target in your product realization processes? At this point get quantitative. Being quantitative helps you to understand which customer outcomes are most important and least satisfied.

    The key to taking advantage of the recovering economy is in changing the way your company approaches your current and future customers. Start now, with a new approach and you’ll shape a true recovery at your company.

    Manufacturing Technology Consumption Up 85% in 2010

    December U.S. manufacturing technology consumption totaled $446.76 million, according to The Association For Manufacturing Technology (AMT) and the American Machine Tool Distributors’ Association (AMTDA). This total, as reported by companies participating in the U. S. Manufacturing Technology Consumption (USMTC) program, was up 40.9 percent from November and up 104.8 percent when compared with the total of $218.16 million reported for December 2009. With a year-to-date total of more than $3.2 billion, 2010 is up 85.3 percent compared with 2009.

    “For the first time in USMTC history, we experienced four months of consecutive growth following IMTS [the International Manufacturing Technology Show], ending the year on a solid upswing,” says Douglas K. Woods, president of AMT. “2010 orders closed strong, up 85 percent over 2009, and December’s orders were 40.9-percent higher than the previous month. With backlogs firming and quotation levels accelerating, we are very optimistic that the industry will see strong results in 2011.”

    The USMTC report, jointly compiled by the two trade associations representing the production and distribution of manufacturing technology, provides regional and national U.S. consumption data of domestic and imported machine tools and related equipment. Analysis of manufacturing technology consumption provides a reliable leading economic indicator as manufacturing industries invest in capital metalworking equipment to increase capacity and improve productivity.

    U.S. manufacturing technology consumption is also reported on a regional basis for five geographic breakdowns of the United States.

    To view the five geographic areas visit the AMT website.

    In The News

    New ISO/IEC 17021 Raises Level of Management System Certification. The International Organization for Standardization’s (ISO) just-published second edition of ISO/IEC 17021 sets new requirements for auditing management systems and for auditor competence in order to increase the value of management system certification to public and private-sector organizations worldwide. The certification bodies that carry out management system certification (independently of ISO), are being given a two-year period to bring their operations in line with the new edition.

    Certification bodies that use the new edition will be able to ensure competent audit teams, with adequate resources, following a consistent process and reporting audit results in a consistent manner. ISO/IEC 17021:2011 was developed by the ISO Committee on Conformity Assessment and is available from ISO national member institutes.

    Manufacturing for Growth. Four leading associations of small- and medium-sized manufacturing companies announced that they are combining resources to host the inaugural Manufacturing for Growth (MFG) meeting, a gathering of hundreds of manufacturing leaders, March 3-6, 2011, in Chandler, AZ. For more event information read press release.

    U.S. to Celebrate World Standards Day 2011. This year, the U.S. Celebration of World Standards Day-Advancing Safety and Sustainability Standards Worldwide-will recognize the crucial role of standards, codes, and conformity assessment in ensuring the health and safety of people and the environment, today and for future generations. Standardization speeds innovation, facilitates harmonized trade, and boosts consumer and government confidence in products, services, systems, and processes. But above all, standardization provides an adaptive framework for developing the most effective solutions to critical global challenges.

    Since the initial celebration in 1970, World Standards Day is now recognized in nations around the globe. U.S. activities are organized annually by a planning committee consisting of representatives from across the standards and conformity assessment community.

    For more information or to register, please visit ANSI website.

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    Justified Versus Unjustified Complaints

    Monday, February 7th, 2011

    Has your organization decided that it’s a good idea to classify customer complaints according to whether they are “justified?” This occurrence just took place with a client of ours that received a complaint due to using a product beyond its capability and felt it wasn’t necessary to utilize their corrective actions system for identification and resolution.

    This may make some logical sense, but it’s the worst thing a company can do for building customer satisfaction.  Take all customer complaints seriously!

    Craig Cochran recently wrote an article for AIAG Quality Standards which highlights ways to ensure your customers are satisfied with how you handle their complaints.

    If I’m a customer, all my complaints are justified. If you try to tell me that my complaint is “unjustified,” it’s only going to make me angrier than I already am. Once the customer experiences a problem, it becomes the company’s problem. Regardless of the fault of the problem, customer satisfaction has been affected, and action must be taken.

    Consider these scenarios:

    (1) The customer used the product incorrectly, and the performance was adversely affected; the complaint is deemed unjustified. But why did the customer use the product incorrectly? Was the application known prior to the sale? Were the instructions unclear? Is there any chance that the customer was misled, even unintentionally?

    (2) The customer says the product was damaged, but the type of damage described could only have happened at the customer location; the complaint is deemed unjustified. But should the product’s packaging be improved? Should you provide guidelines for proper handling?

    In each of these cases, an argument could be made that the problem was the customer’s fault. Taking this position, though, does nothing to enhance customer satisfaction, nor does it further the organization’s long-term objectives. Savvy organizations will look for ways to error-proof their products with customers. Of course, some problems are truly the customer’s fault. When these situations occur, the organization might not be obligated to replace the product, provide credits or refunds, or accept returns. In all cases, however, customers must be treated in a diplomatic, cordial manner.

    Reporting Back to Your Customer. Customers want to know what action has been taken. After all, the customers had a negative experience related to something they spent their hard-earned money on. They even took the time to tell the organization about it. Now they’re curious. What are you going to do about it? If your organization is interested in turning the negative experience into a positive one, someone must take the time to report back to the customer. The communication should include three key elements:

    1. The results of the investigation into the problem;
    2. The action taken; and
    3. A statement of thanks for reporting the problem.

    Reporting action back to the customer closes the loop on the issue. It also lets the customer know that you take his or her feedback seriously and are committed to making improvements. In some cases, it can determine whether your organization remains a supplier to this customer.

    The following steps represent implementation guidelines for an effective complaint system:

    • Determine what information is needed in order to investigate and take action on customer complaints. Build your complaint form/CAR around this information.
    • Establish contact methods for customer complaints. Remember that voice contact is preferred by most customers.
    • Appoint someone as the complaint administrator. This person will be responsible for the entire process.
    • When a complaint occurs, use structured problem-solving techniques to address them in a systematic manner.

    Complaint information should be one of the most widely disseminated topics in an organization. Trend data should be posted on every departmental bulletin board, along with the details of relevant complaints involving that department. Complaints, their root causes and eventual corrective action must be made topics of any regular communication that takes place throughout the organization.

    Does your organization neglect unjustified complaints?  Give us an example and we will provide a direct response to your input with suggestions for improvement.