Category: Quality control vs 1 download


Quality control vs 1 download

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Project Management is the art and science of managing projects with emphasis on quality, cost and time.

quality control vs 1 download

The operative word here is meeting the requirements and hence anything that is done that is not conforming to the requirements is said to be deviating from the norm of quality. In the subsequent paragraphs, I look at the distinction between quality management and the processes of quality control. Quality management is the practice of drawing up plans that determine the standards that need to apply to the project, determining who would be involved in managing quality and their specific duties, meetings to determine if the project is conforming to the quality specifications laid out in the quality management plan and laying out the metrics that are used to measure quality.

Quality control, on the other hand, is the set of processes that measure the metrics of quality by assessing the specific project results against standards. Quality control processes are done during project monitoring and controlling functions whereas quality management is done during the initiating and planning phase PMBOK, Hence, quality control is the subset of quality management and is the final phase of the project management cycle.

Quality management is all encompassing and consist of laying down standards against which the project quality metrics are defined and need to be measured against. Quality management takes into account the lower level details of how the output of the project is to be tracked and measured. Quality control is the process of ensuring that the quality metrics are met. Hence, while quality management is the process of planning and managing the requirements of the project from the perspective of quality, quality control is the process of measuring the level of output and the quality of the output and typically consists of measuring the output against the quality metrics that were decided upon in the quality management plan.

The reason that quality management and quality control are used interchangeably is due to the perception that quality control encompasses the planning aspect as well. This is certainly true in organizations that do not have a separate quality department and quality planning and quality control is the domain of the project management processes. In organizations that have separate quality departments and where there is a well thought out quality plan, quality management and quality control are separate and are handled by different people.

In conclusion, quality management typically produces as its deliverables a comprehensive quality management plan that includes the quality control aspect of it.

Quality control in this case is handled by a different set of people who do the tracking and measuring of metrics in a dedicated manner. Typically, the process of quality management includes the representatives from the quality department and the quality control processes are the reverse with the quality department handling the tracking of metrics and reporting to the project management team.

Quality control is an independent audit of the quality of deliverables and is necessary for the sign off of the project. View All Articles. Similar Articles Under - Project Management. To Know more, click on About Us. The use of this material is free for learning and education purpose.

Please reference authorship of content used, including link s to ManagementStudyGuide. Project Management - Introduction What is a Project?

What is Project Management?The specific objective will be spelled out prior to the inspection. As a minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation each two years as part of the statutory inspection obligation.

These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. He ruled that an OOS result identified as a laboratory error by a failure investigation or an outlier test. The court provided explicit limitations on the use of outlier tests and these are discussed in a later segment of this document. The court ruled on the use of retesting which is covered in a later segment of this document.

OOS results fall into three categories:. An OOS laboratory result can be overcome invalidated when laboratory error has been documented.

However, non-process and process related errors resulting from operators making mistakes, equipment other than laboratory equipment malfunctions, or a manufacturing process that is fundamentally deficient, such as an improper mixing time, represent product failures.

Examine the results of investigations using the guidance in section 5 above and evaluate the decision to release, retest, or rework products. A very important ruling in one recent court decision sets forth a procedure to govern the retesting program. This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmaceutical laboratory, but should not be considered as law, regulation or binding legal precedent.

The court ruled that a firm should have a predetermined testing procedure and it should consider a point at which testing ends and the product is evaluated. If results are not satisfactory, the product is rejected. Firms cannot rely on resampling. The court ordered the recall of one batch of product after having concluded that a successful resample result alone cannot invalidate an initial OOS result.

Averaging can be a rational and valid approach when the object under consideration is total product assay, but as a general rule this practice should be avoided. The court ruled that the firm must recall a batch that was released for content uniformity on the basis of averaged test results. This phenomenon is particularly troubling if testing generates both OOS and passing individual results which when averaged are within specification. Here, relying on the average figure without examining and explaining the individual OOS results is highly misleading and unacceptable.

In the case of microbiological turbidimetric and plate assays an average is preferred by the USP. In this case, it is good practice to include OOS results in the average unless an outlier test microbiological assays suggests the OOS is an anomaly. The laboratory serves a vital function in blend testing which is necessary to increase the likelihood of detecting inferior batches.

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Blend uniformity testing cannot be waived in favor of total reliance on finished product testing because finished product testing is limited. The review of microbiological data on applicable dosage forms is best performed by the microbiologist analyst. Data that should be reviewed include preservative effectiveness testing, bioburden data, and product specific microbiological testing and methods.

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For drug substance labs evaluate methods validation and raw data for sterility, endotoxin testing, environmental monitoring, and filter and filtration validation. Also, evaluate the methods used to test and establish bioburdens. Refer to the Microbiological Inspection Guide for additional information concerning the inspection of microbiological laboratories. Review personal analytical notebooks kept by the analysts in the laboratory and compare them with the worksheets and general lab notebooks and records.

Be prepared to examine all records and worksheets for accuracy and authenticity and to verify that raw data are retained to support the conclusions found in laboratory results.

Review laboratory logs for the sequence of analysis versus the sequence of manufacturing dates. Test dates should correspond to the dates when the sample should have been in the laboratory. If there is a computer data base, determine the protocols for making changes to the data.

There should be an audit trail for changes to data. Ascertain that suitable standards are being used i. Check for the reuse of stock solutions without assuring their stability.Sign Up.

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About RF. Become an Affiliate. Promo Code.Quality Control QC may be defined as a system that is used to maintain a desired level of quality in a product or service.

