Manufacturing quality glossary.

CAPA (corrective and preventive action)

The process of fixing the cause of a quality problem and preventing it, or a similar one, from happening again. A corrective action responds to a problem that has occurred. A preventive action removes the risk of one that has not. A good CAPA record names an owner, a due date and the evidence that the fix worked.

Non-conformance

Any product, process or record that does not meet a specified requirement. A batch outside its fill-weight range, a skipped check or a missing signature are all non-conformances. Serious or repeated ones usually trigger a CAPA.

Root cause analysis

A structured search for the underlying reason a problem happened, rather than its visible symptom. Common methods are the five whys and the fishbone diagram. If the same problem keeps returning, the root cause was probably not found.

Customer complaint

A report from a customer or consumer that a product did not meet expectations, such as a foreign object, a damaged pack or a wrong taste. Complaints are usually tracked as a rate per volume sold, so plants of different sizes can be compared fairly.

Market return

Product sent back from distributors, retailers or customers after it has left the plant. Returns show problems that in-plant checks missed, so they are an important measure of how well quality control works in practice.

Quality scorecard

A summary of the agreed quality measures for each plant or line, shown against targets over time. Scorecards are most useful when every site calculates each measure the same way, which is often the hardest part.

Control chart

A time-ordered chart of a process measurement, such as fill weight, with upper and lower limits calculated from the process itself. Points inside the limits are normal variation. A point outside them, or a run drifting in one direction, signals that something has changed and needs a look.

First pass yield

The share of units that pass every quality check the first time, without rework or repair. If 950 of 1,000 units pass first time, first pass yield is 95 percent. It shows how much hidden effort goes into fixing products before they ship.

OEE (overall equipment effectiveness)

A measure of how well a line uses its planned production time. It multiplies availability (time running), performance (speed against the ideal) and quality (good units against total units). A line at 90 percent availability, 90 percent performance and 95 percent quality has an OEE of about 77 percent.

Audit finding

A documented gap between what an audit expected and what it observed. Findings are usually graded by severity, and each one should lead to an action with an owner and a deadline, often managed as a CAPA.

See how QualityPulse tracks scorecards, complaints and CAPA