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Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 14001, and others. This includes process improvement methods as Six Sigma, lean enterprise and other topics of interest to our readers.
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Are you confused about the process approach to auditing? Let us begin with one definition of a process: a set of interrelated or interacting activities which transform inputs into outputs.
As a result, a process audit is an objective evaluation of a process to determine the extent to which the process is meeting its requirements. Using the process definition, the process audit includes an examination of process inputs, activities, outputs, and outcomes.
However, a process is part of a larger set of processes (a system) that define an operational and quality management system. Therefore, a process audit must also consider the linkage and interaction of a process with these other processes.
A process approach methodology helps illustrate the process elements to be audited.
Want to move your auditing program from boring to brilliant and learn more on how to use this approach to developing effective audit checklists and sustained results?
Many organizations have a difficult time or are unclear as to these types of documents.
Let’s clarify: A document of external origin is explicitly one that originates from outside the organization and contains specific information that the organization needs to fulfill customer requirements, maintain their quality management system (QMS) or comply with statutes, for example.
These documents have their own category because they’re handled differently from those created by the organization. Because of their origins, they carry restrictions. An organization may use them, but it cannot change them, because the authorization for revisions, approvals, withdrawals, etc., resides with those who authored the document. Examples of documents of external origin include:
Examples of documents of external origin:
The typical problem that arises with this category is because they aren’t created by the organization, individuals don’t perceive these documents as part of the QMS documentation. If it defines requirements you need to make your organization run or bring product to market, it’s a document that must be controlled.
Did you know that the ISO 9001:2000 operational and quality system standard has spread across industry and service – and that implementing the standard results in bottom-line benefits?
ISO 10014:2006 provides guidelines for realizing financial and economic benefits from the application of the ISO 9000 quality management principles.
ISO 10014:2006 is directed to top management of an organization and complements ISO 9004 for performance improvements. It provides examples of achievable benefits and identifies management methods and tools that are available to assist with the achievement of those benefits.
See how our client realized the financial benefits of ISO 9001:2000 application. “Moved from a tier 4 (customer audit failure) to tier 1 supplier and a signed 10 year contract.”
Quality Digest asked its readers:
“Is your Company Reluctant to use a Quality Tool?”
Top 5 responses:
What Quality Tool(s) is your company reluctant to use? Send us an e-mail with your input and we will publish the results anonymously in our November issue.
Preview our October events and training opportunities