Author Archives: Ask The Experts

Batch measurements

Question I have a concentration measurement for an ingredient in a bulk final product. This measurement is close to one of the spec limits. Given each measurement has an inherent error (or range), how do I calculate the probability this … Continue reading

Posted in Measuring | Tagged , | Leave a comment

Nonconformance versus CAPA Requests

Question: I need advice on the use of Nonconformance versus Corrective Action/Preventive Action (CAPA) Requests. I understand and have tried to communicate the low risk and high risk definitions to staff with some understanding. In reporting nonconformance’s some evolve into … Continue reading

Posted in CAPA, Other | Leave a comment

Employee Qualification Audit

Question I am a Quality Assurance GxP Auditor and I am being told that I cannot perform employee qualification audit.  I am being told that CV/resumes, job descriptions, and training records are confidential and my viewing them would violate an … Continue reading

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ISO 17025 calibration requirements

Question: I was recently in a discussion with someone about ISO 17025 calibration requirements. It was my understanding that all equipment associated with the tests within our ISO 17025 scope needed to have an uncertainty value reported with each calibration. … Continue reading

Posted in ISO 17025 - Testing and Calibration Laboratories, Metrology

AS9100 Audit

Question: I have recently started work at a company that is registered to AS9100. My previous employer was registered to ISO 9001 and I was trained as an internal auditor. What additional training is required to audit to AS9100? (other … Continue reading

Posted in AS9100 - Aerospace, Auditing | Tagged , ,

Food Safety and Sampling

Question I like to know how to sample a finished product or ingredient so that the sample to be tested is representative of the product as a whole so it will increase confidence in subsequent test result. This is needed … Continue reading

Posted in FDA regulated industries, Sampling | Tagged , ,

TS16949 Certification Requirements

Question My company is a fabless semiconductor company and we provide ASIC design and custom IP services, and manage our customers’ supply chain from foundry to assembly and test, and drop ship. We are gearing ourselves up to supply IC … Continue reading

Posted in TS16949 - Automobiles