Author Archives: Ask The Experts

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

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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

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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

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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

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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

Lead Auditor Qualification

Question My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management system…” Our question … Continue reading

Posted in Auditing, ISO 19011 - Auditing, ISO 9001 - Quality Management Systems | 1 Comment

ISO 9001:2008 Quality Manager Titles

Question: Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such … Continue reading

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Recommended AQLs for Packaging Material in the Pharmaceutical Industry

Question: Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry? Thank you Response: Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to … Continue reading

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ISO 9001:2008

QUESTION ISO 9001:2008 states in 8.2.4 Monitoring and measurement of product:  “Evidence of conformity with the acceptance criteria shall be maintained.” When our plan identifies periodic inspections, variable or attribute, are performed, how can we show evidence without recording the … Continue reading

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