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    Beyond Compliance Design of a Quality System: Tools and Templates for Integrating Auditing Perspectives
    Beyond Compliance Design of a Quality System: Tools and Templates for Integrating Auditing Perspectives
    Beyond Compliance Design of a Quality System: Tools and Templates for Integrating Auditing Perspectives
    Ebook144 pages1 hour

    Beyond Compliance Design of a Quality System: Tools and Templates for Integrating Auditing Perspectives

    By Janet Bautista Smith and Robert Alvarez

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    About this ebook

    Next Level Results for Your QMS
    You don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight.
    Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and templates you can customize for your organization and begin using immediately, including:
    Implementing layered metrics to align with the auditor's perspective
    Employing DMAIC analysis to process customer complaints
    Discovering hidden factories through a Process Grid Walk
    Addressing common pitfalls of documentation systems with lean solutions
    Achieving operational compliance and excellence within processes
    Determining QMS, customer, and auditor satisfaction
    Fostering synergy among the QMS, customer, and auditor perspectives
    Engaging management review for critical support
    LanguageEnglish
    PublisherASQ Quality Press
    Release dateMar 1, 2020
    ISBN9781951058241
    Beyond Compliance Design of a Quality System: Tools and Templates for Integrating Auditing Perspectives
    Author

    Janet Bautista Smith

    Janet Bautista Smith has 38 years of quality management experience in various manufacturing environments, including the medical device, automotive, and military and logistics industries.

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      Book preview

      Beyond Compliance Design of a Quality System - Janet Bautista Smith

      Creation of Quality Management Systems (QMS) Reflecting the Two Sides of Auditing: The QMS Designer’s and the External Auditor’s Perspectives

      The design of a perfect quality management system (QMS) is one of the quality goals and the crowning glory of a QMS designer (typically the function of a quality team). A QMS designer can create a quality management program purportedly worth a million dollars and in full compliance with the designer’s own requirements, and, yet, if the QMS is not aligned with the expectations of the stakeholders—management, customers, business partners, etc.—then it is not worth a cent.

      The million-dollar question, then, is, What are some indicators that will help show the QMS design’s successful alignment with the stakeholders’ requirements and expectations?

      The validation of the QMS by internal and external compliance audits is one of the most visible and dynamic ways of achieving that stamp of certification and implementation of the industry’s best practices. Audit validation of the QMS as the path to implementing best practices is the focus of this book. What follows is dedicated to sharing lessons learned in the deployment of time-tested QMS systems from both the QMS designer’s and the auditors’ experiences. This holistic perspective benefits both beginners and advanced quality professionals.

      External audit certification of a QMS model (i.e., quality certification under an industry standard from ISO, FDA, a military organization, environmental agencies, etc.) offers added validation of a system’s effec­tiveness and increases a company’s market competitiveness. There are many variations of the QMS model, but which one has the highest rate of success? The optimal QMS model for a situation depends on many variables, such as company vision, resource availability, market competition, regulatory requirements, etc.

      This chapter offers samples and guidelines in the selection of the QMS elements that are easy to create and have been validated through years of implementation and audit verifications.

      Figure 1.1 is a pictorial model of a QMS created and implemented by QMS designer and author Janet Smith, during her more than 35 years of quality management employments in various industries, including medical device and automotive manufacturing, design environments, and logistics. A company’s goals and strategies may change, depending on management’s direction, but the core flow remains the same. This core design is time tested, with a proven record of effectiveness through audit validations by the FDA, military, ISO, TS (automotive standard), AS (aerospace standard), C-TPAT (Customs Trade Partnership Against Terrorism, U.S. Customs and Border Protection), and other auditors.

      Robert Alvarez, an external auditor associated with a registrar for more than 25 years, provided review during the development of this project. Alvarez’s feedback to QMS designers, including Janet Smith, during his quality certification audits has been a valuable tool in the continuing improve­ment of their QMS’s effectiveness.

      The model in Figure 1.1 is just one of many QMS design possibilities based on the vision of a company’s stakeholders. Following are some guide­lines for starting your own customized QMS design:

      Step 1: Define the company’s vision or management’s strategic plan.

      How do you get this information? Asking your manager, management, or chief executive officer (CEO) is one direct approach; however, employing the method that makes the most sense for your company’s hierarchy may be a better approach. In the example, the company’s goals were defined as:

      • Increase global value

      • Deliver excellence

      • Reduce costs, and minimize waste and defects

      Step 2: Once the vision or company goals are identified, list the potential strategies to support the goals.

      Imagine these goals as freight to be loaded onto the express train as cargo. The train wheels are the supporting initiatives that will carry the cargo to the destination. The chosen strategies for the example, the company strategies that will help it reach its goals (destination), are:

      • Voice of the customer (VOC), such as customer feedback

      • Process control

      • Continuous improvement

      • Self-evaluation

      • Robust QMS

      • Management review

      Step 3: Identify the initiatives to support the strategies.

      Once strategies to support the vision are selected, as shown previously, then the company can start identifying the feasible initiatives to support the strategies. Some examples are shown in Table 1.1.

      Lessons Learned

      Following are some basic pillars for creating a sustainable QMS and measuring its effectiveness:

      Secure management commitment. Buy-in needs to be secured, struc­tured, visible to the workforce, and demonstrate verifiable evidence of imple­­men­­tation at all levels of the system; otherwise, the QMS will not be supported and will eventually collapse.

      One technique of securing this piece at the outset is to create a document outlining management’s required involvement in the program. Having the document is not enough; it must be read, understood, and approved by the designated management (e.g., CEO or vice-president level). The documented information can be a simple flowchart showing the needed elements of management’s interaction, with things such as participation in management review events, escalation point on roadblocks, etc. In this way, their participation will be well structured and visible to the workforce. An approved management assignee may be considered depending on the company’s hierarchy structure and various restrictions on management (e.g., travel schedules, alternate locations, etc.).

      It has been proven through actual observation that, in some cases, human nature can be resistant to change! As part of unlocking this resistance, it helps to have an official written procedure backed by management, in addition to a clear explanation of the benefits that will be gained if change is embraced. Cultivation of a quality culture that is compatible with the stakeholders’ vision and requirements is key in the success of the company’s goals supported by the workforce’s commitment. The quality culture nurtured by an organization is unique to the organization’s needs and must be developed and supported by the organization’s leadership—it is not one size fits all. There is much published information on this topic that may be used as reference for developing or gathering information on quality culture, such as the following:

      • Apple Inc.’s organizational culture is a key factor in the continuing success of the business. A company’s organizational or corporate culture establishes and maintains the business philosophy, values, beliefs, and related behaviors among employees. For example, the company’s cultural traits are aligned with the drive for innovation, which is a major factor that determines business competitiveness… (Meyer

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