Tag Archives: Jim Werner

Zero Acceptance Number Sampling Plans and the FDA

Question There has been some debate over using the MIL-STD-1916 acceptance sampling plan over the ANSI/ASQ Z1.4-2003 (R2013) sampling plans.  The opinion is that the ANSI/ASQ Z1.4-2003 (R2013) is outdated and no longer an acceptable method of determining a qualification … Continue reading

Posted in FDA regulated industries, Other, Z1.4 & Z1.9 - Sampling | Tagged ,

Approved Supplier List 17025 or 9001?

Question Every once and while our company will need to find a rare or hard to find item on the web. Due to the rarity of the item we sometimes need to look at sites that are not a typical … Continue reading

Posted in ISO 17025 - Testing and Calibration Laboratories, ISO 9001 - Quality Management Systems, Other | Tagged

Z1.4 Sample Size

Question I am trying to determine the sampling size using my ANSI/ASQ Z1.4 table and I wanted to get some clarification. If I am using Table II A and my Sample Size Code letter is D, what would be my … Continue reading

Posted in Other, Sampling, Z1.4 & Z1.9 - Sampling | Tagged , , , | 1 Comment

Audit Timeline

Question What is the ASQ recommended time frame between an auditee receiving a final audit plan and the audit commencing at the auditee’s site? Answers From Charlie Cianfrani: ASQ does not have a recommendation! From George Hummel: This is not … Continue reading

Posted in Auditing, Other | Tagged , , , ,

Is Certification Revocable?

Question If a company is ISO 9001: 2015 certified, is it revocable? Answers From Jim Werner: A company can indeed have its certification revoked.  Being certified means the company has established a qualify management system that meets the requirements of ISO9001:2015.  … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , , , , ,

ISO Certification and Suppliers

Question I work for a small family company that purchases items and potentially processes or packages them into heat protection materials. One of my existing customers is asking for ISO certification for some materials that I will sell to them. … Continue reading

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

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

Posted in Cost of Quality, ISO 9001 - Quality Management Systems, Quality Culture | Tagged ,