Sustain with Layered Process Audits

Sustaining Edge Solutions, Inc. Newsletter )
Performance Improvement Solutions for Your Business Needs August 2010

In this issue

  • Sustain with Layered Process Audits
  • Measuring Customer Satisfaction
  • TL 9000 Latest Changes
  • In The News
  • Exemption from FDA Inspections
  • Training Courses
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    Sustain with Layered Process Audits


    Layered Process Audits (LPAs) have become quite popular and in many cases mandatory for suppliers in the automotive industry. The effects of properly conducted layered process audits can be substantially positive. Because layered process auditing reduces the number of operator errors they have spread to industries outside of automotive.

    So, what is a Layered Process Audit? They are a system of audits performed by multiple layers of supervision and management to monitor key process operations, characteristics and verify process conformance on an ongoing basis. LPAs are an excellent tool for minimizing variation in your processes and error-proofing systems.

    A layered process audit is an ongoing chain of simple verification checks that ensure a defined process is
    followed correctly. It is a powerful management tool that can improve safety, quality and cost savings by
    amplifying problem solving systems and making continuous improvement almost routine. Through observation,
    evaluation and conversations on the manufacturing floor, these checks ensure key work steps are performed
    properly. LPA interactions are also an excellent way for managers to show respect for frontline workers.

    Let’s identify some essential components of a Layered Process Audit Program

    • Management must take ownership of the LPA process
    • Auditors Must identify and ask the right questions
    • All management layers, top to bottom, must participate
    • Immediate containment of nonconformances found
    • Continual improvement must be included in the process
    • Shift, daily, weekly scheduled and performed audits

    Survey data shows excessive process input variation is the single largest cause manufacturing quality problem. This often results from a failure to reinforce process corrective actions. Or, can be attributed to a failure to follow the required steps and methods. Layered process audits reduce this variation along the manufacturing line up through the ranks of plant management. This helps ensure that operators are following the process steps.

    Keep in mind that a layered process audit system must have a documented audit structure (just as quality system standards require) that schedules auditors at pre-determined levels and frequency of audits. These audits focus on process operations and error-proofing, not on finished product inspections.

    One of the most common questions we hear with 5S (and Lean for that matter) is how do you sustain? Sustaining 5S can be very difficult without the use of a formal process. A layered audit program can be used successfully to ensure that your company’s 5S efforts continue.

    Layered Audits are tied directly into the fifth S – Sustain – and they are the means used in Lean Improvement Systems to avoid “backsliding” into old habits, creating sustainable culture change. Layered Process Audits require that multiple operational levels within an organization review the same key operational controls to ensure sustainability. Simply stated, they are an ongoing chain of simple verification checks, which through observation, evaluation and conversations on the line; assure that the process is being properly performed.

    The key is everyone is an “auditor”. This starts with the operator personally checking their process for compliance. Then the first line supervisor checks key processes, where feedback is immediate as are any agreed-upon corrective actions. The next level supervisor would then make the same checks, and so forth.

    The essential part of the Layered Audit is the creation of a standard checklist You must identify and ask the right questions on the checklist. This is where Standard work at all levels of the organization is critical. Layered Audits is a formalization of “management by walking the Gemba”.

    Layered Process Audits can be compared to a pilot’s preflight checklist. Is my operation ready for take-off? Am I confident that everything is in place to build and ship conforming product to my customer? When the day goes smoothly, management and operators can use the time saved to work on improvements. The beauty of LPAs is that managers often can learn much about the manufacturing processes from operators, and operators can learn much about what is important to customers from managers.

    Let’s review some of the proven benefits of LPAs.

    • Reduces variation in processes
    • Improves & maintains operational discipline
    • Reduces scrap and eliminates waste
    • Improves overall quality and reduces costs
    • Stops problems from becoming nonconformances

    Contact us for more information and training about LPAs, 5S, and a Free Layered Audit Checklist.

    Measuring Customer Satisfaction

    Cust Sat

    The International Organization for Standardization (ISO) has developed a new technical specification, ISO/TS 10004:2010, which provides guidance to organizations in establishing effective processes for monitoring and measuring customer satisfaction.

    Customer satisfaction is one of the key elements for the success of an organization, whether it’s in public or private sector. The information obtained from monitoring and measuring customer satisfaction can help identify opportunities for improvement of the organization’s strategies, products, processes, and characteristics that are valued by customers, and which serve the organization’s objectives. Such improvements can strengthen customer confidence and result in commercial and other benefits.

    ISO/TS 10004-“Quality management-Customer satisfaction-Guidelines for monitoring and measuring” deals with:

    • Concept of customer satisfaction and guiding principles
    • Framework for monitoring and measuring customer satisfaction
    • Planning for monitoring and measuring customer satisfaction
    • Processes for monitoring and measuring customer satisfaction
    • Maintenance and improvement of monitoring and measurement processes

    This technical specification is intended for use by organizations regardless of type, size, or product provided. Its focus is on customers external to the organization. It is not intended for certification or contractual purposes, nor is it intended to alter any rights or obligations under applicable statutory or regulatory requirements.

