Seven Basic Tools That Can Improve Quality

Manufacturers can choose from a variety of tools to improve their quality processes. The trick is knowing which tools to use for each situation and increasing the sophistication of the tools in the repertoire.
By: Ashweni Sahni

FDA's quality system regulation (QSR) and ISO 9001 encourage device manufacturers to incorporate continuous quality improvement processes as a part of their quality systems. While companies have adopted different methods to control design and manufacturing outcomes, the intent is always the same: quality improvement.
Hitoshi Kume, a recipient of the 1989 Deming Prize for use of quality principles, defines problems as "undesirable results of a job." Quality …ver más…

Figure 2. A basic production process flowchart displays several paths a part can travel from the time it hits the receiving dock to final shipping.

Flowcharts can be simple, such as the one featured in Figure 2, or they can be made up of numerous boxes, symbols, and if/then directional steps. In more complex versions, flowcharts indicate the process steps in the appropriate sequence, the conditions in those steps, and the related constraints by using elements such as arrows, yes/no choices, or if/then statements.
CHECK SHEETS
Check sheets help organize data by category. They show how many times each particular value occurs, and their information is increasingly helpful as more data are collected. More than 50 observations should be available to be charted for this tool to be really useful. Check sheets minimize clerical work since the operator merely adds a mark to the tally on the prepared sheet rather than writing out a figure (Figure 3). By showing the frequency of a particular defect (e.g., in a molded part) and how often it occurs in a specific location, check sheets help operators spot problems. The check sheet example shows a list of molded part defects on a production line covering a week's time. One can easily see where to set priorities based on results shown on this check sheet. Assuming the production flow is the same on each day, the part with