Monthly Archives: May 2012

ISO 17025; Rounding Measurements

Q: At the lab I work for, certified to ISO 17025:2005 General requirements for the competence of testing and calibration laboratories, the documented quality assurance system does not allow the rounding of numbers. For example, the requirement for the weight … Continue reading

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Exploring ACM and BPM

Q: Can someone explain how to use Adaptive Case Management (ACM) and how to incorporate it in a process diagram? A: First, let’s take a look at Business Process Management (BPM), which approaches the problem of improving an organization’s work … Continue reading

Posted in Process Management | Tagged , , ,

Guidance on Z1.4 Levels

Q: My company is using ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes, and we need some clarification on the levels and the sampling plans. We are specifically looking at Acceptable Quality Limits (AQLs) 1.5, 2.5, 4.0, and … Continue reading

Posted in Z1.4 & Z1.9 - Sampling | Tagged , , , | 3 Comments

OHSAS 18001 and ISO 9001 Work Environment Requirements

Q: We had the opportunity to get the certification for OHSAS 18001:2007 Occupational health and safety management systems — Requirements. While looking at the clause interaction between ISO 9001 Quality management systems–Requirements and OHSAS 18001 given at the end of the … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged , , , | 1 Comment

ASQ re-certification and in-house training requirements

Q: In our corporate audit department, we have a number of individuals that are ASQ certified.  What standards do we need to adhere to in order to provide in-house training that qualifies for ASQ re-certification units? A: You asked ASQ … Continue reading

Posted in Professional Development | Tagged , , | 1 Comment

Operational Qualification (OQ) Challenges; Cpk vs. AQL

Q: We’re completing a validation of a plastic extrusion process, which has raised a few questions with me. This validation exercise encompasses the installation qualification (IQ), operational qualification (OQ), and the performance qualification (PQ). The IQ is self explanatory, but the … Continue reading

Posted in Z1.4 & Z1.9 - Sampling | Tagged , , ,

Six Sigma Standard

Q: How are the new ISO 13053-1:2011 Quantitative methods in process improvement – Six Sigma – Part 1: DMAIC methodology, and ISO 13053-2:2011 Quantitative methods in process improvement – Six Sigma – Part 2: Tools and techniques standards to be … Continue reading

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Delta triangle

Q: When revising drawings to include the delta triangle in the title block, does the drawing index sheet also contain the triangle in the title block? A: The term “delta” refers to a triangle placed on the drawing for reference. … Continue reading

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ISO 9001 management representative and reporting structure

Q: Please define the preferred method of meeting the requirements of the management representative in regards to clause 5.5.2.b in ISO 9001:2008 Quality management systems–Requirements. My organization has reorganized, and I find the role of management representative somewhat detached. I work for a … Continue reading

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ISO 9001 Clause 7.4.1, Supplier Control

Q: My interpretation of  ISO 9001:2008 Quality management systems–Requirements regarding supplier control as addressed in clause 7.4.1 Purchasing process is that suppliers who would require evaluation, selection and registry, would be those who supply products (or services) which affect subsequent product realization, … Continue reading

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