Author Archives: Ask The Experts

Internal Audits

Question If 2nd or 3rd party performs full system audit on my QMS, can it be used as to satisfy requirement for Internal Audit of that year? Answer Thank you for sending your question to ASQ’s Ask The Experts program. … Continue reading

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Sample Size

Question If we have a lot size of 27 and we are using a normal inspection level II with an AQL of 2.5. What is the sample size? Answer Assuming an attribute is being measured, we use ANSI ASQ Z1.4.2013 … Continue reading

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Risk Based Thinking in ISO FDIS 9001:2015

Question In 0.3.3 Clause of the standard – it is said that “A positive deviation of the risk can provide an opportunity, but not all positive effects of risk result in opportunities.”  Can you please clarify this statement? Answer Thanks … Continue reading

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Internal Audits

Question Can the Management Representative be part of the internal auditor team? Answer Thank you for contacting ASQ’s Ask the Experts program.  Concerning your question, ISO 9001:2008, clause 8.2.2, only prohibits persons from auditing their own work.  So provided that … Continue reading

Posted in Auditing, ISO 19011 - Auditing | Tagged | 1 Comment

Approved Supplier List

Question I would like to know how supplier status in the Approved Supplier List (ASL) should be managed so that there is complete traceabilty.  For instance, a vendor status is changed from approved to not approved in the ASL for … Continue reading

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Auditor’s Responsibilities

Question Is it an auditor’s responsibility to seek the “root cause” while conducting an audit? Answer An auditor should not seek the root cause for an audit finding. An auditor’s responsibility is to verify compliance with a requirement (e.g. ISO … Continue reading

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TS16949, ISO9001

Question Our company designs and manufactures commercial and automotive semiconductor products. We used to maintain dual certification (ISO9001 and TS16949) for all of our manufacturing and assembly locations, but recently dropped the ISO9001 certification.  My questions are as follows: 1) … Continue reading

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