Author Archives: Ask The Experts

Six Sigma Statistical Meaning

Question I need to understand the statement, “Adding a 1.5 sigma shift in the mean results …….” I’m used to the bell curve and + /- three sigma. How does the extra +/- three sigma fit in, and what is … Continue reading

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ISO 9001 Certification and Moving

Question  My small company is considering ISO certification because some of our customers are asking for it. My concern is that if we continue growing at our current rate, we may be moving in 12-18 months. Is ISO certification site … Continue reading

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Creating a Culture of Quality

Question I was introduced to Quality Management (& ISO 9001:2015) recently. The culture of the organization that I am concerned with has not embraced Quality Management, and it is often the subject of outright and unprofessional antagonism. I seek direction … Continue reading

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Acceptance Sampling Inspection

Question We have an Acceptance sampling inspection in place where we use the ANSI/ASQ Z1.4 – 2013 standard under Normal Inspection, using General Inspection Level II to drive our samples size and accept, reject criteria. We do not uses switching … Continue reading

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Charging Lab Fees

Question We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and … Continue reading

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Internal Audits, Third Party Audit

Question Shouldn’t a company audit its own processes and procedures to ensure compliance before a third-party audit is scheduled? Answer Thanks for contacting ASQ’s Ask the Experts Program.  In response to your inquiry, yes, it would be a good idea … Continue reading

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Unsigned Audit Report

Question Is it acceptable for an auditor to submit an UNSIGNED audit report in Word version? I’m QA director at a pharmaceutical CRO. We were recently audited by one of our clients. They refuse to provide a signed audit report … Continue reading

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