Archive for March, 2009

When conducting internal audits, planning is key

Tuesday, March 31st, 2009

As consultants and trainers, we are often asked about the internal audit process and the amount of time that should be given to internal auditors to complete their audit. Obviously, there are many factors that go into the calculation of time that should be spent performing an audit. Complexity of process, number of employees, number of facilities and document review all have a big factor in audit time management.

One area that should always be given a significant amount of audit time is document review. Too often, we see companies that provide to their audit team members pre-packaged materials such as audit checklists or a few standard questions that become both predictable and repetitive, and end up providing no real value to the process.

Internal auditors should be given plenty of time to review the appropriate standard, process flow diagrams, procedures, work instructions, key metrics/measureables and previous audit data to ensure that they have a thorough understanding of what should be happening before they conduct the audit. The end result will be an effective audit that can provide real benefits and continual improvement opportunities.

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Prevention of Pollution – More than just a term in ISO 14001!

Monday, March 30th, 2009

Having an environmental management system in place requires a company to make a key commitment to prevention of pollution. This requirement can be found in ISO 14001 section 4.2b and is sometimes treated as a simple verbiage request to be included into the environmental policy.

In order to meet the intent of this requirement, an organization must be able to clearly demonstrate how this is actually done. It cannot be just a simple phrase documented in a policy. A clear connection must be made as to how pollution will be prevented and since it is part of the policy, it should be understood throughout the organization.

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The position of AIAG on OHSAS 18001 – Is it politics once again?

Monday, March 23rd, 2009

In a recent official position statement from the Automotive Industry Action Group (AIAG), there appears to be a rather unenthusiastic regard for the implementation of OHSAS 18001 throughout the automotive supply chain. The statement, dated February 2009, presents the AIAG position quite clearly:

“The Automotive Industry Action Group Health, Safety, and Environmental Steering Committee believes firmly believes that the use of formal management systems are necessary for the effective management of health safety and environmental programs, and thus fully endorse ANSI Z10 and International Organization of Standardization (ISO) programs such as ISO’s 14001 environmental management standard.

We believe that management of safety and health as part of an existing management system is necessary to achieve overall HSE excellence. We believe that the management of health & safety under the BSI OHSAS 18001 program is good practice, but less efficient in terms of both cost and time, as compared to managing health & safety as part of an existing management system. This is fundamental to making safety and health integrated within existing management systems and part of the day-to-day business activities.

In conclusion, AIAG:
• believes that the International Labor Organization (ILO); OHSMS Guidelines of 2001 provide a sound basis for any nation or organization to develop an effective safety and health management system
• is concerned when entities such as BSI issue ’standards’ utilizing a numbering sequence that at the very least confuses many into believing the standard was issued by ISO, and
• will work to integrate health & safety programs within a comprehensive and effective management system, but will not specifically mandate OHSAS 18001 certification.”

Yet again, when it comes to having a so-called “standard”, politics has raised its ugly head one more time. What do you think? Log in and let us know!

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Is AS9100 the right standard for our organization? What about AS9110 and AS9120?

Friday, March 20th, 2009

In order to diversify product lines and reach out to new markets, many manufacturing companies are venturing into the aerospace and defense industries. To make this transition successful, an organization should consider revising their ISO 9001 quality management system to incorporate the requirements of AS9100, AS9110 or AS9120. Some companies have difficulty knowing exactly which standard is right for their product and/or service. There are key differences between the three, and each has a distinct application.

AS9100 – This is for organizations that design, develop, and/or produce aviation, space and defense products or organizations providing post-delivery support.

AS9110 – Any organization whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products is a candidate for this set of requirements.

AS9120 – Designed for organizations that procure parts, materials, and assemblies and resell products to a customer in the aviation, space and defense industries, including organizations that split these commodities into smaller quantities.

If this is still confusing or you find that your company is in a “grey” area between these choices, contact G3 Solutions today!

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Combining management systems has pros and cons – beware the pitfalls!

Wednesday, March 18th, 2009

For most companies, combining the requirements of many ISO standards has its advantages. Common overlap of requirements for most popular quality and environmental standards (ISO 9001, ISO/TS 16949, AS9100, ISO 13485, ISO 14001, etc.) include document and record control, corrective and preventive action, management review, internal audits and many others. This allows for simple and effective methods to document many of those “shall” statements that each standard commands.

What often can get missed in combined systems are the standard specific demands and subtle nuances that are required for a particular standard. For example, continual improvement is the focus for ISO 9001 but maintaining the effectiveness of the system is the goal of ISO 13485. Management review inputs for ISO/TS 16949 differ from ISO 14001. Environmental policy requirements differ from the quality policy requirements of AS9100. These are just a few simple examples – the full list of technical differences can be quite lengthy.

Because of the potential pitfalls of missing some requirements, it is essential that combined systems go through a full document review at least annually to ensure complete conformance to each particular standard. Ideally, this review should be done above and beyond the internal audits that are conducted throughout the year. The result will payoff in system efficiency and effectiveness.

If your combined system has your head spinning, contact the experts at G3 Solutions. Visit our full website at today!

Moving from ISO 9001 to ISO 13485? There’s more to it than a few “add-ons”!