    ISO/TS 10004 belongs to the ISO 10000 series of standards on customer satisfaction. ISO 10001:2007, ISO 10002:2004, and ISO 10003:2007 provide guidance on codes of conduct, complaints handling, and dispute resolution. ISO/TS10004 complements these standards by providing guidance on monitoring and measuring customer satisfaction. Collectively, their guidance can assist the organization to take actions that can help to sustain or enhance customer satisfaction.

    By providing guidance on monitoring and measuring customer satisfaction, ISO/TS 10004 supports the objectives, and is compatible with, ISO 9001:2008-“Quality management systems-Requirements,” and with ISO 9004:2009-“Managing for the sustained success of an organization-A quality management approach.”

    ISO/TS 10004 can be purchased through the ISO Store.

    TL 9000 Latest Changes

    TL 9000 is the globally recognized quality management system standard for the telecommunications industry. It was developed by the QuEST Forum-a consortium of international telecommunications service providers and suppliers. It includes all of the requirements of ISO 9001, supplemented with industry-specific requirements for hardware, software, and services. It is unique in that it also includes a comprehensive set of product- and service-related reliability and quality measurements that can be used to evaluate the effectiveness of an organization’s quality management system.

    TL 9000 requirements were revised in 2009 with Release 5.0 of the Requirements Handbook. These requirements must be implemented by TL 9000-registered companies for assessment in certification body audits conducted after November 10, 2010. The latest revisions to the TL 9000 measurements has been published.

    Key revisions involved in Measurements Handbook Release 4.5 include:

    • A new network support service outage measurement, which will be applicable for outages attributed to installation, engineering, field maintenance, and network operations centers. This replaces the EIO measurement.
    • Changes to counting rules and counting exclusions for the problem report (NPR and FRT) measurements, on-time delivery measurements, system outages, return rates, and defective software fix measurements.
    • Changes to the concept of customer base and measurements sources that require measurement reporting for all customers, so as to enable an organization to gather the required data from its own internal monitoring systems.
    • Reduced problem report resolution threshold timeframes for service provider product categories.
    • Clarification of the treatment of firmware for software measurement reporting purposes.

    Purchase Measurements Handbook 4.5 at the Quest Forum Website.

    In The News

    Policymakers Must Address Manufacturing Challenges-Now. As U.S. manufacturers struggle to recover from the recession, a new report finds that manufacturing fuels economic prosperity but requires pro-growth policies to create jobs and remain globally competitive. The report, released by the National Association of Manufacturers (NAM) and the Council of Manufacturing Associations (CMA), was written by economists Joel Popkin and Kathryn Kobe, noted experts on issues related to prices, wages, productivity and technology.

    Manufacturing industries perform almost two-thirds of the private sector research and development (R&D), driving America’s leading edge in innovation and break-through technologies. But manufacturers in America face serious challenges that threaten to undermine their contributions to U.S. prosperity.”

    The new report, “Manufacturing Resurgence – A Must for U.S. Prosperity,” is available online.

    4th Edition of MSA. The Measurement Systems Analysis (MSA) Reference Manual, 4th Edition is now available. It was jointly developed by Chrysler Group LLC, Ford Motor Company, and General Motors Company to provide guidance to their automotive suppliers.

    The purpose of the document is to present guidelines for assessing the quality of a measurement system. The manual is not intended to be a compendium of analyses for all measurement systems. Its primary focus is measurement systems where the readings can be replicated on each part. Customer approval is required for measurement systems analysis methods not covered in this manual.

    You can begin using the 4th Edition of the MSA reference manual now. The document can be ordered at the AIAG web site.

    19th Annual ASQ Service Quality Conference Sept 13-14, 2010, Las Vegas, NV.

    Exemption from FDA Inspections

    Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485.

    Manufacturers must submit the audit results to the FDA voluntarily. From the audit results, the FDA determines whether to inspect that establishment for one year.

    In a draft guidance issued on May 20, 2010 the “Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program,” the FDA describes how its Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research are implementing section 228 of the Food and Drug Administration Amendments Act of 2007.

    According to provision F of section 228, “For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice.” It further specifies that if the owner or operator of an establishment chooses to submit audit reports, the owner/operator “shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

    Audit reports must provide “a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices.” If the FDA determines there is minimal probability that the establishment will produce nonconforming and/or defective finished devices based on “the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved,” then it will use the audit results in determining whether to remove that establishment from its routine work plan for one year. However, inspections conducted “for cause” will not be affected.

    This draft guidance can be downloaded from the FDA website.

    Contact Us for all your ISO 13485:2003 Medical Devices training and implementation needs.

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