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Popular Posts & Pages
- ISO documentation practices; ISO standard difference between record and document
- ISO 9001 procedure vs. process
- Root cause analysis samples
- Using the 10:1 ratio rule and the 4:1 ratio rule
- Defining Qualification, Verification, and Validation
- ISO 9001 clause 7.4.1, supplier control
- ISO 9001 clause 7.5.1 work instructions
- Z1.4: selecting the sample size
- ISO 9001 SOPs for HR and IT Departments
- ISO 9001 quality manual
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Tag Archives: bud salsbury
Use of correction fluid to modify ISO 9001 QMS documents
Q: During a recent audit, I discovered that my supplier was using correction fluid and scrubbing out the training records of its employees with no control over the documents. I said that would be a major finding, but they state … Continue reading
Dock to Stock
Q: I have been tasked with implementing a dock to stock policy. Does an expert have any advice or information to share towards forming a dock to stock policy? A: To begin, here is a brief definition of dock to … Continue reading
ISO 9001 Certification to Meet Customer Requirements
Q: My company is a small manufacturer that makes one product that I designed and engineered. We have a contract to produce the part for a much larger company. The larger company wants us to become certified to ISO 9001:2008 … Continue reading
ISO 9001, Control of Monitoring and Measuring Equipment
Q: In ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6, there is a requirement which states: “When used in the monitoring and measurement of specified measurements, the ability of computer software to satisfy the intended application shall be confirmed.” … Continue reading
Modifying Programmable Logic Controllers (PLCs)
Q: I am seeking a standard to monitor, control and communicate existing Programmable Logic Controller (PLC) program changes. We have a team of 15 electricians. They have access to various machinery and their PLCs. They can make modifications to majority … Continue reading
ISO 9001 7.6a Calibration and Traceability
Q: ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6a states, in part: “Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable … Continue reading
Accuracy of Measurement Equipment
Q: I work for an incoming quality assurance department. In our recent audits, the auditor claimed that high precision machines such as the Coordinate Measuring Machines (CMM) and touchless measurement system should have higher Gage Repeatability and Reproducibility (GR&R) values … Continue reading
Visual Fill Requirements
Q: I work for a consumer products company where more than 60% of our products have a visual fill requirement. This means, aside from meeting label claim, we must ensure the fill level meets a visual level. What is the … Continue reading
Posted in Metrology
Tagged bud salsbury, manufacturing, measurement, Statistical Process Control (SPC), visual fill
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Defining Qualification, Verification, and Validation
Q: I understand the hierarchy, but I would be hard pressed, if asked, to give a clear definition of the terms: qualification, verification, and validation. Can one of the experts help explain these terms? Thank you. A: This is a … Continue reading
Posted in ISO 9001 - Quality Management Systems
Tagged bud salsbury, definitions, iso 9000:2005, ISO 9001
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Delta triangle
Q: When revising drawings to include the delta triangle in the title block, does the drawing index sheet also contain the triangle in the title block? A: The term “delta” refers to a triangle placed on the drawing for reference. … Continue reading