Friday, March 13th, 2009

An ISO 9001 quality management system is a great start for a company looking to get into the medical device industry, but it may be only the beginning. A transition to ISO 13485 could be required based on the type of product to be manufactured. It is easy to make the mistake of thinking that a transition to ISO 13485 will be an easy task since a quality system foundation is in place. When implementing the additional requirements, it is very important to be aware of (and focus on) the key differences between the two standards.

ISO 13485:2003 is a standard specifically for the medical device industry. It contains a majority of the requirements of ISO 9001, but the differences require substantial changes to an existing ISO 9001 quality management system. The standard, which was revised in 2003, supersedes earlier european and international documents such as EN 46001:1997, EN 46002:1997, ISO 13485:1996 and ISO 13488:1996.

One of the key differences between the standards is that ISO 9001 requires an organization to demonstrate continual improvement. There is a heavy emphasis on this throughout ISO 9001 which can make the transition to ISO 13485 a little difficult. In the ISO 13485 standard, the emphasis is on maintaining the effectiveness of the quality system.

Another area of focus is the promotion and awareness of regulatory requirements, such as United States Quality System Regulation (QSR) 21 CFR 820. Depending on where the device may be sold and used around the globe, additional requirements from other nations or international bodies must be examined.

Other differences include many additional procedures that must be documented and implemented. Risk analysis must be considered throughout product realization (ISO 14971 provides guidance on this subject). Product safety, sterility, inspection and traceability are emphasized along with various additional requirements for documentation, product validation and verification of the effectiveness of corrective and preventive actions.

If you need help with the transition process, contact G3 Solutions today. Visit our full website at today!

ISO/TS 16949 registered? Maintain those customer specific requirements!

Thursday, March 12th, 2009

If your organization is registered to ISO/TS 16949, make sure that you periodically update and maintain your data library with the latest and greatest customer specific requirements. These can be found at the following website:

The site includes the latest and greatest automotive OEM Customer-Specific Requirements for:

  • Chrysler LLC
  • FIAT Group Automobiles SpA
  • Ford Motor Company
  • General Motors
  • IAOB Clarification – Customer Special Status Conditions

    You will also find information on ISO/TS 16949:2002 Sanctioned Interpretations and FAQs. Much of the information that can be found throughout the site is available in English, German, French and Italian.

  • For more information, visit our full website at today!

    Automotive supplier self-assessments CQI 9, CQI 11 & CQI 12 for heat treating, plating, and coating

    Wednesday, March 11th, 2009

    Many smaller plating, heat treating and special coating companies have asked us about the requests they get from their automotive customers regarding self assessments. These are the CQI publications that are published by the Automotive Industry Action Group (AIAG). These are part of GM, Ford, and Chrysler ISO/TS 16949 customer-specific requirements and they apply to heat treating, plating, and coating suppliers. These are process self-assessments and the documents can be purchased through the website.

    The CQIs for these processes are:
    CQI-9 – AIAG Assessment Manual for Heating Treating
    CQI-11 – AIAG Assessment Manual for Plating Processes
    CQI-12 – AIAG Assessment manual for Coating Processes

    If you need assistance with any of these assessments, contact the experts at G3 Solutions. Visit our full website at today!

    ISO 9001 – Avoid the applicability misconception!

    Tuesday, March 10th, 2009

    Many companies that are involved in the service industry are often under the assumption that ISO 9001 will not be of benefit since most of the standard applies to manufacturing. In pervious versions of the standard (specifically 1994 and 1987), it was much easier to make that argument. Businesses that are involved in the service and retail industries typically do not have as much exposure to standards that have their roots in manufacturing, such as ISO 9001, ISO/TS 16949 or AS9100. Therefore, it often feels that the implementation of ISO 9001 will be a tremendous headache rather than a valued initiative to help run the business.

    Nothing could be further from reality. In fact, actual and tangible dollar-measured value from ISO 9001 implementatation can often be seen sooner in a service type organization than in a manufacturing environment where it may take several operational cycle times to reap a similar benefit.

    In the ISO 9001 standard, there are two areas which help to counter the applicability misconception. First, Section 1.2 – Application states “All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.” Additionally, Section 3 – Terms and definitions adds the clarification “Throughout the text of this International Standard, wherever the term ‘product’ occurs, it can also mean ‘service’.”

    ISO 9001 has been successfully implemented by all types of businesses including schools, law firms, real estate agencies, hospitals, farms, investment offices, and many others. It can work for your company. Let us show you how – contact G3 Solutions today! Visit our full website at today!

    AS9100 Rev C is here – how will it affect you?

    Monday, March 9th, 2009

    AS9100 rev. C was released this quarter and contains new requirements in addition to the changes introduced in ISO 9001:2008. There will be a 30 month transition from AS9100 rev. B, but the start date for the proposed transition time has not yet been established by the International Aerospace Quality Group (IAQG). The reason for this gap is that supporting standards and sanctioned auditor training are still being developed. Therefore, registration to AS9100 rev. C is currently unavailable at this time.

    More info will be posted on AS9100C in the coming weeks. Stayed tuned or ask a question now by logging in. Visit our full website at today!