Competent calibration personnel: training records and successful performance indicators. Use of traceable standards: certificates that contain traceability numbers and limits of uncertainty. Provisions for remedial action when an instrument is, for example, found to be out of calibration : a strong and inclusive nonconforming corrective action form used as a tool for quality review board decision making.
The QSR requires that measuring equipment be calibrated according to written procedures that include specific directions and limits for accuracy and precision. Precision has no unit of measure and only indicates a relative degree of repeatability, i.
Repeatability is the result of resolution and stability. Bias is a measure of how closely the mean value in a series of replicate measurements approaches the true value.
The mean value is that number attained by dividing the sum of the individual values in a series of measurements by the total number of individual values. And last but not least, accuracy is the measure of an instrument's capability to approach a true or absolute value. Accuracy is also a function of precision and bias. Because different medical devices have different accuracy requirements, each manufacturer should decide the level of accuracy required for each measurement and provide equipment to achieve that accuracy.
Remedial action includes recalibration and evaluation of the impact of out-of-tolerance measurements on the device design or process validation parameters or data; on the quality of existing components, in-process, or finished devices; and appropriate corrective action plans that include the impact of risk-based decision making made by a cross-functional team of qualified individuals, e.
A sobering scenario could be that the frequency of calibration is once every 12 months, and the yearly check for calibration indicates an out-of-calibration situation for a measuring device being used to release, at least in part, finished goods. Such a scenario could mean that sometime during the past year the instrument went out of calibration, and now every device or component that was measured using this instrument is suspect for possibly not meeting the accuracy and precision requirements aligned with the acceptance criteria in the DMR.
Preventive action for this type of situation could entail performing frequent, documented, and interim calibration checks to preclude letting too much time pass between checks. Device manufacturers include on each device a decal, label, or tag that contains information about the calibration of each piece of equipment. At a minimum, these documents include the equipment identification, the calibration date, the name of the individual performing the calibration check, and the date the next calibration is due to be performed.
If performed by a supplier, who must be qualified using the purchasing controls element of the Quality System, the calibration certificate must be on the company's letterhead, which includes the company's logo and all accreditation information and registrar and accreditation numbers aligned with the scope of same.
There should also be an area for referencing the calibration check history and an obvious place to denote any out-of-calibration result.
The inspection, measuring, and test equipment calibration process must be well thought out, proceduralized as appropriate, and commensurate with the complexity of the QMS. Depending upon the astuteness of the individual conducting the inspection and the criticality of the medical device or QMS, this is a favorite place for inspectors to spend a lot of time during FDA inspections.
He has more than 39 years of experience in quality assurance, operations, process architecture, training, and regulatory affairs. Recipient s will receive an email with a link to 'The Calibration Process: Inspection, Measuring, and Test Equipment Control' and will not need an account to access the content. Sign In or Create an Account. User Tools. Sign In. Skip Nav Destination Article Navigation. Close mobile search navigation Article navigation.
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Need an account? Click here to sign up. Download Free PDF. Quality control, Quality assurance, systems and application. Muhammad Hashim. Mohamed Salah. A short summary of this paper. Download Download PDF. Translate PDF. Faculty of engineering. Structural engineering program Quality control basics and systems. And in order to do that, a new science called Quality control was introduced.
And in order to manage quality effectively, it should be understood clearly. Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. Quality assurance QA refers to the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. In this publication you will find two main tracks of discussion, the quality control procedures in construction field, and also you will find its procedures in project management field in scale of planning, execution, and control.
Also you will find a brief about types of sources of specifications. Also the methodology of six sigma which is mainly used to optimize the quality of production. A standard is a detailed statement of requirements. The primary types of technical standards are: A standard specification is an explicit set of requirements for an item, material, component, system or service.
Create an account Institutional Access:. Metrology has grown significantly, especially in semiconductor manufacturing, and such growth necessitates increased expertise. Until now, this field has never had a book written from the perspective of an engineer in a modern IC manufacturing and development environment.
The topics in this Tutorial Text range from metrology at its most basic level to future predictions and challenges, including measurement methods, industrial applications, fundamentals of traditional measurement system characterization and calibration, semiconductor-specific applications, optical metrology measurement techniques, charged particle measurement techniques, x-ray and in situ metrology, hybrid metrology, and mask making.
The accompanying online supplemental materials includes example spreadsheets of measurement uncertainty analysis—specifically, precision, matching, and relative accuracy. Buy this book on SPIE. This will count as one of your downloads. You will have access to both the presentation and article if available. This content is available for download via your institution's subscription.
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