It is a systematic control of various factors that affect the quality of the product. It depends on materials, tools, machines, type of labor, working conditions etc.

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QC is a broad term, it involves inspection at particular stage but mere inspection does not mean QC. As opposed to inspection, in quality control activity emphasis is placed on the quality future production.

Quality control aims at prevention of defects at the source, relies on effective feedback system and corrective action procedure. Quality control uses inspection as a valuable tool. Types of Quality Control QC is not a function of any single department or a person. It is the primary responsibility of any supervisor to turn out work of acceptable quality. Quality control can be divided into three main sub-areas, those are:.

Steps in Quality Control Following are the steps in quality control process:. Objectives of Quality Control Following are the objectives of quality control:. The broad areas of application of quality control are incoming material control, process control and product control.

Seven Tools for Quality Control To make rational decisions using data obtained on the product, or process, or from the consumer, organizations use certain graphical tools.

These methods help us learn about the characteristics of a process, its operating state of affairs and the kind of output we may expect from it.

Graphical methods are easy to understand and provide comprehensive information; they are a viable tool for the analysis of product and process data.

These tools are effect on quality improvement. The seven quality control tools are:. Example: A Pareto chart of reasons for poor quality. Thus, this is the problem that the manufacturing unit should address first. Example: The plots advertising expenditure against company sales and indicates a strong positive relationship between the two variables. As the level of advertising expenditure increases sales tend to increase.

Often the mean of the data is indicated on the histogram. A bar chart is a series of bare representing the frequency of occurrence of data characteristics, the bar height indicates the number of times a particular quality characteristic was observed.

Characteristics such as sample average, sample range and sample proportion of non-conforming units are plotted. The centre line on a control chart represents the average value of characteristics being plotted.

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These limits are constructed so that if the process is operating under a stable system of chance causes, the problem of an observation falling outside these limits is quite small. The following figure shows a generalized representation of a control chart. Control chart shows the performance of a process from two points of view. Firstthey show a snapshot of the process at the moment the data are collected.Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising.

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quality control vs 1 download

Learn more. Published on Oct 25, Quality control and inspection in pharma. SlideShare Explore Search You. Submit Search. Home Explore.

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Upcoming SlideShare. Like this presentation? Why not share! Embed Size px. Start on. Show related SlideShares at end. WordPress Shortcode. Samiksha Sawant Follow. Published in: Technology. Full Name Comment goes here. Are you sure you want to Yes No. An eBook reader can be a software application for use on a computer such as Microsoft's free Reader application, or a book-sized computer THE is used solely as a reading device such as Nuvomedia's Rocket eBook.With the NGC Quality Control mobile app for Windows tablets, Quality Inspectors can access mobile reports, factory production orders and associated information required for inspection, audits and compliance.

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quality control vs 1 download

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Quality Management vs Quality Control

Published by New Generation Computing Inc. All Rights Reserved. Approximate size The major elements of the quality management, are quality assurance and quality control. Quality Controlon the other hand, ensures that the product will match the requisite standard.

While the former stresses on preventing from defects, the latter concentrates on identifying the defects. In this regard quality management is a system which ensures that the quality in the process, product or services provided are according to the standard. Every organisation works for continual improvement in the customer satisfaction, which can be done with the help of increasing the quality.

Basis for Comparison Quality Assurance Quality Control Meaning Quality Assurance is the process which guarantees that the preferred level of quality is fulfilled in the product or service at each phase of the process.

Quality Control is a technique which ensures that the product quality is, as per the set standards. Here the objective is to find out the cause of non-conformance and take remedial steps to eliminate it, so as to increase the quality level and also assure one. Many transnational companies have a department, which is specifically dedicated to quality assurance.

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Moreover, it helps the entity to gain a competing position in the market. It saves the time and cost of the organisation. A set of planned operational techniques and procedures, which are required to meet the quality criteria of a product is known as Quality Control.

In quality control, there is a need to discover controls for an activity, in terms of process, work in progress stage inspection, performance recording for feedback.

quality control vs 1 download

In this process, all the factors which are employed in the development of the product are taken into consideration for review. Once the product is completed, it has to go through from the testing, to disclose the deficiency in the product. After testing, the anomalies in the product is recorded and reported to the management who decides whether to accept or reject the product.

First of all, the entity should set the quality standards. Then the facts are collected and reported to the management of the company which takes remedial actions for improving the quality of the product.

Every entity wants to gain maximum customer satisfaction. Nowadays people are becoming quality sensitive, and that is why they do not want to compromise with the product which is inferior regarding quality. Your email address will not be published. Save my name, email, and website in this browser for the next time I comment. Key Differences Between Quality Assurance and Quality Control The following are the major differences between quality assurance and quality control.

The set of activities which takes into confidence that the quality of the process by which the product is developed is up to the mark is known as Quality Assurance. The set of procedures which guarantees the fitness of the product is known as Quality Control. Quality Assurance keeps focusing on process, whereas the product is the main focus of Quality control.

Quality Assurance protects the product from defects while Quality Control detects and sort out the defects in the product.

Quality Assurance vs Quality Control[1]

In quality assurance, quality is created during the designing phase. On the contrary, in quality control, quality is created at the control stage. Quality Assurance is a staff function, which is not in the case of Quality Control.

Difference between quality assurance and quality control - Quality Assurance vs Quality Control

Quality Assurance is a preventive action, but Quality Control is a corrective measure. Comments Excellent! Leave a Reply Cancel reply Your email address will not be published. Quality Assurance is the process which guarantees that the preferred level of quality is fulfilled in the product or service at each phase of the process.