Embed Doc
Copy Link
Readcast
Collections

CommentGo Back

Download

MODULE-8QUALITY MANAGEMENT

IIConcept of Specification:Conformance to specifications:-

The easiest definition of quality is conformance to specifications. Thedefinition focuses on the manufacturing process and motivates the qualitymanager to develop mechanisms for ensuring that the specifications are metwith. Every component of a manufactured product has specifications. Aslong as the specifications are met, it is assumed that quality objectives aremet with. Such a definition is very crucial for a manufacturing firm. Theworker on the shop floor requires unambiguous instructions to maintainquality. Just as we have specification for products, specification for servicesof arriving guests should be done in 3 min± 30 seconds. Or in a bank, thetime for servicing a customer at the teller’s counter could be specified andthe process monitored and controlled to meet this specification.

Batch Results, Testing Frequency and Deleting of a Testfrom the Specification:

If synthetic processes are known or suspected to lead to the presenceof metal residues due to the use of a specific metal catalyst or metalreagent, element specific assays should be undertaken to determine theactual amount of these metal residues, particularly during the developmentof the synthetic process.If the synthetic or manufacturing processes have shown to result in theremoval of a potential metal residue, routine testing of that metal residuemay be replaced by non-routine (skip) testing. A metal residue can beconsidered adequately removed if, in 6 consecutive pilot scale batches or 3

consecutive industrial scale batches less than 30 % of the appropriateconcentration limit was found. A change from routine to non-routine testingdoes not mean that the test may also be deleted from the specification.Only for class 3 metals, the test may be deleted from the relevantspecification if the drug product manufacturer sufficiently demonstrates thatthe adequate removal of the metal residue from the pharmaceuticalsubstance or the drug product is guaranteed.

Definition:-

Boundaries or parametersthatdefine acceptableperformancefor aprocess expressed as atargetlimit as well as an upper and lower limit.

Draw the specification limits on the distribution:-

Draw vertical lines on the distribution to represent the lower and upper specification limits.In the example, the lower specification limit (LSL) is 0 minutes (on time) and the upper specification limit (USL) is 14 minutes. Estimate where the two lines should be located inreference to the overall average and the tails of the curve. Label each specification with itsabbreviation and value. The example completed through this step follows.The diagram shows whether any portion of the curve is beyond the specifications. In theexample, some of the distribution is beyond the upper specification. If the overall averageof the distribution is outside the specification, refer to “Variation – Capability analysiswhere the overall average is outside the specification” later in this section.

STATISTICAL QUALITY CONTROL:

Statistical quality control begins with the assumptionthat no two products manufactured by a process, are absolutelyidentical. There will be some attributes of the items due to people,material, machines and equipment, and work methods. Therefore, inthe design quality, the desired vale of a variable is not expressed inabsolute values but in terms of a range, this is the conformance quality.The causes of variation in the quality of products or services fromstandards can be divided in to categories.

1.Chance or common cause of variation:

The variation which results from many minor randomcauses and produces slight difference in product characteristic. Forexample, slight changes in temperature, pressure, metal hardness,and similar factors interact randomly to produce slight variation inproduct quality. This type of variation is permissible, and if notidentified, either due to lack of knowledge or identification, would beuneconomic. They are inherent to a process and cannot be reducedor eliminated without modification in the process itself. When thevariability present in a process is confined to chance variation, theprocess is said to be in a state of statistical control.

2.Assignable or special causes of variation:

The variation that may be due to special non-randomcauses. Such variations can be the result of several factors such as asudden change or abnormal variation in the character or input rawmaterial, improper machine setting, broken or worn parts,mechanical faults in plant, or adjustment of a machine by an